미국의 바이오의약품 수탁 제조 시장 : 규모, 점유율 및 동향 분석 보고서 - 원료별, 서비스별, 제품별, 유형별, 사업 규모별, 치료 영역별 부문 예측(2025-2030년)

U.S. Biopharmaceuticals Contract Manufacturing Market Growth & Trends:

The U.S. biopharmaceuticals contract manufacturing market is anticipated to reach USD 19.54 billion by 2030 and expand at a CAGR of 10.6% from 2025 to 2030, according to a new report by Grand View Research, Inc.The U.S. biopharmaceuticals contract manufacturing market is growing due to the rising demand for biologics and biosimilars, which address complex diseases with innovative therapies. Advancements in manufacturing technologies, such as single-use systems and continuous processing, enhance production efficiency and scalability. These factors enable contract manufacturers to meet the rising need for cost-effective and high-quality biopharmaceuticals, driving market growth and fostering innovation in the industry.

The market thrives due to a focus on cost-effective production and the expansion of Contract Manufacturing Organizations (CMOs). By outsourcing manufacturing, companies reduce operational costs and allocate resources for innovation. CMOs provide scalable solutions, advanced technologies, and specialized expertise, ensuring efficient production. Their growth enables biopharma companies to meet the rising demand for biologics and biosimilars, driving market expansion and fostering innovation in industry.

The growing prevalence of chronic diseases fuels the demand for advanced biopharmaceuticals, including biologics and biosimilars, to address complex health challenges. Simultaneously, technological innovations in bioprocessing, such as single-use systems and continuous manufacturing, are revolutionizing production efficiency and scalability. These advancements empower contract manufacturers to meet the rising need for high-quality, cost-effective therapies and contribute significantly to the growth and evolution of the biopharmaceutical industry in the U.S.

U.S. Biopharmaceuticals Contract Manufacturing Market Report Highlights:

• By source, the mammalian segment held the largest share in 2024, owing toits critical role in producing biologics like monoclonal antibodies and recombinant proteins.
• By service, the process development segment led the market with the largest revenue share of 34.8% in 2024, driven byits pivotal role in optimizing production efficiency and ensuring regulatory compliance.
• Theanalytical & QC studies segment is set to grow at the fastest CAGR over the forecast period, fueled bythe increasing need for stringent quality assurance and regulatory compliance in biopharmaceutical production.
• By products, the biologics segment dominated the market with the largest share in 2024 due toincreasing demand for advanced therapies like monoclonal antibodies, cell and gene therapies, and biosimilars.
• The biosimilars segment is projected to be the fastest-growing segment from 2025 to 2030, attributed to increasing demand for cost-effective alternatives to biologics.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Source
  • 1.2.2. Service
  • 1.2.3. Products
  • 1.2.4. Type
  • 1.2.5. Scale of Operation
  • 1.2.6. Therapeutic Area
• 1.3. Estimates and Forecast Timeline
• 1.4. Research Methodology
• 1.5. Information Procurement
  • 1.5.1. Purchased Database
  • 1.5.2. GVR's Internal Database
  • 1.5.3. Secondary Sources
  • 1.5.4. Primary Research
• 1.6. Information Analysis
  • 1.6.1. Data Analysis Models
• 1.7. Market Formulation & Data Visualization
• 1.8. Model Details
  • 1.8.1. Commodity Flow Analysis
• 1.9. List of Secondary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

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

Chapter 3. U.S. Biopharmaceuticals Contract Manufacturing Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Business Environment Analysis
  • 3.3.1. Industry Analysis - Porter's Five Forces Analysis
    • 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. PESTLE Analysis

Chapter 4. U.S. Biopharmaceuticals Contract Manufacturing Market: Source Business Analysis

• 4.1. Source Market Share, 2024 & 2030
• 4.2. Source Segment Dashboard
• 4.3. Market Size & Forecasts and Trend Analysis, By Source, 2018 to 2030 (USD Million)
• 4.4. Mammalian
  • 4.4.1. Mammalian Market, 2018 - 2030 (USD Million)
• 4.5. Non-mammalian
  • 4.5.1. Non-mammalian Market, 2018 - 2030 (USD Million)

Chapter 5. U.S. Biopharmaceuticals Contract Manufacturing Market: Service Business Analysis

• 5.1. Service Market Share, 2024 & 2030
• 5.2. Service Segment Dashboard
• 5.3. Market Size & Forecasts and Trend Analysis, By Service, 2018 to 2030 (USD Million)
• 5.4. Process Development
  • 5.4.1. Process Development Market, 2018 - 2030 (USD Million)
  • 5.4.2. Downstream
    • 5.4.2.1. Downstream Market, 2018 - 2030 (USD Million)
  • 5.4.3. Upstream
    • 5.4.3.1. Upstream Market, 2018 - 2030 (USD Million)
• 5.5. Fill & Finish Operations
  • 5.5.1. Fill & Finish Operations Market, 2018 - 2030 (USD Million)
• 5.6. Analytical & QC Studies
  • 5.6.1. Analytical & QC Studies Market, 2018 - 2030 (USD Million)
• 5.7. Packaging & Labelling
  • 5.7.1. Packaging & Labelling Market, 2018 - 2030 (USD Million)
• 5.8. Others
  • 5.8.1. Others Market, 2018 - 2030 (USD Million)

Chapter 6. U.S. Biopharmaceuticals Contract Manufacturing Market: Products Business Analysis

• 6.1. Products Market Share, 2024 & 2030
• 6.2. Products Segment Dashboard
• 6.3. Market Size & Forecasts and Trend Analysis, By Products, 2018 to 2030 (USD Million)
• 6.4. Biologics
  • 6.4.1. Biologics Market, 2018 - 2030 (USD Million)
  • 6.4.2. Monoclonal Antibodies (mAbs)
    • 6.4.2.1. Monoclonal Antibodies (mAbs) Market, 2018 - 2030 (USD Million)
  • 6.4.3. Recombinant Proteins
    • 6.4.3.1. Recombinant Proteins Market, 2018 - 2030 (USD Million)
  • 6.4.4. Vaccines
    • 6.4.4.1. Vaccines Market, 2018 - 2030 (USD Million)
  • 6.4.5. Antisense, RNAi, & Molecular Therapy
    • 6.4.5.1. Antisense, RNAi, & Molecular Therapy Market, 2018 - 2030 (USD Million)
  • 6.4.6. Others
    • 6.4.6.1. Others Market, 2018 - 2030 (USD Million)
• 6.5. Biosimilars
  • 6.5.1. Biosimilars Market, 2018 - 2030 (USD Million)

Chapter 7. U.S. Biopharmaceuticals Contract Manufacturing Market: Type Business Analysis

• 7.1. Type Market Share, 2024 & 2030
• 7.2. Type Segment Dashboard
• 7.3. Market Size & Forecasts and Trend Analysis, By Type, 2018 to 2030 (USD Million)
• 7.4. Drug Substance
  • 7.4.1. Drug Substance Market, 2018 - 2030 (USD Million)
• 7.5. Finished Drug Product
  • 7.5.1. Finished Drug Product Market, 2018 - 2030 (USD Million)

Chapter 8. U.S. Biopharmaceuticals Contract Manufacturing Market: Scale of Operation Business Analysis

• 8.1. Scale of Operation Market Share, 2024 & 2030
• 8.2. Scale of Operation Segment Dashboard
• 8.3. Market Size & Forecasts and Trend Analysis, By Scale of Operation, 2018 to 2030 (USD Million)
• 8.4. Clinical
  • 8.4.1. Clinical Market, 2018 - 2030 (USD Million)
• 8.5. Commercial
  • 8.5.1. Commercial Market, 2018 - 2030 (USD Million)

Chapter 9. U.S. Biopharmaceuticals Contract Manufacturing Market: Therapeutic Area Business Analysis

• 9.1. Therapeutic Area Market Share, 2024 & 2030
• 9.2. Therapeutic Area Segment Dashboard
• 9.3. Market Size & Forecasts and Trend Analysis, By Therapeutic Area, 2018 to 2030 (USD Million)
• 9.4. Oncology
  • 9.4.1. Oncology Market, 2018 - 2030 (USD Million)
• 9.5. Autoimmune Diseases
  • 9.5.1. Autoimmune Diseases Market, 2018 - 2030 (USD Million)
• 9.6. Infectious Diseases
  • 9.6.1. Infectious Diseases Market, 2018 - 2030 (USD Million)
• 9.7. Cardiovascular Diseases
  • 9.7.1. Cardiovascular Diseases Market, 2018 - 2030 (USD Million)
• 9.8. Metabolic Diseases
  • 9.8.1. Metabolic Diseases Market, 2018 - 2030 (USD Million)
• 9.9. Neurology
  • 9.9.1. Neurology Market, 2018 - 2030 (USD Million)
• 9.10. Others
  • 9.10.1. Others Market, 2018 - 2030 (USD Million)

Chapter 10. Competitive Landscape

• 10.1. Participant Overview
• 10.2. Company Market Position Analysis
• 10.3. Company Categorization
• 10.4. Strategy Mapping
• 10.5. Company Profiles/Listing
  • 10.5.1. Lonza
    • 10.5.1.1. Overview
    • 10.5.1.2. Financial Performance
    • 10.5.1.3. Product Benchmarking
    • 10.5.1.4. Strategic Initiatives
  • 10.5.2. WuXi Biologics
    • 10.5.2.1. Overview
    • 10.5.2.2. Financial Performance
    • 10.5.2.3. Product Benchmarking
    • 10.5.2.4. Strategic Initiatives
  • 10.5.3. FUJIFILM Diosynth Biotechnologies
    • 10.5.3.1. Overview
    • 10.5.3.2. Financial Performance
    • 10.5.3.3. Product Benchmarking
    • 10.5.3.4. Strategic Initiatives
  • 10.5.4. Boehringer Ingelheim International GmbH
    • 10.5.4.1. Overview
    • 10.5.4.2. Financial Performance
    • 10.5.4.3. Product Benchmarking
    • 10.5.4.4. Strategic Initiatives
  • 10.5.5. Thermo Fisher Scientific Inc.
    • 10.5.5.1. Overview
    • 10.5.5.2. Financial Performance
    • 10.5.5.3. Product Benchmarking
    • 10.5.5.4. Strategic Initiatives
  • 10.5.6. Samsung Biologics
    • 10.5.6.1. Overview
    • 10.5.6.2. Financial Performance
    • 10.5.6.3. Product Benchmarking
    • 10.5.6.4. Strategic Initiatives
  • 10.5.7. AGC Biologics
    • 10.5.7.1. Overview
    • 10.5.7.2. Financial Performance
    • 10.5.7.3. Product Benchmarking
    • 10.5.7.4. Strategic Initiatives
  • 10.5.8. Catalent, Inc
    • 10.5.8.1. Overview
    • 10.5.8.2. Financial Performance
    • 10.5.8.3. Product Benchmarking
    • 10.5.8.4. Strategic Initiatives
  • 10.5.9. Rentschler Biopharma SE
    • 10.5.9.1. Overview
    • 10.5.9.2. Financial Performance
    • 10.5.9.3. Product Benchmarking
    • 10.5.9.4. Strategic Initiatives
  • 10.5.10. Eurofins Scientific
    • 10.5.10.1. Overview
    • 10.5.10.2. Financial Performance
    • 10.5.10.3. Product Benchmarking
    • 10.5.10.4. Strategic Initiatives