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Report
United States Biopharmaceuticals Contract Manufacturing Market By Source (Mammalian, Non-mammalian), By Service (Process Development, Fill & Finish Operations, Analytical & QC studies, Packaging & Labelling, Others), By Product (Biologics, Biosimilars), By Therapeutic Area (Oncology, Autoimmune Diseases, Infectious Diseases, Cardiovascular Diseases, Metabolic Diseases, Neurology, Others), By Region, Competition, Forecast & Opportunities, 2020-2030F
Market Report I 2025-05-23 I 85 Pages I TechSci Research
Market Overview
The United States Biopharmaceuticals Contract Manufacturing Market was valued at USD 10.58 billion in 2024 and is anticipated to grow significantly, reaching USD 19.52 billion by 2030 at a CAGR of 10.72%. This growth is largely fueled by rising demand for biologics and biosimilars used to treat complex diseases through advanced therapies. Evolving manufacturing technologies-such as single-use systems and continuous processing-are improving efficiency and scalability. These innovations enable contract manufacturers to deliver cost-effective, high-quality solutions while supporting the increasing need for flexible, specialized production capabilities, especially for cell and gene therapies and personalized medicines.
Key Market Drivers
Rising Demand for Biologics and Biosimilars
The growing demand for biologics and biosimilars is a key factor accelerating the expansion of the United States Biopharmaceuticals Contract Manufacturing Market. Biologics, including monoclonal antibodies, recombinant proteins, vaccines, and cell and gene therapies, are vital in treating complex and chronic conditions like cancer and autoimmune disorders. These therapies offer high precision and effectiveness, making them valuable in personalized medicine. As of April 1, 2025, the FDA has licensed 69 biosimilars, with 49 launched for 17 reference molecules, reflecting their growing adoption. Additionally, the FDA's Center for Biologics Evaluation and Research reported approving 17 new biologics and 26 supplements in 2024, showcasing strong regulatory support and a thriving development pipeline.
Key Market Challenges
High Capital Investment and Operational Costs
Establishing and operating a compliant biopharmaceutical manufacturing facility in the United States involves considerable financial outlay. Building state-of-the-art infrastructure with advanced equipment, controlled environments, and stringent quality control systems leads to high initial capital expenses. Ongoing costs, including energy consumption, maintenance, skilled labor, and regulatory compliance, further intensify the financial pressure. Contract manufacturers must meet cGMP and other regulatory standards, requiring continuous investment in validation and training to avoid penalties, product recalls, or operational disruptions. These financial demands pose a major challenge, especially for organizations aiming to scale rapidly.
Key Market Trends
Adoption of Single-Use Technologies
Single-use technologies (SUTs) are increasingly being embraced in the U.S. biopharmaceutical contract manufacturing landscape for their benefits in flexibility, cost-effectiveness, and scalability. These systems-comprising disposable bioreactors, filters, and chromatography devices-help minimize contamination risks and eliminate complex cleaning requirements, thus streamlining operations. This is especially critical for CMOs handling multiple client projects and products. The growing use of SUTs reduces downtime and accelerates production timelines, which is particularly beneficial in manufacturing biologics like monoclonal antibodies, vaccines, and gene therapies where speed and compliance are essential.
Key Market Players
- Lonza Group Ltd.
- WuXi Biologics Co., Ltd.
- Boehringer Ingelheim International GmbH
- Thermo Fisher Scientific Inc.
- Rentschler Biopharma SE
- JRS PHARMA GmbH & Co. KG
- AGC Biologics
- ProBioGen AG
- Samsung Biologics
- FUJIFILM Diosynth Biotechnologies
Report Scope:
In this report, the United States Biopharmaceuticals Contract Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
- United States Biopharmaceuticals Contract Manufacturing Market, By Source:
o Mammalian
o Non-mammalian
- United States Biopharmaceuticals Contract Manufacturing Market, By Service:
o Process Development
o Fill & Finish Operations
o Analytical & QC studies
o Packaging & Labelling
o Others
- United States Biopharmaceuticals Contract Manufacturing Market, By Product:
o Biologics
o Biosimilars
- United States Biopharmaceuticals Contract Manufacturing Market, By Therapeutic Area:
o Oncology
o Autoimmune Diseases
o Infectious Diseases
o Cardiovascular Diseases
o Metabolic Diseases
o Neurology
o Others
- United States Biopharmaceuticals Contract Manufacturing Market, By Region:
o North-East
o Mid-West
o West
o South
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the United States Biopharmaceuticals Contract Manufacturing Market.
Available Customizations:
United States Biopharmaceuticals Contract Manufacturing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
Company Information
- Detailed analysis and profiling of additional market players (up to five).
1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. United States Biopharmaceuticals Contract Manufacturing Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Source (Mammalian, Non-mammalian)
5.2.2. By Service (Process Development, Fill & Finish Operations, Analytical & QC studies, Packaging & Labelling, Others)
5.2.3. By Product (Biologics, Biosimilars)
5.2.4. By Therapeutic Area (Oncology, Autoimmune Diseases, Infectious Diseases, Cardiovascular Diseases, Metabolic Diseases, Neurology, Others)
5.2.5. By Region
5.2.6. By Company (2024)
5.3. Market Map
6. North-East Biopharmaceuticals Contract Manufacturing Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Source
6.2.2. By Service
6.2.3. By Product
6.2.4. By Therapeutic Area
7. Mid-West Biopharmaceuticals Contract Manufacturing Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Source
7.2.2. By Service
7.2.3. By Product
7.2.4. By Therapeutic Area
8. West Biopharmaceuticals Contract Manufacturing Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Source
8.2.2. By Service
8.2.3. By Product
8.2.4. By Therapeutic Area
9. South Biopharmaceuticals Contract Manufacturing Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Source
9.2.2. By Service
9.2.3. By Product
9.2.4. By Therapeutic Area
10. Market Dynamics
10.1. Drivers
10.2. Challenges
11. Market Trends & Developments
11.1. Merger & Acquisition (If Any)
11.2. Product Launches (If Any)
11.3. Recent Developments
12. Policy & Regulatory Landscape
13. United States Economic Profile
14. United States Biopharmaceuticals Contract Manufacturing Market: SWOT Analysis
15. Porter's Five Forces Analysis
15.1. Competition in the Industry
15.2. Potential of New Entrants
15.3. Power of Suppliers
15.4. Power of Customers
15.5. Threat of Substitute Products
16. Competitive Landscape
16.1. Lonza Group Ltd.
16.1.1. Business Overview
16.1.2. Company Snapshot
16.1.3. Products & Services
16.1.4. Financials (As Reported)
16.1.5. Recent Developments
16.1.6. Key Personnel Details
16.1.7. SWOT Analysis
16.2. WuXi Biologics Co., Ltd.
16.3. Boehringer Ingelheim International GmbH
16.4. Thermo Fisher Scientific Inc.
16.5. Rentschler Biopharma SE
16.6. JRS PHARMA GmbH & Co. KG
16.7. AGC Biologics
16.8. ProBioGen AG
16.9. Samsung Biologics
16.10. FUJIFILM Diosynth Biotechnologies
17. Strategic Recommendations
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