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市場調查報告書

商品編碼

1629878

全球合約開發與製造 (CDMO) 市場 - 2025-2033

Global Contract Development and Manufacturing (CDMO) Market - 2025-2033

出版日期: 2024年12月30日 | 出版商:

DataM Intelligence | 英文 176 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

全球合約開發和製造（CDMO）市場在2024年達到1501.9億美元，預計到2033年將達到2800.7億美元，2025-2033年預測期間複合年成長率為7.4%。

合約開發和製造組織 (CDMO) 是製藥和生物技術行業的專業服務提供商，在整個藥物開發和製造過程中提供全面支援。 CDMO 透過外包產品開發、配方、製造和包裝的不同部分來幫助製藥公司簡化營運。公司可以透過與 CDMO 合作而不是維護藥物開發和製造的內部設施來節省費用。 CDMO 提供法規遵循、品質保證和現代製造技術的專業知識，有助於提高產品品質和上市速度。製藥公司可以專注於研究和行銷，而 CDMO 則負責藥物開發的技術方面。

對藥品和生物製藥產品的需求不斷成長是預測期內推動市場的促進因素。為了滿足不斷成長的藥品需求，各種組織建立了所需的製造單位和技術。例如，2024 年 9 月，龍沙在法國科爾馬開設了新製造工廠。新的 Innovaform Accelerator 將作為卓越中心，創建和創新用於口服和肺部給藥的基於膠囊的製造和輸送技術。

市場動態：

驅動程式和限制

對藥品和生物製藥產品的需求不斷成長

對藥品和生物製藥產品的需求不斷成長預計將成為全球合約開發和製造（CDMO）市場成長的重要因素。藥品和生物製藥產品需求成長的主要驅動力之一是糖尿病、癌症和心血管疾病等慢性病盛行率的上升。隨著人口老化和與生活方式相關的健康問題變得越來越頻繁，製藥公司面臨越來越大的壓力，需要快速提供有效的治療方法。這種緊迫性導致臨床試驗的增加，以及對能夠有效管理藥物開發和生產的 CDMO 服務的更大需求。

例如，2024年10月，全球合約開發和製造組織（CDMO）三星生物製品公司推出了新的高濃度製劑平台，以幫助高劑量生物製藥的開發和生產。 S-HiConTM 可以檢測不必要的 pH 值變化，提高配方穩定性，並最大限度地降低黏度，以確保功效和最大程度的藥物分佈。

此外，複雜製造技術的使用正在改變 CDMO 市場。連續生產技術越來越受歡迎，因為它們提高了效率，減少了浪費，降低了藥品生產成本。這項技術進步使 CDMO 能夠處理當前藥物的複雜需求，同時保持高品質標準。例如，2024 年 10 月，提供發現、開發和商業供應服務的完全整合 CDMO Enzene 在義大利 CPHI 米蘭活動上推出了新的 EnzeneX 2.0 技術。該專利方法是該公司用於商業生物製品供應的完全整合連續製造（FCCM）平台的延伸。

CDMO產業的另一個重要驅動力是外包趨勢的成長。當製藥公司尋求外部專業知識來加快其研發流程時，他們會向 CDMO 尋求特定知識和資源。例如，2024 年 11 月，瑞士 CDMO Siegfried 在其 Evionnaz 工廠建立了新的全球藥理化合物研發中心。佔地 4,500 平方米的設施包括化學和分析設施、實驗室以及流動化學、蒸餾和製程分析等尖端技術以及辦公空間。大約有 100 個可用工作空間，並創造了 40 個新工作。這包括用於臨床病毒載體研究的中試規模設備，以及細胞和基因療法的分析和製造服務。

嚴格的監管要求

嚴格的監管要求等因素預計將阻礙全球合約開發和製造（CDMO）市場。 CDMO 必須遵循一系列廣泛的要求，包括良好生產規範 (GMP)、良好臨床規範 (GCP) 和良好實驗室規範 (GLP)。這些要求旨在保障病患安全和產品品質，但也為 CDMO 帶來了巨大的營運負擔。 CDMO 必須投入大量資源來維護品質管理系統、教育員工並進行頻繁的審核以滿足這些標準。這種對監管合規性的持續承諾可能會給 CDMO 的財務和營運能力帶來壓力，特別是對於基礎設施或專業知識匱乏的小型公司而言。

A Contract Development and Manufacturing Organization (CDMO) is a specialized service provider in the pharmaceutical and biotechnology industries that provides full support throughout the drug development and manufacturing processes. CDMOs help pharmaceutical companies streamline their operations by outsourcing different components of product development, formulation, manufacturing, and packaging. Companies may save expense by collaborating with CDMOs instead of maintaining in-house facilities for drug development and manufacture. CDMOs contribute specialized knowledge in regulatory compliance, quality assurance, and modern manufacturing technologies, which can help improve product quality and speed to market. Pharmaceutical companies can focus on research and marketing while CDMOs handle the technical aspects of medication development.

The rising demand for pharmaceutical and biopharmaceutical products is the driving factor that drives the market over the forecast period. Inorder to meet the rising demand of pharnmaceuticals, the required manufacturing units and technologies are established by various organizations. For instance, in September 2024, Lonza inaugurated its new manufacturing plant in Colmar, France. The new Innovaform Accelerator will function as a Center of Excellence for creating and innovating capsule-based manufacturing and delivery technologies for oral and pulmonary administration.

Market Dynamics: Drivers & Restraints

Rising demand for pharmaceutical and biopharmaceutical products

The rising demand for pharmaceutical and biopharmaceutical products is expected to be a significant factor in the growth of the global contract development and manufacturing (CDMO) market. One of the primary drivers for rising demand for pharmaceutical and biopharmaceutical products is the rising prevalence of chronic diseases such as diabetes, cancer, and cardiovascular disease. As populations age and lifestyle-related health conditions become more frequent, pharmaceutical companies under increased pressure to provide effective therapies quickly. This urgency has resulted in an increase in clinical trials, as well as a greater demand for CDMO services capable of efficiently managing drug development and production.

For instance, in October 2024, Samsung Biologics, a global contract development and manufacturing organization (CDMO), has launched a new high-concentration formulation platform to help with the development and production of high-dose biopharmaceuticals. S-HiConTM can detect undesired pH changes, improve formulation stability, and minimize viscosity to ensure efficacy and maximum medication distribution.

Furthermore, the use of sophisticated manufacturing techniques is altering the CDMO market. Continuous manufacturing techniques are becoming increasingly popular because they improve efficiency and reduce waste, lowering the cost of drug production. This technical progress allows CDMOs to handle the complicated needs of current medications while maintaining high quality standards. For instance, in October 2024, Enzene, a fully integrated CDMO offering services in discovery, development, and commercial supply, launched its new EnzeneX 2.0 technology at the CPHI Milan event in Italy. The patented method is an extension of the company's fully integrated continuous manufacturing (FCCM) platform for commercial biologics supply.

Another significant driver of the CDMO industry is the growing tendency of outsourcing. As pharmaceutical companies seek external expertise to speed up their R&D processes, they turn to CDMOs for specific knowledge and resources. For instance, in November 2024, Siegfried, a Swiss CDMO, has established its new global R&D center for pharmacological compounds at its Evionnaz facility. The 4,500 m2 facility includes chemical and analytical facilities, laboratories, and cutting-edge technology such as flow chemistry, distillation, and process analytics, as well as office space. There are approximately 100 workspaces available, and 40 new jobs have been created. This includes pilot-scale equipment for clinical viral vector research, as well as analytical and manufacturing services for cell and gene therapies.

Stringent regulatory requirements

Factors such as stringent regulatory requirements are expected to hamper the global contract development and manufacturing (CDMO) market. CDMOs must follow an extensive array of requirements that include Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP). These requirements are intended to safeguard patient safety and product quality, but they also place a significant operational burden on CDMOs. CDMOs must invest significant resources in maintaining quality management systems, educating employees, and conducting frequent audits to satisfy these criteria. This ongoing commitment to regulatory compliance can put a strain on CDMOs' financial and operational capacities, particularly for smaller firms with little infrastructure or expertise.

Segment Analysis

The global contract development and manufacturing (CDMO) market is segmented based on service type, research phase, end-user and region.

Finished dosage formulation (FDF) development and manufacturing segment is expected to dominate the global contract development and manufacturing (CDMO) market share

The Finished dosage formulation (FDF) development and manufacturing segment is anticipated to dominate the global home healthcare devices market. These formulations are preferred due to their long shelf life, convenience of administration, and usefulness in controlling a variety of health issues with minimal side effects. As the global disease burden grows, the demand for effective and dependable dosage forms becomes increasingly important, establishing FDF development as a vital area of growth within the CDMO landscape. In order to develop the formulations and improve the efficiency of medication, organizations has established various production units and latest production methodologies. For instance, in November 2023, Xellia Pharmaceuticals ('Xellia'), a global pioneer in the manufacture of specialty anti-infective treatments and critical care medications, has received approval from the US FDA to manufacture its first premix bag products at its Cleveland, Ohio, facility. Production has begun, and the initial commercial quantities have been released. The Xellia team has worked closely with the FDA to bring the entire Cleveland facility into operation, securing permission for the commercial manufacturing of its first injectable medicinal product.

Another important factor driving the expansion of the FDF industry is the shift toward scientific innovation in medicine formulation. Pharmaceutical companies are increasingly investing on R&D to produce novel treatments that address changing patient needs. CDMOs play an important role in this process by providing specialized skills and resources that allow pharmaceutical companies to develop breakthrough formulations without incurring major capital expenditures in infrastructure. For instance, in November 2024, BioPharma Spec, a global contract research organization (CRO) that specializes in biopharmaceutical discovery and preclinical characterization, recently launched three new European facilities in Freiburg, Germany; Bergamo, Italy; and Vilnius, Lithuania. These facilities will focus on discovery and R&D. The facilities will provide structural and physicochemical characterization services for a broad range of biopharmaceutical goods, such as monoclonal antibodies, antibody-drug conjugates, cell and gene

Geographical Analysis

North America is expected to hold a significant position in the global contract development and manufacturing (CDMO) market share

One of the key factors driving North America's dominant position in the CDMO market is the region's pharmaceutical sector's emphasis on innovation and technological advancement. Many top-tier pharmaceutical corporations and research organizations, particularly in the United States, place an emphasis on cutting-edge drug development techniques. This emphasis on innovation encourages a collaborative atmosphere in which CDMOs can use advanced manufacturing technology and techniques to address the complicated requirements of modern pharmaceuticals. As a result, CDMOs in North America are well-equipped to tackle the complexities associated with biologics, sophisticated generics, and customized medicine, making them appealing partners for pharmaceutical corporations eager to increase their product offerings.

For instance, OmniaBio, a contract development and manufacturing organization (CDMO), has announced the inauguration of a new cell and gene therapy (CGT) manufacturing and artificial intelligence (AI) center of excellence in McMaster Innovation Park in Hamilton, Ontario, Canada. The 120,000-square-foot complex cost CAD 580 million ($417 million) to develop and will employ 250 people. OmniaBio offers services to organizations ranging from preclinical to commercial manufacturing. The new building is intended to allow the corporation to expand its reach throughout North America.

The strategic partnerships in this region, helps to propel market in this region. For instance, in March 2024, Hovione, an integrated CDMO specializing in spray drying and particle engineering, and GEA, a global process technology provider, expanded their collaboration with new development agreements, the launch of the ConsiGma CDC flex, and the installation of a new lab-scale R&D Continuous Tableting rig at Hovione's facility. The two firms combined and complementary experience of continuous tableting is being used to streamline the technology and make it more accessible to pharmaceutical customers around the world. Two teams are working together to bring continuous tableting to the same degree of maturity as batch tableting, allowing for the benefits of continuous manufacturing while minimizing the drawbacks. The presence of advanced machinery, technological advancements and strategic partnerships help to propel market in this region.

Asia Pacific is growing at the fastest pace in the global contract development and manufacturing (CDMO) market

The Asia Pacific region is emerging as the fastest-growing market for contract development and manufacturing (CDMO). This rapid rise is fueled by a number of interconnected factors, including rising pharmaceutical demand, a strong emphasis on research and development (R&D), and a substantial tendency toward outsourcing drug development and manufacturing operations. As pharmaceutical businesses aim to increase efficiency and cut costs, the Asia Pacific area has emerged as a top choice for CDMO services, owing to its lower manufacturing costs compared to North America and Europe.

The recent establishments and technological advancements propels the market in this region. For instance, in April 2024, Goldman Sachs has extended its coverage of the India CRO/CDMO (contract research organization/contract development and manufacturing organization) area as supply diversification in the global pharmaceutical sector.

Competitive Landscape

The major global players in the global contract research organizations (CROs) market include Catalent Inc, Recipharm AB, Jubilant Pharmova Limited, Thermo Fisher Scientific Inc., Boehringer Ingelheim International GmbH, IQVIA, Syneos Health, Parexel International (MA) Corporation, Curia Global, Inc., NextPharma Technologies among others.

Emerging Players

Helix Biotech, Andelyn Biosciences, and Celloid among others

Key Developments

In March 2024, Eurofins CDMO Alphora Inc., a global Contract Development & Manufacturing Organization and part of the international network of Eurofins laboratories, is pleased to announce a significant expansion of its Drug Product Analytical Services Laboratory, located in Mississauga, Canada. The expanded facility marks the addition of specialized equipment and analytical techniques, tailored to offer comprehensive analytical support for drug products.
In September 2024, Seran Bioscience, a developing CDMO, is aiming to bridge the gap between clinic and market for its customers with a significant investment sponsored by Bain Capital and the construction of a new commercial facility. Seran, which has received a $200 million investment from Bain's Life Science subsidiary, plans to develop its first commercial manufacturing plant in 2026.

Why Purchase the Report?

Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
Post-market Surveillance: Uses post-market data to enhance product safety and access.
Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global contract research organizations (CROs) market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
Supply Chain: Distribution and Supply Chain Managers.
Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
Academic & Research: Academic Institutions.

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Service Type
3.2. Snippet by Research Phase
3.3. Snippet by End-User
3.4. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
- 4.1.2. Rising Demand for Pharmaceutical and Biopharmaceutical Products
- 4.1.3. Restraints
- 4.1.4. Stringent Regulatory Requirements
- 4.1.5. Opportunity
- 4.1.6. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Reimbursement Analysis
5.6. Patent Analysis
5.7. SWOT Analysis
5.8. DMI Opinion

6. By Service Type

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Service Type
- 6.1.2. Market Attractiveness Index, By Service Type
6.2. Active Pharmaceutical Ingredient (API) Manufacturing*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Finished Dosage Formulation (FDF) Development and Manufacturing
6.4. Secondary Packaging

7. By Research Phase

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Research Phase
- 7.1.2. Market Attractiveness Index, By Research Phase
7.2. Pre-Clinical*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Phase I
7.4. Phase II
7.5. Phase III
7.6. Phase IV

8. By End-User

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 8.1.2. Market Attractiveness Index, By End-User
8.2. Pharmaceutical Companies*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Contract Research Organizations (CROs)
8.4. Generic Pharmaceutical Companies

9. By Region

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 9.1.2. Market Attractiveness Index, By Region
9.2. North America
- 9.2.1. Introduction
- 9.2.2. Key Region-Specific Dynamics
- 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Service Type
- 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Research Phase
- 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.2.6.1. The U.S.
  - 9.2.6.2. Canada
  - 9.2.6.3. Mexico
9.3. Europe
- 9.3.1. Introduction
- 9.3.2. Key Region-Specific Dynamics
- 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Service Type
- 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Research Phase
- 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.3.6.1. Germany
  - 9.3.6.2. UK
  - 9.3.6.3. France
  - 9.3.6.4. Italy
  - 9.3.6.5. Spain
  - 9.3.6.6. Rest of Europe
9.4. South America
- 9.4.1. Introduction
- 9.4.2. Key Region-Specific Dynamics
- 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Service Type
- 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Research Phase
- 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.4.6.1. Brazil
  - 9.4.6.2. Argentina
  - 9.4.6.3. Rest of South America
9.5. Asia-Pacific
- 9.5.1. Introduction
- 9.5.2. Key Region-Specific Dynamics
- 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Service Type
- 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Research Phase
- 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.5.6.1. China
  - 9.5.6.2. India
  - 9.5.6.3. Japan
  - 9.5.6.4. South Korea
  - 9.5.6.5. Rest of Asia-Pacific
9.6. Middle East and Africa
- 9.6.1. Introduction
- 9.6.2. Key Region-Specific Dynamics
- 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Service Type
- 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Research Phase
- 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

10. Competitive Landscape

10.1. Competitive Scenario
10.2. Market Positioning/Share Analysis
10.3. Mergers and Acquisitions Analysis

11. Company Profiles

11.1. Catalent Inc*
- 11.1.1. Company Overview
- 11.1.2. Product Portfolio and Description
- 11.1.3. Financial Overview
- 11.1.4. Key Developments
11.2. Recipharm AB
11.3. Jubilant Pharmova Limited
11.4. Thermo Fisher Scientific Inc.
11.5. Boehringer Ingelheim International GmbH
11.6. IQVIA
11.7. Syneos Health
11.8. Parexel International (MA) Corporation
11.9. Curia Global, Inc.
11.10. NextPharma Technologies

LIST NOT EXHAUSTIVE