미국의 원료의약품 CDMO 시장 : 규모, 점유율, 동향 분석, 제품별, 합성별, 약제별, 워크플로우별, 용도별, 부문별 예측(2025-2030년)

U.S. Active Pharmaceutical Ingredients CDMO Market Size, Share & Trends Analysis Report By Product (Traditional API, HP-API, ADC), By Synthesis, By Drug, By Workflow, By Application, And Segment Forecasts, 2025 - 2030

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한글목차

시장 규모와 동향

미국의 원료의약품 CDMO 시장은 2024년에 252억 8,000만 달러로 평가되었고, 2025-2030년 CAGR 5.1%로 성장하고, 2030년에는 338억 6,000만 달러에 이를 것으로 예측됩니다. 또한 생물 제제와 고역가 원료에 대한 투자 증가가 시장 확대의 원동력이 되고 있습니다.

이 시장 성장을 지원하는 주요 촉진요인은 수율을 향상시키고 낭비를 없애고 제품 품질을 높이는 공정 화학 및 제조 자동화 기술 진보를 포함합니다. 맞춤형 의약품과 신규 치료법에 대한 관심이 증가하면서 소량의 복잡한 원료의약품(API) 제조에 대한 수요가 늘고 있습니다. 이는 유연성과 전문성을 갖춘 CDMO(위탁개발생산) 기업이 강점을 보이는 분야입니다.

이 시장은 특히 고도로 전문화된 원료제조를 필요로 하는 생물제제, 유전자치료, 세포치료의 개발에 큰 비즈니스 기회를 가져오고 있습니다.

목차

제1장 조사 방법과 범위

제2장 주요 요약

제3장 미국의 원료의약품 CDMO 시장의 변수, 동향, 범위

• 시장 계통의 전망
• 시장 역학
  • 시장 성장 촉진요인 분석
  • 시장 성장 억제요인 분석
  • 산업의 과제
• 산업 분석도구
  • Porter's Five Forces 분석
  • PESTEL 분석

제4장 미국의 원료의약품 CDMO 시장 : 제품별, 추정 및 예측 분석

• 미국의 원료의약품 CDMO 시장, 제품별 : 주요 포인트
• 제품 변동 분석과 시장 점유율, 2024년과 2030년
• 제품별, 2018-2030년
  • 전통적 유효 약제 성분
  • 매우 강력한 유효 약제 성분
  • 항체 약제 복합체(ADC)
  • 기타

제5장 미국의 원료의약품 CDMO 시장 : 합성별, 추정 및 예측 분석

• 미국의 원료의약품 CDMO 시장, 합성별 : 주요 포인트
• 합성 변동 분석과 시장 점유율, 2024년과 2030년
• 합성별, 2018-2030년
  • 합성
  • 생명공학

제6장 미국의 원료의약품 CDMO 시장 : 약제별, 추정 및 예측 분석

• 미국의 원료의약품 CDMO 시장, 약제별 : 주요 포인트
• 약제 변동 분석과 시장 점유율, 2024년과 2030년
• 약제별, 2018-2030년
  • 혁신적
  • 제네릭

제7장 미국의 원료의약품 CDMO 시장 : 워크플로우별, 추정 및 예측 분석

• 미국 원료의약품 CDMO 시장, 워크플로우별 : 주요 포인트
• 워크플로우 변동 분석과 시장 점유율, 2024년과 2030년
• 워크플로우별, 2018-2030년
  • 임상
  • 상용

제8장 미국의 원료의약품 CDMO 시장 : 용도별, 추정 및 예측 분석

• 미국의 원료의약품 CDMO 시장, 용도별 : 주요 포인트
• 용도변동 분석과 시장 점유율, 2024년과 2030년
• 용도별, 2018-2030년
  • 종양학
  • 호르몬
  • 녹내장
  • 심혈관 질환
  • 당뇨병
  • 기타

제9장 경쟁 구도

• 기업 분류
• 기업의 시장 포지셔닝
• 기업 히트맵 분석
• 기업 프로파일/상장 기업
  • Thermo Fisher Scientific Inc.
  • Novo Group(Catalent, Inc.)
  • Cambrex Corporation
  • Piramal Pharma Limited
  • Corden Pharma
  • Siegfried Holding AG
  • Seqens North America
  • SK pharmteco Inc.
  • Noramco.
  • BSP Pharmaceuticals

SHW

영문 목차

영문목차

Market Size & Trends:

The U.S. active pharmaceutical ingredients CDMO market was valued at USD 25.28 billion in 2024 and is projected to reach USD 33.86 billion by 2030, growing at a CAGR of 5.1% from 2025 to 2030. This growth is driven by rising demand for advanced pharmaceutical manufacturing services to support the development of innovative drugs and therapies. In addition, increasing investments in biologics and high-potency APIs drive market expansion. The growing prevalence of chronic diseases and the need for efficient, scalable production solutions also contribute to the market's momentum.

Key drivers supporting this market growth include technological advancements in process chemistry and manufacturing automation, which improve yield, reduce waste, and enhance product quality. Regulatory support encouraging outsourcing to specialized CDMOs is vital, as these organizations help ensure compliance with stringent FDA and international standards. The increasing focus on personalized medicine and novel therapies drives demand for small-batch, complex API manufacturing, areas where CDMOs excel due to their flexibility and expertise. Growing collaborations between pharmaceutical firms and CDMOs also foster innovation and accelerate time-to-market, enabling companies to meet better evolving patient better needs.

The market presents significant opportunities, especially in developing biologics, gene therapies, and cell therapies requiring highly specialized API manufacturing. The trend toward continuous manufacturing and flow chemistry offers avenues for CDMOs to improve efficiency and scalability while reducing costs and environmental impact.

U.S. Active Pharmaceutical Ingredients CDMO Market Report Segmentation

This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. active pharmaceutical ingredients CDMO market report based on product, synthesis, drug, workflow, and application.

• Product Outlook (Revenue, USD Million, 2018 - 2030)
• Traditional Active Pharmaceutical Ingredient
• Highly Potent Active Pharmaceutical Ingredient
• Antibody Drug Conjugate (ADC)
• Other
• Synthesis Outlook (Revenue, USD Million, 2018 - 2030)
• Synthetic
• Biotech
• Drug Outlook (Revenue, USD Million, 2018 - 2030)
• Innovative
• Generic
• Workflow Outlook (Revenue, USD Million, 2018 - 2030)
• Clinical
• Commercial
• Application Outlook (Revenue, USD Million, 2018 - 2030)
• Oncology
• Hormonal
• Glaucoma
• Cardiovascular disease
• Diabetes
• Others

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definition
• 1.3. Information Procurement
  • 1.3.1. Purchased Database
  • 1.3.2. GVR's Internal Database
  • 1.3.3. Secondary Sources and Third-Party Perspectives
  • 1.3.4. Primary Research
• 1.4. Information Analysis
  • 1.4.1. Data Analysis Models
• 1.5. Market Formulation and Data Visualization
• 1.6. Data Validation and Publishing

Chapter 2. Executive Summary

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

Chapter 3. U.S. Active Pharmaceutical Ingredients CDMO Market Variables, Trends and Scope

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
  • 3.2.3. Industry Challenge
• 3.3. Industry Analysis Tools
  • 3.3.1. PORTER's Analysis
    • 3.3.1.1. Bargaining power of the suppliers
    • 3.3.1.2. Bargaining power of the buyers
    • 3.3.1.3. Threats of substitution
    • 3.3.1.4. Threats from new entrants
    • 3.3.1.5. Competitive rivalry
  • 3.3.2. PESTEL Analysis
    • 3.3.2.1. Political landscape
    • 3.3.2.2. Economic and social landscape
    • 3.3.2.3. Technological landscape

Chapter 4. U.S. Active Pharmaceutical Ingredients CDMO Market: Product Estimates and Trend Analysis

• 4.1. U.S. Active Pharmaceutical Ingredients CDMO Market, By Product: Key Takeaways
• 4.2. Product Movement Analysis and Market Share, 2024 and 2030
• 4.3. Market Estimates and Forecasts, By Product, 2018 - 2030 (USD Million)
  • 4.3.1. Traditional Active Pharmaceutical Ingredient
    • 4.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.3.2. Highly Potent Active Pharmaceutical Ingredient
    • 4.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.3.3. Antibody Drug Conjugate (ADC)
    • 4.3.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.3.4. Other
    • 4.3.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. U.S. Active Pharmaceutical Ingredients CDMO Market: Synthesis Estimates and Trend Analysis

• 5.1. U.S. Active Pharmaceutical Ingredients CDMO Market, By Synthesis: Key Takeaways
• 5.2. Synthesis Movement Analysis and Market Share, 2024 and 2030
• 5.3. Market Estimates and Forecasts, By Synthesis, 2018 - 2030 (USD Million)
  • 5.3.1. Synthetic
    • 5.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.3.2. Biotech
    • 5.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. U.S. Active Pharmaceutical Ingredients CDMO Market: Drug Estimates and Trend Analysis

• 6.1. U.S. Active Pharmaceutical Ingredients CDMO Market, By Drug: Key Takeaways
• 6.2. Drug Movement Analysis and Market Share, 2024 and 2030
• 6.3. Market Estimates and Forecasts, By Drug, 2018 - 2030 (USD Million)
  • 6.3.1. Innovative
    • 6.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.3.2. Generic
    • 6.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 7. U.S. Active Pharmaceutical Ingredients CDMO Market: Workflow Estimates and Trend Analysis

• 7.1. U.S. Active Pharmaceutical Ingredients CDMO Market, By Workflow: Key Takeaways
• 7.2. Workflow Movement Analysis and Market Share, 2024 and 2030
• 7.3. Market Estimates and Forecasts, By Workflow, 2018 - 2030 (USD Million)
  • 7.3.1. Clinical
    • 7.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.3.2. Commercial
    • 7.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 8. U.S. Active Pharmaceutical Ingredients CDMO Market: Application Estimates and Trend Analysis

• 8.1. U.S. Active Pharmaceutical Ingredients CDMO Market, By Application: Key Takeaways
• 8.2. Application Movement Analysis and Market Share, 2024 and 2030
• 8.3. Market Estimates and Forecasts, By Application, 2018 - 2030 (USD Million)
  • 8.3.1. Oncology
    • 8.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.2. Hormonal
    • 8.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.3. Glaucoma
    • 8.3.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.4. Cardiovascular disease
    • 8.3.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.5. Diabetes
    • 8.3.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.6. Others
    • 8.3.6.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Company Categorization
• 9.2. Company Market Positioning
• 9.3. Company Heat Map Analysis
• 9.4. Company Profiles/Listing
  • 9.4.1. Thermo Fisher Scientific Inc.
    • 9.4.1.1. Company Overview
    • 9.4.1.2. Financial Performance
    • 9.4.1.3. Product Portfolio
    • 9.4.1.4. Recent Developments/ Strategic Initiatives
  • 9.4.2. Novo Group (Catalent, Inc.)
    • 9.4.2.1. Company Overview
    • 9.4.2.2. Financial Performance
    • 9.4.2.3. Product Portfolio
    • 9.4.2.4. Recent Developments/ Strategic Initiatives
  • 9.4.3. Cambrex Corporation
    • 9.4.3.1. Company Overview
    • 9.4.3.2. Financial Performance
    • 9.4.3.3. Product Portfolio
    • 9.4.3.4. Recent Developments/ Strategic Initiatives
  • 9.4.4. Piramal Pharma Limited
    • 9.4.4.1. Company Overview
    • 9.4.4.2. Financial Performance
    • 9.4.4.3. Product Portfolio
    • 9.4.4.4. Recent Developments/ Strategic Initiatives
  • 9.4.5. Corden Pharma
    • 9.4.5.1. Company Overview
    • 9.4.5.2. Financial Performance
    • 9.4.5.3. Product Portfolio
    • 9.4.5.4. Recent Developments/ Strategic Initiatives
  • 9.4.6. Siegfried Holding AG
    • 9.4.6.1. Company Overview
    • 9.4.6.2. Financial Performance
    • 9.4.6.3. Product Portfolio
    • 9.4.6.4. Recent Developments/ Strategic Initiatives
  • 9.4.7. Seqens North America
    • 9.4.7.1. Company Overview
    • 9.4.7.2. Financial Performance
    • 9.4.7.3. Product Portfolio
    • 9.4.7.4. Recent Developments/ Strategic Initiatives
  • 9.4.8. SK pharmteco Inc.
    • 9.4.8.1. Company Overview
    • 9.4.8.2. Financial Performance
    • 9.4.8.3. Product Portfolio
    • 9.4.8.4. Recent Developments/ Strategic Initiatives
  • 9.4.9. Noramco.
    • 9.4.9.1. Company Overview
    • 9.4.9.2. Financial Performance
    • 9.4.9.3. Product Portfolio
    • 9.4.9.4. Recent Developments/ Strategic Initiatives
  • 9.4.10. BSP Pharmaceuticals
    • 9.4.10.1. Company Overview
    • 9.4.10.2. Financial Performance
    • 9.4.10.3. Product Portfolio
    • 9.4.10.4. Recent Developments/ Strategic Initiatives

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