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市場調查報告書
商品編碼
1884079
GLP-2類似物市場規模、佔有率、成長及全球產業分析:按類型、應用和地區劃分的洞察與預測(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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隨著短腸症候群 (SBS) 和其他胃腸道疾病在全球日益加重,全球GLP-2類似物市場持續快速成長。最新評估顯示,2024年市場規模將達到10.5億美元,主要驅動因素包括診斷率的提高、腸道功能障礙管理水平的改善以及GLP-2類似物療法在臨床上的應用日益廣泛。在對有效SBS療法的強勁需求以及長效製劑創新技術的推動下,預計2025年市場規模將增長至12億美元,到2032年將達到28.3億美元,反映出全球應用範圍的顯著擴大。
GLP-2 類似物模擬天然 GLP-2 激素,促進腸道生長,增強吸收,並減少對腸外營養的依賴。這些療法已成為短腸症候群 (SBS) 治療的基石,改善患者預後,並減少因慢性腸道功能障礙而住院的需求。隨著美國、歐洲和亞太地區研發投入的增加,對這些藥物的需求持續成長。
市場動態
驅動因素
一個關鍵驅動因素是短腸症候群 (SBS) 盛行率的不斷上升,其病因包括先天性異常、胃腸道手術、創傷或導致腸道缺損的疾病。存活率的提高和公眾意識的增強正在擴大需要長期治療的 SBS 患者群體。根據《臨床營養實務(2025)》預測,到2024年,短腸症候群(SBS)的盛行率預計將達到每10萬成年人2.74例,每10萬兒童1.67例,這顯示全球對有效治療方法的需求日益增長。由於GLP-2類似物經臨床驗證可改善腸道吸收,因此在預測期內的需求預計將保持強勁。
限制因子
儘管GLP-2類似物具有許多益處,但高昂的治療費用仍是一大障礙。特度格魯肽治療的年費用超過每位患者40萬美元,這限制了低收入地區的患者獲得治療的機會,即使在已開發市場也造成了經濟負擔。高昂的研發成本也加劇了定價方面的挑戰,並可能減緩市場滲透速度。
機會
開發長效GLP-2類似物蘊藏著巨大的機遇,這些類似物旨在每週給藥一次,而非每日給藥。例如,阿普拉魯肽和格雷帕魯肽等產品旨在提高患者的依從性和便利性。澤蘭製藥的研發管線還包括已展現出顯著臨床潛力的即用型水性類似物。這預示著下一代療法的到來,這些療法將提供更高的療效和更低的注射頻率。
挑戰
監管障礙仍然是一項重大挑戰,因為新的類似物需要進行複雜的安全性評估。對胃腸道不適、胰臟炎和甲狀腺癌等副作用的擔憂需要嚴格的監測和漫長的審批流程。例如,2024年12月,美國FDA對澤蘭製藥的格雷帕魯肽發出了完整回覆函(CRL),推遲了上市。
市場趨勢
一個顯著的趨勢是從全腸外營養 (TPN) 轉向基於 GLP-2 的治療。由於併發症風險高且成本高,TPN(傳統上是短腸症候群 (SBS) 的主要治療方法)正越來越多地被旨在改善腸道功能的藥物解決方案所取代。此外,正在進行的臨床試驗正在探索將適應症擴展到 SBS 以外的疾病,包括克羅恩病、潰瘍性結腸炎、化療引起的腸道疾病和移植物抗宿主疾病。
依藥物分類
特度格魯肽在 2024 年佔據市場主導地位,並憑藉其已證實的安全性、臨床療效和廣泛應用,仍然是領先的 GLP-2 類似物。它是第一個被證實能夠減少對腸外營養依賴的 GLP-2 類似物。同時,阿普拉魯肽和格雷帕魯肽等新興類似物預計將作為長效替代藥物而廣受歡迎。
依給藥途徑
2024年,腸外給藥途徑佔最大市場佔有率,因為大多數已核准的GLP-2類似物都是透過注射給藥。人們對口服製劑的興趣日益增長,Entera Bio在2024年取得的良好藥物動力學結果表明,口服製劑有望成為更容易使用的替代藥物。
按分銷管道
由於便利性和廣泛的可近性,線上藥局和零售藥局在2024年引領市場。同時,醫院藥局在急性短腸症候群(SBS)的治療中繼續發揮至關重要的作用。
北美將在2024年佔據GLP-2類似物市場的主導地位,市場規模將達到8.1億美元,這得益於其最高的藥物採納率和已獲批准類似物最廣泛的臨床應用。在美國,特度格魯肽的專利到期以及一些成功的新臨床試驗(例如Ironwood公司2024年公佈的阿普拉魯肽III期臨床試驗結果)將繼續推動市場成長。
歐洲憑藉其高水準的研發能力和良好的監管環境,繼續保持著強勁的市場佔有率。亞太地區正在快速擴張,這得益於日本、中國和韓國罕見疾病研究的增加以及早期臨床試驗的開展。隨著人們對短腸症候群的認識和診斷能力的提高,拉丁美洲和中東及非洲地區正在穩步取得進展。
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