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.

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 considered to be 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.   

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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 rest of the world.   

The oral protein and peptide therapeutics market is characterized by the presence of over 50 therapy developers; several players claim to have robust drug pipelines targeting disorders with high unmet needs

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). 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.

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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

The 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.

The healthy growth in published scientific literature over the last few years signifies the focused efforts made by researchers to identify and develop novel platforms and therapeutic interventions

Ongoing advancements in drug delivery and formulation have prompted researchers to develop several novel methods to enable the oral administration of large molecule-based therapies. As a result, there has been a significant increase in the number of publications related to oral protein / peptides and associated delivery systems. This chapter provides information on articles focused on oral protein and peptide therapies, which were published between 2016 and 2021.

Further, these publications were analyzed based on various relevant parameters in order to develop more insightful opinions on the prevalent R&D trends in this domain. The insights generated from this study also helped us identify the key objectives of the research being conducted in this industry.

More than 40 innovative technology platforms are presently being leveraged by industry stakeholders for the development of oral proteins and peptides

During our research, we were able to identify close to 45 innovative technologies, which are being leveraged by companies for the development of orally administered oral protein and peptide therapeutics.

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