Biologics Market Report 2025

The biologics market size has grown rapidly in recent years. It will grow from $533.36 billion in 2024 to $610.25 billion in 2025 at a compound annual growth rate (CAGR) of 14.4%. The growth in the historic period can be attributed to aging population, government initiatives, ability to command high prices, and increased need for immunology.

The biologics market size is expected to see rapid growth in the next few years. It will grow to $1.06 trillion in 2029 at a compound annual growth rate (CAGR) of 15%. The growth in the forecast period can be attributed to increase in funding, technological advancements, increase in healthcare access, robust research and development activities for development of oral biologics, lean towards pills over injections, and increasing robust pipeline of biologics. Major trends in the forecast period include leveraging revised and less stringent regulations to develop new and improved biologics, shifting to biologic drug development, investing in R&D for the development of innovative biologics, and investing in research and development of biologics for the treatment of complex diseases.

The rising demand for personalized medicine is significantly boosting the global biologics market. Also known as precision medicine, personalized medicine is a healthcare approach that customizes medical treatment based on the unique characteristics of each patient. This method allows for the tailoring of biological therapies to align with a patient's specific genetic and clinical profile, thereby transforming the healthcare landscape. For instance, in February 2024, the Personalized Medicine Coalition, a U.S.-based hospital and healthcare organization, reported that in 2023, the FDA approved 16 new personalized treatments for patients with rare diseases, an increase from six approvals in 2022. Consequently, the growing demand for personalized medicine is driving the expansion of the biologics market in the future.

Technology stands out as a continued driving force behind market expansion in this period. Physiology simulation modeling, in particular, is poised for significant development and is anticipated to contribute to market growth. Advances in this field promise greater efficiencies, and companies within the biologics market are likely to benefit from such advancements. Notable instances include the adoption of Amazon's Elastic Compute Cloud (EC2) platform by pharmaceutical giants such as Eli Lilly and Pfizer. These companies utilize this technology for conducting simulation models in early drug discovery, significantly reducing the time required for simulations. For instance, tasks that traditionally took weeks can now be completed within hours. Initiatives such as Lilly's Open Innovation Drug Discovery program further underscore efforts to enhance biologics research and development. These technological advancements are expected to streamline processes, lower costs, and accelerate the development phase of biologics, enabling companies to introduce their products to market more swiftly.

The focus of major companies in the biologics industry on developing innovative products, such as oncology biosimilars, reflects their strategic initiatives to strengthen market positions and gain competitive advantages. Oncology biosimilars, specifically designed to treat cancer, are akin to existing biologic drugs and offer highly similar alternatives in terms of efficacy and safety. An example of this pursuit is seen in the collaboration between Biocon Biologics Limited and Viatris Inc., which led to the launch of Abevmy in Canada in May 2022. Abevmy is an oncology biosimilar utilized for cancer treatment, exhibiting similarity to an already authorized biological medicine.

The revisions made by the US Food and Drug Administration (FDA) in its regulations concerning biologics signify a shift toward eliminating outdated requirements. The alterations allow drug manufacturers to adopt new manufacturing technologies and testing capabilities. Specifically, the FDA has amended regulations to enable the sourcing of standard preparations, critical in ensuring the safety, purity, and potency of biologics, from sources beyond the FDA's Center for Biologics Evaluation and Research (CBER). Additionally, the FDA has removed the minimal potency limits rule (Section 610.21 of FDA code) pertaining to certain antibodies and antigens. Furthermore, updates in regulations (Section 610.53 of FDA code) concerning storage periods and conditions for biologics have been introduced. These regulatory amendments aim to enhance flexibility and promote the adoption of contemporary scientific technologies in the manufacturing processes of licensed biological products, fostering innovation and progress in the biologics industry.

Major companies operating in the biologics market include Merck & Co., Inc., AbbVie Inc., F. Hoffmann-La Roche AG, Johnson & Johnson, Pfizer Inc., Bristol Myers Squibb Company, Sanofi S.A., GlaxoSmithKline Plc., Eli Lilly and Company, Amgen Inc., Wockhardt, Zydus Cadilla, China Biologic Products Holdings Inc., ABLbio, Adimmune, Henlius, Innovent Biologics, Bio-Thera, Hisun Pharma, 3SBio, Beijing ShuangLu Pharmaceuticals, Qilu Pharmaceutical, Biocon, Dr.Reddy’s, Mylan, Kyowa Hakko Kirin, Takeda, Mitsubishi Tanabe, AGC Biologics, Tonghua Dongbao Pharmaceutical Co., China Regenerative Medicine International, Shanghai Fosun Pharmaceuticals, Bayer AG, Novartis AG, BiosanaPharma, WuXi, Teva UK Limited, AstraZeneca, Abbott Laboratories, Vectura Group, Fujifilm, Lonza, Seqens, Piramal Pharma Solutions, Corden Pharma, Procos SpA and BSP Pharmaceuticals., Microgen, Geropharm, Valenta, NovaMedica, SynBi, Rani Therapeutics, Enteris BioPharma, Allena Pharmaceuticals, Biogen Inc., Emisphere Technologies Inc., Biogen Inc., Apotex, Gilead Sciences.

North America was the largest region in the biologics market in 2024. Middle East is expected to be the fastest growing region in the forecast period. The regions covered in the biologics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the biologics market report are Australia, China, India, Indonesia, Japan, South Korea, Bangladesh, Thailand, Vietnam, Malaysia, Singapore, Philippines, Hong Kong, New Zealand, USA, Canada, Mexico, Brazil, Chile, Argentina, Colombia, Peru, France, Germany, UK, Austria, Belgium, Denmark, Finland, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, Russia, Czech Republic, Poland, Romania, Ukraine, Saudi Arabia, Israel, Iran, Turkey, UAE, Egypt, Nigeria, South Africa.

The biologics market consists of sales of tumor necrosis factor inhibitors, Interleukin inhibitors, B-cells inhibitors, and T-cells inhibitors. 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.

Biologics are medications derived from organic materials and are utilized to treat a diverse range of illnesses, particularly immune-related conditions such as Crohn's disease, psoriasis, ankylosing spondylitis, and rheumatoid arthritis. One intriguing aspect is that biologics are sourced from various natural materials, including carbohydrates, proteins, nucleic acids, or complex mixtures of these substances.

The primary types of biologics include monoclonal antibodies (MAbs), therapeutic proteins, and vaccines. Monoclonal antibodies, or mAbs, are engineered in laboratories to target specific infections. These biologics can be administered through various routes, including oral, parenteral, and others, and are distributed through channels such as hospital pharmacies, retail pharmacies/drug stores, and others.

The biologics market research report is one of a series of new reports that provides biologics market statistics, including biologics industry global market size, regional shares, competitors with a biologics market share, detailed biologics market segments, market trends, and opportunities, and any further data you may need to thrive in the biologics industry. This biologics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

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.

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