The Oral Proteins and Peptides Market Size is valued at USD 6.51 Bn in 2023 and is predicted to reach USD 28.17 Bn by the year 2031 at an 20.3% CAGR during the forecast period for 2024-2031.
Oral proteins and peptides are therapeutic medicines made from short chains of amino acids, designed for oral administration to leverage their biological properties in treating various ailments. However, their bioavailability is limited due to degradation by digestive enzymes like proteases in the stomach and small intestine. Despite these challenges, the FDA's approval of several novel oral protein and peptide drugs demonstrates the industry's commitment to overcoming these obstacles. These innovative treatments provide a more convenient and comfortable alternative to injections or intravenous administration and hold the potential to revolutionize the treatment of diseases like diabetes and hormone deficiencies. As a result, the oral proteins and peptides market is rapidly evolving, driven by the ability to address unmet medical needs, improve patient compliance, and enhance bioavailability.
The U.S. Food and Drug Administration (FDA) implemented the 21st Century Cures Act to expedite the approval process for innovative drug delivery systems, including oral formulations of proteins and peptides. In 2023, the FDA recognized the potential of Oramed Pharmaceuticals' oral insulin capsule to address unmet needs in diabetes care and awarded it Fast Track Designation, allowing for faster development and more frequent interactions with regulatory reviewers. Such regulatory advancements are crucial in improving patient care and accelerating the availability of oral protein and peptide products, supporting market growth. Additionally, ongoing research in biotechnology is driving the discovery of new therapeutic proteins and peptides, expanding the pipeline of potential oral treatments. The rising prevalence of chronic conditions like diabetes, cancer, and hormonal disorders further increases the demand for effective and patient-friendly therapeutic options.
The oral proteins and peptides market is segmented based on the type of target disease indication, type of molecule, type of biological target, and type of mechanism of action. Based on the type of target disease indication, the market is divided into acromegaly, celiac disease, chronic idiopathic constipation, enteric hyperoxaluria, inflammatory bowel disease, and type II diabetes. Based on the type of molecule, the market is divided into protein and peptide. Based on the type of biological target, the market is divided into GC-C, insulin receptor, oxalate, and others. Based on the type of mechanism of action, the market is divided into receptor stimulation, substrate degradation, and others.
Based on the type of target disease indication, the market is divided into acromegaly, celiac disease, chronic idiopathic constipation, enteric hyperoxaluria, inflammatory bowel disease, and type II diabetes. Among these, the type II diabetes segment is expected to have the highest growth rate during the forecast period. Traditional diabetes treatments, like insulin injections, can be uncomfortable and inconvenient for patients, especially those requiring daily doses.
Oral formulations of proteins and peptides, such as oral insulin, offer a more patient-friendly alternative, significantly improving treatment compliance. Given the chronic nature of Type II Diabetes, the long-term use of medications creates a large and continuous demand for treatment options. Oral protein and peptide therapies for diabetes, especially insulin, cater to this extensive and growing patient population. With a rapidly increasing global prevalence, Type II Diabetes is one of the most common chronic diseases. According to the International Diabetes Federation, hundreds of millions of people are affected worldwide, driving the demand for effective and manageable treatments.
Based on the type of molecule, the market is divided into protein and peptide. Among these, the peptides segment dominates the market. Peptides are smaller than proteins, making them easier to formulate for oral delivery. Their smaller size allows them to more readily navigate the challenges of the gastrointestinal (GI) tract, such as enzyme degradation and absorption barriers. Peptide-based therapies tend to have shorter development timelines compared to protein-based drugs due to their simpler structure. This leads to faster regulatory approval and market entry.
Peptides have diverse biological activities and can be used to treat a variety of diseases, including metabolic disorders (like Type II Diabetes), gastrointestinal issues, and cancer. Their versatility and effectiveness make them attractive candidates for oral formulations. Compared to proteins, peptides generally have better stability in the GI tract and can be engineered to enhance bioavailability. New technologies, such as peptide modification and protective delivery systems, help improve their effectiveness in oral delivery.
The region’s well-established healthcare system and access to cutting-edge medical technologies support the development and adoption of novel therapeutic products, including oral proteins and peptides. This infrastructure also facilitates clinical trials and regulatory approvals, accelerating the market's growth. The U.S. Food and Drug Administration (FDA) provides clear regulatory pathways and programs, such as Fast Track and Breakthrough Therapy Designations, that encourage the development of innovative treatments, including oral proteins and peptides. These regulatory initiatives speed up the approval process, which positively impacts market growth. The aging population in North America is more prone to chronic diseases, increasing the need for convenient and effective treatments. Oral protein and peptide therapies, which offer non-invasive alternatives to injections, are well-suited to this demographic, further driving market growth.
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Report Attribute |
Specifications |
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Market Size Value In 2023 |
USD 6.51 Bn |
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Revenue Forecast In 2031 |
USD 28.17 Bn |
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Growth Rate CAGR |
CAGR of 20.3% from 2024 to 2031 |
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Quantitative Units |
Representation of revenue in US$ Bn and CAGR from 2024 to 2031 |
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Historic Year |
2019 to 2023 |
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Forecast Year |
2024-2031 |
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Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
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Segments Covered |
Type of Target Disease Indication, Type of Molecule, Type of Biological Target, and Type of Mechanism of Action |
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Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
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Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; South Korea; South East Asia |
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Competitive Landscape |
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 |
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Customization Scope |
Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape. |
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Pricing and Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
Chapter 2. Executive Summary
Chapter 3. Global Oral Proteins and Peptides Market Snapshot
Chapter 4. Global Oral Proteins and Peptides Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Porter's Five Forces Analysis
4.7. Incremental Opportunity Analysis (US$ MN), 2024-2031
4.8. Global Oral Proteins and Peptides Market Penetration & Growth Prospect Mapping (US$ Mn), 2023-2031
4.9. Competitive Landscape & Market Share Analysis, By Key Player (2023)
4.10. Use/impact of AI on Oral Proteins and Peptides Industry Trends
Chapter 5. Oral Proteins and Peptides Market Segmentation 1: By Type of Target Disease Indication, Estimates & Trend Analysis
5.1. Market Share by Type of Target Disease Indication, 2023 & 2031
5.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2019 to 2031 for the following Type of Target Disease Indication:
5.2.1. Acromegaly
5.2.2. Celiac Disease
5.2.3. Chronic Idiopathic Constipation
5.2.4. Enteric Hyperoxaluria
5.2.5. Inflammatory Bowel Disease
5.2.6. Type II Diabetes
Chapter 6. Oral Proteins and Peptides Market Segmentation 2: By Type of Molecule, Estimates & Trend Analysis
6.1. Market Share by Type of Molecule, 2023 & 2031
6.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2019 to 2031 for the following Type of Molecules:
6.2.1. Protein
6.2.2. Peptide
Chapter 7. Oral Proteins and Peptides Market Segmentation 3: By Type of Biological Target, Estimates & Trend Analysis
7.1. Market Share by Type of Biological Target, 2023 & 2031
7.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2019 to 2031 for the following Type of Biological Targets:
7.2.1. GC-C
7.2.2. Insulin Receptor
7.2.3. Oxalate
7.2.4. Others
Chapter 8. Oral Proteins and Peptides Market Segmentation 4: By Type of Mechanism of Action, Estimates & Trend Analysis
8.1. Market Share by Type of Mechanism of Action, 2023 & 2031
8.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2019 to 2031 for the following Type of Mechanism of Action:
8.2.1. Receptor Stimulation
8.2.2. Substrate Degradation
8.2.3. Others
Chapter 9. Oral Proteins and Peptides Market Segmentation 5: Regional Estimates & Trend Analysis
9.1. Global Oral Proteins and Peptides Market, Regional Snapshot 2023 & 2031
9.2. North America
9.2.1. North America Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Country, 2024-2031
9.2.1.1. US
9.2.1.2. Canada
9.2.2. North America Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Target Disease Indication, 2024-2031
9.2.3. North America Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Molecule, 2024-2031
9.2.4. North America Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Biological Target, 2024-2031
9.2.5. North America Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Mechanism of Action, 2024-2031
9.3. Europe
9.3.1. Europe Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Country, 2024-2031
9.3.1.1. Germany
9.3.1.2. U.K.
9.3.1.3. France
9.3.1.4. Italy
9.3.1.5. Spain
9.3.1.6. Rest of Europe
9.3.2. Europe Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Target Disease Indication, 2024-2031
9.3.3. Europe Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Molecule, 2024-2031
9.3.4. Europe Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Biological Target, 2024-2031
9.3.5. Europe Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Mechanism of Action, 2024-2031
9.4. Asia Pacific
9.4.1. Asia Pacific Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Country, 2024-2031
9.4.1.1. India
9.4.1.2. China
9.4.1.3. Japan
9.4.1.4. Australia
9.4.1.5. South Korea
9.4.1.6. Hong Kong
9.4.1.7. Southeast Asia
9.4.1.8. Rest of Asia Pacific
9.4.2. Asia Pacific Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Target Disease Indication, 2024-2031
9.4.3. Asia Pacific Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Molecule, 2024-2031
9.4.4. Asia Pacific Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts By Type of Biological Target, 2024-2031
9.4.5. Asia Pacific Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Mechanism of Action, 2024-2031
9.5. Latin America
9.5.1. Latin America Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Country, 2024-2031
9.5.1.1. Brazil
9.5.1.2. Mexico
9.5.1.3. Rest of Latin America
9.5.2. Latin America Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Target Disease Indication, 2024-2031
9.5.3. Latin America Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Molecule, 2024-2031
9.5.4. Latin America Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Biological Target, 2024-2031
9.5.5. Latin America Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Mechanism of Action, 2024-2031
9.6. Middle East & Africa
9.6.1. Middle East & Africa Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by country, 2024-2031
9.6.1.1. GCC Countries
9.6.1.2. Israel
9.6.1.3. South Africa
9.6.1.4. Rest of Middle East and Africa
9.6.2. Middle East & Africa Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Target Disease Indication, 2024-2031
9.6.3. Middle East & Africa Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Molecule, 2024-2031
9.6.4. Middle East & Africa Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Biological Target, 2024-2031
9.6.5. Middle East & Africa Oral Proteins and Peptides Market Revenue (US$ Million) Estimates and Forecasts by Type of Mechanism of Action, 2024-2031
Chapter 10. Competitive Landscape
10.1. Major Mergers and Acquisitions/Strategic Alliances
10.2. Company Profiles
10.2.1. . AstraZeneca
10.2.1.1. Business Overview
10.2.1.2. Key Product/Service Offerings
10.2.1.3. Financial PerType of Target Disease Indicationance
10.2.1.4. Geographical Presence
10.2.1.5. Recent Developments with Business Strategy
10.2.2. Biocon Chiasma
10.2.3. Generex Biotechnology
10.2.4. Novo Nordisk A/S
10.2.5. Allergan
10.2.6. Oramed Pharmaceuticals
10.2.7. Proxima Concepts
10.2.8. Synergy Pharmaceuticals
10.2.9. Tarsa Therapeutics
10.2.10. Sanofi
10.2.11. F. Hoffmann-La Roche Ltd
10.2.12. Novo Nordisk A/S
10.2.13. Abbvie Inc.
10.2.14. Pfizer Inc.
10.2.15. Bausch Health Companies Inc.
10.2.16. Chiesi Farmaceutici S.P.A.
10.2.17. Acadia Pharmaceuticals Inc.
10.2.18. Aurinia Pharmaceuticals Inc.
10.2.19. Merck & Co., Inc.
10.2.20. Johnson & Johnson Services, Inc.
10.2.21. Swk Holdings
10.2.22. R-Pharm Jsc
10.2.23. Entera Bio Ltd.
10.2.24. Proxima Concepts
10.2.25. AstraZeneca Plc
10.2.26. Regor Therapeutics Group
10.2.27. Terns Pharmaceuticals, Inc.
10.2.28. Structure Therapeutics
10.2.29. Viking Therapeutics
10.2.30. Protagonist Therapeutics Inc.
10.2.31. Rani Therapeutics
10.2.32. Carmot Therapeutics, Inc.
10.2.33. Zealand Pharma
10.2.34. Sciwind Biosciences Co., Ltd.
10.2.35. Jiangsu Hengrui Pharmaceuticals Co., Ltd
10.2.36. Corning Incorporated
10.2.37. Other Market Players
Global Oral Proteins and Peptides Market- Type of Target Disease Indication
Global Oral Proteins and Peptides Market – Type of Molecule
Global Oral Proteins and Peptides Market – Type of Biological Target
Global Oral Proteins and Peptides Market – Type of Mechanism of Action
Global Oral Proteins and Peptides Market – By Region
North America-
Europe-
Asia-Pacific-
Latin America-
Middle East & Africa-
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
