경구 단백질 및 펩티드 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the oral proteins and peptides market size was valued at USD 10.83 billion in 2025 and is estimated to grow from USD 12.31 billion in 2026 to reach USD 25.35 billion by 2031, at a CAGR of 15.54% during the forecast period (2026-2031).

This report is Segmented by Molecule Class (Peptides, Proteins & Enzymes), Drug Class (GLP-1 RAs, GC-C Agonists, Somatostatin RAs, Pancreatic Enzymes, Vasopressin Analogs), Indication (T2D, Obesity, IBS-C, CIC, EPI, Acromegaly, Others), and Geography (North America, Europe, Asia-Pacific, MEA, South America). Market Forecasts are Provided in Terms of Value (USD).

Global Oral Proteins And Peptides Market Trends and Insights

GLP-1 Oralization Momentum and Obesity Pill Launches Expand Addressable Market and Adherence

Eli Lilly's Foundayo (orforglipron) won FDA approval in April 2026, and Novo Nordisk's 25 mg oral semaglutide tablet reached U.S. pharmacies in January 2026, creating the first obesity-labeled peptide tablets to hit commercial scale. The Medicare GLP-1 Bridge demonstration, effective July 2026, reimburses both products at a USD 245 net monthly price with a USD 50 out-of-pocket cost, underscoring payer readiness to fund oral peptides that improve persistence. A 78,297-patient U.S. claims analysis found that oral semaglutide achieved 65.1% high adherence at 12 months versus 38.8% for injectables. However, an Italian observational study showed that 18-month persistence fell to 46.0% owing to gastrointestinal intolerance. The data suggest the oral proteins and peptides market will benefit when second-generation tablets reduce fasting windows and nausea rates.

Patient Preference and Adherence Shift from Injections to Oral Macromolecules in Chronic Diseases

High refill adherence correlates with lower disease activity across multiple chronic illnesses, and ease of administration drives that adherence. Real-world studies in inflammatory bowel disease linked 80% medication possession to a 70% fall in active-disease odds. Emerging oral peptides must therefore balance convenience with tolerability; strict "water-only" fasting rules and dose-related dyspepsia threaten persistence. Phase 2 and Phase 3 assets such as Structure Therapeutics' GSBR-1290 and Hansoh Pharma's HS-10535 aim to cut fasting windows below 10 minutes and reduce emetogenicity, suggesting future crowd-out pressure on weekly injectables.

Very Low and Variable Oral Bioavailability Drives High API Loads and Cost of Goods

Classic oral peptides rarely exceed 1% absorption, forcing 10-100X injectable doses and inflating both cost and gastrointestinal side-effects. Oral semaglutide requires 14 mg to match a 1 mg injection and still posts 50-60% coefficient-of-variation in exposure. Variability undermines the oral proteins and peptides market size economics.

Other drivers and restraints analyzed in the detailed report include:

1. Regulatory Tailwinds for Oral Peptides
2. Next-Generation Ingestible Devices Unlock Systemic Delivery of Large Proteins
3. Complex CMC and Stringent Regulatory Evidence for Enhancer/Device Safety

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Peptides held 78.31% of the oral proteins and peptides market in 2025 thanks to entrenched GLP-1 and GC-C franchises. The oral proteins and peptides market size for proteins and enzymes is projected to expand at 16.32% CAGR as ingestible injectors sidestep gut-wall barriers. Ironwood's LINZESS peptide reported USD 272.5 million Q1 2026 revenue, up 97% year over year, illustrating peptide resilience. In parallel, RaniPill achieved 84% bioavailability for ustekinumab biosimilar, validating protein delivery viability. The segment's long-run upside hinges on scaling device manufacturing and proving repeat-dose intestinal safety.

Second-generation enzyme formulations also reinforce protein upside. Updated CREON and Pertzye labels now cite coefficients of fat absorption above 83%, providing clear efficacy endpoints that justify premium reimbursement. Still, proteins face steep cost-of-goods when classical oral formulations demand gram-level API loads, keeping device platforms central to growth.

Geography Analysis

North America retained 45.75% of 2025 revenue, bolstered by payer initiatives like the Medicare GLP-1 Bridge and clear FDA peptide guidance. The region also hosts most ingestible-device clinical sites, positioning it to capture early protein-delivery upside. Yet real-world adherence gaps driven by gastrointestinal side-effects cap long-term share gains.

Europe benefits from centralized health-technology assessments that welcome oral options when they lower nurse-administered costs. EMA alignment on peptide bioequivalence lowers filing risk, encouraging biosimilar entrants that could compress price points.

Asia-Pacific is projected to record a 16.12% CAGR to 2031, supported by China's regulatory openness to incretin innovation and Japan's modality-specific PMDA guidance. Local manufacturing pacts, such as AstraZeneca's USD 1.2 billion CSPC agreement, aim to regionalize supply chains, cutting tariffs and shipping cost for high-dose tablets.

South America and the Middle East & Africa remain nascent, constrained by reimbursement hurdles and limited cold-chain infrastructure. Nonetheless, rising obesity prevalence and tele-pharmacy adoption point toward future opportunities once cheaper generic peptides arrive.

1. Abbvie
2. Astellas Pharma
3. AstraZeneca
4. Bausch Health
5. Biora Therapeutics
6. Bio-Thera Solutions
7. Celltrion
8. Chiesi Group
9. Emisphere/Novo
10. Enteris BioPharma
11. Eli Lilly and Company
12. Ferring Pharmaceuticals
13. i2O Therapeutics
14. Intract Pharma
15. Ironwood Pharmaceuticals
16. Johnson & Johnson
17. Merrion Pharmaceuticals
18. Novo Nordisk
19. Oramed Pharmaceuticals
20. Rani Therapeutics

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 GLP-1 Oralization Momentum and Obesity Pill Launches Expand Addressable Market and Adherence
  • 4.2.2 Patient Preference and Adherence Shift from Injections to Oral Macromolecules in Chronic Diseases
  • 4.2.3 Regulatory Tailwinds for Oral Peptides
  • 4.2.4 Next-Gen Ingestible Devices Unlock Systemic Delivery of Large Proteins
  • 4.2.5 Colon-Targeted Platforms for Local Biologics Transform IBD and GI Antibodies Use-Cases
  • 4.2.6 Ionic-Liquid and Novel Excipient Systems Raise Feasible BA Windows for Select Peptides
• 4.3 Market Restraints
  • 4.3.1 Very Low and Variable Oral Bioavailability Drives High API Loads and CoGs
  • 4.3.2 Complex CMC and Stringent Regulatory Evidence for Enhancer/Device Safety
  • 4.3.3 Long-Term Safety Questions for Chronic Use of Potent Permeation Enhancers
  • 4.3.4 Limited Generalizable Enhancer Chemistries; Platform Applicability Remains Molecule-Specific
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Molecule Class
  • 5.1.1 Peptides
  • 5.1.2 Proteins & Enzymes
• 5.2 By Drug Class
  • 5.2.1 GLP-1 receptor agonists
  • 5.2.2 GC-C agonists
  • 5.2.3 Somatostatin receptor agonists
  • 5.2.4 Pancreatic enzymes
  • 5.2.5 Vasopressin analogs
• 5.3 By Indication
  • 5.3.1 Type 2 Diabetes
  • 5.3.2 Obesity & Overweight Management
  • 5.3.3 IBS-C
  • 5.3.4 Chronic Idiopathic Constipation (CIC)
  • 5.3.5 Exocrine Pancreatic Insufficiency (EPI)
  • 5.3.6 Acromegaly
  • 5.3.7 Others (Celiac Disease, Inflammatory Bowel Disease, etc.)
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia Pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles {(includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)}
  • 6.3.1 AbbVie Inc.
  • 6.3.2 Astellas Pharma
  • 6.3.3 AstraZeneca
  • 6.3.4 Bausch Health
  • 6.3.5 Biora Therapeutics
  • 6.3.6 Bio-Thera Solutions
  • 6.3.7 Celltrion
  • 6.3.8 Chiesi Group
  • 6.3.9 Emisphere/Novo
  • 6.3.10 Enteris BioPharma
  • 6.3.11 Eli Lilly and Company
  • 6.3.12 Ferring Pharmaceuticals
  • 6.3.13 i2O Therapeutics
  • 6.3.14 Intract Pharma
  • 6.3.15 Ironwood Pharmaceuticals, Inc.
  • 6.3.16 Johnson & Johnson
  • 6.3.17 Merrion Pharmaceuticals
  • 6.3.18 Novo Nordisk A/S
  • 6.3.19 Oramed Pharmaceuticals
  • 6.3.20 Rani Therapeutics

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment