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市場調查報告書
商品編碼
1679230
口服蛋白質和多肽市場預測至 2030 年:按產品類型、藥物類型、劑型、生物標的、作用機制、應用、最終用戶和地區進行的全球分析Oral Proteins and Peptides Market Forecasts to 2030 - Global Analysis By Product Type (Oral Peptides and Oral Proteins), Drug Type, Dosage Form, Biological Target, Mechanism of Action, Application, End User and By Geography |
根據 Stratistics MRC 的數據,全球口服蛋白質和胜肽市場預計在 2024 年達到 79 億美元,到 2030 年將達到 259 億美元,預測期內的複合年成長率為 21.9%。
口服蛋白質和胜肽是由胺基酸組成的大型生物活性分子,透過口服可以治療多種健康問題。與低分子量藥物不同,它們有腸道吸收率低、酵素分解等問題。滲透促進劑和奈米顆粒封裝等藥物傳遞技術的發展提高了藥物的生物有效性。這些非侵入性注射替代方法被用於治療自體免疫疾病、糖尿病和骨質疏鬆症,同時維持治療效果。
根據國際糖尿病聯盟的數據,2021 年全球約有 5.37 億成年人患有糖尿病,預計到 2045 年將達到 7.83 億人。
老年人口不斷增加
老年人口的不斷成長是口服蛋白質和胜肽市場的主要動力。老年人通常需要有效且易於操作的慢性病治療方法。隨著老齡人口的增加,特別是在中國、日本和印度等國家,糖尿病、胃腸道疾病和骨病等與老齡化相關的疾病的發病率不斷增加,對口服蛋白質和胜肽療法的需求巨大。這些人口結構的變化正在促進市場的擴張,由於老年患者由於依從性和生活品質的提高而普遍更喜歡非侵入性口服給藥而不是注射,預計全球市場將會成長。
生物有效性低
生物有效性是口服蛋白質和胜肽市場面臨的主要挑戰,限制了這些療法的有效性。大多數口服胜肽在胃腸道中分解,無法穿過上皮屏障,導致生物有效性低於 2%,半衰期短於 30 分鐘。這些分子通常具有高分子量、低親油性以及抑制吸收的帶電功能團。影響生物有效性的其他因素包括對系統性蛋白酶的敏感性、快速代謝、調理作用、構象變化和不穩定側基的破壞,因此需要使用先進的遞送技術來克服這些限制。
擴大治療應用
由於這些製劑發現了超越傳統適應症的新用途,擴大治療用途對口服蛋白質和胜肽市場來說是一個巨大的機會。除了在糖尿病和內分泌失調方面的既定應用外,市場還在不斷擴大,應用於肢端肥大症、乳糜瀉、慢性特發性便秘、腸道高草血症和發炎性腸道疾病疾病等多種疾病。這種應用的多樣化正在刺激技術創新並顯著擴大潛在的市場規模。
副作用
副作用是一個重大威脅,可能會限制其採用和商業性成功。蛋白質和胜肽療法的複雜性增加了口服時出現意外反應的風險。提高生物有效性和穩定性所需的修改可能會改變這些分子的安全性。此外,生物製藥的研發週期一般為10至15年,需要大量的資金投入以確保安全性和有效性,因此開發成本高昂,這對市場發展造成了阻礙,尤其是對於中小企業而言。
COVID-19 疫情最初透過供應鏈挑戰和非緊急治療的延遲擾亂了口服蛋白質和胜肽市場。但隨著醫療保健系統尋求更多可在家中進行的、對患者友善的治療方法,藥物傳遞技術的創新最終加速。這場大流行凸顯了口服藥物的重要性,它可以減少就診次數,對免疫力缺乏的慢性病患者尤其有益。這些治療偏好的轉變為口服蛋白質和胜肽療法提供了持續的發展動力。
預測期內,胰島素受體部分預計將成為最大的部分
由於全球糖尿病盛行率的快速成長,預計胰島素受體部分將在預測期內佔據最大的市場佔有率。根據國際糖尿病聯盟的數據,2021 年全球約有 5.37 億成年人患有糖尿病,預計到 2045 年將達到 7.83 億人。如此龐大的患者族群對口服胰島素製劑的需求龐大,因為口服胰島素製劑可作為傳統注射的非侵入性替代品。諾和諾德、Oramed Pharmaceuticals 等公司正在開發創新的口服胰島素製劑,以克服酶分解和吸收不良的挑戰,從而推動該領域的大量投資和市場成長。
口服溶液/液體製劑部分預計在預測期內以最高複合年成長率成長
口服溶液/液體製劑部分預計在預測期內將出現最高成長率,因為它在生物有效性和患者依從性方面具有顯著優勢。液體製劑可以透過奈米顆粒、滲透促進劑和蛋白酶抑制劑等專門的遞送技術克服胃腸道的吸收障礙。這些配方對老年患者和吞嚥困難的患者特別有益。對於需要快速治療的疾病來說,具有快速起效和精確劑量的液體製劑越來越有吸引力,人們對新型口服溶液技術的研究和開發投入了大量資金。
預計預測期內北美地區將佔據最大的市場佔有率。這項優勢歸功於先進的醫療基礎設施、高昂的醫療成本以及對創新藥物輸送系統的大量投資。美國佔據北美市場的很大佔有率,並投入了全球約40%的醫藥研發資金。該地區受益於有利的監管政策,FDA 等機構加快了對用於治療糖尿病的口服Semaglutide等創新療法的核准,主要市場參與者的存在進一步加強了北美的主導地位。
由於醫療保健投資的快速增加、慢性病盛行率的上升以及患者人數的不斷增加,預計亞太地區將在預測期內呈現最高的複合年成長率。中國、日本和印度等國家老年人口正在大幅增加,導致與老齡化相關的疾病發生率上升,需要有效的治療方法。受可支配收入增加和政府加強醫療保健基礎設施措施的支持,全部區域醫療保健支出不斷增加,為市場提供了巨大動力。
According to Stratistics MRC, the Global Oral Proteins and Peptides Market is accounted for $7.9 billion in 2024 and is expected to reach $25.9 billion by 2030 growing at a CAGR of 21.9% during the forecast period. Oral proteins and peptides are large, biologically active molecules made up of amino acids that are meant to be taken by mouth to treat a variety of health problems. Unlike small-molecule medicines, they have problems such as low intestinal absorption and enzymatic breakdown. Technological developments in drug delivery, such as permeability enhancers and nanoparticle encapsulation, increase the bioavailability of drugs. Non-invasive substitutes for injections, these treatments are used to treat autoimmune diseases, diabetes, and osteoporosis while still having therapeutic efficacy.
According to the International Diabetes Federation, approximately 537 million adults globally were living with diabetes in 2021, with projections reaching 783 million by 2045.
Growing geriatric population
The growing geriatric population significantly drives the oral proteins and peptides market, as older individuals often require effective, easy-to-administer treatments for chronic conditions. As the aging population increases, particularly in countries like China, Japan, and India, there is a higher incidence of age-related diseases such as diabetes, gastrointestinal disorders, and bone diseases, creating substantial demand for oral protein and peptide therapies. This demographic shift contributes to market expansion, with the global market projected to grow as elderly patients typically prefer non-invasive oral administration over injections for improved compliance and quality of life.
Low bioavailability
Low bioavailability presents a significant challenge for the oral proteins and peptides market, limiting the effectiveness of these therapeutics. Most orally administered peptides have a bioavailability of less than 2% and short half-lives of under 30 minutes due to degradation in the gastrointestinal tract and inability to cross the epithelial barrier. These molecules typically have high molecular weights, low lipophilicity, and charged functional groups that hamper absorption. Additional factors affecting bioavailability include susceptibility to systemic proteases, rapid metabolism, opsonization, conformational changes, and destruction of labile side groups, necessitating advanced delivery technologies to overcome these limitations.
Expanding therapeutic applications
Expanding therapeutic applications represent a significant opportunity in the oral proteins and peptides market as these formulations find new uses beyond traditional indications. The market is witnessing growth in applications for various conditions, including acromegaly, celiac disease, chronic idiopathic constipation, enteric hyperoxaluria, and inflammatory bowel disease, alongside established uses for diabetes and hormonal disorders. This diversification of applications is driving innovation and expanding the potential market size substantially.
Adverse side effects
Adverse side effects pose a significant threat, potentially limiting adoption and commercial success. The complex nature of protein and peptide therapeutics increases the risk of unexpected reactions when administered orally. The modifications required to enhance bioavailability and stability may alter the safety profile of these molecules. Additionally, the high development costs associated with ensuring safety and efficacy-with biological drug development taking 10-15 years and requiring substantial capital investment-create barriers to market entry, particularly for smaller players.
The COVID-19 pandemic initially disrupted the oral proteins and peptides market through supply chain challenges and postponed non-emergency treatments. However, it ultimately accelerated innovation in drug delivery technologies as healthcare systems sought more patient-friendly treatments that could be administered at home. The pandemic highlighted the importance of oral formulations that reduce hospital visits, particularly beneficial for immunocompromised patients with chronic conditions. This shift in treatment preferences has created lasting momentum for oral protein and peptide therapeutics.
The insulin receptor segment is expected to be the largest during the forecast period
The insulin receptor segment is expected to account for the largest market share during the forecast period due to the rapidly growing global diabetes prevalence. According to the International Diabetes Federation, approximately 537 million adults were living with diabetes in 2021, with projections reaching 783 million by 2045. This enormous patient population creates substantial demand for oral insulin formulations that offer a non-invasive alternative to traditional injections. Companies like Novo Nordisk and Oramed Pharmaceuticals are developing innovative oral insulin formulations that overcome enzymatic degradation and poor absorption challenges, driving significant investment and market growth in this segment.
The oral solutions/liquid formulations segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the oral solutions/liquid formulations segment is predicted to witness the highest growth rate due to significant advantages in bioavailability and patient compliance. Liquid formulations can overcome some absorption barriers in the gastrointestinal tract through specialized delivery technologies, including nanoparticles, permeability enhancers, and protease inhibitors. These formulations are particularly beneficial for elderly patients and those with swallowing difficulties. The rapid onset of action and potential for precise dosing make liquid formulations increasingly attractive for conditions requiring quick therapeutic responses, driving substantial investment in research and development of novel oral solution technologies.
During the forecast period, the North America region is expected to hold the largest market share. This dominance stems from advanced healthcare infrastructure, high healthcare expenditure, and significant investments in innovative drug delivery systems. The United States accounts for a significant share in the North American market, spending approximately 40% of global pharmaceutical R&D. The region benefits from favorable regulatory policies, with agencies like the FDA expediting approvals for innovative therapies such as oral semaglutide for diabetes, while the presence of key market players further strengthens North America's leadership position.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR driven by rapidly increasing healthcare investments, rising prevalence of chronic diseases, and expanding patient populations. Countries like China, Japan, and India are experiencing significant growth in their geriatric populations, contributing to higher incidences of age-related diseases that require effective therapeutic solutions. Increasing healthcare expenditure across the region, supported by rising disposable incomes and government initiatives aimed at enhancing healthcare infrastructure, is providing substantial market momentum.
Key players in the market
Some of the key players in Oral Proteins and Peptides Market include Novo Nordisk A/S, Eli Lilly and Company, Sanofi, AstraZeneca, AbbVie Inc., Takeda Pharmaceutical Company Limited, Roche Holding AG, Merck & Co., Inc., Pfizer Inc., Novartis AG, Bristol-Myers Squibb Company, Amgen Inc., Biocon Limited, Oramed Pharmaceuticals Inc., Chiasma, Inc., Entera Bio Ltd., Proxima Concepts Limited (Diabetology Ltd) and Rani Therapeutics Holdings, Inc.
In June 2023, Eli Lilly and Company announced new phase 2 data for orforglipron, its first nonpeptide oral glucagon-like peptide-1 (GLP-1) receptor agonist being studied for chronic weight management in participants with obesity or overweighti. The results were shared during an oral presentation at the American Diabetes Association's(R) 83rd Scientific Sessions and were simultaneously published in the New England Journal of Medicine. Orforglipron met both primary and secondary endpoints for the efficacy estimandii and demonstrated clinically significant weight reductions in adults with obesity or overweight, with at least one weight-related comorbidity (not including type 2 diabetes).
In February 2020, Takeda Pharmaceutical Company Limited announced that it has acquired PvP Biologics, Inc. following the conclusion of a Phase 1 proof-of-mechanism study of investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease. TAK-062 is a potential best-in-class, highly potent super glutenase - a protein that degrades ingested gluten - that was computationally engineered to treat celiac disease, a serious autoimmune disease where the ingestion of gluten leads to inflammation and damage in the small intestine. The Phase 1 study investigated TAK-062's safety and tolerability in both healthy volunteers and people with celiac disease. The ability of TAK-062 to degrade ingested gluten was studied in healthy volunteers. Takeda plans to submit data from the Phase 1 study for presentation at an upcoming medical congress.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.