Global Oral Proteins & Peptides Market Size, Trend & Opportunity Analysis Report, by Indication (Acromegaly, Celiac Disease, Chronic Idiopathic Constipation, Enteric Hyperoxaluria, Inflammatory Bowel Disease, Type II Diabetes), Type of Molecule (Protein,
Description
Market Definition and Introduction
The global oral proteins & peptides market is estimated to be worth USD 1.63 billion as of 2024, with projections estimating it to reach USD 12.11 billion by 2035, expanding at a memorable CAGR of 20.00% during the forecast period (2025-2035). The oral formulation delivery of biologics has emerged as a revolutionary modern therapeutic option that affects convenience, compliance, and clinical outcomes in the treatment of chronic diseases. In contrast to classical parenteral routes, oral delivery of proteins and peptides will, in the future, set the stage for a truly patient-centric treatment where painful injections are avoided, thereby improving patient adherence and acceptance of therapies, especially in conditions that require long-term management.
Rapid growth of this field is supported by a simultaneous evolution of the scientific disciplines of drug delivery, biotechnology, and gastrointestinal physiology. An oral delivery of protein is being assisted and espoused by proprietary protein delivery platforms and advanced absorption enhancers, together with an enteric coating. Demand is on a steep increase in conditions such as type II diabetes, acromegaly, and inflammatory bowel diseases, all of which have a growing incidence and unmet therapeutic needs. Front-runners in this process are biotech start-ups and big pharmaceutical companies that have committed huge resources to oral biologic pipelines into existence. Thus, an era of minimally invasive treatment modalities is steadily finding its foothold.
Second change is the evolution of next-generation peptides and proteins with pharmacokinetic profiles to become increasingly targeted and patient-friendly, where realisation is driving the process. The project's focus on not only on rational molecule design and development but also on formulation development to overcome the challenges posed by the gastrointestinal environment and enzymatic degradation. Backed by a favourable regulatory outlook and breakthrough designations, the oral proteins and peptides market appears poised at the intersection of innovation, accessibility, and enduring therapeutic sustainability.
Recent Developments in the Industry
In October 2024, Novo Nordisk announced expanded clinical trials for its oral semaglutide formulation aimed at enhancing glycemic control in patients with type II diabetes. The company's strategic investment underscores the growing confidence in orally administered peptides for chronic metabolic conditions.
In August 2024, Oramed Pharmaceuticals secured regulatory fast-track status from the FDA for its Phase III oral insulin candidate, ORMD-0801. This marks a pivotal move toward reshaping the traditional insulin therapy model and lowering dependency on injectable regimens.
In January 2023, Rani Therapeutics unveiled positive Phase II data for RT-102, an oral formulation of parathyroid hormone. Leveraging its robotic RaniPill platform, the company demonstrated significant bioavailability improvements, reigniting momentum for peptide delivery innovation.
Market Dynamics
Increasing burden of lifestyle and autoimmune diseases, a more urgent requirement for alternative treatment formats has arisen.
Type II diabetes, inflammatory bowel disease, and celiac disease are among the diseases affecting millions around the globe, creating fertile ground for oral therapeutics. Given the option, today, patients prefer not to resort to painful injections. The general uptake of orally administered biologics refers to this behaviour change. Biopharma players are adopting a more aggressive investment in gastrointestinal-compatible delivery systems and formulation technologies to respond to this behavioural change.
Incentives provided by regulatory authorities, influx of investments, further accelerate clinical development and expansion of pipelines.
he FDA in America and EMA, regulatory pressure is mounting toward oral biologics along with fast-track designation, orphan status, and breakthrough therapy advancement. This would avert clinical pipelines and possibly draw good amounts of venture financing. Both startups and established companies forge alliances or enter licensing agreements to upscale their research and penetration of the high-demand therapeutic field.
Patient-centricity has brought an entirely new outlook toward formulation strategy and market penetration.
Increased patient-centricity by the industries has stimulated innovations in dosage forms, packaging, and ease of administration. Oral therapy provides further benefit not just with convenience but also with psychological comfort, especially cherished by pediatric and geriatric segments. While healthcare moves toward a decentralised model with self-administration at its core, oral delivery platforms would play a pivotal role in attending to the global reach of therapeutics.
Strategic partnerships and licensing agreements are driving competitive market expansion.
Strategic partnerships with biopharmaceutical companies have catalysed innovation but have also shared the perceived commercial risk. Licensing deals that target proprietary delivery technologies and co-development pathways are becoming widespread, enabling promising oral therapeutics to access wider marketing geography and faster commercialisation times.
Attractive Opportunities in the Market
Oral Insulin Revolution – Rising demand for needle-free diabetes treatment fuels innovation in oral insulin delivery.
Gastrointestinal Peptide Stability Technologies – Encapsulation, enteric coatings, and pH-responsive systems drive bioavailability enhancements.
Pipeline Expansion in Inflammatory Diseases – Oral delivery targeting IBD, celiac, and Crohn’s disease opens new therapeutic avenues.
Strategic Licensing Agreements – Collaborations for oral peptide formulations with delivery technology developers accelerate market entry.
Regulatory Fast-Track Pathways – Supportive FDA and EMA frameworks incentivise accelerated clinical development and approvals.
Smart Capsules and Robotic Pills – Advanced delivery mechanisms using microneedles and autonomous capsules redefine oral delivery science.
Rise of Speciality Biotech Startups – Emerging players with proprietary delivery IPs dominate early-stage innovation and partnering models.
Oral GLP-1 & PTH Therapies – Metabolic and endocrine-focused oral biologics witness clinical and commercial breakthroughs.
Report Segmentation
By Indication: Acromegaly, Celiac Disease, Chronic Idiopathic Constipation, Enteric Hyperoxaluria, Inflammatory Bowel Disease, Type II Diabetes
By Type of Molecule: Protein, Peptide
By Region: North America (U.S., Canada, Mexico), Europe (UK, Germany, France, Spain, Italy, Spain, Rest of Europe), Asia-Pacific (China, India, Japan, Australia, South Korea, Rest of Asia-Pacific), LAMEA (Brazil, Argentina, UAE, Saudi Arabia (KSA), Africa Rest of Latin America)
Key Market Players
Novo Nordisk A/S, Oramed Pharmaceuticals Inc., Chiasma, Inc. (an Amryt Pharma Company), Entera Bio Ltd., Eli Lilly and Company, Biocon Limited, Pfizer Inc., Rani Therapeutics, Protagonist Therapeutics, Amgen Inc.
Report Aspects
Base Year: 2024
Historic Years: 2022, 2023, 2024
Forecast Period: 2025-2035
Report Pages: 293
Dominating Segments
Peptides segment currently dominates the global oral proteins and peptides landscape due to their relatively smaller molecular size for improved absorption.
The accelerated adoption of this segment has been especially witnessed in type 2 diabetes and metabolic diseases, with an oral GLP-1 analogue leading the way. Technological advancements further complement the improvements with the development of mucoadhesive tablets and protective carriers that enhance peptide stability against enzymatic degradation, hence safeguarding therapeutic efficacy and fostering wide commercial uptake.
Type II Diabetes Emerges as the Largest Indication Due to High Disease Burden and Patient Preference for Oral Medications
Among indications, type II diabetes accounts for the greatest share of the market due to the rising demand for non-invasive, patient-friendly treatment regimens. With over 500 million people suffering from diabetes across the globe, the burden that daily injections pose on both the healthcare profession and the patients is shifting the focus toward oral therapies, with semaglutide and oral insulin being front-runners. Competitive intensity in this domain is spawning innovations in the design of the molecules and the absorption technologies to foster glycemic control and patient adherence.
Rising Market Interest for Inflammatory Bowel Disease Due to Targeted Gut-Localised Delivery Requirements
IBD—ulcerative colitis and Crohn's disease—represents a high-impact market opportunity for oral biologics due to their localised disease pathology. New oral peptides that can survive intestinal transit and selectively target inflamed tissues are under clinical investigation. The increase in the incidence of disease globally, especially in developed countries, is making IBD a top priority for pharmaceutical companies in their oral biologic pipelines.
Key Takeaways
Oral Biologics Gain Ground – Rising demand for injectable-free delivery of peptides and proteins fuels R&D.
Peptides Dominate – Enhanced stability, formulation ease, and wide therapeutic applications drive peptide leadership.
Type II Diabetes at the Forefront – Patient preference for oral solutions reshapes diabetes care paradigms.
Bioavailability Solutions Expand – Protease inhibitors, coatings, and smart capsules improve GI survivability.
Technology-Driven Alliances – Pharma-biotech collaborations catalyse innovation and commercial readiness.
Fast-Tracked Approvals – Regulatory incentives speed up development for critical and orphan indications.
Global Demand for Convenience – Oral formats gain favour in paediatrics, geriatrics, and self-care settings.
Asia-Pacific to See Explosive Growth – Regional diabetes burden and manufacturing capacity accelerate adoption.
Smart Pills Shape Future – Robotic and programmable pills revolutionise oral protein/peptide delivery methods.
Chronic Disease Trends Support Market – Ongoing rise in metabolic and autoimmune conditions supports long-term demand.
Regional Insights
North America Leading all Regions in the Global Market for Oral Proteins and Peptides With Strong Pipeline Activity and Patient-Centric Innovations
North America has the lion's share of the oral proteins and peptides market, where the United States is at the heart of innovation, clinical trials, and regulatory progression. Companies keen on developing oral routes of administration include Oramed and Rani Therapeutics, where the two have developed oral insulins, while Amgen has established its research on oral parathyroid hormones and other peptides aimed at chronic disease burdens. The FDA also facilitates a quicker track for regulatory approval, which makes North America a conducive area for market development.
Europe Locally Engaged in a Strong Market Interface Driven by Innovation on the Delivery Platforms and by Autoimmune Claims
Europe Locally Engaged in a Strong Market Interface Driven by Innovation on the Delivery Platforms and by Autoimmune Claims. Germany, the UK, and Switzerland are strong contributors to investment and partnerships in this market, as well as significant contributors to the efforts of many European nations. The region is already showing a lot of interest in targeting celiac disease and inflammatory bowel disorders through oral peptide technologies. The progressive regulations on biologics by the EMA advanced cross-border growth and technology exchange across the region.
Asia-Pacific to Rapidly Advance Due to the Heavy Disease Burden and Excellent R&D Environment
The fastest growth in the Asia-Pacific region is expected over the entire forecast period and is supported by a high prevalence of diabetes and improving biotechnological infrastructures in India, China, and South Korea. All government healthcare initiatives, in addition to increased investment in devices for drug delivery, make the region a competitive environment for both innovation and mass-scale production.
LATAM and MEA markets register steady growth due to improved access to healthcare and modernisation.
These regions, while still in their infancy, have started integrating oral protein and peptide therapies into their chronic disease management protocols. Investment in increased healthcare awareness and development of medical infrastructure in these regions means that they are still relatively virgin markets yet to capitalise on the potential expansion opportunities in performance, particularly as there is a considerable cost and logistics issue limiting the uptake of these injectable biologics.
Core Strategic Questions Answered in This Report
Q. What is the expected growth trajectory of the oral proteins & peptides market from 2024 to 2035?
The global oral proteins and peptides market is expected to grow from USD 1.63 billion in 2024 to USD 12.11 billion by 2035, recording a robust CAGR of 20.00%. This growth is fuelled by the rising need for patient-centric biologics, especially in chronic conditions like diabetes and inflammatory diseases, and the advancement of oral delivery platforms that improve bioavailability.
Q. Which key factors are fuelling the growth of the oral proteins & peptides market?
Rising demand for non-invasive therapies for chronic illnesses such as type II diabetes and IBD.
Breakthrough innovations in oral delivery systems, including smart capsules and mucoadhesive technologies.
Increased funding and fast-track approvals supporting pipeline acceleration.
Improved patient compliance and reduced healthcare costs associated with oral formats.
Expansion of pharmaceutical partnerships to advance oral biologic formulations.
Q. What are the primary challenges hindering the growth of the oral proteins & peptides market?
Low bioavailability and stability of proteins and peptides in the gastrointestinal tract.
High costs and complexities in formulating and scaling oral biologics.
Regulatory scrutiny on novel delivery mechanisms requires comprehensive validation.
Limited awareness among healthcare providers in developing markets.
Technical challenges in delivering large molecules through oral routes.
Q. Which regions currently lead the oral proteins & peptides market in terms of market share?
North America leads the global market, driven by strong R&D pipelines, regulatory support, and the presence of major biopharma players. Europe follows with its innovation-focused biotechnological ecosystem and emphasis on autoimmune disorders and metabolic diseases.
Q. What emerging opportunities are anticipated in the oral proteins & peptides market?
Development of oral insulin, PTH, and GLP-1 analogues for chronic disease treatment.
Smart pill technology enabling targeted, programmable drug release.
Collaborative partnerships to bring novel oral delivery technologies to market.
Rapid expansion in Asia-Pacific driven by healthcare modernisation.
Favourable regulatory designations fostering accelerated clinical development.
Key Benefits for Stakeholders
The report offers a quantitative assessment of market segments, emerging trends, projections, and market dynamics for the period 2024 to 2035.
The report presents comprehensive market research, including insights into key growth drivers, challenges, and potential opportunities.
Porter's Five Forces analysis evaluates the influence of buyers and suppliers, helping stakeholders make strategic, profit-driven decisions and strengthen their supplier-buyer relationships.
A detailed examination of market segmentation helps identify existing and emerging opportunities.
Key countries within each region are analysed based on their revenue contributions to the overall market.
The positioning of market players enables effective benchmarking and provides clarity on their current standing within the industry.
The report covers regional and global market trends, major players, key segments, application areas, and strategies for market expansion.
The global oral proteins & peptides market is estimated to be worth USD 1.63 billion as of 2024, with projections estimating it to reach USD 12.11 billion by 2035, expanding at a memorable CAGR of 20.00% during the forecast period (2025-2035). The oral formulation delivery of biologics has emerged as a revolutionary modern therapeutic option that affects convenience, compliance, and clinical outcomes in the treatment of chronic diseases. In contrast to classical parenteral routes, oral delivery of proteins and peptides will, in the future, set the stage for a truly patient-centric treatment where painful injections are avoided, thereby improving patient adherence and acceptance of therapies, especially in conditions that require long-term management.
Rapid growth of this field is supported by a simultaneous evolution of the scientific disciplines of drug delivery, biotechnology, and gastrointestinal physiology. An oral delivery of protein is being assisted and espoused by proprietary protein delivery platforms and advanced absorption enhancers, together with an enteric coating. Demand is on a steep increase in conditions such as type II diabetes, acromegaly, and inflammatory bowel diseases, all of which have a growing incidence and unmet therapeutic needs. Front-runners in this process are biotech start-ups and big pharmaceutical companies that have committed huge resources to oral biologic pipelines into existence. Thus, an era of minimally invasive treatment modalities is steadily finding its foothold.
Second change is the evolution of next-generation peptides and proteins with pharmacokinetic profiles to become increasingly targeted and patient-friendly, where realisation is driving the process. The project's focus on not only on rational molecule design and development but also on formulation development to overcome the challenges posed by the gastrointestinal environment and enzymatic degradation. Backed by a favourable regulatory outlook and breakthrough designations, the oral proteins and peptides market appears poised at the intersection of innovation, accessibility, and enduring therapeutic sustainability.
Recent Developments in the Industry
In October 2024, Novo Nordisk announced expanded clinical trials for its oral semaglutide formulation aimed at enhancing glycemic control in patients with type II diabetes. The company's strategic investment underscores the growing confidence in orally administered peptides for chronic metabolic conditions.
In August 2024, Oramed Pharmaceuticals secured regulatory fast-track status from the FDA for its Phase III oral insulin candidate, ORMD-0801. This marks a pivotal move toward reshaping the traditional insulin therapy model and lowering dependency on injectable regimens.
In January 2023, Rani Therapeutics unveiled positive Phase II data for RT-102, an oral formulation of parathyroid hormone. Leveraging its robotic RaniPill platform, the company demonstrated significant bioavailability improvements, reigniting momentum for peptide delivery innovation.
Market Dynamics
Increasing burden of lifestyle and autoimmune diseases, a more urgent requirement for alternative treatment formats has arisen.
Type II diabetes, inflammatory bowel disease, and celiac disease are among the diseases affecting millions around the globe, creating fertile ground for oral therapeutics. Given the option, today, patients prefer not to resort to painful injections. The general uptake of orally administered biologics refers to this behaviour change. Biopharma players are adopting a more aggressive investment in gastrointestinal-compatible delivery systems and formulation technologies to respond to this behavioural change.
Incentives provided by regulatory authorities, influx of investments, further accelerate clinical development and expansion of pipelines.
he FDA in America and EMA, regulatory pressure is mounting toward oral biologics along with fast-track designation, orphan status, and breakthrough therapy advancement. This would avert clinical pipelines and possibly draw good amounts of venture financing. Both startups and established companies forge alliances or enter licensing agreements to upscale their research and penetration of the high-demand therapeutic field.
Patient-centricity has brought an entirely new outlook toward formulation strategy and market penetration.
Increased patient-centricity by the industries has stimulated innovations in dosage forms, packaging, and ease of administration. Oral therapy provides further benefit not just with convenience but also with psychological comfort, especially cherished by pediatric and geriatric segments. While healthcare moves toward a decentralised model with self-administration at its core, oral delivery platforms would play a pivotal role in attending to the global reach of therapeutics.
Strategic partnerships and licensing agreements are driving competitive market expansion.
Strategic partnerships with biopharmaceutical companies have catalysed innovation but have also shared the perceived commercial risk. Licensing deals that target proprietary delivery technologies and co-development pathways are becoming widespread, enabling promising oral therapeutics to access wider marketing geography and faster commercialisation times.
Attractive Opportunities in the Market
Oral Insulin Revolution – Rising demand for needle-free diabetes treatment fuels innovation in oral insulin delivery.
Gastrointestinal Peptide Stability Technologies – Encapsulation, enteric coatings, and pH-responsive systems drive bioavailability enhancements.
Pipeline Expansion in Inflammatory Diseases – Oral delivery targeting IBD, celiac, and Crohn’s disease opens new therapeutic avenues.
Strategic Licensing Agreements – Collaborations for oral peptide formulations with delivery technology developers accelerate market entry.
Regulatory Fast-Track Pathways – Supportive FDA and EMA frameworks incentivise accelerated clinical development and approvals.
Smart Capsules and Robotic Pills – Advanced delivery mechanisms using microneedles and autonomous capsules redefine oral delivery science.
Rise of Speciality Biotech Startups – Emerging players with proprietary delivery IPs dominate early-stage innovation and partnering models.
Oral GLP-1 & PTH Therapies – Metabolic and endocrine-focused oral biologics witness clinical and commercial breakthroughs.
Report Segmentation
By Indication: Acromegaly, Celiac Disease, Chronic Idiopathic Constipation, Enteric Hyperoxaluria, Inflammatory Bowel Disease, Type II Diabetes
By Type of Molecule: Protein, Peptide
By Region: North America (U.S., Canada, Mexico), Europe (UK, Germany, France, Spain, Italy, Spain, Rest of Europe), Asia-Pacific (China, India, Japan, Australia, South Korea, Rest of Asia-Pacific), LAMEA (Brazil, Argentina, UAE, Saudi Arabia (KSA), Africa Rest of Latin America)
Key Market Players
Novo Nordisk A/S, Oramed Pharmaceuticals Inc., Chiasma, Inc. (an Amryt Pharma Company), Entera Bio Ltd., Eli Lilly and Company, Biocon Limited, Pfizer Inc., Rani Therapeutics, Protagonist Therapeutics, Amgen Inc.
Report Aspects
Base Year: 2024
Historic Years: 2022, 2023, 2024
Forecast Period: 2025-2035
Report Pages: 293
Dominating Segments
Peptides segment currently dominates the global oral proteins and peptides landscape due to their relatively smaller molecular size for improved absorption.
The accelerated adoption of this segment has been especially witnessed in type 2 diabetes and metabolic diseases, with an oral GLP-1 analogue leading the way. Technological advancements further complement the improvements with the development of mucoadhesive tablets and protective carriers that enhance peptide stability against enzymatic degradation, hence safeguarding therapeutic efficacy and fostering wide commercial uptake.
Type II Diabetes Emerges as the Largest Indication Due to High Disease Burden and Patient Preference for Oral Medications
Among indications, type II diabetes accounts for the greatest share of the market due to the rising demand for non-invasive, patient-friendly treatment regimens. With over 500 million people suffering from diabetes across the globe, the burden that daily injections pose on both the healthcare profession and the patients is shifting the focus toward oral therapies, with semaglutide and oral insulin being front-runners. Competitive intensity in this domain is spawning innovations in the design of the molecules and the absorption technologies to foster glycemic control and patient adherence.
Rising Market Interest for Inflammatory Bowel Disease Due to Targeted Gut-Localised Delivery Requirements
IBD—ulcerative colitis and Crohn's disease—represents a high-impact market opportunity for oral biologics due to their localised disease pathology. New oral peptides that can survive intestinal transit and selectively target inflamed tissues are under clinical investigation. The increase in the incidence of disease globally, especially in developed countries, is making IBD a top priority for pharmaceutical companies in their oral biologic pipelines.
Key Takeaways
Oral Biologics Gain Ground – Rising demand for injectable-free delivery of peptides and proteins fuels R&D.
Peptides Dominate – Enhanced stability, formulation ease, and wide therapeutic applications drive peptide leadership.
Type II Diabetes at the Forefront – Patient preference for oral solutions reshapes diabetes care paradigms.
Bioavailability Solutions Expand – Protease inhibitors, coatings, and smart capsules improve GI survivability.
Technology-Driven Alliances – Pharma-biotech collaborations catalyse innovation and commercial readiness.
Fast-Tracked Approvals – Regulatory incentives speed up development for critical and orphan indications.
Global Demand for Convenience – Oral formats gain favour in paediatrics, geriatrics, and self-care settings.
Asia-Pacific to See Explosive Growth – Regional diabetes burden and manufacturing capacity accelerate adoption.
Smart Pills Shape Future – Robotic and programmable pills revolutionise oral protein/peptide delivery methods.
Chronic Disease Trends Support Market – Ongoing rise in metabolic and autoimmune conditions supports long-term demand.
Regional Insights
North America Leading all Regions in the Global Market for Oral Proteins and Peptides With Strong Pipeline Activity and Patient-Centric Innovations
North America has the lion's share of the oral proteins and peptides market, where the United States is at the heart of innovation, clinical trials, and regulatory progression. Companies keen on developing oral routes of administration include Oramed and Rani Therapeutics, where the two have developed oral insulins, while Amgen has established its research on oral parathyroid hormones and other peptides aimed at chronic disease burdens. The FDA also facilitates a quicker track for regulatory approval, which makes North America a conducive area for market development.
Europe Locally Engaged in a Strong Market Interface Driven by Innovation on the Delivery Platforms and by Autoimmune Claims
Europe Locally Engaged in a Strong Market Interface Driven by Innovation on the Delivery Platforms and by Autoimmune Claims. Germany, the UK, and Switzerland are strong contributors to investment and partnerships in this market, as well as significant contributors to the efforts of many European nations. The region is already showing a lot of interest in targeting celiac disease and inflammatory bowel disorders through oral peptide technologies. The progressive regulations on biologics by the EMA advanced cross-border growth and technology exchange across the region.
Asia-Pacific to Rapidly Advance Due to the Heavy Disease Burden and Excellent R&D Environment
The fastest growth in the Asia-Pacific region is expected over the entire forecast period and is supported by a high prevalence of diabetes and improving biotechnological infrastructures in India, China, and South Korea. All government healthcare initiatives, in addition to increased investment in devices for drug delivery, make the region a competitive environment for both innovation and mass-scale production.
LATAM and MEA markets register steady growth due to improved access to healthcare and modernisation.
These regions, while still in their infancy, have started integrating oral protein and peptide therapies into their chronic disease management protocols. Investment in increased healthcare awareness and development of medical infrastructure in these regions means that they are still relatively virgin markets yet to capitalise on the potential expansion opportunities in performance, particularly as there is a considerable cost and logistics issue limiting the uptake of these injectable biologics.
Core Strategic Questions Answered in This Report
Q. What is the expected growth trajectory of the oral proteins & peptides market from 2024 to 2035?
The global oral proteins and peptides market is expected to grow from USD 1.63 billion in 2024 to USD 12.11 billion by 2035, recording a robust CAGR of 20.00%. This growth is fuelled by the rising need for patient-centric biologics, especially in chronic conditions like diabetes and inflammatory diseases, and the advancement of oral delivery platforms that improve bioavailability.
Q. Which key factors are fuelling the growth of the oral proteins & peptides market?
Rising demand for non-invasive therapies for chronic illnesses such as type II diabetes and IBD.
Breakthrough innovations in oral delivery systems, including smart capsules and mucoadhesive technologies.
Increased funding and fast-track approvals supporting pipeline acceleration.
Improved patient compliance and reduced healthcare costs associated with oral formats.
Expansion of pharmaceutical partnerships to advance oral biologic formulations.
Q. What are the primary challenges hindering the growth of the oral proteins & peptides market?
Low bioavailability and stability of proteins and peptides in the gastrointestinal tract.
High costs and complexities in formulating and scaling oral biologics.
Regulatory scrutiny on novel delivery mechanisms requires comprehensive validation.
Limited awareness among healthcare providers in developing markets.
Technical challenges in delivering large molecules through oral routes.
Q. Which regions currently lead the oral proteins & peptides market in terms of market share?
North America leads the global market, driven by strong R&D pipelines, regulatory support, and the presence of major biopharma players. Europe follows with its innovation-focused biotechnological ecosystem and emphasis on autoimmune disorders and metabolic diseases.
Q. What emerging opportunities are anticipated in the oral proteins & peptides market?
Development of oral insulin, PTH, and GLP-1 analogues for chronic disease treatment.
Smart pill technology enabling targeted, programmable drug release.
Collaborative partnerships to bring novel oral delivery technologies to market.
Rapid expansion in Asia-Pacific driven by healthcare modernisation.
Favourable regulatory designations fostering accelerated clinical development.
Key Benefits for Stakeholders
The report offers a quantitative assessment of market segments, emerging trends, projections, and market dynamics for the period 2024 to 2035.
The report presents comprehensive market research, including insights into key growth drivers, challenges, and potential opportunities.
Porter's Five Forces analysis evaluates the influence of buyers and suppliers, helping stakeholders make strategic, profit-driven decisions and strengthen their supplier-buyer relationships.
A detailed examination of market segmentation helps identify existing and emerging opportunities.
Key countries within each region are analysed based on their revenue contributions to the overall market.
The positioning of market players enables effective benchmarking and provides clarity on their current standing within the industry.
The report covers regional and global market trends, major players, key segments, application areas, and strategies for market expansion.
Table of Contents
285 Pages
- Chapter 1. Market Snapshot
- 1.1. Market Definition & Report Overview
- 1.2. Market Segmentation
- 1.3. Key Takeaways
- 1.3.1. Top Investment Pockets
- 1.3.2. Top Winning Strategies
- 1.3.3. Market Indicators Analysis
- 1.3.4. Top Impacting Factors
- 1.4. Industry Ecosystem Analysis
- 1.4.1. 360’ Analysis
- Chapter 2. Executive Summary
- 2.1. CEO/CXO Standpoint
- 2.2. Strategic Insights
- 2.3. ESG Analysis
- 2.4 Market Attractiveness Analysis (top leader’s point of view on market)
- 2.5.key Findings
- Chapter 3. Research Methodology
- 3.1 Research Objective
- 3.2 Supply Side Analysis
- 3.1.1. Primary Research
- 3.1.2. Secondary Research
- 3.3 Demand Side Analysis
- 3.1.3. Primary Research
- 3.1.4. Secondary Research
- 3.2. Forecasting Models
- 3.2.1. Assumptions
- 3.2.2. Forecasts Parameters
- 3.3. Competitive breakdown
- 3.3.1. Market Positioning
- 3.3.2. Competitive Strength
- 3.4. Scope of the Study
- 3.4.1. Research Assumption
- 3.4.2. Inclusion & Exclusion
- 3.4.3. Limitations
- Chapter 4. Industry Landscape
- 4.1. Market Dynamics
- 4.1.1. Drivers
- 4.1.2. Restraints
- 4.1.3. Opportunities
- 4.2. Porter’s 5 Forces Model
- 4.2.1. Bargaining Power of Buyer
- 4.2.2. Bargaining Power of Supplier
- 4.2.3. Threat of New Entrants
- 4.2.4. Threat of Substitutes
- 4.2.5. Competitive Rivalry
- 4.3. Value Chain Analysis
- 4.4. PESTEL Analysis
- 4.5. Pricing Analysis and Trends
- 4.6. Key growth factors and trends analysis
- 4.7. Market Share Analysis (2025)
- 4.8. Top Winning Strategies (2025)
- 4.9. Trade Data Analysis (Import Export)
- 4.10. Regulatory Guidelines
- 4.11. Historical Data Analysis
- 4.12. Analyst Recommendation & Conclusion
- Chapter 5. Global Oral Proteins & Peptides Market Size & Forecasts by Indication 2025-2035
- 5.1. Market Overview
- 5.1.1. Market Size and Forecast By Indication 2025-2035
- 5.2. Acromegaly
- 5.2.1. Market definition, current market trends, growth factors, and opportunities
- 5.2.2. Market size analysis, by region, 2025-2035
- 5.2.3. Market share analysis, by country, 2025-2035
- 5.3. Celiac Disease
- 5.3.1. Market definition, current market trends, growth factors, and opportunities
- 5.3.2. Market size analysis, by region, 2025-2035
- 5.3.3. Market share analysis, by country, 2025-2035
- 5.4. Chronic Idiopathic Constipation
- 5.4.1. Market definition, current market trends, growth factors, and opportunities
- 5.4.2. Market size analysis, by region, 2025-2035
- 5.4.3. Market share analysis, by country, 2025-2035
- 5.5. Enteric Hyperoxaluria
- 5.5.1. Market definition, current market trends, growth factors, and opportunities
- 5.5.2. Market size analysis, by region, 2025-2035
- 5.5.3. Market share analysis, by country, 2025-2035
- 5.6. Inflammatory Bowel Disease
- 5.6.1. Market definition, current market trends, growth factors, and opportunities
- 5.6.2. Market size analysis, by region, 2025-2035
- 5.6.3. Market share analysis, by country, 2025-2035
- 5.7. Type II Diabetes
- 5.7.1. Market definition, current market trends, growth factors, and opportunities
- 5.7.2. Market size analysis, by region, 2025-2035
- 5.7.3. Market share analysis, by country, 2025-2035
- Chapter 6. Global Oral Proteins & Peptides Market Size & Forecasts by Type of Molecule 2025–2035
- 6.1. Market Overview
- 6.1.1. Market Size and Forecast By Type of Molecule 2025-2035
- 6.2. Protein
- 6.2.1. Market definition, current market trends, growth factors, and opportunities
- 6.2.2. Market size analysis, by region, 2025-2035
- 6.2.3. Market share analysis, by country, 2025-2035
- 6.3. Peptide
- 6.3.1. Market definition, current market trends, growth factors, and opportunities
- 6.3.2. Market size analysis, by region, 2025-2035
- 6.3.3. Market share analysis, by country, 2025-2035
- Chapter 7. Global Oral Proteins & Peptides Market Size & Forecasts by Region 2025–2035
- 7.1. Regional Overview 2025-2035
- 7.2. Top Leading and Emerging Nations
- 7.3. North America Oral Proteins & Peptides Market
- 7.3.1. U.S. Oral Proteins & Peptides Market
- 7.3.1.1. Indication breakdown size & forecasts, 2025-2035
- 7.3.1.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.3.2. Canada Oral Proteins & Peptides Market
- 7.3.2.1. Indication breakdown size & forecasts, 2025-2035
- 7.3.2.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.3.3. Mexico Oral Proteins & Peptides Market
- 7.3.3.1. Indication breakdown size & forecasts, 2025-2035
- 7.3.3.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.4. Europe Oral Proteins & Peptides Market
- 7.4.1. UK Oral Proteins & Peptides Market
- 7.4.1.1. Indication breakdown size & forecasts, 2025-2035
- 7.4.1.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.4.2. Germany Oral Proteins & Peptides Market
- 7.4.2.1. Indication breakdown size & forecasts, 2025-2035
- 7.4.2.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.4.3. France Oral Proteins & Peptides Market
- 7.4.3.1. Indication breakdown size & forecasts, 2025-2035
- 7.4.3.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.4.4. Spain Oral Proteins & Peptides Market
- 7.4.4.1. Indication breakdown size & forecasts, 2025-2035
- 7.4.4.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.4.5. Italy Oral Proteins & Peptides Market
- 7.4.5.1. Indication breakdown size & forecasts, 2025-2035
- 7.4.5.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.4.6. Rest of Europe Oral Proteins & Peptides Market
- 7.4.6.1. Indication breakdown size & forecasts, 2025-2035
- 7.4.6.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.5. Asia Pacific Oral Proteins & Peptides Market
- 7.5.1. China Oral Proteins & Peptides Market
- 7.5.1.1. Indication breakdown size & forecasts, 2025-2035
- 7.5.1.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.5.2. India Oral Proteins & Peptides Market
- 7.5.2.1. Indication breakdown size & forecasts, 2025-2035
- 7.5.2.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.5.3. Japan Oral Proteins & Peptides Market
- 7.5.3.1. Indication breakdown size & forecasts, 2025-2035
- 7.5.3.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.5.4. Australia Oral Proteins & Peptides Market
- 7.5.4.1. Indication breakdown size & forecasts, 2025-2035
- 7.5.4.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.5.5. South Korea Oral Proteins & Peptides Market
- 7.5.5.1. Indication breakdown size & forecasts, 2025-2035
- 7.5.5.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.5.6. Rest of APAC Oral Proteins & Peptides Market
- 7.5.6.1. Indication breakdown size & forecasts, 2025-2035
- 7.5.6.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.6. LAMEA Oral Proteins & Peptides Market
- 7.6.1. Brazil Oral Proteins & Peptides Market
- 7.6.1.1. Indication breakdown size & forecasts, 2025-2035
- 7.6.1.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.6.2. Argentina Oral Proteins & Peptides Market
- 7.6.2.1. Indication breakdown size & forecasts, 2025-2035
- 7.6.2.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.6.3. UAE Oral Proteins & Peptides Market
- 7.6.3.1. Indication breakdown size & forecasts, 2025-2035
- 7.6.3.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.6.4. Saudi Arabia (KSA Oral Proteins & Peptides Market
- 7.6.4.1. Indication breakdown size & forecasts, 2025-2035
- 7.6.4.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.6.5. Africa Oral Proteins & Peptides Market
- 7.6.5.1. Indication breakdown size & forecasts, 2025-2035
- 7.6.5.2. Type of Molecule breakdown size & forecasts, 2025-2035
- 7.6.6. Rest of LAMEA Oral Proteins & Peptides Market
- 7.6.6.1. Indication breakdown size & forecasts, 2025-2035
- 7.6.6.2. Type of Molecule breakdown size & forecasts, 2025-2035
- Chapter 8. Company Profiles
- 8.1. Top Market Strategies
- 8.2. Company Profiles
- 8.2.1. Novo Nordisk A/S
- 8.2.1.1. Company Overview
- 8.2.1.2. Key Executives
- 8.2.1.3. Company Snapshot
- 8.2.1.4. Financial Performance (Subject to Data Availability)
- 8.2.1.5. Product/Services Port
- 8.2.1.6. Recent Development
- 8.2.1.7. Market Strategies
- 8.2.1.8. SWOT Analysis
- 8.2.2. Oramed Pharmaceuticals Inc.
- 8.2.3. Chiasma, Inc. (an Amryt Pharma Company)
- 8.2.4. Entera Bio Ltd.
- 8.2.5. Eli Lilly and Company
- 8.2.6. Biocon Limited
- 8.2.7. Pfizer Inc.
- 8.2.8. Rani Therapeutics
- 8.2.9. Protagonist Therapeutics
- 8.2.10. Amgen Inc.
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