Oral Biologics & Biosimilar Drugs Market Report 2026

The oral biologics & biosimilar drugs market size has grown exponentially in recent years. It will grow from $8.6 billion in 2025 to $10.41 billion in 2026 at a compound annual growth rate (CAGR) of 21%. The growth in the historic period can be attributed to limited availability of oral biologics, reliance on injectable biologics, rising prevalence of autoimmune and inflammatory diseases, increasing patient demand for cost-effective therapies, early approvals of monoclonal antibody drugs.

The oral biologics & biosimilar drugs market size is expected to see rapid growth in the next few years. It will grow to $17.17 billion in 2030 at a compound annual growth rate (CAGR) of 13.3%. The growth in the forecast period can be attributed to development of next-generation oral biologics, expansion of biosimilar pipeline, increasing adoption of combination therapies, growing digital health platforms for patient monitoring, rising regulatory support for biosimilar approvals. Major trends in the forecast period include rising adoption of oral biologics and biosimilar drugs, increasing focus on chronic disease management using biologics, expansion of hospital and retail pharmacy distribution channels, growth in patient awareness and acceptance of biosimilars, development of targeted therapies for autoimmune and inflammatory diseases.

The increasing prevalence of chronic diseases such as arthritis, asthma, and cancer is expected to be a key factor driving the growth of the oral biologics and biosimilars market. Factors including long working hours, reduced physical activity, and unhealthy dietary and lifestyle habits contribute to the rising incidence of chronic conditions, and biologics are increasingly being used for their treatment. Biologics stimulate the immune system to respond against cancer cells, thereby helping the body eliminate them. For example, in May 2023, according to a United Nations article, the share of global deaths attributed to chronic diseases is projected to rise to 70% of total deaths by 2030, with the overall global burden of chronic diseases expected to reach approximately 60%. As a result, the growing prevalence of chronic diseases is anticipated to increase demand for biologics and biosimilars, thereby driving growth in the oral biologics and biosimilar drugs market.

Leading companies in the oral biologics and biosimilar markets are emphasizing the development of innovative products, such as incretin triagonists, to improve patient outcomes, enhance drug effectiveness, and offer alternatives to injectable treatments. Incretin triagonists are therapies that simultaneously activate three hormone receptors - GLP-1, GIP, and glucagon - which play a role in regulating blood glucose levels, appetite, and metabolism. For instance, in October 2024, Rani Therapeutics Holdings Inc., a US-based biotechnology company, announced new preclinical pharmacokinetic data supporting the transenteric delivery of a GLP-1 incretin triagonist. Its RaniPill, an oral capsule designed to deliver biologics that traditionally require injections, successfully administered an incretin triagonist targeting GLP-1, GIP, and glucagon receptors, which are key targets in obesity treatment. The RaniPill demonstrated efficacy comparable to subcutaneous injections while offering a needle-free option with high bioavailability and flexible dosing, positioning it as a promising approach for obesity drug candidates.

In August 2023, Oramed Pharmaceuticals Inc., a US-based pharmaceutical company, entered into a joint venture with Hefei Tianhui Incubator of Technologies Co., Ltd. (HTIT) to develop and commercialize oral drug products. The partnership is intended to accelerate the development of innovative oral formulations, enhance patient compliance, and broaden access to orally administered therapies, thereby strengthening treatment options while supporting growth and innovation in the oral drug delivery market. Hefei Tianhui Incubator of Technologies Co., Ltd. (HTIT) is a China-based healthcare technology and innovation company focused on advancing next-generation pharmaceutical solutions.

Major companies operating in the oral biologics & biosimilar drugs market are 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., GlaxoSmithKline PLC, Concord Biotech Limited, Sanofi S.A., F. Hoffmann-La Roche Ltd., Allergan Pharmaceuticals International Limited, Mylan N.V., Pfizer Inc., Sandoz International GmbH, Teva Pharmaceutical Industries Ltd.

North America was the largest region in the oral biologics and biosimilar drugs market in 2025. 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, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the oral biologics & biosimilar drugs market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Tariffs have impacted the oral biologics and biosimilar drugs market by increasing costs of imported biologics, active pharmaceutical ingredients, and packaging materials. Segments like tumor necrosis factor-alpha inhibitors and interleukin inhibitors are most affected, particularly in North America and Europe, which rely heavily on imports. This has led to higher treatment costs and slower adoption rates. On the positive side, tariffs have encouraged local production, domestic R&D investment, and innovation in cost-optimized oral biologic formulations.

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

Oral biologics are biologic medicines designed for oral administration to enable the effective delivery of complex biomolecules through the digestive system. Biosimilar drugs are highly comparable versions of approved biologic medicines that demonstrate similar safety, quality, and efficacy. Together, they broaden treatment options by enhancing accessibility and lowering healthcare costs.

The primary therapy types include oral biologics and biosimilar lymphocyte modulators, interleukin inhibitors, and tumor necrosis factor-alpha inhibitors. Interleukin inhibitors are immunosuppressive agents that inhibit the activity of interleukins. Interleukins are a group of cytokines produced by lymphocytes, monocytes, macrophages, and certain other cells, and they play a vital role in regulating the immune system. These therapies are used to treat a wide range of diseases such as asthma, Crohn’s disease, carcinoma, arthritis, diabetes, multiple myeloma, enterocolitis, multiple sclerosis, sarcoma, psoriasis, and others, through vaccines, proteins and peptides, monoclonal antibodies, and additional formulations. The drugs are distributed via hospital pharmacies, retail pharmacies, and online pharmacies.

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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