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市场调查报告书
商品编码
1884079
GLP-2类似物市场规模、占有率、成长及全球产业分析:按类型、应用和地区划分的洞察与预测(2024-2032)GLP-2 Analogs Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032 |
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随着短肠症候群 (SBS) 和其他胃肠道疾病在全球日益加重,全球GLP-2类似物市场持续快速成长。最新评估显示,2024年市场规模将达到10.5亿美元,主要驱动因素包括诊断率的提高、肠道功能障碍管理水平的改善以及GLP-2类似物疗法在临床上的应用日益广泛。在对有效SBS疗法的强劲需求以及长效製剂创新技术的推动下,预计2025年市场规模将增长至12亿美元,到2032年将达到28.3亿美元,反映出全球应用范围的显着扩大。
GLP-2 类似物模拟天然 GLP-2 激素,促进肠道生长,增强吸收,并减少对肠外营养的依赖。这些疗法已成为短肠症候群 (SBS) 治疗的基石,改善患者预后,并减少因慢性肠道功能障碍而住院的需求。随着美国、欧洲和亚太地区研发投入的增加,对这些药物的需求持续成长。
市场动态
驱动因素
一个关键驱动因素是短肠症候群 (SBS) 盛行率的不断上升,其病因包括先天性异常、胃肠道手术、创伤或导致肠道缺损的疾病。存活率的提高和公众意识的增强正在扩大需要长期治疗的 SBS 患者群体。根据《临床营养实务(2025)》预测,到2024年,短肠症候群(SBS)的盛行率预计将达到每10万成年人2.74例,每10万儿童1.67例,这显示全球对有效治疗方法的需求日益增长。由于GLP-2类似物经临床验证可改善肠道吸收,因此在预测期内的需求预计将保持强劲。
限制因子
儘管GLP-2类似物具有许多益处,但高昂的治疗费用仍是一大障碍。特度格鲁肽治疗的年费用超过每位患者40万美元,这限制了低收入地区的患者获得治疗的机会,即使在已开发市场也造成了经济负担。高昂的研发成本也加剧了定价方面的挑战,并可能减缓市场渗透速度。
机会
开发长效GLP-2类似物蕴藏着巨大的机遇,这些类似物旨在每週给药一次,而非每日给药。例如,阿普拉鲁肽和格雷帕鲁肽等产品旨在提高患者的依从性和便利性。泽兰製药的研发管线还包括已展现出显着临床潜力的即用型水性类似物。这预示着下一代疗法的到来,这些疗法将提供更高的疗效和更低的注射频率。
挑战
监管障碍仍然是一项重大挑战,因为新的类似物需要进行复杂的安全性评估。对胃肠道不适、胰臟炎和甲状腺癌等副作用的担忧需要严格的监测和漫长的审批流程。例如,2024年12月,美国FDA对泽兰製药的格雷帕鲁肽发出了完整回覆函(CRL),推迟了上市。
市场趋势
一个显着的趋势是从全肠外营养 (TPN) 转向基于 GLP-2 的治疗。由于併发症风险高且成本高,TPN(传统上是短肠症候群 (SBS) 的主要治疗方法)正越来越多地被旨在改善肠道功能的药物解决方案所取代。此外,正在进行的临床试验正在探索将适应症扩展到 SBS 以外的疾病,包括克罗恩病、溃疡性结肠炎、化疗引起的肠道疾病和移植物抗宿主疾病。
依药物分类
特度格鲁肽在 2024 年占据市场主导地位,并凭藉其已证实的安全性、临床疗效和广泛应用,仍然是领先的 GLP-2 类似物。它是第一个被证实能够减少对肠外营养依赖的 GLP-2 类似物。同时,阿普拉鲁肽和格雷帕鲁肽等新兴类似物预计将作为长效替代药物而广受欢迎。
依给药途径
2024年,肠外给药途径占最大市场占有率,因为大多数已核准的GLP-2类似物都是透过注射给药。人们对口服製剂的兴趣日益增长,Entera Bio在2024年取得的良好药物动力学结果表明,口服製剂有望成为更容易使用的替代药物。
按分销管道
由于便利性和广泛的可近性,线上药局和零售药局在2024年引领市场。同时,医院药局在急性短肠症候群(SBS)的治疗中继续发挥至关重要的作用。
北美将在2024年占据GLP-2类似物市场的主导地位,市场规模将达到8.1亿美元,这得益于其最高的药物采纳率和已获批准类似物最广泛的临床应用。在美国,特度格鲁肽的专利到期以及一些成功的新临床试验(例如Ironwood公司2024年公布的阿普拉鲁肽III期临床试验结果)将继续推动市场成长。
欧洲凭藉其高水准的研发能力和良好的监管环境,继续保持着强劲的市场占有率。亚太地区正在快速扩张,这得益于日本、中国和韩国罕见疾病研究的增加以及早期临床试验的开展。随着人们对短肠症候群的认识和诊断能力的提高,拉丁美洲和中东及非洲地区正在稳步取得进展。
The global GLP-2 analogs market continues to expand rapidly as the burden of short bowel syndrome (SBS) and other gastrointestinal disorders grows worldwide. According to the latest assessment, the market was valued at USD 1.05 billion in 2024, driven by increased diagnosis rates, improving intestinal failure management, and rising clinical acceptance of GLP-2 analog-based therapies. Owing to strong demand for effective SBS treatment options and innovations in long-acting formulations, the market is projected to increase to USD 1.20 billion in 2025, eventually reaching USD 2.83 billion by 2032, reflecting a significant rise in global adoption.
GLP-2 analogs function by mimicking the natural GLP-2 hormone to enhance intestinal growth, promote absorption, and reduce reliance on parenteral nutrition. These therapies have become a cornerstone in managing SBS, offering improved patient outcomes and reducing hospitalization needs associated with chronic intestinal failure. With the U.S., Europe, and Asia Pacific intensifying research and development efforts, the demand for these drugs continues to escalate.
Market Dynamics
Drivers
A primary driver is the increasing prevalence of short bowel syndrome, caused by congenital defects, gastrointestinal surgeries, trauma, or diseases leading to intestinal loss. Rising survival rates and improved awareness have expanded the SBS patient pool requiring long-term treatment. According to Nutrition in Clinical Practice (2025), SBS prevalence in 2024 reached 2.74 per 100,000 adults and 1.67 per 100,000 children, demonstrating a growing global need for effective therapies. As GLP-2 analogs offer clinically proven improvements in intestinal absorption, demand is expected to remain strong across the forecast period.
Restraints
Despite their benefits, high treatment costs remain a significant barrier. The annual cost of Teduglutide therapy exceeds USD 400,000 per patient, limiting accessibility in lower-income regions and creating financial strain even in developed markets. High research and development expenses further contribute to pricing challenges, potentially slowing market penetration.
Opportunities
A promising opportunity lies in the development of long-acting GLP-2 analogs, designed for weekly rather than daily dosing. Products such as Apraglutide and Glepaglutide aim to improve patient compliance and convenience. Zealand Pharma's pipeline, including ready-to-use aqueous analogs, has shown substantial clinical promise, signaling an upcoming wave of next-generation treatments with enhanced efficacy and fewer injections.
Challenges
Regulatory hurdles remain a key challenge as new analogs undergo complex safety evaluations. Concerns over adverse effects-such as gastrointestinal discomfort, pancreatitis, and thyroid cancer-necessitate stringent monitoring and lengthy approval processes. For example, in December 2024, the U.S. FDA issued a complete response letter for Zealand Pharma's Glepaglutide, delaying its entry into the market.
Market Trends
One notable trend is the shift from total parenteral nutrition (TPN) to GLP-2-based therapies. While TPN was historically the primary treatment for SBS, its high complication risks and cost have pushed clinicians toward pharmacological solutions that improve intestinal function. Additionally, ongoing clinical trials are expanding therapeutic indications beyond SBS, with research exploring use in Crohn's disease, ulcerative colitis, chemotherapy-induced enteropathy, and graft-versus-host disease.
By Drug
Teduglutide dominated the market in 2024 and remains the leading GLP-2 analog due to proven safety, clinical efficacy, and widespread adoption. It is the first GLP-2 analog demonstrating reduced dependence on parenteral support. Meanwhile, emerging analogs such as Apraglutide and Glepaglutide are projected to gain traction as long-acting alternatives.
By Route of Administration
The parenteral segment held the largest share in 2024, as most approved GLP-2 analogs are administered by injection. Oral formulations are gaining interest, with Entera Bio's 2024 positive pharmacokinetic results indicating future potential for easier-to-use alternatives.
By Distribution Channel
Online and retail pharmacies led the market in 2024 due to convenience and broad accessibility, while hospital pharmacies remain essential for acute SBS management.
North America dominated the GLP-2 analogs market with USD 0.81 billion in 2024, representing the highest adoption and strongest clinical usage of approved analogs. In the U.S., patent expiry for Teduglutide and new clinical trial successes, such as Ironwood's 2024 Apraglutide phase 3 results, continue to stimulate growth.
Europe maintains a strong share due to high research output and supportive regulatory environments. The Asia Pacific region is expanding rapidly, supported by increasing rare disease research and early-stage clinical trials in Japan, China, and South Korea. Latin America and the Middle East & Africa show steady progression as awareness and diagnostic capabilities improve.
Conclusion
The global GLP-2 analogs market is poised for robust growth through 2032 as clinical innovation, long-acting formulations, and expanding disease indications transform SBS management. With the market rising from USD 1.05 billion in 2024 to USD 2.83 billion by 2032, GLP-2 therapies are becoming critical to improving outcomes and reducing the long-term burden of intestinal failure.
Segmentation By Drug
By Route of Administration
By Distribution Channel
By Geography