查看購物車
  • Simplified Chinese
  • English
  • Japanese
  • Korean
封面
市場調查報告書
商品編碼
1552878

IND（臨床實驗新藥）CDMO 市場規模、佔有率、趨勢分析報告：按產品、服務、最終用途、地區、細分市場預測，2024-2030 年

Investigational New Drug CDMO Market Size, Share & Trends Analysis Report By Product (Small Molecule, Large Molecule), By Service (Upstream, Downstream), By End-use, By Region, And Segment Forecasts, 2024 - 2030
出版日期: | 出版商: Grand View Research | 英文 120 Pages | 商品交期: 2-10個工作天內

價格
簡介目錄

IND（臨床實驗新藥）CDMO 市場的成長與趨勢：

Grand View Research, Inc.最新報告顯示，到2030年，全球IND（在臨床實驗新藥）CDMO市場規模預計將達到77.9億美元，預測期內複合年成長率為6.9%。

這主要是由於研發投入的增加和 IND 法規的嚴格化。

美國FDA 和歐洲藥品管理局 (EMA) 是分別監管美國和歐盟臨床實驗藥物使用的衛生當局機構。此外，美國的臨床實驗審查委員會 (IRB) 和歐盟的倫理委員會 (EC) 必須核准藥物用於人類。

聯邦法律要求藥物必須經過核准的行銷申請才能在州際分銷或運輸。因此，尋求利用 IND 進行臨床試驗的申辦者必須獲得 FDA 的豁免，以允許將臨床實驗臨床實驗運送給多個州的研究人員。

疫情對2020年全球經濟產生重大影響，並持續影響各產業。然而，IND（臨床實驗新藥）CDMO市場卻從疫情中受益。在 COVID-19 之前，潛在贊助商要求進行設施審核，以確保 CDMO 擁有開展計劃所需的能力、設備和人員。 CDMO 現在需要尋找新的方法來吸引新的贊助商。例如視訊、虛擬實境和其他允許贊助商虛擬體驗場景的技術。

IND（臨床實驗新藥）CDMO 市場報告亮點

  • 從產品來看，小分子細分市場在市場上佔據主導地位，到 2023 年，其銷售佔有率將達到 88.4%。這主要是由於開發中的小分子數量不斷增加。此外， 新藥認證，小分子佔所有NME核准的79%。
  • 按服務分類，合約開發領域在 2023 年引領市場。與內部開發相比，合約開發具有多種優勢，包括接觸行業專家、更快的上市時間、成本效益以及專注於核心能力。
  • 以最終用途分類，2023年製藥公司佔最大佔有率。這是因為製藥業的變化會影響研發策略，進而影響新藥認證趨勢。
  • 亞太地區在預測期內將實現最快的成長率，達到 7.8%。隨著印度和中國等開發中國家製藥公司和受託製造廠商的快速成長，該地區很可能在不久的將來超過歐洲和北美。

目錄

第1章調查方法與範圍

第 2 章執行摘要

第3章全球 IND（臨床實驗新藥）CDMO 市場：變數、趨勢、範圍

  • 市場區隔和範圍
  • 市場動態
  • 滲透率和成長前景圖
  • COVID-19 對市場的影響
  • 主要交易及策略聯盟分析
  • 全球 IND（臨床實驗新藥）CDMO：市場分析工具

第4章全球 IND（臨床實驗新藥）CDMO 市場：產品細分分析

  • 全球 IND（臨床實驗新藥）CDMO 市場：2023 年和 2030 年產品市場佔有率分析
  • 低分子
  • 大分子

第5章全球 IND（臨床實驗藥物）CDMO 市場：按服務細分分析

  • 全球 IND（臨床實驗新藥）CDMO 市場：2023 年和 2030 年服務市場佔有率分析
  • 合約開發
  • 契約製造

第6章全球 IND（臨床實驗藥物）CDMO 市場：最終用戶的細分分析

  • 全球 IND（臨床實驗新藥）CDMO 市場：2023 年和 2030 年最終用戶市場佔有率分析
  • 製藥公司
  • 生物技術
  • 其他

第7章全球 IND（臨床實驗新藥）CDMO 市場：區域分析

  • 全球 IND（臨床實驗新藥）CDMO 市場：2023 年和 2030 年區域市場佔有率分析
  • 北美洲
  • 歐洲
  • 亞太地區
  • 拉丁美洲
  • 中東/非洲

第8章 公司簡介

  • Catalent, Inc.
  • Lonza
  • Recipharm AB
  • Siegfried Holding AG
  • Patheon Inc.
  • Covance
  • IQVIA Holdings Inc.
  • Cambrex Corporation
  • Charles River Laboratories International, Inc.
  • Syneous Health
簡介目錄
Product Code: GVR-4-68039-537-3

Investigational New Drug CDMO Market Growth & Trends:

The global investigational new drug CDMO market size is expected to reach USD 7.79 billion by 2030, registering a CAGR of 6.9% during the forecast period, according to a new report by Grand View Research, Inc. This is largely due to the increased R&D investments, along with stringent regulations pertaining to IND.

The U.S. FDA and the European Medicines Agency (EMA) are health authority bodies that regulate the use of investigational drugs in the U.S. and the European Union, respectively. In addition, investigational review boards (IRBs) in the U.S. and ethics committees (ECs) in the European Union must approve the use of drugs in humans.

It is the requirement of a federal law that a drug be the subject of an approved marketing application prior to it is distributed or transported across the state lines. Hence, sponsors aiming to conduct clinical studies that involve an IND should gain exemption from the FDA to permit the shipping of the investigational drug to clinical investigators in several states.

The pandemic has significantly impacted the global economy in 2020 and has an ongoing impact on various industries. However, the market for IND CDMO has benefited from the pandemic. Prior to COVID-19, prospective sponsors demanded facility audits to ensure CDMOs had the required capacity, equipment, and personnel to undertake their projects. Nowadays, CDMOs should find new ways to attract new sponsors, such as through videos, virtual reality, and other technologies that allow sponsors to virtually experience the site.

Investigational New Drug CDMO Market Report Highlights:

  • In terms of product, the small molecule segment dominated the market with a revenue share of 88.4% in 2023. This is largely due to the increasing number of small molecules in development. Besides, in 2019, the small molecules dominated the new drug approvals accounting for 79% of all the NME approvals
  • Based on service, the contract development segment led the market in 2023. The contract development offers several benefits over in-house development of drugs, such as access to industry experts, less time to market, cost-effectiveness, and more focus on core competencies
  • By end user, pharmaceutical companies accounted for the largest share in 2023. This is due to the changes in the pharmaceutical industry that have an impact on research and development strategies, which, in turn, influence new drug approval trends
  • Asia Pacific to register the fastest growth rate of 7.8% over the forecast period. Due to the rapid growth of pharmaceutical firms and contract manufacturing organizations in developing countries, such as India and China, the region is likely to overtake Europe and North America in the near future.

Table of Contents

Chapter 1 Methodology and Scope

  • 1.1 Market Segmentation & Scope
    • 1.1.1 Estimates And Forecast Timeline
  • 1.2 Research Methodology
  • 1.3 Information Procurement
    • 1.3.1 Purchased Database
    • 1.3.2 GVR's Internal Database
    • 1.3.3 Secondary Sources
    • 1.3.4 Primary Research
    • 1.3.5 Details of Primary Research
  • 1.4 Information or Data Analysis
    • 1.4.1 Data Analysis Models
  • 1.5 Market Formulation & Validation
  • 1.6 Region Wise Market Calculation
    • 1.6.1 Region Wise Market: Base Estimates
    • 1.6.2 Global Market: CAGR Calculation
  • 1.7 List of Secondary Sources
  • 1.8 Objectives
    • 1.8.1 Objective - 1: Understanding market dynamics
    • 1.8.2 Objective - 2: Understanding market estimates and forecasts
    • 1.8.3 Objective - 3: Understanding attributes such as strategy framework and competitor categorization
    • 1.8.4 Objective - 4: Understanding the key service and application scopes to conclude on the market size.

Chapter 2 Executive Summary

  • 2.1 Market Outlook

Chapter 3 Global Investigational New Drug CDMO Market: Variables, Trends, & Scope

  • 3.1 Market Segmentation and Scope
  • 3.2 Market Dynamics
    • 3.2.1 Market Driver Analysis
      • 3.2.1.1 Increasing outsourcing services by pharmaceutical companies
      • 3.2.1.2 Rising investment in R&D
      • 3.2.1.3 Growing pharmaceutical industry
      • 3.2.1.5 Stringent regulatory requirements
    • 3.2.2 Market Restraint Analysis
      • 3.2.2.1 Compliance issues while outsourcing
      • 3.2.2.2 Changing scenario in developing countries
  • 3.3 Penetration & Growth Prospect Mapping
  • 3.4 COVID-19 Impact on the Market
  • 3.5 Major Deals and Strategic Alliances Analysis
  • 3.6 Global Investigational New Drug CDMO: Market Analysis Tools
    • 3.6.1 Industry Analysis - Porter's
    • 3.6.3 PESTEL Analysis

Chapter 4 Global Investigational New Drug CDMO Market: Product Segment Analysis

  • 4.1 Global Investigational New Drug CDMO Market: Product Market Share Analysis, 2023 & 2030
  • 4.2 Small Molecule
    • 4.2.1 Small Molecule Market, 2018 - 2030 (USD Million)
  • 4.3 Large Molecule
    • 4.3.1 Large Molecule Market, 2018 - 2030 (USD Million)

Chapter 5 Global Investigational New Drug CDMO Market: Service Segment Analysis

  • 5.1 Global Investigational New Drug CDMO Market: Service Market Share Analysis, 2023 & 2030
  • 5.2 Contract Development
    • 5.2.1 Contract Development market, 2018 - 2030 (USD Million)
    • 5.2.2 Small Molecule
      • 5.2.2.1 Small Molecule market, 2018 - 2030 (USD Million)
        • 5.2.2.2.1 Bioanalysis and DMPK studies
        • 5.2.2.2.2 Bioanalysis and DMPK studies market, 2018 - 2030 (USD Million)
        • 5.2.2.2.3 Toxicology Testing
        • 5.2.2.2.4 Toxicology Testing market, 2018 - 2030 (USD Million)
        • 5.2.2.2.5 Pathology and safety pharmacology studies
        • 5.2.2.2.6 Pathology and safety pharmacology studies market, 2018 - 2030 (USD Million)
        • 5.2.2.2.7 Drug substance synthetic route development
        • 5.2.2.2.8 Drug substance synthetic route development market, 2018 - 2030 (USD Million)
        • 5.2.2.2.9 Drug substance process development
        • 5.2.2.2.10 Drug substance process development market, 2018 - 2030 (USD Million)
        • 5.2.2.2.11 Drug substance synthetic route development
        • 5.2.2.2.12 Drug substance synthetic route development market, 2018 - 2030 (USD Million)
        • 5.2.2.2.13 Form selection crystallization process development
        • 5.2.2.2.14 Form selection crystallization process development market, 2018 - 2030 (USD Million)
        • 5.2.2.2.15 Scale up of drug substance
        • 5.2.2.2.16 Scale up of drug substance market, 2018 - 2030 (USD Million)
        • 5.2.2.2.17 Preformulation
        • 5.2.2.2.18 Preformulation market, 2018 - 2030 (USD Million)
        • 5.2.2.2.19 Preclinical formulation selection
        • 5.2.2.2.20 Preclinical formulation selection market, 2018 - 2030 (USD Million)
        • 5.2.2.2.21 First in Man Formulation/ Process Development
        • 5.2.2.2.22 First in Man Formulation/ Process Development market, 2018 - 2030 (USD Million)
        • 5.2.2.2.23 Analytical method development / validation
        • 5.2.2.2.24 Analytical method development / validation market, 2018 - 2030 (USD Million)
        • 5.2.2.2.25 Release testing of drug substance and drug product
        • 5.2.2.2.25 Release testing of drug substance and drug product market, 2018 - 2030 (USD Million)
        • 5.2.2.2.26 Work up Purification Steps
        • 5.2.2.2.27 Work up purification steps market, 2018 - 2030 (USD Million)
        • 5.2.2.2.28 Telescoping & Process Refining
        • 5.2.2.2.29 Telescoping & Process Refining market, 2018 - 2030 (USD Million)
        • 5.2.2.2.30 Initial Optimization
        • 5.2.2.2.31 Initial Optimization market, 2018 - 2030 (USD Million)
        • 5.2.2.2.32 Formal stability of drug substance and drug product
        • 5.2.2.2.33 Formal stability of drug substance and drug product market, 2018 - 2030 (USD Million)
    • 5.2.3 Large Molecule
      • 5.2.3.1 Large Molecule market, 2018 - 2030 (USD Million)
      • 5.2.3.2 Cell Line development
      • 5.2.3.3 Cell line development market, 2018 - 2030 (USD Million)
      • 5.2.3.4 Process development
      • 5.2.3.5 Process development market, 2018 - 2030 (USD Million)
        • 5.2.3.4.1 Upstream
          • 5.2.3.4.1.1 Upstream market, 2018 - 2030 (USD Million)
          • 5.2.3.4.1.2 Microbial
          • 5.2.3.4.1.3 Microbial market, 2018 - 2030 (USD Million)
          • 5.2.3.4.1.4 Mammalian
          • 5.2.3.4.1.5 Mammalian market, 2018 - 2030 (USD Million)
          • 5.2.3.4.1.6 Others
          • 5.2.3.4.1.7 Others market, 2018 - 2030 (USD Million)
          • 5.2.3.4.1.8 Upstream
          • 5.2.3.4.1.9 Upstream market, 2018 - 2030 (USD Million)
        • 5.2.3.4.2 Downstream
          • 5.2.3.4.2.1 Downstream market, 2018 - 2030 (USD Million)
          • 5.2.3.4.2.2 MABs
          • 5.2.3.4.2.3 MABs market, 2018 - 2030 (USD Million)
          • 5.2.3.4.2.4 Recombinant Proteins
          • 5.2.3.4.2.5 Recombinant Proteins market, 2018 - 2030 (USD Million)
          • 5.2.3.4.2.6 Others
          • 5.2.3.4.2.7 Others market, 2018 - 2030 (USD Million)
  • 5.3 Contract Manufacturing
    • 5.3.1 Contract Manufacturing market, 2018 - 2030 (USD Million)
      • 5.3.1.1 Small Molecule
      • 5.3.1.2 Small Molecule market, 2018 - 2030 (USD Million)
        • 5.3.1.1.1 Oral Solids
        • 5.3.1.1.2 Oral Solids market, 2018 - 2030 (USD Million)
        • 5.3.1.1.1 Liquid & Semi-solids
        • 5.3.1.1.2 Liquid & Semi-solids market, 2018 - 2030 (USD Million)
        • 5.3.1.1.3 Injectables
        • 5.3.1.1.4 Injectables market, 2018 - 2030 (USD Million)
        • 5.3.1.1.5 Others
        • 5.3.1.1.6 Others market, 2018 - 2030 (USD Million)
    • 5.3.2 Large Molecule
      • 5.3.2.1 Large Molecule market, 2018 - 2030 (USD Million)
        • 5.3.2.1.1 MABs
        • 5.3.2.1.2 MABs market, 2018 - 2030 (USD Million)
        • 5.3.2.1.3 Recombinant Proteins
        • 5.3.2.1.4 Recombinant Proteins market, 2018 - 2030 (USD Million)
        • 5.3.2.1.5 MABs
        • 5.3.2.1.6 MABs market, 2018 - 2030 (USD Million)
        • 5.3.2.1.7 Others
        • 5.3.2.1.8 Others market, 2018 - 2030 (USD Million)

Chapter 6 Global Investigational New Drug CDMO Market: End-user Segment Analysis

  • 6.1 Global Investigational New Drug CDMO Market: End-user Market Share Analysis, 2023 & 2030
  • 6.2 Pharmaceutical Companies
    • 6.2.1 Pharmaceutical companies Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
  • 6.3 Biotech
    • 6.3.2. Biotech Companies Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
  • 6.4 Others
    • 6.4.2. Others Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)

Chapter 7 Global Investigational New Drug CDMO Market: Regional Analysis

  • 7.1 Global Investigational New Drug CDMO Market: Regional Market Share Analysis, 2023 & 2030
  • 7.2 North America
    • 7.2.1 North America Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.2.2 U.S.
      • 7.2.2.1 U.S. Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.2.3 Canada
      • 7.2.3.1 Canada Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
  • 7.3 Europe
    • 7.3.1 Europe Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.3.2 U.K.
      • 7.3.2.1 U.K. Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.3.3 Germany
      • 7.3.3.1 Germany Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.3.4 France
      • 7.3.4.1 France Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.3.5 Italy
      • 7.3.5.1 Italy Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.3.6 Spain
      • 7.3.6.1 Spain Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
  • 7.4 Asia Pacific
    • 7.4.1 Asia Pacific Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.4.2 Japan
      • 7.4.2.1 Japan Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.4.3 China
      • 7.4.3.1 China Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.4.4 India
      • 7.4.4.1 India Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.4.5 Australia
      • 7.4.5.1 Australia Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.4.6 South Korea
      • 7.4.6.1 South Korea Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
  • 7.5 Latin America
    • 7.5.1 Latin America Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.5.2 Brazil
      • 7.5.2.1 Brazil Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.5.3 Mexico
      • 7.5.3.1 Mexico Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.5.4 Argentina
      • 7.5.4.1 Argentina Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
  • 7.6 MEA
    • 7.6.1 MEA Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.6.2 South Africa
      • 7.6.2.1 South Africa Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.6.3 Saudi Arabia
      • 7.6.3.1 Saudi Arabia Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)
    • 7.6.4 UAE
      • 7.6.4.1 UAE Investigational New Drug CDMO Market, 2018 - 2030 (USD Million)

Chapter 8 Company Profiles

  • 8.1 Catalent, Inc.
    • 8.1.1 Company Overview
    • 8.1.2 Service Benchmarking
    • 8.1.3 Financial Performance
    • 8.1.4 Strategic Initiatives
  • 8.2 Lonza
    • 8.2.1 Company Overview
    • 8.2.2 Financial Performance
    • 8.2.3 Service Benchmarking
    • 8.2.5 Strategic Initiatives
  • 8.3 Recipharm AB
    • 8.3.1 Company Overview
    • 8.3.2 Service Benchmarking
    • 8.3.3 Strategic Initiatives
  • 8.4 Siegfried Holding AG
    • 8.4.1 Company Overview
    • 8.4.2 Financial Performance
    • 8.4.3 Service Benchmarking
  • 8.5 Patheon Inc.
    • 8.5.1 Company Overview
    • 8.5.2 Financial Performance
    • 8.5.3 Service Benchmarking
  • 8.6 Covance
    • 8.6.1 Company Overview
    • 8.6.2 Financial Performance
    • 8.6.3 Service Benchmarking
  • 8.7 IQVIA Holdings Inc.
    • 8.7.1 Company Overview
    • 8.7.2 Financial Performance
    • 8.7.3 Service Benchmarking
    • 8.7.4 Strategic Initiatives
  • 8.8 Cambrex Corporation
    • 8.8.1 Company Overview
    • 8.8.2 Financial Performance
    • 8.8.3 Service Benchmarking
  • 8.9 Charles River Laboratories International, Inc.
    • 8.9.1 Company Overview
    • 8.9.2 Financial Performance
    • 8.9.3 Service Benchmarking
    • 8.9.4 Strategic Initiatives
  • 8.10 Syneous Health
    • 8.10.1 Company Overview
    • 8.10.2 Financial Performance
    • 8.10.3 Service Benchmarking
    • 8.10.4 Strategic Initiatives