According to a Coherent Market Insights, the global Oral Biologics Market is poised for significant growth over the next decade. According to recent market analyses, the sector is projected to expand at a steady compound annual growth rate (CAGR) of 35.4% from 2023 to 2030. The market size is expected to increase from US$ 2.62 Billion in 2023 to approximately US$ 21.84 Billion by 2030.
Market Dynamics
The oral biologics market is driven by the rising incidence of autoimmune diseases globally. According to a report by the American Autoimmune Related Diseases Association, more than 50 million Americans suffer from one or more autoimmune diseases. Autoimmune diseases include Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD), Psoriasis, Uveitis and others. Oral biologics provide effective treatment options for chronic autoimmune diseases with advantages of oral administration over injectables. Moreover, advances in biotechnology have enabled development of novel oral biologics with high potency and specificity to treat autoimmune conditions more effectively.
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Key Market Trends:
Development of targeted oral biologics is one of the major trends witnessed in the oral biologics market. Key players are focusing on developing oral biologics with novel mechanisms of action to specifically target disease pathways. For instance, companies are developing oral biologics that selectively inhibit Janus kinase, integrated stress response pathways, or regulatory T cells to combat various autoimmune conditions. Further, companies are investing in development of innovative drug delivery technologies such as polymeric nanoparticles and microspheres to encapsulate biologics and enable their protective release in the gastrointestinal tract after oral administration. This is expected to improve the bioavailability and efficacy of orally delivered biologics over the forecast period.
Oral Biologics Market Report Coverage
Report Coverage |
Details |
Market Revenue in 2023 |
US$ 2.62 billion |
Estimated Value by 2030 |
US$ 21.84 billion |
Growth Rate |
Poised to grow at a CAGR of 35.4% |
Historical Data |
2018–2021 |
Forecast Period |
2023–2030 |
Forecast Units |
Value (USD Million/Billion) |
Report Coverage |
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
Segments Covered |
By Drug Class, By Disease Indication, By Distribution channel |
Geographies Covered |
North America, Europe, Asia Pacific, and Rest of World |
Growth Drivers |
• Increasing prevalence of diabetes • Increasing research and development activities |
Restraints & Challenges |
• Voluntary product recalls by the manufacturers |
Market Opportunities
The oral biologics market, by drug class insights, is segmented into bisphosphonates, anti-resorptives, enzyme inhibitors, immunomodulators, and others. The bisphosphonates segment is expected to hold the largest share in the market owing to wide applications in diseases such as osteoporosis. Bisphosphonates are the first line of treatment prescribed for osteoporosis patients due to their effectiveness in building bone mass and reducing fracture risks.
The disease indication segment of the oral biologics market includes osteoporosis, inflammatory bowel disease, diabetes, hyperuricemia and others. The osteoporosis segment is anticipated to dominate the market during the forecast period. Osteoporosis affects millions worldwide and oral biologics provide an effective treatment option with reduced side effects compared to other routes of administration like injection. The non-invasive nature of oral drugs makes them a preferred choice for chronic disease management like osteoporosis.
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Key Market Takeaways
The oral biologics market is anticipated to witness a CAGR of 35.4% during the forecast period 2024-2031, owing to the rising prevalence of chronic diseases that require long term treatment and management. On the basis of drug class, bisphosphonates segment is expected to hold a dominant position, owing to wide scale use in osteoporosis. On the basis of disease indication, the osteoporosis segment is expected to hold the largest share over the forecast period, due to large patient pool and oral drugs being first line of treatment.
Region wise, North America is expected to hold the dominant position over the forecast period, due to high healthcare expenditure and availability of advanced treatment options.
Competitor Insights:
Allena Pharmaceuticals,Inc
Chiasma Inc
Glycadia Pharmaceuticals
Recent Developments
In June 2023, Catalent invested $100 million to accelerate the development of multiple novel oral biologics projects. Evox Therapeutics closed a $80 million Series B financing round in August 2023 to progress its oral RNA therapies. Highlight Therapeutics raised $55 million in April 2024 to advance its pipeline programs including HIG-OX1, an oral PD-1 inhibitor.
In 2023 several Humira biosimilars will enter markets like the United States that can disrupt AbbVie's dominance. The availability of interchangeable biosimilars will allow automatic substitution of Humira at the pharmacy level. This is likely to rapidly shift market share away from the originator product.
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