トレプロスチニル製剤の世界市場-2022-2029

市場力学

近年、トレプロスチニル製剤の普及率の上昇と、政府の取り組みに伴う様々な新しい技術革新が、市場の成長を高める要因となっています。

欧州呼吸器学会（ERS）の報告によると、PAHの世界の有病率は100万人あたり10～52件で、毎年10～20万人の範囲にあると推定されています。

米国では、希少疾病用医薬品法（Orphan Drug Act：ODA）1983年や希少疾病法（Rare Disease Act：RDA）2002年などの政府支援により、税制優遇措置（開発費の半分に相当する税の軽減/控除）、臨床研究助成、特許保護・販売権向上などの特典を得て、オーファン医薬品の開発を促進することができます。革新的な医薬品や治療法の上市の増加、各国政府による好意的な取り組み、医療費の増加が市場の成長を支えています。

さらに、RDAは、研究を調整するための集中的な構造（法的認可）を作成したり、より良い研究と教育を促進するための国家研究課題を推奨するために改正されました。

血管拡張剤は、フローラン（エポプロステノール）、リモデュリン／オレンイトラム／タイバソ（トレプロスチニル）、ベンタビス（イロプロスト）、アプトラビ（セレキシパグ）、ベレトリ（エポプロステノール）などのプロスタサイクリンおよびプロスタサイクリン類似物質の処方数および販売数が増加し、予測期間中の市場成長を牽引すると思われます。これらの血管拡張剤は、近年UptraviやVentavisなどのブロックバスター薬が発売され、間もなく潜在的なパイプライン薬が発売されるため、収益面ではエンドセリン受容体拮抗薬（ERA）を凌ぐと予想されます。

主要な市場参加者の存在、政府の支援策、高度な医療インフラ、米国およびカナダにおけるPAHのリスク要因の増加により、予測期間を通じて北米が優位に立つと予想

一部の脊髄小脳変性症（SCA）に関連する副作用が市場成長の妨げになると予想されます。

これらの薬剤は、肺動脈性肺高血圧症の治療に使用されます。それは有益ですが、協調を担う小脳に影響を与える神経疾患である脊髄小脳失調症など、いくつかの副作用も持っています。この要因は、トレプロスチニル製剤市場の成長を阻害する可能性があります。

産業分析

トレプロスチニル製剤の世界市場は、ポーターの5つの力、規制分析、サプライチェーン分析、疫学、アンメットニーズ、製品革新などの様々な産業要因に基づいて、市場の詳細な分析を提供します。

世界のトレプロスチニル製剤市場レポートでは、約45+市場データ表、40+図、180ページの構成で提供しています。

目次

第1章 調査手法と調査範囲

• 調査手法
• 調査目的および調査範囲

第2章 市場の定義と概要

第3章 エグゼクティブサマリー

第4章 市場の力学

• 市場影響要因
  • 促進要因
    • トレプロスチニル製剤市場の普及率の上昇とトレプロスチニル製剤市場の技術革新
  • 抑制要因
    • 一部の脊髄小脳変性症（SCA）に関連する副作用
  • ビジネスチャンス
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• 規制分析
• サプライチェーン分析
• 疫学
• アンメットニーズ
• 製品イノベーション

第6章 製品タイプ別

• リモデュリン
• タイバソ
• オレイニトラム

第7章 販売チャネル別

• 薬局
• クリニックセンター
• 病院薬局
• 小売薬局
• オンライン

第8章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他の南米地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • オーストラリア
  • その他アジア太平洋地域
• 中東・アフリカ地域

第9章 競合情勢

• 主な展開と戦略
• 企業シェア分析
• 製品タイプ別ベンチマーク
• 注目の主要企業リスト

第10章 企業プロファイル

• United Therapeutics
  • 企業概要
  • 製品タイプ別ポートフォリオと内容
  • 主なハイライト
  • 財務概要
• Novartis
• Teva
• Ascendis Pharma
• Ferrer
• Lee's Pharmaceutical
• Mochida Pharmaceutical
• GlaxoSmithKline
• Pfizer

第11章 トレプロスチニル製剤の世界市場-DataM

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.

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Market Definition and Overview

3. Executive Summary

4. Market Dynamics

• 4.1. Market Impacting Factors
  • 4.1.1. Drivers:
    • 4.1.1.1. Increasing Prevalence of Treprostinil Drugs Market and Technological Innovations in Treprostinil Drugs Market
  • 4.1.2. Restraints:
    • 4.1.2.1. Adverse effects associated with Some Spinocerebellar Ataxia (SCA)
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Forces Analysis
• 5.2. Regulatory Analysis
• 5.3. Supply Chain Analysis
• 5.4. Epidemiology
• 5.5. Unmet Needs
• 5.6. Product innovations

6. By Product Type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type Segment
  • 6.1.2. Market Attractiveness Index, By Product Type Segment
• 6.2. Remodulin
  • 6.2.1.1. Introduction
  • 6.2.1.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
• 6.3. Tyvaso
• 6.4. Orenitram

7. By Distribution Channel

• 7.1. Introduction
  • 7.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel Segment
  • 7.1.2. Market Attractiveness Index, By Distribution Channel Segment
• 7.2. Pharmacies
  • 7.2.1.1. Introduction
  • 7.2.1.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
• 7.3. Clinic Centers
• 7.4. Hospital pharmacies
• 7.5. Retail pharmacies
• 7.6. Online

8. By Region

• 8.1. Introduction
  • 8.1.1. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029, By Region
  • 8.1.2. Market Attractiveness Index, By Region
• 8.2. North America
  • 8.2.1. Introduction
  • 8.2.2. Key Region-Specific Dynamics
  • 8.2.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
  • 8.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 8.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 8.2.5.1. U.S.
    • 8.2.5.2. Canada
    • 8.2.5.3. Mexico
• 8.3. Europe
  • 8.3.1. Introduction
  • 8.3.2. Key Region-Specific Dynamics
  • 8.3.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
  • 8.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 8.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 8.3.5.1. Germany
    • 8.3.5.2. U.K.
    • 8.3.5.3. France
    • 8.3.5.4. Italy
    • 8.3.5.5. Spain
    • 8.3.5.6. Rest of Europe
• 8.4. South America
  • 8.4.1. Introduction
  • 8.4.2. Key Region-Specific Dynamics
  • 8.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
  • 8.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 8.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 8.4.5.1. Brazil
    • 8.4.5.2. Argentina
    • 8.4.5.3. Rest of South America
• 8.5. Asia Pacific
  • 8.5.1. Introduction
  • 8.5.2. Key Region-Specific Dynamics
  • 8.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
  • 8.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 8.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 8.5.5.1. China
    • 8.5.5.2. India
    • 8.5.5.3. Japan
    • 8.5.5.4. Australia
    • 8.5.5.5. Rest of Asia Pacific
• 8.6. Middle East and Africa
  • 8.6.1. Introduction
  • 8.6.2. Key Region-Specific Dynamics
  • 8.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
  • 8.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel

9. Competitive Landscape

• 9.1. Key Developments and Strategies
• 9.2. Company Share Analysis
• 9.3. Product Types Benchmarking
• 9.4. List of Key Companies to Watch

10. Company Profiles

• 10.1. United Therapeutics
  • 10.1.1. Company Overview
  • 10.1.2. Product Type Portfolio and Description
  • 10.1.3. Key Highlights
  • 10.1.4. Financial Overview
• 10.2. Novartis
• 10.3. Teva
• 10.4. Ascendis Pharma
• 10.5. Ferrer
• 10.6. Lee's Pharmaceutical
• 10.7. Mochida Pharmaceutical
• 10.8. GlaxoSmithKline
• 10.9. Pfizer

LIST NOT EXHAUSTIVE

11. Global Treprostinil Drugs Market - DataM

• 11.1. Appendix
• 11.2. About Us and End User
• 11.3. Contact Us