Oral Proteins and Peptides Market Know the Scope and Trends

InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the “Oral Proteins and Peptides Market”-, By Type of Target Disease Indication (Acromegaly, Celiac Disease, Chronic Idiopathic Constipation, Enteric Hyperoxaluria, Inflammatory Bowel Disease, and Type II Diabetes), Type of Molecule (Protein and Peptide), Type of Biological Target (GC-C, Insulin Receptor, Oxalate and others), Type of Mechanism of Action (Receptor Stimulation, Substrate Degradation and Others), and Global Forecasts, 2024-2031 And Segment Revenue and Forecast To 2031.”

The Oral Proteins and Peptides Market is estimated to reach over USD 28.17 billion by 2031, exhibiting a CAGR of 20.3% during the forecast period. 

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Proteins and peptides, essential to biological processes, continue to demonstrate strong therapeutic potential across a wide range of medical conditions. Over the past three decades—and particularly in the last ten years—the development of therapeutic proteins has progressed rapidly, resulting in a marked increase in the number of protein- and peptide-based drugs available commercially. However, oral administration of these biomolecules remains a significant challenge due to their fragile tertiary structures and complex conformations, which are susceptible to degradation in the gastrointestinal (GI) tract. Enhancing the oral bioavailability of these compounds remains a priority, with advancements in formulation technologies expected to play a pivotal role in overcoming this barrier.

Breakthroughs in peptide delivery methods—such as nanoparticle encapsulation, peptide structure modifications, and the incorporation of permeation enhancers—have greatly improved the feasibility of oral peptide administration. These innovations help protect therapeutic peptides from enzymatic degradation and harsh GI conditions, thereby improving absorption and therapeutic efficacy. 

List of Prominent Players in the Oral Proteins and Peptides Market:

• AstraZeneca
• Biocon Chiasma
• Generex Biotechnology
• Novo Nordisk A/S
• Allergan
• Oramed Pharmaceuticals
• Proxima Concepts
• Synergy Pharmaceuticals
• Tarsa Therapeutics
• Sanofi
• F. Hoffmann-La Roche Ltd
• Novo Nordisk A/S
• Abbvie Inc.
• Pfizer Inc.
• Bausch Health Companies Inc.
• Chiesi Farmaceutici S.P.A.
• Acadia Pharmaceuticals Inc.
• Aurinia Pharmaceuticals Inc.
• Merck & Co., Inc.
• Johnson & Johnson Services, Inc.
• Swk Holdings
• R-Pharm Jsc
• Entera Bio Ltd.
• Proxima Concepts
• Astrazeneca Plc
• Regor Therapeutics Group
• Terns Pharmaceuticals, Inc.
• Structure Therapeutics
• Viking Therapeutics
• Protagonist Therapeutics Inc.
• Rani Therapeutics
• Carmot Therapeutics, Inc.
• Zealand Pharma
• Sciwind Biosciences Co., Ltd.
• Jiangsu Hengrui Pharmaceuticals Co., Ltd

Market Dynamics:

Drivers:

Recent technological advancements have significantly enhanced the viability of oral protein and peptide delivery. Innovations such as nanoparticle-based drug carriers, enteric-coated capsules, and enzyme inhibitors have increased the stability and bioavailability of these compounds, facilitating their passage through the gastrointestinal tract. As the global prevalence of chronic illnesses such as diabetes, cancer, and hormonal disorders continues to rise, so too does the demand for more convenient and patient-friendly therapeutic options.

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Challenges:

Despite significant progress, the development of effective oral protein and peptide drugs remains complex and resource-intensive. These biologics face degradation by stomach acids and digestive enzymes, which severely limits their bioavailability. To address these challenges, manufacturers must adopt sophisticated formulation strategies—such as structural modifications or encapsulation techniques—which significantly increase production costs and prolong development timelines. These technical barriers present a major hurdle for broader market adoption.

Regional Trends:

North America currently leads the market, underpinned by a well-established pharmaceutical infrastructure and substantial investment in biotech R&D. Regulatory initiatives like the FDA’s Fast Track and Breakthrough Therapy Designations further enhance the region’s ability to bring innovative therapies to market efficiently. The region's leadership is also supported by robust collaboration between research institutions and biotech companies focused on oral peptide development.

Recent Developments:

• In June 2023, Pfizer Inc. declared its intention to proceed with the clinical development of a single oral late-stage glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidate for the possible treatment of people with Type 2 diabetes mellitus (T2DM) and obesity. Subject to the outcomes of the ongoing Phase 2 trial, the company will proceed with the clinical development of lotiglipron (PF-07081532) and continue to advance the clinical program for danuglipron (PF-06882961). The business is working on a once-daily modified release version of danuglipron and anticipates having preparations for the late-stage program finalized by the end of 2023.
• In August 2023, Entera Bio, presented abstracts at the annual conference of the American Society for Bone and Mineral Research (ASBMR) on its First-in-Class, Once Daily Oral hPTH(1-34) Peptide Tablets (EB613) for the treatment of postmenopausal women at high risk of fracture.

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Segmentation of Oral Proteins and Peptides Market.

Global Oral Proteins and Peptides Market- Type of Target Disease Indication     

• Acromegaly
• Celiac Disease
• Chronic Idiopathic Constipation
• Enteric Hyperoxaluria
• Inflammatory Bowel Disease
• Type II Diabetes

Global Oral Proteins and Peptides Market – Type of Molecule   

• Protein
• Peptide

Global Oral Proteins and Peptides Market – Type of Biological Target     

• GC-C
• Insulin Receptor
• Oxalate
• Others

Global Oral Proteins and Peptides Market – Type of Mechanism of Action          

• Receptor Stimulation
• Substrate Degradation
• Others

Global Oral Proteins and Peptides Market – By Region

North America-

·       The US

·       Canada

·       Mexico

Europe-

·       Germany

·       The UK

·       France

·       Italy

·       Spain

·       Rest of Europe

Asia-Pacific-

·       China

·       Japan

·       India

·       South Korea

·       Southeast Asia

·       Rest of Asia Pacific

Latin America-

·       Brazil

·       Argentina

·       Rest of Latin America

 Middle East & Africa-

·       GCC Countries

·       South Africa

·       Rest of the Middle East and Africa

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