Oral Biologics & Biosimilars Market Report 2025

The oral biologics & biosimilars market size has grown exponentially in recent years. It will grow from $7.04 billion in 2024 to $8.69 billion in 2025 at a compound annual growth rate (CAGR) of 23.5%. The growth in the historic period can be attributed to increased collaboration and partnerships between market players for better insights, increased need for immunology, increased demand due to cost-effective manufacturing process, aging population, government initiatives, and the ability to command high prices.

The oral biologics & biosimilars market size is expected to see exponential growth in the next few years. It will grow to $19.13 billion in 2029 at a compound annual growth rate (CAGR) of 21.8%. The growth in the forecast period can be attributed to robust research and development activities for the development of oral biologics, lean towards pills over injections, adoption of unhealthy lifestyles, technological advances, ease of use of oral biologics, increase in healthcare access, reimbursement of biologics, rise in biosimilars, and rising prevalence of chronic diseases. Major trends in the forecast period include investing in the oral biologics market to benefit from potentially strong profit margins, shifting to biologics, as the innovation rate is increasing in that field, developing microneedle injectors-based drugs to increase the bioavailability and eliminating side effects of subcutaneous route.

The growth of the oral biologics and biosimilar market is expected to be driven by the increasing prevalence of chronic diseases such as arthritis, asthma, and cancer. Unhealthy lifestyle factors, including long working hours, limited physical activity, and poor dietary habits, contribute to the rising incidence of chronic diseases. Biologics play a crucial role in treating these conditions, stimulating the immune system to combat diseases such as cancer. According to the United Nations, it is anticipated that chronic diseases will account for 70% of global fatalities by 2030. This surge in chronic diseases is a significant factor propelling the expansion of the biologics and biosimilar market.

The growth of the oral biologics and biosimilars market is also expected to be fueled by the increasing healthcare expenditure. Healthcare expenditure, measured in monetary terms, encompasses the total resources spent on healthcare goods and services within a specific period. The implications of healthcare expenditure impact the development, adoption, and accessibility of oral biologics and biosimilars. For instance, the Centers for Medicare & Medicaid Services project that the average National Health Expenditures (NHE) growth will exceed the average GDP growth, resulting in a rise in health spending as a share of GDP. The increasing healthcare expenditure, coupled with the high prevalence of chronic diseases, is expected to drive the growth of the oral biologics and biosimilars market.

The development of new insulin biosimilars is a prominent trend gaining traction in the oral biologics and biosimilar market. Major players in this market are investing in creating biosimilar versions of insulin to capture a larger market share. For example, in January 2023, Amgen, a US-based biotechnology firm, launched Amjevita, a biosimilar to Humira, reflecting advancements in the creation of insulin biosimilars. The goal is to reduce costs and enhance access to essential treatments. Amjevita offers a more affordable option for conditions such as arthritis and Crohn's disease, while insulin biosimilars aim to make diabetes treatments more accessible. These developments are fostering competition and driving innovation in the biologics sector. Amgen is dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics.

The role of technology is anticipated to continue driving market growth, particularly in the area of physiology simulation modeling. Advancements in this field contribute to greater efficiencies, such as Eli Lilly and Pfizer utilizing Amazon’s Elastic Compute Cloud (EC2) platform for simulation models in early drug discovery. This approach significantly reduces the time required for simulations compared to traditional methods. The adoption of technology, especially in physiological simulation modeling, is expected to play a pivotal role in the further development of the oral biologics and biosimilar market.

In September 2023, Biocon Limited, an Indian pharmaceutical company, completed the acquisition of Eywa Pharma Inc. for $7.7 million. This strategic acquisition enhances Biocon's manufacturing infrastructure, ensuring a continuous supply and providing capacities for oral solid dosage products ahead of schedule. Eywa Pharma, Inc., a US-based pharmaceutical company specializing in oral biologics and biosimilars, aligns with Biocon's commitment to diversify and strengthen its market position.

Major companies operating in the oral biologics & biosimilars market include Merck & Co. Inc., GlaxoSmithKline, Novo Nordisk, ALK-Abelló, Aimmune Therapeutics Inc., VIVUS Inc, Materia Medica Holding, VECTOR-MEDICA, Henlius, Innovent Biologics, Bio-Thera, Hisun Pharma, 3SBio, Beijing ShuangLu Pharmaceuticals, Qilu Pharmaceutical, Shanghai Fosun Pharmaceuticals, Biocon, Dr.Reddy’s, Mylan, Kyowa Hakko Kirin, Takeda, Mitsubishi Tanabe, AGC Biologics, 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., Aché, 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 2024. 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, 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, Russia, South Korea, UK, USA, Italy, Spain, Canada.

Biologics represent pharmaceuticals derived from living cells through highly intricate technology, whereas biosimilars are designed to function similarly to biologics but are not exact replicas. Within the oral biologics and biosimilar market, these drugs are administered orally to specifically target conditions such as Alzheimer's, multiple sclerosis, HIV/AIDS, and other serious ailments, as well as to address chronic diseases such as diabetes, arthritis, and cancer.

The primary therapy categories for oral biologics and biosimilars encompass lymphocyte modulators, interleukin inhibitors, tumor necrosis factor-alpha inhibitors, immunostimulants, GPCR modulators, and others. Interleukin inhibitors serve as immunosuppressive medications that impede the function of interleukins. Various diseases treated include asthma, Crohn's disease, cancer, infectious disease, other autoimmune conditions, and more, employing molecular types such as vaccines, proteins and peptides, monoclonal antibodies, and other therapies. Distribution channels for these treatments include hospital pharmacies, retail pharmacies, and online pharmacies.

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

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