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市场调查报告书
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1766038
艾森曼格症候群管理市场预测至 2032 年:按药物类型、治疗方法、诊断、患者年龄层、分销管道、最终用户和地区进行的全球分析Eisenmenger Complex Management Market Forecasts to 2032 - Global Analysis By Drug Type, Therapy, Diagnosis, Patient Age Group, Distribution Channel, End User and By Geography |
根据 Stratistics MRC 的数据,全球艾森曼格症候群管理市场预计在 2025 年达到 13.6 亿美元,预计到 2032 年将达到 28.2 亿美元,预测期内的复合年增长率为 11.0%。
艾森曼格症候群的治疗是一种多学科方法,旨在改善生活品质、预防併发症并缓解症状,因为肺血管疾病一旦进展通常无法逆转。氧气疗法和肺血管扩张剂(例如磷酸二酯酶-5抑制剂、内皮素受体拮抗剂和前列腺环素类似物)均属于降低肺动脉压的医疗管理措施的一部分。此外,患者应避免高海拔、脱水和剧烈运动。严重的高黏滞血症症状可透过放血疗法治疗,同时也应治疗缺铁症。在更严重的病例中,唯一的治疗方法仍然是心肺联合移植或肺移植,通常与心臟缺陷修復相结合。
根据肺动脉高压协会的数据,高达40%的先天性心臟疾病(CHD) 患者有心臟缺陷,这使其容易罹患肺动脉高压 (PH),其中约10%的患者最终会发展为肺动脉高压。在治疗资源匮乏的地区,高达30%的未修復先天性心臟病患者会发展为艾森曼格氏症候群。
先天性心臟疾病(CHD)盛行率不断上升
根据世界卫生组织 (WHO) 的数据,先天性心臟疾病的发生率约为每千名活产婴儿 9-10 人,是全球最常见的先天性心臟疾病之一。尤其是较大的间隔缺损,可导致肺血管重塑和肺血流量增加。如果不及时治疗,可能会发展为艾森曼格症候群。此外,随着中低收入国家医疗体系诊断能力的提高,越来越多的先天性心臟病 (CHD) 病例被发现,这使得针对艾森曼格症候群的治疗策略日益重要。
治疗选择有限
儘管治疗方法有所改进,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,大多数治疗方法都属于安宁疗护,着重于控制症状而非阻止病情进展。由于长期免疫抑制、手术风险以及捐赠者短缺等挑战,肺部或心臟移植等根治性手术很少见。此外,缺乏确定性治疗方案也限制了从支持性治疗到治癒性治疗的过渡,并影响了患者的预后。
针对特异性疾病的药物创新
目前,用于治疗艾森曼格症候群的大多数药物都是特发性肺动脉高血压(IPAH) 药物的改良版。艾森曼格症候群独特的病理生理学为开发针对该疾病的特异性治疗方法将进一步鼓励生物技术创新。
与其他罕见疾病治疗重点的竞争
随着製药公司和全球医疗保健系统更加重视罕见疾病,脊髓性肌肉萎缩症、肌肉萎缩症和囊肿纤维化等备受关注或常见的罕见疾病可能会争夺艾森曼格综合征的研究资金。研究经费、津贴和商业投资更有可能分配给拥有更完善的病患登记、倡导网路和生物标记开发的疾病。此外,艾森曼格症候群在罕见疾病研发管线中可能无法获得足够的关注,从而阻碍临床试验和药物开发。
新冠疫情对艾森门格症候群管理市场造成了重大衝击,导致择期手术延误,常规医疗服务中断,并限制了治疗这种复杂疾病所需的专科护理设施。大量艾森门格症候群患者因心肺功能受损而本已处于高风险状态,如今更容易受到新冠疫情的严重影响,这增加了对居家监护和远端医疗的需求。然而,疫情也加速了远距会诊和数位医疗工具的普及,提高了人们对心血管疾病和慢性呼吸系统疾病的认识,并为疫情后加强疾病管理基础设施创造了长期机会。
内皮素受体拮抗剂预计在预测期内占比最大
预计内皮素受体拮抗剂领域将在预测期内占据最大的市场占有率。这些药物,例如波生坦和安立生坦,已被临床证明可有效提高艾森曼格症候群患者的运动耐受性、降低肺血管阻力并改善其生活品质。由于内皮素通路是肺动脉高血压(PAH) 的主要原因,这些药物在控制症状和减缓病情进展方面非常有效。这些药物在国际指南中受到大力推荐,并因其有效性、安全性得到验证且在孤儿药框架下在全球广泛应用而占据治疗领域的主导地位。
预计心导管术领域在预测期内将达到最高复合年增长率
预计心导管插入术领域将在预测期内达到最高成长率。此诊断程序可以准确直接地测量肺动脉压力、血管阻力和分流大小,从而评估艾森曼格症候群的严重程度和病程。随着治疗方法的个人化程度不断提高,对侵入性血流动力学评估的需求日益增长,以指导标靶治疗。即时成像和更先进的导管设备等技术发展提高了安全性和准确性。此外,它在移植前评估和研究试验中的作用使其成为先进艾森曼格诊断技术的主要驱动力,并增强了其应用。
预计北美将在预测期内占据最大的市场占有率。其主要原因是先进的肺动脉高压治疗技术、人们对先天性心臟疾病的高度认知以及完善的医疗保健系统。强大的罕见疾病保险覆盖范围、专业的成人先天性心臟疾病(ACHD) 中心以及顶尖的製药公司,共同巩固了该地区的主导地位。此外,积极的临床研究以及肺动脉高压协会 (PHA) 等倡导团体的大力支持,也为早期诊断和最佳治疗提供了支持。 FDA 授予孤儿药资格等有利的监管途径,进一步推动了北美的治疗方法创新和市场扩张。
预计亚太地区将在预测期内实现最高的复合年增长率,这得益于尖端诊断和治疗手段的普及、医疗支出的增加以及人们对先天性心臟疾病认识的不断提高。透过利用数位医疗工具和公共卫生倡议,中国、日本和印度等国家正在提升其早期诊断能力。高出生率和儿科心臟护理服务历来受限,导致未治疗的先天性心臟疾病盛行率不断上升,使大量人口面临风险。此外,外国製药公司的进入以及政府对罕见疾病倡议的支持也推动了该地区市场的扩张。
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.