Oral Biologics & Biosimilar Drugs Market Report 2025

This Oral Biologics & Biosimilar Drugs market report provides a comprehensive analysis of the market’s characteristics, size, and growth, including segmentation, regional and country-level breakdowns, competitive landscape, market shares, trends, and strategies. It also tracks historical and forecasted market growth across various geographies.

The oral biologics & biosimilar drugs market size has grown rapidly in recent years. It will grow from $7.19 billion in 2024 to $8.6 billion in 2025 at a compound annual growth rate (CAGR) of 19.6%. The growth in the historic period can be attributed to rising prevalence of chronic diseases, growing awareness of oral biologics, increasing patent expirations, rising demand for biosimilars.

The oral biologics & biosimilar drugs market size is expected to see rapid growth in the next few years. It will grow to $15.11 billion in 2029 at a compound annual growth rate (CAGR) of 15.1%. The growth in the forecast period can be attributed to targeted therapy, increasing focus on preventive medicine, rising healthcare spending, aging population. Major trends in the forecast period include advancements in oral delivery technology, orally administered biologics, biosimilar innovation, and patient-centric care.

The prevalence of chronic conditions like arthritis, asthma, and cancer is anticipated to drive growth in the oral biologics and biosimilar market. Factors such as extended work hours, limited physical activity, and unhealthy dietary habits contribute to the rise in chronic diseases, and biologics are increasingly utilized for their treatment. These medications trigger the immune system to combat cancer cells, aiding in their elimination. The United Nations projects that by 2030, about 70% of global deaths will be attributed to chronic diseases, with the global burden of these conditions expected to reach approximately 60%. Consequently, the surge in chronic diseases is expected to fuel demand for biologics and biosimilars, spurring growth in the oral biologics and biosimilar drugs market.

The escalating demand for personalized medicine is set to propel growth in the oral biologics and biosimilar drugs market. Personalized medicine involves tailoring medical decisions and drug therapies to individual patients. This approach aligns with the development and utilization of oral biologics and biosimilars, optimizing treatment efficacy while minimizing side effects and reducing trial-and-error methods, leading to higher response rates and extended survival. Reports by STAT in October 2022 indicated over 75,000 genetic testing products and 300 personalized medicines, underscoring the increasing demand for personalized medicine driving growth in the oncology molecular diagnostics market.

A noteworthy trend in the oral biologics and biosimilar market is the creation of new insulin biosimilars. Key market players are investing in developing biosimilar versions of insulin, fostering competition among different biosimilar manufacturers. For instance, in April 2023, Eli Lilly and Company introduced Rezvoglar (insulin glargine-aglr), a biosimilar of insulin glargine used for improving glycemic control in adults, children, and infants with type 1 diabetes, as well as adults with type 2 diabetes.

Major companies in the oral biologics and biosimilar markets are concentrating on innovative products, such as incretin triagonists, to improve patient outcomes, enhance drug efficacy, and provide alternatives to injectable therapies. Incretin triagonists are medications that activate three hormone receptors - GLP-1, GIP, and glucagon - helping to regulate blood sugar, appetite, and metabolism. For example, in October 2024, Rani Therapeutics Holdings Inc., a biotechnology company based in the US, announced new preclinical pharmacokinetic data that supports the transenteric delivery of a GLP-1 incretin triagonist. Their RaniPill, an oral capsule designed to deliver biologics that typically require injections, successfully administered an incretin triagonist targeting the GLP-1, GIP, and glucagon receptors, which are critical in obesity treatment. The RaniPill showed effectiveness comparable to subcutaneous injections, providing a needle-free alternative with high bioavailability and flexible dosing, positioning it as a promising option for obesity drug candidates.

Major companies operating in the oral biologics & biosimilar drugs market include Novartis International AG, Rani Therapeutics Holdings Inc., Eli Lilly and Company, AstraZeneca plc, Novo Nordisk A/S, Biocon Limited, Oramed Pharmaceuticals Inc., BiosanaPharma, Entera Bio Ltd., Allergan plc, Emisphere Technologies Inc., Enteris BioPharma Inc., Chiasma Inc., Allena Pharmaceuticals Inc., Gelgen Corporation, 3SBio Inc., Innovent Biologics Inc., Changchun High & New Technology Industries (Group) Inc., Dong Bao Pharmaceutical Co. Ltd., CP Guojian Pharmaceutical Co. Ltd., GlaxoSmithKline PLC, Concord Biotech Limited, Aurobindo Pharma Limited, H. Lundbeck A/S, Sanofi S.A., F. Hoffmann-La Roche Ltd., Allergan Pharmaceuticals International Limited, Hikma Pharmaceuticals PLC, Mylan N.V., Pfizer Inc., Sandoz International GmbH, Teva Pharmaceutical Industries Ltd.

A biosimilar is a medication designed to closely resemble a biologic drug both structurally and functionally. Biologic drugs are treatments produced using biological systems like yeast, bacteria, or animal cells. A biological product is deemed 'biosimilar' if it closely matches an FDA-approved reference product with no clinically discernible differences.

Within therapy types, there are oral biologics and biosimilars categorized as lymphocyte modulators, interleukin inhibitors, and tumor necrosis factor-alpha inhibitors. Interleukin inhibitors are immunosuppressive drugs that hinder interleukins' functionality. Interleukins are a group of cytokines generated by lymphocytes, monocytes, macrophages, and various other cells, crucial in regulating the immune system. These drugs treat various conditions such as asthma, Crohn’s disease, carcinoma, arthritis, diabetes, multiple myeloma, enterocolitis, multiple sclerosis, sarcoma, psoriasis, and others. They are available in forms like vaccines, proteins, peptides, monoclonal antibodies, distributed through hospital pharmacies, retail pharmacies, and online pharmacies.

The oral biologics and biosimilar market research report is one of a series of new reports that provides oral biologics and biosimilar market statistics, including oral biologics and biosimilar industry global market size, regional shares, competitors with an oral biologics and biosimilar market share, detailed oral biologics and biosimilar market segments, market trends and opportunities, and any further data you may need to thrive in the oral biologics and biosimilar industry. This oral biologics and biosimilar 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.

North America was the largest region in the oral biologics and biosimilar drugs market in 2024. The Middle East is expected to be the fastest growing region in the oral biologics & biosimilar drugs market report during the forecast period. The regions covered in the oral biologics & biosimilar drugs market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the oral biologics & biosimilar drugs market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Spain, Canada.

The oral biologics and biosimilar market consist of sales of therapeutic proteins, cystic fibrosis, somatic cells, and allergenics. 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.

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