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市场调查报告书
商品编码
1679230
口服蛋白质和多肽市场预测至 2030 年:按产品类型、药物类型、剂型、生物标的、作用机制、应用、最终用户和地区进行的全球分析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 |
根据 Stratistics MRC 的数据,全球口服蛋白质和胜肽市场预计在 2024 年达到 79 亿美元,到 2030 年将达到 259 亿美元,预测期内的复合年增长率为 21.9%。
口服蛋白质和胜肽是由胺基酸组成的大型生物活性分子,透过口服可以治疗多种健康问题。与低分子量药物不同,它们有肠道吸收率低、酵素降解等问题。渗透促进剂和奈米颗粒封装等药物传递技术的发展提高了药物的生物有效性。这些非侵入性注射替代方法被用于治疗自体免疫疾病、糖尿病和骨质疏鬆症,同时维持治疗效果。
根据国际糖尿病联盟的数据,2021 年全球约有 5.37 亿成年人患有糖尿病,预计到 2045 年将达到 7.83 亿人。
老年人口不断增加
老年人口的不断增长是口服蛋白质和胜肽市场的主要动力。老年人通常需要有效且易于操作的慢性病治疗方法。随着老龄人口的增加,特别是在中国、日本和印度等国家,糖尿病、胃肠道疾病和骨病等与老龄化相关的疾病的发病率不断增加,对口服蛋白质和胜肽疗法的需求巨大。这些人口结构的变化正在促进市场的扩张,由于老年患者由于依从性和生活品质的提高而普遍更喜欢非侵入性口服给药而不是注射,预计全球市场将会成长。
生物有效性低
生物有效性是口服蛋白质和胜肽市场面临的主要挑战,限制了这些疗法的有效性。大多数口服胜肽在胃肠道中降解,无法穿过上皮屏障,导致生物有效性低于 2%,半衰期短于 30 分钟。这些分子通常具有高分子量、低亲油性以及抑制吸收的带电功能团。影响生物有效性的其他因素包括对系统性蛋白酶的敏感性、快速代谢、调理作用、构象变化和不稳定侧基的破坏,因此需要使用先进的递送技术来克服这些限制。
扩大治疗应用
由于这些製剂发现了超越传统适应症的新用途,扩大治疗用途对口服蛋白质和胜肽市场来说是一个巨大的机会。除了在糖尿病和内分泌失调方面的既定应用外,市场还在不断扩大,应用于肢端肥大症、乳糜泻、慢性特发性便秘、肠道高草血症和发炎性肠道疾病疾病等多种疾病。这种应用的多样化正在刺激技术创新并显着扩大潜在的市场规模。
副作用
副作用是一个重大威胁,可能会限制其采用和商业性成功。蛋白质和胜肽疗法的复杂性增加了口服时出现意外反应的风险。提高生物有效性和稳定性所需的修改可能会改变这些分子的安全性。此外,生物製药的研发週期一般为10至15年,需要大量的资金投入以确保安全性和有效性,因此开发成本高昂,这对市场发展造成了阻碍,尤其是对于中小企业而言。
COVID-19 疫情最初透过供应链挑战和非紧急治疗的延迟扰乱了口服蛋白质和胜肽市场。但随着医疗保健系统寻求更多可在家中进行的、对患者友善的治疗方法,药物传递技术的创新最终加速。这场大流行凸显了口服药物的重要性,它可以减少就诊次数,对免疫力缺乏的慢性病患者尤其有益。这些治疗偏好的转变为口服蛋白质和胜肽疗法提供了持续的发展动力。
预测期内,胰岛素受体部分预计将成为最大的部分
由于全球糖尿病盛行率的快速增长,预计胰岛素受体部分将在预测期内占据最大的市场占有率。根据国际糖尿病联盟的数据,2021 年全球约有 5.37 亿成年人患有糖尿病,预计到 2045 年将达到 7.83 亿人。如此庞大的患者族群对口服胰岛素製剂的需求庞大,因为口服胰岛素製剂可作为传统注射的非侵入性替代品。诺和诺德、Oramed Pharmaceuticals 等公司正在开发创新的口服胰岛素製剂,以克服酶降解和吸收不良的挑战,从而推动该领域的大量投资和市场成长。
口服溶液/液体製剂部分预计在预测期内以最高复合年增长率成长
口服溶液/液体製剂部分预计在预测期内将出现最高成长率,因为它在生物有效性和患者依从性方面具有显着优势。液体製剂可以透过奈米颗粒、渗透促进剂和蛋白酶抑制剂等专门的递送技术克服胃肠道的吸收障碍。这些配方对老年患者和吞嚥困难的患者特别有益。对于需要快速治疗的疾病来说,具有快速起效和精确剂量的液体製剂越来越有吸引力,人们对新型口服溶液技术的研究和开发投入了大量资金。
预计预测期内北美地区将占据最大的市场占有率。这项优势归功于先进的医疗基础设施、高昂的医疗成本以及对创新药物输送系统的大量投资。美国占据北美市场的很大份额,并投入了全球约40%的医药研发资金。该地区受益于有利的监管政策,FDA 等机构加快了对用于治疗糖尿病的口服Semaglutide等创新疗法的核准,主要市场参与者的存在进一步加强了北美的主导地位。
由于医疗保健投资的快速增加、慢性病盛行率的上升以及患者人数的不断增加,预计亚太地区将在预测期内呈现最高的复合年增长率。中国、日本和印度等国家老年人口正在大幅增加,导致与老龄化相关的疾病发生率上升,需要有效的治疗方法。受可支配收入增加和政府加强医疗保健基础设施措施的支持,全部区域医疗保健支出不断增加,为市场提供了巨大动力。
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.