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U.S. Small Molecule Innovator API CDMO Market Size, Share & Trends Analysis Report By Stage Type (Preclinical, Clinical, Commercial), By Service, By Customer Type, By Therapeutic Area, By Region, And Segment Forecasts, 2025 - 2030

¹ßÇàÀÏ: | ¸®¼­Ä¡»ç: Grand View Research | ÆäÀÌÁö Á¤º¸: ¿µ¹® 120 Pages | ¹è¼Û¾È³» : 2-10ÀÏ (¿µ¾÷ÀÏ ±âÁØ)

    
    
    




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    • CordenPharma International
    • Samsung Biologics
    • Labcorp
    • Ajinomoto Bio-Pharma Services
    • Piramal Pharma Solutions
    • Jubilant Life Sciences(Jubilant Biosys Limited)
AJY 25.05.29

U.S. Small Molecule Innovator API CDMO Market Growth & Trends:

The U.S. small molecule innovator API CDMO market size is anticipated to reach USD 12.60 billion by 2030 and is projected to grow at a CAGR of 6.0% from 2025 to 2030, according to a new report by Grand View Research, Inc. Agrowing outsourcing trend among pharmaceutical companies, increasing demand for small molecule drugs, and surge in clinical trials are anticipated to influence the U.S. market positively.

Small molecules continue to play an important role in developing new treatments globally. Specialty medicines are increasingly driving U.S. pharmaceutical growth, particularly in developed markets, with small molecule applications accounting for over half of specialty sales. In addition, enhanced efficiency serves as another pivotal driver for pharmaceutical outsourcing. With mounting pressure on pharmaceutical companies to expedite the introduction of new drugs to the market, outsourcing emerges as a solution to accelerate the drug development process. Leveraging their expertise, experience, and cutting-edge equipment, CDMOs facilitate the swift & efficient production of high-quality drugs, enabling pharmaceutical firms to adhere to their development schedules.

The pharmaceutical/biotechnology companies increasingly opt for CDMO services to leverage their expertise. CDMOs offer flexibility & scalability in manufacturing capacity, allowing pharmaceutical companies to adapt to changing market demands and accelerate time to market for new therapies. In addition to providing extended expertise and assisting in improved cash flow management, outsourcing brings significant manufacturing advantages, including reducing investment risks. In the context of early-stage technologies and products, establishing expensive in-house capabilities entails substantial risks across the product development phases. At the same time, outsourcing serves as a risk-averse alternative.

The preference for outsourcing small molecule API has grown as an effective strategy until market demand for products becomes well-established and understood. For instance, in May 2022, Piramal Pharma Limited's Pharma Solutions business, a CDMO, inaugurated a new API facility at its site in Aurora, Ontario. This state-of-the-art plant has commenced operations & has completed its initial production runs.

U.S. Small Molecule Innovator API CDMO Market Report Highlights:

  • Based on stage, the clinical segment led the market with the largest revenue share of 54.68% in 2024. The segment growth can be attributed to the rising clinical trial (Phase I-III) activities, growing small molecule development pipeline, and increasing availability of expertise
  • Based on the customer type, the pharmaceutical segment held the market with the largest revenue share in 2024, attributing to rising funding for drug development is propelling segment growth
  • Based on therapeutic area, the oncology segment accounted for the largest revenue share in 2024. The segment is driven by increasing prevalence of cancer in U.S. In addition, high R&D investments in advanced therapeutics to minimize cancer disease burden are expected to boost segment growth
  • West Group dominated the U.S. market with the largest revenue share of 33.07% in 2024. The presence of various factors, such as increasing prevalence of chronic diseases, demand for APIs & CDMO services and improving healthcare infrastructure is expected to drive market significantly

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
    • 1.1.1. Regional Scope
    • 1.1.2. Estimates and Forecast Timeline
  • 1.2. Market Definitions
  • 1.3. Research Methodology
    • 1.3.1. Information Procurement
    • 1.3.2. Purchased Database
    • 1.3.3. GVR's Internal Database
    • 1.3.4. Secondary Sources
    • 1.3.5. Primary Research
  • 1.4. Information or Data Analysis
    • 1.4.1. Information Analysis
    • 1.4.2. Market Formulation & Data Visualization
    • 1.4.3. Data Validation & Publishing
  • 1.5. Model Details
    • 1.5.1. Commodity Flow Analysis (Model 1)
    • 1.5.2. Top Down Market Estimation (Model 2)
    • 1.5.3. Value-Chain-Based Sizing & Forecasting (Model 3)
    • 1.5.4. Multivariate Analysis (Model 4)
  • 1.6. List of Secondary Sources
  • 1.7. List of Abbreviations
  • 1.8. Objectives

Chapter 2. Executive Summary

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

Chapter 3. 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 Trends and Outlook
  • 3.3. Market Dynamics
    • 3.3.1. Market Driver Analysis
    • 3.3.2. Market Restraint Analysis
  • 3.4. Investments & Funding Perspective
  • 3.5. Clinical Trials Volume Analysis, (2024)
    • 3.5.1. Total Number of Clinical Trials, by Phase (2024)
    • 3.5.2. Total Number of Clinical Trials, by Study Design (2024)
    • 3.5.3. Total Number of Clinical Trials, by Key Therapeutic Area (2024)
  • 3.6. Technology Landscape
    • 3.6.1. Integration Of AI In Small Molecule Innovator API CDMO Market
  • 3.7. Pricing Model Analysis
  • 3.8. Regulatory Framework
  • 3.9. Industry Analysis Tools
    • 3.9.1. Porter's Five Forces Analysis
    • 3.9.2. PESTEL by SWOT Analysis
    • 3.9.3. COVID-19 Impact Analysis

Chapter 4. U.S. Small Molecule Innovator API CDMO Market: Stage Type Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. U.S. Small Molecule Innovator API CDMO Market; Stage Type Movement Analysis
  • 4.3. U.S. Small Molecule Innovator API CDMO Size & Trend Analysis, by Stage Type, 2018 to 2030 (USD Million)
  • 4.4. Preclinical
    • 4.4.1. Preclinical market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.5. Clinical
    • 4.5.1. Clinical market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.5.2. Phase I
      • 4.5.2.1. Phase I market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.5.3. Phase II
      • 4.5.3.1. Phase II market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.5.4. Phase III
      • 4.5.4.1. Phase III market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.6. Commercial
    • 4.6.1. Commercial market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 5. U.S. Small Molecule Innovator API CDMO Market: Service Estimates & Trend Analysis

  • 5.1. Segment Dashboard
  • 5.2. U.S. Small Molecule Innovator API CDMO Market; Service Movement Analysis
  • 5.3. U.S. Small Molecule Innovator API CDMO Size & Trend Analysis, by Service, 2018 to 2030 (USD Million)
  • 5.4. Process Development
    • 5.4.1. Process development market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.2. Preclinical development
      • 5.4.2.1. Preclinical development market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.3. Clinical development
      • 5.4.3.1. Clinical development market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.4. Scale-up optimization
      • 5.4.4.1. Scale-up optimization market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.5. Contract Manufacturing
    • 5.5.1. Contract manufacturing market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.5.2. Clinical
      • 5.5.2.1. Clinical market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.5.3. Commercial
      • 5.5.3.1. Commercial market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.6. Analytical Testing and Quality Control
    • 5.6.1. Analytical testing and quality control market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.7. Packaging and Supply Chain Solutions
    • 5.7.1. Packaging and supply chain solutions market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.8. Others
    • 5.8.1. Others market estimates and forecasts 2018 to 2030 (USD Million)

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

  • 6.1. Segment Dashboard
  • 6.2. U.S. Small Molecule Innovator API CDMO Market; Customer Type Movement Analysis
  • 6.3. U.S. Small Molecule Innovator API CDMO Size & Trend Analysis, by Customer Type, 2018 to 2030 (USD Million)
  • 6.4. Pharmaceutical
    • 6.4.1. Pharmaceutical market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.4.2. Small
      • 6.4.2.1. Small market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.4.3. Medium
      • 6.4.3.1. Medium market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.4.4. Large
      • 6.4.4.1. Large market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.5. Biotechnology
    • 6.5.1. Biotechnology market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.5.2. Small
      • 6.5.2.1. Small market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.5.3. Medium
      • 6.5.3.1. Medium market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.5.4. Large
      • 6.5.4.1. Large market estimates and forecasts 2018 to 2030 (USD Million)

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

  • 7.1. Segment Dashboard
  • 7.2. U.S. Small Molecule Innovator API CDMO Market; Therapeutic Area Movement Analysis
  • 7.3. U.S. Small Molecule Innovator API CDMO Size & Trend Analysis, by Therapeutic Area, 2018 to 2030 (USD Million)
  • 7.4. Cardiovascular Diseases
    • 7.4.1. Cardiovascular diseases market estimates and forecasts 2018 to 2030 (USD Million)
  • 7.5. Oncology
    • 7.5.1. Oncology market estimates and forecasts 2018 to 2030 (USD Million)
  • 7.6. Respiratory Disorders
    • 7.6.1. Respiratory disorders market estimates and forecasts 2018 to 2030 (USD Million)
  • 7.7. Neurology
    • 7.7.1. Neurology market estimates and forecasts 2018 to 2030 (USD Million)
  • 7.8. Metabolic Disorders
    • 7.8.1. Metabolic disorders market estimates and forecasts 2018 to 2030 (USD Million)
  • 7.9. Infectious Diseases
    • 7.9.1. Infectious diseases market estimates and forecasts 2018 to 2030 (USD Million)
  • 7.10. Others
    • 7.10.1. Others market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 8. U.S. Small Molecule Innovator API CDMO Market: Regional Business Analysis

  • 8.1. Regional Dashboard
  • 8.2. Market Size & Forecasts and Trend Analysis, 2018 to 2030 (USD Million)
  • 8.3. Northeast
    • 8.3.1. Competitive scenario
    • 8.3.2. Northeast small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)
    • 8.3.3. New Jersey
      • 8.3.3.1. Competitive scenario
      • 8.3.3.2. New Jersey small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)
    • 8.3.4. New York
      • 8.3.4.1. Competitive scenario
      • 8.3.4.2. New York small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)
    • 8.3.5. Massachusetts
      • 8.3.5.1. Competitive scenario
      • 8.3.5.2. Massachusetts small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)
  • 8.4. Midwest
    • 8.4.1. Competitive scenario
    • 8.4.2. Midwest small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)
    • 8.4.3. Illinois
      • 8.4.3.1. Competitive scenario
      • 8.4.3.2. Illinois small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)
    • 8.4.4. Missouri
      • 8.4.4.1. Competitive scenario
      • 8.4.4.2. Missouri small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)
    • 8.4.5. North Carolina
      • 8.4.5.1. Competitive scenario
      • 8.4.5.2. North Carolina small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)
  • 8.5. West Group
    • 8.5.1. Competitive scenario
    • 8.5.2. West Group small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)
    • 8.5.3. California
      • 8.5.3.1. Competitive scenario
      • 8.5.3.2. California small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)
    • 8.5.4. Washington
      • 8.5.4.1. Competitive scenario
      • 8.5.4.2. Washington small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)
  • 8.6. South
    • 8.6.1. Competitive scenario
    • 8.6.2. South small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)
    • 8.6.3. Texas
      • 8.6.3.1. Competitive scenario
      • 8.6.3.2. Texas small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)
    • 8.6.4. Florida
      • 8.6.4.1. Competitive scenario
      • 8.6.4.2. Florida small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)
    • 8.6.5. Georgia
      • 8.6.5.1. Competitive scenario
      • 8.6.5.2. Georgia small Molecule Innovator API CDMO market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 9. Competitive Landscape

  • 9.1. Company Categorization
  • 9.2. Company Market Position Analysis, 2024
  • 9.3. Company Profiles
    • 9.3.1. Lonza Group Ltd.
      • 9.3.1.1. Company overview
      • 9.3.1.2. Financial performance
      • 9.3.1.3. Service benchmarking
      • 9.3.1.4. Strategic initiatives
    • 9.3.2. Novo Holdings (Catalent, Inc.)
      • 9.3.2.1. Company overview
      • 9.3.2.2. Financial performance
      • 9.3.2.3. Service benchmarking
      • 9.3.2.4. Strategic initiatives
    • 9.3.3. Thermo Fisher Scientific, Inc.
      • 9.3.3.1. Company overview
      • 9.3.3.2. Financial performance
      • 9.3.3.3. Service benchmarking
      • 9.3.3.4. Strategic initiatives
    • 9.3.4. Siegfried Holding AG
      • 9.3.4.1. Company overview
      • 9.3.4.2. Financial performance
      • 9.3.4.3. Service benchmarking
      • 9.3.4.4. Strategic initiatives
    • 9.3.5. Recipharm AB
      • 9.3.5.1. Company overview
      • 9.3.5.2. Financial performance
      • 9.3.5.3. Service benchmarking
      • 9.3.5.4. Strategic initiatives
    • 9.3.6. CordenPharma International
      • 9.3.6.1. Company overview
      • 9.3.6.2. Financial performance
      • 9.3.6.3. Service benchmarking
      • 9.3.6.4. Strategic initiatives
    • 9.3.7. Samsung Biologics
      • 9.3.7.1. Company overview
      • 9.3.7.2. Financial performance
      • 9.3.7.3. Service benchmarking
      • 9.3.7.4. Strategic initiatives
    • 9.3.8. Labcorp
      • 9.3.8.1. Company overview
      • 9.3.8.2. Financial performance
      • 9.3.8.3. Service benchmarking
      • 9.3.8.4. Strategic initiatives
    • 9.3.9. Ajinomoto Bio-Pharma Services
      • 9.3.9.1. Company overview
      • 9.3.9.2. Financial performance
      • 9.3.9.3. Service benchmarking
      • 9.3.9.4. Strategic initiatives
    • 9.3.10. Piramal Pharma Solutions
      • 9.3.10.1. Company overview
      • 9.3.10.2. Financial performance
      • 9.3.10.3. Service benchmarking
      • 9.3.10.4. Strategic initiatives
    • 9.3.11. Jubilant Life Sciences (Jubilant Biosys Limited)
      • 9.3.11.1. Company overview
      • 9.3.11.2. Financial performance
      • 9.3.11.3. Service benchmarking
      • 9.3.11.4. Strategic initiatives
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