Global Treprostinil Drugs Market - 2022-2029

Market Overview

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.

Market Dynamics

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.

Segment Analysis

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).

Geographical Analysis

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.

Competitive Landscape

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.

Key Companies to Watch

United Therapeutics:

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.

Product Portfolio:

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.