미국의 저분자 이노베이터 CDMO 시장 규모, 점유율, 동향 분석 보고서 : 제품별, 스테이지 유형별, 치료 영역별, 고객 유형별, 부문 예측(2025-2033년)

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