[시장보고서]미국의 생물제제 수탁 개발 시장 : 규모, 점유율, 동향 분석(원료별, 제품 서비스별, 적응증별), 부문별 예측(2025-2033년)

미국의 생물제제 수탁 개발 시장 : 규모, 점유율, 동향 분석(원료별, 제품 서비스별, 적응증별), 부문별 예측(2025-2033년)

U.S. Biologics Contract Development Market Size, Share, & Trends Analysis Report By Source (Mammalian, Microbial), By Product Service (Cell-line Development, Process Development), By Indication, And Segment Forecasts, 2025 - 2033

상품코드 : 1869866

리서치사 : Grand View Research

발행일 : 2025년 10월

페이지 정보 : 영문 100 Pages

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한글목차

샘플 요청 목록에 추가

미국의 생물제제 수탁 개발 시장 요약

미국의 생물제제 수탁 개발 시장 규모는 2024년 28억 2,000만 달러였고, 2033년까지 44억 8,000만 달러에 이를 것으로 예측됩니다.

2025년부터 2033년까지 CAGR은 5.3%로 예상됩니다. 시장을 견인하고 있는 요인으로는 M&A 활동의 활성화, 바이오 생산에서 첨단 기술의 채용 증가, 투자, 개발도상국에서의 임상시험의 규제환경의 개선, 제약 및 생물제제기업에 의한 연구개발 활동의 아웃소싱 증가 등을 들 수 있습니다.

높은 초기 비용, 규제 부담, 시장 투입까지의 속도 필요성으로부터, 많은 제약 및 바이오테크놀러지 기업은 개발과 제조를 수탁 개발 제조 기관(CDMO)에 위탁하고 있습니다. 특히 미국의 생물제제 수탁 개발업계 중소기업은 자사내의 능력이 제한되어 있기 때문에 주로 CDMO에 의존하고 있습니다.

또한 심혈관 질환, 신경 질환, 암 등 만성 질환의 유병률 상승이 신규 생물학적 제제 요법에 대한 수요를 촉진하고 있습니다. 미국 질병 예방 관리 센터(CDC)가 2024년 2월에 발표한 보고서에 따르면 심장병, 당뇨병, 비만 등의 만성 질환은 미국의 주요 건강 문제이며 약 1억 2,900만 명에 영향을 미쳤습니다. 많은 미국 국민들이 복수의 만성 질환을 가지고 생활하고 있으며, 국내 연간 건강 관리 4조 1,000억의 약 90%가 이러한 질환의 관리에 충당되고 있기 때문에 의료 제도에 큰 부담이 가해지고 있습니다.

주요 시장 진출기업에 의한 최근의 동향과 영향 분석
기업/경쟁의 분류
벤더 상황
- 주요 기업 히트맵 분석, 2024년
기업 프로파일
- WuXi Biologics.
- Abzena
- FUJIFILM Diosynth Biotechnologies.
- KBI Biopharma
- AGC Biologics.
- Thermo Fisher Scientific Inc.
- Curia Global, Inc.
- GenScript
- Bionova Scientific LLC
- Boehringer Ingelheim International
- STC Biologics

JHS

영문 목차

영문목차

U.S. Biologics Contract Development Market Summary

The U.S. biologics contract development market size was estimated at USD 2.82 billion in 2024 and is projected to reach USD 4.48 billion by 2033, growing at a CAGR of 5.3% from 2025 to 2033. Factors such as growing M&A activities; increasing adoption of advanced technologies for biological production; investment, a favorable regulatory environment for clinical trials in developing countries, and a rise in outsourcing of R&D activities by pharma and biopharma companies are driving the market.

High upfront costs, regulatory burdens, and the need for speed-to-market have led many pharmaceutical and biotech firms to outsource development and manufacturing to Contract Development and Manufacturing Organization (CDMOs). Small and mid-sized biotech companies in the U.S. biologics contract development industry, in particular, rely mostly on CDMOs due to limited in-house capabilities.

Furthermore, the rising prevalence of chronic diseases, such as cardiovascular disorders, neurological disorders, and cancer, fuels the demand for novel biologic therapies. According to a report published by the CDC in February 2024, chronic diseases such as heart disease, diabetes, and obesity are a major health challenge in the U.S., affecting about 129 million people. Many Americans live with more than one chronic condition, which is putting heavy pressure on the healthcare system, as about 90% of the country's USD 4.1 trillion annual healthcare spending goes toward managing these illnesses.

U.S. Biologics Contract Development Market Report 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 U.S. biologics contract development market report based on source, product service, and indication:

Source Outlook (Revenue, USD Million, 2021 - 2033)
Mammalian
Microbial
Others
Product Service Outlook (Revenue, USD Million, 2021 - 2033)
Cell Line Development
- Microbial
- Mammalian
- Others
Process Development
- Upstream
- Microbial
- Mammalian
- Others
- Downstream
- Bioanalytical methods
- Impurity, isolation, & identification
- Physicochemical characterization
- Pharmaceutical analysis
- Others
- Product
- MABs
- Recombinant proteins
- Others
Indication Outlook (Revenue, USD Million, 2021 - 2033)
Oncology
Immunological Disorders
Cardiovascular Disorders
Hematological Disorders
Others

Chapter 1. Methodology and Scope

1.1. Market Segmentation & Scope
1.2. Segment Definitions
- 1.2.1. Source
- 1.2.2. Product Service
- 1.2.3. Indication
- 1.2.4. Estimates and forecasts timeline
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
- 1.4.5. Details of primary research
1.5. Information or Data Analysis
- 1.5.1. Data analysis models
1.6. Market formulation & Validation
1.7. Model Details
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 Outlook
- 2.2.1. Source Outlook
- 2.2.2. Product Service Outlook
- 2.2.3. Indication Outlook
2.3. Competitive Insights

Chapter 3. U.S. Biologics Contract Development 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 Dynamics
- 3.2.1. Market Driver Analysis
- 3.2.2. Market Restraint Analysis
3.3. U.S. Biologics Contract Development Market Analysis Tools
- 3.3.1. Industry Analysis - Porter's
  - 3.3.1.1. Supplier Power
  - 3.3.1.2. Buyer Power
  - 3.3.1.3. Substitution Threat
  - 3.3.1.4. Threat of New Entrant
  - 3.3.1.5. Competitive Rivalry
- 3.3.2. PESTEL Analysis
  - 3.3.2.1. Political Landscape
  - 3.3.2.2. Technological Landscape
  - 3.3.2.3. Economic Landscape

Chapter 4. U.S. Biologics Contract Development Market: Source Estimates & Trend Analysis

4.1. Source Segment Dashboard
4.2. U.S. Biologics Contract Development Market: Source Movement Analysis
4.3. U.S. Biologics Contract Development Market Size & Trend Analysis, by Source, 2021 - 2033 (USD Million)
- 4.3.1. Microbial
  - 4.3.1.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
- 4.3.2. Mammalian
  - 4.3.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
- 4.3.3. Others
  - 4.3.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)

Chapter 5. U.S. Biologics Contract Development Market: Product Service Estimates & Trend Analysis

5.1. Product Service Segment Dashboard
5.2. U.S. Biologics Contract Development Market: Product Service Movement Analysis
5.3. U.S. Biologics Contract Development Market Size & Trend Analysis, by Product Service, 2021 - 2033 (USD Million)
- 5.3.1. Cell Line Development
  - 5.3.1.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
  - 5.3.1.2. Microbial
    - 5.3.1.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
  - 5.3.1.3. Mammalian
    - 5.3.1.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
  - 5.3.1.4. Others
    - 5.3.1.4.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
- 5.3.2. Process Development
  - 5.3.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
  - 5.3.2.2. Upstream
    - 5.3.2.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
    - 5.3.2.2.2. Microbial
      - 5.3.2.2.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
    - 5.3.2.2.3. Mammalian
      - 5.3.2.2.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
    - 5.3.2.2.4. Others
      - 5.3.2.2.4.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
  - 5.3.2.3. Downstream
    - 5.3.2.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
    - 5.3.2.3.2. Bioanalytical Methods
      - 5.3.2.3.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
      - 5.3.2.3.2.2. Impurity, isolation, & identification
        
        5.3.2.3.2.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
      - 5.3.2.3.2.3. Physicochemical characterization
        
        5.3.2.3.2.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
      - 5.3.2.3.2.4. Pharmaceutical analysis
        
        5.3.2.3.2.4.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
      - 5.3.2.3.2.5. Others
        
        5.3.2.3.2.5.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
    - 5.3.2.3.3. Product
      - 5.3.2.3.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
      - 5.3.2.3.3.2. MABs
        
        5.3.2.3.3.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
      - 5.3.2.3.3.3. Recombinant proteins
        
        5.3.2.3.3.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
      - 5.3.2.3.3.4. Others
        
        5.3.2.3.3.4.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)

Chapter 6. U.S. Biologics Contract Development Market: Indication Estimates & Trend Analysis

6.1. Indication Segment Dashboard
6.2. U.S. Biologics Contract Development Market: Indication Movement Analysis
6.3. U.S. Biologics Contract Development Market Size & Trend Analysis, by Indication, 2021 - 2033 (USD Million)
- 6.3.1. Oncology
  - 6.3.1.1. Market Estimates and Forecasts 2021 - 2033 (USD million)
- 6.3.2. Immunological Disorders
  - 6.3.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
- 6.3.3. Cardiovascular Disorders
  - 6.3.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
- 6.3.4. Hematological Disorders
  - 6.3.4.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
- 6.3.5. Others
  - 6.3.5.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)

Chapter 7. Competitive Landscape

7.1. Recent Developments & Impact Analysis, By Key Market Participants
7.2. Company/Competition Categorization
7.3. Vendor Landscape
- 7.3.1. Key company heat map analysis, 2024
7.4. Company Profiles
- 7.4.1. WuXi Biologics.
  - 7.4.1.1. Company overview
  - 7.4.1.2. Financial performance
  - 7.4.1.3. Product benchmarking
  - 7.4.1.4. Strategic initiatives
- 7.4.2. Abzena
  - 7.4.2.1. Company overview
  - 7.4.2.2. Financial performance
  - 7.4.2.3. Product benchmarking
  - 7.4.2.4. Strategic initiatives
- 7.4.3. FUJIFILM Diosynth Biotechnologies.
  - 7.4.3.1. Company overview
  - 7.4.3.2. Financial performance
  - 7.4.3.3. Product benchmarking
  - 7.4.3.4. Strategic initiatives
- 7.4.4. KBI Biopharma
  - 7.4.4.1. Company overview
  - 7.4.4.2. Financial performance
  - 7.4.4.3. Product benchmarking
  - 7.4.4.4. Strategic initiatives
- 7.4.5. AGC Biologics.
  - 7.4.5.1. Company overview
  - 7.4.5.2. Financial performance
  - 7.4.5.3. Product benchmarking
  - 7.4.5.4. Strategic initiatives
- 7.4.6. Thermo Fisher Scientific Inc.
  - 7.4.6.1. Company overview
  - 7.4.6.2. Financial performance
  - 7.4.6.3. Product benchmarking
  - 7.4.6.4. Strategic initiatives
- 7.4.7. Curia Global, Inc.
  - 7.4.7.1. Company overview
  - 7.4.7.2. Financial performance
  - 7.4.7.3. Product benchmarking
  - 7.4.7.4. Strategic initiatives
- 7.4.8. GenScript
  - 7.4.8.1. Company overview
  - 7.4.8.2. Financial performance
  - 7.4.8.3. Product benchmarking
  - 7.4.8.4. Strategic initiatives
- 7.4.9. Bionova Scientific LLC
  - 7.4.9.1. Company overview
  - 7.4.9.2. Financial performance
  - 7.4.9.3. Product benchmarking
  - 7.4.9.4. Strategic initiatives
- 7.4.10. Boehringer Ingelheim International
  - 7.4.10.1. Company overview
  - 7.4.10.2. Financial performance
  - 7.4.10.3. Product benchmarking
  - 7.4.10.4. Strategic initiatives
- 7.4.11. STC Biologics
  - 7.4.11.1. Company overview
  - 7.4.11.2. Financial performance
  - 7.4.11.3. Product benchmarking
  - 7.4.11.4. Strategic initiatives

한글목차

미국의 생물제제 수탁 개발 시장 요약

목차

제1장 조사 방법과 범위

제2장 주요 요약

제3장 미국의 생물제제 수탁 개발 시장의 변수, 동향, 범위

제4장 미국의 생물제제 수탁 개발 시장 : 원료별 추정 및 동향 분석

제5장 미국의 생물제제 수탁 개발 시장 : 제품 서비스별 추정 및 동향 분석

제6장 미국의 생물제제 수탁 개발 시장 : 적응증별 추정 및 동향 분석

제7장 경쟁 구도