查看购物车
  • Traditional Chinese
  • English
  • Japanese
  • Korean
封面
市场调查报告书
商品编码
1552878

IND（临床实验新药）CDMO 市场规模、份额、趋势分析报告：按产品、服务、最终用途、地区、细分市场预测，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个工作天内

价格
简介目录

IND（临床实验新药）CDMO 市场的成长与趋势：

Grand View Research, Inc.最新报告显示，到2030年，全球IND（在临床实验新药）CDMO市场规模预计将达到77.9亿美元，预测期内复合年增长率为6.9%。

这主要是由于研发投入的增加和 IND 法规的严格化。

美国FDA 和欧洲药品管理局 (EMA) 是分别监管美国和欧盟临床实验药物使用的卫生当局机构。此外，美国的临床实验审查委员会 (IRB) 和欧盟的伦理委员会 (EC) 必须核准药物用于人类。

联邦法律要求药物必须经过核准的营销申请才能在州际分销或运输。因此，寻求利用 IND 进行临床试验的申办者必须获得 FDA 的豁免，以允许将临床实验临床实验运送给多个州的研究人员。

疫情对2020年全球经济产生重大影响，并持续影响各产业。然而，IND（临床实验新药）CDMO市场却从疫情中受益。在 COVID-19 之前，潜在赞助商要求进行设施审核，以确保 CDMO 拥有开展计划所需的能力、设备和人员。 CDMO 现在需要寻找新的方法来吸引新的赞助商。例如视讯、虚拟实境和其他允许赞助商虚拟体验场景的技术。

IND（临床实验新药）CDMO 市场报告亮点

  • 从产品来看，小分子细分市场在市场上占据主导地位，到 2023 年，其销售份额将达到 88.4%。这主要是由于开发中的小分子数量不断增加。此外， 新药认证，小分子占所有NME核准的79%。
  • 按服务划分，合约开发领域在 2023 年引领市场。与内部开发相比，合约开发具有多种优势，包括接触行业专家、更快的上市时间、成本效益以及专注于核心能力。
  • 以最终用途划分，2023年製药公司占最大份额。这是因为製药业的变化会影响研发策略，进而影响新药认证趋势。
  • 亚太地区在预测期内将实现最快的成长率，达到 7.8%。随着印度和中国等开发中国家製药公司和受託製造厂商的快速成长，该地区很可能在不久的将来超过欧洲和北美。

目录

第一章调查方法与范围

第 2 章执行摘要

第三章全球 IND（临床实验新药）CDMO 市场：变数、趋势、范围

  • 市场区隔和范围
  • 市场动态
  • 渗透率和成长前景图
  • COVID-19 对市场的影响
  • 主要交易及策略联盟分析
  • 全球 IND（临床实验新药）CDMO：市场分析工具

第四章全球 IND（临床实验新药）CDMO 市场：产品細項分析

  • 全球 IND（临床实验新药）CDMO 市场：2023 年和 2030 年产品市场占有率分析
  • 低分子
  • 大分子

第五章全球 IND（临床实验药物）CDMO 市场：按服务細項分析

  • 全球 IND（临床实验新药）CDMO 市场：2023 年和 2030 年服务市场占有率分析
  • 合约开发
  • 契约製造

第六章全球 IND（临床实验药物）CDMO 市场：最终用户的細項分析

  • 全球 IND（临床实验新药）CDMO 市场：2023 年和 2030 年最终用户市场占有率分析
  • 製药公司
  • 生物技术
  • 其他的

第七章全球 IND（临床实验新药）CDMO 市场：区域分析

  • 全球 IND（临床实验新药）CDMO 市场：2023 年和 2030 年区域市场占有率分析
  • 北美洲
  • 欧洲
  • 亚太地区
  • 拉丁美洲
  • 中东/非洲

第八章 公司简介

  • Catalent, Inc.
  • Lonza
  • Recipharm AB
  • Siegfried Holding AG
  • Patheon Inc.
  • Covance
  • IQVIA Holdings Inc.
  • Cambrex Corporation
  • Charles River Laboratories International, Inc.
  • Syneous Health
简介目录
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