Oral Biologics & Biosimilars Market Forecast 2025-2034: Evaluating Growth Factors, Segments, and Emerging Trends

Which drivers are expected to have the greatest impact on the over the oral biologics & biosimilars market's growth?
The escalating occurrence of chronic conditions like arthritis, asthma, and cancer is projected to boost the expansion of the oral biologics and biosimilar market. Excessive work hours, limited physical exercise and unhealthy food and beverage habits are contributors to the emergence of chronic diseases, for which biologics are being more frequently utilized for treatment. Biologics incite the immune system to target cancerous cells, supporting the body's inherent defenses to eliminate the cells causing disease. An article produced by the United Nations, an intergovernmental organization based in the U.S, predicts that by 2030, chronic diseases will constitute 70% of all deaths globally. It is presumed that chronic disease will cause nearly 60% of all global deaths. Thus, the surge in chronic disease prevalence is stimulating the growth of the biologics and biosimilar market.

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What is the future CAGR of the oral biologics & biosimilars market, and how will it impact industry expansion?
The market size for oral biologics and biosimilars has seen considerable enlargement in the past few years. Its rise from $7.04 billion in 2024 to $8.69 billion in 2025, with a Compound Annual Growth Rate (CAGR) of 23.5%, is remarkable. The substantial growth during the previous years can be credited to enhanced cooperation and alliances among market players for improved comprehension, amplified need for immunology, increased demand spurred by cost-effective production processes, an aging populace, governmental programs, and the capability to set elevated prices.

In the coming years, the market size for oral biologics & biosimilars is poised for significant expansion, predicted to reach $19.13 billion in 2029, showing a compound annual growth rate of 21.8%. The augmentation during this forecast period can be credited to factors such as robust research and development endeavors for oral biologics production, preference for pills over injections, pervasive unhealthy lifestyles, advancements in technology, convenience of using oral biologics, better healthcare access, biologics reimbursement, a surge in biosimilars, and an increase in chronic disease incidence. Key trends predicted for this period include investing in the oral biologics market for stronger profit margins, favoring biologics due to the higher innovation rate, and the development of drugs based on microneedle injectors to enhance bioavailability and reduce side effects associated with the subcutaneous route.

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What are the emerging trends shaping the future of the oral biologics & biosimilars market?
A key emerging trend in the oral biologics and biosimilar market is the development of new insulin biosimilars. Industry leaders in the oral biologics and biosimilars space are aiming to seize a portion of the market by investing in the creation of an insulin biosimilar. For instance, U.S. based biotech firm, Amgen, launched Amjevita, a biosimilar to Humira, in January 2023, reflecting the advancements made in the production of insulin biosimilars. The objective is to reduce expenses and enhance access to essential treatments. Amjevita offers a cost-effective solution for ailments such as arthritis and Crohn's disease, while insulin biosimilars make treatments for diabetes more accessible and affordable. This is fostering competition and pushing innovation in biologics. Amgen's focus is centered on the discovery, development, manufacturing, and distribution of innovative human therapeutic solutions.

Which key market segments comprise the oral biologics & biosimilars market and drive its revenue growth?
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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What regions are at the forefront of oral biologics & biosimilars market expansion?
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.

Who are the leading players fueling growth in the oral biologics & biosimilars market?
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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What Is Covered In The Oral Biologics & Biosimilars Global Market Report?

• Market Size Forecast: Examine the oral biologics & biosimilars market size across key regions, countries, product categories, and applications.
• Segmentation Insights: Identify and classify subsegments within the oral biologics & biosimilars market for a structured understanding.
• Key Players Overview: Analyze major players in the oral biologics & biosimilars market, including their market value, share, and competitive positioning.
• Growth Trends Exploration: Assess individual growth patterns and future opportunities in the oral biologics & biosimilars market.
• Segment Contributions: Evaluate how different segments drive overall growth in the oral biologics & biosimilars market.
• Growth Factors: Highlight key drivers and opportunities influencing the expansion of the oral biologics & biosimilars market.
• Industry Challenges: Identify potential risks and obstacles affecting the oral biologics & biosimilars market.
• Competitive Landscape: Review strategic developments in the oral biologics & biosimilars market, including expansions, agreements, and new product launches.

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