Oral Proteins and Peptides Market (4th Edition) by Target Disease Indication (acromegaly, celiac disease, chronic idiopathic constipation, enteric hyperoxaluria, inflammatory bowel disease and type II diabetes), Type of Molecule (protein and peptide), Tec

Oral Proteins and Peptides Market (4th Edition) by Target Disease Indication (acromegaly, celiac disease, chronic idiopathic constipation, enteric hyperoxaluria, inflammatory bowel disease and type II diabetes), Type of Molecule (protein and peptide), Technology Platforms, Biological Target (GC-C, insulin receptor, oxalate and others), Mechanism of Action (receptor stimulation, substrate degradation and others) Key Players and Key Geographical Regions (North America, Europe, Asia-Pacific and RoW), 2022-2032

INTRODUCTION

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.

SCOPE OF THE REPORT

The ‘Oral Proteins and Peptides Market (4th Edition) by Target Disease Indication (acromegaly, celiac disease, chronic idiopathic constipation, enteric hyperoxaluria, inflammatory bowel disease and type II diabetes), Type of Molecule (protein and peptide), Technology Platforms, Biological Target (GC-C, insulin receptor, oxalate and others), Mechanism of Action (receptor stimulation, substrate degradation and others), Key Players, and Key Geographical Regions (North America, Europe, Asia-Pacific and RoW), 2022-2032’ 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. 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.

One of the key objectives of this study was to understand the primary growth drivers and estimate the future size of the market based on various parameters, such as target consumer segments, likely adoption rates and expected pricing. We have also provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2022-2032. In addition, we have provided the likely distribution of the market based on [A] target disease indication (acromegaly, celiac disease, chronic idiopathic constipation, enteric hyperoxaluria, inflammatory bowel disease and type II diabetes), [B] type of molecule (protein and peptide), [C] technology platforms, [D] biological target (GC-C, insulin receptor, oxalate, others), [E] mechanism of action (receptor stimulation, substrate degradation and others) [F] key players, and [G] key geographical regions (North America, Europe, Asia-Pacific and RoW). In order to account for the uncertainties associated with the growth of the oral proteins / peptides market and to add robustness to our model, we have provided three forecast scenarios, portraying conservative, base and optimistic tracks of the market’s evolution.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The study includes detailed transcripts of discussions held with Dinesh Srinivasan (Director, Anthera Pharmaceuticals), Stig K Hansen (Co-founder and CEO, Carmot Therapeutics), Terry Dyck (CEO, IGY Life Sciences and Technology) and Richard Franklin (CEO, Constant Therapeutics).

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include

Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

While the focus has been on forecasting the market over the coming decade, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

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?

CHAPTER OUTLINES

Chapter 2 is an executive summary of key insights captured in our research. It offers a high-level view on the current state of oral protein / peptide therapeutics market and its likely evolution in the short to mid-term, and long term.

Chapter 3 provides a comparison of the key characteristics of small molecules and large molecules / biologics. In addition, it includes a detailed discussion on proteins / peptides, highlighting their potential as therapeutic agents. Further, it features a discussion on the various routes of administration used for the delivery of drugs, with special focus on oral route. The chapter elaborates on the likely advantages and challenges associated with the oral route of administration. In addition, it includes a comprehensive discussion on the various approaches developed / under development for the effective oral delivery of proteins / peptides.

Chapter 4 includes information on over 125 programs for oral protein / peptide therapeutics that are either approved or being developed across different stages (commercial, clinical, preclinical or discovery stage) for the treatment of various indications. It features a comprehensive analysis of pipeline molecules, based on the 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.

Chapter 5 provides 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.

Chapter 6 presents the key insights derived from the study. It features 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

Chapter 7 provides 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) to this field.

Chapter 8 highlights the potential target indications (segregated by therapeutic areas) that are currently the prime focus of companies developing oral proteins / peptides. These include metabolic disorders, gastrointestinal disorders and autoimmune disorders. The chapter also provides details on disease epidemiology, available diagnostic tests, and currently available treatment options for each indication and their likely side effects.

Chapter 9 contains detailed profiles of drugs that are either marketed or are in late stage (phase II / III and above) of development. Each profile features an overview of the drug, history of development, mechanism of action, dosage information (if available), manufacturing information (if available), current status of development, clinical trial information, key clinical trial results, historical sales (if marketed) and information on the developer.

Chapter 10 provides a review of oral proteins / peptides belonging other drug classes, namely cyclic peptides and PERTs, which are either commercialized or still under development. The chapter features detailed profiles of three popular orally administrable, therapeutic proteins / peptides (Minirin®, Sandimmune® and Sollpura®), which were discovered before 2000. Each profile contains an overview of the drug, history of development, chemical structure and mechanism of action, dosage information (if marketed), clinical trial information (if the product is currently under development), patent portfolio (if available) and information on the other commercially available treatment options for the disease indications for which each drug is approved.

Chapter 11 provides an overview of the market landscape of technology platforms available for the development of oral protein/ peptide therapeutics, including an analysis based on parameters, such as type of platform (drug formulation, drug development), compatible API types (peptide, protein and others), target therapeutics area, dosage form and status of development of products. In addition, the chapter also includes an analysis on the companies developing these platforms, based on year of their establishment, company size, and location of headquarters.

Chapter 12 features a 2X2 matrix, comparing product competitiveness and supplier power of the oral drug delivery technology platforms that are presently being utilized for the generation 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).

Chapter 13 features detailed profiles of some of the key technologies that have been used to develop oral protein / peptide therapeutics. Each profile contains details on the technology, including mechanism of action, pipeline molecules developed using the technology, its advantages and the various partnerships that were established related to the technology.

Chapter 14 presents details on various investments received by companies that are engaged in the development of oral protein / peptide therapeutics and / or associated delivery technologies. It also includes detailed analysis of the funding instances, based on several parameters, such as number of instances, amount invested, type of funding, focus aera, area of application, target therapeutic area, most active players and geographical analysis.

Chapter 15 provides a detailed analysis of the recent collaborations established since 2017. It includes analysis based on relevant parameters, such as year of partnership, type of agreement, focus area, type of partner and regional distribution of partnerships.

Chapter 16 presents a detailed review of more than 300 peer-reviewed, scientific articles related to research on oral protein / peptides, which have been published since 2017, including analysis based on parameters, such as year of publication, key focus area, type of molecule, popular keywords, key journals (in terms of number of articles published in this domain and impact factor of the journal) and affiliations.

Chapter 17 presents 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.

Chapter 18 provides 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.

Chapter 19 presents 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.

Chapter 20 presents an insightful market forecast analysis, highlighting the likely growth of oral protein / peptide therapeutics market, till 2032. In order to provide a detailed future outlook, our projections have been segmented across [A] target disease indication (acromegaly, celiac disease, chronic idiopathic constipation, enteric hyperoxaluria, inflammatory bowel disease and type II diabetes), [B] type of molecule (protein and peptide), [C] technology platforms, [D] biological target (GC-C, insulin receptor, oxalate, others), [E] mechanism of action (receptor stimulation, substrate degradation and others) [F] key players, and [G] key geographical regions (North America, Europe, Asia-Pacific and RoW).

Chapter 21 features a case study on the role of CMOs in the field of oral proteins / peptides. It provides details on the various factors that need to be considered while selecting the right CMO partner for the pharmaceutical companies. In addition, it includes a list of over 140 contract manufacturers that claim to have the necessary capabilities for protein / peptide manufacturing.

Chapter 22 provides 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.

Chapter 23 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of the oral proteins / peptides market, under a comprehensive SWOT framework. The chapter also features a schematic Harvey ball analysis to highlight the relative impact of each SWOT parameter on the overall oral proteins / peptides market.

Chapter 24 summarizes the overall report, wherein we have mentioned all the key facts and figures described in the previous chapters. The chapter also highlights important evolutionary trends that were identified during the course of the study and are expected to influence the future of the oral protein / peptide therapeutics market.

Chapter 25 is a collection of interview transcripts of discussions held with key stakeholders in this market. In this chapter, we have presented the details of our conversations with Dinesh Srinivasan (Director, Anthera Pharmaceuticals), Stig K Hansen (Co-founder and CEO, Carmot Therapeutics), Terry Dyck (CEO, IGY Life Sciences and Technology) and Richard Franklin (CEO, Constant Therapeutics).

Chapter 26 is an appendix, which provides tabulated information on the historical developments.

Chapter 27 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 28 is an appendix, which contains a list of companies and organizations.



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