U.S. Biopharmaceuticals Contract Manufacturing Market Size, Share, & Trends Analysis Report By Service (Upstream, Downstream, Fill/Finish), By Source (Mammalian, Non-mammalian), By Product (Biologics, Biosimilar), And Segment- Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2024-2033

The U.S. biopharmaceuticals contract manufacturing market size was estimated at USD 5.19 billion in 2023 and is expected to surpass around USD 7.83 billion by 2033 and poised to grow at a compound annual growth rate (CAGR) of 4.2% during the forecast period 2024 to 2033.

Key Takeaways:

• The mammalian source segment accounted for the highest share of 56.19% in 2023.
• The non-mammalian segment is anticipated to witness the fastest CAGR during the forecast period.
• Process development services led the market in 2023 and accounted for a share of 32.11%.
• The analytical & QC studies segment is anticipated to witness the fastest CAGR from 2024 to 2033.
• The biologics product segment led the market in 2023, with a share of over 81.18%.
• The biosimilar segment is expected to witness a significant growth from 2024 to 2033.

U.S. Biopharmaceuticals Contract Manufacturing Market Growth

With a perpetual expansion of the biopharmaceutical industry, companies are facing production issues, such as the need for more expertise and sophisticated equipment while practicing in-house manufacturing. The maturity of biotechnology and the availability of external funding has resulted in growth of several early-stage bio/pharma companies. These companies are recognized as core customers of CMOs, as these organizations lack the capabilities to develop robust manufacturing operations.

The market is witnessing lucrative growth owing to rising R&D spending for the biologic’s development coupled with the presence of large number of FDA approved drugs in the country. U.S. is hosting many biopharmaceutical pipeline in various stages of development. More than 900 biologic molecules are under clinical investigation in the country. Steady growth in the number of new biological approvals in the country is anticipated to boost revenue generation for the market.

Increasing adoption and investment in advanced manufacturing technologies by CMOs based in the U.S. is propelling the market growth. In addition, quality services offered by service providers are driving the biopharma and CMO partnerships in the country. Also, expansion of foreign CMOs and CROs into the country is expected to propel the market growth.

U.S. Biopharmaceuticals Contract Manufacturing Market Report Scope

Segments Insights:

Source Insights

The mammalian source segment accounted for the highest share of 56.19% in 2023. The growth is attributable to the higher costs of obtaining products from these sources. Companies that provide contract services using mammalian cell culture include AbbVie Contract Manufacturing, AMRI, Avid Bioservices, Boehringer Ingelheim Biopharmaceuticals Gmbh, and Catalent Pharma Solutions. Consequently, companies such as Lonza and Charles River Laboratories are significantly investing in expanding their mammalian cell culture manufacturing facilities for biologics and biosimilar development.

The non-mammalian segment is anticipated to witness the fastest CAGR during the forecast period. Non-mammalian cell line -E. coli is recognized as the widely adopted non-mammalian cell culture for biopharmaceutical production owing to its rapid access and cost-effective cultivation. Development of transgenic non-mammalian expression system is projected to be opportunistic for market growth. Abbott Bioresearch, Avecia Biotechnology, BioReliance, Biovitrum AB, Dow Pharmaceutical, and Celltrion are a few companies working as CMOs using microbial cultures.

Service Insights

Process development services led the market in 2023 and accounted for a share of 32.11%. This is due to high capital expenditure in downstream processing. Downstream operations demand vigorous attention for final product recovery and purification steps to maintain product quality and prevent wastage. CMOs have provided biopharma players with a wide array of services ranging from cell cultivation to final packaging of the product.

The analytical & QC studies segment is anticipated to witness the fastest CAGR from 2024 to 2033. Growing quality concerns and regulatory changes for biopharmaceutical development are expected to impel future growth opportunities for this segment. The analytical capabilities and expertise offered by the market players have a wide range of technologies & services to support the proper launch of products in market. These capabilities are implemented for MAbs, fusion proteins, chemically conjugated proteins, hormones, enzymes, and other biopharmaceuticals. Furthermore, entities offer validated analytical methods to assist release of early phase clinical products.

Product Insights

The biologics product segment led the market in 2023, with a share of over 81.18%. Contract manufacturers have played a vital role in the success of both biologics and biosimilars. This is majorly due to the huge commercial success of biologics, which is depicted through the presence of many FDA-approved biologics in the market. Among all the biologics, Monoclonal Antibodies (MAb) have captured the largest share in 2023. A high capital requirement for the construction of a MAb plant has accelerated the uptake of contract services for Mab production, thereby contributing to the major share of this segment.

The biosimilar segment is expected to witness a significant growth from 2024 to 2033. Biosimilar production is considered one of the key strategies for business expansion in comparison with biologics because investment in biosimilar manufacturing helps in speedy market reach of biopharmaceuticals. Moreover, biosimilars have supported the biopharmaceutical CMO industry owing to cost-saving advantages. Hence, the low cost of production, along with the growing patent expiry of blockbuster biologics, has further boosted the demand for its manufacturing services, including outsourced services.

Recent Developments

• In May 2023, Aurigene Pharmaceutical Services Limited, a biopharmaceutical CDMO, announced the construction of a state-of-the-art manufacturing and development facility for therapeutic proteins, viral vectors, and antibodies.
• In June 2022, FUJIFILM Corporation acquired cell therapy manufacturing facility from Atara Biotherapeutics, Inc. This acquisition expands its CDMO capability for production of cell therapies for clinical and commercial purposes.
• In April 2022, Lonza extended the capability of its Coccon platform used in the manufacturing of automated cell therapy. The new capabilities included integrated capabilities in cell separation, cell binding, and bead removal.
• In March 2022, Cambrex, expanded its biopharmaceutical testing services business with the addition of 11 cGMP laboratories in its U.S. facility. The expansion included the addition of instruments for nanoparticle size analysis, qPCR, imaging, mass spectrometry, immunoblotting, and next-generation sequencing, as well as for other applications.
• In February 2022, Thermo Fisher Scientific, Inc. invested $40 million to build a bioprocessing manufacturing site in Millersburg, Pennsylvania for developing critical vaccines and biologics.

Key U.S. Biopharmaceuticals Contract Manufacturing Company Insights

The companies in U.S. biopharmaceuticals contract manufacturing market are focused on the expansion of their manufacturing capabilities as well as establishing new services to meet the growing demand of biopharmaceutical companies. Along with small players, these entities are also engaged in a partnership with established biopharma companies. All the major biopharmaceutical firms have a wide-ranging product pipeline and are investing in developing new products.

Key U.S. Biopharmaceuticals Contract Manufacturing Companies:

• Lonza
• WuXi Biologics
• FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
• Boehringer Ingelheim
• Thermo Fisher Scientific Inc.
• Samsung BioLogics
• AGC Biologics
• Catalent Pharma Solutions
• Rentschler Biopharma SE
• Eurofins Scientific SE

Segments Covered in the Report

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, Nova one advisor, Inc. has segmented the U.S. Biopharmaceuticals Contract Manufacturing market.

By Source 

• Mammalian
• Non-mammalian

By Service 

• Process Development
  • Downstream
  • Upstream
• Fill & Finish Operations
• Analytical & QC studies
• Packaging

By Product 

• Biologics
  • Monoclonal antibodies (MABs)
  • Recombinant Proteins
  • Vaccines
  • Antisense, RNAi, & Molecular Therapy
  • Others
• Biosimilar