Oral Proteins & Peptides Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Drug Type (Calcitonin, Insulin, Linaclotide, Octreotide, Plecanatide), By Application (Bone Diseases, Diabetes, Gastric & Digestive Disorders, Hormonal Disorders), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.37 Billion
CAGR (2026-2031)	9.49%
Fastest Growing Segment	Plecanatide
Largest Market	North America
Market Size (2031)	USD 2.36 Billion

Market Overview

The Global Oral Proteins & Peptides Market will grow from USD 1.37 Billion in 2025 to USD 2.36 Billion by 2031 at a 9.49% CAGR. Oral proteins and peptides are therapeutic biologic molecules, such as hormones and enzymes, formulated for ingestion to offer a non-invasive alternative to traditional injectable therapies. The market is primarily propelled by the rising global incidence of chronic metabolic conditions and the consequent demand for patient-friendly delivery methods that enhance treatment adherence. Key drivers include the critical need to manage long-term diseases more effectively without the pain or inconvenience of needles. According to the International Diabetes Federation, in 2025, approximately 589 million adults were living with diabetes globally, underscoring the substantial demand for accessible management solutions. This expanding patient population significantly bolsters the commercial viability of oral biologic formulations.

Despite this strong demand, the market faces a substantial impediment regarding the inherent low bioavailability of these large molecules. The human gastrointestinal tract presents a harsh environment where enzymatic degradation and acidic pH levels rapidly break down proteins before they can be absorbed into the systemic circulation. Consequently, developing advanced delivery technologies that effectively protect the drug and ensure sufficient therapeutic absorption remains a significant technical challenge that could impede rapid market expansion.

Key Market Drivers

Technological Breakthroughs in Oral Protein Delivery Systems are fundamentally reshaping the market by overcoming the historical barriers of enzymatic degradation and poor absorption. Innovations in permeation enhancers and carrier technologies now allow biologic therapies to achieve therapeutic levels comparable to subcutaneous injections. A prime example of this progress is the oral formulation of dual agonists for metabolic conditions. According to Viking Therapeutics, August 2025, in the 'Phase 2 VENTURE-Oral Dosing Trial', patients receiving the oral tablet formulation of VK2735 demonstrated a mean weight loss of up to 12.2% after 13 weeks. This level of efficacy confirms that oral modalities can effectively compete with established parenteral standards, thereby expanding the potential patient base. Furthermore, this efficacy extends to bone health applications; according to Entera Bio, October 2025, their Phase 2 trial analysis showed that the oral parathyroid hormone candidate EB613 yielded a 3.1% increase in lumbar spine bone mineral density.

Surge in Strategic Collaborations and Technology Licensing Deals is serving as a critical commercial accelerator, infusing the sector with necessary capital and development expertise. Large pharmaceutical entities are actively partnering with specialized biotech firms to integrate proprietary oral delivery platforms into their pipelines, mitigating the high risks associated with internal de novo development. These partnerships often involve substantial financial commitments that validate the technology's commercial potential. For instance, according to Rani Therapeutics, October 2025, in their 'Collaboration and License Agreement' announcement, the company entered a partnership with Chugai Pharmaceutical valued at up to $1.085 billion to develop oral biologics using the RaniPill capsule. Such high-value agreements underscore the industry's strategic pivot towards non-invasive delivery mechanisms, ensuring that promising oral biologic candidates move rapidly from clinical validation to market availability.

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Key Market Challenges

The primary obstacle obstructing the expansion of the Global Oral Proteins & Peptides Market is the inherent low bioavailability of these large molecules caused by gastrointestinal instability. The human digestive system is evolutionarily designed to break down proteins into amino acids through enzymatic activity and acidic pH levels. This aggressive environment degrades therapeutic peptides before they can permeate the intestinal epithelium and enter systemic circulation. Consequently, pharmaceutical developers face high attrition rates during clinical trials, as achieving consistent therapeutic blood levels proves exceptionally difficult without using invasive delivery mechanisms.

This technical barrier directly impacts the market's commercial trajectory by escalating development costs and lengthening regulatory timelines. Investors and manufacturers are often deterred by the high risk-to-reward ratio associated with oral biologic programs compared to established injectable routes. The difficulty in securing regulatory approval for these complex formulations is evident in recent industry output. According to the U.S. Food and Drug Administration (FDA), in 2025, the Center for Biologics Evaluation and Research (CBER) approved only 18 new biological treatments, a figure that reflects the persistent challenges in successfully bringing stable, effective biologic formulations to the commercial market.

Key Market Trends

The Expansion into Autoimmune and Oncology Therapeutic Areas represents a structural shift as developers successfully adapt oral peptide technologies for complex inflammatory diseases, moving beyond the sector's traditional reliance on metabolic indications. This trend is characterized by the clinical validation of oral receptor antagonists that offer the efficacy of injectable biologics with the convenience of a daily pill, thereby addressing significant unmet needs in chronic autoimmune management. According to Protagonist Therapeutics, March 2025, in the 'Protagonist Reports Positive Top Line Results from Phase 2b Study' announcement, the investigational oral peptide icotrokinra demonstrated a clinical response rate of 63.5% in patients with moderately to severely active ulcerative colitis, highlighting the potential of oral modalities to compete effectively in high-value therapeutic categories.

Concurrently, the Emergence of Ingestible Robotic Pill Technologies is introducing a mechanical delivery paradigm that transcends the limitations of chemical permeation enhancers. These device-based formulations are designed to physically inject macromolecules into the intestinal wall, overcoming the capacity constraints that often hinder conventional oral biologic development. This approach allows for the administration of significantly larger drug volumes, enabling the delivery of complex proteins that require higher dosages. According to Biora Therapeutics, March 2025, in the 'Biora Therapeutics Successfully Completes Restructuring Process' press release, the company’s BioJet platform is now capable of delivering payloads of over 300 microliters, a technical specification that positions these devices to handle therapeutic loads previously restricted to parenteral administration.

Segmental Insights

The Plecanatide segment currently represents the most rapidly expanding category within the Global Oral Proteins & Peptides Market. This growth is primarily driven by the increasing global prevalence of gastrointestinal disorders, specifically chronic idiopathic constipation and irritable bowel syndrome with constipation. The segment gained significant commercial momentum following approval from the US Food and Drug Administration, which validated its safety and efficacy as an oral treatment. This regulatory endorsement supports a shift away from injectable therapies, as the convenience of oral administration enhances patient compliance and positions Plecanatide as a preferred therapeutic option in this sector.

Regional Insights

North America maintains a dominant position in the Global Oral Proteins & Peptides Market due to substantial investments in pharmaceutical research and a highly developed biotechnology landscape. The region benefits from the concentrated presence of major manufacturers innovating in oral biologics delivery. Furthermore, the U.S. Food and Drug Administration (FDA) provides a structured regulatory pathway that supports the approval and commercialization of these therapeutic agents. This conducive environment, combined with rising patient demand for non-invasive treatments for chronic conditions, secures North America’s leadership in the global sector.

Recent Developments

• In November 2024, Viking Therapeutics released updated results from a Phase 1 clinical trial evaluating the oral tablet formulation of VK2735, a dual GLP-1 and GIP receptor agonist. The data revealed that patients receiving the highest evaluated daily dose of the oral peptide achieved a mean weight reduction of up to 6.8% after 28 days, with a favorable safety profile. The study indicated that the oral version of the drug was well-tolerated, with mild gastrointestinal side effects comparable to the placebo. These findings paved the way for the company to progress the oral candidate into Phase 2 clinical studies for obesity treatment.
• In September 2024, Entera Bio presented new comparative pharmacological data for its lead oral peptide candidate, EB613, at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting. The company highlighted that its oral formulation of parathyroid hormone (PTH 1-34) showed a physiological profile capable of stimulating bone formation, distinguishing it from standard injectable treatments. The presented data supported the ongoing development of the daily tablet as a potential first-in-class oral osteoanabolic therapy for post-menopausal women with osteoporosis. This event underscored the continued advancement of oral delivery technologies for peptide hormone replacement.
• In June 2024, Rani Therapeutics entered into a strategic collaboration with ProGen Co., Ltd. to co-develop and commercialize a novel oral therapeutic for obesity. The partnership focuses on combining a proprietary robotic pill technology with ProGen’s PG-102, a long-acting GLP-1/GLP-2 dual agonist peptide. Under the agreement, the companies aim to create a capsule that delivers the biologic drug directly through the intestinal wall, potentially replacing subcutaneous injections. The collaboration leverages the unique pharmacokinetic profile of the peptide to support a convenient dosing schedule for patients managing chronic weight-related conditions.
• In March 2024, a Danish multinational pharmaceutical company announced positive Phase 1 clinical trial results for its investigational oral obesity treatment, amycretin. The early-stage study demonstrated that participants receiving the oral formulation achieved a 13.1% weight loss after 12 weeks, significantly surpassing the 1.1% reduction observed in the placebo group. Amycretin acts as a co-agonist targeting both GLP-1 and amylin receptors, a mechanism designed to improve weight management efficacy compared to existing therapies. This development highlights the company’s progress in expanding its pipeline of oral peptide-based treatments for metabolic conditions.

Key Market Players

• AbbVie Inc.
• Merck & Co Inc
• Pfizer Inc
• Novo Nordisk A/S
• Hoffmann-La Roche Inc
• Sanofi SA
• AstraZeneca PLC
• Bristol-Myers Squibb Co
• Tarsa Therapeutics Inc
• Novartis AG

By Drug Type	By Application	By Region
Calcitonin Insulin Linaclotide Octreotide Plecanatide	Bone Diseases Diabetes Gastric & Digestive Disorders Hormonal Disorders	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Oral Proteins & Peptides Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Oral Proteins & Peptides Market, By Drug Type:

• Calcitonin
• Insulin
• Linaclotide
• Octreotide
• Plecanatide

• Oral Proteins & Peptides Market, By Application:

• Bone Diseases
• Diabetes
• Gastric & Digestive Disorders
• Hormonal Disorders

• Oral Proteins & Peptides Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE