表紙:嚢胞性線維症の世界市場:2030年までの医薬品分析・予測
市場調査レポート
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1024810

嚢胞性線維症の世界市場:2030年までの医薬品分析・予測

Cystic Fibrosis - Global Drug Forecast and Market Analysis to 2030

出版日: | 発行: GlobalData | ページ情報: 英文 122 Pages | 納期: 即納可能 即納可能とは

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嚢胞性線維症の世界市場:2030年までの医薬品分析・予測
出版日: 2021年08月23日
発行: GlobalData
ページ情報: 英文 122 Pages
納期: 即納可能 即納可能とは
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  • 概要
  • 図表
  • 目次
概要

世界主要7ヶ国の医薬品市場(米国、フランス、ドイツ、イタリア、スペイン、英国、カナダ)における嚢胞性線維症(CF)市場は、予測期間中に4.5%のCAGRで成長し、収益は2020年の82億米ドルから2030年には127億米ドルに達すると予測されています。同市場の主な成長要因には、主要7ヶ国全体の人口増加、CF患者の平均寿命の伸びによるCF患者数の継続的な増加、高価格帯医薬品の発売や普及が挙げられます。

ただし、一部のEU諸国およびカナダにおける新規CFTRモジュレーターの償還の遅れや、粘液溶解剤や吸入剤の分野におけるCF市場へ参入する新製品の少なさなどは、同市場の成長を妨げるおそれがあります。

当レポートは、世界主要7ヶ国(米国、フランス、ドイツ、イタリア、スペイン、英国、カ7ヶ国の嚢胞性線維症市場について調査しており、2030年までの医薬品分析・予測に焦点を当てています。疾患の概要、疫学、競合、アンメットニーズや機会の評価、研究開発戦略、パイプライン分析、地域別の市場分析、市場の見通しなどの情報を提供しています。

目次

第1章 嚢胞性線維症:エグゼクティブサマリー

  • CF膜貫通コンダクタンス調整器モジュレーターによる2020年から2030年までの嚢胞性線維症市場の大幅な成長促進
  • 主要疾患修飾薬によるCF市場独占
  • 市販のCFTRモジュレーターがCF患者の大部分に適切な治療を提供する一方で残るアンメットニーズ
  • パイプラインエージェントの機会
  • 医師の見解

第2章 イントロダクション

  • 触媒
  • 関連レポート
  • 今後のレポート

第3章 疾患の概要

  • 病因と病態生理学
    • 病因
    • 病態生理学
    • バイオマーカー/影響のあるターゲット
  • 分類
  • 症状
  • 予後
  • QOL

第4章 疫学

  • 疾患の背景
  • 危険因子と併存疾患
  • 世界および過去の動向
    • レジストリベースで診断されたCFの有病率
    • 過小評価のために調整されたレジストリベースの診断された有病率
  • 予測調査手法
  • CFの疫学予測(2020-2030)
  • ディスカッション

第5章 疾病管理

  • 診断と治療の概要
    • 診断
    • 治療ガイドラインと主要な処方薬
  • 疾病管理に関するKOLの洞察
    • 早期の診断とより多くの治療オプションによる軽度の疾患を持つCF患者との繋がり
    • 疾患の重症度評価
    • 治療アプローチ
    • 小児から成人への移行

第6章 競合の評価

  • 概要

第7章 アンメットニーズと機会の評価

  • 概要
  • より効果的または治癒的な治療法の開発
  • 慢性肺感染症治療法の開発
  • 粘液溶解療法の開発
  • 治療コンプライアンスの改善

第8章 研究開発戦略

  • 概要
    • 再処方戦略
    • CFTRモジュレーターと疾患修飾療法
    • 抗炎症薬の開発
  • 臨床試験デザイン
    • 現在の臨床試験
    • CFTRモジュレーター臨床試験

第9章 パイプライン評価

  • 概要
  • 臨床開発における有望な薬剤

第10章 パイプライン評価分析

  • 概要
  • 競合の評価
    • CFTRモジュレーター
    • 抗炎症剤

第11章 現在および今後の企業

  • 概要
  • 取引の動向

第12章 市場の見通し

  • 世界の市場
    • 予測
    • 成長要因と障壁-国際問題
  • 米国
    • 予測
    • 主なイベント
  • EU5ヵ国
  • カナダ

第13章 付録

図表

List of Tables

List of Tables

  • Table 1: CF: Key Metrics in the 7MM
  • Table 2: Onset of CF by Approximate Age
  • Table 3: Classification and Criteria of the CFTR Gene Mutations in CF
  • Table 4: Symptoms of CF
  • Table 5: Risk Factors and Comorbidities for CF
  • Table 6: Treatment Guidelines for CF
  • Table 7: Leading Treatments for CF, 2021
  • Table 8: CF Market - Global Drivers and Barriers, 2020-2030
  • Table 9: Key Events Impacting Sales for CF in the US, 2020-2030
  • Table 10: Key Events Impacting Sales for CF in the US, 2020-2030
  • Table 11: Key Events Impacting Sales for CF in Canada, 2020-2030
  • Table 12: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

List of Figures

  • Figure 1: Global (7MM) Sales Forecast by Country for CF in 2020 and 2030
  • Figure 2: Analysis of the Company Portfolio Gap in CF During the Forecast Period
  • Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of CF During the Forecast Period
  • Figure 4: CFTR Mutation Classes in CF
  • Figure 5: 7MM, Registry-Based Diagnosed Prevalence of CF, Men and Women, All Ages, 2010-2030 (%)
  • Figure 6: 7MM, Registry-Based Diagnosed Prevalence of CF Adjusted for Underestimation, Men and Women, All Ages, 2010-2030 (%)
  • Figure 7: Sources Used for Registry-Based Diagnosed Prevalent Cases of CF
  • Figure 8: Sources Used for Registry-Based Diagnosed Prevalent Cases of CF by Specific Mutation
  • Figure 9: Sources Used for Registry-Based Diagnosed Prevalent Cases of CF with Chronic MRSA Infection
  • Figure 10: Sources Used for Registry-Based Diagnosed Prevalent Cases of CF Adjusted for Underestimation
  • Figure 11: Registry-Based Diagnosed Prevalent Cases of CF, 7MM, Men and Women, All Ages, 2020
  • Figure 12: 7MM, Age-Specific Registry-Based Diagnosed Prevalent Cases of CF, Men and Women, 2020 (N)
  • Figure 13: 7MM, Sex-Specific Registry-Based Diagnosed Prevalent Cases of CF, All Ages, 2020 (N)
  • Figure 14: 7MM, Registry-Based Diagnosed Prevalent Cases of CF with Specific Mutations, Men and Women, All Ages, 2020 (N)
  • Figure 15: 7MM, Registry-Based Diagnosed Prevalent Cases of CF with Chronic MRSA Infection, Men and Women, All Ages, 2020 (N)
  • Figure 16: Registry-Based Diagnosed Prevalent Cases of CF Adjusted for Underestimation, 7MM, Men and Women, All Ages, 2020
  • Figure 17: 7MM, Age-Specific Registry-Based Diagnosed Prevalent Cases of CF Adjusted for Underestimation, Men and Women, 2020 (N)
  • Figure 18: 7MM, Sex-Specific Registry-Based Diagnosed Prevalent Cases of CF Adjusted for Underestimation, All Ages, 2020 (N)
  • Figure 19: 7MM, Registry-Based Diagnosed Prevalent Cases of CF with Mutations Adjusted for Underestimation, Men and Women, All Ages, 2020 (N)
  • Figure 20: 7MM, Registry-Based Diagnosed Prevalent Cases of CF with Chronic MRSA Infection Adjusted for Underestimation, Men and Women, All Ages, 2020 (N)
  • Figure 21: Genetics of CF
  • Figure 22: Unmet Needs and Opportunities in CF
  • Figure 23: Overview of the Development Pipeline (Phase I and II) in CF
  • Figure 24: Key Late-Stage Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for CF in the 7MM During the Forecast Period
  • Figure 25: Competitive Assessment of Pipeline CFTR Modulators Benchmarked Against the SOCs, Kalydeco and Trikafta/Kaftrio
  • Figure 26: Competitive Assessment of the Pipeline Anti-inflammatory Drug, LAU-7b, Benchmarked Against the SOC, Azithromycin
  • Figure 27: Analysis of the Company Portfolio Gap in CF During the Forecast Period
  • Figure 28: Global (7MM) Sales Forecast by Country for CF in 2020 and 2030
  • Figure 29: Sales Forecast by Class for CF in the US in 2020 and 2030
  • Figure 30: Sales Forecast by Class for CF in the 5EU in 2020 and 2030
  • Figure 31: Sales Forecast by Class for CF in Canada in 2020 and 2030
目次
Product Code: GDHC225PIDR

Cystic fibrosis (CF) is an autosomal recessive disease characterized by pancreatic insufficiency and chronic endobronchial airway infection. The disease is caused by mutations in the CF transmembrane conductance regulator (CFTR) gene. The most common mutation is the deletion of phenylalanine at codon 508 (known as F508del). Recent progress in the understanding of the disease, increased newborn screening, and discovery of disease-modifying drugs have revolutionized the treatment approach and improved the quality of life and life expectancy of CF patients.

Marketed drugs currently available for CF target multiple aspects of the disease. Inhaled antibiotics are used for the treatment of chronic lung infections, mucolytic agents are used for reducing the viscosity of the mucus in the lungs, pancreatic enzyme replacement therapies (PERTs) are used for the treatment of CF-related Exocrine pancreatic insufficiency (EPI), and CFTR modulators enhance CFTR function, targeting the underlying cause of disease. The disease-modifying nature of CFTR modulators has transformed the treatment paradigm for CF over the last decade, a trend that is likely to persist.

Over the past decade, there have been significant changes in the CF market due to the development of CFTR modulator therapies that target the underlying cause of CF. The most recently launched CFTR modulator, Vertex Therapeutics' Trikafta/Kaftrio, is the first triple drug combination treatment and quickly became the gold standard soon after approval. However, GlobalData is expecting the emergence of a next-generation triple-combination CFTR modulator, Vertex's VX-121 + tezacaftor + VX-561 (deutivacaftor), to take over the market by the end of the forecast period.

GlobalData projects that the global CF market, which comprises the seven major pharmaceutical markets (7MM) (US, France, Germany, Italy, Spain, UK, and Canada), will experience growth during the forecast period, at a Compound Annual Growth Rate (CAGR) of 4.5%, with sales growing from $8.2B in 2020 to $12.7B in 2030.

The greatest drivers of growth in the global CF market include -

  • The continued uptake of high-priced Trikafta/Kaftrio and label expansion to a growing population of CF patients
  • The launch of VX-121 + tezacaftor + VX-561 (deutivacaftor) in 2025 in the US and in 2026 in the 5EU, a high-priced next-generation triple combination.
  • Continued growth of the CF patient population due to overall population growth across the 7MM and increasing life expectancy of CF patients.

The main barrier to growth in the CF market include -

  • Slow reimbursement for novel CFTR modulators in some 5EU countries and Canada.
  • Decreased usage of symptomatic drug classes such antibiotics, mucolytics, and anti-inflammatory drugs due to overall improvements to lung health following use of Trikafta/Kaftrio.
  • Lack of novel products entering the CF market in the mucolytic or inhaled drug class.
  • Key unmet needs include the lack of curative therapies, the need for better antibiotic regimens to fight lung infections, limited choice in mucolytic products, and low patient adherence to treatment.

KEY QUESTIONS ANSWERED

  • Which unmet needs are limiting the treatment of CF in the 7MM?
  • What strategies can the pharmaceutical industry employ to increase treatment rates for CF? How should these strategies differ across different geographical markets?
  • What effect will the launch of generics have on the sales of branded agents?
  • What are the main R&D trends in the CF market and which companies are leading the way?
  • Are there major differences in the mechanisms of action used by therapies in late-stage versus early-stage clinical development?

Scope

  • Overview of CF including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Topline CF market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.
  • Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting CF therapeutics sales in the 7MM.
  • Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global CF therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

The report will enable you to -

  • Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
  • Develop business strategies by understanding the trends shaping and driving the global CF therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CF 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.
  • Track drug sales in the global CF therapeutics market from 2020-2030.
  • 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 Cystic Fibrosis: Executive Summary

  • 1.1 CF Transmembrane Conductance Regulator Modulators Will Drive Substantial Growth in the Cystic Fibrosis Market from 2020-2030
  • 1.2 Vertex's Disease-Modifying Drugs Monopolize the CF Market
  • 1.3 Marketed CFTR Modulators Will Provide Appropriate Treatment for the Majority of the CF Population, but the High Unmet Needs Will Remain
  • 1.4 Opportunity for Pipeline Agents
  • 1.5 What Do Physicians Think?

2 Introduction

  • 2.1 Catalyst
  • 2.2 Related Reports
  • 2.3 Upcoming Reports

3 Disease Overview

  • 3.1 Etiology and Pathophysiology
    • 3.1.1 Etiology
    • 3.1.2 Pathophysiology
    • 3.1.3 Biomarkers/Targets of Interest
  • 3.2 Classification
  • 3.3 Symptoms
  • 3.4 Prognosis
  • 3.5 Quality of Life

4 Epidemiology

  • 4.1 Disease Background
  • 4.2 Risk Factors and Comorbidities
  • 4.3 Global and Historical Trends
    • 4.3.1 Registry-Based Diagnosed Prevalence of CF
    • 4.3.2 Registry-Based Diagnosed Prevalent Cases Adjusted for Underestimation
  • 4.4 Forecast Methodology
    • 4.4.1 Sources
    • 4.4.2 Sources Not Used
    • 4.4.3 Forecast Assumptions and Methods
    • 4.4.4 Registry-Based Diagnosed Prevalent Cases of CF
    • 4.4.5 Registry-Based Diagnosed Prevalent Cases of CF by Specific Mutation
    • 4.4.6 Registry-Based Diagnosed Prevalent Cases of CF with Chronic MRSA Infection
    • 4.4.7 Registry-Based Diagnosed Prevalent Cases Adjusted for Underestimation
  • 4.5 Epidemiological Forecast for CF (2020-2030)
    • 4.5.1 Registry-Based Diagnosed Prevalent Cases of CF
    • 4.5.2 Age-Specific Registry-Based Diagnosed Prevalent Cases of CF
    • 4.5.3 Sex-Specific Registry-Based Diagnosed Prevalent Cases of CF
    • 4.5.4 Registry-Based Diagnosed Prevalent Cases of CF with Specific Mutations
    • 4.5.5 Registry-Based Diagnosed Prevalent Cases of CF with Chronic MRSA Infection
    • 4.5.6 Registry-Based Diagnosed Prevalent Cases of CF Adjusted for Underestimation
    • 4.5.7 Age-Specific Registry-Based Diagnosed Prevalent Cases of CF Adjusted for Underestimation
    • 4.5.8 Sex-Specific Registry-Based Diagnosed Prevalent Cases of CF Adjusted for Underestimation
    • 4.5.9 Registry-Based Diagnosed Prevalent Cases of CF with Specific Mutations Adjusted for Underestimation
    • 4.5.10 Registry-Based Diagnosed Prevalent Cases of CF with Chronic MRSA Infection Adjusted for Underestimation
  • 4.6 Discussion
    • 4.6.1 Epidemiological Forecast Insight
    • 4.6.2 COVID-19 Impact
    • 4.6.3 Limitations of Analysis
    • 4.6.4 Strengths of Analysis

5 Disease Management

  • 5.1 Diagnosis and Treatment Overview
    • 5.1.1 Diagnosis
    • 5.1.2 Treatment Guidelines and Leading Prescribed Drugs
  • 5.2 KOL Insights on Disease Management
    • 5.2.1 Earlier Diagnosis and More Treatment Options Have Led to a CF Patient Population with Milder Disease
    • 5.2.2 Evaluation of Disease Severity
    • 5.2.3 Treatment Approach
    • 5.2.4 Transition from Pediatric to Adult Care

6 Competitive Assessment

  • 6.1 Overview

7 Unmet Needs and Opportunity Assessment

  • 7.1 Overview
  • 7.2 Development of More Effective or Curative Therapies
  • 7.3 Development of Chronic Lung Infection Therapies
  • 7.4 Development of Mucolytic Therapies
  • 7.5 Improvement of Treatment Compliance

8 R&D Strategies

  • 8.1 Overview
    • 8.1.1 Reformulation Strategies
    • 8.1.2 CFTR Modulators and Disease-Modifying Therapies
    • 8.1.3 Development of Anti-Inflammatory Drugs
  • 8.2 Clinical Trials Design
    • 8.2.1 Current Clinical Trials
    • 8.2.2 CFTR Modulator Clinical Trials

9 Pipeline Assessment

  • 9.1 Overview
  • 9.2 Promising Drugs in Clinical Development

10 Pipeline Valuation Analysis

  • 10.1 Overview
  • 10.2 Competitive Assessment
    • 10.2.1 CFTR Modulators
    • 10.2.2 Anti-inflammatory Agents

11 Current and Future Players

  • 11.1 Overview
  • 11.2 Deal-Making Trends

12 Market Outlook

  • 12.1 Global Markets
    • 12.1.1 Forecast
    • 12.1.2 Drivers and Barriers - Global Issues
  • 12.2 US
    • 12.2.1 Forecast
    • 12.2.2 Key Events
  • 12.3 5EU
    • 12.3.1 Forecast
    • 12.3.2 Key Events
  • 12.4 Canada
    • 12.4.1 Forecast
    • 12.4.2 Key Events

13 Appendix