查看购物车
  • Traditional Chinese
  • English
  • Japanese
封面
市场调查报告书
商品编码
1842288

美国临床实验CDMO 市场规模、份额和趋势分析报告：按服务、最终用途和细分市场预测，2025 年至 2033 年

U.S. Investigational New Drug CDMO Market Size, Share & Trends Analysis Report By Service (Contract Development, Contract Manufacturing), By End Use (Pharmaceutical Companies, Biotech Companies), And Segment Forecasts, 2025 - 2033
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

美国临床实验CDMO市场摘要

美国临床实验试验 CDMO 市场规模预计在 2024 年达到 18.2 亿美元，预计到 2033 年将达到 35.8 亿美元，2025 年至 2033 年的复合年增长率为 9.38%。

在美国，新药临床实验(IND) CDMO 正在经历显着成长，这得益于广泛而复杂的早期研发管线，尤其是在肿瘤学、罕见疾病和先进药物等领域。

此外，新兴生物製药公司注重成本效益和快速的IND准备，因为它们依赖外部合作伙伴提供化学、生产和控制 (CMC) 以及非临床和临床材料。供应链韧性、对国内生产能力的偏好以及更快的监管响应等因素进一步推动了外包。平台流程的实施、结构化的技术转移以及分阶段的品质措施有助于降低专案风险，使全面的IND验证成为一个利润更高的外包市场。

此外，不断扩展的技术进步，特别是在数位能力和特定于模式的方法方面的进步，正在促进市场成长。人工智慧辅助实验设计 (DoE)、数位双胞胎技术和自动批次记录的采用有助于缩短时间表并提高执行准确性。在可行的情况下，一次性和连续处理方法的使用正在扩展到 I 期生产，同时正在采用高通量分析和先进的生物检测测定来降低 CMC 包装风险。透过流动化学、固体控制和製程分析技术 (PAT) 等技术，正在加强在 mRNA/脂质奈米颗粒 (LNP)、病毒载体、质体和高固体药物成分 (HPAPI) 等各个领域的专业知识。此外，资料完整性正在透过电子品管系统 (eQMS) 和实验室资讯管理系统 (LIMS) 紧密整合。

此外，对模组化良好生产规范 (GMP)、无菌填充能力、载体和质体生产能力、微流体LNP 平台以及可扩展品管(QC) 实验室的投资不断增加，正在支持市场成长。用于 IND 的毒理学和生物分析能力正在不断扩展，以确保单一合约课责。正在进行策略性併购，以整合基本能力和地理冗余，同时优先考虑新建和维修以加快速度。用于劳动力发展和技术人员培训的资金旨在缓解生技药品和无菌加工中的瓶颈。采用商业结构，包括基于里程碑的定价和预留产能选项，旨在紧密结合奖励。

此外，监管格局受到FDA对ICH Q8-Q12中概述的分阶段CMC、严格的资料完整性措施（编纂于21 CFR第11部分）以及明确定义的可比性策略的期望的影响。 IND前期合作正被用来确保控制策略、分析验证方法和稳定性要求的一致性。快速通道、突破性疗法和再生医学先进疗法(RMAT)等加速认定的采用，要求在开发早期就建立健全的流程和详尽的文件记录。对于无菌药品，无菌处理和污染控制的标准从一开始就在製定中，并且实施数位审核追踪和基于电脑软体保障(CSA)的验证已成为标准做法。因此，该行业正在出现提供全方位服务的IND推动者与高度专业化的提供者之间的分化。

营运框架正在不断完善，以利用标准化平台、平行工作流程和整合计划管理，这些对于缩短週期至关重要。优先供应商协议和长期主服务协议正变得越来越普遍，以确保优先获得载体和无菌填充等有限资源。透过基于绩效的收费模式和产能储备所建立的风险分担机制也越来越普遍。因此，预计市场将进一步整合和选择性专业化，成长机会将惠及那些能够展现数位化能力、跨模式深度和韧性的国内供应链的CDMO。

目录

第一章调查方法与范围

第二章执行摘要

第 3 章美国临床实验CDMO 市场变数、趋势与范围

  • 市场体系展望
    • 母市场展望
    • 相关/辅助市场展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
  • 技术格局
  • 定价模式分析
  • 关税影响分析
  • 价值链分析
    • 供应趋势
    • 需求趋势
  • 市场分析工具
    • 波特五力分析
    • PESTEL 与 SWOT 分析

第四章：美国临床实验CDMO 市场：服务估算与趋势分析

  • 美国临床实验CDMO 市场（按服务）：细分仪表板
  • 美国临床实验CDMO市场（按服务）：波动分析
  • 按服务分类，2021-2033 年
  • 合约开发
    • 小分子
    • 高分子
  • 契约製造
    • 小分子
    • 高分子

第五章美国临床实验CDMO市场：最终用途估计与趋势分析

  • 美国临床实验试验 CDMO 市场（依最终用途）：细分仪表板
  • 美国临床实验CDMO 市场（依最终用途划分）：波动分析
  • 依最终用途，2021-2033年
  • 製药公司
  • 生技公司
  • 其他的

第六章 竞争态势

  • 主要参与者分类
    • 市场领导者
    • 新兴企业
  • 2024年市占率/评级分析（热图分析）
  • 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.
    • Syneos Health
    • Syngene International
    • Jubilant Pharmova
    • Piramal Pharma Solutions
    • Dr. Reddy's CPS
    • Dishman Carbogen Amcis
    • Biocon Biologics
    • Laurus Labs
Product Code: GVR-4-68040-736-1

U.S. Investigational New Drug CDMO Market Summary

The U.S. investigational new drug CDMO market size was estimated at USD 1.82 billion in 2024 and is projected to reach USD 3.58 billion by 2033, growing at a CAGR of 9.38% from 2025 to 2033. The Investigational New Drug (IND) CDMO is experiencing significant growth in the U.S., driven by an extensive and complex early-stage pipeline, particularly in areas such as oncology, rare diseases, and advanced modalities.

Besides, emerging biopharma companies are focusing on cost efficiency and swift IND readiness as they depend on external partners for Chemistry, Manufacturing, and Controls (CMC), as well as nonclinical and clinical materials. Aspects like supply-chain resilience, a preference for domestic capacity, and faster regulatory pathways are further encouraging outsourcing. The implementation of platform processes, structured tech transfers, and phase-appropriate quality measures has helped mitigate program risks, thereby making comprehensive IND enablement more favorable outsourcing market.

In addition, growing technological advancements, particularly in digital capabilities and modality-specific approaches, have contributed to market growth. The adoption of AI-assisted Design of Experiments (DoE), digital twin technology, and automated batch-recording is helping to shorten timelines and improve execution accuracy. The use of single-use and continuous processing methods is being extended into Phase I manufacturing where feasible, and high-throughput analytics and advanced bioassays are being employed to reduce CMC package risks. Expertise in various domains, such as mRNA/Lipid Nanoparticles (LNP), viral vectors, plasmids, and highly potent active pharmaceutical ingredients (HPAPI), has been enhanced through techniques, including flow chemistry, solid-state control, and Process Analytical Technology (PAT). Besides, data integrity is being firmly integrated through electronic Quality Management Systems (eQMS) and Laboratory Information Management Systems (LIMS).

Moreover, growing investments in modular Good Manufacturing Practice (GMP), aseptic fill-finish capabilities, vector, and plasmid production capacity, microfluidic LNP platforms, and expandable Quality Control (QC) laboratories support the market growth. IND-enabling toxicology and bioanalytical capabilities are being scaled up to ensure single-contract accountability. Strategic mergers and acquisitions are being undertaken to incorporate essential capabilities and geographic redundancy, while new builds and retrofits are being prioritized for speed. Funding for workforce development and technician training is aimed at alleviating bottlenecks in biologics and sterile operations. The adoption of commercial constructs that include milestone-based pricing and reserved capacity options is intended to align incentives closely.

Furthermore, the regulatory landscape is being influenced by FDA expectations regarding phase-appropriate CMC as outlined in ICH Q8-Q12, strict data integrity measures (coded as 21 CFR Part 11), and well-defined comparability strategies. Pre-IND engagements are being utilized to ensure alignment on control strategies, analytical validation methods, and stability requirements. Expedited designations such as Fast Track, Breakthrough Therapy, and Regenerative Medicine Advanced Therapy (RMAT) status are being employed, necessitating robust processes and thorough documentation early in development. Standards for sterile products regarding aseptic processing and contamination control practices are being established from the beginning, while the incorporation of digital audit trails and Computer Software Assurance (CSA)-based validation has become a standard practice. Thus, the industry is witnessing a divide between full-service IND enablers and hyper-specialized providers.

Operational frameworks are being refined to leverage standardized platforms, simultaneous workstreams, and integrated project management, which are key to reducing cycle times. Preferred-provider agreements and long-term master service contracts are gaining traction to ensure priority access to limited resources such as vectors and sterile filling. Risk-sharing mechanisms are being employed through success-fee models and capacity reservations. Hence, the market is likely to see further consolidation and selective specialization, with growth opportunities favoring CDMOs that can demonstrate digital sophistication, depth in various modalities, and resilient domestic supply chains, all while consistently achieving first-pass IND approvals.

U.S. Investigational New Drug CDMO Market Report Segmentation

This report forecasts revenue growth at and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. investigational new drug CDMO market report based on service and end use.

  • Service Outlook (Revenue, USD Million, 2021 - 2033
  • Contract Development
    • Small Molecule
    • Bioanalysis and DMPK Studies
    • Toxicology Testing
    • Pathology and Safety Pharmacology Studies
    • Drug Substance Development
    • Synthetic Route Development
    • Process Development
    • Form Selection Crystallization Process Development
    • Scale-up of Drug Substance
    • Formulation Development
    • Pre Formulation
    • Preclinical Formulation Selection
    • First In Man Formulation/ Process Development
    • Analytical & Quality Services
    • Analytical Method Development / Validation
    • Release Testing of Drug Substance and Drug Product
    • Formal Stability of Drug Substance and Drug Product
    • Process Optimization
    • Work Up Purification Steps
    • Telescoping & Process Refining
    • Initial Optimization
    • Large Molecule
    • Cell Line Development
    • Process Development
    • Upstream
    • Microbial
    • Mammalian
    • Others
    • Downstream
    • MABs
    • Recombinant Proteins
    • Others
  • Contract Manufacturing
    • Small Molecule
    • Oral Solids
    • Semi-Solids
    • Liquids & Injectables
    • Others
    • Large Molecule
    • MABs
    • Recombinant Proteins
    • Others
  • End Use Outlook (Revenue, USD Million, 2021 - 2033)
  • Pharmaceutical Companies
  • Biotech Companies
  • Others

Table of Contents

Chapter 1. Research Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Segment Definitions
    • 1.2.1. Service
    • 1.2.2. End Use
  • 1.3. Research Methodology
  • 1.4. Information Procurement
    • 1.4.1. Purchased Database
    • 1.4.2. GVR's Internal Database
    • 1.4.3. Secondary Sources
    • 1.4.4. Primary Research
  • 1.5. Information Or Data Analysis
    • 1.5.1. Data Analysis Models
  • 1.6. Market Formulation & Validation
  • 1.7. Model Details
    • 1.7.1. Commodity Flow Analysis
    • 1.7.2. Top-Down Analysis
    • 1.7.3. Bottom-Up Approach
    • 1.7.4. Multivariate Analysis
  • 1.8. List Of Secondary Sources
  • 1.9. List Of Abbreviations
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
  • 2.3. Competitive Insights

Chapter 3. U.S. Investigational New Drug CDMO Market Variables, Trends & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent Market Outlook
    • 3.1.2. Related/Ancillary Market Outlook
  • 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
      • 3.2.1.4. 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. Technology Landscape
  • 3.4. Pricing Model Analysis
  • 3.5. Tariff Impact Analysis
  • 3.6. Value Chain Analysis
    • 3.6.1. Supply Trends
    • 3.6.2. Demand Trends
  • 3.7. Market Analysis Tools
    • 3.7.1. Porter's Five Forces Analysis
    • 3.7.2. PESTEL by SWOT Analysis

Chapter 4. U.S. Investigational New Drug CDMO Market: Service Estimates & Trend Analysis

  • 4.1. U.S. Investigational New Drug CDMO Market, By Service: Segment Dashboard
  • 4.2. U.S. Investigational New Drug CDMO Market, By Service: Movement Analysis
  • 4.3. U.S. Investigational New Drug CDMO Market Estimates & Forecasts, By Service, 2021 - 2033 (USD Million)
  • 4.4. Contract Development
    • 4.4.1. Contract Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.4.2. Small Molecule
      • 4.4.2.1. Small Molecule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.4.2.2. Bioanalysis and DMPK Studies
        • 4.4.2.2.1. Bioanalysis and DMPK Studies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.4.2.3. Toxicology Testing
        • 4.4.2.3.1. Toxicology Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.4.2.4. Pathology and Safety Pharmacology Studies
        • 4.4.2.4.1. Pathology and Safety Pharmacology Studies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.4.2.5. Drug Substance Development
        • 4.4.2.5.1. Drug Substance Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.2.5.2. Synthetic Route Development
          • 4.4.2.5.2.1. Synthetic Route Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.2.5.3. Process Development
          • 4.4.2.5.3.1. Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.2.5.4. Form Selection Crystallization Process Development
          • 4.4.2.5.4.1. Form Selection Crystallization Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.2.5.5. Scale-up of Drug Substance
          • 4.4.2.5.5.1. Scale-up of Drug Substance Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.4.2.6. Formulation Development
        • 4.4.2.6.1. Formulation Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.2.6.2. Pre Formulation
          • 4.4.2.6.2.1. Pre Formulation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.2.6.3. Preclinical Formulation Selection
          • 4.4.2.6.3.1. Preclinical Formulation Selection Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.2.6.4. First In Man Formulation/ Process Development
          • 4.4.2.6.4.1. First In Man Formulation/ Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.4.2.7. Analytical & Quality Services
        • 4.4.2.7.1. Analytical & Quality Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.2.7.2. Analytical Method Development / Validation
          • 4.4.2.7.2.1. Analytical Method Development / Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.2.7.3. Release Testing of Drug Substance and Drug Product
          • 4.4.2.7.3.1. Release Testing of Drug Substance and Drug Product Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.2.7.4. Formal Stability of Drug Substance and Drug Product
          • 4.4.2.7.4.1. Formal Stability of Drug Substance and Drug Product Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.4.2.8. Process Optimization
        • 4.4.2.8.1. Process Optimization Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.2.8.2. Work Up Purification Steps
          • 4.4.2.8.2.1. Work Up Purification Steps Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.2.8.3. Telescoping & Process Refining
          • 4.4.2.8.3.1. Telescoping & Process Refining Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.2.8.4. Initial Optimization
          • 4.4.2.8.4.1. Initial Optimization Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.4.3. Large Molecule
      • 4.4.3.1. Large Molecule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.4.3.2. Cell Line Development
        • 4.4.3.2.1. Cell Line Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.4.3.3. Process Development
        • 4.4.3.3.1. Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.3.3.2. Upstream
          • 4.4.3.3.2.1. Upstream Market Estimates and Forecasts, 2021 - 2033 (USD Million)
          • 4.4.3.3.2.2. Microbial
            • 4.4.3.3.2.2.1. Microbial Market Estimates and Forecasts, 2021 - 2033 (USD Million)
          • 4.4.3.3.2.3. Mammalian
            • 4.4.3.3.2.3.1. Mammalian Market Estimates and Forecasts, 2021 - 2033 (USD Million)
          • 4.4.3.3.2.4. Others
            • 4.4.3.3.2.4.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
        • 4.4.3.3.3. Downstream
          • 4.4.3.3.3.1. Downstream Market Estimates and Forecasts, 2021 - 2033 (USD Million)
          • 4.4.3.3.3.2. MABs
            • 4.4.3.3.3.2.1. MABs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
          • 4.4.3.3.3.3. Recombinant Proteins
            • 4.4.3.3.3.3.1. Recombinant Proteins Market Estimates and Forecasts, 2021 - 2033 (USD Million)
          • 4.4.3.3.3.4. Others
            • 4.4.3.3.3.4.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5. Contract Manufacturing
    • 4.5.1. Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.5.2. Small Molecule
      • 4.5.2.1. Small Molecule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.5.2.2. Oral Solids
        • 4.5.2.2.1. Oral Solids Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.5.2.3. Semi-Solids
        • 4.5.2.3.1. Semi-Solids Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.5.2.4. Liquids & Injectables
        • 4.5.2.4.1. Liquids & Injectables Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.5.2.5. Others
        • 4.5.2.5.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.5.3. Large Molecule
      • 4.5.3.1. Large Molecule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.5.3.2. MABs
        • 4.5.3.2.1. MABs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.5.3.3. Recombinant Proteins
        • 4.5.3.3.1. Recombinant Proteins Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 4.5.3.4. Others
        • 4.5.3.4.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Investigational New Drug CDMO Market: by End Use Estimates & Trend Analysis

  • 5.1. U.S. Investigational New Drug CDMO Market, by End Use: Segment Dashboard
  • 5.2. U.S. Investigational New Drug CDMO Market, by End Use: Movement Analysis
  • 5.3. U.S. Investigational New Drug CDMO Market Estimates & Forecasts, by End Use, 2021 - 2033 (USD Million)
  • 5.4. Pharmaceutical Companies
    • 5.4.1. Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5. Biotech Companies
    • 5.5.1. Biotech Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.6. Others
    • 5.6.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Competitive Landscape

  • 6.1. Key Participant Categorization
    • 6.1.1. Market Leaders
    • 6.1.2. Emerging Players
  • 6.2. Market Share/Assessment Analysis, 2024 (Heat Map Analysis)
  • 6.3. Company Profiles
    • 6.3.1. Catalent, Inc.
      • 6.3.1.1. Company Overview
      • 6.3.1.2. Financial Performance
      • 6.3.1.3. Service Benchmarking
      • 6.3.1.4. Strategic Initiatives
    • 6.3.2. Lonza
      • 6.3.2.1. Company Overview
      • 6.3.2.2. Financial Performance
      • 6.3.2.3. Service Benchmarking
      • 6.3.2.4. Strategic Initiatives
    • 6.3.3. Recipharm AB
      • 6.3.3.1. Company Overview
      • 6.3.3.2. Financial Performance
      • 6.3.3.3. Service Benchmarking
      • 6.3.3.4. Strategic Initiatives
    • 6.3.4. Siegfried Holding AG
      • 6.3.4.1. Company Overview
      • 6.3.4.2. Financial Performance
      • 6.3.4.3. Service Benchmarking
      • 6.3.4.4. Strategic Initiatives
    • 6.3.5. Patheon Inc.
      • 6.3.5.1. Company Overview
      • 6.3.5.2. Financial Performance
      • 6.3.5.3. Service Benchmarking
      • 6.3.5.4. Strategic Initiatives
    • 6.3.6. Covance
      • 6.3.6.1. Company Overview
      • 6.3.6.2. Financial Performance
      • 6.3.6.3. Service Benchmarking
      • 6.3.6.4. Strategic Initiatives
    • 6.3.7. IQVIA Holdings Inc.
      • 6.3.7.1. Company Overview
      • 6.3.7.2. Financial Performance
      • 6.3.7.3. Service Benchmarking
      • 6.3.7.4. Strategic Initiatives
    • 6.3.8. Cambrex Corporation
      • 6.3.8.1. Company Overview
      • 6.3.8.2. Financial Performance
      • 6.3.8.3. Service Benchmarking
      • 6.3.8.4. Strategic Initiatives
    • 6.3.9. Charles River Laboratories International, Inc.
      • 6.3.9.1. Company Overview
      • 6.3.9.2. Financial Performance
      • 6.3.9.3. Service Benchmarking
      • 6.3.9.4. Strategic Initiatives
    • 6.3.10. Syneos Health
      • 6.3.10.1. Company Overview
      • 6.3.10.2. Financial Performance
      • 6.3.10.3. Service Benchmarking
      • 6.3.10.4. Strategic Initiatives
    • 6.3.11. Syngene International
      • 6.3.11.1. Company Overview
      • 6.3.11.2. Financial Performance
      • 6.3.11.3. Service Benchmarking
      • 6.3.11.4. Strategic Initiatives
    • 6.3.12. Jubilant Pharmova
      • 6.3.12.1. Company Overview
      • 6.3.12.2. Financial Performance
      • 6.3.12.3. Service Benchmarking
      • 6.3.12.4. Strategic Initiatives
    • 6.3.13. Piramal Pharma Solutions
      • 6.3.13.1. Company Overview
      • 6.3.13.2. Financial Performance
      • 6.3.13.3. Service Benchmarking
      • 6.3.13.4. Strategic Initiatives
    • 6.3.14. Dr. Reddy's CPS
      • 6.3.14.1. Company Overview
      • 6.3.14.2. Financial Performance
      • 6.3.14.3. Service Benchmarking
      • 6.3.14.4. Strategic Initiatives
    • 6.3.15. Dishman Carbogen Amcis
      • 6.3.15.1. Company Overview
      • 6.3.15.2. Financial Performance
      • 6.3.15.3. Service Benchmarking
      • 6.3.15.4. Strategic Initiatives
    • 6.3.16. Biocon Biologics
      • 6.3.16.1. Company Overview
      • 6.3.16.2. Financial Performance
      • 6.3.16.3. Service Benchmarking
      • 6.3.16.4. Strategic Initiatives
    • 6.3.17. Laurus Labs
      • 6.3.17.1. Company Overview
      • 6.3.17.2. Financial Performance
      • 6.3.17.3. Service Benchmarking
      • 6.3.17.4. Strategic Initiatives

List of Tables

  • Table 1 List of Secondary Sources
  • Table 2 List of Abbreviations
  • Table 3 US Investigational New Drug CDMO Market Estimates and Forecasts, by Service, 2021 - 2033 (USD Million)
  • Table 4 US Investigational New Drug CDMO Market Estimates and Forecasts, by End Use, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Information procurement
  • Fig. 3 Primary research pattern
  • Fig. 4 Market research approaches
  • Fig. 5 Market formulation & validation
  • Fig. 6 Commodity flow analysis
  • Fig. 7 Value-chain-based sizing & forecasting
  • Fig. 8 QFD model sizing & forecasting
  • Fig. 9 Bottom-up approach
  • Fig. 10 Market snapshot
  • Fig. 11 Segment snapshot 1
  • Fig. 12 Segment snapshot 2
  • Fig. 13 Competitive landscape snapshot
  • Fig. 14 Parent market outlook, 2024 (USD Billion)
  • Fig. 15 Ancillary market outlook, 2024 (USD Billion)
  • Fig. 16 U.S. Investigational New Drug CDMO Market Dynamics
  • Fig. 17 Porter's Five Forces analysis
  • Fig. 18 PESTEL analysis
  • Fig. 19 U.S. Investigational New Drug CDMO Market: Service outlook and key takeaways
  • Fig. 20 U.S. Investigational New Drug CDMO Market: Service movement analysis
  • Fig. 21 Contract Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 22 Small Molecule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 23 Bioanalysis and DMPK Studies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 24 Toxicology Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 25 Pathology and Safety Pharmacology Studies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 26 Drug Substance Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 27 Synthetic Route Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 28 Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 29 Form Selection Crystallization Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 30 Scale-up of Drug Substance Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 31 Formulation Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 32 Pre Formulation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 33 Preclinical Formulation Selection Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 34 First In Man Formulation/ Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 35 Analytical & Quality Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 36 Analytical Method Development / Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 37 Release Testing of Drug Substance and Drug Product Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 38 Formal Stability of Drug Substance and Drug Product Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 39 Process Optimization Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 40 Work Up Purification Steps Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 41 Telescoping & Process Refining Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 42 Initial Optimization Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 43 Large Molecule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 44 Cell Line Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 45 Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 46 Upstream Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 47 Microbial Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 48 Mammalian Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 49 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 50 Downstream Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 51 MABs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 52 Recombinant Proteins Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 53 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 54 Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 55 Small Molecule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 56 Oral Solids Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 57 Semi-Solids Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 58 Liquids & Injectables Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 59 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 60 Large Molecule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 61 MABs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 62 Recombinant Proteins Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 63 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 64 U.S. Investigational New Drug CDMO Market: End Use outlook and key takeaways
  • Fig. 65 U.S. Investigational New Drug CDMO Market: End Use movement analysis
  • Fig. 66 Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 67 Biotech Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 68 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 69 Key company categorization
  • Fig. 70 Service heat map analysis
  • Fig. 71 Strategic framework