ナルコレプシー：上市薬とパイプライン薬の評価、臨床試験、競合情勢

2022年、16の上市薬市場においてナルコレプシーと診断された有病例は1,600万人を超えると予想されています。ナルコレプシーの治療薬として、現在4つの主要な上市薬が販売されています。パイプライン薬開発は控えめで、フェーズIIIに2つ、フェーズIIに5つの候補があるのみです。臨床試験開発は商業スポンサーが中心で、米国がナルコレプシーの試験実施における主要国として台頭してきています。

当レポートでは、世界のナルコレプシー市場について調査分析し、疾患の情勢、上市薬・パイプライン薬・臨床試験の評価、取引情勢、市場企業のほか、パイプライン製品および技術のレビュー、市場を形成/牽引する動向、競合情勢などに関する情報を提供しています。

目次

目次

第1章 序文

• コンテンツ
• 調査範囲
• 図表一覧
• 略語

第2章 調査結果

第3章 疾患の情勢

• 疾患の概要
• 疫学の概要
• 治療の概要

第4章 上市薬の評価

• 主要な上市薬
• 概要：作用機序別
• 概要：投与経路別
• 概要：分子タイプ別
• 上市薬プロファイルと売上予測

第5章 パイプライン薬の評価

• 後期パイプライン薬
• 概要：開発段階別
• 概要：作用機序別
• 概要：投与経路別
• 概要：分子タイプ別
• 薬剤固有の相転移成功率（PTSR）および承認の可能性（LoA）
• 治療領域および適応症固有のPTSRおよびLoA

第6章 臨床試験の評価

• 過去の概要
• 概要：フェーズ別
• 概要：ステータス別
• 概要：進行中/計画中の試験段階別
• 仮の成分による試験
• 地理的概要
• 単一国試験と多国籍試験：地域別
• 内訳付き上位20のスポンサー：フェーズ別
• 内訳付き上位20のスポンサー：ステータス別
• 概要：評価項目ステータス別
• 概要：人種と民族別
• 登録データ
• 試験サイトの上位20か国
• 世界の上位20サイト
• 実現可能性分析 - 地理的概要
• 実現可能性分析 - ベンチマークモデル

第7章 取引情勢

• 合併、買収、戦略的提携：地域別
• 最近の合併、買収、戦略的提携

第8章 商業的評価

• 主要な市場企業

第9章 将来の市場カタリスト

第10章 付録

• 調査手法
• 調査手法 - PTSRおよびLoA分析
• 著者について
• 連絡先
• 免責事項

Abstract

This reports provides a data-driven overview of the current and future competitive landscape in Narcolepsy therapeutics.

• There will be more than 900,000 diagnosed prevalent cases of narcolepsy in 2023 in the 16 countries covered in GlobalData's epidemiology forecast.
• The majority of marketed drugs for the treatment of narcolepsy are transport inhibitors and receptor agonists.
• The narcolepsy pipeline consists of only 26 pharmaceuticals spanning all stages of development.
• Commercial sponsors dominate clinical trial development in narcolepsy, with the US emerging as the key country for conducting Phase III trials in narcolepsy.
• Globally, deals involving licensing agreements were the most common type of deals involving companies developing narcolepsy assets.

Scope

GlobalData's Narcolepsy: Competitive Landscape combines data from the Pharma Intelligence Center with in-house analyst expertise to provide a competitive assessment of the disease marketplace.

Components of the report include -

• Disease Landscape
• Disease Overview
• Epidemiology Overview
• Treatment Overview
• Marketed Products Assessment
• Breakdown by Mechanism of Action, Molecule Type, Route of Administration
• Product Profiles with Sales Forecast
• Pricing and Reimbursement Assessment
• Annual Therapy Cost
• Time to Pricing and Time to Reimbursement
• Pipeline Assessment
• Breakdown by Development Stage, Mechanism of Action, Molecule Type, Route of Administration
• Product Profiles with Sales Forecast
• Late-to-mid-stage Pipeline Drugs
• Phase Transition Success Rate and Likelihood of Approval
• Clinical Trials Assessment
• Breakdown of Trials by Phase, Status, Virtual Components, Sponsors, Geography, and Endpoint Status
• Enrolment Analytics, Site Analytics, Feasibility Analysis
• Deals Landscape
• Mergers, Acquisitions, and Strategic Alliances by Region
• Overview of Recent Deals
• Commercial Assessment
• Key Market Players
• Future Market Catalysts

Reasons to Buy

• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
• Develop business strategies by understanding the trends shaping and driving the Narcolepsy market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global Narcolepsy market in the future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

Table of Contents

Table of Contents

1 Preface

• 1.1 Contents
• 1.2 Report Scope
• 1.3 List of Tables and Figures
• 1.4 Abbreviations

2 Key Findings

3 Disease Landscape

• 3.1 Disease Overview
• 3.2 Epidemiology Overview
• 3.3 Treatment Overview

4 Marketed Drugs Assessment

• 4.1 Leading Marketed Drugs
• 4.2 Overview by Mechanism of Action
• 4.3 Overview by Route of Administration
• 4.4 Marketed Drugs Profiles and Sales Forecasts

5 Pricing and Reimbursement Assessment

• 5.1 Annual Therapy Cost
• 5.2 Time to Pricing and Reimbursement

6 Pipeline Drugs Assessment

• 6.1 Phase III Pipeline Drugs
• 6.2 Overview by Development Stage
• 6.3 Overview by Molecule Type
• 6.4 Overview by Mechanism of Action
• 6.5 Overview by Route of Administration
• 6.6 Drug Specific Phase Transition Success Rate (PTSR) and Likelihood of Approval (LoA)
• 6.7 Therapy Area and Indication-specific PTSR and LoA

7 Clinical Trials Assessment

• 7.1 Historical Overview
• 7.2 Overview by Phase
• 7.3 Overview by Status
• 7.4 Overview by Phase for Ongoing and Planned Trials
• 7.5 Trials with Virtual Components
• 7.6 Geographic Overview
• 7.7 Single-Country and Multinational Trials by Region
• 7.8 Top 20 Sponsors with Breakdown by Phase
• 7.9 Top 20 Sponsors with Breakdown by Status
• 7.10 Overview by Endpoint Status
• 7.11 Overview by Race and Ethnicity
• 7.12 Enrollment Data
• 7.13 Top 20 countries for Trial Sites
• 7.14 Top 20 Sites Globally
• 7.15 Feasibility Analysis - Geographic Overview
• 7.16 Feasibility Analysis - Benchmark Models

8 Deals Landscape

• 8.1 Mergers, Acquisitions, and Strategic Alliances by Region
• 8.2 Recent Mergers, Acquisitions, and Strategic Alliances

9 Commercial Assessment

• 9.1 Key Market Players

10 Future Market Catalysts

11 Appendix

• 11.1 Methodology
• 11.2 Methodology - Sales Forecast
• 11.3 Methodology - Pricing and Reimbursement
• 11.4 Methodology - PTSR and LoA Analysis
• 11.5 About the Authors
• 11.6 Contact Us
• 11.7 Disclaimer