Table of Content

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines

2. EXECUTIVE SUMMARY
2.1. Chapter Overview

3. INTRODUCTION
3.1. Chapter Overview
3.2. Comparison of Biologics and Small Molecules
3.3. Introduction to Proteins
3.3.1. Protein Structure
3.3.2. Classification of Proteins
3.4. Introduction to Peptides
3.4.1. Peptide Structure
3.4.2. Classification of Peptides
3.4.2.1. Synthetic Peptides
3.4.2.2. Recombinant Peptides
3.5. Routes of Administration for Proteins / Peptides
3.5.1. Parenteral Administration
3.5.1.1. Intramuscular Route
3.5.1.2. Intravenous Route
3.5.1.3. Subcutaneous Route
3.5.2. Non-Parenteral Administration
3.5.2.1. Buccal / Sublingual Route
3.5.2.2. Intranasal Route
3.5.2.3. Oral Route
3.5.2.4. Ocular Route
3.5.2.5. Pulmonary Route / Inhalation
3.5.2.6. Rectal Route
3.5.2.7. Transdermal Route
3.5.3. Comparison of Different Routes of Drug Administration
3.6. Oral Delivery of Proteins / Peptides
3.6.1. Key Advantages of Oral Administration
3.6.2. Key Challenges Associated with Oral Administration
3.7. Approaches Used for Structural and Bioavailability Enhancement
3.7.1. Absorption Enhancers
3.7.2. Chemical Modification
3.7.2.1 Pro Drug Approach
3.7.3. Enzyme Inhibitors
3.7.4. Muco-Adhesive Polymeric Systems
3.7.5. Nanoparticular Delivery Systems
3.7.5.1. Liposomes
3.7.5.2. Nanoparticles / Microparticles
3.7.6. PEGylation
3.8. Concluding Remarks

4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. Oral Proteins / Peptide Therapeutics: Market Landscape
4.2.1. Analysis by Type of Molecule
4.2.2. Analysis by Phase of Development
4.2.3. Analysis by Target Therapeutic Area
4.2.4. Analysis by Biological Target
4.2.5. Analysis by Mechanism of Action
4.2.6. Analysis by Phase of Development and Mechanism of Action
4.2.7. Analysis by Number of Amino Acids
4.2.8. Key Drug Development Platforms: Analysis by Number of Products
4.3. Oral Proteins / Peptide Therapeutics: Developer Landscape
4.3.1. Analysis by Year of Establishment
4.3.2. Analysis by Company Size
4.3.3. Analysis by Location of Headquarters
4.3.4. Analysis by Company Size and Location of Headquarters
4.3.5. Most Active Players: Analysis by Number of Pipeline Candidates

5. COMPANY COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2. Key Assumptions and Parameters
5.3. Oral Protein / Peptide Therapy Developers: Competitiveness Analysis

6. KEY INSIGHTS
6.1. Chapter Overview
6.2. Oral Proteins / Peptides Pipeline: Grid Analysis
6.3. Oral Proteins / Peptides Pipeline: Developer Landscape
6.4. Oral Proteins / Peptides Pipeline: Regional Landscape (Industry Players)

7. KOL ANALYSIS
7.1. Chapter Overview
7.2. Oral Protein / Peptide Therapeutics: List of Key Opinion Leaders
7.2.1. Analysis by Type of Current Organization
7.2.2. Analysis by Geography
7.2.2.1. Analysis by Region (Continent-wise)
7.2.2.2. Analysis by Region (Country-wise)
7.2.3. Analysis by Number of Investigators and Current Organization
7.2.4. Analysis by Qualification of KOL
7.2.5. Comparison of KOL Activeness v/s Strength (Scatter Plot)
7.2.6. Comparison of Roots Analysis Score v/s Third Party Score
7.2.7. Prominent Players: Comparison of Roots Analysis Score v/s Third Party Score
7.2.8. Most Active Key Opinion Leaders: Comparison of Professional Network v/s Academic Strength

8. KEY THERAPEUTIC AREAS
8.1. Chapter Overview
8.2. Metabolic Disorders
8.2.1. Diabetes
8.2.1.1. Disease Description
8.2.1.2. Associated Health Risks / Complications
8.2.1.3. Epidemiology
8.2.1.4. Disease Diagnosis
8.2.1.5. Current Treatment Options
8.2.1.5.1. Insulin Therapies
8.2.1.5.2. Non-Insulin Therapies
8.2.1.6. Side Effects of Current Treatment Options
8.2.1.7. Oral Proteins / Peptides for Diabetes
8.2.2. Obesity
8.2.2.1. Disease Description
8.2.2.2. Epidemiology
8.2.2.3. Current Treatment Options
8.2.2.4. Side Effects of Current Treatment Options
8.2.2.5. Oral Proteins / Peptides for Obesity
8.2.3. Non-alcoholic Steatohepatitis (NASH)
8.2.3.1. Disease Description
8.2.3.2. Epidemiology
8.2.3.3. Current Treatment Options
8.2.3.4. Oral Proteins / Peptides for NASH
8.3. Digestive and Gastrointestinal Disorders
8.3.1. Ulcerative Colitis
8.3.1.1. Disease Description
8.3.1.2. Epidemiology
8.3.1.3. Current Treatment Options
8.3.1.4. Side Effects of Current Treatment Options
8.3.1.5. Oral Proteins / Peptides for Ulcerative Colitis
8.3.2. Crohn’s Disease
8.3.2.1. Disease Description
8.3.2.2. Epidemiology
8.3.2.3. Current Treatment Options
8.3.2.4. Side Effects of Current Treatment Options
8.3.2.5. Oral Proteins / Peptides for Crohn’s Disease
8.4. Infectious Diseases
8.4.1. C. difficile Infections (CDIs)
8.4.1.1. Disease Description
8.4.1.2. Epidemiology
8.4.1.3. Disease Diagnosis
8.4.1.4. Current Treatment Options
8.4.1.5. Side Effects of Current Treatment Options
8.4.1.6. Oral Proteins / Peptides for CDIs
8.5. Autoimmune Disorders
8.5.1. Celiac Disease
8.5.1.1. Disease Description
8.5.1.2. Epidemiology
8.5.1.3. Disease Diagnosis
8.5.1.4. Current Treatment Options
8.5.1.5. Oral Proteins / Peptides for Celiac Disease
8.6. Hormonal Disorders
8.6.1. Acromegaly
8.6.1.1. Disease Description
8.6.1.2. Epidemiology
8.6.1.3. Disease Diagnosis
8.6.1.4. Current Treatment Options
8.6.1.5. Side Effects of Current Treatment Options
8.6.1.6. Oral Proteins / Peptides for Acromegaly
8.7. Bone Disorders
8.7.1. Osteoporosis
8.7.1.1. Disease Description
8.7.1.2. Epidemiology
8.7.1.3. Disease Diagnosis
8.7.1.4. Current Treatment Options
8.7.1.5. Side Effects of Current Treatment Options
8.7.1.6. Oral Proteins / Peptides for Osteoporosis

9. MARKETED AND LATE-STAGE DRUG PROFILES
9.1. Chapter Overview
9.2. Linzess? / Constella? / Linaclotide (Ironwood Pharmaceuticals)
9.2.1. Drug Overview
9.2.2. History of Development
9.2.3. Mechanism of Action
9.2.4. Dosage Form, Treatment Regimen and Price
9.2.5. Manufacturing Information
9.2.6. Current Status of Development
9.2.7. Clinical Studies
9.2.8. Key Clinical Trial Results
9.2.9. Historical Sales
9.2.10. Developer Overview
9.3. Trulance? / Plecanatide (Synergy Pharmaceuticals)
9.3.1. Drug Overview
9.3.2. History of Development
9.3.3. Mechanism of Action
9.3.4. Dosage Form, Treatment Regimen and Price
9.3.5. Manufacturing Information
9.3.6. Current Status of Development
9.3.7. Clinical Studies
9.3.8. Key Clinical Trial Results
9.3.9. Historical Sales
9.3.10. Developer Overview
9.4. TBRIA? / Oral Calcitonin (Tarsa Therapeutics / Enteris BioPharma)
9.4.1. Drug Overview
9.4.2. History of Development
9.4.3. Mechanism of Action
9.4.4. Manufacturing Information
9.4.5. Current Status of Development
9.4.6. Clinical Studies
9.4.7. Key Clinical Trial Results
9.4.8. Developer Overview
9.5. Mycapssa? / (Chiasma Pharma)
9.5.1. Drug Overview
9.5.2. History of Development
9.5.3. Mechanism of Action
9.5.4. Manufacturing Information
9.5.5. Current Status of Development
9.5.6. Clinical Studies
9.5.7. Key Clinical Trial Results
9.5.8. Developer Overview
9.6. ALLN-177 (Allena Pharmaceuticals)
9.7. INN-202 (9 Meters Biopharma)
9.8. ORMD-0801 (Oramed Pharmaceuticals)
9.9. IN-105 (Biocon)
9.10. Oral HDV Insulin (Diasome Pharmaceuticals)
10. CASE STUDIES: MINIRIN?, SANDIMMUNE? AND SOLLPURA?
10.1. Chapter Overview
10.2. Minirin? / DDAVP (Ferring Pharmaceuticals)
10.2.1. Drug Overview
10.2.2. History of Development
10.2.3. Chemical Structure and Mechanism of Action
10.2.4. Dosage Form, Treatment Regimen and Price
10.2.5. Patent Portfolio
10.2.6. Competitive Landscape
10.3. Sandimmune? / Neoral? (Novartis)
10.3.1. Drug Overview
10.3.2. History of Development
10.3.3. Mechanism of Action
10.3.4. Dosage Form, Treatment Regimen and Price
10.3.5. Patent Portfolio
10.3.6. Competitive Landscape
10.4. Sollpura? / Liprotamase (Anthera Pharmaceuticals)
10.4.1. Drug Overview
10.4.2. History of Development
10.4.3. Chemical Structure and Mechanism of Action
10.4.4. Current Status of Development
10.4.5. Clinical Studies
10.4.6. Competitive Landscape
11. ORAL PROTEIN / PEPTIDE DEVELOPMENT TECHNOLOGIES: MARKET LANDSCAPE
11.1. Chapter Overview
11.2. Oral Protein / Peptide Development Technologies: Market Landscape
11.2.1. Analysis by Type of Technology
11.2.2. Analysis by Compatible API Types
11.2.3. Analysis by Target Therapeutic Area
11.2.4. Analysis by Dosage Form
11.2.5. Analysis by Status of Development of Products
11.3. Oral Protein / Peptide Development Technologies: Developer Landscape
11.3.1 Analysis by Year of Establishment
11.3.2. Analysis by Company Size
11.3.3 Analysis by Location of Headquarters
11.3.4. Analysis by Company Size and Location of Headquarters

12. PRODUCT COMPETITIVENESS ANALYSIS
12.1. Chapter Overview
12.2. Scope and Methodology
12.3. Product Competitiveness Analysis: Key Technologies

13. ORAL DRUG DELIVERY TECHNOLOGY PLATFORMS
13.1. Chapter Overview
13.2. Oral Drug Delivery: List of Technology Platforms
13.3. Technology Profiles
13.3.1. Axcess? Oral Drug Delivery Technology (Proxima Concepts)
13.3.1.1. Developer Overview
13.3.1.2. Technology Overview
13.3.1.3. Drug Delivery Mechanism
13.3.1.4. Key Advantages
13.3.1.5. Oral Proteins / Peptides Pipeline
13.3.1.6. Collaborations
13.3.2. Eligen? Technology (Emisphere Technologies)
13.3.2.1. Developer Overview
13.3.2.2. Technology Overview
13.3.2.3. Drug Delivery Mechanism
13.3.2.4. Key Advantages
13.3.2.5. Oral Proteins / Peptides Pipeline
13.3.2.6. Collaborations
13.3.3. Entera Technology (Entera Bio)
13.3.3.1. Developer Overview
13.3.3.2. Technology Overview
13.3.3.3. Drug Delivery Mechanism
13.3.3.4. Key Advantages
13.3.3.5. Oral Proteins / Peptides Pipeline
13.3.4. NTRA Oral Delivery Technology (Nutrinia)
13.3.4.1. Developer Overview
13.3.4.2. Technology Overview
13.3.4.3. Drug Delivery Mechanism
13.3.4.4. Key Advantages
13.3.4.5. Oral Proteins / Peptides Pipeline
13.3.5. Peptelligence? Technology (Enteris BioPharma)
13.3.5.1. Developer Overview
13.3.5.2. Technology Overview
13.3.5.3. Drug Delivery Mechanism
13.3.5.4. Key Advantages
13.3.5.5. Oral Proteins / Peptides Pipeline
13.3.5.6. Collaborations
13.3.6. Protein Oral Delivery (POD?) Technology (Oramed Pharmaceuticals)
13.3.6.1. Developer Overview
13.3.6.2. Technology Overview
13.3.6.3. Drug Delivery Mechanism
13.3.6.4. Key Advantages
13.3.6.5. Oral Proteins / Peptides Pipeline
13.3.7. Transient Permeability Enhancer (TPE?) Technology (Chiasma Pharma)
13.3.7.1. Developer Overview
13.3.7.2. Technology Overview
13.3.7.3. Drug Delivery Mechanism
13.3.7.4. Key Advantages
13.3.7.5. Oral Proteins / Peptides Pipeline
13.3.8. Uroguanylin Analogue Technology (Synergy Pharmaceuticals)
13.3.8.1. Developer Overview
13.3.8.2. Technology Overview
13.3.8.3. Drug Delivery Mechanism
13.3.8.4. Key Advantages
13.3.8.5. Oral Proteins / Peptides Pipeline

14. FUNDING AND INVESTMENT ANALYSIS
14.1. Chapter Overview
14.2. Types of Funding
14.3. Oral Proteins / Peptides: Funding and Investment Analysis
14.3.1. Analysis by Cumulative Number of Funding Instances
14.3.2. Analysis by Cumulative Amount Invested
14.3.3. Analysis by Type of Funding
14.3.4. Analysis by Year, Type of Funding and Amount Invested
14.3.5. Analysis by Focus Area
14.3.6. Analysis by Area of Application
14.3.7. Analysis by Target Therapeutic Area
14.3.8. Analysis by Geography
14.3.9. Most Active Players: Analysis by Number of Instances
14.3.10. Most Active Players: Analysis by Amount Invested
14.4. Concluding Remarks

15. RECENT COLLABORATIONS
15.1. Chapter Overview
15.2. Partnership Models
15.3. Oral Proteins / Peptides: Partnerships and Collaborations
15.3.1. Analysis by Year of Partnership
15.3.2. Analysis by Type of Partnership
15.3.3. Analysis by Area of Application
15.3.4. Analysis by Type of Partner
15.3.5. Analysis by Focus Area
15.3.6. Analysis by Target Therapeutic Area
15.3.7. Most Active Players: Analysis by Number of Partnerships
15.3.8. Analysis by Geography
15.3.9. Intercontinental and Intracontinental Agreements

16. PUBLICATION ANALYSIS
16.1. Chapter Overview
16.2. Oral Proteins / Peptides: List of Publications
16.2.1. Analysis by Year of Publication
16.2.2. Analysis by Type of Molecule
16.2.3. Analysis by Target Therapeutic Area
16.2.4. Word Cloud of Study Titles
16.2.5. Most Prominent Journals: Analysis by Number of Publications
16.2.6. Most Prominent Authors: Analysis by Number of Publications

17. CLINICAL TRIAL ANALYSIS
17.1. Chapter Overview
17.2. Scope and Methodology
17.3. Oral Protein / Peptide Therapeutics: Clinical Trial Analysis
17.3.1. Analysis by Trial Registration Year
17.3.2. Analysis by Trial Registration Year and Enrolled Patient Population
17.3.3. Analysis by Trial Status
17.3.4. Analysis by Trial Phase
17.3.5. Analysis by Trial Registration Year and Trial Status
17.3.6. Analysis by Enrolled Patient Population and Trial Phase
17.3.7. Analysis by Type of Sponsor / Collaborator
17.3.8. Analysis by Patient Segment
17.3.9. Analysis by Target Therapeutic Area
17.3.10. Analysis by Study Design
17.3.11. Most Active Players: Analysis by Number of Registered Trials
17.3.12. Analysis by Number of Trials and Geographical Location
17.3.13. Analysis by Number of Trials, Trial Status and Geographical Location
17.3.14. Analysis by Enrolled Patient Population and Trial Status

18. PATENT ANALYSIS
18.1. Chapter Overview
18.2. Scope and Methodology
18.3. Oral Protein / Peptide Therapeutics: Patent Analysis
18.3.1. Analysis by Publication Year
18.3.2. Analysis by Patent Jurisdiction
18.3.3. Analysis by Legal Status
18.3.4. Analysis by CPC Symbols
18.3.5. Emerging Focus Areas
18.3.6. Analysis by Type of Applicant
18.3.7. Leading Players: Analysis by Number of Patents
18.3.8. Key Inventors: Analysis by Number of Patents
18.4. Oral Protein / Peptide Therapeutics: Patent Benchmarking Analysis
18.4.1. Analysis by Patent Characteristics
18.4.2. Analysis by Geography
18.5. Oral Protein / Peptide Therapeutics: Patent Valuation Analysis

19. BIG PHARMA ANALYSIS
19.1. Chapter Overview
19.2. Key Assumptions and Methodology
19.3. Oral Protein / Peptide Therapeutics: Big Pharma Initiatives
19.3.1. Analysis by Target Therapeutic Area
19.3.2. Analysis by Type of Initiative
19.3.3. Big Pharma Players: Benchmarking Analysis

20. MARKET FORECAST AND OPPORTUNITY ANALYSIS
20.1. Chapter Overview
20.2. Scope and Limitations
20.3. Forecast Methodology
20.4. Global Oral Protein / Peptide Therapy Market, 2022-2032
20.4.1. Oral Protein / Peptide Therapy Market: Distribution by Target Disease Indication
20.4.2. Oral Protein / Peptide Therapy Market: Distribution by Type of Molecule
20.4.3. Oral Protein / Peptide Therapy Market: Distribution by Technology Platform
20.4.4. Oral Protein / Peptide Therapy Market: Distribution by Biological Target
20.4.5. Oral Protein / Peptide Therapy Market: Distribution by Mechanism of Action
20.4.6. Oral Protein / Peptide Therapy Market: Distribution by Key Players
20.4.7. Oral Protein / Peptide Therapy Market: Distribution by Geography
20.5. Oral Proteins / Peptides Market: Product-wise Sales Forecasts
20.5.1. Linzess? / Constella? / Linaclotide (Ironwood Pharmaceuticals)
20.5.1.1. Target Patient Population
20.5.1.2. Sales Forecast
20.5.2. Trulance? / Plecanatide (Synergy Pharmaceuticals)
20.5.2.1. Target Patient Population
20.5.2.2. Sales Forecast
20.5.3. Mycapssa? / Octreolin (Chiasma Pharma)
20.5.3.1. Target Patient Population
20.5.3.2. Sales Forecast
20.5.4. ALLN-177 (Allena Pharmaceuticals)
20.5.4.1. Target Patient Population
20.5.4.2. Sales Forecast
20.5.5. Larazotide INN-202 (Innovate Biopharmaceuticals)
20.5.5.1. Target Patient Population
20.5.5.2. Sales Forecast
20.5.6. Oral HDV Insulin (Diasome Pharmaceuticals)
20.5.6.1. Target Patient Population
20.5.6.2. Sales Forecast
20.5.7. ORMD-0801 (Oramed Pharmaceuticals)
20.5.7.1. Target Patient Population
20.5.7.2. Sales Forecast
20.5.8. IN-105 / Insulin Tregopil (Biocon)
20.5.8.1. Target Patient Population
20.5.8.2. Sales Forecast
21. CASE STUDY: PROTEIN / PEPTIDE MANUFACTURING
21.1. Chapter Overview
21.2. Key Steps Involved in Protein / Peptide Manufacturing
21.3. Challenges Associated with Protein / Peptide Manufacturing
21.4. Current Scenario of Protein / Peptide Manufacturing
21.5. Growing Demand for Contract Manufacturing
21.5.1. Selecting A Suitable CMO Partner
21.5.2. Protein / Peptide CMOs: Market Landscape
21.5.2.1. Analysis by Year of Establishment
21.5.2.2. Analysis by Company Size
21.5.2.3. Analysis by Location of Headquarters
22. KEY COMMERCIALIZATION / LIFECYCLE MANAGEMENT STRATEGIES
22.1. Successful Drug Launch Strategy: ROOTS Framework
22.2. Successful Drug Launch Strategy: Product Differentiation
22.3. Commonly Adopted Commercialization Strategies based on the Development Stage of the Product
22.4. Key Commercialization / Lifecycle Management Strategies Adopted by Companies Focused on Oral Protein / Peptide Therapeutics
22.4.1. Strategies Adopted Before Therapy Approval
22.5. Strategies Adopted During / Post Therapy Approval
22.6. Analysis by Ease of Implementation, Value Addition and Current Adoption (Harvey Ball Framework)
23. SWOT ANALYSIS
23.1. Chapter Overview
23.2. Comparison of SWOT Factors
24. CONCLUSION
24.1 Chapter Overview
25. EXECUTIVE INSIGHTS
25.1. Chapter Overview
25.2. Anthera Pharmaceuticals
25.2.1. Company Snapshot
25.2.2. Interview Transcript: Dinesh Srinivasan, Director
25.3. Carmot Therapeutics
25.3.1. Company Snapshot
25.3.2. Interview Transcript: Stig K Hansen, CEO
25.4. IGY Life Sciences and Technology
25.4.1. Company Snapshot
25.4.2. Interview Transcript: Terry Dyck, President and CEO
25.5. Constant Therapeutics
25.5.1. Company Snapshot
25.5.2. Interview Transcript: Richard Franklin, CEO
26. APPENDIX 1: RECENT DEVELOPMENTS
27. APPENDIX 2: TABULATED DATA
28. APPENDIX 3: LIST OF COMPANIES