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市場調查報告書
商品編碼
1766038
艾森曼格症候群管理市場預測至 2032 年:按藥物類型、治療方法、診斷、患者年齡層、分銷管道、最終用戶和地區進行的全球分析Eisenmenger Complex Management Market Forecasts to 2032 - Global Analysis By Drug Type, Therapy, Diagnosis, Patient Age Group, Distribution Channel, End User and By Geography |
根據 Stratistics MRC 的數據,全球艾森曼格症候群管理市場預計在 2025 年達到 13.6 億美元,預計到 2032 年將達到 28.2 億美元,預測期內的複合年成長率為 11.0%。
艾森曼格症候群的治療是一種多學科方法,旨在改善生活品質、預防併發症並緩解症狀,因為肺血管疾病一旦進展通常無法逆轉。氧氣療法和肺血管擴張劑(例如磷酸二酯酶-5抑制劑、內皮素受體拮抗劑和前列腺環素類似物)均屬於降低肺動脈壓的醫療管理措施的一部分。此外,患者應避免高海拔、脫水和劇烈運動。嚴重的高黏滯血症症狀可透過放血療法治療,同時也應治療缺鐵症。在更嚴重的病例中,唯一的治療方法仍然是心肺聯合移植或肺移植,通常與心臟缺陷修復相結合。
根據肺動脈高壓協會的數據,高達40%的先天性心臟疾病(CHD) 患者有心臟缺陷,這使其容易罹患肺動脈高壓 (PH),其中約10%的患者最終會發展為肺動脈高壓。在治療資源匱乏的地區,高達30%的未修復先天性心臟病患者會發展為艾森曼格氏症候群。
先天性心臟疾病(CHD)盛行率不斷上升
根據世界衛生組織 (WHO) 的數據,先天性心臟疾病的發生率約為每千名活產嬰兒 9-10 人,是全球最常見的先天性心臟疾病之一。尤其是較大的間隔缺損,可導致肺血管重塑和肺血流量增加。如果不及時治療,可能會發展為艾森曼格症候群。此外,隨著中低收入國家醫療體系診斷能力的提高,越來越多的先天性心臟病 (CHD) 病例被發現,這使得針對艾森曼格症候群的治療策略日益重要。
治療選擇有限
儘管治療方法有所改進,但一旦肺血管重塑形成,艾森曼格症候群的病情基本上不可逆。目前,大多數治療方法都屬於安寧療護,著重於控制症狀而非阻止病情進展。由於長期免疫抑制、手術風險以及捐贈者短缺等挑戰,肺部或心臟移植等根治性手術很少見。此外,缺乏確定性治療方案也限制了從支持性治療到治癒性治療的過渡,並影響了患者的預後。
針對特異性疾病的藥物創新
目前,用於治療艾森曼格症候群的大多數藥物都是特發性肺動脈高血壓(IPAH) 藥物的改良版。艾森曼格症候群獨特的病理生理學為開發針對該疾病的特異性治療方法將進一步鼓勵生物技術創新。
與其他罕見疾病治療重點的競爭
隨著製藥公司和全球醫療保健系統更加重視罕見疾病,脊髓性肌肉萎縮症、肌肉萎縮症和囊腫纖維化等備受關注或常見的罕見疾病可能會爭奪艾森曼格症候群的研究資金。研究經費、津貼和商業投資更有可能分配給擁有更完善的病患登記、倡導網路和生物標記開發的疾病。此外,艾森曼格症候群在罕見疾病研發管線中可能無法獲得足夠的關注,從而阻礙臨床試驗和藥物開發。
新冠疫情對艾森門格症候群管理市場造成了重大衝擊,導致擇期手術延誤,常規醫療服務中斷,並限制了治療這種複雜疾病所需的專科護理設施。大量艾森門格症候群患者因心肺功能受損而本已處於高風險狀態,如今更容易受到新冠疫情的嚴重影響,這增加了對居家監護和遠端醫療的需求。然而,疫情也加速了遠距會診和數位醫療工具的普及,提高了人們對心血管疾病和慢性呼吸系統疾病的認知,並為疫情後加強疾病管理基礎設施創造了長期機會。
內皮素受體拮抗劑預計在預測期內佔比最大
預計內皮素受體拮抗劑領域將在預測期內佔據最大的市場佔有率。這些藥物,例如波生坦和安立生坦,已被臨床證明可有效提高艾森曼格症候群患者的運動耐受性、降低肺血管阻力並改善其生活品質。由於內皮素通路是肺動脈高血壓(PAH) 的主要原因,這些藥物在控制症狀和減緩病情進展方面非常有效。這些藥物在國際指南中受到大力推薦,並因其有效性、安全性得到驗證且在孤兒藥框架下在全球廣泛應用而佔據治療領域的主導地位。
預計心導管術領域在預測期內將達到最高複合年成長率
預計心導管插入術領域將在預測期內達到最高成長率。此診斷程序可以準確直接地測量肺動脈壓力、血管阻力和分流大小,從而評估艾森曼格症候群的嚴重程度和病程。隨著治療方法的個人化程度不斷提高,對侵入性血流動力學評估的需求日益成長,以指導標靶治療。即時成像和更先進的導管設備等技術發展提高了安全性和準確性。此外,它在移植前評估和研究試驗中的作用使其成為先進艾森曼格診斷技術的主要驅動力,並增強了其應用。
預計北美將在預測期內佔據最大的市場佔有率。其主要原因是先進的肺動脈高壓治療技術、人們對先天性心臟疾病的高度認知以及完善的醫療保健系統。強大的罕見疾病保險覆蓋範圍、專業的成人先天性心臟疾病(ACHD) 中心以及頂尖的製藥公司,共同鞏固了該地區的主導地位。此外,積極的臨床研究以及肺動脈高壓協會 (PHA) 等倡導團體的大力支持,也為早期診斷和最佳治療提供了支持。 FDA 授予孤兒藥資格等有利的監管途徑,進一步推動了北美的治療方法創新和市場擴張。
預計亞太地區將在預測期內實現最高的複合年成長率,這得益於尖端診斷和治療手段的普及、醫療支出的增加以及人們對先天性心臟疾病認知的不斷提高。透過利用數位醫療工具和公共衛生舉措,中國、日本和印度等國家正在提升其早期診斷能力。高出生率和兒科心臟護理服務歷來受限,導致未治療的先天性心臟疾病盛行率不斷上升,使大量人口面臨風險。此外,外國製藥公司的進入以及政府對罕見疾病舉措的支持也推動了該地區市場的擴張。
According to Stratistics MRC, the Global Eisenmenger Complex Management Market is accounted for $1.36 billion in 2025 and is expected to reach $2.82 billion by 2032 growing at a CAGR of 11.0% during the forecast period. Eisenmenger complex management is a multidisciplinary approach that aims to improve quality of life, prevent complications, and alleviate symptoms because pulmonary vascular disease is usually irreversible once it has advanced. Oxygen therapy and pulmonary vasodilators like phosphodiesterase-5 inhibitors, endothelin receptor antagonists, and prostacyclin analogs are all part of medical management to lower pulmonary arterial pressure. Moreover, high altitudes, dehydration, and vigorous physical activity are discouraged for patients. Severe hyperviscosity symptoms can sometimes be treated with phlebotomy, and iron deficiency needs to be treated. The only cure in more severe cases is still heart-lung or lung transplantation, frequently combined with repair of the cardiac defect.
According to data from the Pulmonary Hypertension Association, up to 40 % of congenital heart disease (CHD) patients have cardiac defects that predispose them to pulmonary hypertension (PH), and approximately 10 % of these patients actually develop PH. In regions with limited access to care, up to 30 % of patients with unrepaired CHD progress to Eisenmenger syndrome.
Increased congenital heart disease (CHD) prevalence
With an incidence rate of roughly 9-10 per 1,000 live births, congenital heart diseases continue to rank among the most prevalent birth defects worldwide, according to the World Health Organization (WHO). Large septal defects in particular have the potential to cause pulmonary vascular remodeling and increased pulmonary blood flow. They develop into Eisenmenger syndrome if they are not treated. Additionally, Eisenmenger-specific management strategies are becoming more and more necessary as more undiagnosed CHD cases are discovered later in life as healthcare systems in low- and middle-income nations continue to advance their diagnostic capabilities.
Restricted options for curative treatment
Eisenmenger syndrome is still mostly irreversible once pulmonary vascular remodeling is established, even with improvements in treatment. The majority of modern therapies are palliative in nature, concentrating on managing symptoms rather than stopping the progression of the illness. Due to long-term immunosuppression problems, surgical risks, and donor shortages, curative procedures such as lung or heart transplantation are uncommon. Furthermore, this lack of conclusive treatment options limits the market's ability to shift from supportive to curative care models and limits patient outcomes.
Innovation in disease-specific medicines
Currently, the majority of drugs used to treat Eisenmenger syndrome are modified versions of those used to treat idiopathic pulmonary arterial hypertension (IPAH). Eisenmenger's distinct pathophysiology presents a great opportunity for the development of disease-specific treatments, especially in light of the cyanotic state, right-to-left shunting, and hyperviscosity problems. Improved clinical outcomes and quality of life may result from novel agents that more precisely address endothelial dysfunction, hypoxemia, or microvascular remodeling. Moreover, the designation of orphan drugs and expedited regulatory processes for rare diseases further entice biotech innovation.
Rivalry with other priorities for rare diseases
Higher-profile or more common orphan diseases like spinal muscular atrophy, muscular dystrophies, or cystic fibrosis may compete for funding for Eisenmenger syndrome as pharmaceutical companies and global healthcare systems place a greater emphasis on rare diseases. Research funding, grants, and commercial investment are more likely to be allocated to conditions with stronger patient registries, advocacy networks, and biomarker development. Additionally, Eisenmenger syndrome may therefore find it difficult to get attention in rare disease pipelines, which would impede clinical trials and medication development.
The COVID-19 pandemic had a major effect on the Eisenmenger Complex Management Market because it delayed elective surgeries, interfered with regular healthcare services, and restricted access to specialized care facilities-all of which are necessary for managing this complicated illness. Numerous Eisenmenger patients, who are already at high risk because of underlying cardiopulmonary compromise, were more susceptible to serious COVID-19 consequences, which increased the need for home-based monitoring and telemedicine. However, the pandemic also hastened the adoption of remote consultations and digital health tools and increased awareness of cardiovascular and chronic respiratory conditions, which has led to long-term opportunities for enhancing post-pandemic disease management infrastructure.
The endothelin receptor antagonists segment is expected to be the largest during the forecast period
The endothelin receptor antagonists segment is expected to account for the largest market share during the forecast period. These medications, like bosentan and ambrisentan, have been clinically shown to increase exercise tolerance, lower pulmonary vascular resistance, and improve quality of life in Eisenmenger syndrome patients. Since the endothelin pathway is a major contributor to pulmonary arterial hypertension (PAH), they are very effective at controlling symptoms and delaying the course of the disease. Since they are effective, have proven safety profiles, and are becoming more widely available worldwide under orphan drug frameworks, these medications are highly recommended by international guidelines and control the treatment landscape.
The cardiac catheterization segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the cardiac catheterization segment is predicted to witness the highest growth rate. The severity and course of Eisenmenger syndrome can be evaluated with the help of this diagnostic procedure, which offers accurate and direct measurements of pulmonary artery pressure, vascular resistance, and shunt magnitude. The need for invasive hemodynamic evaluation to direct targeted therapies has grown as treatment regimens become more customized. Safety and accuracy have been improved by technological developments, such as the incorporation of real-time imaging and better catheter-based instruments. Furthermore, it is a major growth driver in advanced Eisenmenger diagnostics due to its role in pre-transplant evaluation and research trials, which reinforces its adoption.
During the forecast period, the North America region is expected to hold the largest market share, mainly because of its sophisticated pulmonary hypertension treatments, high awareness of congenital heart conditions, and well-established healthcare system. Strong insurance coverage for rare diseases, specialized adult congenital heart disease (ACHD) centers, and top pharmaceutical companies all contribute to the region's advantages. Moreover, active clinical research and robust backing from advocacy groups such as the Pulmonary Hypertension Association (PHA) support early diagnosis and optimal care. Therapeutic innovation and market expansion in North America are further supported by favorable regulatory pathways, such as the FDA's designation of orphan drugs.
Over the forecast period, the Asia-Pacific region is anticipated to exhibit the highest CAGR, driven by growing access to cutting-edge diagnostics and treatments, growing healthcare spending, and growing awareness of congenital cardiac conditions. Through the use of digital healthcare tools and public health initiatives, nations such as China, Japan, and India are enhancing their capacity for early diagnosis. A sizable population is at risk because of the rising prevalence of untreated congenital heart defects brought on by high birth rates and historically restricted access to pediatric cardiac care. Additionally, the entry of foreign pharmaceutical companies and government assistance for rare disease initiatives are also speeding up the region's market expansion.
Key players in the market
Some of the key players in Eisenmenger Complex Management Market include Bayer AG, Gilead Sciences Inc., Actelion Pharmaceuticals Ltd, Merck and Co., Inc., Novartis AG, AstraZeneca plc., Pfizer, Inc., Teva Pharmaceutical Industries Ltd. and United Therapeutics Corporation.
In March 2025, Merck and Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced that the companies have entered into an exclusive license agreement for HRS-5346, an investigational oral small molecule Lipoprotein(a), or Lp(a), inhibitor currently being evaluated in a Phase 2 clinical trial in China. Under the agreement, Hengrui Pharma has granted Merck exclusive rights to develop, manufacture and commercialize HRS-5346 worldwide, excluding Greater China region.
In January 2025, Bayer announced that the company has signed a new exclusive distribution agreement with UK-based Ecospray to market a biological liquid nematicide sourced from garlic. The product presents a biological alternative to traditional synthetic chemical nematicides in vegetable and potato crops, and will be marketed in the European Union under the new name Velsinum(TM).
In December 2024, Gilead Sciences, Inc. and Tubulis announced that they have entered into an exclusive option and license agreement to discover and develop an antibody-drug conjugate (ADC) against a solid tumor target. Through this agreement, Gilead will gain access to Tubulis' proprietary Tubutecan and Alco5 platforms.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.