PUBLISHER: The Business Research Company | PRODUCT CODE: 1889316
PUBLISHER: The Business Research Company | PRODUCT CODE: 1889316
Biologics manufacturing is the complex process of producing medicines derived from living organisms or their components. It involves cultivating genetically engineered cells or microorganisms in bioreactors to generate therapeutic proteins or other biological products, followed by purification methods such as filtration and chromatography to ensure safety and quality. This process supports the development of safe, effective, and high quality biologic drugs, advancing personalized medicine and improving patient outcomes.
The main modes of manufacturing in biologics manufacturing are contract manufacturing and in-house manufacturing. Contract manufacturing refers to a production approach in which a company assigns the manufacturing of its biologic products to a specialized third party organization. The different modalities include monoclonal antibodies (mAbs), biosimilar and recombinant proteins, vaccines, cell and gene therapies, and ribonucleic acid based therapeutics, and are indicated for oncology, autoimmune disorders, infectious diseases, neurological disorders, and other disease areas.
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 sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.
The biologics manufacturing market research report is one of a series of new reports from The Business Research Company that provides biologics manufacturing market statistics, including biologics manufacturing industry global market size, regional shares, competitors with a biologics manufacturing market share, detailed biologics manufacturing market segments, market trends and opportunities, and any further data you may need to thrive in the biologics manufacturing industry. This biologics manufacturing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The biologics manufacturing market size has grown exponentially in recent years. It will grow from $34.82 billion in 2024 to $42.04 billion in 2025 at a compound annual growth rate (CAGR) of 20.7%. The growth in the historic period can be attributed to rising demand for therapeutic proteins, increasing prevalence of chronic diseases, expanding use of monoclonal antibodies, growing government support for biologics development, and increasing reliance on contract manufacturing organizations.
The biologics manufacturing market size is expected to see exponential growth in the next few years. It will grow to $88.28 billion in 2029 at a compound annual growth rate (CAGR) of 20.4%. The growth in the forecast period can be attributed to rising demand for personalized medicine, increasing investments in cell and gene therapies, growing use of advanced bioprocessing technologies, increasing emphasis on sustainable manufacturing methods, and expanding pipeline of biologic drug candidates. Major trends in the forecast period include a move toward continuous bioprocessing, increasing use of single use technologies, growth in modular biomanufacturing facilities, integration of AI and automation in production, and emphasis on sustainable and green manufacturing approaches.
The rising prevalence of chronic diseases is expected to propel the growth of the biologics manufacturing market going forward. Chronic diseases are persistent health conditions that develop slowly and last for an extended period, often requiring continuous medical care. The growing prevalence of chronic diseases is partly due to inactive lifestyles, as prolonged sitting and minimal physical activity raise the risk of diseases such as heart conditions and diabetes. Biologics manufacturing enhances chronic disease management by producing targeted therapies, making them effective for conditions such as diabetes, cancer, and autoimmune disorders. It reduces disease burden by providing consistent, high quality biologic medicines, improving patient outcomes and treatment efficiency. For instance, in June 2024, according to the National Health Service, a UK based government department, 3615330 individuals registered with a general practitioner were diagnosed with non diabetic hyperglycemia or pre diabetes in 2023, marking an 18 percent increase from 3065825 cases in 2022. Therefore, the rising prevalence of chronic diseases is driving the growth of the biologics manufacturing market.
Major companies operating in the biologics manufacturing market are focusing on developing advanced solutions such as integrated biologics contract development and manufacturing organization platforms to enhance end to end biologics development, production efficiency, and supply chain integration across multiple therapeutic modalities. Integrated biologics contract development and manufacturing organization platform refers to a comprehensive framework that combines biologics development, production, and supply services within a single unified system. For instance, in June 2023, Catalent Inc., a US based contract development and manufacturing company, expanded its OneBio Suite for integrated development, manufacturing, and supply across biologic modalities. The enhanced OneBio Suite offers a fully integrated biologics contract development and manufacturing organization platform that supports antibodies, cell and gene therapies, and mRNA based products. It provides end to end services from development to fill finish and packaging through a single contract and harmonized project management, enabling faster development timelines, improved scalability, and seamless global supply integration.
In September 2025, Terumo Corporation, a Japan based medical technology company, acquired WuXi Biologics Cayman Inc. for an undisclosed amount. Through this acquisition, Terumo aims to expand its contract development and manufacturing organization production capacity and global presence, enhancing its ability to provide integrated biologics manufacturing and fill finish services for injectable therapies. WuXi Biologics Cayman Inc. is a China based company offering end to end solutions for the discovery, development, and manufacturing of biologics.
Major companies operating in the biologics manufacturing market are Johnson & Johnson, F. Hoffmann La-Roche Ltd., Pfizer Inc, AbbVie Inc., Eli Lilly and Company, Novartis AG, Bristol-Myers Squibb Company, Thermo Fisher Scientific Inc., LG Life Sciences Ltd., Novo Nordisk A/S, Amgen Inc., FUJIFILM Holdings Corporation, Boehringer Ingelheim International GmbH, Teva Pharmaceutical Industries Ltd., Lonza Group Ltd., Intas Pharmaceuticals Ltd., Samsung Biologics Co. Ltd., Fareva SA, Celltrion Inc., Evotec SE
North America was the largest region in the biologics manufacturing market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in biologics manufacturing report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the biologics manufacturing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The biologics manufacturing market consists of sales of therapeutic proteins, enzymes, recombinant DNA products, blood factors, and other biologic-based therapeutics. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
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.
Biologics 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 biologics 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 biologics 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 biologics 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.