by Oral biologics refer to biological therapeutics that are administered through the oral route of administration. Traditionally, most biologics have been delivered via injection due to their instability in the gastrointestinal tract and risk of degradation. However, recent advances in formulation sciences and drug delivery technologies have enabled the development of orally administered biologics. Oral biologics offer advantages over injectable drugs such as improved patient compliance, self-administration, and lower production costs. Areas of application of oral biologics include diabetes, osteoporosis, cancers and autoimmune disorders.
The Global Oral Biologics Market is estimated to be valued at US$ 4.81 Bn in 2024 and is expected to exhibit a CAGR of 35% over the forecast period 2024 To 2031.
Key Takeaways
Key players operating in the Oral Biologics market are Novo Nordisk A/S, Biocon Limited, Oramed Pharmaceuticals, Inc., Rani Therapeutics, Entera Bio Ltd., AbbVie Inc., Enteris BioPharma, Inc., Chiasma, Inc. and Allena Pharmaceuticals, Inc. These players are focusing on developing novel oral formulations of peptides and proteins using nanoparticle encapsulation and absorption enhancer technologies.
The key opportunities in the Oral Biologics Market Demand include a large patient pool requiring biologic therapeutics, high demand for self-administrable drugs, and recent regulatory approvals for oral formulations of large molecules. A few molecules under development include oral formulations of insulin, PTH for osteoporosis, and monoclonal antibodies for cancers.
Technological advancements such as absorption enhancers, mucoadhesive nanoparticles and intestinal pH-sensitive release systems have enabled effective delivery of biologics through the oral route. These delivery technologies protect biologics from degradation in the GI tract and facilitate their transport across the intestinal epithelial cells.
Market Drivers
The rising prevalence of chronic diseases globally is a major driver for the oral biologics market. As per estimates, diabetes affects over 463 million people worldwide. Similarly, cancer incidence is on the rise. Self-administrable oral drugs can significantly improve patient adherence for long-term management of chronic conditions compared to frequent injections. This is expected to propel the demand for oral biologics.
Challenges in Oral Biologics Market:
The oral biologics market faces various challenges in terms of development and commercialization of products. Developing oral formulations of biologics is complicated due to harsh environmental conditions in the gastrointestinal tract such as varying pH levels and hostile enzymatic activities. Ensuring drug stability as well as efficient absorption through the intestinal walls remains a major challenge for developers. Further, high manufacturing costs associated with oral biologics pose affordability issues for patients. Long developmental times and regulatory norms also add to the barriers. Players need to overcome hurdles in functional delivery mechanisms, intestinal permeability and pharmacokinetic/pharmacodynamic aspects to drive growth in this sector.
SWOT Analysis
Strength: Oral formulations provide convenience over injectables by eliminating the need for injections and medical supervision. This improves patient compliance for chronic therapies.
Weakness: Developing robust technologies for protecting biologics from gastric degradation and efficiently delivering them through the intestinal walls remains difficult. High costs of goods further impact affordability.
Opportunity: Rising prevalence of diabetes, autoimmune disorders, gastrointestinal diseases and cancer is driving demand for novel oral drugs. Growth opportunities also lie in pediatric and geriatric patient segments due to swallowing difficulties.
Threats: Stringent regulations for bioequivalence and clinical trials pose delays. Further, biosimilars threaten patent cliffs and squeeze profit margins of pioneer drugs.
Geographically, North America currently dominates the oral biologics market, both in terms of value and volume, owing to rising healthcare investments, new product approvals and growing patient awareness in the region. Asia Pacific is expected to witness the fastest growth during the forecast period, driven by expansion of healthcare infrastructure, increasing disposable incomes, and growing prominence of generics in lucrative markets of India and China.
The United States accounts for the major share of the global oral biologics market currently. However, China is anticipated to register the fastest CAGR over the forecast period amid growing localization of pharmaceutical manufacturing and favorable business environment for international players in the country. Other emerging Asian markets such as India are also estimated to provide high growth opportunities backed by their large population base and increasing healthcare expenditures.
*Note:
1. Source: Coherent Market Insights, Public Source, Desk Research
2. We have leveraged AI tools to mine information and compile it.
About Author - Priya Pandey
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