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.
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The U.S. biopharmaceuticals contract manufacturing market is witnessing major growth contributed by technological innovations and advancements in bioprocessing have played a crucial role in the process of contract service players by tackling production issues like high production cost. Furthermore, major players in the countries undertake many strategies to boost their portfolios. All these factors can contribute to the market expansion in the country further.
One of the major opportunities driving the growth of the market in the U.S. is the increasing emphasis of the CMOs on offering convenient drug products for many patients. Moreover, the increasing incidence of chronic conditions among the majority of the population propels the demand for advanced biological therapies, which necessitate specialized production processes.
Artificial intelligence is acting as an unprecedented force for transforming the market, especially the sector of sales endeavors and research and development (R&D) in the biopharmaceutical industry. Furthermore, AI tools use large datasets to forecast molecule behaviors and drug efficacy. This increases potential treatment success rate and speed as they travel through the pipeline system also analyses key market trends and customer behaviors to facilitate sales strategies and customized engagement with healthcare providers.
Market Trends
· Increasing Demand for Biologics and Biosimilars: The growing demand for biosimilars and biologics is the key factor driving the growth of the market. As global healthcare settings shift towards more innovative biologics, therapies, that provide targeted treatments for complex and chronic diseases, have garnered significant market share in recent years.
· In January 2023, PharmaCo Solutions announced a strategic partnership with BioGenex Pharmaceuticals to expand its capabilities in biologics manufacturing. The collaboration aims to leverage BioGenex's expertise in biologics development and manufacturing to enhance PharmaCo Solutions' service offerings in the pharmaceutical contract manufacturing market.
· Regulatory and Compliance Support: The growing complexity of regulatory needs for biopharmaceutical manufacturing is a recent market trend. The U.S. biopharmaceuticals contract manufacturing market players possess the desired experience and expertise to navigate these regulations to ensure proper compliance with Good Manufacturing Practices (GMP). This trend can impact positive market growth further.
· Rising Shift Towards Outsourcing: A key trend in the market is the ongoing shift towards outsourcing by major pharmaceutical companies. Because the demand for more advanced therapies such as gene therapies and biologics increases many biopharma companies are seeking to outsource manufacturing to contract manufacturers who have the required resources and expertise.
Country-level Analysis
· The market is experiencing substantial growth in the country due to increasing investment and adoption of advanced production technologies by CMOs in the U.S. The U.S. is also hosting various biopharmaceutical pipelines in several stages of development. Up to 900 biological molecules in the country are under clinical investigation. Rapid growth in the amount of new biological approvals in the US is expected to propel the market expansion in the country further.
The U.S. Biopharmaceuticals Contract Manufacturing Market Trends
· In June 2024, Asahi Kasei Medical's U.S. subsidiary Bionova Scientific, a full-service biologics CDMO, has decided to launch a new business line providing services leveraging plasmid DNA and establish a dedicated facility for this purpose in Texas, the U.S.The bioprocess business of Asahi Kasei Medical is one of the 10 Growth Gears (GG10), businesses to lead the next phase of growth.
U.S. Biopharmaceuticals Contract Manufacturing Market Report Scope
|
Report Attribute |
Details |
|
Market Size in 2024 |
USD 5.41 Billion |
|
Market Size by 2033 |
USD 7.83 Billion |
|
Growth Rate From 2024 to 2033 |
CAGR of 4.2% |
|
Base Year |
2023 |
|
Forecast Period |
2024 to 2033 |
|
Segments Covered |
Source, service, product |
|
Market Analysis (Terms Used) |
Value (US$ Million/Billion) or (Volume/Units) |
|
Report Coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Key Companies Profiled |
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 |
Segment Insights
By Source Insights
The mammalian source segment accounted for the highest share of 56.19% in 2023. The dominance of the segment can be attributed to the higher costs of getting this product from mammalian sources. Market players that provide contract services using these sources include AMRI, Avid Bioservices, AbbVie Contract Manufacturing, and Catalent Pharma Solutions. In addition, companies like Charles River Laboratories and Lonza are substantially investing in extending their mammalian cell culture production facilities.
The non-mammalian segment is expected to grow at the fastest rate over the forecast period. The growth of the segment can be linked to the advancement of transgenic non-mammalian expression systems. The non-mammalian cell line is widely identified as they extensively use non-mammalian cell cultures for the manufacturing of biopharmaceuticals.
By Service Insights
Process development services led the market in 2023 and accounted for a share of 32.11%. The dominance of the segment can be credited to the increasing capital investment in downstream processing. This operation requires vigorous attention to purification steps and final product recovery to prevent wastage and product quality. CMOs also offered biopharma players an extensive array of services.
The analytical & QC studies segment is estimated to grow at the fastest rate over the projected period. The growth of the segment can be driven by increasing regulatory changes and quality concerns for biopharmaceutical development. Furthermore, the analytical capabilities provided by key players have an extensive range of technologies & services to strengthen the rapid launch of products in the market.
By Product Insights
The biologics product segment led the market in 2023, with a share of over 81.18%. The dominance of the segment is owing to the important role of contract manufacturers in the success of biosimilars and biologics. Also, among all the biologics Monoclonal Antibodies (MAb) led the market in 2024. A huge amount of capital is needed for the construction of a MAb plant for Mab production, hence contributing to the segment's growth.
The biosimilar segment is expected to grow at the fastest rate during the period studied. The growth of the segment is because of increasing patent expiry of major biologics along with the low cost of production. Furthermore, biosimilars have boosted the biopharmaceutical CMO market due to cost-saving benefits. Which has strengthened the market expansion soon.
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Related Report
· U.S. Drug Discovery Outsourcing Market - https://www.novaoneadvisor.com/report/us-drug-discovery-outsourcing-market
· U.S. Biopharmaceuticals Contract Manufacturing Market - https://www.novaoneadvisor.com/report/us-biopharmaceuticals-contract-manufacturing-market
· Biopharmaceuticals Market - https://www.precedenceresearch.com/biopharmaceutical-market
U.S. Biopharmaceuticals Contract Manufacturing Market Top Companies
· Lonza
· WuXi Biologics
· FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
· Thermo Fisher Scientific Inc.
· Samsung BioLogics
· AGC Biologics
· Catalent Pharma Solutions
· Rentschler Biopharma SE
· Eurofins Scientific SE
U.S. Biopharmaceuticals Contract Manufacturing Market Recent Developments
· In Nov 2024, FUJIFILM Diosynth Biotechnologies signed a multi-year manufacturing agreement with TG Therapeutics for BRIUMVI® production at their new Holly Springs, North Carolina facility.
· In October 2024, Lonza extended a collaboration with a major biopharmaceutical partner for ADC manufacturing.
· In October 2024, Thermo Fisher Scientific launched comprehensive CDMO and CRO drug development solutions.
· 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.
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
o Downstream
o Upstream
· Fill & Finish Operations
· Analytical & QC studies
· Packaging
By Product
· Biologics
o Monoclonal antibodies (MABs)
o Recombinant Proteins
o Vaccines
o Antisense, RNAi, & Molecular Therapy
o Others
· Biosimilar
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