The field of oral proteins / peptides has enormous opportunities. I believe the field will continue to grow at a rapid pace considering the healthy clinical pipeline of oral proteins / peptides.
-Chief Executive Officer, US based small-sized developer
Oral Proteins and Oral Peptides Market Overview
The oral proteins and oral peptides market is estimated to be worth $1.4 billion in 2022 and is expected to grow at compounded annual growth rate (CAGR) of over 20% during the forecast period. 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 / peptide pills.
Interestingly, in the last decade, three FDA approved peptides based therapies have been successfully introduced, 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 peptide pills 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 oral proteins and oral peptides market 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 market growth during the forecast period.
Key Technologies in Oral Proteins and Oral Peptides Market
Examples of key technology platforms used for the production of oral proteins and oral peptides (which have also been profiled in this market report; the complete list of technology platforms is available in the full report) include Axcess™ Oral Drug Delivery Technology, Eligen™ Technology, Entera Technology, NTRA Oral Delivery Technology, Peptelligence® Technology, Protein Oral Delivery (POD™) Technology, Transient Permeability Enhancer (TPE®) Technology and Uroguanylin Analogue Technology. This market report includes an easily searchable excel database of all the oral proteins, oral peptides, technology platforms and companies providing involved in oral proteins and oral peptides market, worldwide.
Recent Developments in Oral Proteins and Oral Peptides Market:
Several recent developments have taken place in the field of oral proteins and oral peptides market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.
- In August 2023, Entera Bio presented abstracts on its First-in-Class, Once Daily Oral hPTH(1-34) Peptide Tablets (EB613) for the treatment of post-menopausal women at high risk of fracture at the American Society for Bone and Mineral Research (ASBMR) annual meeting.
- In February 2023, Biora Therapeutics announced bioavailability results for oral delivery of GLP-1 receptor agonist.
- In February 2023, Entera Bio announced the FDA acceptance of a Type D meeting review to affirm design of the pivotal, phase 3 protocol for EB613 PTH mini tablets, as the first oral osteoanabolic treatment of post-menopausal osteoporosis.
Scope of the Report
The ‘Oral Proteins and Oral 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’ market report provides an extensive study on the current market landscape, market size, market forecast and future opportunities for the orally administrable protein / peptide-based therapeutics during the forecast period. In addition, market research report provides an in-depth analysis, highlighting the market landscape of technology providers engaged in oral proteins and oral peptides market.
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 oral proteins and oral peptides market.
- 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 oral proteins and oral peptides market.
- An analysis of the partnerships that have been established in oral proteins and oral peptides market, 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 oral proteins and oral peptides market, 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 oral proteins and oral peptides market 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 market report is to provide a detailed market forecast analysis in order to estimate the existing market size and future opportunity of the oral proteins and oral peptides market during forecast period. 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 forecast 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 and oral peptides market and to add robustness to our model, we have provided three market forecast scenarios, portraying conservative, base and optimistic tracks of the market’s evolution.
The opinions and insights presented in the market report were also influenced by discussions held with senior stakeholders in the industry. The market research report includes detailed transcripts of discussions held with
- Director, Small Company, US
- Co-founder and CEO, Small Company, US
- CEO, Small Company, US; CEO, Small Company, US
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.
Frequently Asked Questions
Question 1: What are oral peptides? Answer:
Oral peptides refer to a special kind of pharmaceutical composition which can be administered orally for the treatment of a myriad of disease indications across multiple therapeutic areas.
Question 2: How big is the oral proteins and oral peptides market? Answer:
The oral proteins and oral peptides market size is estimated to be worth $1.4 billion in 2022.
Question 3: What is the projected market growth of the oral proteins and oral peptides market? Answer:
The oral proteins and oral peptides market is expected to grow at compounded annual growth rate (CAGR) of over 20% during the forecast period 2022 - 2032.
Question 4: Which are the leading technology platforms in the oral proteins and oral peptides market ? Answer:
Examples of key technologies employed in oral proteins and oral peptides market (which have also been profiled in this market report; the complete list of technology platforms is available in the full report) include Axcess™ Oral Drug Delivery Technology, Eligen™ Technology, Entera Technology, NTRA Oral Delivery Technology, Peptelligence® Technology, Protein Oral Delivery (POD™) Technology, Transient Permeability Enhancer (TPE®) Technology and Uroguanylin Analogue Technology.
Question 5: How many articles have been published on the oral proteins and oral peptides over the last few years? Answer:
Since 2015, close to 400 articles have been published on the oral proteins and oral peptides, highlighting the ongoing research in the field.
Question 6: How much money has been invested by stakeholders in the oral proteins and oral peptides market? Answer:
USD 2.5 billion has been invested in the last five years by stakeholders to augment the development of novel products in the oral proteins and oral peptides market.
Question 7: Which region is the hub for companies engaged in the oral proteins and oral peptides market? Answer:
North America emerged as the hub for companies engaged in the oral proteins and oral peptides market, with majority of the players established in the region.