Oral Proteins and Peptides Market

Oral Proteins and Peptides Market Size:

The global oral proteins and peptides market size reached USD 1.8 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 3.4 Billion by 2033, exhibiting a growth rate (CAGR) of 7.13% during 2025-2033. The market is growing due to advancements in drug delivery technologies and the rising demand for non-invasive treatments. Key drivers include the increasing prevalence of chronic diseases like diabetes and cancer coupled with ongoing collaborations between biotech firms and research institutions fostering innovation.

Oral Proteins and Peptides Market Analysis:

• Major Market Drivers: The market is mainly driven by the rising prevalence of chronic disease across the world which contributes to the rising demand for more effective and convenient treatment options. Oral formulations of proteins and peptides provide a non-invasive alternatives to injections which improves patient compliance and comfort which is the priority for long term therapies. Technological advancement in drug delivery systems like nanoparticle encapsulation and enteric coatings, have also enhanced the bioavailability and stability of these components which makes oral administration more feasible. Furthermore, the increase in patient preference for non-invasive treatment methods and the continuous development of new products by pharmaceutical companies further propels oral proteins and peptides market growth.
• Key Market Trends: Key market trends include the increase in incorporation of advanced drug delivery technologies such as nanotechnology and 3D printing which further enhances the stability and bioavailability of these molecules for oral intake. There is also a notable shift towards patient centric development where treatments nowadays are tailored for individual needs and preferences which leads to more personalized medicine approaches. Furthermore, the market is witnessing a rise in development of oral peptide-based therapies for conditions like cancer and autoimmune disease which in turn expands the potential application of these biomolecules. The convergence of these trends is propelling the oral proteins and peptides market growth.
• Geographical Trends: The geographical trends in the market show significant regional variations and potential growth opportunities. North America currently leads the market mainly due to its advanced healthcare infrastructure, high healthcare spending and strong presence of leading pharmaceutical companies which are actively investing in oral protein and peptide therapeutics. Europe follows closely mainly driven by the rising regulatory support and rising prevalence of chronic disease across the region. The Asia Pacific region is set for rapid growth mainly fueled by the expansion of healthcare access, rise in economic development and a growing middle-class population which demands more advanced medical treatments. Furthermore, increased investments in biotechnology and pharmaceutical research and development in countries like China and India are accelerating the oral proteins and peptides market growth in this region. These geographical trends underscore the global shift towards more advanced and patient friendly therapeutic options across various healthcare systems.
• Competitive Landscape: Some of the major market players in the oral proteins and peptides industry include Amryt Pharma Plc, AstraZeneca PLC, Biocon Limited, Novo Nordisk A/S, Oramed Ltd, Proxima Concepts Limited, among many others.
• Challenges and Opportunities: Market faces various challenges which includes the instability of peptides in gastrointestinal tract and poor absorption across intestinal wall which complicates effective delivery. In line with this, the high costs associated with the development along with a strict regulatory requirement also poses significant hurdles. However, the market also presents significant opportunities. Advancements in drug delivery technologies like nanoparticle carriers and permeation enhancers, are enhancing the bioavailability of oral peptides. Rising prevalence of chronic like diabetes and cancer along with a growing preference for non-invasive treatments further drives the market demand. Collaborations between biotech firms and research institutions are also fostering innovation and expanding market potential.
   

Oral Proteins and Peptides Market Trends:

Technological Advancements in Drug Delivery

Technological advancements in drug delivery particularly through nanotechnology and genetic engineering, are enhancing the effectiveness of oral proteins and peptides. For instance, Pfizer scientists are delving into nanotechnology to develop a new method for targeting tumors using nanoparticles. These minuscule particles are designed to deliver drugs precisely to the tumor at a controlled rate potentially minimizing side effects. If successful, this approach could revolutionize cancer treatment by sparing healthy cells from damage. These innovations improve the stability and bioavailability of these molecules within the harsh gastrointestinal environment, overcoming previous barriers to oral administration. By enabling oral proteins and peptides to withstand digestive processes, these technologies expand the potential for treating a wider range of conditions with non-invasive oral therapies.​

Rising Demand for Non-Invasive Treatments

The increasing demand for non-invasive treatments is driving the development of oral proteins and peptides particularly for chronic conditions requiring long-term management. These treatments offer a significant advantage by eliminating the discomfort and inconvenience associated with frequent injections. Oral administration enhances patient compliance and comfort, making it easier for patients to adhere to their therapeutic regimens. In October 2023, GE HealthCare and Novo Nordisk collaborated to advance a non-invasive treatment for type 2 diabetes and obesity using ultrasound technology. Personalized peripheral-focused ultrasound therapy aims to offer a non-pharmacological alternative for managing chronic diseases. This collaboration combines GE HealthCare's expertise in ultrasound technology with Novo Nordisk's experience in metabolic disease treatment to develop solutions for improving patient care. The technology has shown promising results in pre-clinical and early clinical data, with potential use for people with type 2 diabetes. This shift towards non-invasive options is particularly transformative for managing diseases such as diabetes, where regular medication intake is crucial for effective management.

Rising Prevalence of Chronic Diseases

As chronic diseases like diabetes, heart disease and autoimmune disorders become more prevalent globally there is a growing demand for treatments that are not only effective but also user-friendly. According to the data published by Centers for Diseases Prevention and Control, an estimated 129 million people in the United States suffer from at least one chronic disease. This rising demand is driving significant growth in the oral proteins and peptides market. These treatments are highly appealing because they offer a convenient alternative to traditional methods, such as injections, enhancing patient adherence and overall treatment experience. This trend is especially crucial as the global population ages and more individuals require ongoing treatment regimens for chronic conditions.

Oral Proteins and Peptides Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2025-2033. Our report has categorized the market based on drug type and application.

Breakup by Drug Type:

• Linaclotide
• Plecanatide
• Calcitonin
• Insulin
• Octreotide
   

Insulin accounts for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the drug type. This includes linaclotide, plecanatide, calcitonin, insulin, and octreotide. According to the report, Insulin represented the largest segment.

Insulin dominates the oral proteins and peptides market, accounting for the majority of its share. This is primarily driven by the growing prevalence of diabetes worldwide and the urgent need for non-invasive insulin delivery methods. Traditional injectable insulin therapies pose challenges such as patient discomfort and compliance issues, making oral insulin an attractive alternative. Advances in drug delivery technologies have significantly improved the stability and bioavailability of oral insulin, enhancing its therapeutic efficacy. Major pharmaceutical companies and biotech firms are investing heavily in research and development to bring innovative oral insulin formulations to market, further bolstering its leading position within this sector.

Breakup by Application:

• Gastric and Digestive Disorders
• Bone Diseases
• Diabetes
• Hormonal Disorders
   

Diabetes holds the largest share of the industry

A detailed breakup and analysis of the market based on the applications have also been provided in the report. This includes gastric and digestive disorders, bone diseases, diabetes, and hormonal disorders. According to the report, diabetes accounted for the largest market share.

Diabetes holds the largest share of the oral proteins and peptides market due to the high global prevalence of the disease and the critical need for effective, patient-friendly treatments. Oral delivery of proteins and peptides, particularly insulin, addresses significant challenges associated with injectable forms, such as patient compliance and discomfort. The growing diabetic population drives demand for innovative oral formulations that offer better glycemic control and improved quality of life. Continuous advancements in drug delivery technologies and increased research and development investments by pharmaceutical companies further support the dominance of diabetes-related treatments in the oral proteins and peptides market.

Breakup by Region:

• North America
  • United States
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa
   

North America leads the market, accounting for the largest oral proteins and peptides market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represents the largest regional market for oral proteins and peptides.

North America leads the oral proteins and peptides market, accounting for the largest market share due to several factors. The region boasts advanced healthcare infrastructure, significant investments in research and development, and a high prevalence of chronic diseases such as diabetes and cancer. For instance, there are over 6,000 hospitals and numerous clinics in the U.S., supporting over 1 million hospital beds. The government allocated $1 trillion in 2021 and an additional $10 billion through the Build Back Better Act for healthcare facility projects. Initiatives in Texas, Utah, and Michigan, as well as in Kansas and Alabama, will involve the construction, renovation, or modernization of medical facilities, with projected completion dates between 2024 and 2027. The presence of major pharmaceutical companies and biotech firms accelerates innovation and the development of new oral peptide formulations. Additionally, favorable regulatory environments and increasing awareness about non-invasive treatment options contribute to market growth. Strong healthcare expenditure and supportive government initiatives further enhance North America's leading position in the global oral proteins and peptides market.

Competitive Landscape:

• The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the major market players in the oral proteins and peptides industry include Amryt Pharma Plc, AstraZeneca PLC, Biocon Limited, Novo Nordisk A/S, Oramed Ltd, Proxima Concepts Limited, etc.
  
  (Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
   
• API production is integral to the oral proteins and peptides market, as the quality and efficacy of these therapies heavily depend on the Active Pharmaceutical Ingredients used. Efficient API production ensures the stability, bioavailability, and therapeutic effectiveness of oral proteins and peptides, which are crucial for treating chronic diseases such as diabetes. Companies like Novo Nordisk, and Biocon invest in advanced manufacturing processes to produce high-quality APIs, maintaining a competitive edge. For instance, in November 2023, Novo Nordisk invested €5.6 billion to expand API production in Denmark. The investment will increase production capacity, with a majority focused on API capacity. The new multi-product facility will cover 170,000 m2 and create 800 new jobs upon completion in 2029. Novo Nordisk sees the investment as crucial for utilizing existing sites and supporting future product portfolios. This follows the company's earlier confirmation of awaiting approvals for a new production site in Denmark. Additionally, innovations in API production technologies can reduce costs and improve scalability, directly impacting the market's growth and the development of new oral protein and peptide therapies.

Oral Proteins and Peptides Market Recent Developments:

• In April 2023, Chiesi Farmaceutici S.p.A. successfully acquired Amryt Pharma Plc, a global biopharmaceutical company focusing on rare diseases. The acquisition will enable Chiesi to broaden access to approved treatments and progress in developing new therapies. With this partnership, Chiesi aims to expand patient reach and strengthen its position in the rare diseases space. Chiesi's commitment to patient-centric and sustainable care aligns with Amryt's innovative products, fostering hope for those in need.
• In May 2024, Biocon Limited entered into an exclusive licensing and supply agreement with Handok, a specialty pharmaceutical company in South Korea, for the commercialization of Synthetic Liraglutide. Under this agreement, Biocon will handle the development, manufacturing, and supply of the drug product, while Handok will be responsible for obtaining regulatory approval and commercializing it in the South Korean market. This strategic partnership aims to address the unmet needs of patients dealing with weight management in South Korea.

Oral proteins and peptides Market Report Scope:

Key Questions Answered in This Report:

• How has the global oral proteins and peptides market performed so far, and how will it perform in the coming years?
• What are the drivers, restraints, and opportunities in the global oral proteins and peptides market?
• What is the impact of each driver, restraint, and opportunity on the global oral proteins and peptides market?
• What are the key regional markets?
• Which countries represent the most attractive oral proteins and peptides market?
• What is the breakup of the market based on the drug type?
• Which is the most attractive drug type in the oral proteins and peptides market?
• What is the breakup of the market based on the application?
• Which is the most attractive application in the oral proteins and peptides market?
• What is the breakup of the market based on the region?
• Which is the most attractive region in the oral proteins and peptides market?
• What is the competitive structure of the market?
• Who are the key players/companies in the global oral proteins and peptides market?

Key Benefits for Stakeholders:

• IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the oral proteins and peptides market from 2019-2033.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the global oral proteins and peptides market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the oral proteins and peptides industry and its attractiveness.
• The competitive landscape allows stakeholders to understand their competitive environment and provides insight into the current positions of key players in the market.