Published: June 2022
The approval of three oral protein / peptide-based therapies has led to a substantial increase in the R&D initiatives being undertaken in this domain, to evaluate the use of such non-invasive therapies for the treatment of a myriad of disease indications
Over the past few years, technological advancements in delivery formulations have enabled the adoption of the oral route of administration in lieu of the widely adopted subcutaneous route. Since the approval of the first oral protein / peptide in 2012, there has been an increase in the demand for this class of therapeutics, owing to their ability to treat a myriad of disease indications. Further, considering the ease of administration, increased treatment adherence and reduced risk of non-compliance associated with this delivery approach, the domain is anticipated to gain significant traction in the foreseen future.
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More than 130 oral proteins / peptides are currently under development
Over 60% of the therapies in this domain are based on peptide molecules. It is worth mentioning that most of the drug candidates are being developed for the treatment of metabolic disorders. Further, majority of these therapies (58%) are based on receptor stimulation mechanism.
~52 companies claim to be engaged in the development of oral proteins / peptides, globally
Since 2006, 22 companies have been established in this market. Further, around 57% of the industry stakeholders are small companies. In addition, majority (65%) of the oral proteins / peptide developers are based in North America, primarily in the US.
Close to 320 patents have been filed / granted for oral proteins / peptides, since 2016
Owing to the rising research efforts of several industry and non-industry players engaged in this domain, close to 70% of patent applications have been filed post 2018. It is worth noting that, around 75% of the patents were filed / granted in the US. This was followed by European Patent Office (24.7%).
Partnership activity has increased at an annualized rate of over 44% in this domain, during 2018-2021
Maximum number of partnerships were inked in 2021, indicating an increase in the activity in this domain. Majority of these agreements were reported to be licensing agreements, representing over 30% of the total number of instances.
USD 2.5+ billion has been invested by both private and public investors, since 2017
The maximum funding amount was raised through debt financing (36%), secondary offerings (27%) and venture capital (13%) funding. Further, around 92% of the funding instances were reported by players based in the US.
235+ clinical trials evaluating oral proteins / peptides have been registered, worldwide
The clinical research activity (in terms of number of trials registered) related to oral proteins and peptides increased at a CAGR of 28%, during the period 2016-2021. Of the total number of trials, 77% have already been completed, while 23% studies are presently active.
North America is anticipated to capture over 80% of the global market share in 2032
Around 44% of the market revenues are expected to be generated from sales of therapeutics intended for the treatment of type II diabetes, in 2032. Further, therapies based on the receptor stimulation mechanism are expected to occupy a larger share (62%) of the overall market in 2032.
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The financial opportunity within the oral proteins / peptides market has been analyzed across the following segments:
The report features inputs from eminent industry stakeholders, according to whom, the oral proteins / peptides market is primarily driven by the increasing demand for such molecules. The report includes detailed transcripts of discussions held with the following experts:
The research includes detailed profiles of drugs being developed by key players (listed below); each profile features an overview of the drug and technology used, current development status, and recent clinical trial results.
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