Global Oral Proteins and Peptides Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2031

Oral Proteins and Peptides Market Analysis

The oral proteins and peptides market is growing rapidly, fueled by advancements in drug delivery technologies and increasing demand for non-invasive treatment options. Oral formulations offer a more convenient alternative to injections, potentially enhancing patient adherence and improving quality of life. The market is driven by rising cases of chronic diseases, such as diabetes and hormonal disorders, where effective oral therapies are in high demand. Innovations in formulations, such as enteric coatings and advanced carriers, have significantly improved the stability and absorption of these compounds. Recent approvals of oral therapies such as semaglutide for diabetes and oral calcitonin for bone diseases highlight the market's potential.

Oral Proteins and Peptides Market Size

The global oral proteins and peptides market size was valued at USD 1.10 billion in 2023 and is projected to reach USD 2.38 billion by 2031, with a CAGR of 10.12% during the forecast period of 2024 to 2031. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Oral Proteins and Peptides Market Trends

“Development of Advanced Delivery Technologies”

Oral proteins and peptides market's leading trend is the development of advanced delivery technologies to improve the bioavailability and efficacy of oral formulations. Recent innovations include the use of nanotechnology, polymer-based delivery systems, and enzyme inhibitors to enhance the stability of proteins and peptides as they pass through the gastrointestinal tract. For instance, companies are leveraging nanoencapsulation techniques to protect these sensitive molecules from digestive enzymes and acidic conditions, thereby increasing their absorption. Such trend reflects a growing focus on overcoming the challenges associated with oral administration of proteins and peptides, aiming to provide more convenient and effective treatment options.

Report Scope and Oral Proteins and Peptides Market Segmentation 

Oral Proteins and Peptides Market Definition

Oral proteins and peptides refer to therapeutic compounds consisting of proteins or peptides that are administered orally, rather than through injections or other delivery methods. These molecules are designed to be absorbed through the digestive system to achieve their therapeutic effects. Unlike traditional injectables, oral proteins and peptides offer convenience and ease of use, aiming to improve patient adherence to treatment regimens. The challenge lies in ensuring that these compounds remain stable and effective as they pass through the gastrointestinal tract and are absorbed into the bloodstream.

Oral Proteins and Peptides Market Dynamics

Drivers

• Rising Prevalence of Chronic Diseases

The increasing prevalence of chronic diseases is significantly driving demand for effective and convenient treatment options, with oral formulations of proteins and peptides emerging as a promising solution. For instance, according to the International Diabetes Federation, the number of adults with diabetes is expected to reach 700 million by 2045, highlighting the urgent need for accessible treatment options. Oral formulations, such as those being developed for insulin and other peptide-based therapies, offer a non-invasive alternative to traditional injections, potentially improving patient compliance and quality of life. Such advancements address the growing demand for more patient-friendly treatments, positioning oral proteins and peptides as a key component in the future of chronic disease management.

• Patient Preference for Oral Medications

Patient preference for oral medications plays a pivotal role in shaping the oral proteins and peptides market, as many patients opt for oral solutions over injections due to their convenience and ease of use. Research on National Library of Medicine namely Patients' preferences for once‐daily oral versus once‐weekly injectable diabetes medications: The REVISE study, highlights that more than 90% of the participants were taking oral type 2 diabetes mellitus medication against injectable. Additionally, Oral formulations offer a more user-friendly approach, potentially improving adherence rates and overall patient satisfaction. As a result, the drive for developing effective oral proteins and peptides is growing, aligning with patient demands and shaping market trends towards less invasive treatment options.

Opportunities

• Increasing Research And Development (R&D) Investments

Enhanced research and development (R&D) investments are pivotal for advancing oral delivery systems and formulations of proteins and peptides. Pharmaceutical companies such as Novo Nordisk and Oramed Pharmaceuticals are investing heavily in R&D to develop novel oral formulations of insulin and other peptides. Novo Nordisk’s investment in oral GLP-1 receptor agonists, demonstrated in clinical trials, showcases the potential for improved patient outcomes and market leadership. By focusing on innovative approaches and cutting-edge technologies, companies can address current limitations and position themselves as leaders in the evolving oral proteins and peptides market.

• Advancements In Regulatory Frameworks

Regulatory support is a critical factor driving the growth of the Oral Proteins and Peptides Market, as advancements in regulatory frameworks are facilitating faster approvals and market entry for new products. For instance, the U.S. Food and Drug Administration (FDA) has implemented the 21st Century Cures Act, which includes provisions to expedite the approval process for novel drug delivery technologies, including oral formulations of proteins and peptides. In 2023, the FDA granted Fast Track Designation to Oramed Pharmaceuticals' oral insulin capsule, acknowledging its potential to address unmet needs in diabetes management. This designation allows for more frequent interactions with regulatory reviewers and accelerated development timelines. Such regulatory advancements are crucial for speeding up the availability of oral protein and peptide products and improving patient care. Consequently fostering the oral proteins and peptides market.

Restraints/Challenges

• Substantial Difficulties In Manufacturing

Manufacturing difficulties pose a major restraint in the oral proteins and peptides market, particularly when scaling up production of complex formulations. For instance, maintaining the stability of proteins such as insulin during production and storage involves careful control of temperature, humidity, and formulation conditions to prevent degradation. As production scales, the complexity of managing such factors increases, potentially leading to issues such as inconsistent product quality and stability. Such complexity impacts the cost-effectiveness of manufacturing, as additional resources and sophisticated technology are needed to ensure that each batch meets rigorous quality standards. The difficulty in scaling up not only increases production costs but also poses risks of delays in bringing products to market, Consequently hindering the overall growth and accessibility of oral protein and peptide therapies.

• Variable Patient Responses

Variable patient responses to oral proteins and peptides present a significant challenge in the market, affecting both treatment efficacy and patient adherence. Unlike traditional medications, oral formulations of proteins and peptides can be influenced by individual factors such as digestive enzyme levels, gastric pH, and overall gastrointestinal health, leading to inconsistent drug absorption and variable therapeutic outcomes. Such variability necessitates the development of personalized treatment approaches and tailored dosing regimens, complicating the management of therapy and potentially increasing the complexity of treatment protocols. As a result, ensuring uniform efficacy and improving adherence across diverse patient populations becomes more challenging, ultimately impacting the overall success of oral protein and peptide therapies in the market.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Oral Proteins and Peptides Market Scope

The market is segmented on the basis of drug type, application, product type and, end user. The growth amongst these segments will help you analyse meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Drug Type

• Linaclotide
• Plecanatide
• Calcitonin
• Insulin
• Octreotide

Application

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

Product Type

• Low Molecular Weight Iron Dextran
• Ferric Gluconate
• Iron Sucrose
• Ferric Carboxyl Maltose

End User

• Hospital
• Pharmaceutical Company
• Others

Oral Proteins and Peptides Market Regional Analysis

The market is analysed and market size insights and trends are provided by country, drug type, application, product type, and end user as referenced above.

The countries covered in the market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

The U.S. leads the North American oral proteins and peptides market, driven by growing awareness of the benefits of these products and an increasing geriatric population in the region. Additionally, advancements in healthcare infrastructure and a strong emphasis on innovative therapies further contribute to the market's growth in the U.S.

Asia-Pacific is anticipated to experience the highest growth rate from 2021 to 2028, driven by increasing demand for effective drugs and advanced technologies. Additionally, the region's expanding healthcare infrastructure and a growing focus on improving access to innovative treatments further propel market growth.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.  

Oral Proteins and Peptides Market Share

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

Oral Proteins and Peptides Market Leaders Operating in the Market Are:

• Biocon (India)
• Diabetology Ltd. (U.K.)
• Novo Nordisk A/S (Denmark)
• Tarsa Therapeutics, Inc. (U.S.)
• Sanofi (France)
• F. Hoffmann-La Roche Ltd (Switzerland)
• Theriva Biologics (U.S.)
• Hovione (Portugal)
• Novartis AG (Switzerland)
• Zydus Group (India)
• Johnson & Johnson Services, Inc. (U.S.)
• Abbott (U.S.)
• Pfizer Inc. (U.S.)
• AstraZeneca (U.K.)
• AbbVie Inc. (U.S.)
• Abeona Therapeutics Inc. (U.S.)
• Amgen Inc. (U.S.)
• Bayer AG (Germany)

Latest Developments in Oral Proteins and Peptides Market

• In May 2024, Biocon Limited entered into an exclusive licensing and supply agreement with Handok, a specialty pharmaceutical company based in South Korea, to commercialize Synthetic Liraglutide. Biocon will oversee the development, manufacturing, and supply of the drug, while Handok will be responsible for securing regulatory approval and managing its commercialization in the South Korean market.
• In August 2023, Entera Bio showcased an abstract at the American Society for Bone and Mineral Research (ASBMR) annual meeting on their groundbreaking once-daily oral hPTH (1-34) peptide tablets (EB613), designed to treat post-menopausal women at high risk of fractures.

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