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시장보고서
상품코드
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폐동맥 고혈압 : 시장 인사이트, 역학 및 예측(2036년)Pulmonary Arterial Hypertension - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
폐동맥 고혈압 시장 규모 및 전망
본 폐동맥 고혈압 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. PAH 환자의 부담 동향, 수익 및 시장 점유율 동향, 피크 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가함과 동시에, 주요 7개 국가 및 지역 전체에 걸친 상세한 시장 규모 평가 및 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시하고 있습니다. 본 보고서에서는 PAH 분야의 주요 미충족 수요 사항을 부각시키고, 경쟁 구도 및 임상 상황을 분석하여 고부가가치의 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
PAH의 개요와 진단
폐동맥 고혈압(PAH)은 폐혈관 저항 및 동맥압의 상승을 특징으로 하며, 인구 100만 명당 약 15-60명이 이 질환을 앓고 있는 것으로 추정되며, 여성에서 더 많이 진단되고 있습니다. PAH는 호흡 곤란, 피로, 흉통, 무력감 등 다양한 비특이적 증상을 유발하며, 이 질환의 진행성 및 쇠약화시키는 특성으로 인해 발생하는 심각한 유병률 및 사망률과 관련이 있으며, 결국 우심부전이나 사망으로 이어집니다. 질병의 증상이 환자의 신체 활동 능력이나 정서 상태에 미치는 영향은 건강 관련 삶의 질(HRQoL)에 부정적인 영향을 미칩니다.
PAH는 심장이나 폐 질환에서 나타나는 증상과 유사한 증상을 특징으로 합니다. PAH 진단에는 흉부 X선 검사, 혈액 검사, 심장 카테터 검사, 심전도 검사, 심초음파 검사 등 여러 가지 검사 방법이 사용됩니다.
현재 폐동맥 고혈압(PAH)의 치료 현황
PAH 치료에 일반적으로 사용되는 4가지 약물군(PDE5 억제제, sGC 자극제, 엔도세린 수용체 길항제(ERA), 프로스타사이클린 유사체·작용제)은 프로스타사이클린, 엔도세린, 일산화질소라는 3가지 주요 신호 전달 경로를 표적으로 삼고 있습니다.
마시텐탄은 PAH 치료에 사용되는 엔도세린 수용체 길항제로, 폐혈관 저항을 낮춤으로써 운동 내성을 개선하고 증상을 완화합니다. 마시텐탄 요법의 최적 시작 시기나 용량 조절에 대해서는 여전히 불분명한 점이 있지만, 특히 진행성 사례의 경우, PAH 관리에 있어 중요한 선택지 중 하나로 간주되고 있습니다. 프로스타사이클린 계열 약물은 PAH 치료에 사용되는 가장 오랜 역사를 가진 약물군으로, cAMP 농도를 상승시켜 폐혈관 확장 작용을 발휘합니다. 에포프로스테놀은 PAH 치료 전용으로 최초로 도입된 약물로, 1995년에 미국 FDA(식품의약국)의 승인을 받았습니다. 그러나 외래 진료에서는 정맥 내 투여로만 제한되었고, 중심정맥 접근이 필요했기 때문에 그 범용성에는 한계가 있었습니다. 현재는 투여 경로가 개선된 여러 가지 프로스타사이클린 유도체가 존재합니다. 여기에는 흡입형 이프로프로스트 및 트레프로스티닐, 피하 또는 정맥 투여용 트레프로스티닐, 경구 투여용 트레프로스티닐·지오라민, 그리고 경구용 프로스타사이클린 작용제인 셀렉시파그가 포함됩니다.
PAH의 역학 분석 및 예측에 관한 주요 조사 결과
현재의 치료법은 주로 폐혈관을 확장시켜 저항을 낮추고, 심장 기능을 개선하는 것을 목적으로 하고 있습니다. 치료 전략은 임상적, 기능적 및 혈역학적 매개변수를 바탕으로 한 위험도 평가를 기반으로 수립되며, 저위험 상태를 달성하고 생존율, 삶의 질, 증상 관리 등의 예후를 개선하는 것을 목표로 합니다. 주로 사용되는 약물의 분류로는 PDE5 억제제, sGC 자극제, 엔도세린 수용체 길항제, 그리고 프로스타사이클린 유사체/작용제가 있으며, 이들은 일산화질소, 엔도세린, 프로스타사이클린의 각 경로를 표적으로 합니다.
PAH 치료제로 시판되고 있는 약물은 몇 가지가 있으며, 각각 서로 다른 작용기전을 가지고 있습니다. TYVASO/TYVASO DPI/TREPROSTINIL, ORENITRAM 및 OPSYNVI/YUVANCI는 프로스타사이클린 경로를 표적으로 합니다. 소타텔셉트(WINREVAIR)는 신호 전달을 조절하여 혈관 기능을 개선합니다.
PAH 환자 치료를 위해 개발 중인 새로운 치료법에는 후기 및 중기 단계의 후보 약물이 포함됩니다. DelveInsight사의 추정 및 예측에 따르면, 예측 기간 동안 큰 변화를 가져올 가능성이 있는 약물로는 세랄티닙(GB-002), 트레프로스티닐 리포솜 제제(L-606), 라리네파그 등이 있습니다.
약제 분류별/폐동맥 고혈압(PAH)의 주요 신흥 치료법에 대한 인사이트(2022-2036년 전망)
저분자 화합물 : 저분자 화합물을 이용한 치료법은 질환의 진행에 관여하는 주요 분자 경로를 정확하게 표적으로 삼을 수 있다는 특징 덕분에, 폐동맥 고혈압(PAH) 관리에서 점점 더 중요한 역할을 하고 있습니다. 이러한 저분자량 덕분에, 특히 흡입을 통한 효율적인 전달이 가능해지며, 전신 노출을 최소화하면서도 폐혈관계로의 약물 직접 침착을 보장합니다. 이러한 표적 중심의 접근 방식을 통해 혈관 수축, 혈관 증식, 리모델링과 같은 중요한 기전을 조절할 수 있게 됩니다. 세랄티닙(GB002)과 같은 약물은 PDGF 수용체 신호 전달을 억제하여 혈관 리모델링을 억제함으로써 이러한 전략을 구현하고 있습니다. 마찬가지로, 휴대용 건식 분말 흡입기를 통해 투여되는 트레프로스티닐 흡입 제제는 편의성과 국소적 효능을 높여주고 있습니다.
재조합 융합 단백질 : 재조합 융합 단백질은 폐동맥 고혈압(PAH)에 대한 첨단 생물학적 치료법 중 하나로, 치료 효과를 높이기 위해 서로 다른 단백질의 기능 도메인을 결합하여 설계되었습니다. 이러한 약물은 혈관 리모델링 및 비정상적인 세포 증식에 관여하는 주요 신호 전달 경로를 표적으로 하여, 기존의 혈관 확장제를 뛰어넘는 질환 수정적 접근법을 제공합니다. 대표적인 예로, 액티빈 신호 전달 억제제인 소타텔셉트(WINREVAIR)를 들 수 있습니다. 이는 폐혈관계에서 증식 촉진 경로와 증식 억제 경로의 균형을 회복시키는 것입니다.
Pulmonary Arterial Hypertension (PAH) Market size and forecast
DelveInsight's "Pulmonary Arterial Hypertension (PAH) - Market Insights, Epidemiology, and Market Forecast - 2036" report delivers an in-depth understanding of PAH, historical and forecasted epidemiology, as well as the PAH market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
The PAH market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, PAH patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across the 7MM regions. The report highlights key unmet medical needs in PAH and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.
PAH Overview and Diagnosis
Pulmonary arterial hypertension (PAH), characterized by increased pulmonary vascular resistance and arterial pressure, affects an estimated 15-60 per million of the population and is more commonly diagnosed in women. PAH causes a range of nonspecific symptoms (including breathlessness, fatigue, chest pain, and weakness) and is associated with significant morbidity and mortality triggered by the debilitating progressive nature of the disease, which eventually leads to right heart failure and death. The effect of disease symptoms on the patient's physical mobility and emotional state adversely affects health-related quality of life (HRQoL).
PAH is characterized by similar symptoms that appear during heart and lung conditions. Several techniques and blood tests, such as chest X-rays, blood tests, cardiac catheterization, electrocardiograms, and echocardiograms, are used for diagnosing PAH.
Current Pulmonary Arterial Hypertension (PAH) Treatment Landscape
The four drug classes commonly used to treat PAH-PDE5 inhibitors, sGC stimulators, Endothelin Receptor Antagonists (ERAs), and prostacyclin analogs and agonists-target three major signaling pathways: prostacyclin, endothelin, and nitric oxide.
Macitentan is an endothelin receptor antagonist used to treat PAH, improving exercise capacity and reducing symptoms by lowering pulmonary vascular resistance. While the optimal initiation and adjustment of macitentan therapy remain unclear, it is considered a key option for managing PAH, especially for advanced cases. Prostacyclin medications are the oldest group used to treat PAH; these increase cAMP concentrations to produce pulmonary vasodilation. Epoprostenol was the first drug introduced specifically for treating PAH and was approved by the US FDA in 1995. However, it was limited in its versatility by its restriction to IV use in the outpatient setting, requiring central venous access. There are several different prostacyclin derivatives with various modes of delivery that are improved; these include inhaled iloprost and treprostinil, SC or IV treprostinil, oral treprostinil diolamine, and an oral prostacyclin agonist selexipag.
Pulmonary Arterial Hypertension (PAH) Unmet Needs
The section "unmet needs of PAH" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.
Key Findings from PAH Epidemiological Analysis and Forecast
Pulmonary Arterial Hypertension (PAH) Drug Analysis & Competitive Landscape
The PAH drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships upcoming key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the PAH treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the PAH therapeutics market.
Approved Therapies for Pulmonary Arterial Hypertension (PAH)
Inhaled treprostinil (YUTREPIA): Liquidia Technologies
Treprostinil (YUTREPIA), developed by Liquidia Technologies, is an inhaled dry powder formulation of treprostinil delivered through a convenient, palm-sized device designed using Liquidia's PRINT technology to enhance deep-lung delivery to treat PAH.
Pulmonary Arterial Hypertension (PAH) Pipeline Analysis
Ralinepag: United Therapeutics
Ralinepag is a novel, oral, selective, and potent prostacyclin receptor agonist being developed by United Therapeutics for the treatment of PAH. In vitro studies indicate that ralinepag has high binding affinity and selectivity at the human prostacyclin (IP) receptor. In phase II studies, ralinepag demonstrated a potential for a once-a-day dosing profile and potentially enhanced affinity compared to selexipag.
Pulmonary Arterial Hypertension (PAH) Key Players, Market Leaders and Emerging Companies
Pulmonary Arterial Hypertension (PAH) Drug Updates
Current therapies primarily work by dilating pulmonary blood vessels to reduce resistance and improve heart function, with treatment strategies guided by risk assessment based on clinical, functional, and hemodynamic parameters to achieve a low-risk status and improve outcomes such as survival, quality of life, and symptom control. The main drug classes used include PDE5 inhibitors, sGC stimulators, endothelin receptor antagonists, and prostacyclin analogs/agonists, which target the nitric oxide, endothelin, and prostacyclin pathways.
There are several marketed drugs for PAH, each with distinct mechanisms. TYVASO/TYVASO DPI/TREPROSTINIL, ORENITRAM, and OPSYNVI/YUVANCI target prostacyclin pathways. Sotatercept (WINREVAIR) modulates signaling to improve vascular function.
The emerging therapies developed to treat PAH patients include late-stage and mid-stage candidates. As per DelveInsight's estimates, the potential drugs that can mark a significant change in the forecast period includes seralutinib (GB-002), treprostinil liposomal (L-606), Ralinepag and others.
Drug Class/Insights into Leading Emerging Therapies in Pulmonary Arterial Hypertension (PAH) (2022-2036 Forecast)
Small Molecule: Small-molecule therapies are playing an increasingly pivotal role in the management of pulmonary arterial hypertension (PAH), driven by their ability to precisely target key molecular pathways involved in disease progression. Their low molecular weight enables efficient delivery, particularly via inhalation, ensuring direct drug deposition in the pulmonary vasculature while minimizing systemic exposure. This targeted approach allows modulation of critical mechanisms such as vasoconstriction, vascular proliferation, and remodeling. Agents like seralutinib (GB002) exemplify this strategy by inhibiting PDGF receptor signaling to address vascular remodeling. Similarly, inhaled formulations of treprostinil, delivered through portable dry powder inhalers, enhance convenience and localized efficacy.
Recombinant fusion proteins: Recombinant fusion proteins represent an advanced class of biologic therapies in pulmonary arterial hypertension (PAH), engineered by combining functional domains of different proteins to enhance therapeutic activity. These agents target key signaling pathways involved in vascular remodeling and abnormal cell proliferation, offering a disease-modifying approach beyond conventional vasodilators. A leading example is sotatercept (WINREVAIR), an activin signaling inhibitor that restores the balance between pro- and anti-proliferative pathways in the pulmonary vasculature.
Pulmonary Arterial Hypertension (PAH) Drug Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the PAH drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.
The current mainstay therapies to treat PAH act to dilate the pulmonary vasculature, decreasing pulmonary vascular resistance and secondarily improving right ventricular function, thereby improving functional capacity. The overall treatment goal is to improve survival, quality of life, exercise capacity, symptom burden, and clinical worsening, with risk stratification tools increasingly used to guide therapy and improve each of these elements.
Vardenafil (RT234), developed by Respira Therapeutics, is a first-in-class inhaled, as-needed (PRN) therapy for PAH that delivers vardenafil via a novel Axial Oscillating Sphere (AOS) dry powder inhaler, enabling rapid pulmonary vasodilation and on-demand relief of exertional breathlessness while improving exercise tolerance. Positioned as a complementary option to chronic background therapies, RT234 is expected to see moderate adoption, with an estimated ~7 years to peak uptake.
Detailed insights of emerging therapies' drug uptake is included in the report
Market Access and Reimbursement of therapies in Pulmonary Arterial Hypertension (PAH)
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.
NOTE: Further Details are provided in the final report....
Pulmonary Arterial Hypertension (PAH) therapies Price Scenario & Trends
Pricing and analogue assessment of PAH therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.
Selexipag (UPTRAVI) is an oral, selective prostacyclin IP receptor agonist approved for the treatment of PAH, more than three-quarters (76%) of PAH patients treated with UPTRAVI (selexipag) either maintained (56%) or reduced (20%) their 1-year mortality risk score. It is associated with a relatively high annual treatment cost in the United States, estimated at approximately USD 260,000.
Industry Experts and Physician Views for Pulmonary Arterial Hypertension (PAH)
To keep up with PAH market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the PAH emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in PAH, including MD, PhD, Instructor, Pos tdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts connected with 8+ KOLs to gather insights at country level. Centers such as the University of Pennsylvania Hospital, University of Chicago, University of Pittsburgh, Medizinische Hochschule Hannover etc. were contacted.
Qualitative Analysis: SWOT and Attribute Analysis
We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and attribute analysis.
In the SWOT analysis of PAH, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provide attribute analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Insights