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U.S. Biopharmaceuticals Contract Manufacturing Market Size, Share, & Trends Analysis Report by Source (Mammalian, Non-mammalian), Service, Products (Biologics, Biosimilars), Type, Scale of Operation, Therapeutic Area, with Growth Forecasts, 2025-2030

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    Report

  • 80 Pages
  • April 2025
  • Region: United States
  • Grand View Research
  • ID: 6085742
The U.S. Biopharmaceuticals Contract Manufacturing Market was valued at USD 10.67 Billion in 2024, and is projected to reach USD 19.54 Billion by 2030, rising at a CAGR of 10.60%. The 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.

Why Should You Buy This Report?

  • Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
  • Competitive Landscape: Explore the market presence of key players.
  • Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
  • Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.

This report addresses:

  • Market intelligence to enable effective decision-making
  • Market estimates and forecasts from 2018 to 2030
  • Growth opportunities and trend analyses
  • Segment and regional revenue forecasts for market assessment
  • Competition strategy and market share analysis
  • Product innovation listings for you to stay ahead of the curve

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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. 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
List of Tables
Table 1 List of Secondary Sources
Table 2 List of Abbreviations
Table 3 U.S. Biopharmaceuticals Contract Manufacturing Market, By Source, 2018-2030 (USD Million)
Table 4 U.S. Biopharmaceuticals Contract Manufacturing Market, By Service, 2018-2030 (USD Million)
Table 5 U.S. Biopharmaceuticals Contract Manufacturing Market, By Products, 2018-2030 (USD Million)
Table 6 U.S. Biopharmaceuticals Contract Manufacturing Market, By Type, 2018-2030 (USD Million)
Table 7 U.S. Biopharmaceuticals Contract Manufacturing Market, By Scale of Operation, 2018-2030 (USD Million)
Table 8 U.S. Biopharmaceuticals Contract Manufacturing Market, By Therapeutic Area, 2018-2030 (USD Million)
List of Figures
Figure 1 U.S. Biopharmaceuticals Contract Manufacturing Market Segmentation
Figure 2 Market Research Process
Figure 3 Data Triangulation Techniques
Figure 4 Primary Research Pattern
Figure 5 Market Research Approaches
Figure 6 Value-Chain-Based Sizing & Forecasting
Figure 7 Market Formulation & Validation
Figure 8 Market Snapshot
Figure 9 Service and Technique Outlook (USD Million)
Figure 10 Competitive Landscape
Figure 11 U.S. Biopharmaceuticals Contract Manufacturing Market Dynamics
Figure 12 U.S. Biopharmaceuticals Contract Manufacturing Market: Porter’s Five Forces analysis
Figure 13 U.S. Biopharmaceuticals Contract Manufacturing Market: PESTLE Analysis
Figure 14 U.S. Biopharmaceuticals Contract Manufacturing Market: Source Segment Dashboard
Figure 15 U.S. Biopharmaceuticals Contract Manufacturing Market: Source Market Share Analysis, 2024 & 2030
Figure 16 Mammalian Market, 2018-2030 (USD Million)
Figure 17 Mammalian Market, 2018-2030 (USD Million)
Figure 18 U.S. Biopharmaceuticals Contract Manufacturing Market: Service Segment Dashboard
Figure 19 U.S. Biopharmaceuticals Contract Manufacturing Market: Service Market Share Analysis, 2024 & 2030
Figure 20 Process Development Market, 2018-2030 (USD Million)
Figure 21 Downstream Market, 2018-2030 (USD Million)
Figure 22 Upstream Market, 2018-2030 (USD Million)
Figure 23 Fill & Finish Operations Market, 2018-2030 (USD Million)
Figure 24 Analytical & QC Studies Market, 2018-2030 (USD Million)
Figure 25 Packaging & Labelling Market, 2018-2030 (USD Million)
Figure 26 Others Market, 2018-2030 (USD Million)
Figure 27 U.S. Biopharmaceuticals Contract Manufacturing Market: Products Segment Dashboard
Figure 28 U.S. Biopharmaceuticals Contract Manufacturing Market: Products Market Share Analysis, 2024 & 2030
Figure 29 Biologics Market, 2018-2030 (USD Million)
Figure 30 Monoclonal Antibodies (mAbs) Market, 2018-2030 (USD Million)
Figure 31 Recombinant Proteins Market, 2018-2030 (USD Million)
Figure 32 Vaccines Market, 2018-2030 (USD Million)
Figure 33 Antisense, RNAi, & Molecular Therapy Market, 2018-2030 (USD Million)
Figure 34 Others Market, 2018-2030 (USD Million)
Figure 35 Biosimilars Market, 2018-2030 (USD Million)
Figure 36 U.S. Biopharmaceuticals Contract Manufacturing Market: Type Segment Dashboard
Figure 37 U.S. Biopharmaceuticals Contract Manufacturing Market: Type Market Share Analysis, 2024 & 2030
Figure 38 Drug Substance Market, 2018-2030 (USD Million)
Figure 39 Finished Drug Product Market, 2018-2030 (USD Million)
Figure 40 U.S. Biopharmaceuticals Contract Manufacturing Market: Scale of Operation Segment Dashboard
Figure 41 U.S. Biopharmaceuticals Contract Manufacturing Market: Scale of Operation Market Share Analysis, 2024 & 2030
Figure 42 Clinical Market, 2018-2030 (USD Million)
Figure 43 Commercial Market, 2018-2030 (USD Million)
Figure 44 U.S. Biopharmaceuticals Contract Manufacturing Market: Therapeutic Area Segment Dashboard
Figure 45 U.S. Biopharmaceuticals Contract Manufacturing Market: Therapeutic Area Market Share Analysis, 2024 & 2030
Figure 46 Oncology Market, 2018-2030 (USD Million)
Figure 47 Autoimmune Diseases Market, 2018-2030 (USD Million)
Figure 48 Infectious Diseases Market, 2018-2030 (USD Million)
Figure 49 Cardiovascular Diseases Market, 2018-2030 (USD Million)
Figure 50 Metabolic Diseases Market, 2018-2030 (USD Million)
Figure 51 Neurology Market, 2018-2030 (USD Million)
Figure 52 Others Market, 2018-2030 (USD Million)
Figure 53 Company Categorization
Figure 54 Company Market Position Analysis
Figure 55 Strategic Framework

Companies Mentioned

The companies profiled in this U.S. Biopharmaceuticals Contract Manufacturing market report include:
  • Lonza
  • WuXi Biologics
  • FUJIFILM Diosynth Biotechnologies
  • Boehringer Ingelheim International GmbH
  • Thermo Fisher Scientific Inc.
  • Samsung Biologics
  • AGC Biologics
  • Catalent, Inc
  • Rentschler Biopharma SE
  • Eurofins Scientific

Methodology

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Table Information