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生物醫藥品受託製造的全球市場:各提供服務類型，各製造的生物製藥類型，所使用的表現系統類別，各產業規模，不同企業規模，主要各地區 - 產業趨勢與預測(2022年～2035年)

市場調查報告書

商品編碼

1130891

生物醫藥品受託製造的全球市場:各提供服務類型，各製造的生物製藥類型，所使用的表現系統類別，各產業規模，不同企業規模，主要各地區 - 產業趨勢與預測(2022年～2035年)

Biopharmaceutical Contract Manufacturing Market by Type of Service Offered, Type of Biologic Manufactured, Type of Expression System Used, Scale of Operation, Company Size, and Key Geographical Regions : Industry Trends and Global Forecasts, 2022 - 2035

出版日期: 2023年08月01日 | 出版商:

Roots Analysis | 英文 799 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄圖表

本報告提供生物醫藥品受託製造市場相關調查分析，提供目前的市場情勢與今後十年間的未來可能性，加上主要促進因素和趨勢，主要企業等相關之最新資訊。

章概要
主要的前提條件與手法
醫藥品受託製造設施整體形勢
地區的生產能力分析:北美的生物醫藥品受託製造設施
地區的生產能力分析:歐洲的生物醫藥品受託製造設施
地區的生產能力分析:亞太地區·其他地區的生物醫藥品受託製造設施

第6章北美的生物醫藥品受託製造

章概要
美國的生物醫藥品受託製造的法規Scenario
北美的主要的生物醫藥品CMO

第7章歐洲的生物醫藥品受託製造

章概要
歐洲的生物醫藥品受託製造:法規Scenario
歐洲的主要的生物醫藥品CMO

第8章亞太地區·其他地區的生物醫藥品受託製造

章概要
中國的生物醫藥品受託製造
中國的主要生物醫藥品CMO
印度的生物醫藥品受託製造
印度的主要的生物醫藥品CMO
日本的生物醫藥品受託製造
日本的主要的生物醫藥品CMO
韓國的生物醫藥品受託製造
韓國的主要的生物醫藥品CMO
澳洲的生物醫藥品受託製造
澳洲的主要的生物醫藥品CMO

第9章最適合的生物醫藥品部門

章概要
雙特異性抗體
抗體藥物複合體(ADC)
細胞治療
基因治療
質體DNA

第10章案例研究:生物相似藥的外包

章概要
生物相似藥:簡介
生物相似藥:開發階段
生物相似藥的授權相關法規必要條件
生物相似藥的開發與製造外包需求
對全球受託製造市場的生物相似藥的影響
生物相似藥受託製造服務供應商
生物相似藥製造業務的外包相關的課題

第11章案例研究:低分子·高分子的醫藥品/治療的比較

章概要
低分子·高分子醫藥品/治療

第12章案例研究:公司內部製造

章概要
公司內部製造
生物醫藥品產業的外包趨勢
已批准生物製藥所使用的製造方法
恰當策略的選擇:公司內部製造 vs. 外包

第13章製造 vs. 購買的決策架構

第14章大型製藥公司的主張

第15章夥伴關係和合作

第16章 M&A

第17章最近的擴張

第18章最近的發展

第19章生產能力分析

第20章需求分析

第21章生物醫藥品受託製造組織的總持有成本

第22章市場預測與機會分析

章概要
主要的前提條件與手法
全球生物醫藥品受託製造市場(2022年～2035年)
生物醫藥品受託製造市場 - 分析:各提供服務類型
生物醫藥品受託製造市場 - 分析:製造的生物製藥類別
生物醫藥品受託製造市場 - 分析:所使用的表現系統類別
生物醫藥品受託製造市場 - 分析:各產業規模
生物醫藥品受託製造市場 - 分析:不同企業規模(2022年～2035年)
生物醫藥品受託製造市場 - 分析:各地區

第23章案例研究:虛擬製藥企業

第24章 SWOT分析

第25章生物醫藥品CMO市場未來

第26章調查分析

第27章結論

第28章採訪記錄

第29章附錄I:表格形式的資料

第30章附錄II:企業/組織的清單

簡介目錄圖表

Product Code: RA100379

INTRODUCTION

Over the last few decades, the development landscape of small molecule drugs has been significantly impacted by various biotechnology breakthroughs. Further, with the advent of novel technologies, biologics have made a significant impact in the pharmaceutical domain, delivering ground-breaking treatment for a myriad of disease indications, including immunological, oncological and rare disorders. In this context, it is worth highlighting those 14 biopharmaceutical products (including cell therapies, gene therapies, monoclonal antibodies and recombinant proteins) were approved in the US alone, in 2021. Further, promising results from ongoing clinical research initiatives have encouraged various government and private firms to make significant investments in this domain. For instance, in 2021, a sum of over USD 70 billion was invested in the cell and gene therapy domain. However, manufacturing of biologics is fraught with various challenges. Some of the key concerns of contemporary innovators include rate of attrition of pipeline drugs / therapies, prolonged development timelines, current facility limitations, regulatory and compliance-related issues, and inconsistencies related to quality attributes of the final product. Therefore, therapy developers are actively exploring avenues that enable them to overcome the existing challenges. Amongst other alternatives, outsourcing has emerged as a lucrative option for biologic drug developers.

Currently, a significant number of players engaged in the biopharmaceutical domain prefer to outsource various operations to contract service providers. In fact, currently over 275 companies claim to offer contract manufacturing services for biologic therapeutics, in compliance with the regulatory standards. It is also worth highlighting that biopharmaceutical contract manufacturers are actively trying to consolidate their presence in this field by entering into strategic alliances in order to meet the indubitably rising demand for biologics. For this purpose, substantial expansions, and mergers and acquisitions have been reported in this market, as service providers strive to become one-stop-shops, to cater to the diverse needs of their clientele. With outsourcing being increasingly accepted as a viable and beneficial business model within this field, we anticipate the biopharmaceutical contract manufacturing market to grow at a commendable pace in the coming years.

SCOPE OF THE REPORT

The "Biopharmaceutical Contract Manufacturing Market by Type of Service(s) Offered (API, FDF), Type of Biologic Manufactured (Antibodies, Cell Therapies, Vaccines and Other Biologics), Type of Expression System Used (Mammalian, Microbial and Others), Scale of Operation (Preclinical / Clinical and Commercial), Company Size (Small, Mid-sized, and Large and Very Large), and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America and MENA): Industry Trends and Global Forecasts, 2022 - 2035" report features an extensive study of the current market landscape and the likely future potential associated with the biopharmaceutical contract manufacturing market, over the next decade.

The study also includes a detailed analysis of key drivers and trends within this evolving market. Amongst other elements, the report features:

A detailed overview of the overall landscape of companies engaged in offering contract manufacturing services for biologics, including a detailed analysis based on several relevant parameters, such as year of establishment, company size (based on number of employees), location of headquarters, type of service(s) offered (API and FDF manufacturing), type of biologic manufactured (ADCs, antibodies, biosimilars, cell therapies, gene therapies, nucleic acids / oligonucleotides, plasmid DNA / viral vectors, proteins / peptides, vaccines and others), scale of operation (preclinical, clinical and commercial), type of expression system used (mammalian, microbial and others), type of bioreactor used (single use, stainless steel and others) and mode of operation of bioreactor (batch, fed batch and perfusion / continuous).

A detailed landscape of the biopharmaceutical manufacturing facilities established across the key geographical regions (North America, Europe, Asia-Pacific and Rest of the World), highlighting the manufacturing hubs for biologics.

Elaborate profiles of key industry players based in North America, Europe and Asia-Pacific that offer contract manufacturing services for biologics. Each profile features a brief overview of the company, details related to its biologic-related service portfolio, manufacturing facilities, recent developments, and an informed future outlook.

A detailed discussion on the key enablers in this domain, including certain niche product classes, such as antibody drug conjugates (ADCs), bispecific antibodies, cell therapies, gene therapies and viral vectors, which are likely to have a significant impact on the growth of the contract services market.

A case study on the growing global biosimilars market, highlighting the associated opportunities for biopharmaceutical CMOs and CDMOs.

A case study comparing the key characteristics of small and large molecule drugs, along with details on the various steps involved in their respective manufacturing processes.

A detailed discussion on the benefits and challenges associated with in-house manufacturing, featuring a brief overview of the various parameters that a drug / therapy developer may need to take into consideration while deciding whether to manufacture its products in-house or outsource the production operations.

A qualitative analysis, highlighting various factors that need to be taken into consideration by biopharmaceutical developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.

A review of the various biopharmaceutical-focused manufacturing initiatives undertaken by top 10 big pharma players (shortlisted on the basis of 2021 revenues), highlighting trends across various parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of biologic manufactured.

An analysis of the recent collaborations within the biopharmaceutical contract manufacturing industry, based on several relevant parameters, such as year of partnership, type of partnership, type of biologic manufactured, therapeutic area, most active players (in terms of number of deals inked) and regional distribution of partnership activity that have taken place in this domain, during the period 2015-2022.

A detailed analysis of the various mergers and acquisitions that have taken place within this domain, during the period 2015-2022, based on several relevant parameters, such as year of agreement, type of deal, geographical location of companies, type of acquisition, type of biologic manufactured and key value drivers.

A detailed review of expansion initiatives undertaken by biopharmaceutical contract manufacturers, during the period 2016-2022, along with information on several relevant parameters, such as year of expansion, purpose of expansion, type of biologic manufactured and location of expanded facility.

An analysis of the recent developments within the biopharmaceutical contract manufacturing industry, highlighting information on the funding investments made during the period 2016-2022, along with information on the technology advancements related to biomanufacturing.

An estimate of the overall, installed capacity for the manufacturing of biopharmaceuticals, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity, based on size of manufacturer (small, mid-sized and large and very large), scale of operation (preclinical, clinical and commercial), type of expression system used (mammalian, microbial and others) and geography (North America, Europe, Asia-Pacific and Rest of the World).

An informed estimate of the annual demand for biologics, taking into account the top 20 biologics, based on various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products.

A company size-wise, detailed analysis of the total cost of ownership for biopharmaceuticals contract manufacturing organizations, during the period 2022-2042.

A case study on the virtual business model concept, along with its role in the overall biopharmaceutical industry. It also features a discussion on the advantages and risks / challenges associated with outsourcing operations from virtual service providers.

A discussion on affiliated trends, key drivers and challenges, under an elaborate SWOT framework, which are likely to impact the industry's evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall biopharmaceutical industry.

A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing contract manufacturing services to biopharmaceutical developers.

One of the key objectives of the report was to estimate the existing market size and estimate the future size of biopharmaceutical contract manufacturing market. We have provided informed estimates on the evolution of the market, over the period 2022-2035. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] type of service(s) offered (API, FDF), [B] type of biologic manufactured (antibodies, cell therapies, vaccines and other biologics), [C] type of expression system used (mammalian, microbial and others), [D] scale of operation (preclinical / clinical and commercial), [E] company size (small, mid-sized, and large and very large), and [F] key geographical regions (North America, Europe, Asia-Pacific, Latin America and MENA).

In order to account for future uncertainties associated with some of the key parameters and to add robustness to our forecast model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

KEY QUESTIONS ANSWERED

Who are the key players engaged in offering contract manufacturing services for biopharmaceuticals?

What are the different partnerships and expansion initiatives undertaken by biopharmaceutical contract manufacturers in the recent past?

Which regions represent the current key contract manufacturing hubs for biopharmaceuticals?

What is the current, installed capacity for contract manufacturing of biopharmaceuticals?

What is the current, global demand for biologics? How is the demand for such candidates likely to evolve in the foreseen future?

What percentage of the biopharmaceuticals manufacturing operations are presently outsourced?

What factors should be taken into consideration while deciding whether the manufacturing operations for biopharmaceuticals should be kept in-house or outsourced?

How is the current and future opportunity likely to be distributed across key market segments?

CHAPTER OUTLINES

Chapter 2 is an executive summary of key insights captured during our research. It offers a high-level view on the current state of biopharmaceutical contract manufacturing market and its likely evolution in the short to mid-term and long-term.

Chapter 3 provides a general introduction to biopharmaceuticals and biopharmaceutical manufacturing processes. The chapter also includes an overview of the various expression systems used for the development of different types of biotherapeutic products. It features a brief overview of contract manufacturing, along with a detailed discussion on the need for outsourcing within the biopharmaceutical industry. Furthermore, it provides information on the challenges faced by players currently engaged in this domain.

Chapter 4 provides a detailed assessment of the current market landscape of companies engaged in offering contract manufacturing services for biologics, including a detailed analysis based on several relevant parameters, such as year of establishment, company size (based on number of employees), location of headquarters, type of service(s) offered (API and FDF manufacturing), type of biologic manufactured (ADCs, antibodies, biosimilars, cell therapies, gene therapies, nucleic acids / oligonucleotides, plasmid DNA / viral vectors, proteins / peptides, vaccines and others), scale of operation (preclinical, clinical and commercial), type of expression system used (mammalian, microbial and others), type of bioreactor used (single use, stainless steel and others) and mode of operation of bioreactor (batch, fed batch and perfusion / continuous).

Chapter 5 provides a detailed landscape of the biopharmaceutical manufacturing facilities established across the key geographical regions (North America, Europe, Asia-Pacific and Rest of the World), highlighting the manufacturing hubs for biologics.

Chapter 6 provides elaborate profiles of key industry players based in North America that offer contract manufacturing services for biologics. Each profile features a brief overview of the company, details related to its biologic-related service portfolio, manufacturing facilities, recent developments, and an informed future outlook.

Chapter 7 provides elaborate profiles of key industry players based in Europe that offer contract manufacturing services for biologics. Each profile features a brief overview of the company, details related to its biologic-related service portfolio, manufacturing facilities, recent developments, and an informed future outlook.

Chapter 8 provides elaborate profiles of key industry players based in Asia-Pacific that offer contract manufacturing services for biologics. Each profile features a brief overview of the company, details related to its biologic-related service portfolio, manufacturing facilities, recent developments, and an informed future outlook.

Chapter 9 provides a detailed discussion on the key enablers in this domain, including certain niche product classes, such as antibody drug conjugates (ADCs), bispecific antibodies, cell therapies, gene therapies and viral vectors, which are likely to have a significant impact on the growth of the contract services market.

Chapter 10 presents a case study on the growing global biosimilars market, highlighting the associated opportunities for biopharmaceutical CMOs and CDMOs.

Chapter 11 presents a case study comparing the key characteristics of small and large molecule drugs, along with details on the various steps involved in their respective manufacturing processes.

Chapter 12 provides a detailed discussion on the benefits and challenges associated with in-house manufacturing, featuring a brief overview of the various parameters that a drug / therapy developer may need to take into consideration while deciding whether to manufacture its products in-house or outsource the production operations.

Chapter 13 presents a qualitative analysis, highlighting various factors that need to be taken into consideration by biopharmaceutical developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.

Chapter 14 provides a review of the various biopharmaceutical-focused manufacturing initiatives undertaken by top 10 big pharma players (shortlisted on the basis of 2021 revenues), highlighting trends across various parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of biologic manufactured.

Chapter 15 presents an analysis of the recent collaborations within the biopharmaceutical contract manufacturing industry, based on several relevant parameters, such as year of partnership, type of partnership, type of biologic manufactured, therapeutic area, most active players (in terms of number of deals inked) and regional distribution of partnership activity that have taken place in this domain, during the period 2015-2022.

Chapter 16 provides a detailed analysis of the various mergers and acquisitions that have taken place within this domain, during the period 2015-2022, based on several relevant parameters, such as year of agreement, type of deal, geographical location of companies, type of acquisition, type of biologic manufactured and key value drivers.

Chapter 17 presents a detailed review of expansion initiatives undertaken by biopharmaceutical contract manufacturers, during the period 2016-2022, along with information on several relevant parameters, such as year of expansion, purpose of expansion, type of biologic manufactured and location of expanded facility.

Chapter 18 presents an analysis of the recent developments within the biopharmaceutical contract manufacturing industry, highlighting information on the funding investments made during the period 2016-2022, along with information on the technology advancements related to biomanufacturing.

Chapter 19 provides an estimate of the overall, installed capacity for the manufacturing of biopharmaceuticals, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity, based on size of manufacturer (small, mid-sized, and large and very large), scale of operation (preclinical, clinical and commercial), type of expression system used (mammalian, microbial and others) and geography (North America, Europe, Asia-Pacific and Rest of the World).

Chapter 20 presents an informed estimate of the annual demand for biologics, taking into account the top 20 biologics, based on various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products.

Chapter 21 presents a company size-wise, detailed analysis of the total cost of ownership for biopharmaceuticals contract manufacturing organizations, during the period 2022-2042.

Chapter 22 presents an insightful market forecast analysis, highlighting the future potential of biopharmaceutical contract manufacturing market till 2035. We have segmented the market on the basis of type of service(s) offered (API, FDF), type of biologic manufactured (antibodies, cell therapies, vaccines and other biologics), type of expression system used (mammalian, microbial and others), scale of operation (preclinical / clinical and commercial) , company size (small, mid-sized, and large and very large), and key geographical regions (North America, Europe, Asia-Pacific, Latin America and MENA).

Chapter 23 presents a case study on the virtual business model concept, along with its role in the overall biopharmaceutical industry. It also features a discussion on the advantages and risks / challenges associated with outsourcing operations from virtual service providers.

Chapter 24 provides a discussion on affiliated trends, key drivers and challenges, under an elaborate SWOT framework, which are likely to impact the industry's evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall biopharmaceutical industry.

Chapter 25 features an elaborate discussion on the future opportunities / trends within the biopharmaceutical contract manufacturing market that are likely to influence the growth of this domain over the coming years.

Chapter 26 provides a survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing contract manufacturing services to biopharmaceutical developers.

Chapter 27 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of the biopharmaceutical contract manufacturing market, based on the research and analysis described in the previous chapters.

Chapter 28 is a collection of transcripts of interviews conducted with various stakeholders in the industry.

Chapter 29 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 30 is an appendix, which provides the list of companies and organizations mentioned in the report.

1. PREFACE

1.1. Scope of the Report
1.2. Market Segmentations
1.3. Research Methodology
1.4. Key Questions Answered
1.5. Chapter Outlines

2. EXECUTIVE SUMMARY

2.1. Chapter Overview

3. INTRODUCTION

3.1. Chapter Overview
3.2. Overview of Biopharmaceuticals
3.3. Expression Systems for Biopharmaceuticals
- 3.3.1. Insect Expression Systems
- 3.3.2. Mammalian Expression Systems
- 3.3.3. Microbial Expression Systems
  - 3.3.3.1. Bacterial Expression Systems
  - 3.3.3.2. Fungal Expression Systems
  - 3.3.3.3. Yeast Expression Systems
- 3.3.4. Plant Expression Systems
- 3.3.5. Mammalian versus Microbial Expression Systems
3.4. Manufacturing Process of Biopharmaceuticals
- 3.4.1. Upstream Processing
- 3.4.2. Fermentation
- 3.4.3. Downstream Processing
3.5. Overview of Contract Manufacturing
3.6. Need for Outsourcing Biopharmaceutical Manufacturing Operations
- 3.6.1. Commonly Outsourced Manufacturing Operations for Biopharmaceuticals
- 3.6.2. Advantages of Outsourcing Biopharmaceutical Manufacturing Operations
- 3.6.3. Risks and Challenges Associated with Outsourcing Biopharmaceutical Manufacturing Operations
3.7. Key Considerations While Selecting a Contract Manufacturing Partner
3.8. Future Perspectives

4. MARKET LANDSCAPE

4.1. Chapter Overview
4.2. Biopharmaceutical Contract Manufacturers: Overall Market Landscape
- 4.2.1. Analysis by Year of Establishment
- 4.2.2. Analysis by Company Size
- 4.2.3. Analysis by Location of Headquarters
- 4.2.4. Analysis by Type of Service(s) Offered
- 4.2.5. Analysis by Type of Biologic Manufactured
- 4.2.6. Analysis by Scale of Operation
- 4.2.7. Analysis by Type of Expression System Used
- 4.2.8. Analysis by Type of Bioreactor Used
- 4.2.9. Analysis by Mode of Operation of Bioreactor

5. REGIONAL CAPABILITY ANALYSIS

5.1. Chapter Overview
5.2. Key Assumptions and Methodology
5.3. Overall Landscape of Biopharmaceutical Contract Manufacturing Facilities
- 5.3.1. Analysis by Type of Service(s) Offered
- 5.3.2. Analysis by Scale of Operation
- 5.3.3. Analysis by Type of Expression System Used
5.4. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities in North America
5.5. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities in Europe
5.6. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities in Asia-Pacific and Rest of the World

6. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN NORTH AMERICA

6.1. Chapter Overview
6.2. Regulatory Scenario of Biopharmaceutical Contract Manufacturing in the US
6.3. Leading Biopharmaceutical CMOs in North America
- 6.3.1. AGC Biologics
  - 6.3.1.1. Company Overview
  - 6.3.1.2. Service Portfolio
    - 6.3.1.2.1. Process Development
    - 6.3.1.2.2. cGMP Manufacturing
    - 6.3.1.2.3. Quality and Regulatory
    - 6.3.1.2.4. Process Validation
  - 6.3.1.3. Financial Information
  - 6.3.1.4. Manufacturing Facilities
  - 6.3.1.5. Recent Developments and Future Outlook
- 6.3.2. Catalent (Catalent Pharma Solutions)
  - 6.3.2.1. Company Overview
  - 6.3.2.2. Service Portfolio
    - 6.3.2.2.1. Cell Line Development
    - 6.3.2.2.2. Manufacturing (Biomanufacturing)
    - 6.3.2.2.3. ADCs and Bioconjugates Manufacturing
    - 6.3.2.2.4. Biosimilars Development and Manufacturing
    - 6.3.2.2.5. Proprietary Delivery and Fill / Finish Solutions
    - 6.3.2.2.6. Analytical Services
  - 6.3.2.3. Clinical Supply Services
  - 6.3.2.4. Financial Information
  - 6.3.2.5. Manufacturing Facilities
  - 6.3.2.6. Recent Developments and Future Outlook
- 6.3.3. Cytiva (GE Healthcare)
  - 6.3.3.1. Company Overview
  - 6.3.3.2. Service Portfolio
    - 6.3.3.2.1. Biomanufacturing Services
    - 6.3.3.2.2. Scientific Support
    - 6.3.3.2.3. OptiRun Service Solutions
    - 6.3.3.2.4. Instruments Qualification Services
  - 6.3.3.3. Financial Information
  - 6.3.3.4. Manufacturing Facilities
  - 6.3.3.5. Recent Developments and Future Outlook
- 6.3.4. FUJIFILM Diosynth Biotechnologies
  - 6.3.4.1. Company Overview
  - 6.3.4.2. Service Portfolio
    - 6.3.4.2.1. Strain Development
    - 6.3.4.2.2. Process Development
    - 6.3.4.2.3. GMP Contract Manufacturing
    - 6.3.4.2.4. Analytical Solutions
  - 6.3.4.3. Financial Information
  - 6.3.4.4. Manufacturing Facilities
  - 6.3.4.5. Recent Developments and Future Outlook
- 6.3.5. KBI Biopharma
  - 6.3.5.1. Company Overview
  - 6.3.5.2. Service Portfolio
    - 6.3.5.2.1. Process Development
    - 6.3.5.2.2. Analytical Development
    - 6.3.5.2.3. GMP Manufacturing
    - 6.3.5.2.4. Clinical Cell Therapy Support
  - 6.3.5.3. Recent Developments and Future Outlook
- 6.3.6. Patheon (acquired by Thermo Fisher Scientific)
  - 6.3.6.1 Company Overview
  - 6.3.6.2. Service Portfolio
    - 6.3.6.2.1. Biologics
      - 6.3.6.2.1.1. Drug Substance
    - 6.3.6.2.2. Analytical Services
    - 6.3.6.2.3. Product Development
    - 6.3.6.2.4. Commercial Product Supply
  - 6.3.6.3. Financial Information
  - 6.3.6.4. Manufacturing Facilities
  - 6.3.6.5. Recent Developments and Future Outlook
- 6.3.7. Piramal Pharma Solutions
  - 6.3.7.1 Company Overview
  - 6.3.7.2. Service Portfolio
    - 6.3.7.2.1. Antibody Drug Conjugation Services
    - 6.3.7.2.2. Other Services
  - 6.3.7.3. Financial Information
  - 6.3.7.4. Manufacturing Facilities
  - 6.3.7.5. Recent Developments and Future Outlook

7. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN EUROPE

7.1. Chapter Overview
7.2. Biopharmaceutical Contract Manufacturing in Europe: Regulatory Scenario
- 7.2.1. EMA's cGMP Regulations
7.3. Leading Biopharmaceutical CMOs in Europe
- 7.3.1. Boehringer Ingelheim (BioXcellence)
  - 7.3.1.1. Company Overview
  - 7.3.1.2. Service Portfolio
    - 7.3.1.2.1. Process Development
      - 7.3.1.2.1.1. Expression Systems
      - 7.3.1.2.1.2. Upstream Technology
      - 7.3.1.2.1.3. Downstream Technology
      - 7.3.1.2.1.4. Other Process Development Services
    - 7.3.1.2.2. Quality Assurance
    - 7.3.1.2.3. Fill / Finish
  - 7.3.1.3. Financial Information
  - 7.3.1.4. Manufacturing Facilities
  - 7.3.1.5. Recent Developments and Future Outlook
- 7.3.2. Lonza
  - 7.3.2.1. Company Overview
  - 7.3.2.2. Service Portfolio
  - 7.3.2.3. Manufacturing Services
  - 7.3.2.4. Financial Information
  - 7.3.2.5. Manufacturing Facilities
  - 7.3.2.6. Recent Developments and Future Outlook
- 7.3.3. Novasep
  - 7.3.3.1 Company Overview
  - 7.3.3.2. Service Portfolio
    - 7.3.3.2.1. Services for Viruses and Viral Vectors
    - 7.3.3.2.2. Services for Monoclonal Antibodies
    - 7.3.3.2.3. Services for ADCs
    - 7.3.3.2.4. Quality, Regulatory and Other Services
  - 7.3.3.3. Manufacturing Facilities
  - 7.3.3.4. Recent Developments and Future Outlook
- 7.3.4. Olon
  - 7.3.4.1. Company Overview
  - 7.3.4.2. Service Portfolio
  - 7.3.4.3. Manufacturing Facilities
  - 7.3.4.4. Recent Developments and Future Outlook
- 7.3.5. Rentschler Biopharma
  - 7.3.5.1. Company Overview
  - 7.3.5.2. Service Portfolio
    - 7.3.5.2.1. Bioprocess Development
    - 7.3.5.2.2. Biomanufacturing Services
    - 7.3.5.2.3. Other Services
  - 7.3.5.3. Manufacturing Facilities
  - 7.3.5.4. Recent Developments and Future Outlook
- 7.3.6. Sandoz
  - 7.3.6.1. Company Overview
  - 7.3.6.2. Service Portfolio
  - 7.3.6.3. Financial Information
  - 7.3.6.4. Recent Developments and Future Outlook

8. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN ASIA-PACIFIC AND THE REST OF THE WORLD

8.1. Chapter Overview
8.2. Biopharmaceutical Contract Manufacturing in China
- 8.2.1. Biopharmaceutical Contract Manufacturing in China: Regulatory Scenario
- 8.2.2. Challenges Faced while Outsourcing to China
8.3. Leading Biopharmaceutical CMOs in China
- 8.3.1. WuXi Biologics
  - 8.3.1.1. Company Overview
  - 8.3.1.2. Service Portfolio
    - 8.3.1.2.1. Discovery Services
    - 8.3.1.2.2. Development Services
    - 8.3.1.2.3. Testing Services
    - 8.3.1.2.4. Clinical Manufacturing Services
    - 8.3.1.2.5. Fill / Finish Operations
  - 8.3.1.3. Financial Information
  - 8.3.1.4. Manufacturing Facilities
  - 8.3.1.5. Recent Developments and Future Outlook
8.4. Biopharmaceutical Contract Manufacturing in India
- 8.4.1. Biopharmaceutical Contract Manufacturing in India: Regulatory Scenario
- 8.4.2. Challenges Faced while Outsourcing to India
8.5. Leading Biopharmaceutical CMOs in India
- 8.5.1. Kemwell Biopharma
  - 8.5.1.1. Company Overview
  - 8.5.1.2. Service Portfolio
    - 8.5.1.2.1. Development Services for Biopharmaceuticals
    - 8.5.1.2.2. Manufacturing Services for Biopharmaceuticals
  - 8.5.1.3. Manufacturing Facilities
  - 8.5.1.4. Recent Developments and Future Outlook
8.6. Biopharmaceutical Contract Manufacturing in Japan
- 8.6.1. Biopharmaceutical Contract Manufacturing in Japan: Regulatory Scenario
8.7. Leading Biopharmaceutical CMOs in Japan
- 8.7.1. Minaris Regenerative Medicine
  - 8.7.1.1. Company Overview
  - 8.7.1.2. Service Portfolio
    - 8.7.1.2.1. Manufacturing Development
    - 8.7.1.2.2. GMP Manufacturing
  - 8.7.1.3. Manufacturing Facilities
  - 8.7.1.4. Recent Developments and Future Outlook
- 8.7.2. Takara Bio
  - 8.7.2.1. Company Overview
  - 8.7.2.2. Service Portfolio
  - 8.7.2.3. Financial Information
  - 8.7.2.4. Manufacturing Facilities
  - 8.7.2.5. Recent Developments and Future Outlook
8.8. Biopharmaceutical Contract Manufacturing in South Korea
- 8.8.1. Biopharmaceutical Contract Manufacturing in South Korea: Regulatory Scenario
8.9. Leading Biopharmaceutical CMOs in South Korea
- 8.9.1. Celltrion
  - 8.9.1.1. Company Overview
  - 8.9.1.2. Service Portfolio
  - 8.9.1.3. Financial Information
  - 8.9.1.4. Manufacturing Facilities
  - 8.9.1.5. Recent Developments and Future Outlook
- 8.9.2. Samsung BioLogics
  - 8.9.2.1. Company Overview
  - 8.9.2.2. Service Portfolio
    - 8.9.2.2.1. Process Development
    - 8.9.2.2.2. Analytical Services
    - 8.9.2.2.3. cGMP Manufacturing Services
    - 8.9.2.2.4. Aseptic Fill / Finish
    - 8.9.2.2.5. Quality Services
    - 8.9.2.2.6. Other Services
  - 8.9.2.3. Financial Information
  - 8.9.2.4. Manufacturing Facilities
  - 8.9.2.5. Recent Developments and Future Outlook
8.10. Biopharmaceutical Contract Manufacturing in Australia
- 8.10.1. Biopharmaceutical Contract Manufacturing in Australia: Regulatory Scenario
8.11. Leading Biopharmaceutical CMOs in Australia
- 8.11.1. Cell Therapies
  - 8.11.1.1. Company Overview
  - 8.11.1.2. Service Portfolio
  - 8.11.1.3. Manufacturing Facilities
  - 8.11.1.4. Recent Developments and Future Outlook
- 8.11.2. Luina Bio
  - 8.11.2.1. Company Overview
  - 8.11.2.2. Service Portfolio
    - 8.11.2.2.1. Microbial Products
    - 8.11.2.2.2. Vaccines
    - 8.11.2.2.3. Support Services
    - 8.11.2.2.4. Quality-related Services
  - 8.11.2.3. Manufacturing Facilities
  - 8.11.2.4. Recent Developments and Future Outlook

9. NICHE BIOPHARMACEUTICAL SECTORS

9.1. Chapter Overview
9.2. Bispecific Antibodies
- 9.2.1. Introduction
- 9.2.2. Pipeline Analysis
  - 9.2.2.1. Bispecific Antibody Therapeutics: Clinical Pipeline
  - 9.2.2.2. Bispecific Antibody Therapeutics: Early Stage Pipeline
  - 9.2.2.3. Multivalent Drug Candidates
- 9.2.3. Analysis by Phase of Development
- 9.2.4. Analysis by Target Indication
- 9.2.5. Bispecific Antibody Therapeutics: List of Technology Providers
- 9.2.6. Key Manufacturing Considerations and Challenges
- 9.2.7. Contract Manufacturing Scenario
  - 9.2.7.1. CMOs Offering Services for Bispecific Antibodies
9.3. Antibody Drug Conjugates (ADCs)
- 9.3.1. Components of ADCs
  - 9.3.1.1. Antibody
  - 9.3.1.2. Cytotoxin
  - 9.3.1.3. Linker
- 9.3.2. Manufacturing Process
- 9.3.3. Pipeline Analysis
- 9.3.4. Analysis by Phase of Development
- 9.3.5. Analysis by Target Indication
- 9.3.6. Key Technology Players: Analysis by Number of ADC Therapeutics
- 9.3.7. Novel Drug Conjugates
- 9.3.8. Key Manufacturing Considerations and Challenges
- 9.3.9. Contract Manufacturing Scenario
  - 9.3.9.1. CMOs Offering Services for ADCs
9.4. Cell Therapies
- 9.4.1. Introduction
- 9.4.2. Current Market Landscape
- 9.4.3. Cell Therapy Manufacturing
  - 9.4.3.1. Cell Therapy Manufacturing Models
    - 9.4.3.1.1. Centralized Manufacturing
    - 9.4.3.1.2. Decentralized Manufacturing
- 9.4.4. Key Manufacturing Considerations and Challenges
- 9.4.5. Factors Influencing Cell Therapy Manufacturing
  - 9.4.5.1. Characterization
  - 9.4.5.2. Cost of Goods
  - 9.4.5.3. Automation of Cell Therapy Manufacturing
- 9.4.6. Analysis by Types of Cells Manufactured
- 9.4.7. Stem Cell Therapies: Analysis by Phase of Development
- 9.4.8. T-Cell Therapies: Analysis by Phase of Development
- 9.4.9. Contract Manufacturing Scenario
  - 9.4.9.1. CMOs Offering Services for Cell Therapy
9.5. Gene Therapies
- 9.5.1. Gene Therapies Market: Pipeline Analysis
  - 9.5.1.1. Analysis by Stage of Development
  - 9.5.1.2. Analysis by Phase of Development
  - 9.5.1.3. Analysis by Type of Vector Used
    - 9.5.1.3.1. Clinical Pipeline
    - 9.5.1.3.2. Preclinical Pipeline
  - 9.5.1.4. Analysis by Target Indication
    - 9.5.1.4.1. Clinical and Commercial Pipeline
    - 9.5.1.4.1. Preclinical Pipeline
  - 9.5.1.5. Analysis by Location of Manufacturing Facility
  - 9.5.1.6 Analysis by Type of Viral Vector Used
- 9.5.2. Contract Manufacturing Scenario
  - 9.5.2.1. CMOs Offering Services for Viral Vectors
9.6. Plasmid DNA
- 9.6.1. Introduction
- 9.6.2. Analysis by Location of Manufacturing Facility
- 9.6.3. Contract Manufacturing Scenario
  - 9.6.3.1. CMOs Offering Services for Plasmid DNA

10. CASE STUDY: OUTSOURCING OF BIOSIMILARS

10.1. Chapter Overview
10.2. Biosimilars: An Introduction
10.3. Biosimilars: Development Stages
10.4. Regulatory Requirements for Licensing of Biosimilars
10.5. Need for Outsourcing Biosimilar Development and Manufacturing
10.6. Impact of Biosimilars on the Global Contract Manufacturing Market
- 10.6.1. Biosimilars: Historical Trend of FDA Approval
10.7. Biosimilars Contract Manufacturing Service Providers
10.8. Challenges Associated with Outsourcing of Biosimilar Manufacturing Operations

11. CASE STUDY: COMPARISON OF SMALL AND LARGE MOLECULES DRUGS / THERAPIES

11.1. Chapter Overview
11.2. Small Molecule and Large Molecule Drugs / Therapies
- 11.2.1. Comparison of General Characteristics
- 11.2.2. Comparison of Key Specifications
- 11.2.3. Comparison of Manufacturing Process
- 11.2.4. Comparison of Key Manufacturing Challenges

12. CASE STUDY: IN-HOUSE MANUFACTURING

12.1. Chapter Overview
12.2. In-House Manufacturing
- 12.2.1. Benefits Associated with In-House Manufacturing
- 12.2.2. Risks Associated with In-House Manufacturing
12.3. Outsourcing Trends in the Biopharmaceutical Industry
- 12.3.1. Types of Outsourcing Partners
12.4. Manufacturing Approaches Used for Approved Biologics, 2016-2022
- 12.4.1. Approved Biologics: Analysis by Company Size and Type of Manufacturing Model Adopted
- 12.4.2. Approved Biologics: Analysis by Company Size and Type of Biologic Manufactured
12.5. Choosing the Right Strategy: In-House Manufacturing versus Outsourcing

13. MAKE VERSUS BUY DECISION MAKING FRAMEWORK

13.1. Chapter Overview
13.2. Assumptions and Key Parameters
13.3. Biopharmaceutical Contract Manufacturers: Make versus Buy Decision Making
- 13.3.1. Scenario 1
- 13.3.2. Scenario 2
- 13.3.3. Scenario 3
- 13.3.4. Scenario 4
13.4. Conclusion

14. BIG PHARMA INITIATIVES

14.1. Chapter Overview
14.2. Biopharmaceutical Related Initiatives of Big Pharmaceutical Players
- 14.2.1. Analysis by Number of Initiatives
- 14.2.2. Analysis by Year of Initiative
- 14.2.3. Analysis by Purpose of Initiative
- 14.2.4. Analysis by Type of Initiative
  - 14.2.4.1. Analysis by Type of Partnership
  - 14.2.4.2. Analysis by Type of Expansion
- 14.2.5. Analysis by Scale of Operation
- 14.2.6. Analysis by Type of Biologic Manufactured
- 14.2.7. Analysis by Year of Initiative and Company
- 14.2.8. Analysis by Purpose of Initiative and Company
- 14.2.9. Analysis by Year and Type of Initiative
- 14.2.10. Analysis by Region of Expansion and Company
- 14.2.11. Analysis by Type of Biologic Manufactured and Company
14.3. Competitive Benchmarking of Big Pharma Players

15. PARTNERSHIPS AND COLLABORATIONS

15.1. Chapter Overview
15.2. Partnership Models
15.3. Biopharmaceutical Contract Manufacturing: Partnerships and Collaborations
- 15.3.1. Analysis by Year of Partnership
- 15.3.2. Analysis by Type of Partnership
- 15.3.3. Analysis by Year and Type of Partnership
- 15.3.4. Analysis by Type of Biologic Manufactured
- 15.3.5. Analysis by Year of Partnership and Type of Biologic Manufactured
- 15.3.6. Analysis by Type of Partnership and Type of Biologic Manufactured
- 15.3.7. Analysis by Type of Biologic Manufactured and Geography
- 15.3.8. Analysis by Therapeutic Area
- 15.3.9. Most Active Players: Analysis by Number of Partnerships
- 15.3.10. Analysis by Region
  - 15.3.10.1. Intracontinental and Intercontinental Agreements
  - 15.3.10.2. Local and International Agreements

16. MERGERS AND ACQUISITIONS

16.1. Chapter Overview
16.2. Merger and Acquisition Models
16.3. Biopharmaceutical Contract Manufacturing: Mergers and Acquisitions
- 16.3.1. Cumulative Year-wise Trend of Mergers and Acquisitions
- 16.3.2. Analysis by Type of Acquisition
- 16.3.3. Analysis by Region
  - 16.3.3.1. Mergers and Acquisitions: Continent-wise Distribution
  - 16.3.3.2. Mergers and Acquisitions: Country-wise Distribution
  - 16.3.3.3. Mergers and Acquisitions: Year-wise Trend in North America, Europe and Asia-Pacific
- 16.3.4 Most Active Acquirers: Analysis by Number of Acquisitions
- 16.3.5 Analysis by Key Value Drivers
- 16.3.6. Analysis by Year of Acquisition and Key Value Drivers
- 16.3.7. Analysis by Type of Biologic Manufactured
- 16.3.8. Analysis by Key Value Drivers and Type of Biologic Manufactured
16.4. Key Acquisitions: Deal Multiples
- 16.4.1. Year-wise Trend of Deal Multiple Amount

17. RECENT EXPANSIONS

17.1. Chapter Overview
17.2. Biopharmaceutical Contract Manufacturing: Recent Expansions
- 17.2.1. Analysis by Year of Expansion
- 17.2.2. Analysis by Purpose of Expansion
- 17.2.3. Analysis by Year and Purpose of Expansion
- 17.2.4. Analysis by Type of Biologic Manufactured
- 17.2.5. Analysis by Purpose of Expansion and Type of Biologic Manufactured
- 17.2.6. Analysis by Location of Expanded Facility
- 17.2.7. Most Active Players: Analysis by Number of Recent Expansions
- 17.2.8. Analysis by Purpose of Expansion and Location of Expanded Facility
- 17.2.9. Analysis by Amount Invested
- 17.2.10. Recent Expansions: 2016-2020 and 2016-2022 Scenario

18. RECENT DEVELOPMENTS

18.1. Chapter Overview
18.2. Types of Funding
18.3. Biopharmaceutical Contract Manufacturing: Funding and Investments
- 18.3.1. Cumulative Year-wise Distribution by Number of Instances
- 18.3.2. Cumulative Year-wise Distribution of Amount Invested
- 18.3.3. Analysis of Instances by Type of Funding
- 18.3.4. Analysis of Total Amount Invested by Type of Funding
- 18.3.5. Analysis by Year and Type of Funding
- 18.3.6. Regional Analysis of Total Amount Invested and Number of Funding Instances (Continent-wise)
- 18.3.7. Regional Analysis of Total Amount Invested and Number of Funding Instances (Country-wise)
- 18.3.8. Most Active Players: Analysis by Number of Funding Instances
- 18.3.9. Most Active Players: Analysis by Total Amount Raised
- 18.3.10. Most Active Investors: Analysis by Number of Funding Instances
18.4. Technological Advancements
- 18.4.1. Single Use Technology
- 18.4.2. Process Analytical Technology (PAT)
- 18.4.3. Continuous Processing
- 18.4.4. Quality by Design (QbD) in Bio-Processing
- 18.4.5. Modular / Podular Biopharma Facilities

19. CAPACITY ANALYSIS

19.1. Chapter Overview
19.2. Key Assumptions and Methodology
19.3. Biopharmaceutical Contract Manufacturers: Global Production Capacity
- 19.3.1. Analysis by Company Size
- 19.3.2. Analysis by Type of Expression System Used
- 19.3.3. Analysis by Scale of Operation
- 19.3.4. Analysis by Region
  - 19.3.4.1. Analysis of Biopharmaceutical Contract Manufacturing Capacity in North America
  - 19.3.4.2. Analysis of Biopharmaceutical Contract Manufacturing Capacity in Europe
  - 19.3.4.3. Analysis of Biopharmaceutical Contract Manufacturing Capacity in Asia-Pacific
19.4. Concluding Remarks

20. DEMAND ANALYSIS

20.1. Chapter Overview
20.2. Key Assumptions and Methodology
20.3. Global Demand for Biopharmaceuticals
- 20.3.1. Analysis by Therapeutic Area
20.4. Relationship Between Annual Demand and Capacity
20.5. Annual Demand for Emerging Novel Biologics
- 20.5.1. ADC Therapeutics: Overall Annual Demand
- 20.5.2. ADC Therapeutics: Demand and Supply Analysis
20.6. Global Demand for Cell Therapy Manufacturing

21. TOTAL COST OF OWNERSHIP FOR BIOPHARMACEUTICAL CONTRACT MANUFACTURING ORGANIZATIONS

21.1. Chapter Overview
21.2. Key Parameters
21.3. Assumptions and Methodology
21.4. Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations, 2022-2042
21.5. Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations: Analysis by CAPEX and OPEX, 2023-2042
- 21.5.1. Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations: Analysis by CAPEX, 2023-2042
- 21.5.2. Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations: Analysis by OPEX, 2023-2042

22. MARKET FORECAST AND OPPORTUNITY ANALYSIS

22.1. Chapter Overview
22.2. Key Assumptions and Methodology
22.3. Global Biopharmaceutical Contract Manufacturing Market, 2022-2035
22.4. Biopharmaceutical Contract Manufacturing Market: Analysis by Type of Service(s) Offered
- 22.4.1. Biopharmaceutical Contract Manufacturing Market for APIs, 2022-2035
- 22.4.2. Biopharmaceutical Contract Manufacturing Market for FDFs, 2022-2035
22.5. Biopharmaceutical Contract Manufacturing Market: Analysis by Type of Biologic Manufactured
- 22.5.1. Biopharmaceutical Contract Manufacturing Market for Antibodies, 2022-2035
- 22.5.2. Biopharmaceutical Contract Manufacturing Market for Cell Therapies, 2022- 2035
- 22.5.3. Biopharmaceutical Contract Manufacturing Market for Vaccines, 2022-2035
- 22.5.4. Biopharmaceutical Contract Manufacturing Market for Other Biologics, 2022- 2035
22.6. Biopharmaceutical Contract Manufacturing Market: Analysis by Type of Expression System Used
- 22.6.1. Biopharmaceutical Contract Manufacturing Market for Mammalian Cell-based Operations, 2022-2035
- 22.6.2. Biopharmaceutical Contract Manufacturing Market for Microbial Cell-based Operations, 2022-2035
- 22.6.3. Biopharmaceutical Contract Manufacturing Market for Other Expression System- based Operations, 2022-2035
22.7. Biopharmaceutical Contract Manufacturing Market: Analysis by Scale of Operation
- 22.7.1. Biopharmaceutical Contract Manufacturing Market for Preclinical / Clinical Operations, 2022-2035
- 22.7.2. Biopharmaceutical Contract Manufacturing Market for Commercial Operations, 2022-2035
22.8. Biopharmaceutical Contract Manufacturing Market: Analysis by Company Size, 2022-2035
- 22.8.1. Biopharmaceutical Contract Manufacturing Market for Small Companies, 2022- 2035
- 22.8.2. Biopharmaceutical Contract Manufacturing Market for Mid-sized Companies, 2022-2035
- 22.8.3. Biopharmaceutical Contract Manufacturing Market for Large and Very Large Companies, 2022-2035
22.9. Biopharmaceutical Contract Manufacturing Market: Analysis by Geography
- 22.9.1. Biopharmaceutical Contract Manufacturing Market in North America, 2022- 2035
  - 22.9.1.1. Biopharmaceutical Contract Manufacturing Market in the US, 2022-2035
  - 22.9.1.2. Biopharmaceutical Contract Manufacturing Market in Canada, 2022-2035
- 22.9.2. Biopharmaceutical Contract Manufacturing Market in Europe, 2022-2035
  - 22.9.2.1. Biopharmaceutical Contract Manufacturing Market in Italy, 2022-2035
  - 22.9.2.2. Biopharmaceutical Contract Manufacturing Market in Germany, 2022-2035
  - 22.9.2.3. Biopharmaceutical Contract Manufacturing Market in France, 2022-2035
  - 22.9.2.4. Biopharmaceutical Contract Manufacturing Market in Spain, 2022-2035
  - 22.9.2.5. Biopharmaceutical Contract Manufacturing Market in the UK, 2022-2035
  - 22.9.2.6. Biopharmaceutical Contract Manufacturing Market in Rest of Europe, 2022-2035
- 22.9.3. Biopharmaceutical Contract Manufacturing Market in Asia-Pacific, 2022-2035
  - 22.9.3.1. Biopharmaceutical Contract Manufacturing Market in China, 2022-2035
  - 22.9.3.2. Biopharmaceutical Contract Manufacturing Market in India, 2022-2035
  - 22.9.3.3. Biopharmaceutical Contract Manufacturing Market in South Korea, 2022-2035
  - 22.9.3.4. Biopharmaceutical Contract Manufacturing Market in Japan, 2022-2035
  - 22.9.3.5. Biopharmaceutical Contract Manufacturing Market in Rest of Asia-Pacific, 2022- 2035
- 22.9.4. Biopharmaceutical Contract Manufacturing Market in Latin America, 2022-2035
- 22.9.5. Biopharmaceutical Contract Manufacturing Market in Middle East and North Africa, 2022-2035

23. CASE STUDY: VIRTUAL PHARMACEUTICAL COMPANIES

23.1. Chapter Overview
23.2. Historical Evolution of the Virtual Business Model
23.3. Virtual Pharmaceutical Companies as a Subset of the Overall Biopharmaceutical Industry
23.4. Advantages Associated with Outsourcing Operations to Service Providers
23.5. Key Challenges Associated with Outsourcing Operations to Service Providers

24. SWOT ANALYSIS

24.1 Chapter Overview
24.2. Strengths
24.3. Weaknesses
24.4. Opportunities
24.5. Threats
24.6. Comparison of SWOT Factors
24.7. Conclusion

25. FUTURE OF THE BIOPHARMACEUTICAL CMO MARKET

25.1. Chapter Overview
25.2. Outsourcing Activities to Witness Significant Growth in the Coming Years
25.3. Shift from One-time Contracts to Strategic Partnerships
25.4. Integration / Adoption of Innovative Technologies
- 25.4.1. Single use Bioreactors
- 25.4.2. Novel Bioprocess Techniques
- 25.4.3. Bioprocess Automation
25.5. Focus on Niche Therapeutic Areas
25.6. Growing Biosimilars Market to Contribute to the Growth of the Contract Services Segment
25.7. Capability and Expertise Expansions by CMOs to become One-Stop-Shops
25.8. Offshoring Outsourcing Activities to Maximize Profits and Expand Existing Capacities
25.9. Increase in Financial Inflow and Outsourcing Budgets
25.10. Challenges Faced by both Sponsors and Service Providers
- 25.10.1. Concerns Related to Single Use Systems
- 25.10.2. Issues Related to Capacity Fluctuations
25.11. Concluding Remarks

26. SURVEY ANALYSIS

26.1. Chapter Overview
- 26.1.1. Overview of Respondents
- 26.1.2. Analysis by Designation of Respondents
26.2. Analysis by Biologic Manufacturing Expertise
26.3. Analysis by Scale of Manufacturing
26.4. Analysis by Location of Production Facilities
26.5. Analysis by Type of Expression System Used
26.6. Analysis by Type of Bioreactor Used
26.7. Analysis by Mode of Operation of Bioreactor

27. CONCLUSION

27.1. Chapter Overview

28. INTERVIEW TRANSCRIPTS

28.1. Chapter Overview
28.2. Andrea Conforto, Sales & Marketing, Bioservices Director, Olon
28.3. Astrid Brammer, Key Account Manager, Richter Helm
28.4. Birgit Schwab, Senior Manager Strategic Marketing, Rentschler Biotechnologie
28.5. Christian Bailly, ex-Director of CDMO, Pierre Fabre
28.6. Claire Otjes, Communication Manager, Batavia Biosciences
28.7. David C Cunningham, Director Corporate Development, Goodwin Biotechnology
28.8. Dietmar Katinger, Chief Executive Officer, Polymun Scientific
28.9. Denis Angioletti, Chief Commercial Officer, Cerbios-Pharma
28.10. Jeffrey Hung, General Manager, Vigene Biosciences
28.11. Kevin Daley, Director Pharmaceuticals, Novasep
28.12. Mark Wright, ex-Site Head, Grangemouth, Piramal Healthcare
28.13. Max Rossetto, General Manager - Business Development, Luina Bio
28.14. Nicolas Grandchamp, R&D Leader, GEG Tech
28.15. Raquel Fortunato, Chief Executive Officer, GenIbet Biopharmaceuticals
28.16. Sebastian Schuck, Head of Business Development, Wacker Biotech
28.17. Tatjana Buchholz, Marketing Manager, Plasmid Factory and Marco Schmeer, ex- Project Manager
28.18. Tim Oldham, ex- Chief Executive Officer, Cell Therapies
28.19. Traci Kyes, Vice President of Commercial Operations, Arranta Bio
28.20. Vijayakumar Ramaraj, Chief Manager, Shilpa Biologicals

29. APPENDIX I: TABULATED DATA

30. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

簡介目錄圖表

LIST OF TABLES

Table 3.1 Mammalian versus Microbial Expression Systems
Table 4.1 List of Biopharmaceutical Contract Manufacturers
Table 4.2 Biopharmaceutical Contract Manufacturers: Information on Type of Service(s) Offered
Table 4.3 Biopharmaceutical Contract Manufacturers: Information on Type of Biologic Manufactured
Table 4.4 Biopharmaceutical CMOs: Information on Scale of Operation
Table 4.5 Biopharmaceutical Contract Manufacturers: Information on Type of Expression System Used
Table 4.6 Biopharmaceutical Contract Manufacturers: Information on Type of Bioreactor Used
Table 4.7 Biopharmaceutical Contract Manufacturers: Information on Mode of Operation of Bioreactor
Table 5.1 List of Biopharmaceutical Contract Manufacturing Facilities in North America
Table 5.2 List of Biopharmaceutical Contract Manufacturing Facilities in Europe
Table 5.3 List of Biopharmaceutical Contract Manufacturing Facilities in Asia-Pacific and Rest of the World
Table 6.1 AGC Biologics: Company Overview
Table 6.2 AGC Biologics: Biologics Manufacturing Facilities
Table 6.3 AGC Biologics: Recent Developments and Future Outlook
Table 6.4 Catalent: Company Overview
Table 6.5 Catalent: Biologics Manufacturing Facilities
Table 6.6 Catalent: Recent Developments and Future Outlook
Table 6.7 Cytiva: Company Overview
Table 6.8 Cytiva: Manufacturing Facilities
Table 6.9 FUJIFILM Diosynth Biotechnologies: Company Overview
Table 6.10 FUJIFILM Diosynth Biotechnologies: Biopharmaceutical Facilities
Table 6.11 FUJIFILM Diosynth Biotechnologies: Recent Developments and Future Outlook
Table 6.12 KBI Biopharma: Company Overview,
Table 6.13 KBI Biopharma: Overview of Manufacturing Capabilities
Table 6.14 KBI Biopharma: Recent Developments and Future Outlook
Table 6.15 Patheon: Company Overview
Table 6.16 Patheon: Biopharmaceutical Manufacturing and Development Facilities
Table 6.17 Patheon: Future Outlook
Table 6.18 Piramal Pharma Solutions: Company Overview
Table 6.19 Piramal Pharma Solutions: Facilities
Table 6.20 Piramal Pharma Solutions: Recent Developments and Future Outlook
Table 7.1 FDA Quality Agreement and EMA cGMP Regulations: A Comparative Analysis
Table 7.2 Boehringer Ingelheim: Company Overview
Table 7.3 Boehringer Ingelheim: Biopharmaceutical Facilities
Table 7.4 Boehringer Ingelheim: Recent Developments and Future Outlook
Table 7.5 Lonza: Company Overview
Table 7.6 Lonza: Biopharmaceutical Facilities
Table 7.7 Lonza: Recent Developments and Future Outlook
Table 7.8 Novasep: Company Overview
Table 7.9 Novasep: Biologics Manufacturing Facilities
Table 7.10 Novasep: Recent Developments and Future Outlook
Table 7.11 Olon: Company Overview
Table 7.12 Olon: Biopharmaceutical Facilities
Table 7.13 Olon: Recent Developments and Future Outlook
Table 7.14 Rentschler Biopharma: Company Overview
Table 7.15 Rentschler Biopharma: Recent Developments and Future Outlook
Table 7.16 Sandoz: Company Overview
Table 8.1 WuXi Biologics: Company Overview
Table 8.2 WuXi Biologics: Recent Developments and Future Outlook
Table 8.3 Kemwell Biopharma: Company Overview
Table 8.4 Kemwell Biopharma: Recent Developments and Future Outlook
Table 8.5 Minaris Regenerative Medicine: Company Overview
Table 8.6 Minaris Regenerative Medicine: Manufacturing Facilities
Table 8.7 Minaris Regenerative Medicine: Recent Developments and Future Outlook
Table 8.8 Takara Bio: Company Overview
Table 8.9 Takara Bio: Biologics Manufacturing Facilities
Table 8.10 Takara Bio: Recent Developments and Future Outlook
Table 8.11 Celltrion: Company Overview
Table 8.12 Celltrion: Biologics Manufacturing Facilities
Table 8.13 Celltrion: Recent Developments and Future Outlook
Table 8.14 Samsung BioLogics: Company Overview
Table 8.15 Samsung BioLogics: Biopharmaceutical Facilities
Table 8.16 Samsung BioLogics: Recent Developments and Future Outlook
Table 8.17 Cell Therapies: Company Overview
Table 8.18 Cell Therapies: Recent Developments and Future Outlook
Table 8.19 Luina Bio: Company Overview
Table 8.20 Luina Bio: Recent Developments and Future Outlook
Table 9.1 Bispecific Antibody Therapeutics: Information on Developer(s), Platform / Technology Used, Phase of Development, Target Antigens and Antibody Format
Table 9.2 Bispecific Antibody Therapeutics: Information on Developer(s), Technology Used, Phase of Development, Target Antigens, Mechanism of Action, Disease Indication, Therapeutic Area and Broader Disease Segment
Table 9.3 List of Other Emerging Multivalent Drug Candidates
Table 9.4 Bispecific Antibody Therapeutics: List of Technology Platforms
Table 9.5 Bispecific Antibody Contract Manufacturers: List of Companies
Table 9.6 Commonly Used Cytotoxins for ADC Therapeutics
Table 9.7 Occupational Exposure Limit Bands, Safebridge Consultants
Table 9.8 Antibody Drug Conjugates: Drug Pipeline
Table 9.9 Novel Drug Conjugates: List of Developers
Table 9.10 ADC Contract Manufacturers: List of Companies
Table 9.11 Applications of Cell-based Therapies
Table 9.12 Cell-based Therapies: Commercialized Products,
Table 9.13 Assessments for Key Cell Therapy Manufacturing Steps
Table 9.14 Advantages and Disadvantages of Centralized and Decentralized Manufacturing Models
Table 9.15 Cell Therapy Manufacturing (Industry Players): Information on Type of Cell Manufactured
Table 9.16 Cell Therapy Contract Manufacturers: List of Cell Therapy Contract Manufacturers
Table 9.17 Cell Therapy Contract Manufacturers: List of Non-Industry Players
Table 9.18 Viral Vectors Manufacturers: Information on Type of Viral Vector Used
Table 9.19 Viral Vectors Contract Manufacturers: List of Companies,
Table 9.20 Plasmid DNA Contract Manufacturers: List of Companies
Table 10.1 List of Biosimilars Contract Manufacturing Service Providers
Table 11.1 Small Molecules and Large Molecules: Strengths and Weaknesses
Table 11.2 Small Molecules and Large Molecules: Comparison of Key Characteristics
Table 11.3 Small Molecules and Large Molecules: Comparison of Development Characteristics
Table 12.1 List of FDA Approved Biologics (2016-2022)
Table 14.1 Big Pharma Players: List of Biopharmaceutical Manufacturing Initiatives
Table 15.1 Biopharmaceutical Contract Manufacturing: List of Partnerships and Collaborations, 2015-2022
Table 15.2 Partnerships and Collaborations: Information on Type of Biologic Manufactured
Table 16.1 Biopharmaceutical Contract Manufacturing: List of Mergers and Acquisitions, 2015-2022
Table 16.2 Biopharmaceutical Contract Manufacturing Mergers and Acquisitions: Information on Key Value Drivers and Type of Biologic Manufactured, 2015- 2022
Table 16.3 Mergers and Acquisitions: Information on Deal Multiples, 2015-2022
Table 17.1 Biopharmaceutical Contract Manufacturing: List of Recent Expansions
Table 18.1 Biopharmaceutical Contract Manufacturing Market: Funding and Investment
Table 18.2 Funding and Investment Analysis: Summary of Investments
Table 18.3 Funding and Investment Analysis: Summary of Venture Capital Funding
Table 19.1 Capacity Analysis: Information on Contract Biomanufacturing Capacity
Table 19.2 Capacity Analysis: Average Capacity per Category (Sample Data Set)
Table 19.3 Capacity Analysis: Average Capacity for Mammalian Expression System (Sample Data Set)
Table 19.4 Capacity Analysis: Average Capacity for Microbial Expression System (Sample Data Set)
Table 19.5 Capacity Analysis: Global Contract Biomanufacturing Capacity
Table 20.1 Annual Biomanufacturing Capacity, 2022-2035 (Million Liters)
Table 20.2 ADC Therapeutics: Annual Demand for Outsourcing, 2022-2030 (in kilograms)
Table 20.3 ADC Therapeutics: Annual Supply for Outsourcing, 2022-2030 (in kilograms)
Table 23.1 List of Virtual Biopharmaceutical Companies
Table 24.1 Global Biopharmaceuticals Market: Patent Approval and Expiry Details of Best- selling Biologics
Table 26.1 Survey Analysis: Overview of Respondents
Table 26.2 Survey Analysis: Distribution of Respondents by Designation
Table 26.3 Survey Analysis: Biologics Manufacturing Expertise
Table 26.4 Survey Analysis: Scale of Manufacturing
Table 26.5 Survey Analysis: Location of Production Facilities
Table 26.6 Survey Analysis: Type of Expression System Used
Table 26.7 Survey Analysis: Type of Bioreactor Used
Table 26.8 Survey Analysis: Mode of Operation of Bioreactor
Table 29.1 Biopharmaceutical CMOs: Distribution by Year of Establishment
Table 29.2 Biopharmaceutical CMOs: Distribution by Company Size
Table 29.3 Biopharmaceutical CMOs: Distribution by Location of Headquarters (Region- wise)
Table 29.4 Biopharmaceutical CMOs: Distribution by Location of Headquarters (Country- wise)
Table 29.5 Biopharmaceutical CMOs: Distribution by Company Size, Year of Establishment and Location of Headquarters
Table 29.6 Biopharmaceutical CMOs: Distribution by Type of Service(s) Offered
Table 29.7 Biopharmaceutical CMOs: Distribution by Type of Biologic Manufactured
Table 29.8 Biopharmaceutical CMOs: Distribution by Type of Biologic Manufactured and Location of Headquarters
Table 29.9 Biopharmaceutical CMOs: Distribution by Type of Biologic Manufactured and Company Size
Table 29.10 Biopharmaceutical CMOs: Distribution by Scale of Operation
Table 29.11 Biopharmaceutical CMOs: Distribution by Type of Biologic Manufactured and Scale of Operation
Table 29.12 Biopharmaceutical CMOs: Distribution by Type of Expression System Used
Table 29.13 Biopharmaceutical CMOs: Distribution by Type of Expression System Used and Location of Headquarters
Table 29.14 Biopharmaceutical CMOs: Distribution by Type of Bioreactor Used
Table 29.15 Biopharmaceutical CMOs: Distribution by Mode of Operation of Bioreactor
Table 29.16 Regional Distribution of Biopharmaceutical Contract Manufacturing Facilities
Table 29.17 Biopharmaceutical Contract Manufacturing Facilities: Distribution of Type of Service(s) Offered
Table 29.18 Biopharmaceutical Contract Manufacturing Facilities: Distribution by Scale of Operation
Table 29.19 Biopharmaceutical Contract Manufacturing Facilities: Distribution by Type of Expression System Used
Table 29.20 AGC Biologics: Annual Revenues FY 2017-Q1 2022 (JPY Billion)
Table 29.21 Catalent: Annual Revenues, FY 2017-9M 2022 (USD Million)
Table 29.22 Cytiva: Annual Revenues, FY 2017-FY 2021 (USD Million)
Table 29.23 FUJIFILM Diosynth Biotechnologies: Annual Revenues, FY 2017-FY 2021 (JPY Billion)
Table 29.24 FUJIFILM Holdings: Annual Revenues by Business Divisions (JPY Billion)
Table 29.25 Patheon: Annual Revenues, FY 2017-FY 2021 (USD Million)
Table 29.26 Piramal Enterprises: Annual Revenues, FY 2017-FY 2021 (INR Crores)
Table 29.27 Boehringer Ingelheim: Annual Revenues, FY 2017-FY 2021 (EUR Billion)
Table 29.28 Lonza: Annual Revenues, FY 2017-FY 2021 (CHF Billion)
Table 29.29 Lonza: Annual Revenues by Business Divisions (CHF Billion)
Table 29.30 Sandoz: Annual Revenues, FY 2017-Q1 2022 (USD Billion)
Table 29.31 WuXi Biologics: Annual Revenues, FY 2017-FY 2021 (RMB Million)
Table 29.32 Takara Bio: Annual Revenues, FY 2017-FY 2021 (JPY Million)
Table 29.33 Celltrion: Annual Revenues, FY 2017-Q1 2022 (KRW Billion)
Table 29.34 Samsung Biologics: Annual Revenues, FY 2017-Q1 2022 (KRW Billion)
Table 29.35 Bispecific Antibody Therapeutics Pipeline: Distribution by Phase of Development
Table 29.36 Bispecific Antibody Therapeutics Pipeline: Distribution by Target Indication
Table 29.37 Antibody Drug Conjugates: Distribution by Status of Development
Table 29.38 Antibody Drug Conjugates: Distribution by Target Indication
Table 29.39 Key ADC Technology Providers: Distribution by Number of Candidates
Table 29.40 Stem Cell Therapies: Distribution by Phase of Development
Table 29.41 T-Cell Therapies: Distribution by Phase of Development
Table 29.42 Gene Therapies: Distribution by Stage of Development
Table 29.43 Gene Therapies: Distribution by Phase of Development
Table 29.44 Clinical and Commercial Pipeline of Gene Therapies: Distribution by Type of Vector Used
Table 29.45 Early-Stage Pipeline of Gene Therapies: Distribution by Type of Vector Used
Table 29.46 Clinical and Commercial Pipeline of Gene Therapies: Distribution by Therapeutic Area
Table 29.47 Early-Stage Pipeline of Gene Therapies: Distribution by Therapeutic Area
Table 29.48 Viral Vector Manufacturers: Distribution by Location of Manufacturing Facility
Table 29.49 Plasmid DNA Manufacturers: Distribution by Location of Manufacturing Facility
Table 29.50 Biosimilars: Historical Trend of FDA Approval, 2015-2021
Table 29.51 Small Molecule and Large Molecule Drugs: Historical Trend of FDA Approval, 2005-2021
Table 29.52 Big Pharma Players: Distribution by Number of Biopharmaceutical Contract Manufacturing Focused Initiatives, 1980-2022
Table 29.53 Big Pharma Players: Cumulative Distribution by Year of Initiative
Table 29.54 Big Pharma Players: Distribution by Purpose of Initiative
Table 29.55 Big Pharma Players: Distribution by Type of Initiative
Table 29.56 Big Pharma Players: Distribution by Type of Expansion
Table 29.57 Big Pharma Players: Distribution by Scale of Operation
Table 29.58 Big Pharma Players: Distribution by Type of Biologic Manufactured
Table 29.59 Big Pharma Players: Distribution by Purpose of Initiative and Company
Table 29.60 Big Pharma Players: Distribution by Year and Type of Initiative
Table 29.61 Big Pharma Players: Distribution by Region of Expansion and Company
Table 29.62 Partnerships and Collaborations: Cumulative Year-wise Trend, 2015-2022
Table 29.63 Partnerships and Collaborations: Distribution by Type of Partnership
Table 29.64 Partnerships and Collaborations: Distribution by Type of Biologic Manufactured
Table 29.65 Partnerships and Collaborations: Distribution by Year of Partnership and Type of Biologic Manufactured
Table 29.66 Partnerships and Collaborations: Distribution by Type of Biologic Manufactured and Geography
Table 29.67 Partnerships and Collaborations: Distribution by Therapeutic Area
Table 29.68 Most Active Players: Distribution by Number of Partnerships
Table 29.69 Partnerships and Collaborations: Local and International Agreements
Table 29.70 Mergers and Acquisitions: Cumulative Year-Wise Trend (2015-2022)
Table 29.71 Mergers and Acquisitions: Distribution by Type of Acquisition
Table 29.72 Mergers and Acquisitions: Distribution by Region (Continent-wise)
Table 29.73 Mergers and Acquisitions: Distribution by Region (Country-wise)
Table 29.74 Mergers and Acquisitions: Year-Wise Trend in North America, Europe and Asia- Pacific (2015-2022)
Table 29.75 Most Active Acquirers: Distribution by Number of Acquisitions
Table 29.76 Mergers and Acquisitions: Distribution by Key Value Drivers
Table 29.77 Mergers and Acquisitions: Distribution by Year of Acquisition and Key Value Drivers
Table 29.78 Mergers and Acquisitions: Distribution by Type of Biologic Manufactured
Table 29.79 Mergers and Acquisitions: Distribution by Key Value Drivers and Type of Biologic Manufactured
Table 29.80 Mergers and Acquisitions: Year-wise Trend of Deal Multiple Amount (USD Million)
Table 29.81 Recent Expansions: Cumulative Year-wise Trend, 2016-2022
Table 29.82 Recent Expansions: Distribution by Purpose of Expansion
Table 29.83 Recent Expansions: Distribution by Year and Purpose of Expansion
Table 29.84 Recent Expansions: Distribution by Type of Biologic Manufactured
Table 29.85 Recent Expansions: Distribution by Purpose of Expansion and Type of Biologic Manufactured
Table 29.86 Recent Expansions: Distribution by Location of Expanded Facility
Table 29.87 Most Active Players: Distribution by Number of Recent Expansions
Table 29.88 Recent Expansions: Distribution by Location of Headquarters and Purpose of Expansion
Table 29.89 Recent Expansions: Distribution by Amount Invested (USD Million)
Table 29.90 Funding and Investment Analysis: Cumulative Year-wise Trend of Number of Funding Instances, 2016-2022
Table 29.91 Funding and Investment Analysis: Cumulative Year-wise Trend of Total Amount Invested, 2016-2022 (USD Million)
Table 29.92 Funding and Investment Analysis: Distribution of Number of Funding Instances by Type of Funding
Table 29.93 Funding and Investment Analysis: Distribution of Total Amount Invested by Type of Funding (USD Million)
Table 29.94 Funding and Investment Analysis: Distribution by Year and Type of Funding, 2016-2022
Table 29.95 Funding and Investment Analysis: Distribution of Number of Funding Instances and Total Amount Invested by Geography (Continent-wise) (USD Million)
Table 29.96 Funding and Investment Analysis: Distribution of Number of Funding Instances and Total Amount Invested by Geography (Country-wise) (USD Million)
Table 29.97 Most Active Players: Distribution by Number of Funding Instances
Table 29.98 Most Active Players: Distribution by Total Amount Raised (USD Million)
Table 29.99 Most Active Investors: Distribution by Number of Funding Instances
Table 29.100 Capacity Analysis: Distribution by Company Size
Table 29.101 Capacity Analysis: Distribution by Type of Expression System Used
Table 29.102 Capacity Analysis: Distribution by Scale of Operation
Table 29.103 Capacity Analysis: Distribution by Region
Table 29.104 Capacity Analysis: Biopharmaceutical Contract Manufacturing Capacity in North America
Table 29.105 Capacity Analysis: Biopharmaceutical Contract Manufacturing Capacity in Europe
Table 29.106 Capacity Analysis: Biopharmaceutical Contract Manufacturing Capacity in Asia- Pacific
Table 29.107 Global Demand for Biopharmaceuticals, 2022-2035 (in kilograms)
Table 29.108 Demand Analysis: Distribution of Annual Demand by Therapeutic Area
Table 29.109 Demand and Supply Scenario for Biopharmaceuticals, 2022-2035 (Million Liters)
Table 29.110 Demand Analysis: Annual Demand for ADC Therapeutics (in kilograms), 2022- 2030
Table 29.111 Global Demand for Cell Therapies, 2022-2030 (in terms of Number of Patients)
Table 29.112 Global Demand for Cell Therapies, 2022-2030 (Billion Cells)
Table 29.113 Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations, 2022-2042 (USD Million)
Table 29.114 Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations: Distribution by CAPEX and OPEX, 2023 and 2042 (USD Million)
Table 29.115 Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations, 2023: Distribution of CAPEX (USD Million)
Table 29.116 Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations, 2023-2042: Distribution by OPEX (USD Million)
Table 29.117 Global Biopharmaceutical Contract Manufacturing Market, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.118 Biopharmaceutical Contract Manufacturing Market: Distribution by Type of Service(s) Offered, 2022 and 2035
Table 29.119 Biopharmaceutical Contract Manufacturing Market for APIs, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.120 Biopharmaceutical Contract Manufacturing Market for FDFs, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.121 Biopharmaceutical Contract Manufacturing Market: Distribution by Type of Biologic Manufactured
Table 29.122 Biopharmaceutical Contract Manufacturing Market for Antibodies, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.123 Biopharmaceutical Contract Manufacturing Market for Cell Therapies, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.124 Biopharmaceutical Contract Manufacturing Market for Vaccines, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.125 Biopharmaceutical Contract Manufacturing Market for Other Biologics, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.126 Biopharmaceutical Contract Manufacturing Market: Distribution by Type of Expression System Used
Table 29.127 Biopharmaceutical Contract Manufacturing Market for Mammalian Cell-based Operations, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.128 Biopharmaceutical Contract Manufacturing Market for Microbial Cell-based Operations, Conservative, Base and Optimistic Scenarios 2022-2035 (USD Billion)
Table 29.129 Biopharmaceutical Contract Manufacturing Market for Other Expression System- based Operations, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.130 Biopharmaceutical Contract Manufacturing Market: Distribution by Scale of Operation
Table 29.131 Biopharmaceutical Contract Manufacturing Market for Preclinical / Clinical Operations, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.132 Biopharmaceutical Contract Manufacturing Market for Commercial Operations, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.133 Biopharmaceutical Contract Manufacturing Market: Distribution by Company Size
Table 29.134 Biopharmaceutical Contract Manufacturing Market for Small Companies, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.135 Biopharmaceutical Contract Manufacturing Market for Mid-sized Companies, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.136 Biopharmaceutical Contract Manufacturing Market for Large and Very Large Companies, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.137 Biopharmaceutical Contract Manufacturing Market: Distribution by Geography
Table 29.138 Biopharmaceutical Contract Manufacturing Market in North America, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.139 Biopharmaceutical Contract Manufacturing Market in the US, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.140 Biopharmaceutical Contract Manufacturing Market in Canada, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.141 Biopharmaceutical Contract Manufacturing Market in Europe, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.142 Biopharmaceutical Contract Manufacturing Market in Italy, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.143 Biopharmaceutical Contract Manufacturing Market in Germany, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.144 Biopharmaceutical Contract Manufacturing Market in France, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.145 Biopharmaceutical Contract Manufacturing Market in Spain, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.146 Biopharmaceutical Contract Manufacturing Market in the UK, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.147 Biopharmaceutical Contract Manufacturing Market in Rest of Europe, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.148 Biopharmaceutical Contract Manufacturing Market in Asia-Pacific, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.149 Biopharmaceutical Contract Manufacturing Market in China, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.150 Biopharmaceutical Contract Manufacturing Market in India, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.151 Biopharmaceutical Contract Manufacturing Market in South Korea, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.152 Biopharmaceutical Contract Manufacturing Market in Japan, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.153 Biopharmaceutical Contract Manufacturing Market in Rest of Asia-Pacific, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.154 Biopharmaceutical Contract Manufacturing Market in Latin America, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.155 Biopharmaceutical Contract Manufacturing Market in Middle East and North Africa, Conservative, Base and Optimistic Scenarios, 2022-2035 (USD Billion)
Table 29.156 Overall Share of Virtual Biopharmaceutical Companies in the Biopharmaceutical Market in 2022 (USD Billion)
Table 29.157 Global Biopharmaceuticals Market: Distribution of Number of FDA Approvals by Year, 2005-2022
Table 29.158 Survey Analysis: Distribution of Respondents by Company Type
Table 29.159 Survey Analysis: Distribution of Respondents by Location of Headquarters
Table 29.160 Survey Analysis: Distribution of Respondents by Designation
Table 29.161 Survey Analysis: Distribution by Biologics Manufacturing Expertise
Table 29.162 Survey Analysis: Distribution by Scale of Manufacturing
Table 29.163 Survey Analysis: Distribution by Location of Production Facilities
Table 29.164 Survey Analysis: Distribution by Type of Expression System Used
Table 29.168 Survey Analysis: Distribution by Mode of Operation of Bioreactor

LIST OF FIGURES

Figure 2.1 Executive Summary: Overall Market Landscape
Figure 2.2 Executive Summary: Partnerships and Collaborations
Figure 2.3 Executive Summary: Mergers and Acquisitions
Figure 2.4 Executive Summary: Recent Expansions
Figure 2.5 Executive Summary: Demand Analysis
Figure 2.6 Executive Summary: Market Forecast and Opportunity Analysis
Figure 3.1 Types of Biopharmaceuticals
Figure 3.2 Types of Expression Systems Used for the Production of Biopharmaceuticals
Figure 3.3 Stages of the Biomanufacturing Process
Figure 3.4 Types of Third-Party Service Providers
Figure 3.5 Commonly Outsourced Biopharmaceutical Contract Manufacturing Operations
Figure 4.1 Biopharmaceutical Contract Manufacturers: Distribution by Year of Establishment
Figure 4.2 Biopharmaceutical Contract Manufacturers: Distribution by Company Size
Figure 4.3 Biopharmaceutical Contract Manufacturers: Distribution by Location of Headquarters (Region-wise)
Figure 4.4 Biopharmaceutical Contract Manufacturers: Distribution by Location of Headquarters (Country-wise)
Figure 4.5 Biopharmaceutical Contract Manufacturers: Distribution by Company Size, Year of Establishment and Location of Headquarters
Figure 4.6 Biopharmaceutical CMOs: Distribution by Type of Service(s) Offered
Figure 4.7 Biopharmaceutical CMOs: Distribution by Type of Biologic Manufactured
Figure 4.8 Biopharmaceutical Contract Manufacturers: Distribution by Type of Biologic Manufactured and Location of Headquarters
Figure 4.9 Biopharmaceutical Contract Manufacturers: Distribution by Type of Biologic Manufactured and Company Size
Figure 4.10 Biopharmaceutical Contract Manufacturers: Distribution by Scale of Operation
Figure 4.11 Biopharmaceutical Contract Manufacturers: Distribution by Type of Biologic Manufactured and Scale of Operation
Figure 4.12 Biopharmaceutical Contract Manufacturers: Distribution by Type of Expression System Used
Figure 4.13 Biopharmaceutical Contract Manufacturers: Distribution by Types of Expression Systems Used and Location of Headquarters
Figure 4.14 Biopharmaceutical Contract Manufacturers: Distribution by Type of Bioreactor Used
Figure 4.15 Biopharmaceutical Contract Manufacturers: Distribution by Mode of Operation of Bioreactor
Figure 5.1 Regional Distribution of Biopharmaceutical Contract Manufacturing Facilities
Figure 5.2 Biopharmaceutical Contract Manufacturing Facilities: Distribution by Type of Service(s) Offered
Figure 5.3 Biopharmaceutical Contract Manufacturing Facilities: Distribution by Scale of Operation
Figure 5.4 Biopharmaceutical Contract Manufacturing Facilities: Distribution by Type of Expression System Used
Figure 5.5 Regional Capability Analysis: Biopharmaceutical Contract Manufacturers in North America
Figure 5.6 Regional Capability Analysis: Biopharmaceutical Contract Manufacturers in Europe
Figure 5.7 Regional Capability Analysis: Biopharmaceutical Contract Manufacturers in Asia-Pacific and Rest of the World
Figure 6.1 Biopharmaceutical Industry: The US Market Scenario
Figure 6.2 Biopharmaceutical Contract Manufacturing in the US: Growth Drivers and Challenges
Figure 6.3 US FDA Guidelines: Elements of a Quality Agreement
Figure 6.4 US FDA Guidelines: Key Considerations for Biologic Manufacturing Operations
Figure 6.5 AGC Biologics: Annual Revenues, FY 2017-Q1 2022 (JPY Billion)
Figure 6.6 Catalent: Service Portfolio
Figure 6.7 Catalent: Biosimilars Service Portfolio
Figure 6.8 Catalent: Annual Revenues, FY 2017-9M 2022 (USD Million)
Figure 6.9 Cytiva: Service Portfolio
Figure 6.10 Cytiva: Annual Revenues, FY 2017-FY 2021 (USD Million)
Figure 6.11 FUJIFILM Diosynth Biotechnologies: Service Portfolio
Figure 6.12 FUJIFILM Diosynth Biotechnologies: Annual Revenues, FY 2017-FY 2021 (JPY Billion)
Figure 6.13 FUJIFILM Holdings: Annual Revenues by Business Divisions (JPY Billion)
Figure 6.14 KBI Biopharma: Service Portfolio
Figure 6.15 Patheon: Service Portfolio
Figure 6.16 Patheon: Services and Solutions for Biologics
Figure 6.17 Patheon: Annual Revenues, FY 2017-FY 2021 (USD Million)
Figure 6.18 Piramal Enterprises: Annual Revenues, FY 2017-FY 2021 (INR Crores)
Figure 7.1 Biopharmaceutical Contract Manufacturing in Europe: Growth Drivers and Challenges
Figure 7.2 EMA GMP Guidelines: Key Considerations of the Contract Giver, Contract Acceptor and the Contract
Figure 7.3 Boehringer Ingelheim: Service Portfolio
Figure 7.4 Boehringer Ingelheim: Annual Revenues, FY 2017-FY 2021 (EUR Billion)
Figure 7.5 Lonza: Service Portfolio
Figure 7.6 Lonza: Annual Revenues, FY 2017-FY 2021 (CHF Billion)
Figure 7.7 Lonza: Annual Revenues by Business Divisions (CHF Billion)
Figure 7.8 Novasep: Product Portfolio
Figure 7.9 Rentschler Biopharma: Service Portfolio
Figure 7.10 Sandoz: Annual Revenues, FY 2017-Q1 2022 (USD Billion)
Figure 8.1 Chinese Regulatory Guidelines: Key Considerations of the Contract Giver
Figure 8.2 Chinese Regulatory Guidelines: Key Considerations of the Contract Acceptor
Figure 8.3 Chinese Regulatory Guidelines: Key Aspects of the Contract
Figure 8.4 Biopharmaceutical Contract Manufacturing in China: Challenges
Figure 8.5 WuXi Biologics: Service Portfolio
Figure 8.6 Wuxi Biologics: Annual Revenues, FY 2017-FY 2021 (RMB Million)
Figure 8.7 Biopharmaceutical Contract Manufacturing in India: Growth Drivers
Figure 8.8 Biopharmaceutical Contract Manufacturing in India: Challenges
Figure 8.9 Minaris Regenerative Medicine: Service Portfolio
Figure 8.10 Takara Bio: Service Portfolio
Figure 8.11 Takara Bio: Annual Revenues, FY 2017-FY 2021 (JPY Million)
Figure 8.12 Celltrion: Service Portfolio
Figure 8.13 Celltrion: Annual Revenues, FY 2017-Q1 2022 (KRW Billion)
Figure 8.14 Samsung BioLogics: Service Portfolio
Figure 8.15 Samsung BioLogics: Annual Revenues, FY 2017-Q1 2022 (KRW Billion)
Figure 8.16 Cell Therapies: Service Portfolio
Figure 8.17 Luina Bio: Service Portfolio
Figure 9.1 Structure of a Bispecific Antibody
Figure 9.2 Bispecific Antibody Therapeutics Pipeline: Distribution by Phase of Development
Figure 9.3 Bispecific Antibody Therapeutics Pipeline: Distribution by Target Indication
Figure 9.4 Structure of an Antibody Drug Conjugate (ADC)
Figure 9.5 Antibody Drug Conjugates: Distribution by Status of Development
Figure 9.6 Antibody Drug Conjugates: Distribution by Target Indication
Figure 9.7 Key ADC Technology Providers: Distribution by Number of Candidates
Figure 9.8 Decentralized Manufacturing: Process Model
Figure 9.9 Cell Therapy Manufacturing: Challenges and Growth Drivers
Figure 9.10 Cell Therapy: Potency as Critical Quality Attribute
Figure 9.11 Stem Cell Therapies: Distribution by Phase of Development
Figure 9.12 T-Cell Therapies: Distribution by Phase of Development
Figure 9.13 Gene Therapies: Distribution by Stage of Development
Figure 9.14 Gene Therapies: Distribution by Phase of Development
Figure 9.15 Clinical and Commercial Pipeline of Gene Therapies: Distribution by Type of Vector Used
Figure 9.16 Early-Stage Pipeline of Gene Therapies: Distribution by Type of Vector Used
Figure 9.17 Clinical and Commercial Pipeline of Gene Therapies: Distribution by Therapeutic Area
Figure 9.18 Early-Stage Pipeline of Gene Therapies: Distribution by Therapeutic Area
Figure 9.19 Viral Vector Manufacturers: Distribution by Location of Manufacturing Facility
Figure 9.20 Plasmid DNA Manufacturers: Distribution by Location of Manufacturing Facility
Figure 10.1 Manufacturing Stages of a Biosimilar Product
Figure 10.2 Analytical and Functional Characterization Methods for Key Biosimilar Product
Figure 10.3 Regulatory Process Adopted for Licensing of a Biosimilar Product
Figure 10.4 Need for Outsourcing Biosimilar Manufacturing Operations
Figure 10.5 Biosimilars: Historical Trend of FDA Approval, 2015-2021
Figure 10.6 Challenges Associated with Outsourcing Biosimilar Manufacturing Operations
Figure 11.1 Small Molecule and Large Molecule Drugs: Historical Trend of FDA Approval, 2005-2021
Figure 11.2 Small Molecules versus Large Molecules: Comparison of Manufacturing Process
Figure 12.1 Benefits Associated with In-House Manufacturing
Figure 12.2 Risks Associated with In-House Manufacturing
Figure 12.3 Advantages and Disadvantages of Different Types of Outsourcing Partnerships
Figure 13.1 Make versus Buy Decision Making Framework
Figure 13.2 Make versus Buy Decision Making: Possible Scenario Descriptions
Figure 14.1 Big Pharma Players: Distribution by Number of Biopharmaceutical Contract Manufacturing Focused Initiatives, 1980-2022
Figure 14.2 Big Pharma Players: Cumulative Distribution by Year of Initiative
Figure 14.3 Big Pharma Players: Distribution by Purpose of Initiative
Figure 14.4 Big Pharma Players: Distribution by Type of Initiative
Figure 14.5 Big Pharma Players: Distribution by Type of Partnership
Figure 14.6 Big Pharma Players: Distribution by Type of Expansion
Figure 14.7 Big Pharma Players: Distribution by Scale of Operation
Figure 14.8 Big Pharma Players: Distribution by Type of Biologic Manufactured
Figure 14.9 Big Pharma Players: Distribution by Year of Initiative and Company (Heat Map Representation)
Figure 14.10 Big Pharma Players: Distribution by Purpose of Initiative and Company
Figure 14.11 Big Pharma Players: Distribution by Year and Type of Initiative
Figure 14.12 Big Pharma Players: Distribution by Region of Expansion and Company
Figure 14.13 Big Pharma Players: Distribution by Type of Biologic Manufactured and Company
Figure 14.14 Big Pharma Players: Distribution of Top Pharmaceutical Companies (Heat Map Representation)
Figure 15.1 Partnerships and Collaborations: Cumulative Year-wise Trend, 2015-2022
Figure 15.2 Partnerships and Collaborations: Distribution by Type of Partnership
Figure 15.3 Partnerships and Collaborations: Distribution by Year and Type of Partnership
Figure 15.4 Partnerships and Collaborations: Distribution by Type of Biologic Manufactured
Figure 15.5 Partnerships and Collaborations: Distribution by Year of Partnership and Type of Biologic Manufactured
Figure 15.6 Partnerships and Collaborations: Distribution by Type of Partnership and Type of Biologic Manufactured
Figure 15.7 Partnerships and Collaborations: Distribution by Type of Biologic Manufactured and Geography
Figure 15.8 Partnerships and Collaborations: Distribution by Therapeutic Area
Figure 15.9 Most Active Players: Distribution by Number of Partnerships
Figure 15.10 Partnerships and Collaborations: Intracontinental and Intercontinental Agreements
Figure 15.11 Partnerships and Collaborations: Local and International Agreements
Figure 16.1 Mergers and Acquisitions: Year-Wise Cumulative Trend (2015- 2022)
Figure 16.2 Mergers and Acquisitions: Distribution by Type of Acquisition
Figure 16.3 Mergers and Acquisitions: Distribution by Region (Continent-wise)
Figure 16.4 Mergers and Acquisitions: Distribution by Region (Country-wise)
Figure 16.5 Mergers and Acquisitions: Year-Wise Trend in North America, Europe and Asia-Pacific (2015- 2022)
Figure 16.6 Most Active Acquirers: Distribution by Number of Acquisitions
Figure 16.7 Catalent Biologics: Information on Key Acquisitions
Figure 16.8 Mergers and Acquisitions: Distribution by Key Value Drivers
Figure 16.9 Mergers and Acquisitions: Distribution by Year of Acquisition and Key Value Drivers
Figure 16.10 Mergers and Acquisitions: Distribution by Type of Biologic Manufactured
Figure 16.11 Mergers and Acquisitions: Distribution by Key Value Drivers and Type of Biologic Manufactured
Figure 16.12 Mergers and Acquisitions: Year-Wise Trend of Deal Multiple Amount (USD Million)
Figure 17.1 Recent Expansions: Cumulative Year-wise Trend, 2016-2022
Figure 17.2 Recent Expansions: Distribution by Purpose of Expansion
Figure 17.3 Recent Expansions: Distribution by Year and Purpose of Expansion
Figure 17.4 Recent Expansions: Distribution by Type of Biologic Manufactured
Figure 17.5 Recent Expansions: Distribution by Purpose of Expansion and Type of Biologic Manufactured
Figure 17.6 Recent Expansions: Distribution by Location of Expanded Facility
Figure 17.7 Most Active Players: Distribution by Number of Recent Expansions
Figure 17.8 Recent Expansions: Distribution by Location of Headquarters and Purpose of Expansion
Figure 17.9 Recent Expansions: Distribution by Amount Invested (USD Million)
Figure 17.10 Recent Expansions: Regional Comparison 2016-2020 and 2016-2022 Scenario
Figure 18.1 Funding and Investment Analysis: Cumulative Year-wise Trend of Number of Funding Instances, 2016-2022
Figure 18.2 Funding and Investments: Cumulative Year-wise Trend of Total Amount Invested, 2016-2022 (USD Million)
Figure 18.3 Funding and Investment Analysis: Distribution of Number of Instances by Type of Funding
Figure 18.4 Funding and Investment Analysis: Distribution of Total Amount Invested by Type of Funding (USD Million)
Figure 18.5 Funding and Investment Analysis: Distribution by Year and Type of Funding
Figure 18.6 Funding and Investment Analysis: Distribution of Number of Funding Instances and Total Amount Invested by Geography (Continent-wise) (USD Million)
Figure 18.7 Funding and Investment Analysis: Distribution of Number of Funding Instances and Total Amount Invested by Geography (Country-wise) (USD Million)
Figure 18.8 Most Active Players: Distribution by Number of Funding Instances
Figure 18.9 Most Active Players: Distribution by Total Amount Invested (USD Million)
Figure 18.10 Most Active Investors: Analysis by Number of Funding Instances
Figure 19.1 Capacity Analysis: Distribution by Company Size
Figure 19.2 Capacity Analysis: Distribution by Type of Expression System Used
Figure 19.3 Capacity Analysis: Distribution by Scale of Operation
Figure 19.4 Capacity Analysis: Distribution by Region
Figure 19.5 Capacity Analysis: Biopharmaceutical Contract Manufacturing Capacity in North America
Figure 19.6 Capacity Analysis: Biopharmaceutical Contract Manufacturing Capacity in Europe
Figure 19.7 Capacity Analysis: Biopharmaceutical Contract Manufacturing Capacity in Asia-Pacific
Figure 20.1 Global Demand for Biopharmaceuticals, 2022-2035 (in kilograms)
Figure 20.2 Demand Analysis: Distribution of Annual Demand by Therapeutic Area
Figure 20.3 Demand and Supply Scenario for Biopharmaceuticals, 2022-2035 (Million Liters)
Figure 20.4 Demand Analysis: Annual Demand for ADC Therapeutics (in kilograms), 2022-2030
Figure 20.5 ADC Therapeutics: Demand and Supply Scenario, 2022-2030
Figure 20.6 Global Demand for Cell Therapies, 2022-2030 (in terms of Number of Patients)
Figure 20.7 Global Demand for Cell Therapies, 2022-2030 (Billion Cells)
Figure 21.1 Total Cost of Ownership: Capital Expenditures (CAPEX)
Figure 21.2 Total Cost of Ownership: Operational Expenditures (OPEX)
Figure 21.3 Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations, 2022-2042 (USD Million)
Figure 21.4 Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations: Distribution by CAPEX and OPEX, 2023 and 2042 (USD Million)
Figure 21.5 Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations, 2023: Distribution by CAPEX (USD Million)
Figure 21.6 Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations, 2023-2042: Distribution by OPEX (USD Million)
Figure 22.1 Global Biopharmaceutical Contract Manufacturing Market, 2022-2035 (USD Billion)
Figure 22.2 Biopharmaceutical Contract Manufacturing Market: Distribution by Type of Service(s) Offered
Figure 22.3 Biopharmaceutical Contract Manufacturing Market for APIs, 2022-2035 (USD Billion)
Figure 22.4 Biopharmaceutical Contract Manufacturing Market for FDFs, 2022-2035 (USD Billion)
Figure 22.5 Biopharmaceutical Contract Manufacturing Market: Distribution by Type of Biologic Manufactured
Figure 22.6 Biopharmaceutical Contract Manufacturing Market for Antibodies, 2022-2035 (USD Billion)
Figure 22.7 Biopharmaceutical Contract Manufacturing Market for Cell Therapies, 2022-2035 (USD Billion)
Figure 22.8 Biopharmaceutical Contract Manufacturing Market for Vaccines, 2022-2035 (USD Billion)
Figure 22.9 Biopharmaceutical Contract Manufacturing Market for Other Biologics, 2022-2035 (USD Billion)
Figure 22.10 Biopharmaceutical Contract Manufacturing Market: Distribution by Type of Expression System Used
Figure 22.11 Biopharmaceutical Contract Manufacturing Market for Mammalian Cell-based Operations, 2022-2035 (USD Billion)
Figure 22.12 Biopharmaceutical Contract Manufacturing Market for Microbial Cell-based Operations, 2022-2035 (USD Billion)
Figure 22.13 Biopharmaceutical Contract Manufacturing Market for Other Expression System-based Operations, 2022-2035 (USD Billion)
Figure 22.14 Biopharmaceutical Contract Manufacturing Market: Distribution by Scale of Operation
Figure 22.15 Biopharmaceutical Contract Manufacturing Market for Clinical Operations, 2022-2035 (USD Billion)
Figure 22.16 Biopharmaceutical Contract Manufacturing Market for Commercial Operations, 2022-2035 (USD Billion)
Figure 22.17 Biopharmaceutical Contract Manufacturing Market: Distribution by Company Size
Figure 22.18 Biopharmaceutical Contract Manufacturing Market for Small Companies, 2022-2035 (USD Billion)
Figure 22.19 Biopharmaceutical Contract Manufacturing Market for Mid-sized Companies, 2022-2035 (USD Billion)
Figure 22.20 Biopharmaceutical Contract Manufacturing Market for Large and Very Large Companies, 2022-2035 (USD Billion)
Figure 22.21 Biopharmaceutical Contract Manufacturing Market: Distribution by Geography
Figure 22.22 Biopharmaceutical Contract Manufacturing Market in North America, 2022-2035 (USD Billion)
Figure 22.23 Biopharmaceutical Contract Manufacturing Market in the US, 2022-2035 (USD Billion)
Figure 22.24 Biopharmaceutical Contract Manufacturing Market in Canada, 2022-2035 (USD Billion)
Figure 22.25 Biopharmaceutical Contract Manufacturing Market in Europe, 2022-2035 (USD Billion)
Figure 22.26 Biopharmaceutical Contract Manufacturing Market in Italy, 2022-2035 (USD Billion)
Figure 22.27 Biopharmaceutical Contract Manufacturing Market in Germany, 2022-2035 (USD Billion)
Figure 22.28 Biopharmaceutical Contract Manufacturing Market in France, 2022-2035 (USD Billion)
Figure 22.29 Biopharmaceutical Contract Manufacturing Market in Spain, 2022-2035 (USD Billion)
Figure 22.30 Biopharmaceutical Contract Manufacturing Market in the UK, 2022-2035 (USD Billion)
Figure 22.31 Biopharmaceutical Contract Manufacturing Market in Rest of Europe, 2022-2035 (USD Billion)
Figure 22.32 Biopharmaceutical Contract Manufacturing Market in Asia-Pacific, 2022-2035 (USD Billion)
Figure 22.33 Biopharmaceutical Contract Manufacturing Market in China, 2022-2035 (USD Billion)
Figure 22.34 Biopharmaceutical Contract Manufacturing Market in India, 2022-2035 (USD Billion)
Figure 22.35 Biopharmaceutical Contract Manufacturing Market in South Korea, 2022-2035 (USD Billion)
Figure 22.36 Biopharmaceutical Contract Manufacturing Market in Japan, 2022-2035 (USD Billion)
Figure 22.37 Biopharmaceutical Contract Manufacturing Market in Rest of Asia-Pacific, 2022-2035 (USD Billion)
Figure 22.38 Biopharmaceutical Contract Manufacturing Market in Latin America, 2022-2035 (USD Billion)
Figure 22.39 Biopharmaceutical Contract Manufacturing Market in Middle East and North Africa, 2022-2035 (USD Billion)
Figure 23.1 Overall Share of Virtual Biopharmaceutical Companies in the Biopharmaceutical Market (USD Billion)
Figure 23.2 Overall Share of Virtual Biopharmaceutical Companies in the Biopharmaceutical Contract Manufacturing Market in 2022 (USD Billion)
Figure 24.1 Biopharmaceutical Contract Manufacturing: SWOT Analysis
Figure 24.2 Global Biopharmaceuticals Market: Distribution of Number of FDA Approvals by Year, 2005-2022
Figure 24.3 Comparison of SWOT Factors: Harvey Ball Analysis
Figure 26.1 Survey Analysis: Distribution of Respondents by Company Type
Figure 26.2 Survey Analysis: Distribution of Respondents by Location of Headquarters
Figure 26.3 Survey Analysis: Distribution of Respondents by Designation
Figure 26.4 Survey Analysis: Distribution by Biologics Manufacturing Expertise
Figure 26.5 Survey Analysis: Distribution by Scale of Manufacturing
Figure 26.6 Survey Analysis: Distribution by Location of Production Facilities
Figure 26.7 Survey Analysis: Distribution by Type of Expression System Used
Figure 26.8 Survey Analysis: Distribution by Type of Bioreactor Used
Figure 26.9 Survey Analysis: Distribution by Mode of Operation of Bioreactor
Figure 27.1 Concluding Remarks: Overall Market Landscape
Figure 27.2 Concluding Remarks: Partnerships and Collaborations
Figure 27.3 Concluding Remarks: Mergers and Acquisitions
Figure 27.4 Concluding Remarks: Recent Expansions
Figure 27.5 Concluding Remarks: Capacity Analysis
Figure 27.6 Concluding Remarks: Demand Analysis
Figure 27.7 Concluding Remarks: Market Forecast and Opportunity Analysis
Figure 27.8 Concluding Remarks: Market Forecast and Opportunity Analysis

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生物醫藥品受託製造的全球市場:各提供服務類型，各製造的生物製藥類型，所使用的表現系統類別，各產業規模，不同企業規模，主要各地區 - 產業趨勢與預測(2022年～2035年)

Biopharmaceutical Contract Manufacturing Market by Type of Service Offered, Type of Biologic Manufactured, Type of Expression System Used, Scale of Operation, Company Size, and Key Geographical Regions : Industry Trends and Global Forecasts, 2022 - 2035

目錄

第1章 序文

第2章 摘要整理

第3章 簡介

第4章 市場形勢

第5章 地區的生產能力分析

第6章 北美的生物醫藥品受託製造

第7章 歐洲的生物醫藥品受託製造

第8章 亞太地區·其他地區的生物醫藥品受託製造

第9章 最適合的生物醫藥品部門

第10章 案例研究:生物相似藥的外包

第11章 案例研究:低分子·高分子的醫藥品/治療的比較

第12章 案例研究:公司內部製造

第13章 製造 vs. 購買的決策架構

第14章 大型製藥公司的主張

第15章 夥伴關係和合作

第16章 M&A

第17章 最近的擴張

第18章 最近的發展

第19章 生產能力分析

第20章 需求分析

第21章 生物醫藥品受託製造組織的總持有成本

第22章 市場預測與機會分析

第23章 案例研究:虛擬製藥企業

第24章 SWOT分析

第25章 生物醫藥品CMO市場未來

第26章 調查分析

第27章 結論

第28章 採訪記錄

第29章 附錄I:表格形式的資料

第30章 附錄II:企業/組織的清單

INTRODUCTION

SCOPE OF THE REPORT

KEY QUESTIONS ANSWERED

CHAPTER OUTLINES

TABLE OF CONTENTS

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION

4. MARKET LANDSCAPE

5. REGIONAL CAPABILITY ANALYSIS

6. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN NORTH AMERICA

7. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN EUROPE

8. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN ASIA-PACIFIC AND THE REST OF THE WORLD

9. NICHE BIOPHARMACEUTICAL SECTORS

10. CASE STUDY: OUTSOURCING OF BIOSIMILARS

11. CASE STUDY: COMPARISON OF SMALL AND LARGE MOLECULES DRUGS / THERAPIES

12. CASE STUDY: IN-HOUSE MANUFACTURING

13. MAKE VERSUS BUY DECISION MAKING FRAMEWORK

14. BIG PHARMA INITIATIVES

15. PARTNERSHIPS AND COLLABORATIONS

16. MERGERS AND ACQUISITIONS

17. RECENT EXPANSIONS

18. RECENT DEVELOPMENTS

19. CAPACITY ANALYSIS

20. DEMAND ANALYSIS

21. TOTAL COST OF OWNERSHIP FOR BIOPHARMACEUTICAL CONTRACT MANUFACTURING ORGANIZATIONS

22. MARKET FORECAST AND OPPORTUNITY ANALYSIS

23. CASE STUDY: VIRTUAL PHARMACEUTICAL COMPANIES

24. SWOT ANALYSIS

25. FUTURE OF THE BIOPHARMACEUTICAL CMO MARKET

26. SURVEY ANALYSIS

27. CONCLUSION

28. INTERVIEW TRANSCRIPTS

29. APPENDIX I: TABULATED DATA

30. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

LIST OF TABLES

LIST OF FIGURES

第1章序文

第2章摘要整理

第3章簡介

第4章市場形勢

第5章地區的生產能力分析

第6章北美的生物醫藥品受託製造

第7章歐洲的生物醫藥品受託製造

第8章亞太地區·其他地區的生物醫藥品受託製造

第9章最適合的生物醫藥品部門

第10章案例研究:生物相似藥的外包

第11章案例研究:低分子·高分子的醫藥品/治療的比較

第12章案例研究:公司內部製造

第13章製造 vs. 購買的決策架構

第14章大型製藥公司的主張

第15章夥伴關係和合作

第17章最近的擴張

第18章最近的發展

第19章生產能力分析

第20章需求分析

第21章生物醫藥品受託製造組織的總持有成本

第22章市場預測與機會分析

第23章案例研究:虛擬製藥企業

第25章生物醫藥品CMO市場未來

第26章調查分析

第27章結論

第28章採訪記錄

第29章附錄I:表格形式的資料

第30章附錄II:企業/組織的清單