Oral Proteins & Peptides Market: Growth, Size, Share, and Trends

Chronic diseases such as diabetes, heart disease, stroke, and cancer remain among the leading causes of morbidity and mortality worldwide. With rising life expectancy, both the prevalence and economic burden of these conditions continue to increase. According to the Mayo Clinic Foundation, the global cost of chronic diseases is projected to reach USD 47 trillion by 2030. In the U.S., the CDC estimates that nearly 90% of the nation’s USD 4.5 trillion annual healthcare spending is directed toward people with chronic and mental health conditions. Several oral peptide drugs have already been approved for the management of chronic diseases, including RYBELSUS (Semaglutide) for type 2 diabetes, DAYBUE (Trofinetide) for Rett syndrome, LUPKYNIS (Voclosporin) for lupus nephritis, and TRULANCE (Plecanatide) for chronic idiopathic constipation and irritable bowel syndrome with constipation.

The development of oral proteins and peptides is advancing rapidly, offering significant potential to improve patient adherence and quality of life. However, the high cost of development remains a major restraint, limiting broader adoption and market availability. These therapies face inherent challenges, including enzymatic degradation in the gastrointestinal tract and poor intestinal absorption. To overcome these barriers, complex formulation strategies are required to protect molecules from harsh stomach conditions and enhance bioavailability. Approaches such as enteric coatings, permeation enhancers, and nanoparticle carriers have shown promise but involve substantial expense. Advanced technologies, such as liposomes, micelles, and nano-encapsulation, further improve stability and absorption, but add considerable costs through extensive research, clinical testing, and manufacturing requirements.

The current clinical pipeline for oral proteins and peptides encompasses a wide range of therapeutic areas, including obesity and overweight conditions, hormonal disorders, and plaque psoriasis. Candidates such as somatostatin analogs, PCSK6 inhibitors, and interleukin-23 (IL-23) receptor antagonists highlight the expanding potential of oral peptides beyond traditional indications, creating new market opportunities. Notably, oral GLP-1 receptor agonists (e.g., Semaglutide) are showing strong results in clinical trials, signaling the development of effective oral alternatives to injectable peptide therapies. This broadens their clinical and commercial applications.

The formulation and stability of oral proteins and peptides remain major challenges that limit market growth. Unlike traditional small molecules, proteins and peptides are large, complex, and highly sensitive to environmental conditions. When administered orally, they encounter the harsh gastrointestinal (GI) environment, where proteolytic enzymes such as pepsin (in the stomach) and trypsin and chymotrypsin (in the small intestine) break them down into inactive fragments. This enzymatic degradation greatly reduces their bioavailability, making it difficult to achieve effective therapeutic levels through oral delivery.