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市場調査レポート
商品コード
1800821
肺動脈性肺高血圧症治療薬の市場レポート:薬剤クラス別、投与経路別、エンドユーザー別、地域別、2025~2033年Pulmonary Arterial Hypertension Drugs Market Report by Drug Class, Route of Administration, End User, and Region 2025-2033 |
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肺動脈性肺高血圧症治療薬の市場レポート:薬剤クラス別、投与経路別、エンドユーザー別、地域別、2025~2033年 |
出版日: 2025年08月01日
発行: IMARC
ページ情報: 英文 144 Pages
納期: 2~3営業日
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世界の肺動脈性肺高血圧症(PAH)治療薬の市場規模は2024年に80億米ドルに達しました。今後、IMARC Groupは、市場が2033年までに120億米ドルに達し、2025~2033年にかけて4.4%の成長率(CAGR)を示すと予測しています。同市場は、標的治療の進歩、PAHの有病率の増加、認知度の向上などを主な要因として大きな成長を遂げています。研究開発(R&D)活動の拡大も、世界的に市場の明るい展望を生み出しています。
併用療法の増加
肺動脈性肺高血圧症(PAH)の治療効果を高めるために、併用療法を採用する医師が増えています。異なる治療クラスの薬剤を組み合わせて処方することで、PAHに関与する複数の生物学的経路を標的とします。この多面的なアプローチは、症状を管理し、病気の進行を遅らせ、全体的な患者の転帰をより効果的に改善するのに役立ちます。さらに、併用療法は個々の薬剤の投与量を減らすことができ、副作用を軽減し、患者のアドヒアランスを高める可能性があります。臨床エビデンスがその利点を裏付けていることから、併用治療はPAH管理における標準治療となりつつあり、市場の成長と技術革新を牽引しています。例えば、2024年3月、Johnson & JohnsonのOPSYNVI(R)(マシテンタンとタダラフィル)は、成人の肺動脈性肺高血圧症(PAH)患者に対する初の1日1回単剤併用療法として米国FDAから承認されました。この承認は、有意な肺血行動態の改善を示した第3相A DUE試験の成功に基づいています。OPSYNVI(R)は、確立された2つの治療を1錠にまとめたもので、早期併用療法に関する臨床ガイドラインの推奨に沿ったものです。
革新的治療への注目の高まり
肺動脈性肺高血圧症(PAH)における革新的治療への注目の高まりは、疾患の根本原因に対処することを目的とした遺伝子治療や標的生物学的製剤の探求を後押ししています。遺伝子治療は、PAHに関与する遺伝的因子を修正する可能性を秘めており、単なる対症療法ではなく長期的な解決策を提供します。一方、標的生物学的製剤は、疾患の進行に関与する特定の分子経路に焦点を当て、より個別化された効果的な治療を可能にします。これらの新しいアプローチは、疾患改善における重要なブレークスルーをもたらし、PAH患者の生存率と全体的なQOLを改善する可能性があります。これに伴い、2024年8月、Liquidia CorporationのYUTREPIA(TM)(一般名 トレプロスチニル)吸入用粉末は、成人の肺動脈性肺高血圧症(PAH)および間質性肺疾患に伴う肺高血圧症(PH-ILD)の治療薬として、米国FDAより暫定承認を取得しました。今回の承認は、YUTREPIAの安全性と有効性を実証した第3相INSPIRE試験に基づいています。同社は、PAHおよびPH-ILD患者のアンメットニーズに対応するため、早期に最終承認を取得する予定です。
患者中心ケアとデジタルヘルス
患者中心ケアへの取り組みとデジタルヘルスツールの統合は、治療のアドヒアランスとアウトカムを向上させることで、肺動脈性肺高血圧症治療薬市場のダイナミクスに影響を与えています。モバイルアプリやウェアラブルデバイスを含むデジタルヘルスツールは、心拍数や酸素レベルなどのバイタルサインの継続的なモニタリングを可能にします。さらに、デジタルプラットフォームは患者と医療チーム間のシームレスなコミュニケーションを促進し、全体的な疾病管理を強化します。このような統合は、患者の転帰を改善するだけでなく、患者がPAHの管理に積極的な役割を果たすことを促し、QOLの向上とヘルスケア提供の効率化につながります。さらに、AJMCが2024年に発表した論文では、ツイン技術が肺高血圧症(PH)治療に革命をもたらす可能性が示唆されています。この技術は、患者のバーチャルモデルを作成し、病気の進行をシミュレーションし、治療結果を予測するものです。この研究では、個別化医療とインシリコ臨床試験の可能性が示されており、従来の臨床試験に伴う時間とコストを削減できる可能性があります。このようなデジタルヘルスとデジタルツイン技術の進歩は、前向きな肺動脈性肺高血圧症治療薬市場の展望を生み出し、成長を促進し、患者ケアを改善しています。
The global pulmonary arterial hypertension (PAH) drugs market size reached USD 8.0 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 12.0 Billion by 2033, exhibiting a growth rate (CAGR) of 4.4% during 2025-2033. The market is experiencing significant growth mainly driven by advancements in targeted therapies, increasing prevalence of PAH and growing awareness. Expanding research and development (R&D) efforts are also creating a positive outlook for the market further across the world.
Increased Use of Combination Therapies
Physicians are increasingly adopting combination therapies to enhance treatment efficacy in Pulmonary Arterial Hypertension (PAH). By prescribing a mix of drugs from different therapeutic classes, they target multiple biological pathways involved in PAH. This multifaceted approach helps to manage symptoms, slow disease progression, and improve overall patient outcomes more effectively. Additionally, combination therapies can allow for lower doses of individual medications, potentially reducing side effects and enhancing patient adherence. As clinical evidence supports their benefits, combination treatments are becoming the standard of care in PAH management, driving market growth and innovation. For instance, in March 2024, Johnson & Johnson's OPSYNVI(R) (macitentan and tadalafil) was approved by the U.S. FDA as the first once-daily single-tablet combination therapy for adults with pulmonary arterial hypertension (PAH). This approval is based on the successful Phase 3 A DUE study, which showed significant pulmonary hemodynamic improvement. OPSYNVI(R) combines two established treatments into a single tablet, aligning with clinical guideline recommendations for early combination therapy.
Rising Focus on Innovative Therapies
The rising focus on innovative therapies in Pulmonary Arterial Hypertension (PAH) is driving the exploration of gene therapies and targeted biologics, which aim to address the root causes of the disease. Gene therapies hold the potential to modify genetic factors involved in PAH, offering a long-term solution rather than just symptom management. Targeted biologics, on the other hand, focus on specific molecular pathways contributing to disease progression, allowing for more personalized and effective treatments. These novel approaches could lead to significant breakthroughs in disease modification, improving survival rates and overall quality of life for PAH patients. In line with this, in August 2024, Liquidia Corporation's YUTREPIA(TM) (treprostinil) inhalation powder received tentative approval from the U.S. FDA to treat adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The approval is based on the Phase 3 INSPIRE trial, which demonstrated the safety and efficacy of YUTREPIA. The company plans to seek final approval at the earliest to address the unmet needs of PAH and PH-ILD patients.
Patient-Centered Care and Digital Health
Patient-centered care initiatives and the integration of digital health tools are influencing the pulmonary arterial hypertension drugs market dynamics by enhancing treatment adherence and outcomes. Digital health tools, including mobile apps and wearable devices, enable continuous monitoring of vital signs such as heart rate and oxygen levels. Additionally, digital platforms facilitate seamless communication between patients and medical teams, enhancing overall disease management. This integration not only improves patient outcomes but also empowers individuals to take an active role in managing their PAH, leading to increased quality of life and more efficient healthcare delivery. Moreover, in an article published by AJMC in 2024, it was suggested that twin technology has the potential to revolutionize pulmonary hypertension (PH) treatment. This technology involves creating virtual models of patients to simulate disease progression and predict treatment outcomes. The study emphasizes the potential for personalized care and in silico clinical trials, which could reduce the time and costs associated with traditional trials. These advancements in digital health and twin technology are creating a positive pulmonary arterial hypertension drugs market outlook, driving growth and improving patient care.
Prostacyclin and Prostacyclin Analogs accounts for the majority of the market share
Prostacyclin and prostacyclin analogs dominate the pulmonary arterial hypertension (PAH) drugs market, accounting for the largest market share due to their critical role in managing the disease. These medications work by dilating blood vessels, reducing vascular resistance, and inhibiting platelet aggregation, which effectively lowers blood pressure in the pulmonary arteries. Their proven efficacy in improving exercise capacity and delaying disease progression makes them a cornerstone of PAH therapy. Additionally, the availability of various administration forms, such as intravenous, subcutaneous, and inhaled options, enhances their accessibility and convenience for patients. Ongoing advancements and the introduction of newer analogs further solidify their leading position, driving sustained pulmonary arterial hypertension drugs market growth.
Oral Administration holds the largest share of the industry
Oral administration holds the largest share of the pulmonary arterial hypertension (PAH) drugs market due to its significant advantages in patient convenience and adherence. Oral medications are easy to administer, non-invasive, and can be taken at home without the need for specialized medical facilities, making them highly attractive for long-term treatment. This ease of use enhances patient compliance, which is crucial for managing a chronic condition like PAH. Additionally, advancements in pharmaceutical formulations have improved the efficacy and safety profiles of oral PAH drugs, thereby reducing side effects and increasing their appeal. For instance, in December 2023, Granules obtained approval from the U.S. Food and Drug Administration for its generic version of Viatris Specialty's Revatio, a treatment for pulmonary arterial hypertension (PAH). The product is bioequivalent and therapeutically equivalent to Viatris's Sildenafil for oral suspension, 10 mg/ml. Granules stated that the drug is intended to enhance exercise ability and delay clinical worsening in PAH patients.
Hospitals are a primary end user in the Pulmonary Arterial Hypertension (PAH) drugs market, playing a crucial role in diagnosis, treatment, and ongoing management of the condition. Equipped with advanced diagnostic tools and specialized cardiology and pulmonology departments, hospitals facilitate the accurate identification of PAH, enabling timely and effective intervention. They administer a wide range of PAH medications, including advanced biologics and combination therapies, ensuring comprehensive patient care. Additionally, hospitals often participate in clinical trials and research initiatives, driving innovation and the development of new treatments. The centralized infrastructure and multidisciplinary approach in hospitals significantly contribute to the growth and adoption of PAH drugs in the market.
Clinics are essential end users in the Pulmonary Arterial Hypertension (PAH) drugs market, providing accessible and continuous care for patients with PAH. These outpatient facilities offer routine monitoring, medication management, and personalized treatment plans, enhancing patient adherence and outcomes. Clinics often collaborate with specialists to deliver comprehensive care, utilizing a variety of PAH drugs, including oral therapies and injectable medications. The convenience and localized presence of clinics make them pivotal in managing chronic conditions like PAH, ensuring that patients receive timely adjustments to their treatment regimens. Additionally, clinics contribute to market growth by increasing the distribution channels for PAH medications and fostering patient education and support initiatives.
North America leads the market, accounting for the largest pulmonary arterial hypertension drugs market share
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represents the largest regional market for pulmonary arterial hypertension (PAH) drugs.
North America leads the Pulmonary Arterial Hypertension (PAH) drugs market, accounting for the largest market share due to several key factors. The region benefits from a highly advanced healthcare infrastructure and widespread access to specialized medical facilities, enabling effective diagnosis and treatment of PAH. According to pulmonary arterial hypertension drugs market overview, the rising prevalence of cardiovascular and respiratory diseases drives the demand for PAH medications across the region. Additionally, North America is home to major pharmaceutical companies that invest heavily in research and development (R&D), fostering innovation and the introduction of new therapies. Favorable regulatory frameworks and substantial healthcare funding further support market growth. Moreover, increased awareness and education about PAH contribute to the early detection and higher treatment rates, solidifying North America's dominant market position. For instance, in September 2023, researchers at Vanderbilt University developed a new drug, VU6047534, to treat pulmonary arterial hypertension without serious neurological side effects. The drug targets serotonin 2B receptors in the heart and lungs, promoting organ healing and potentially reversing damage from heart attacks. The compound, designed to stay out of the brain, represents a promising therapy for PAH. The research was funded by the National Institutes of Health and Vanderbilt University.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)