Oral Proteins and Peptides Market | Industry Analysis | Market Size, 2022-2032

1. Oral Proteins And Peptides Market | Industry Analysis | Market Size, 2022-2032 Driven by the increased adoption and rising unmet need associated with parenteral drugs, industry stakeholders have made significant investments towards the development of orally administered protein and peptide therapeutics. Considering the therapeutic advantages associated with proteins and peptides, this field has witnessed significant activity; researchers are actively evaluating orally bioavailable interventions. Over the years, advances in recombinant DNA technology and ex vivo synthesis of biomolecules have led to the development and (in some cases) approval of several protein / peptide-based therapeutics. However, owing to their inherently complex structure and comparatively low stability (in in vivo conditions), proteins / peptides are predominantly administered parenterally.

2. Recent strides in drug delivery solutions have enabled scientists to successfully explore and exploit alternative routes of drug delivery, such as transdermal, intranasal, pulmonary, and oral, for protein / peptide-based therapeutics. Of these, the oral route of delivery is the most patient- friendly. This has led several companies to invest in the development of orally administered biologics. The delivery of proteins and peptides utilizes the following routes of administration. Although studies have reported that over XX oral drug delivery technologies have been designed so far, our research indicates that only XX% of the technologies are currently being used to develop therapeutic proteins / peptides. Owing to the numerous advantages of oral drug delivery, including ease of administration, minimal pain and risk of drug reaction, and self-administration, we are led to believe that the oral protein / peptide therapeutics market is anticipated to witness significant growth in the coming future. ORAL PROTEIN AND PEPTIDE THERAPIES:MARKET OVERVIEW During our research, we were able to identify over 120 oral protein / peptide therapeutics that are approved or under development, for the treatment of various disease indications. Most of the small and mid-sized companies are presently headquartered in North America. It is also worth mentioning that 50% of the large companies (2) are headquartered in Asia-Pacific and the rest of the world. Further, most of the players engaged in this domain were established between 2000-2005 (XX%). Examples of players established between 2011 and 2021 include (in alphabetical order, with information on year of establishment) 9 Meters Biopharma (2012), Allena Pharmaceuticals (2011), XX and XX.

3. As can be observed in the figure, most of the therapies (XX) are peptide-based. This was followed by protein-based drugs (XX), of which, most of the therapies are antibody-based (XX), followed by enzyme-based therapies (XX). This can be attributed to the fact that over the years, several oral peptide therapeutics have received approval from regulatory authorities across the globe and have established their efficacy in this domain. Further, most of the oral protein / peptide therapies (XX) are being investigated for the treatment of metabolic disorders; of these, a maximum number of drug candidates are being targeted for the treatment of type II diabetes (XX). This was followed by therapies being evaluated for the treatment of gastrointestinal disorders (XX), infectious disorders (XX) and autoimmune disorders (XX). DEVELOPMENT OF ORAL PROTEIN / PEPTIDE THERAPEUTICS This chapter provides a detailed competitiveness analysis of the players involved in the development of oral protein / peptide therapeutics, based on several relevant parameters, such as supplier power (company size, years of experience) and pipeline strength (number of drugs in pipeline, stage of development). Additionally, the insights on company competitiveness have been presented in the form of a 3-D bubble representation, with supplier power score (abscissa) on the x-axis, pipeline strength (ordinate) on the y-axis and number of pipeline candidates on z-axis (size of the bubble).

4. The primary purpose of this analysis was to develop a better understanding of the overall potential and capabilities of the oral protein / peptide therapy developers. It is important to mention that the data used for this analysis was collated from various publicly available sources and at no point should the inferences presented in this section be construed as a recommendation that one company is better than another.

5. OVER 200 CLINICAL TRIALS FOCUSED ON ORAL PROTEIN AND PEPTIDES HAVE BEEN REGISTERED ACROSS THE GLOBE; A MAJORITY OF THESE TRIALS ARE EVALUATING THERAPIES INTENDED FOR CHRONIC CONSTIPATION,DIABETES, AND IRRITABLE BOWEL SYNDROME Till date, several companies engaged in the development of oral protein / peptide therapeutics have made significant efforts in conducting clinical trials of its product candidates for the treatment of various disease indications. The number of trials and their geographical distribution are two important indicators of therapeutic viability (reflecting the current interest of industry stakeholders) and future potential (which markets the product is likely to be available soon after approval) of novel and innovative pharmacological interventions. This domain has witnessed a gradual increase in clinical research activity. This growth can be attributed to the established therapeutic potential of some of the approved orally administered peptide therapeutics. As can be observed in the figure, most (XX%) of the trials in this domain are phase II studies, followed by phase III (XX%) and phase I (XX%) studies. With three oral protein / peptide therapies already approved and several in late stages of development, it is evident that the current pace of research in this domain is fast. Further, most of the trials (XX) are centered in North America. Within this region, majority of the trials were / are being conducted in sites in the US (XX), followed by those located in Mexico (XX) and Canada (XX). It is also worth highlighting that a total of XX clinical trials are being conducted across XX European countries. 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).

6. 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. Key Questions Answered 1.Who are the key players involved in the development of oral protein / peptide therapeutics? 2.Which technologies are leveraged the most by oral protein / peptide therapy developers? 3.Who are the key opinion leaders in this domain? 4.Which geographies are the most active in conducting clinical trials focused on oral protein / peptide therapeutics? 5.Which companies have received the maximum funding for the development for oral protein / peptide therapeutics? Who are the most prominent investors? 6.Which partnership models are commonly adopted by industry stakeholders in the development of oral protein / peptide therapeutics? 7.Which organizations have filed the maximum number of patents in this field? 8.How is the current and future market opportunity likely to be distributed across key market segments?