PUBLISHER: The Business Research Company | PRODUCT CODE: 1957539
PUBLISHER: The Business Research Company | PRODUCT CODE: 1957539
Biologics are drugs derived from living cells using highly sophisticated technologies, whereas biosimilars are developed to act similarly to biologics but are not exact replicas. Oral biologics and biosimilars include biologic and biosimilar drugs administered orally for the targeted treatment of conditions such as Alzheimer's, multiple sclerosis, HIV/AIDS, and other serious diseases. They are also used to manage chronic illnesses like diabetes, arthritis, and cancer.
The main therapy types of oral biologics and biosimilar lymphocytes are modulators, interleukin inhibitors, tumor necrosis factor-alpha inhibitors, immunostimulants, GPCR modulators, and others. Interleukin inhibitors are immunosuppressive drugs that block the activity of interleukins. These therapies address diseases including asthma, Crohn's disease, cancer, infectious diseases, autoimmune disorders, and others, using molecular types such as vaccines, proteins and peptides, monoclonal antibodies, and additional therapeutics. They are distributed through hospital pharmacies, retail pharmacies, and online channels.
Tariffs have impacted the oral biologics and biosimilars market by increasing the cost of imported active pharmaceutical ingredients, proteins, and peptides used in oral biologic formulations. Segments such as monoclonal antibodies and protein-based therapies are most affected, particularly in North America and Europe where imports dominate. This has led to higher treatment costs and potential delays in product availability. On the positive side, tariffs have encouraged local manufacturing, innovation in cost-effective oral formulations, and diversification of the supply chain.
The oral biologics & biosimilars market research report is one of a series of new reports from The Business Research Company that provides oral biologics & biosimilars market statistics, including oral biologics & biosimilars industry global market size, regional shares, competitors with a oral biologics & biosimilars market share, detailed oral biologics & biosimilars market segments, market trends and opportunities, and any further data you may need to thrive in the oral biologics & biosimilars industry. This oral biologics & biosimilars 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 oral biologics & biosimilars market size has grown exponentially in recent years. It will grow from $9.37 billion in 2025 to $11.28 billion in 2026 at a compound annual growth rate (CAGR) of 20.3%. The growth in the historic period can be attributed to limited availability of oral biologics, high cost of biologic therapies, reliance on injectable formulations, increasing prevalence of chronic diseases, growing hospital and retail pharmacy networks.
The oral biologics & biosimilars market size is expected to see exponential growth in the next few years. It will grow to $24.69 billion in 2030 at a compound annual growth rate (CAGR) of 21.6%. The growth in the forecast period can be attributed to development of biosimilars and combination therapies, expansion of oral biologics pipelines, increasing patient preference for oral medications, rising adoption of digital adherence tools, growing government support and reimbursement policies. Major trends in the forecast period include rising adoption of oral biologics and biosimilars for chronic diseases, growth in targeted therapies for diabetes, arthritis, and cancer, increasing development of monoclonal antibody-based oral treatments, expansion of hospital, retail, and online pharmacy distribution channels, focus on patient adherence and personalized treatment plans.
The mounting prevalence of chronic diseases is poised to boost the oral biologics and biosimilars market ahead. Chronic diseases are persistent health conditions that develop gradually, including diabetes, heart disorders, and lung issues. Their surge largely stems from inactive lifestyles, where extended lack of movement raises risks of obesity, cardiovascular problems, type 2 diabetes, and select cancers. Oral biologics and biosimilars advance this area by delivering convenient, economical, patient-friendly options for ongoing chronic care. For instance, in January 2023, the Centers for Disease Control and Prevention (CDC), a US-based federal agency, reported 76.4% of U.S. adults-about 194 million-had at least one chronic condition that year, with rates hitting 59.5% in young adults, 78.4% in midlife adults, and 93.0% in older adults. Therefore, the rising prevalence of chronic diseases is driving the growth of the oral biologics and biosimilar market.
Prominent companies in the oral biologics & biosimilars market are pioneering tailored smart capsule services to refine oral biologic delivery, lift bioavailability, and offer easier dosing over injections. Smart capsules employ specialized coatings, timed-release systems, or shielding agents to protect biologics from gut breakdown and pinpoint intestinal uptake, presenting a needle-free path with better compliance. For instance, in December 2024, Lonza Group AG, a Switzerland-based contract development and manufacturing organization (CDMO), rolled out a custom smart capsule development service for oral biologics. It covers bespoke formulation crafting, excipient picking, and capsule design for biologic stability and precise release; it works by boosting fragile biomolecule absorption while preserving potency; highlights feature full-cycle aid from idea to preclinicals, multi-modality fit (proteins, peptides, nucleic acids), and scalable production; uses include oral monoclonal antibodies, peptides, and vaccines; advantages span patient ease, less injection dependence, stronger adherence, and quicker timelines for oral therapies.
In September 2023, Biocon Limited, an India-based pharmaceutical company, acquired Eywa Pharma Inc. for $7.7 million. The acquisition additionally enables businesses to diversify their manufacturing infrastructure, ensuring supply continuity and providing oral solid dosage capacities for new products ahead of schedule. Eywa Pharma Inc. is a US-based pharmaceutical company that specializes in oral biologics and biosimilars.
Major companies operating in the oral biologics & biosimilars market are Merck & Co. Inc., GlaxoSmithKline, Novo Nordisk, BiosanaPharma, AstraZeneca, Bayer, Boehringer Ingelheim, Sanofi, Microgen, Geropharm, Valenta, NovaMedica, SynBio, Roche, Rani Therapeutics, Eli Lilly and Company, Emisphere Technologies Inc., Enteris BioPharma, Allena Pharmaceuticals, Abbvie, Johnson & Johnson, Pfizer Inc., Biogen Inc., Ache, Eurofarma, Teva Pharmaceuticals, Oramed Pharmaceuticals, Entera Bio, Julphar, Hikma Pharmaceuticals, Altis Biologics, Cipla Medpro South Africa, Genzyme
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 forecast period. The regions covered in the oral biologics & biosimilars 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 & biosimilars market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The oral biologics and biosimilar market consists of sales of receptor modulators, biological agents, and biosimilar lymphocytes. 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.
Oral Biologics & Biosimilars Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses oral biologics & biosimilars 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 oral biologics & biosimilars ? 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 oral biologics & biosimilars 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, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
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