Insights on the Oral Proteins and Peptides Global Market to 2032 - Key Drivers and Challenges

DUBLIN, March 21, 2022 /PRNewswire/ -- The "Oral Proteins and Peptides Market by Target Disease Indication, Type of Molecule, Technology Platforms, Biological Target, Mechanism of Action, Key Players, and Key Geographical Regions, 2022-2032" report has been added to ResearchAndMarkets.com's offering.

This report provides an extensive study on the current market landscape of orally administrable protein / peptide-based therapeutics, along with the future market potential. In addition, it provides an in-depth analysis, highlighting the market landscape of technology providers engaged in this domain. 

Since the approval of the first protein / peptide-based therapy (recombinant human insulin) in 1982, there has been a substantial increase in the R&D initiatives focused on such products. Earlier, majority of the biologics were administered subcutaneously. However, with the technological advancements in delivery formulations, oral delivery of therapeutic interventions has gained significant traction, prompting stakeholders to leverage their expertise in the development of orally administrable proteins / peptides.

Interestingly, in the last decade, three orally administered protein / peptide-based therapies have been approved, namely Mycapssa (2020), Trulance (2017) and Linzess (2012) across different geographies. The rising popularity of this upcoming class of therapeutics has led to the reformulation / development of oral protein / peptide-based product candidates for the treatment of a myriad of disease indications across multiple therapeutic areas (including but not limited to metabolic disorders, gastrointestinal disorders, autoimmune disorders). It is worth mentioning that oral administration is a favorable route for delivery of drugs to pediatric and geriatric patients, primarily due to its non-invasive nature. In addition, the ease of administration associated with the oral delivery method has been demonstrated increase treatment adherence to as well as reduce the risk of non-compliance.

Protein / peptide-based therapeutics have revolutionized the pharmaceutical landscape, this can be attributed to the wide applications and target specific nature of such interventions. However, oral formulations of protein / peptide-based drugs have been associated with several drawbacks, including poor bioavailability and drug decomposition in the gastrointestinal tract. In order to mitigate the aforementioned challenges, players engaged in this domain have conducted extensive research for the development of novel biological targets, thereby, strengthening their research pipelines.

In addition, this segment of the industry has also attracted the attention of both private and public sector investors / investment funds, which have extended financial support to the initiatives of developers. It is also worth mentioning that, over the last few years, the market has witnessed an active participation of big pharma players and substantial partnership activity. Given the ongoing research and development initiatives and an encouraging response to the already marketed drugs, the oral protein / peptide therapies market is poised to witness significant growth over the coming decade.

Amongst other elements, the report features:

• A detailed assessment of the current market landscape of oral proteins / peptides, providing information on the developer, type of molecule (protein or peptide), phase of development (commercial, clinical, preclinical or discovery stage), target therapeutic area(s), biological target, mechanism of action, number of amino acids and affiliated technology platform. In addition, the chapter includes information on drug developer(s), highlighting their year of establishment, company size, and location of headquarters.
• A detailed competitiveness analysis of oral protein / peptide therapy developers based on several relevant parameters, such as supplier power (in terms of years of experience and employee count), pipeline strength and phase of development.
• An in-depth analysis of the product pipeline and developer companies, featuring three schematic representations; these include [A] a four dimensional grid analysis, representing the distribution of oral proteins / peptides (on the basis of the type of molecule) across various target therapeutic areas and stages of development, [B] a logo landscape of companies involved in the development of oral protein / peptide-based drugs, distributed on the basis of phase of development of pipeline candidates and size of developer companies (small, mid-sized and large companies), and [C] a schematic world map representation, highlighting the most active geographies, in terms of the presence of various industry players engaged in the development of oral proteins / peptides.
• A detailed analysis identifying the key opinion leaders (KOLs), featuring a 2X2 analysis to assess the relative experience of certain KOLs, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) in this field.
• An overview of the current market landscape of technology platforms available for the development of oral protein / peptide therapeutics, along with information on their developer, type of platform, compatible API types, target therapeutic area, dosage form and status of development of products. In addition, the chapter includes information on technology developer(s), highlighting their year of their establishment, company size and location of headquarters.
• A 2X2 matrix, comparing product competitiveness and supplier power of the technology platforms that are presently being used for the development of oral proteins / peptides. The analysis takes into consideration several parameters, such as year of establishment, company size and development activity (number of drugs in both preclinical / clinical stages of development).
• An analysis of the investments made at various stages of development, such as seed financing, venture capital financing, debt financing, grants / awards, capital raised from IPOs and subsequent offerings, by companies that are engaged in this field.
• An analysis of the partnerships that have been established in the domain, over the last five years, covering licensing agreements, acquisitions, R&D agreements, product commercialization agreements, clinical trial agreements and other relevant deals.
• A detailed review of more than 300 peer-reviewed, scientific articles related to research on oral protein / peptides, which have been published since 2017.
• A detailed analysis of completed, ongoing and planned clinical studies, based on several relevant parameters, such as trial registration year, enrolled patient population, trial status, trial phase, type of sponsor / collaborator, patient segment, target therapeutic area, study design, most active players (industry and non-industry) and regional distribution of trials.
• An in-depth analysis of the patents related to oral protein / peptides, filed / granted since 2017, based on several relevant parameters, such as publication year, geographical location / patent jurisdiction, legal status, CPC symbols, emerging focus areas, type of applicant and leading players (by number of patents). In addition, it features a patent valuation analysis which evaluates the qualitative and quantitative aspects of the patents.
• An analysis of big pharma players engaged in this domain, featuring a spider-web analysis based on several relevant parameters, such as number of pipeline candidates, partnership agreements and publications.
• A detailed case study on protein / peptide contract manufacturing, featuring a list of over 140 CMOs that are currently offering contract manufacturing services for such products / product candidates.
• An elaborate discussion on the various commercialization and lifecycle management strategies that have been adopted by drug developers engaged in this domain across different stages of therapy development, including prior to drug launch, at / during drug launch and post-marketing stage.
• A discussion on affiliated trends, key drivers and challenges, under a SWOT framework. The analysis features a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall oral proteins / peptides market.

Key Questions Answered

• Who are the key players involved in the development of oral protein / peptide therapeutics?
• Which technologies are leveraged the most by oral protein / peptide therapy developers?
• Who are the key opinion leaders in this domain?
• Which geographies are the most active in conducting clinical trials focused on oral protein / peptide therapeutics?
• Which companies have received the maximum funding for the development for oral protein / peptide therapeutics? Who are the most prominent investors?
• Which partnership models are commonly adopted by industry stakeholders in the development of oral protein / peptide therapeutics?
• Which organizations have filed the maximum number of patents in this field?
• How is the current and future market opportunity likely to be distributed across key market segments?

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION

4. MARKET OVERVIEW

5. COMPANY COMPETITIVENESS ANALYSIS

6. KEY INSIGHTS

7. KOL ANALYSIS

8. KEY THERAPEUTIC AREAS

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)
9.4. TBRIAT / Oral Calcitonin (Tarsa Therapeutics / Enteris BioPharma)
9.5. Mycapssa / (Chiasma Pharma)
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)
10.4. Sollpura / Liprotamase (Anthera Pharmaceuticals)

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. AxcessT 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. EligenT Technology (Emisphere Technologies)
13.3.3. Entera Technology (Entera Bio)
13.3.4. NTRA Oral Delivery Technology (Nutrinia)
13.3.5. Peptelligence Technology (Enteris BioPharma)
13.3.6. Protein Oral Delivery (PODT) Technology (Oramed Pharmaceuticals)
13.3.7. Transient Permeability Enhancer (TPE) Technology (Chiasma Pharma)
13.3.8. Uroguanylin Analogue Technology (Synergy Pharmaceuticals)

14. FUNDING AND INVESTMENT ANALYSIS

15. RECENT COLLABORATIONS

16. PUBLICATION ANALYSIS

17. CLINICAL TRIAL ANALYSIS

18. PATENT ANALYSIS

19. BIG PHARMA ANALYSIS

20. MARKET FORECAST AND OPPORTUNITY ANALYSIS

21. CASE STUDY: PROTEIN / PEPTIDE MANUFACTURING

22. KEY COMMERCIALIZATION / LIFECYCLE MANAGEMENT STRATEGIES

23. SWOT ANALYSIS

24. CONCLUSION

25. EXECUTIVE INSIGHTS

26. APPENDIX 1: RECENT DEVELOPMENTS

27. APPENDIX 2: TABULATED DATA

28. APPENDIX 3: LIST OF COMPANIES

For more information about this report visit https://www.researchandmarkets.com/r/vtq1mr

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