PUBLISHER: The Business Research Company | PRODUCT CODE: 1807784
PUBLISHER: The Business Research Company | PRODUCT CODE: 1807784
Biopharmaceutical contract manufacturing involves a process where a biopharmaceutical company engages a third-party manufacturer to produce drugs or biologic products on its behalf. This practice is employed when pharmaceutical businesses utilize external facilities to manufacture pharmaceuticals under their brand, akin to private label or third-party production.
The primary products of biopharmaceutical contract manufacturing encompass a range of biologics, monoclonal antibodies (mABs), recombinant proteins, vaccines, antisense, mai, molecular therapy, and biosimilars. Monoclonal antibodies (MABs) are laboratory-engineered proteins designed to mimic the function of antibodies within the human body. These antibodies are derived from mammalian and non-mammalian sources. Services offered in this domain include process development, fill and finish operations, analytical and quality control studies, as well as packaging, catering to both clinical and commercial applications.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sharp rise in U.S. tariffs and the ensuing trade tensions in spring 2025 are taking a toll on the professional services sector, especially within legal, consulting, architectural, and engineering fields. Increased duties on imported technology, software, office hardware, and digital infrastructure have pushed up operational costs for firms that rely on global systems and resources. Cross-border consulting engagements are experiencing delays and higher expenses due to elevated travel costs and limited access to international data and tools. Moreover, industries heavily impacted by tariffs such as manufacturing, construction, and logistics are reducing their reliance on outsourced services, dampening demand for professional support. In response, service providers are reassessing pricing models, strengthening ties with domestic vendors, and accelerating the adoption of AI and automation to maintain profitability and client satisfaction in an increasingly volatile environment.
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The biopharmaceuticals contract manufacturing market size has grown rapidly in recent years. It will grow from $20.13 billion in 2024 to $22.22 billion in 2025 at a compound annual growth rate (CAGR) of 10.4%. The growth in the historic period can be attributed to increased biopharmaceutical development, cost efficiency and risk mitigation, growing pipeline of biologics, globalization of biopharmaceutical industry, flexible manufacturing solutions.
The biopharmaceuticals contract manufacturing market size is expected to see rapid growth in the next few years. It will grow to $33.99 billion in 2029 at a compound annual growth rate (CAGR) of 11.2%. The growth in the forecast period can be attributed to increasing outsourcing trends, biosimilar development, shorter time-to-market requirements, global market expansion, focus on specialized services. Major trends in the forecast period include technological integration, outsourcing expansion beyond large molecules, advanced manufacturing technologies adoption, focus on quality and compliance, rise of biosimilars manufacturing,.
The forecast of 11.2% growth over the next five years reflects a modest reduction of 0.2% from the previous estimate for this market. This reduction is primarily due to the impact of tariffs between the US and other countries. The imposition of tariffs may disrupt U.S. drug developers by inflating prices for single-use bioreactors and cell culture media sourced from Switzerland and Denmark, potentially delaying clinical trial production and increasing biologics manufacturing costs. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.
The rising demand for personalized medicine is anticipated to significantly boost the growth of the biopharmaceutical contract manufacturing market in the coming years. Personalized medicine represents a tailored healthcare approach that considers individual patient characteristics, such as genetics, environment, and lifestyle, to improve treatment effectiveness and outcomes. Several factors are driving the demand for personalized medicine, including advancements in genomics, increased patient empowerment, and enhanced treatment efficacy. Contract manufacturers are able to develop customized production processes that meet the specific needs of personalized therapies, accommodating small batch sizes and unique formulations. For example, a report from the Personalized Medicine Coalition, a U.S.-based non-profit organization, noted that in February 2024, the FDA approved 16 new personalized therapies for patients with rare diseases in 2023, compared to just six in 2022. Consequently, the increasing demand for personalized medicine is fueling the growth of the biopharmaceutical contract manufacturing market.
The growth trajectory of the biopharmaceuticals contract manufacturing market is strongly influenced by the increasing number of clinical trials. These trials, crucial for assessing medical interventions, rely on efficient production and supply of investigational drugs facilitated by biopharmaceutical contract manufacturing. As indicated by Xtalks in May 2023, there has been a substantial rise in registered clinical trials globally on ClinicalTrials.gov, reaching 452,604, a significant increase from early 2021's over 365,000. Hence, the upsurge in clinical trials directly propels the biopharmaceuticals contract manufacturing market.
A prominent trend shaping the biopharmaceuticals contract manufacturing market is product innovation. Major industry players are investing in innovative products to maintain their market position. An example is the strategic contract manufacturing agreement between Thermo Fisher Scientific and Elektrofi in February 2023. This collaboration aims to support the commercial production of Elektrofi's pioneering ultra-high concentration subcutaneous products using innovative microparticle technology. This advancement allows patients to self-administer biologics at home, revolutionizing the delivery of crucial medications.
A significant focus within the biopharmaceutical contract manufacturing market is the development of monoclonal antibodies using advanced platforms such as the go-to cell line platform. KBI Biopharma Inc's launch of SUREmAb in September 2023 exemplifies this focus. Leveraging KBI's SUREtechnology Platform, SUREmAb streamlines processes, enabling swift research cell bank development and a rapid transition from DNA to GMP drug substance. The collaboration between KBI Biopharma and Selexis contributed to this operational optimization, enhancing monoclonal antibody development.
In June 2022, Asahi Kasei Medical Co. Ltd., a chemical company based in Japan, successfully acquired Bionova Scientific, LLC, for an undisclosed sum. This strategic acquisition enables Asahi Kasei Medical to broaden its bioprocess business by integrating a biopharmaceutical Contract Development and Manufacturing Organization (CDMO), thereby expanding its reach to a more diverse customer base, including those at the forefront of developing cutting-edge next-generation biopharmaceuticals. Bionova Scientific, LLC, based in the US, specializes in providing contract process development services and Good Manufacturing Practice (GMP)-compliant contract manufacturing services to biopharmaceutical firms.
Major companies operating in the biopharmaceuticals contract manufacturing market include Boehringer Ingelheim GmbH, Lonza Group Ltd., Inno Biologics Sdn Bhd, Rentschler Biopharma SE, Samsung Biologics Co. Ltd., AGC Biologics, ProBioGen AG, FUJIFILM Diosynth Biotechnologies, Thermo Fisher Scientific Inc., Binex Co. Ltd., AbbVie Inc., Catalent Inc, Pfizer Inc., Merck KGaA, Pressure BioSciences, Novartis International AG, Cambrex Corporation, Emergent BioSolutions Inc., JRS Pharma GmbH & Co. KG, WuXi Biologics, Siegfried Holding AG, Toyobo Co. Ltd., ADMA Biologics Inc., UCB S.A., AstraZeneca PLC, Johnson & Johnson, Takeda Pharmaceutical Company Limited, Shire Pharmaceuticals LLC, Baxter International Inc., Becton Dickinson and Company, Polyphor Ltd., Patheon Inc., Alcami Corporation
North America was the largest region in the biopharmaceutical contract manufacturing market in 2024. Asia-Pacific is expected to be the fastest-growing region in the global biopharmaceuticals contract manufacturing market forecast period. The regions covered in the biopharmaceuticals contract manufacturing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa
The countries covered in the biopharmaceuticals contract manufacturing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain
The biopharmaceutical contract manufacturing market includes revenues earned by entities providing services such as formulation development, GMP manufacturing, and supply chain management. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Biopharmaceuticals Contract Manufacturing Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on biopharmaceuticals contract manufacturing market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for biopharmaceuticals contract manufacturing ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The biopharmaceuticals contract manufacturing market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.