Understanding Key Drivers and Growth Opportunities in the Oral Biologics & Biosimilars Market: Trends and Market Size Insights
2025 Market Reports Update: Market Size Forecasts to 2034, Key Trends, Leading Players, and Top Regions – Get Ahead of the Competition Today!
What Industry-Specific Factors Are Fueling the Growth of theOral Biologics & Biosimilars Market?
The growth of the oral biologics and biosimilar market is anticipated to be driven by the increasing incidence of chronic diseases such as cancer, arthritis, and asthma. Long hours of work, a lack of physical exercise, along with poor dietary and lifestyle habits are major contributors to the spread of chronic diseases. Biologics, which boost the body’s natural immune response against cancer cells, are being used more for treating these chronic illnesses. A report from a U.S.-based intergovernmental organization under the United Nations projects that by 2030, chronic diseases are expected to be responsible for 70% of all deaths globally. In fact, nearly 60% of total mortality worldwide is predicted to be due to chronic diseases. Therefore, the expanding prevalence of chronic diseases is propelling the growth of the biologics and biosimilar market.
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#What Growth Opportunities Will Drive the Oral Biologics & Biosimilars Market’s CAGR Through 2034?
The market size for oral biologics & biosimilars has seen a significant surge in growth in recent times, escalating from $7.04 billion in 2024 to an estimated $8.69 billion in 2025. This corresponds to a compound annual growth rate (CAGR) of 23.5%. Factors that contributed to this historic growth include heightened collaboration and partnerships among market participants for improved insights, the rising need for immunology, a boost in demand due to the cost-effectiveness of the manufacturing process, an aging population, initiatives put forth by governments, and the capacity to set high prices.
In the coming years, substantial expansion is anticipated in the oral biologics & biosimilars market, with projections predicting it to reach $19.13 billion in 2029, displaying a compound annual growth rate (CAGR) of 21.8%. This promising forecast is linked to numerous factors including rigorous R&D in the development of oral biologics, a growing preference for pills over injections, the adoption of unhealthy lifestyles, advancements in technology, the simplicity involved in using oral biologics, improved healthcare access, biologics reimbursement, increasing biosimilars, and a rising prevalence of chronic diseases. The forecast period also hints towards major trends, such as capitalizing on the oral biologics market for potentially lucrative profit margins, adapting to biologics due to an escalating innovation rate in the sector, and the creation of drugs based on microneedle injectors to elevate bioavailability and eradicate side effects associated with the subcutaneous route.
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What Key Market Trends and Innovations Are Shaping the Future of theOral Biologics & Biosimilars Industry?
A central trend emerging within the oral biologics and biosimilar market is the production of novel insulin biosimilars. Leading companies within the market are investing resources into developing a biosimilar version of insulin in a bid to seize a larger market share. For instance, January 2023 saw US-based biotech company, Amgen, launch Amjevita (which is a biosimilar to Humira), a vital step forward in the creation of insulin biosimilars. Their objective is to cut costs and enhance accessibility to essential treatments. The availability of Amjevita as a lower-cost alternative for conditions like arthritis and Crohn’s disease, together with insulin biosimilars for more cost-effective and accessible diabetes care is promoting competition and fostering innovation within the realm of biologics. The company’s core focus lies in the discovery, development, manufacture, and delivery of innovative human therapeutics.
Which Companies Are Leading the Charge in Expanding theOral Biologics & Biosimilars Market Growth?
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
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How is the Global Oral Biologics & Biosimilars Market Segemented?
The oral biologics & biosimilars market covered in this report is segmented –
1) By Therapy: Lymphocyte Modulators, Interleukin Inhibitors, Tumor Necrosis Factor-Alpha Inhibitors, Immunostimulants, GPCR Modulators, Other Tharpies
2) By Disease: Diabetes, Arthritis and Crohn’s Disease, Cancer, Infectious Disease, Other Autoimmune Disease, Other Diseases
3) By Molecule Type: Vaccines, Proteins and Peptides, Monoclonal Antibodies, Other Molecule Types
4) By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies
Subsegments:
1) By Lymphocyte Modulators: T-Cell Modulators, B-Cell Modulators, Sphingosine-1-Phosphate Receptor Modulators
2) By Interleukin Inhibitors: IL-1 Inhibitors, IL-6 Inhibitors, IL-17 Inhibitors, IL-23 Inhibitors
3) By Tumor Necrosis Factor-Alpha Inhibitors: TNF-a Blockers, Monoclonal Antibodies Targeting TNF-a
4) By Immunostimulants: Cytokines, Immune Checkpoint Inhibitors, Adjuvants
5) By GPCR Modulators: Agonists, Antagonists, Biased Ligands
6) By Other Therapies: Cell-Based Therapies, Gene Therapies, Combination Therapies
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Which Geographics are Influencing the Growth of the Oral Biologics & Biosimilars Market?
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.
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