IND(임상시험용 의약품) CDMO 시장 규모, 점유율, 동향 분석 보고서 : 제품별, 서비스별, 최종 용도별, 지역별, 부문별 예측(2024-2030년)

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

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한글목차

IND(임상시험용 의약품) CDMO 시장 성장 및 동향:

Grand View Research, Inc.의 최신 보고서에 따르면, 세계 IND(임상시험용 의약품) CDMO 시장 규모는 2030년까지 77억 9,000만 달러에 달할 것으로 예상되며, 예측 기간 동안 6.9%의 CAGR을 기록할 것으로 예상됩니다.

이는 연구개발 투자 증가와 IND에 대한 엄격한 규제에 기인하는 바가 큽니다.

미국 FDA와 유럽의약품청(EMA)은 각각 미국과 유럽연합에서 임상시험용 의약품의 사용을 규제하는 보건당국 기관입니다. 또한 미국에서는 임상시험심사위원회(IRB)가, 유럽연합에서는 윤리위원회(EC)가 인간을 대상으로 한 의약품의 사용을 승인해야 합니다.

의약품이 주를 넘어 유통 또는 운송되기 전에 승인된 판매 신청서를 제출해야 하는 것은 연방법의 요건입니다. 따라서 IND와 함께 임상시험을 수행하려는 스폰서는 FDA로부터 임상시험용 의약품을 여러 주에 있는 임상시험 책임자에게 운송하는 것을 허용하는 면제를 받아야 합니다.

COVID-19는 2020년 세계 경제에 큰 영향을 미쳤으며, 다양한 산업에 지속적인 영향을 미치고 있습니다. 그러나 IND(임상시험용 의약품) CDMO 시장은 COVID-19 이전에는 CDMO가 프로젝트를 수행하는 데 필요한 역량, 장비 및 인력을 보유하고 있는지 확인하기 위해 시설 감사를 요구했습니다. 이제 CDMO는 새로운 스폰서를 유치할 수 있는 새로운 방법을 찾아야 합니다. 예를 들어, 비디오, 가상현실, 기타 스폰서들이 현장을 가상으로 체험할 수 있는 기술 등이 있습니다.

IND(임상시험용 의약품) CDMO 시장 보고서의 주요 내용

• 제품별로는 저분자 부문이 2023년 88.4%의 매출 점유율로 시장을 주도했습니다. 이는 개발 중인 저분자 의약품의 수가 증가하고 있기 때문입니다. 또한, 2019년 신약 승인에서 저분자는 전체 NME 승인 중 79%를 차지했습니다.
• 서비스별로는 위탁 개발 분야가 2023년 시장을 주도했습니다. 위탁 개발은 업계 전문가에 대한 접근성, 시장 출시 시간 단축, 비용 효율성, 핵심 역량에 대한 집중 등 자체 개발보다 몇 가지 이점을 제공합니다.
• 최종 용도별로는 제약회사가 2023년 가장 큰 점유율을 차지했습니다. 이는 제약 업계의 변화가 R&D 전략에 영향을 미쳐 신약 승인 동향에 영향을 미치기 때문입니다.
• 아시아태평양은 예측 기간 동안 7.8%의 가장 빠른 성장률을 기록할 것입니다. 인도, 중국 등 개발도상국의 제약기업과 위탁생산 기관이 빠르게 성장하고 있기 때문에 이 지역은 가까운 미래에 유럽과 북미를 추월할 가능성이 높습니다.

목차

제1장 조사 방법과 범위

제2장 주요 요약

제3장 세계의 IND(임상시험용 의약품) CDMO 시장 : 변수, 동향, 범위

• 시장 세분화와 범위
• 시장 역학
• 침투와 성장 전망 매핑
• COVID-19의 시장에 대한 영향
• 주요 거래와 전략적 제휴 분석
• 세계 IND(임상시험용 의약품) CDMO : 시장 분석 툴

제4장 세계의 IND(임상시험용 의약품) CDMO 시장 : 제품 부문 분석

• 세계의 IND(임상시험용 의약품) CDMO 시장 : 제품 시장 점유율 분석, 2023년 및 2030년
• 저분자
• 대분자

제5장 세계의 IND(임상시험용 의약품) CDMO 시장 : 서비스별 부문 분석

• 세계의 IND(임상시험용 의약품) CDMO 시장 : 서비스 시장 점유율 분석, 2023년 및 2030년
• 수탁개발
• 수탁제조

제6장 세계의 IND(임상시험용 의약품) CDMO 시장 : 최종사용자별 부문 분석

• 세계의 IND(임상시험용 의약품) CDMO 시장 : 최종사용자 시장 점유율 분석, 2023년 및 2030년
• 제약회사
• 바이오테크놀러지
• 기타

제7장 세계의 IND(임상시험용 의약품) CDMO 시장 : 지역별 분석

• 세계의 IND(임상시험용 의약품) CDMO 시장 : 지역별 시장 점유율 분석, 2023년 및 2030년
• 북미
• 유럽
• 아시아태평양
• 라틴아메리카
• 중동 및 아프리카

제8장 기업 개요

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

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영문 목차

영문목차

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

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