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市场调查报告书
商品编码
1813852

美国小分子创新 CDMO 市场规模、份额和趋势分析报告：按产品、阶段类型、治疗领域、客户类型和细分预测，2025-2033 年

U.S. Small Molecule Innovator CDMO Market Size, Share & Trends Analysis Report By Product (Small Molecule API, Small Molecule Drug Product), By Stage Type, By Therapeutic Area, By Customer Type, 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

美国小分子创新企业CDMO趋势

据估计，2024 年美国小分子创新 CDMO 市值为 155.8 亿美元，预计到 2033 年将达到 260.6 亿美元，2025 年至 2033 年的复合年增长率为 6.04%。市场发展受到开发新型化学实体的新兴和中型製药公司日益增长的需求的推动。这些公司通常缺乏内部製造基础设施，越来越依赖 CDMO 进行 API 合成、製剂开发和早期临床供应。随着肿瘤学、神经病学、代谢疾病、感染疾病等领域的小分子管线创新不断进步，具有处理复杂化学反应、高效价原料药和口服固体製剂强大能力的 CDMO 的计划数量正在增加。成本压力、对临床速度的需求以及对加速途径的监管支援进一步推动了外包决策。

此外，新化学实体 (NCE) 的激增，尤其是来自中小型製药公司的NCE，也推动了市场的发展。随着这些公司从药物发现转向临床试验，它们越来越多地寻求外包合作伙伴来管理製程开发、规模化生产和GMP生产。现今的小分子候选药物非常复杂，包括高效能原料药(HPAPI)、掌性化合物和难溶性分子，这需要CDMO具备独特的专业技术力。此外，首次人体试验和快速通道审批的监管灵活性正在鼓励创新者缩短开发週期，进一步推动了对提供一体化早期服务的CDMO的需求。

此外，为了应对供应链脆弱性和地缘政治不确定性，越来越多的企业倾向于在国内生产，这也推动了市场成长。出于对品质保证、较长的前置作业时间和法规遵从性问题的担忧，创新製药公司正越来越多地放弃海外生产，尤其是在印度和中国。政府奖励进一步强化了这一趋势，例如美国食品药物管理局 (FDA) 对国内先进製造的支持以及透过 BARDA 和 ASPR 计画提供的资金。因此，拥有符合 cGMP 标准的设施、良好的品质记录以及接近性临床基地的美国CDMO 正成为早期和商业化生产的首选。

美国小分子创新公司 CDMO 市场区隔

该报告预测了 2021 年至 2033 年各国的收益成长情况，并对每个细分市场的最新行业趋势进行了分析。在这项研究中，Grand View Research 根据产品类型、阶段类型、客户类型和治疗领域对全球美国小分子创新 CDMO 市场报告进行了细分。

  • 产品展望（2021-2033 年销售情形）
  • 小分子原料药
  • 小分子药物
    • 口服固态剂型
    • 半固态剂型
    • 液体给药
    • 其他的
  • 阶段类型展望（销售额，2021-2033）
  • 临床前
  • 临床
    • 第一阶段
    • 小规模
    • 中等尺寸
    • 大规模
    • 第二阶段
    • 小规模
    • 中等尺寸
    • 大规模
    • 第三阶段
    • 小规模
    • 中等尺寸
    • 大规模
  • 商业
  • 客户类型展望（收入，2021-2033）
  • 製药
    • 小规模
    • 中等尺寸
    • 大规模
  • 生物技术
  • 治疗领域展望（销售额，2021-2033）
  • 心血管疾病
  • 肿瘤学
  • 呼吸系统疾病
  • 神经病学
  • 代谢紊乱
  • 感染疾病
  • 其他的

目录

第一章调查方法与范围

第二章执行摘要

第 3 章美国小分子创新 CDMO 市场：变数、趋势与范围

  • 市场体系展望
  • 美国小分子创新公司 CDMO 市场动态
  • 技术格局
  • 定价模式分析
  • 美国小分子创新者 CDMO 市场：分析工具

第四章美国小分子创新CDMO市场：产品预估与趋势分析

  • 细分仪表板
  • 美国小分子创新公司CDMO市场产品趋势分析
  • 2021-2033 年美国小分子创新 CDMO 市场规模及趋势分析（依产品）
  • 小分子API
  • 小分子药物
    • 口服固态剂型
    • 半固态
    • 液体剂量
    • 其他的

第五章美国小分子创新 CDMO 市场：依阶段类型估计与趋势分析

  • 细分仪表板
  • 美国小分子创新企业CDMO市场阶段类型变化分析
  • 美国小分子创新 CDMO 市场规模及趋势分析（按阶段类型），2021-2033 年
  • 临床前
  • 临床
    • 第一阶段
    • 第二阶段
    • 第三阶段
  • 商业的

第六章美国小分子创新CDMO市场：客户类型估计与趋势分析

  • 细分仪表板
  • 美国小分子创新企业CDMO市场客户类型变化分析
  • 美国小分子创新 CDMO 市场规模及趋势分析（依顾客类型），2021-2033 年
  • 製药
    • 小的
    • 中等的
    • 大的
  • 生物技术

第七章美国小分子创新CDMO市场：治疗领域估计与趋势分析

  • 细分仪表板
  • 美国小分子创新药CDMO市场治疗领域变化分析
  • 美国小分子创新 CDMO 市场规模及趋势分析（依治疗领域），2021-2033 年
  • 心血管疾病
  • 肿瘤学
  • 呼吸系统疾病
  • 神经病学
  • 代谢紊乱
  • 感染疾病
  • 其他的

第八章 竞争态势

  • 公司分类
  • 美国小分子创新公司 CDMO 市占率分析（2024 年）
  • 公司简介
    • Piramal Pharma Solutions
    • CordenPharma International
    • Wuxi AppTec
    • Cambrex Corporation
    • Recipharm AB
    • Thermo Fisher Scientific, Inc.
    • Lonza
    • Catalent Inc.
    • Siegfried Holding AG
    • Boehringer Ingelheim
    • Labcorp
Product Code: GVR-4-68040-703-0

U.S. Small Molecule Innovator CDMO Trends

The U.S. small molecule innovator CDMO market size was estimated at USD 15.58 billion in 2024 and is projected to reach USD 26.06 billion by 2033, growing at a CAGR of 6.04% from 2025 to 2033. The growth of the market is due to the rising demand from emerging and mid-sized pharmaceutical companies developing novel chemical entities. These firms often lack in-house manufacturing infrastructure and are increasingly relying on CDMOs for API synthesis, formulation development, and early-phase clinical supply. As innovation in small molecule pipelines continues across oncology, neurology, metabolic disorders, and anti-infectives, CDMOs with strong capabilities in handling complex chemistry, high-potency APIs, and oral solid dosage forms are witnessing increased project volumes. Cost pressures, the need for speed-to-clinic, and regulatory support for accelerated pathways are further fueling outsourcing decisions.

Furthermore, the market is primarily driven by the surge in novel chemical entity (NCE) development, particularly from small and mid-sized pharmaceutical firms. These companies increasingly seek outsourced partners to manage process development, scale-up, and GMP manufacturing as they move from discovery to clinical testing. The complexity of today's small molecule drug candidates, including highly potent APIs (HPAPIs), chiral compounds, and poorly soluble molecules demand specialized technical capabilities that CDMOs are uniquely positioned to provide. Moreover, regulatory flexibility for first-in-human and fast-track pathways is encouraging innovators to compress development timelines, further elevating demand for CDMOs with integrated early-phase services.

In addition, the growing preference for domestic manufacturing in response to supply chain vulnerabilities and geopolitical uncertainty is also driving the market growth. Innovator pharmaceutical companies are increasingly shifting away from offshore production, particularly in India and China, due to concerns around quality assurance, long lead times, and regulatory compliance issues. This trend has been further reinforced by government incentives such as the U.S. FDA's support for onshore advanced manufacturing and funding through the BARDA and ASPR programs. As a result, U.S.-based CDMOs with cGMP-compliant facilities, strong quality track records, and proximity to clinical sites are being prioritized for both early-phase and commercial production.

U.S. Small Molecule Innovator CDMO Market Segmentation

This report forecasts revenue growth at 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 global U.S. small molecule innovator CDMO market report based on product, stage type, customer type, and therapeutic area.

  • Product Outlook (Revenue, USD Million, 2021 - 2033)
  • Small Molecule API
  • Small Molecule Drug Product
    • Oral Solid Dose
    • Semi-Solid Dose
    • Liquid Dose
    • Others
  • Stage Type Outlook (Revenue, USD Million, 2021 - 2033)
  • Preclinical
  • Clinical
    • Phase I
    • Small
    • Medium
    • Large
    • Phase II
    • Small
    • Medium
    • Large
    • Phase III
    • Small
    • Medium
    • Large
  • Commercial
  • Customer Type Outlook (Revenue, USD Million, 2021 - 2033)
  • Pharmaceutical
    • Small
    • Medium
    • Large
  • Biotechnology
  • Therapeutic Area Outlook (Revenue, USD Million, 2021 - 2033)
  • Cardiovascular Diseases
  • Oncology
  • Respiratory Disorders
  • Neurology
  • Metabolic Disorders
  • Infectious Diseases
  • Others

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation and Scope
  • 1.2. Market Definitions
  • 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 (Model 1)
    • 1.7.2. Value chain based analysis (Model 2)
    • 1.7.3. Multivariate Analysis (Model 3)
  • 1.8. List of Secondary Sources
  • 1.9. List of Primary Sources
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Snapshot
  • 2.3. Competitive Landscape Snapshot

Chapter 3. U.S. Small Molecule Innovator CDMO Market: Variables, Trends, & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent Market Outlook
    • 3.1.2. Ancillary Market Outlook
  • 3.2. U.S. Small Molecule Innovator CDMO Market Dynamics
    • 3.2.1. Market Driver Impact Analysis
    • 3.2.2. Market Restraint Analysis
  • 3.3. Technological Landscape
  • 3.4. Pricing Model Analysis
  • 3.5. U.S. Small Molecule Innovator CDMO Market: Analysis Tools
    • 3.5.1. Porter's Five Forces Analysis
    • 3.5.2. PESTEL Analysis

Chapter 4. U.S. Small Molecule Innovator CDMO Market: Product Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. U.S. Small Molecule Innovator CDMO Market Product Movement Analysis
  • 4.3. U.S. Small Molecule Innovator CDMO Market Size & Trend Analysis, by Product, 2021 to 2033 (USD Million)
  • 4.4. Small Molecule API
    • 4.4.1. Small Molecule API Market Estimates and Forecasts, 2021 - 2033 (USD million)
  • 4.5. Small Molecule Drug Product
    • 4.5.1. Small Molecule Drug Product Market Estimates and Forecasts, 2021 - 2033 (USD million)
    • 4.5.2. Oral Solid Dose
      • 4.5.2.1. Oral Solid Dose Market Estimates and Forecasts, 2021 - 2033 (USD million)
    • 4.5.3. Semi-Solid Dose
      • 4.5.3.1. Semi-Solid Dose Market Estimates and Forecasts, 2021 - 2033 (USD million)
    • 4.5.4. Liquid Dose
      • 4.5.4.1. Liquid Dose Market Estimates and Forecasts, 2021 - 2033 (USD million)
    • 4.5.5. Others
      • 4.5.5.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD million)

Chapter 5. U.S. Small Molecule Innovator CDMO Market: Stage Type Estimates & Trend Analysis

  • 5.1. Segment Dashboard
  • 5.2. U.S. Small Molecule Innovator CDMO Market Stage Type Movement Analysis
  • 5.3. U.S. Small Molecule Innovator CDMO Market Size & Trend Analysis, by Stage Type, 2021 to 2033 (USD Million)
  • 5.4. Preclinical
    • 5.4.1. Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5. Clinical
    • 5.5.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.5.2. Phase I
      • 5.5.2.1. Phase I Market Estimates and Forecasts, 2021 - 2033 (USD million)
      • 5.5.2.2. Small
        • 5.5.2.2.1. Small Market Estimates and Forecasts, 2021 - 2033 (USD million)
      • 5.5.2.3. Medium
        • 5.5.2.3.1. Medium Market Estimates and Forecasts, 2021 - 2033 (USD million)
      • 5.5.2.4. Large
        • 5.5.2.4.1. Large Market Estimates and Forecasts, 2021 - 2033 (USD million)
    • 5.5.3. Phase II
      • 5.5.3.1. Phase II Market Estimates and Forecasts, 2021 - 2033 (USD million)
      • 5.5.3.2. Small
        • 5.5.3.2.1. Small Market Estimates and Forecasts, 2021 - 2033 (USD million)
      • 5.5.3.3. Medium
        • 5.5.3.3.1. Medium Market Estimates and Forecasts, 2021 - 2033 (USD million)
      • 5.5.3.4. Large
        • 5.5.3.4.1. Large Market Estimates and Forecasts, 2021 - 2033 (USD million)
    • 5.5.4. Phase III
      • 5.5.4.1. Phase III Market Estimates and Forecasts, 2021 - 2033 (USD million)
      • 5.5.4.2. Small
        • 5.5.4.2.1. Small Market Estimates and Forecasts, 2021 - 2033 (USD million)
      • 5.5.4.3. Medium
        • 5.5.4.3.1. Medium Market Estimates and Forecasts, 2021 - 2033 (USD million)
      • 5.5.4.4. Large
        • 5.5.4.4.1. Large Market Estimates and Forecasts, 2021 - 2033 (USD million)
  • 5.6. Commercial
    • 5.6.1. Commercial Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Small Molecule Innovator CDMO Market: Customer Type Estimates & Trend Analysis

  • 6.1. Segment Dashboard
  • 6.2. U.S. Small Molecule Innovator CDMO Market Customer Type Movement Analysis
  • 6.3. U.S. Small Molecule Innovator CDMO Market Size & Trend Analysis, by Customer Type, 2021 to 2033 (USD Million)
  • 6.4. Pharmaceutical
    • 6.4.1. Pharmaceutical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.4.2. Small
      • 6.4.2.1. Small Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.4.3. Medium
      • 6.4.3.1. Medium Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.4.4. Large
      • 6.4.4.1. Large Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5. Biotechnology
    • 6.5.1. Biotechnology Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. U.S. Small Molecule Innovator CDMO Market: Therapeutic Area Estimates & Trend Analysis

  • 7.1. Segment Dashboard
  • 7.2. U.S. Small Molecule Innovator CDMO Market Therapeutic Area Movement Analysis
  • 7.3. U.S. Small Molecule Innovator CDMO Market Size & Trend Analysis, by Therapeutic Area, 2021 to 2033 (USD Million)
  • 7.4. Cardiovascular diseases
    • 7.4.1. Cardiovascular diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5. Oncology
    • 7.5.1. Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6. Respiratory disorders
    • 7.6.1. Respiratory disorders Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7. Neurology
    • 7.7.1. Neurology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8. Metabolic Disorders
    • 7.8.1. Metabolic Disorders Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.9. Infectious Diseases
    • 7.9.1. Infectious Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.10. Others
    • 7.10.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

  • 8.1. Company Categorization
  • 8.2. U.S. Small Molecule Innovator CDMO Market Share Analysis, 2024
  • 8.3. Company Profiles
    • 8.3.1. Piramal Pharma Solutions
      • 8.3.1.1. Company overview
      • 8.3.1.2. Financial performance
      • 8.3.1.3. Product benchmarking
      • 8.3.1.4. Strategic initiatives
    • 8.3.2. CordenPharma International
      • 8.3.2.1. Company overview
      • 8.3.2.2. Financial performance
      • 8.3.2.3. Product benchmarking
      • 8.3.2.4. Strategic initiatives
    • 8.3.3. Wuxi AppTec
      • 8.3.3.1. Company overview
      • 8.3.3.2. Financial performance
      • 8.3.3.3. Product benchmarking
      • 8.3.3.4. Strategic initiatives
    • 8.3.4. Cambrex Corporation
      • 8.3.4.1. Company overview
      • 8.3.4.2. Financial performance
      • 8.3.4.3. Product benchmarking
      • 8.3.4.4. Strategic initiatives
    • 8.3.5. Recipharm AB
      • 8.3.5.1. Company overview
      • 8.3.5.2. Financial performance
      • 8.3.5.3. Product benchmarking
      • 8.3.5.4. Strategic initiatives
    • 8.3.6. Thermo Fisher Scientific, Inc.
      • 8.3.6.1. Company overview
      • 8.3.6.2. Financial performance
      • 8.3.6.3. Product benchmarking
      • 8.3.6.4. Strategic initiatives
    • 8.3.7. Lonza
      • 8.3.7.1. Company overview
      • 8.3.7.2. Financial performance
      • 8.3.7.3. Product benchmarking
      • 8.3.7.4. Strategic initiatives
    • 8.3.8. Catalent Inc.
      • 8.3.8.1. Company overview
      • 8.3.8.2. Financial performance
      • 8.3.8.3. Product benchmarking
      • 8.3.8.4. Strategic initiatives
    • 8.3.9. Siegfried Holding AG
      • 8.3.9.1. Company overview
      • 8.3.9.2. Financial performance
      • 8.3.9.3. Product benchmarking
      • 8.3.9.4. Strategic initiatives
    • 8.3.10. Boehringer Ingelheim
      • 8.3.10.1. Company overview
      • 8.3.10.2. Financial performance
      • 8.3.10.3. Product benchmarking
      • 8.3.10.4. Strategic initiatives
    • 8.3.11. Labcorp
      • 8.3.11.1. Company overview
      • 8.3.11.2. Financial performance
      • 8.3.11.3. Product benchmarking
      • 8.3.11.4. Strategic initiatives

List of Tables

  • Table 1 List of abbreviations
  • Table 2 U.S. Small Molecule Innovator CDMO market, by product, 2021 - 2033 (USD Million)
  • Table 3 U.S. Small Molecule Innovator CDMO market, by stage type, 2021 - 2033 (USD Million)
  • Table 4 U.S. Small Molecule Innovator CDMO market, by customer type, 2021 - 2033 (USD Million)
  • Table 5 U.S. Small Molecule Innovator CDMO market, by therapeutic area, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 U.S. Small Molecule Innovator CDMO market segmentation
  • Fig. 2 Market research process
  • Fig. 3 Information procurement
  • Fig. 4 Primary research pattern
  • Fig. 5 Market research approaches
  • Fig. 6 Market formulation & validation
  • Fig. 7 Commodity flow analysis
  • Fig. 8 Value-Chain-Based Sizing & Forecasting
  • Fig. 9 QFD model sizing & forecasting
  • Fig. 10 Bottom-up approach
  • Fig. 11 Market snapshot
  • Fig. 12 Segment snapshot
  • Fig. 13 Segment snapshot
  • Fig. 14 Segment snapshot
  • Fig. 15 Competitive landscape snapshot
  • Fig. 16 Parent market outlook, 2024 (USD Million)
  • Fig. 17 Ancillary market outlook, 2024 (USD Million)
  • Fig. 18 U.S. Small Molecule Innovator CDMO market dynamics
  • Fig. 19 Porter's five forces analysis
  • Fig. 20 PESTEL analysis
  • Fig. 21 U.S. Small Molecule Innovator CDMO market Product outlook: Segment dashboard
  • Fig. 22 U.S. Small Molecule Innovator CDMO market, by Product segment: Market share, 2024 & 2033
  • Fig. 23 Small Molecule API market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 24 Small Molecule Drug Product market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 25 Oral Solid Dose market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 26 Semi-Solid Dose market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 27 Liquid Dose market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 28 Others market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 29 U.S. Small Molecule Innovator CDMO market Stage Type outlook: Segment dashboard
  • Fig. 30 Small Molecule Innovator CDMO market, by Stage Type segment: Market share, 2024 & 2033
  • Fig. 31 Preclinical market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 32 Clinical market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 33 Phase I market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 34 Phase II market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 35 Phase III market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 36 U.S. Small Molecule Innovator CDMO market Customer Type outlook: Segment dashboard
  • Fig. 37 Small Molecule Innovator CDMO market, by Customer Type segment: Market share, 2024 & 2033
  • Fig. 38 Pharmaceutical market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 39 Biotechnology market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 40 U.S. Small Molecule Innovator CDMO market Therapeutic Area outlook: Segment dashboard
  • Fig. 41 Small Molecule Innovator CDMO market, by Therapeutic Area segment: Market share, 2024 & 2033
  • Fig. 42 Cardiovascular diseases market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 43 Oncology market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 44 Respiratory disorders market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 45 Neurology market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 46 Metabolic Disorders market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 47 Infectious Diseases market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 48 Others market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 49 Market participant categorization
  • Fig. 50 Heat map analysis