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市場調查報告書
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1813852

美國小分子創新 CDMO 市場規模、佔有率和趨勢分析報告：按產品、階段類型、治療領域、客戶類型和細分預測，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個工作天內

價格

美國小分子創新企業CDMO趨勢

據估計，2024 年美國小分子創新 CDMO 市值為 155.8 億美元，預計到 2033 年將達到 260.6 億美元，2025 年至 2033 年的複合年成長率為 6.04%。市場發展受到開發新型化學實體的新興和中型製藥公司日益成長的需求的推動。這些公司通常缺乏內部製造基礎設施，越來越依賴 CDMO 進行 API 合成、製劑開發和早期臨床供應。隨著腫瘤學、神經病學、代謝疾病、感染疾病等領域的小分子管線創新不斷進步，具有處理複雜化學反應、高效價原料藥和口服固體製劑強大能力的 CDMO 的計劃數量正在增加。成本壓力、對臨床速度的需求以及對加速途徑的監管支援進一步推動了外包決策。

此外，新化學實體 (NCE) 的激增，尤其是來自中小型製藥公司的NCE，也推動了市場的發展。隨著這些公司從藥物發現轉向臨床試驗，它們擴大尋求外包合作夥伴來管理製程開發、規模化生產和GMP生產。現今的小分子候選藥物非常複雜，包括高效能原料藥(HPAPI)、掌性化合物和難溶性分子，這需要CDMO具備獨特的專業技術力。此外，首次人體試驗和快速通道核准的監管靈活性正在鼓勵創新者縮短開發週期，進一步推動了對提供一體化早期服務的CDMO的需求。

此外，為了應對供應鏈脆弱性和地緣政治不確定性，越來越多的企業傾向於在國內生產，這也推動了市場成長。出於對品質保證、較長的前置作業時間和法規遵從性問題的擔憂，創新製藥公司正擴大放棄海外生產，尤其是在印度和中國。政府獎勵進一步強化了這一趨勢，例如美國食品藥物管理局 (FDA) 對國內先進製造的支持以及透過 BARDA 和 ASPR 計畫提供的資金。因此，擁有符合 cGMP 標準的設施、良好的品質記錄以及接近性臨床基地的美國CDMO 正成為早期和商業化生產的首選。

美國小分子創新公司 CDMO 市場區隔

該報告預測了 2021 年至 2033 年各國的收益成長情況，並對每個細分市場的最新行業趨勢進行了分析。在這項研究中，Grand View Research 根據產品類型、階段類型、客戶類型和治療領域對全球美國小分子創新 CDMO 市場報告進行了細分。

  • 產品展望（2021-2033 年銷售情形）
  • 小分子原料藥
  • 小分子藥物
    • 口服固態劑型
    • 半固態劑型
    • 液體給藥
    • 其他
  • 階段類型展望（銷售額，2021-2033）
  • 臨床前
  • 臨床
    • 第一階段
    • 小規模
    • 中等尺寸
    • 大規模
    • 第二階段
    • 小規模
    • 中等尺寸
    • 大規模
    • 第三階段
    • 小規模
    • 中等尺寸
    • 大規模
  • 商業
  • 客戶類型展望（收入，2021-2033）
  • 製藥
    • 小規模
    • 中等尺寸
    • 大規模
  • 生物技術
  • 治療領域展望（銷售額，2021-2033）
  • 心血管疾病
  • 腫瘤學
  • 呼吸系統疾病
  • 神經病學
  • 代謝紊亂
  • 感染疾病
  • 其他

目錄

第1章調查方法與範圍

第2章執行摘要

第 3 章美國小分子創新 CDMO 市場：變數、趨勢與範圍

  • 市場體系展望
  • 美國小分子創新公司 CDMO 市場動態
  • 技術格局
  • 定價模式分析
  • 美國小分子創新者 CDMO 市場：分析工具

第4章美國小分子創新CDMO市場：產品預估與趨勢分析

  • 細分儀表板
  • 美國小分子創新公司CDMO市場產品趨勢分析
  • 2021-2033 年美國小分子創新 CDMO 市場規模及趨勢分析（依產品）
  • 小分子API
  • 小分子藥物
    • 口服固態劑型
    • 半固態
    • 液體劑量
    • 其他

第5章美國小分子創新 CDMO 市場：依階段類型估計與趨勢分析

  • 細分儀表板
  • 美國小分子創新企業CDMO市場階段類型變化分析
  • 美國小分子創新 CDMO 市場規模及趨勢分析（按階段類型），2021-2033 年
  • 臨床前
  • 臨床
    • 第一階段
    • 第二階段
    • 第三階段
  • 商業的

第6章美國小分子創新CDMO市場：客戶類型估計與趨勢分析

  • 細分儀表板
  • 美國小分子創新企業CDMO市場客戶類型變化分析
  • 美國小分子創新 CDMO 市場規模及趨勢分析（依顧客類型），2021-2033 年
  • 製藥
    • 小的
    • 中等的
    • 大的
  • 生物技術

第7章美國小分子創新CDMO市場：治療領域估計與趨勢分析

  • 細分儀表板
  • 美國小分子創新藥CDMO市場治療領域變化分析
  • 美國小分子創新 CDMO 市場規模及趨勢分析（依治療領域），2021-2033 年
  • 心血管疾病
  • 腫瘤學
  • 呼吸系統疾病
  • 神經病學
  • 代謝紊亂
  • 感染疾病
  • 其他

第8章 競爭態勢

  • 公司分類
  • 美國小分子創新公司 CDMO 市佔率分析（2024 年）
  • 公司簡介
    • 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