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IND（治験薬）CDMOの市場規模、シェア、動向分析レポート：製品別、サービス別、最終用途別、地域別、セグメント予測、2024年～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
ページ情報
英文 120 Pages
納期
2～10営業日
カスタマイズ可能
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=146.72円
IND（治験薬）CDMOの市場規模、シェア、動向分析レポート：製品別、サービス別、最終用途別、地域別、セグメント予測、2024年～2030年
出版日: 2024年08月07日
発行: Grand View Research
ページ情報: 英文 120 Pages
納期: 2～10営業日
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  • 概要
  • 目次
概要

IND（治験薬）CDMO市場の成長と動向：

Grand View Research, Inc.の最新レポートによると、世界のIND（治験薬）CDMO市場規模は2030年までに77億9,000万米ドルに達し、予測期間中のCAGRは6.9％を記録すると予測されています。

これは、研究開発投資の増加とINDに関する厳しい規制によるところが大きいです。

米国FDAと欧州医薬品庁（EMA）は、それぞれ米国と欧州連合における治験薬の使用を規制する保健当局機関です。さらに、米国では治験審査委員会（IRB）、欧州連合では倫理委員会（EC）が、ヒトへの医薬品の使用を承認しなければならないです。

医薬品が州を越えて流通または輸送される前に、承認された販売申請の対象であることは連邦法の要件です。したがって、INDを伴う臨床試験の実施を目指すスポンサーは、複数の州の治験責任医師への治験薬の輸送を許可する免除をFDAから得る必要があります。

パンデミックは2020年の世界経済に大きな影響を与え、様々な産業に継続的な影響を及ぼしています。しかし、IND（治験薬）CDMO市場はパンデミックの恩恵を受けています。COVID-19以前は、スポンサー候補はCDMOがプロジェクトを遂行するのに必要な能力、設備、人員を有していることを確認するために施設監査を要求しました。現在では、CDMOは新たなスポンサーを惹きつける新たな方法を見つける必要があります。例えば、ビデオやバーチャル・リアリティ、その他スポンサーが現場をバーチャルに体験できる技術などです。

IND（治験薬）CDMO市場レポートのハイライト

  • 製品別では、低分子セグメントが2023年の売上高シェア88.4%で市場を独占しています。これは、開発中の低分子の数が増加していることが主因です。また、2019年の新薬承認では、低分子がNME承認全体の79%を占めました。
  • サービス別では、受託開発分野が2023年の市場をリードしました。受託開発は、業界の専門家へのアクセス、市場投入までの時間の短縮、費用対効果、コアコンピタンスへの集中など、自社開発よりもいくつかの利点を提供します。
  • 最終用途別では、製薬会社が2023年に最大のシェアを占めました。これは、製薬業界の変化が研究開発戦略に影響を与え、ひいては新薬承認動向に影響を与えるためです。
  • アジア太平洋地域は予測期間中に7.8%という最も速い成長率を記録します。インドや中国などの発展途上国では製薬企業や製造受託機関が急成長しているため、この地域は近い将来、欧州や北米を追い抜く可能性が高いです。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 世界のIND（治験薬）CDMO市場：変数、動向、範囲

  • 市場セグメンテーションと範囲
  • 市場力学
  • 浸透と成長の見込みマッピング
  • COVID-19による市場への影響
  • 主要取引と戦略的提携の分析
  • 世界IND（治験薬）CDMO：市場分析ツール

第4章 世界のIND（治験薬）CDMO市場：製品セグメント分析

  • 世界のIND（治験薬）CDMO市場：製品市場シェア分析、2023年および2030年
  • 低分子
  • 大分子

第5章 世界のIND（治験薬）CDMO市場：サービス別セグメント分析

  • 世界のIND（治験薬）CDMO市場：サービス市場シェア分析、2023年および2030年
  • 受託開発
  • 受託製造

第6章 世界のIND（治験薬）CDMO市場：エンドユーザー別セグメント分析

  • 世界のIND（治験薬）CDMO市場：エンドユーザー市場シェア分析、2023年および2030年
  • 製薬会社
  • バイオテクノロジー
  • その他

第7章 世界のIND（治験薬）CDMO市場：地域別分析

  • 世界のIND（治験薬）CDMO市場：地域別市場シェア分析、2023年および2030年
  • 北米
  • 欧州
  • アジア太平洋
  • ラテンアメリカ
  • 中東・アフリカ

第8章 企業プロファイル

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