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Oral Proteins & Peptides Market - Global Forecast 2025-2032

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    Report

  • 190 Pages
  • October 2025
  • Region: Global
  • 360iResearch™
  • ID: 4968731
UP TO OFF until Jan 01st 2026
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The oral proteins and peptides market is experiencing rapid evolution, spurred by advanced delivery systems and novel formulations that create new possibilities for pharmaceutical innovation and patient outcomes. This transformation captures the attention of senior leaders seeking to align with fast-moving trends and emerging opportunities in global healthcare.

Market Snapshot: Oral Proteins & Peptides Market Size and Growth

The oral proteins & peptides market moved forward significantly, expanding from USD 6.89 billion in 2024 to USD 7.78 billion in 2025. This segment demonstrates a robust compound annual growth rate (CAGR) of 13.67%, with projections suggesting a scale-up to USD 19.21 billion by 2032. Underlying this acceleration is heightened demand for orally administered protein and peptide drugs, supported by clinical research breakthroughs, evolving product innovations, and escalating chronic disease rates. The advancing trajectory indicates a period of strategic transformation for development pipelines, commercialization pathways, and adoption strategies across major regions worldwide.

Scope & Segmentation of the Oral Proteins & Peptides Market

  • Product Types: The market covers insulin-based proteins, peptide therapeutics, combination insulin products, long-acting and rapid-acting insulin analogues, recombinant human insulin, calcitonin-based products, glucagon-like peptide-1 receptor agonists, and vasopressin analogs. These diverse products address a broad spectrum of therapeutic needs and provide a competitive edge through portfolio diversification.
  • Formulation: Offerings include capsules, liquids, powders, and tablets, each enabling tailored drug delivery strategies and improved patient compliance. The flexibility across these formats allows manufacturers to better address patient-centric requirements and market preferences.
  • Development Stage: The market encompasses products and candidates ranging from preclinical research to Phase I, II, and III trials, and extends to ongoing post-market surveillance. This wide development spectrum ensures innovation stays aligned with evolving safety, efficacy, and regulatory demands.
  • Application: Targeted therapeutic areas span cancer treatment, cardiovascular diseases, diabetes management, and hormonal disorders, reflecting the industry’s commitment to addressing major clinical challenges and driving wider adoption across indications.
  • End-User: Utilization is broad, reaching home care settings, hospitals, clinics, research laboratories, and specialized treatment facilities. This diverse end-user profile underlines the market’s ability to serve both acute care and chronic management needs.
  • Geographical Coverage: The market spans the Americas, Europe, the Middle East, Africa, and Asia-Pacific, with regional coverage in countries including the United States, China, Brazil, Germany, India, South Africa, and Australia. Each geography presents unique regulatory, economic, and commercial considerations relevant for strategic decisions.
  • Companies Profiled: Key stakeholders include AbbVie Inc., Amgen Inc., Biocon Limited, AstraZeneca PLC, Johnson & Johnson Services, Inc., Novo Nordisk A/S, and Sanofi S.A. These players shape the landscape by strengthening pipelines, expanding footprints, and driving platform innovations.
  • Technological Focus: Innovation activities are centered around permeation enhancers, protective coatings, lipid-based nanocarriers, polymeric nanoparticles, peptide stabilization agents, microencapsulation, modular microfluidic reactors, and next-generation solid-dose technologies. These technologies improve drug stability, absorption, and therapeutic performance, setting the stage for future market expansion.

Key Takeaways: Strategic Insights for Senior Decision-Makers

  • Innovative oral formulations and optimized delivery technologies are enhancing the clinical and commercial feasibility of protein and peptide drugs, widening potential indications and making adoption more attainable.
  • Regulatory frameworks are evolving to support noninvasive therapies, creating pathways for market entry and accelerating patient access as governing agencies adapt to new product classes.
  • Collaboration among manufacturers, research entities, and healthcare providers is intensifying, with a significant focus on alliances, digital health integration, and platform consolidation to boost sector competitiveness.
  • Adaptive engagement strategies and cross-border alignment are becoming essential, as local incentives and harmonized regulatory environments drive the pace of market penetration regionally.
  • Reinforcing supply chain resilience through local sourcing strategies and robust domestic manufacturing is crucial to mitigate regulatory and logistical uncertainties inherent to international procurement.

Tariff Impact on the Oral Proteins & Peptides Market

The implementation of recent tariff policies in the United States has altered the marketplace landscape, compelling manufacturers to adjust their sourcing and procurement strategies. These developments have increased costs for vital raw materials and excipients, prompting companies to reinforce domestic partnerships, expand local production capacity, and broaden procurement options as means of ensuring business continuity and regulatory compliance across borders.

Methodology & Data Sources

This report leverages secondary research from scientific literature, regulatory records, and industry databases, as well as primary insights from domain experts. Triangulated methodologies validate all findings, supporting thorough segmentation, geographic analysis, and company profiling.

Why This Oral Proteins & Peptides Market Report Matters

  • Equips senior executives with actionable market intelligence, highlighting innovation drivers, regulatory progress, and the evolving competitive environment to inform planning and investment decisions.
  • Helps organizations proactively manage risk by analyzing supply chain challenges and tariff impacts, offering targeted recommendations that respond to dynamic marketplace changes.

Conclusion

Sustained advances in oral protein and peptide delivery, combined with wider sector collaboration, are reshaping the outlook for this industry. Market participants who move decisively are positioned to realize new opportunities as expansion continues.

 

Additional Product Information:

  • Purchase of this report includes 1 year online access with quarterly updates.
  • This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Advancements in lipidation and PEGylation techniques to enhance oral peptide stability and bioavailability
5.2. Integration of next generation permeation enhancers to facilitate transcellular transport of oral protein drugs
5.3. Development of self-emulsifying drug delivery systems for oral insulin and GLP-1 analogues in diabetic therapy
5.4. Adoption of novel protease inhibitors in formulation design to protect therapeutic peptides from gastrointestinal degradation
5.5. Emerging use of microbiome-targeted peptide therapeutics to modulate gut flora and improve oral drug efficacy
5.6. Strategic partnerships between biotech and pharmaceutical firms to accelerate commercialization of oral peptide vaccines and therapies
5.7. Regulatory harmonization efforts in the US and EU driving streamlined approval pathways for oral peptide drug candidates
5.8. Application of AI-driven peptide engineering platforms to optimize oral bioavailability and reduce development timelines
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Oral Proteins & Peptides Market, by Product Type
8.1. Insulin-Based Proteins
8.1.1. Combination Insulin Products
8.1.2. Long-Acting Insulin Analogues
8.1.3. Rapid-Acting Insulin Analogues
8.1.4. Recombinant Human Insulin
8.2. Peptide Therapeutics
8.2.1. Calcitonin-Based Therapies
8.2.2. Glucagon-Like Peptide-1 Receptor Agonists
8.2.3. Vasopressin Analogs
9. Oral Proteins & Peptides Market, by Formulation
9.1. Capsule Formulations
9.2. Liquid Formulations
9.3. Powder Formulations
9.4. Tablet Formulations
10. Oral Proteins & Peptides Market, by Development Stage
10.1. Phase I & II Clinical Trials
10.2. Phase III Clinical Trials
10.3. Post-Market Surveillance
10.4. Preclinical Studies
11. Oral Proteins & Peptides Market, by Application
11.1. Cancer Treatment
11.2. Cardiovascular Diseases
11.3. Diabetes Management
11.4. Hormonal Disorders
12. Oral Proteins & Peptides Market, by End-User
12.1. Home Care Settings
12.2. Hospitals & Clinics
12.3. Research Laboratories
12.4. Specialty Clinics
13. Oral Proteins & Peptides Market, by Region
13.1. Americas
13.1.1. North America
13.1.2. Latin America
13.2. Europe, Middle East & Africa
13.2.1. Europe
13.2.2. Middle East
13.2.3. Africa
13.3. Asia-Pacific
14. Oral Proteins & Peptides Market, by Group
14.1. ASEAN
14.2. GCC
14.3. European Union
14.4. BRICS
14.5. G7
14.6. NATO
15. Oral Proteins & Peptides Market, by Country
15.1. United States
15.2. Canada
15.3. Mexico
15.4. Brazil
15.5. United Kingdom
15.6. Germany
15.7. France
15.8. Russia
15.9. Italy
15.10. Spain
15.11. China
15.12. India
15.13. Japan
15.14. Australia
15.15. South Korea
16. Competitive Landscape
16.1. Market Share Analysis, 2024
16.2. FPNV Positioning Matrix, 2024
16.3. Competitive Analysis
16.3.1. AbbVie Inc.
16.3.2. Amgen Inc.
16.3.3. Amryt Pharma plc
16.3.4. Astellas Pharma Inc.
16.3.5. AstraZeneca PLC
16.3.6. Biocon Limited
16.3.7. Boehringer Ingelheim International GmbH
16.3.8. Catalent, Inc.
16.3.9. Entera Bio Ltd. by DNA Biomedical Solutions
16.3.10. F. Hoffmann-La Roche AG
16.3.11. Hunan Huateng Pharmaceutical Co., Ltd. by Tasly Capital
16.3.12. Johnson & Johnson Services, Inc.
16.3.13. Merck KGaA
16.3.14. Novartis AG
16.3.15. Novo Nordisk A/S
16.3.16. Oramed Pharmaceuticals Inc.
16.3.17. PeptiDream Inc.
16.3.18. Pfizer, Inc.
16.3.19. Protagonist Therapeutics, Inc.
16.3.20. Proxima Concepts Limited
16.3.21. Rani Therapeutics, LLC
16.3.22. Sanofi S.A.
16.3.23. Tarsa Therapeutics, Inc.
16.3.24. Teva Pharmaceutical Industries Ltd.
16.3.25. Zealand Pharma A/S
List of Tables
List of Figures

Samples

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Companies Mentioned

The key companies profiled in this Oral Proteins & Peptides market report include:
  • AbbVie Inc.
  • Amgen Inc.
  • Amryt Pharma plc
  • Astellas Pharma Inc.
  • AstraZeneca PLC
  • Biocon Limited
  • Boehringer Ingelheim International GmbH
  • Catalent, Inc.
  • Entera Bio Ltd. by DNA Biomedical Solutions
  • F. Hoffmann-La Roche AG
  • Hunan Huateng Pharmaceutical Co., Ltd. by Tasly Capital
  • Johnson & Johnson Services, Inc.
  • Merck KGaA
  • Novartis AG
  • Novo Nordisk A/S
  • Oramed Pharmaceuticals Inc.
  • PeptiDream Inc.
  • Pfizer, Inc.
  • Protagonist Therapeutics, Inc.
  • Proxima Concepts Limited
  • Rani Therapeutics, LLC
  • Sanofi S.A.
  • Tarsa Therapeutics, Inc.
  • Teva Pharmaceutical Industries Ltd.
  • Zealand Pharma A/S

Table Information