경구 단백질 및 펩티드 시장 보고서 : 동향, 예측 및 경쟁 분석(-2035년)

Oral Protein and Peptide Market

The future of the global oral protein and peptide market looks promising with opportunities in the gastric & digestive disorder, bone diseases, diabetes, and hormonal disorder markets. The global oral protein and peptide market is expected to reach an estimated $10.1 billion by 2035 from $4.4 billion in 2027 with a CAGR of 11.7% from 2027 to 2035. The major drivers for this market are the increasing demand for protein-based supplements, the rising prevalence of metabolic disorders, and the growing focus on personalized nutrition solutions.

• Lucintel forecasts that, within the drug type category, linaclotide is expected to witness the highest growth over the forecast period due to high demand for linaclotide in gastrointestinal disorders.
• Within the application category, diabetes is expected to witness the highest growth over the forecast period due to rising incidence of diabetes leading to an increase in oral peptide therapy.
• In terms of regions, North America is expected to witness the highest growth over the forecast period due to well-developed healthcare systems and increased diabetes cases.

Emerging Trends in Oral Protein and Peptide Market

There have been shifts in the oral protein and peptide market away from traditional tablets. Other delivery systems are being developed and favorably appear to protect biologics from enzymatic degradation. The time period from 2025 to 2027 will see continued competition to commercialize oral platforms. During this time, various factors such as the ability to manufacture and endorse oral platforms in a cost efficient and reimbursable manner will impact the market. According to Lucintel, there will be further investments in this area.

• Oral Delivery of Biologics: Novo Nordisk aims to launch the first oral semaglutide (25 mg) in 2025. Rybelsus (oral GLP-1) demonstrates that oral therapy can disrupt existing markets (i.e. GLP-1 therapy). Additional delivery systems that promote protein and peptide absorption will reduce reliance on parenteral therapy.
• Peptide Therapy: The application of oral peptide delivery has focused on various unmet medical conditions. The pharmaceutical industry has invested significant funds to develop oral therapies for obesity and other metabolic disorders. It is anticipated that positive results from current and near-term clinical trials will facilitate the commercial launch of these products.
• Advances in Scale-up and Production: While research remains the core differentiator for pharmaceutical companies, specific advantages in the manufacture of oral solid dosage forms are becoming increasingly important. For example, strong growth in the demand for oral semaglutide in 2025 required further expansion of manufacturing capacity. As larger and larger batches of oral forms of biologics become available, injectable forms may be replaced.
• Trends in Consumer Preferences: A number of 2025 studies documented that both patients and prescribers prefer oral forms of medication over injectable forms based on convenience, ease of storage and disposal, and embarrassment associated with injection. In the absence of other forms of treatment, convenience may improve the adherence and, as a result, the clinical outcomes of treatments.
• Changes in Partnerships and Alliances: Formulation and technology alliances remain the basis for collaboration in the pharmaceutical industry, as evidenced by multiple alliances for the development of oral forms of peptides. These alliances facilitate the rapid introduction of oral forms of medications.

While oral forms of biologics remain more expensive than injectable forms in the short-term, convenience may lead to improved adherence for treatments of diabetes, obesity and other conditions.

Recent Developments in the Oral Protein and Peptide Market

Between the years 2025 to 2027, the protein and peptide drug market will be driven by the growing preference for patient-convenient, non-injectable forms of drug delivery. Active pharmaceutical ingredient (API) synthesis and absorption technology and manufacturing platforms will also see an increase in funding over the same period. Increased confidence in the pharmaceutical industry, primarily due to progressive policymaking and regulations, has led to an uptick in collaborations.

• Regulatory Approvals: The FDA's approval in December 2025 of an oral formulation of similitude for the treatment of obesity fostered further development of oral forms of therapeutic peptides and proteins, and accelerated the shift of the pharmaceutical industry from injectable forms of therapy.
• Technology Partnerships: In March 2026, Entera Bio announced a partnership with a multinational pharmaceutical company to develop an oral-peptide drug conjugate (ODPC) using technology to enhance peptide absorption in the intestine.
• Expansion of GLP-1 Manufacturing Capacity: Expanding capacity Novo Nordisk's $6B+ commitment to expand production of injectable and oral medications will help them meet the anticipated increase in demand when oral GLP-1 medications become widely available. Additionally, this increased capacity will enable them to produce larger quantities of their GLP-1 medications for greater distribution.
• Increased Clinical Trial Funding for Oral GLP-1 Therapies: Clinical trial funding The increase in funding for clinical trials of oral GLP-1 medications in 2025 indicated confidence in the development of this technology and the potential for oral medications to effectively treat diabetes and obesity.
• Strategic Partnerships and Consolidation in Peptide Delivery: Partnering for peptide delivery In 2025, large pharmaceutical companies continued to purchase or license companies specializing in the delivery of peptides, particularly for the treatment of diabetes and obesity. This consolidation will allow large pharmaceutical companies to control and regulate the technology to produce affordable, oral medications with the potential to treat diabetes and obesity.

Between 2025 and 2030, companies will invest to acquire technological know-how to develop oral medications with similar efficacy to injectable medications. This will help reduce the stigma associated with the use of injectable medications. The oral medications must also be affordable and readily available. While the oral medications to treat diabetes and obesity may not revolutionize the pharmaceutical industry, they will improve accessibility and change perceptions about the conditions.

Strategic Growth Opportunities in the Oral Protein and Peptide Market

The oral protein and peptide market is expected to undergo significant changes between 2024 and 2026 with various new products and delivery systems for obesity and diabetes coming into the market. Patent expirations, public interest, and other factors have accelerated the need for alternative methods of delivering therapeutic proteins and peptides. Similar to other pharmaceutical markets, the main constraint in the protein and peptide market will be the ability of the end-user to absorb and adhere to the treatment, and the formulation and economics of the delivery system.

• Oral Metabolic Therapies: Between 2024 and 2026, we will likely see a significant expansion in the oral therapies for obesity and diabetes with the entry of numerous competing products. Novo Nordisk projects that Wegovy (GLP-1 agonist for obesity) will generate approximately DKK 79.1 billion in sales in 2025.
• Advanced Absorption Technologies: Numerous other technologies for improving the oral delivery of peptides and proteins are expected to reach the market in the next 3-5 years. In 2025, Oramed reported that their oral insulin product achieved a bioavailability of 30%.
• Specialty Chronic Indications: Similar to the recent expansion in the use of biologics for the treatment of rare disorders and oncology, oral formulations of biologics will enable the treatment of rare and chronic disorders that are currently untreatable. 2025 saw the approval of 14 new rare and specialty drugs by the FDA.
• Premium Personalized Formulations: There is strong industry interest (64% of biopharma, October 2025) in the development of personalized medicines, and various factors such as patient weight and renal function, and level of response to treatment may allow use of tailored dosage forms e.g. dose-flexible capsules and tablets and MPs. Premium pricing may be justified for tailored medicines, particularly when healthcare practitioners need to closely control (tight adjust) the patient's dose and/or when adherence to treatment needs to be closely monitored.
• Regional Manufacturing: The biologics sector in India, Southeast Asia and the Middle East is rapidly developing; Indian pharmaceutical exports were $30.5 billion between April and December 2025 (2026). Local manufacturing of biologics will improve access, particularly in the developing countries that lack adequate cold-chain infrastructure for the storage and distribution of biologics.

Biologics that may allow for improved storage and protection against enzymatic degradation are likely to be successful. Significant costs and risks may be associated with the conversion of biologics to small molecules; however, if a sponsor is able to demonstrate that the small molecule provides a significant improvement in the clinical outcome, and is cost effective and convenient, it may be successful. Regional partnerships will help with product launch.

Oral Protein and Peptide Market Drivers and Challenges

The oral protein and peptide market is shaped by technological advances, rising chronic-disease prevalence, economic pressures, and evolving regulatory requirements. Improved delivery systems are expanding oral bioavailability, while patients increasingly prefer tablets over injections. Manufacturing investment, sustainability goals, and product innovation also support growth. However, formulation complexity, affordability, safety validation, and supply-chain constraints remain important barriers. Lucintel indicates that long-term expansion will depend on balancing convenience, clinical effectiveness, and commercial scalability across global healthcare markets.

The factors responsible for driving the oral protein and peptide market include:-

• Patient Preference and Demand: Growing dissatisfaction with frequent injections is increasing interest in convenient oral alternatives for diabetes, obesity, hormone disorders, and other chronic conditions. In September 2025, global diabetes prevalence was estimated at more than 589 million adults, strengthening demand for easier long-term treatment options. Over the next three to five years, adherence advantages and improved patient acceptance should encourage physicians and payers to consider oral therapies when clinical outcomes are comparable with injectable products.
• Drug-Delivery Technology: Advances in permeation enhancers, nanocarriers, enzyme inhibitors, enteric coatings, and mucoadhesive systems are improving the absorption of fragile proteins and peptides through the gastrointestinal tract. In March 2025, oral peptide-development programs continued testing technologies designed to overcome enzymatic degradation and intestinal barriers. During the next three to five years, better bioavailability, lower dose requirements, and more consistent absorption could expand the number of biologics suitable for oral administration and improve the commercial viability of previously unsuccessful formulations.
• Product Innovation: Pharmaceutical companies are applying formulation science to create oral versions of therapies traditionally delivered by injection, including metabolic, endocrine, and gastrointestinal medicines. In 2025, oral GLP-1 development programs commonly evaluated hundreds of participants in mid- and late-stage studies, demonstrating the sector's movement beyond early feasibility research. Over the next three to five years, broader clinical pipelines and combination formulations should increase competition, diversify treatment choices, and generate new opportunities across both prescription and specialty pharmaceutical segments.
• Manufacturing Efficiency: Improvements in continuous processing, high-throughput screening, analytical testing, and process automation are helping manufacturers reduce development time and improve batch consistency. In October 2025, several advanced biologics facilities worldwide were operating with increasingly automated quality-control systems and digital manufacturing records. Over the next three to five years, manufacturing efficiency should lower unit costs, strengthen reproducibility, and support commercial-scale production, particularly as oral peptide products require reliable control of potency, dissolution, stability, and content uniformity.
• Regulatory and Infrastructure Support: Regulatory agencies are gaining experience with complex oral biologics, while pharmaceutical infrastructure is expanding for specialized formulation, clinical testing, and quality assessment. In February 2025, international development programs continued prioritizing treatments for diabetes and obesity, conditions affecting hundreds of millions of people globally. Over the next three to five years, clearer regulatory pathways, improved testing standards, and investment in pharmaceutical infrastructure should reduce uncertainty and accelerate the progression of promising oral protein and peptide candidates.

The challenges facing this Market include:

• Limited Bioavailability: Proteins and peptides are vulnerable to digestive enzymes, acidic stomach conditions, and poor intestinal permeability, resulting in low and variable absorption. In June 2025, many oral peptide candidates still reported single-digit systemic bioavailability, requiring advanced enhancers or comparatively high doses. Over the next three to five years, inconsistent exposure may limit clinical reliability, increase formulation costs, and make oral products less competitive with injections unless delivery technologies achieve stronger and more predictable absorption.
• High Development Costs and Pricing Pressure: Developing oral biologics requires extensive formulation research, specialized clinical trials, sophisticated manufacturing, and long-term stability testing. In April 2025, late-stage pharmaceutical programs frequently involved trials enrolling more than 1,000 participants, increasing capital requirements before commercialization. Over the next three to five years, reimbursement scrutiny and competition from established injectable therapies may pressure prices, forcing manufacturers to demonstrate superior adherence, comparable outcomes, or meaningful reductions in total healthcare costs.
• Regulatory, Safety, and Supply-Chain Complexity: Oral protein and peptide products must satisfy demanding requirements related to absorption variability, food effects, immunogenicity, excipient safety, packaging, and dose consistency. In November 2025, pharmaceutical supply chains continued managing shortages and extended lead times for specialized ingredients and delivery components. Over the next three to five years, changing regulatory expectations and dependence on limited suppliers may delay launches, increase inventory requirements, and create operational risks for manufacturers serving multiple international markets.

The oral protein and peptide market is advancing through strong patient demand, delivery-system innovation, expanding clinical pipelines, and improving manufacturing capabilities. These forces can make biologic treatment more convenient, scalable, and potentially more affordable. Nevertheless, poor absorption, high development costs, complex regulation, and supply-chain limitations continue to restrict broad commercialization. Over the next three to five years, market growth will depend on whether companies can demonstrate reliable bioavailability, strong clinical outcomes, competitive pricing, and consistent production. Successful products are likely to combine patient-friendly dosing with measurable therapeutic and economic advantages over established injectable alternatives.

List of Oral Protein and Peptide Market Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. Through these strategies oral protein and peptide market companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the oral protein and peptide market companies profiled in this report include-

• Novo Nordisk A/S
• Synergy Pharmaceuticals Inc.
• Oramed Pharmaceuticals Inc.
• Allergan Plc.
• Proxima Concepts Limited

Oral Protein and Peptide Market by Segment

The study includes a forecast for the global oral protein and peptide market by drug type, application, and region.

Oral Protein and Peptide Market by Drug Type [Value ($B) from 2019 to 2035]:

• Linaclotide
• Plecanatide
• Calcitonin
• Insulin
• Octreotide

Oral Protein and Peptide Market by Application [Value ($B) from 2019 to 2035]:

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

Oral Protein and Peptide Market by Region [Value ($B) from 2019 to 2035]:

• North America
• Europe
• Asia Pacific
• The Rest of the World

Country Wise Outlook for the Oral Protein and Peptide Market

The Pancreatic oral protein and peptide market is transitioning from the clinical stage to commercialization. Oral GLP-1 drugs and methods to protect drugs from degradation in the gastrointestinal tract are catalyzing this transition. According to Lucintel, the next few years will be pertaining to regulatory occurrences and expansion of manufacturing plants.

• United States: There will be increased regulatory and manufacturing efforts in this region. In April 2025, Eli Lilly announced positive phase three results for an oral form of orglipron. Additionally, in June 2021, Lilly announced a 25 year, $27 billion commitment to new drug and manufacturing facilities in Indiana.
• China: Peptide drug development and manufacturing is growing. AstraZeneca, through its March 2025 acquisition of Gracell, gained a number of peptide drug programs. AstraZeneca and PegBio formed a similar partnership in March 2021. This will enhance the technology and manufacturing of oral peptide drugs.
• Germany: German firms are investing in global peptide drug discovery. Boehringer Ingelheim and Zealand Pharma are carrying out phase three clinical trials on survividutide (June 2025) for the treatment of obesity and liver disease. This further strengthens European's peptide drug development, clinical trials, and large-scale manufacturing.
• India: Peptide manufacturing and complex drug delivery system partnering have increased. Biocon Biologics, a biosimilar manufacturer, reported a revenue of US $1.2 billion (April 2025). The company established manufacturing facilities in regulated markets. Oral peptide drug development, allied services, and technology partnering will be sponsored by this.
• Japan: Advanced drug manufacturing is of interest to the government and the pharmaceutical industry. Oral semaglutide for the treatment of diabetes, which is based on a pre-existing drug, was approved by the Ministry of Health and Welfare. The Japanese pharmaceutical market was worth ¥11 trillion (April 2024). This will catalyze oral peptide drug development.

Features of the Global Oral Protein and Peptide Market

• Market Size Estimates: oral protein and peptide market size estimation in terms of value ($B).
• Trend and Forecast Analysis: Market trends (2019 to 2026) and forecast (2027 to 2035) by various segments and regions.
• Segmentation Analysis: oral protein and peptide market size by drug type, application, and region in terms of value ($B).
• Regional Analysis: oral protein and peptide market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
• Growth Opportunities: Analysis of growth opportunities in different drug types, applications, and regions for the oral protein and peptide market.
• Strategic Analysis: This includes M&A, new product development, and competitive landscape of the oral protein and peptide market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

If you are looking to expand your business in this or adjacent markets, then contact us. We have done hundreds of strategic consulting projects in market entry, opportunity screening, due diligence, supply chain analysis, M & A, and more.

This report answers following 11 key questions:

• Q.1. What are some of the most promising, high-growth opportunities for the oral protein and peptide market by drug type (linaclotide, plecanatide, calcitonin, insulin, and octreotide), application (gastric & digestive disorders, bone diseases, diabetes, and hormonal disorders), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
• Q.2. Which segments will grow at a faster pace and why?
• Q.3. Which region will grow at a faster pace and why?
• Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
• Q.5. What are the business risks and competitive threats in this market?
• Q.6. What are the emerging trends in this market and the reasons behind them?
• Q.7. What are some of the changing demands of customers in the market?
• Q.8. What are the new developments in the market? Which companies are leading these developments?
• Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
• Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
• Q.11. What M&A activity has occurred in the last 8 years and what has its impact been on the industry?

Table of Contents

1. Executive Summary

2. Market Overview

• 2.1 Background and Classifications
• 2.2 Supply Chain

3. Market Trends & Forecast Analysis

• 3.1 Macroeconomic Trends and Forecasts
• 3.2 Industry Drivers and Challenges
• 3.3 PESTLE Analysis
• 3.4 Patent Analysis
• 3.5 Regulatory Environment

4. Global Oral Protein and Peptide Market by Drug Type

• 4.1 Overview
• 4.2 Attractiveness Analysis by Drug Type
• 4.3 Linaclotide : Trends and Forecast 2019 to 2035
• 4.4 Plecanatide : Trends and Forecast 2019 to 2035
• 4.5 Calcitonin : Trends and Forecast 2019 to 2035
• 4.6 Insulin : Trends and Forecast 2019 to 2035
• 4.7 Octreotide : Trends and Forecast 2019 to 2035

5. Global Oral Protein and Peptide Market by Application

• 5.1 Overview
• 5.2 Attractiveness Analysis by Application
• 5.3 Gastric & Digestive Disorders : Trends and Forecast 2019 to 2035
• 5.4 Bone Diseases : Trends and Forecast 2019 to 2035
• 5.5 Diabetes : Trends and Forecast 2019 to 2035
• 5.6 Hormonal Disorders : Trends and Forecast 2019 to 2035

6. Regional Analysis

• 6.1 Overview
• 6.2 Global Oral Protein and Peptide Market by Region

7. North American Oral Protein and Peptide Market

• 7.1 Overview
• 7.2 North American Oral Protein and Peptide Market by Drug Type
• 7.3 North American Oral Protein and Peptide Market by Application
• 7.4 The United States Oral Protein and Peptide Market
• 7.5 Canadian Oral Protein and Peptide Market
• 7.6 Mexican Oral Protein and Peptide Market

8. European Oral Protein and Peptide Market

• 8.1 Overview
• 8.2 European Oral Protein and Peptide Market by Drug Type
• 8.3 European Oral Protein and Peptide Market by Application
• 8.4 German Oral Protein and Peptide Market
• 8.5 French Oral Protein and Peptide Market
• 8.6 Italian Oral Protein and Peptide Market
• 8.7 Spanish Oral Protein and Peptide Market
• 8.8 The United Kingdom Oral Protein and Peptide Market

9. APAC Oral Protein and Peptide Market

• 9.1 Overview
• 9.2 APAC Oral Protein and Peptide Market by Drug Type
• 9.3 APAC Oral Protein and Peptide Market by Application
• 9.4 Chinese Oral Protein and Peptide Market
• 9.5 Indian Oral Protein and Peptide Market
• 9.6 Japanese Oral Protein and Peptide Market
• 9.7 South Korean Oral Protein and Peptide Market
• 9.8 Indonesian Oral Protein and Peptide Market

10. ROW Oral Protein and Peptide Market

• 10.1 Overview
• 10.2 ROW Oral Protein and Peptide Market by Drug Type
• 10.3 ROW Oral Protein and Peptide Market by Application
• 10.4 Middle Eastern Oral Protein and Peptide Market
• 10.5 South American Oral Protein and Peptide Market
• 10.6 African Oral Protein and Peptide Market

11. Competitor Analysis

• 11.1 Product Portfolio Analysis
• 11.2 Operational Integration
• 11.3 Porter's Five Forces Analysis
  • Competitive Rivalry
  • Bargaining Power of Buyers
  • Bargaining Power of Suppliers
  • Threat of Substitutes
  • Threat of New Entrants
• 11.4 Market Share Analysis

12. Opportunities & Strategic Analysis

• 12.1 Value Chain Analysis
• 12.2 Growth Opportunity Analysis
  • 12.2.1 Growth Opportunity by Drug Type
  • 12.2.2 Growth Opportunity by Application
• 12.3 Emerging Trends in the Global Oral Protein and Peptide Market
• 12.4 Strategic Analysis
  • 12.4.1 New Product Development
  • 12.4.2 Certification and Licensing
  • 12.4.3 Mergers, Acquisitions, Agreements, Collaborations, and Joint Ventures

13. Company Profiles of the Leading Players Across the Value Chain

• 13.1 Competitive Analysis Overview
• 13.2 Novo Nordisk A/S
  • Company Overview
  • Oral Protein and Peptide Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.3 Synergy Pharmaceuticals Inc.
  • Company Overview
  • Oral Protein and Peptide Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.4 Oramed Pharmaceuticals Inc.
  • Company Overview
  • Oral Protein and Peptide Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.5 Allergan Plc.
  • Company Overview
  • Oral Protein and Peptide Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.6 Proxima Concepts Limited
  • Company Overview
  • Oral Protein and Peptide Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.7 Biocon Limited
  • Company Overview
  • Oral Protein and Peptide Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.8 Generex Biotechnology Corp.
  • Company Overview
  • Oral Protein and Peptide Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.9 AstraZeneca PLC
  • Company Overview
  • Oral Protein and Peptide Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.10 Tarsa Therapeutics Inc.
  • Company Overview
  • Oral Protein and Peptide Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.11 Chiasma Inc.
  • Company Overview
  • Oral Protein and Peptide Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing

14. Appendix

• 14.1 List of Figures
• 14.2 List of Tables
• 14.3 Research Methodology
• 14.4 Disclaimer
• 14.5 Copyright
• 14.6 Abbreviations and Technical Units
• 14.7 About Us
• 14.8 Contact Us