U.S. Biopharmaceuticals Contract Manufacturing Market- Growth, Share, Opportunities & Competitive Analysis, 2024 – 2032
Description
Market Overview
The U.S. Biopharmaceuticals Contract Manufacturing Market is forecasted to expand from USD 4,555.40 million in 2023 to USD 16,804.92 million by 2032, reflecting a robust compound annual growth rate (CAGR) of 15.61%.
This market’s growth is underpinned by the escalating demand for biologics, personalized therapies, and the rapid advancement of cell and gene therapies. The need for cost-efficient manufacturing solutions, alongside innovations such as single-use technologies and continuous production systems, is driving momentum. Outsourcing manufacturing functions enables companies to streamline operations, reduce capital expenditure, and prioritize core activities. Increased production of biologics—driven by evolving healthcare demands and the integration of precision medicine—is also fueling expansion. Additionally, the industry is witnessing a rise in collaborative engagements between biopharmaceutical firms and contract manufacturers, enhancing market development. Heightened regulatory scrutiny on quality standards is pushing contract manufacturers to invest in advanced infrastructure, ensuring adherence to stringent compliance mandates and supporting market acceleration.
Market Drivers
Strategic Collaborations and Compliance Standards
A key growth driver is the rise in strategic alliances between biopharmaceutical firms and contract manufacturers. These collaborations leverage the technical capabilities of contract partners, particularly in regulatory compliance, supply logistics, and quality assurance. The U.S. pharmaceutical sector's rigorous regulatory environment compels adherence to high safety and quality standards, encouraging investment in cutting-edge, GMP-compliant facilities. Regulatory bodies like the FDA are introducing reforms to expedite drug approvals, facilitating faster market access. Such partnerships ensure compliance and timely delivery, which in turn contribute to sustained market growth.
Market Challenges Analysis
Navigating Complex Regulatory Requirements
The market faces notable challenges due to the increasing intricacy of regulatory frameworks. Biopharmaceutical manufacturing must align with stringent protocols from authorities like the FDA, including strict adherence to GMP and quality control mandates. Recent FDA revisions demand the adoption of sophisticated monitoring and quality systems. Contract manufacturers are required to allocate significant resources to maintain compliance, which can elevate operational costs and extend timelines. Non-compliance may result in production delays, recalls, or market exclusion. Moreover, the emergence of personalized, gene, and cell therapies is intensifying regulatory complexity, requiring agile adaptation to evolving standards.
Market Segmentation
By Source:
Mammalian
Non-mammalian
By Service:
Process Development
Downstream
Upstream
Fill & Finish Operations
Analytical & QC Studies
Packaging & Labeling
Others
By Drug Type:
Biologics
Monoclonal Antibodies (mAbs)
Recombinant Proteins
Vaccines
Antisense, RNAi, & Molecular Therapy
Others
Biosimilars
By Type:
Drug Substance
Finished Drug Product
By Scale of Operation:
Clinical
Commercial
By Therapeutic Area:
Oncology
Autoimmune Diseases
Cardiovascular Diseases
Infectious Diseases
Others
By Geography:
Western United States
Midwestern United States
Southern United States
Northeastern United States
Key Player Analysis
Boehringer Ingelheim GmbH
Lonza
JRS PHARMA
AGC Biologics
ProBioGen
FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
Samsung Biologics
Thermo Fisher Scientific, Inc.
Binex Co., Ltd.
WuXi Biologics
Catalent, Inc.
Cambrex Corporation
Pfizer Inc.
Siegfried Holding AG
The U.S. Biopharmaceuticals Contract Manufacturing Market is forecasted to expand from USD 4,555.40 million in 2023 to USD 16,804.92 million by 2032, reflecting a robust compound annual growth rate (CAGR) of 15.61%.
This market’s growth is underpinned by the escalating demand for biologics, personalized therapies, and the rapid advancement of cell and gene therapies. The need for cost-efficient manufacturing solutions, alongside innovations such as single-use technologies and continuous production systems, is driving momentum. Outsourcing manufacturing functions enables companies to streamline operations, reduce capital expenditure, and prioritize core activities. Increased production of biologics—driven by evolving healthcare demands and the integration of precision medicine—is also fueling expansion. Additionally, the industry is witnessing a rise in collaborative engagements between biopharmaceutical firms and contract manufacturers, enhancing market development. Heightened regulatory scrutiny on quality standards is pushing contract manufacturers to invest in advanced infrastructure, ensuring adherence to stringent compliance mandates and supporting market acceleration.
Market Drivers
Strategic Collaborations and Compliance Standards
A key growth driver is the rise in strategic alliances between biopharmaceutical firms and contract manufacturers. These collaborations leverage the technical capabilities of contract partners, particularly in regulatory compliance, supply logistics, and quality assurance. The U.S. pharmaceutical sector's rigorous regulatory environment compels adherence to high safety and quality standards, encouraging investment in cutting-edge, GMP-compliant facilities. Regulatory bodies like the FDA are introducing reforms to expedite drug approvals, facilitating faster market access. Such partnerships ensure compliance and timely delivery, which in turn contribute to sustained market growth.
Market Challenges Analysis
Navigating Complex Regulatory Requirements
The market faces notable challenges due to the increasing intricacy of regulatory frameworks. Biopharmaceutical manufacturing must align with stringent protocols from authorities like the FDA, including strict adherence to GMP and quality control mandates. Recent FDA revisions demand the adoption of sophisticated monitoring and quality systems. Contract manufacturers are required to allocate significant resources to maintain compliance, which can elevate operational costs and extend timelines. Non-compliance may result in production delays, recalls, or market exclusion. Moreover, the emergence of personalized, gene, and cell therapies is intensifying regulatory complexity, requiring agile adaptation to evolving standards.
Market Segmentation
By Source:
Mammalian
Non-mammalian
By Service:
Process Development
Downstream
Upstream
Fill & Finish Operations
Analytical & QC Studies
Packaging & Labeling
Others
By Drug Type:
Biologics
Monoclonal Antibodies (mAbs)
Recombinant Proteins
Vaccines
Antisense, RNAi, & Molecular Therapy
Others
Biosimilars
By Type:
Drug Substance
Finished Drug Product
By Scale of Operation:
Clinical
Commercial
By Therapeutic Area:
Oncology
Autoimmune Diseases
Cardiovascular Diseases
Infectious Diseases
Others
By Geography:
Western United States
Midwestern United States
Southern United States
Northeastern United States
Key Player Analysis
Boehringer Ingelheim GmbH
Lonza
JRS PHARMA
AGC Biologics
ProBioGen
FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
Samsung Biologics
Thermo Fisher Scientific, Inc.
Binex Co., Ltd.
WuXi Biologics
Catalent, Inc.
Cambrex Corporation
Pfizer Inc.
Siegfried Holding AG
Table of Contents
196 Pages
- CHAPTER NO. 1 : INTRODUCTION
- 1.1.1. Report Description
- Purpose of the Report
- USP & Key Offerings
- 1.1.2. Key Benefits for Stakeholders
- 1.1.3. Target Audience
- 1.1.4. Report Scope
- CHAPTER NO. 2 : EXECUTIVE SUMMARY
- 2.1. U.S. Biopharmaceuticals Contract Manufacturing Market Snapshot
- 2.1.1. U.S. Biopharmaceuticals Contract Manufacturing Market, 2018 - 2032 (USD Million)
- CHAPTER NO. 3 : U.S. Biopharmaceuticals Contract Manufacturing Market – INDUSTRY ANALYSIS
- 3.1. Introduction
- 3.2. Market Drivers
- 3.3. Market Restraints
- 3.4. Market Opportunities
- 3.5. Porter’s Five Forces Analysis
- CHAPTER NO. 4 : ANALYSIS COMPETITIVE LANDSCAPE
- 4.1. Company Market Share Analysis – 2023
- 4.2. U.S. Biopharmaceuticals Contract Manufacturing Market Company Revenue Market Share, 2023
- 4.3. Company Assessment Metrics, 2023
- 4.4. Start-ups /SMEs Assessment Metrics, 2023
- 4.5. Strategic Developments
- 4.6. Key Players Product Matrix
- CHAPTER NO. 5 : PESTEL & ADJACENT MARKET ANALYSIS
- CHAPTER NO. 6 : U.S. Biopharmaceuticals Contract Manufacturing Market – BY Based on Source: ANALYSIS
- CHAPTER NO. 7 : U.S. Biopharmaceuticals Contract Manufacturing Market – BY Based on Service: ANALYSIS
- CHAPTER NO. 8 : U.S. Biopharmaceuticals Contract Manufacturing Market – BY Based on Drug Type: ANALYSIS
- CHAPTER NO. 9 : U.S. Biopharmaceuticals Contract Manufacturing Market – BY Based on Type: ANALYSIS
- CHAPTER NO. 10 : U.S. Biopharmaceuticals Contract Manufacturing Market – BY Based on Scale of Operation: ANALYSIS
- CHAPTER NO. 11 : U.S. Biopharmaceuticals Contract Manufacturing Market – BY Based on Therapeutic Area: ANALYSIS
- CHAPTER NO. 12 : U.S. Biopharmaceuticals Contract Manufacturing Market – BY Based on the Geography: ANALYSIS
- CHAPTER NO. 13 : COMPANY PROFILES
- 13.1. Boehringer Ingelheim GmbH
- 13.1.1. Company Overview
- 13.1.2. Product Portfolio
- 13.1.3. Swot Analysis
- 13.1.4. Business Strategy
- 13.1.5. Financial Overview
- 13.2. Lonza
- 13.3. JRS PHARMA
- 13.4. AGC Biologics
- 13.5. ProBioGen
- 13.6. FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
- 13.7. Samsung Biologics
- 13.8. Thermo Fisher Scientific, Inc.
- 13.9. Binex Co., Ltd.
- 13.10. WuXi Biologics
- 13.11. Catalent, Inc
- 13.12. Cambrex Corporation
- 13.13. Pfizer Inc.
- 13.14. Siegfried Holding AG
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