市場調查報告書
商品編碼
1138353
曲前列素製劑全球市場-2022-2029Global Treprostinil Drugs Market - 2022-2029 |
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近年來,曲前列素製劑滲透率的提高以及伴隨政府舉措的各種新技術創新是推動市場增長的因素。
歐洲呼吸學會 (ERS) 報告稱,全球 PAH 患病率估計為每百萬人 10-52 例,每年範圍為 100,000-200,000 人。
在美國,可以獲得稅收優惠(相當於稅收減免等福利的一□□半)、臨床研究資助、專利保護和改進的營銷權,以加速孤兒藥的開發。創新藥物和治療方法的推出增加、政府的積極舉措以及醫療保健成本的上漲正在支持市場的增長。
此外,RDA 已經過修訂,以創建中央結構(法律制裁)以協調研究並推薦國家研究議程以促進更好的研究和教學。.
血管擴張劑包括前列環素和前列環素類似物,如 Flolan(依前列醇)、Rimodulin/Olenitrum/Taivaso(曲前列素)、Ventavis(伊洛前列素)、Aptravi(司來帕格)和 Beletri(依前列醇)。預計增加的處方和銷售量將推動市場增長預測期。這些血管擴張劑在收入方面有望超過內皮素受體拮抗劑(ERA),近年來推出了Uptravi和Ventavis等重磅藥物,即將推出潛在的管道藥物。由於主要市場參與者的存在、政府支持措施、先進的醫療保健基礎設施以及美國和加拿大 PAH 風險因素的增加,預計北美將在預測期內佔據主導地位
一些與脊髓小腦共濟失調 (SCA) 相關的副作用預計會阻礙市場增長。
這些藥物用於治療肺動脈高壓。這是有益的,但它也有一些副作用,例如脊髓小腦共濟失調,一種影響小腦的神經系統疾病,小腦負責協調。這一因素可能會阻礙曲前列素市場的□□增長。
行業分析
曲前列素製劑全球市場根據波特五力、監管分析、供應鏈分析、流行病學、未滿足的需求和產品創新等各種行業因素對市場進行了深入分析。
全球曲前列環素製劑市場報告提供大約 45 多個市場數據表、40 多個數字和 180 頁內容。
Treprostinil Drugs Market is expected to grow at a CAGR of 4.5% during the forecasting period (2022-2029).
Treprostinil is a vasodilator/ synthetic analog of prostacyclin that is used for the treatment of pulmonary arterial hypertension (PAH), where Treprostinil dilates (widens) the arteries and decreases the amount of blood clotting platelets in the body. These effects lower blood pressure in the pulmonary artery that leads from the heart to the lungs.
In recent time, the rise in the prevalence of treprostinil drugs and various novel technological innovations along with government initiatives are the factors that are increasing the growth of market.
Increasing prevalence of treprostinil drugs and technological innovations in treprostinil drugs market are expected to drive market growth
The European Respiratory Society (ERS) reported that the worldwide prevalence of PAH is ranging from 10 to 52 cases per million and estimated to be in the range of 100,000-200,000 every year.
The presence of favourable government support in the U.S. such as Orphan Drug Act (ODA) 1983 and the Rare Disease Act (RDA) of 2002 to facilitate the development of orphan drugs with benefits including tax incentives (reduced taxes/tax credits equal to half of the development costs), clinical research subsidies, and improved patent protection & marketing rights. Increasing launches of innovative drugs & treatment therapies, favourable initiatives by various governments, and rising spending over healthcare is supporting the market growth.
Besides, RDA amended to create a centralized structure (statutory authorization) for coordinating the research or recommend national research agendas to better facilitate the research & education.
The vasodilators would drive the growth of market during the forecast period due to rising number of prescriptions & sale of prostacyclin and prostacyclin analogs such as Flolan (epoprostenol), Remodulin/Orenitram/Tyvaso (treprostinil), Ventavis (iloprost), Uptravi (selexipag), and Veletri (epoprostenol). These vasodilators will surpass the endothelin receptor antagonists (ERAs) in terms of revenue due to the launch of blockbuster drugs like Uptravi and Ventavis in recent years, and launch of potential pipeline drugs shortly.
The presence of key market participants, supportive government initiatives, and sophisticated healthcare infrastructure, and rising prevalence of risk factors for PAH in the U.S. and Canada would facilitate North America's supremacy throughout the forecast period
Adverse effects associated with some spinocerebellar ataxia (SCA) are expected to hamper the market growth.
These drugs are used for treating pulmonary arterial hypertension. It is beneficial but also have some side effects such as Spinocerebellar Ataxia that is a neurological disorder that affects the cerebellum that is responsible for the coordination. This factor can hamper the growth of Treprostinil drugs market.
Industry Analysis
The global treprostinil drugs market provides in-depth analysis of the market based on various industry factors such as Porter's Five Forces, Regulatory Analysis, Supply Chain Analysis, Epidemiology, Unmet Needs, Product Innovations.
Product Type segment is expected to hold the largest market share in global treprostinil drugs market
Based on product type, the global Treprostinil drugs are fragmented into three segments Remodulin, Tyvaso, and Orenitram.
Remodulin: Treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).
Dosage and administration of remodelling (PAH) in patients with NYHA Class II-IV symptoms
a) Initial dose for patients new to prostacyclin infusion therapy: 1.25 ng/kg/min; increase based on clinical response (increments of 1.25 ng/kg/min per week for the first 4 weeks of treatment, later 2.5 ng/kg/min per week).
b) Mild to moderate hepatic insufficiency: Decrease initial dose to 0.625 ng/kg/min.
Tyvaso: It is a follow-on product to Remodulin. As an inhaled formulation of Treprostinil, Tyvaso is better tolerated than continuously and subcutaneously administered Remodulin. United Therapeutics has created a large market niche for its inhaled Treprostinil formulation, Tyvaso, despite the drug being relegated to later lines of therapy and being unavailable outside the US. However, this niche is now under threat from newer, more convenient oral prostacyclins such as Uptravi (selexipag; Johnson & Johnson/Nippon Shinyaku), which further possesses a much stronger clinical dataset, as well as United Therapeutics' own oral Orenitram (Treprostinil).
North America region holds the largest market share in the global treprostinil drugs market
North America holds the dominant market share for Treprostinil drug due to increasing prevalence of pulmonary arterial hypertension which is a progressive disease characterized by elevated pulmonary arterial pressure (PAP) and pulmonary vascular resistance (PVR), leading to right ventricular failure and death. PAH is a rare disease, with an estimated prevalence ranging from 10 to 52 cases per million
Supportive government initiatives for the development of orphan drugs (drugs for rare diseases) are projected to support market growth. For instance, the Rare Disease Act 2002 and the Orphan Drug Act (ODA) 1983 in the U.S. offer incentives, such as tax credits, for the development of orphan drugs. The Orphan Drug Act enables tax credits up to 50% of total R&D cost, funding for R&D, protocol assistance, and waiver in Food and Drug Administration (FDA) fees and clinical tax incentives. These incentives foster pharmaceutical companies to invest in the development of orphan drugs.
The patient-focused Drug Development (PFDD) initiative highlights the power and advocacy for patient care in the U.S. Under these initiatives, meetings were held with a group of people suffering from rare diseases. The agenda of these meetings was to understand disease severity, its impact on patients' lives, and available treatment options.
The major players covered in Treprostinil drugs are GlaxoSmithKline plc; Pfizer Inc.; Gilead Sciences, Inc.; Novartis International AG; Bayer AG; Merck KGaA; Bristol-Myers Squibb Company; United Therapeutics Corporation; Actelion Pharmaceuticals Ltd; Reata Pharmaceuticals, Inc.; Toray Industries, Inc.; Liquidia Technologies, Inc.; and Nuventra Pharma Sciences.
To remain in the forefront of the competitive market, the leading market players are focusing on expanding their geographical presence and investing in product development The adoption of various new strategies by the players help the Treprostinil drugs market to grow at a significant growth rate. For instance, in Sep 2019, New Drug Application of United Therapeutics got approved by U.S. FDA for survey of Trevyent.
Overview: United Therapeutics is American biotechnology company that is publicly merchandised. They are developing various new technologies for patients that can be life-extending in lung disorders and organ manufacturing fields. This company is co-headquartered in Silver Spring, Maryland and Research Triangle Park, North Carolina, United States.
Tyvaso inhalation: Tyvaso inhalation is utilized for the treatment of pulmonary arterial hypertension. It widens arteries and reduces the number of blood clotting platelets in the body. This leads to lower blood pressure in the pulmonary artery.
Key Developments: In May 2022, United Therapeutics Tyvaso DPI got FDA approval. This is the first time that a dry powder inhaler got approved for the treatment of pulmonary arterial hypertension.
The global treprostinil drugs market report would provide an access to an approx. 45+market data table, 40+figures and 180pages.
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