Oral Proteins & Peptides Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Drug Type (Calcitonin, Insulin, Linaclotide, Octreotide, Plecanatide), By Application (Bone Diseases, Diabetes, Gastric & Digestive Disorders, Hormonal Disorders), By Region & Competition, 2020-2030F

Market Overview

Global Oral Proteins & Peptides Market was valued at USD 1.33 billion in 2024 and is anticipated to project impressive growth in the forecast period with a CAGR of 9.42% through 2030. The global oral proteins and peptides market is a rapidly growing segment within the pharmaceutical and biotechnology industry. Oral proteins and peptides are bioactive molecules that can be administered orally, typically in the form of tablets, capsules, or liquids, as an alternative to injections. This mode of administration offers several advantages, including improved patient compliance, reduced pain, and lower healthcare costs.

Key Market Drivers

Rising Prevalence of Chronic Diseases

The most obvious way in which the prevalence of chronic diseases is fueling the growth of the oral proteins and peptides market is through the sheer increase in the number of patients requiring treatment. As the global population ages and lifestyles become increasingly sedentary and unhealthy, chronic diseases are becoming more common. This translates to a larger pool of potential patients who may benefit from oral protein and peptide therapies. For instance, according to World Health Organization, noncommunicable diseases (NCDs) caused 43 million deaths, representing 75% of global non-pandemic-related fatalities. Cardiovascular diseases led with 19 million deaths, followed by cancers (10 million), chronic respiratory diseases (4 million), and diabetes (over 2 million). Low- and middle-income countries accounted for 73% of NCD deaths.

Patients are increasingly seeking treatment options that are not only effective but also convenient. Many individuals with chronic conditions require long-term or even lifelong therapy, which can be burdensome with traditional treatment methods such as injections or infusions. Oral proteins and peptides offer a more patient-friendly approach, as they can be administered simply by swallowing a pill or liquid, eliminating the need for painful and frequent injections.

Non-adherence to prescribed treatments is a significant issue in managing chronic diseases. Oral formulations provide a solution to this problem by increasing patient compliance. When treatment is easier to administer and less intrusive, patients are more likely to stick to their prescribed regimens, leading to better health outcomes.

The burden of chronic diseases on healthcare systems is substantial. Hospitalizations, doctor visits, and frequent injections can drive up healthcare costs significantly. Oral proteins and peptides can help mitigate some of these costs by reducing the need for invasive medical procedures and hospital stays. This makes them an attractive option for both patients and healthcare providers.

Scientific advancements in oral drug delivery technologies have enhanced the bioavailability and stability of proteins and peptides in the gastrointestinal tract. Enteric coatings, nanoparticles, and other formulations have improved the efficiency of oral drug absorption. This has expanded the range of diseases that can be effectively treated with oral therapies, further driving market growth.

Researchers and pharmaceutical companies are actively developing oral protein and peptide therapies tailored to specific chronic diseases. For example, oral insulin for diabetes management and oral biologics for inflammatory bowel disease are in various stages of development. This targeted approach can significantly improve treatment outcomes and is likely to drive market expansion.­

Technological Advancements in Drug Delivery

Historically, one of the major challenges in administering proteins and peptides orally was their vulnerability to degradation in the harsh environment of the gastrointestinal tract. However, technological breakthroughs have paved the way for the development of enteric coatings and specialized formulations that protect these fragile molecules. This has significantly improved their bioavailability and stability, making oral delivery a viable option for an increasing number of therapeutic proteins and peptides. For instance, in April 2023, researchers at the Georgia Institute of Technology received a $700,000 grant from the National Science Foundation (NSF) to advance therapeutic peptide discovery for multiple sclerosis. Such funding supports the development of novel peptide drugs, contributing to innovation and driving market growth throughout the study period.

Nanotechnology has ushered in a new era in drug delivery. Nanoparticles and nanocarriers can be designed to encapsulate and protect proteins and peptides until they reach their target sites in the body. This precise delivery system not only enhances therapeutic efficacy but also minimizes side effects. Such innovations are driving the development of oral protein and peptide therapies for a wide range of diseases.

Researchers have developed absorption enhancers that can facilitate the uptake of proteins and peptides in the gastrointestinal tract. These substances improve the transport of therapeutic molecules across the intestinal epithelium, enhancing their bioavailability. As a result, oral protein and peptide therapies can achieve therapeutic levels in the bloodstream, making them more effective. For instance, as of October 2024, ClinicalTrials.gov reported three active peptide therapeutics studies in Mexico, focusing on diabetes, neoplasms, and metabolic disorders. These research initiatives are expected to drive market growth in the region throughout the study period.

Technology has enabled the creation of customized drug delivery systems tailored to the needs of specific proteins and peptides. These systems can be fine-tuned to release the drug at the right time and in the right place within the body. Such precision ensures optimal therapeutic outcomes and minimizes the risk of adverse effects.

Technological advancements have also extended to the design of patient-centric devices that aid in the administration of oral proteins and peptides. These devices ensure accurate dosing and ease of use, improving patient compliance. For example, smart pill bottles can remind patients to take their medication and provide valuable data to healthcare providers.

Progress in drug delivery technology is expanding the therapeutic landscape for oral proteins and peptides. Previously, these molecules were primarily used for conditions like diabetes and gastrointestinal disorders. However, with improved delivery methods, researchers are exploring their use in a broader range of diseases, including cancer, autoimmune disorders, and rare genetic conditions.

Diabetes Management Revolution

Traditionally, diabetes management primarily relied on insulin injections, often multiple times a day. This regimen posed a significant burden on patients, impacting their quality of life and adherence to treatment. The introduction of oral proteins and peptides for diabetes management represents a paradigm shift, offering a less invasive and more convenient alternative. According to the article publoshed in 2024, NK2R activation could transform obesity and diabetes treatment by burning energy and reducing appetite without side effects. This promising approach offers new hope for nearly 400 million people living with these conditions.

Oral insulin is at the forefront of the diabetes management revolution. Researchers and pharmaceutical companies are actively working on developing formulations that allow insulin to be administered orally, eliminating the need for injections. Such innovations can drastically improve patient compliance, particularly among those who are reluctant to self-inject.

Technological advancements in drug delivery, including the use of absorption enhancers and nanoparticle formulations, have greatly enhanced the bioavailability of oral insulin and other diabetes-related proteins and peptides. This means that these molecules can survive the digestive process and reach the bloodstream in therapeutic concentrations, ensuring effective glycemic control.

The revolution in diabetes management is marked by a patient-centric approach. Oral proteins and peptides provide patients with more autonomy and control over their treatment. This empowerment can lead to better self-management of diabetes and improved long-term outcomes.

Hypoglycemia, or low blood sugar, is a common and potentially dangerous side effect of insulin therapy. Oral insulin formulations offer the advantage of mimicking the body's natural insulin release more closely, reducing the risk of hypoglycemia compared to rapid-acting injectable insulin.

The availability of oral proteins and peptides for diabetes management is broadening the spectrum of treatment options. This is especially crucial for individuals with specific needs, such as children with type 1 diabetes, who may benefit from less invasive and more user-friendly therapies.

Targeted Treatment for Gastrointestinal Disorders

Gastrointestinal disorders encompass a wide range of conditions, including inflammatory bowel disease (IBD), celiac disease, Crohn's disease, and irritable bowel syndrome (IBS). These disorders often require localized treatment within the gastrointestinal tract. Oral proteins and peptides can be engineered and administered to precisely target affected areas, delivering therapeutic molecules directly to the source of the disease.

Traditional treatments for gastrointestinal disorders, such as corticosteroids and immunosuppressants, can lead to systemic side effects due to their widespread distribution in the body. Targeted oral therapies, on the other hand, minimize these systemic side effects by concentrating the treatment where it's needed, thereby enhancing patient comfort and adherence.

By specifically targeting the gastrointestinal tract, oral proteins and peptides can achieve higher concentrations at the site of inflammation or damage. This localized treatment approach enhances therapeutic efficacy, allowing for more effective management of conditions like IBD and celiac disease.

Many gastrointestinal disorders require regular endoscopies, colonoscopies, or other invasive procedures to assess disease progression and administer treatments. Targeted oral therapies can potentially reduce the need for these invasive interventions, making treatment more convenient and less burdensome for patients.

Technological innovations in drug delivery, such as enteric coatings and nanoparticles, have improved the bioavailability and stability of oral proteins and peptides within the gastrointestinal environment. These advancements ensure that the therapeutic molecules reach their intended target effectively.

As research and development in this field continue to progress, targeted oral therapies are being explored for an expanding array of gastrointestinal disorders. This includes conditions that were previously difficult to treat effectively, offering new hope to patients and increasing the market's growth potential.

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Key Market Challenges

Stability and Bioavailability

The oral administration of proteins and peptides presents a significant challenge due to their susceptibility to degradation in the harsh environment of the gastrointestinal tract. Maintaining stability and ensuring sufficient bioavailability of these molecules is a complex problem that requires sophisticated formulation techniques.

Dosage and Dosing Frequency

Determining the appropriate dosage and dosing frequency for oral protein and peptide therapies is not straightforward. Finding the right balance between effective treatment and minimizing side effects is a delicate process that often requires extensive clinical testing.

Manufacturing Complexity

The production of oral proteins and peptides can be complex and costly. Maintaining the stability and purity of these molecules during manufacturing is a challenge that must be addressed to ensure consistent product quality.

Key Market Trends

Nanotechnology and Drug Delivery Innovations

Nanotechnology is revolutionizing drug delivery in the oral proteins and peptides market. Nanoparticles and nanocarriers are being designed to encapsulate and protect these delicate molecules, enabling precise delivery and enhanced bioavailability. These innovations will expand the range of treatable diseases and improve therapeutic outcomes.

Oral Insulin Advancements

Oral insulin is a hot topic in diabetes management. Ongoing research aims to overcome the challenges of delivering insulin orally, potentially transforming the way diabetes is treated. Innovations in oral insulin formulations have the potential to revolutionize diabetes care by eliminating the need for injections.

Microbiome-Based Therapies

The gut microbiome plays a critical role in overall health, including the efficacy of oral protein and peptide therapies. Researchers are exploring microbiome-based therapies that can enhance drug absorption and response. This trend holds promise for improving treatment outcomes in gastrointestinal disorders.

Segmental Insights

Application Insights

The projected increase in forecast for Gastric & Digestive Disorders within the Global Oral Proteins & Peptides Market stems from several compelling factors. There is a growing prevalence of gastric and digestive disorders globally, driven by dietary changes, lifestyle factors, and an aging population. As these conditions become more prevalent, the demand for effective treatments, such as oral proteins and peptides, is expected to surge. Advancements in pharmaceutical research and development have led to the creation of innovative therapies targeting these disorders, offering promising treatment options for patients. The convenience and patient-friendly nature of oral administration further contribute to the expected rise in demand for oral proteins and peptides in this therapeutic area. Consequently, as awareness and acceptance of these novel therapies grow, Gastric & Digestive Disorders are anticipated to witness an upward trajectory in the global market, meeting the evolving healthcare needs of patients worldwide.

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Regional Insights

The North American region was  poised for a significant upturn in the forecast of the Global Oral Proteins & Peptides Market in 2024 for several compelling reasons. First and foremost, North America boasts a robust healthcare infrastructure and a well-established pharmaceutical industry, fostering an environment conducive to the development and commercialization of oral protein and peptide-based therapies. A heightened focus on research and innovation, coupled with substantial investments in biotechnology and pharmaceutical companies, has led to the emergence of cutting-edge oral protein and peptide drug candidates specifically tailored to address various medical conditions. A growing patient population, along with increasing awareness and acceptance of these innovative treatments, is expected to drive substantial demand in the region. As regulatory agencies continue to streamline approval processes and as healthcare providers increasingly integrate these therapies into their treatment protocols, North America is primed to experience a noteworthy surge in its share of the Global Oral Proteins & Peptides Market.

Recent Developments

• In September 2023, EnteraBio announced a research collaboration with OPKO Biologics, Inc. Under this agreement, OPKO will provide its proprietary long-acting GLP-2 peptide and specific Oxyntomodulin analogs to support the development of oral tablet formulations. This partnership leverages EnteraBio’s expertise in oral drug delivery technology to explore new treatment possibilities. By combining OPKO’s innovative peptides with EnteraBio’s advanced formulation techniques, the collaboration aims to enhance patient convenience and improve therapeutic outcomes. This agreement marks a strategic step toward developing effective oral alternatives to injectable treatments for metabolic and gastrointestinal disorders.
• In October 2022, Pfizer acquired Biohaven Pharmaceutical Holding Company Ltd., the developer of NURTEC ODT (rimegepant), an oral peptide therapy for migraine. NURTEC ODT is approved for both acute treatment and prevention of episodic migraine in adults. This acquisition strengthens Pfizer’s neurology portfolio, expanding its presence in the migraine market with an innovative, patient-friendly treatment option.
• In February 2022, Novo Nordisk unveiled the introduction of oral semaglutide in the Indian market, heralding it as the world's first "peptide in a tablet" designed for blood sugar management. Semaglutide belongs to the GLP-1 receptor analog category, a type of diabetes medication typically administered via injection, which provides a more appealing option for individuals averse to needles.
• In April 2023, Chiesi Farmaceutici S.p.A. acquired Amryt Pharma, a biopharmaceutical company specializing in rare disease treatments. The acquisition includes Mycapssa (octreotide capsules), a key product of Amryt Pharma, strengthening Chiesi’s rare disease portfolio and expanding its global presence in specialized therapeutics.
• In December 2023, Pfizer secured Health Canada’s approval for NURTEC ODT (rimegepant) to treat acute migraine, expanding its market presence and offering a new treatment option for migraine patients in Canada.

Key Market Players

• AbbVie Inc.
• Merck & Co Inc
• Pfizer Inc
• Novo Nordisk A/S
• Hoffmann-La Roche Inc
• Sanofi SA
• AstraZeneca PLC
• Bristol-Myers Squibb Co
• Tarsa Therapeutics Inc
• Novartis AG

Report Scope:

In this report, the Global Oral Proteins & Peptides Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Oral Proteins & Peptides Market, By Drug Type:

o   Calcitonin

o   Insulin

o   Linaclotide

o   Octreotide

o   Plecanatide

• Oral Proteins & Peptides Market, By Application:

o   Bone Diseases

o   Diabetes

o   Gastric & Digestive Disorders

o   Hormonal Disorders

• Oral Proteins & Peptides Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  Germany

§  United Kingdom

§  France

§  Italy

§  Spain

o   Asia-Pacific

§  China

§  Japan

§  India

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

§  Kuwait

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Oral Proteins & Peptides Market.

Available Customizations:

Global Oral Proteins & Peptides market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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