慢性閉塞性肺疾患（COPD）：主要7ヶ国市場の薬剤予測と市場分析

慢性閉塞性肺疾患（COPD）治療薬の市場規模は2023年から2033年にかけて安定した成長が見込まれ、予測期間全体の年間平均成長率（CAGR）は10.3%になるとみられています。また、2023年のCOPD市場規模は主要7ヶ国市場全体で115億米ドル、米国が市場の79.4%を占めました。EU5ヶ国は20億米ドルで世界のCOPD市場の17.5%を占め、日本のCOPD市場は2023年に3億6,100万米ドル、市場の3.1%を占めました。

予測期間中、COPD市場は2033年には308億米ドル規模に成長すると予測され、米国は世界市場の78.9%を占め、市場規模は243億米ドルと予測されています。米国はCAGR 10.3%で成長し、英国はCAGR 15.3%でこの期間に最も急成長し、2033年には市場価値8億5,400万米ドルに達すると予測されています。

予測期間中にサノフィとリジェネロンのデュピクセントを含む抗好酸球生物学的製剤が参入することで、これらの治療薬が獲得する患者シェアは低いとはいえ、COPD全体の売上が押し上げられます。これらの治療薬は好酸球の多いCOPD患者にのみ適応されまするが、単価は高いものとなっています。

当レポートでは、主要7ヶ国のCOPD市場について調査し、疾患の概要とともに、疫学動向、現在の治療法とアンメットニーズ、パイプライン動向などについてまとめています。

目次

第1章 慢性閉塞性肺疾患：エグゼクティブサマリー

第2章 イントロダクション

第3章 疾患の概要

• 病因と病態生理学
• 2016 GOLD分類またはステージングシステム
• 2023年の新GOLD分類システム
• 症状
• 喘息とCOPDの重複

第4章 疫学

• 病気の背景
• リスク要因と併存疾患
• 世界と歴史の動向
• 予測調査手法
• COPDの疫学的予測
• 議論

第5章 疾病管理

• 診断と治療の概要
• 米国
• EU
• 日本

第6章 現在の治療オプション

第7章 アンメットニーズと機会の評価

• 概要
• COPDの進行を逆転させる疾患修飾治療
• スパイロメトリーへのアクセスとトレーニングの不足
• COPDのバイオマーカー
• 臨床試験デザインの改善
• 早期診断と認識

第8章 研究開発戦略

• 概要
• 臨床試験の設計

第9章 パイプライン評価

• 概要
• 臨床開発中の有望な薬剤

第10章 パイプライン評価分析

• 概要
• 競争力評価

第11章 現在の参入企業と将来の参入企業

• 概要
• 取引の動向

第12章 市場見通し

• 世界市場
• 米国
• EU5ヶ国
• 日本

第13章 付録

List of Tables

• Table 1: COPD - Key metrics in the 7MM
• Table 2: GOLD criteria for the classification of COPD, 2018
• Table 3: Symptoms of COPD
• Table 4: Modified mMRC Dyspnea Scale
• Table 5: Risk factors and comorbidities for COPD
• Table 6 Treatment guidelines for COPD
• Table 7 Country profile - US, 2023
• Table 8 Region profile - 5EU, 2023
• Table 9 Country profile - Japan, 2023
• Table 10: Top 10 deals by value, 2019-2024
• Table 11: COPD market - global drivers and barriers, 2023-2033
• Table 12: Key events impacting sales for COPD in the US, 2023-2033
• Table 13: COPD market - drivers and barriers in the US, 2023-2033
• Table 14: Key events impacting sales for COPD in the 5EU, 2023-2033
• Table 15: COPD market - drivers and barriers in the 5EU, 2023-2033
• Table 16: Key events impacting sales for COPD in Japan, 2023-2033
• Table 17: COPD market - drivers and barriers in Japan, 2023-2033
• Table 18: High-prescribing physicians (non-KOLs) surveyed, by country

List of Figures

• Figure 1: Global sales forecast by country for COPD in 2023 and 2033
• Figure 2: Analysis of the company portfolio gap in COPD during the forecast period
• Figure 3: Competitive assessment of the late-stage pipeline agents that GlobalData expects to be licensed for the treatment of COPD during the forecast period
• Figure 4: Normal lungs and lungs with COPD
• Figure 5: The pathogenesis of COPD
• Figure 6: 2023 GOLD classification and segmentation of COPD patients
• Figure 7: 7MM, total prevalence of COPD (%), men and women, ages >=35 years, 2023
• Figure 8: 7MM, diagnosed prevalence of COPD (%), men and women, ages >=35 years, 2023
• Figure 9: 7MM, sources used and not used to forecast the total prevalent cases of COPD
• Figure 10: 7MM, sources used and not used to forecast the diagnosed prevalent cases of COPD
• Figure 11: 7MM, sources used and not used to forecast the diagnosed prevalent cases of COPD by severity - GOLD 2016 criteria using mMRC score
• Figure 12: 7MM, sources used and not used to forecast the diagnosed prevalent cases of COPD by severity - GOLD 2016 criteria using CAT score
• Figure 13: 7MM, sources used to forecast the diagnosed prevalent cases of COPD by severity - GOLD 2023 criteria using mMRC or CAT scores
• Figure 14: 7MM, total prevalent cases of COPD, N, both sexes, ages >=35 years, 2023
• Figure 15: 7MM, diagnosed prevalent cases of COPD, N, both sexes, ages >=35 years, 2023
• Figure 16: 7MM, diagnosed prevalent cases of COPD by age, N, both sexes, 2023
• Figure 17: 7MM, diagnosed prevalent cases of COPD by sex, N, ages >=35 years, 2023
• Figure 18: 7MM, diagnosed prevalent cases of COPD by GOLD 2016 criteria using mMRC score, N, both sexes, ages >=35 years, 2023
• Figure 19: 7MM, diagnosed prevalent cases of COPD by GOLD 2016 criteria using CAT score, N, both sexes, ages >=35 years, 2023
• Figure 20: 7MM, diagnosed prevalent cases of COPD by GOLD 2023 criteria using mMRC score, N, both sexes, ages >=35 years, 2023
• Figure 21: 7MM, diagnosed prevalent cases of COPD by GOLD 2023 criteria using CAT score, N, both sexes, ages >=35 years, 2023
• Figure 22: COPD initial treatment algorithm according to 2023 GOLD guidelines
• Figure 23: Pharmacological treatment of COPD patients in the follow-up algorithm
• Figure 24: Unmet needs and opportunities in COPD
• Figure 25: Overview of the development pipeline in COPD
• Figure 26: Key Phase II/III trials for promising pipeline agents
• Figure 27: Competitive assessment of the marketed and pipeline small molecules benchmarked against Roflumilast
• Figure 28: Competitive assessment of the marketed and pipeline biologics benchmarked against Dupixent
• Figure 29: Analysis of the company portfolio gap in COPD during the forecast period
• Figure 30: Global (7MM) sales forecast by country for COPD in 2023 and 2033
• Figure 31: Sales forecast by class for COPD in the US, 2023 and 2033
• Figure 32: Sales forecast by class for COPD in the 5EU, 2023 and 2033
• Figure 33: Sales forecast by class for COPD in Japan, 2023 and 2033

This report covers the 7MM (US, France, Germany, Italy, Spain, UK, Japan) and provides an Excel-based forecast model for the COPD market through 2033.

Drug sales in the COPD drug market are expected to grow at a steady rate between 2023 and 2033, with an overall compound annual growth rate (CAGR) of 10.3% over the forecast period. In 2023, GlobalData estimated the total COPD market to be valued at $11.5 billion across the 7MM, with the US accounting for 79.4% of the market. The 5EU accounted for 17.5% of the global COPD market with an estimated value of $2.0 billion, and Japan's COPD market was estimated to be $361 million in 2023, accounting for 3.1% of the market.

Over the forecast period, the COPD market is anticipated to grow to a value of $30.8 billion in 2033, with the US anticipated to account for 78.9% of the global market and a market value of $24.3 billion. The US is forecast to grow at a CAGR of 10.3%, while the UK is anticipated to experience the fastest growth during this period with a CAGR of 15.3%, to reach a market value of $854 million by 2033.

Major drivers of growth in the COPD market during the forecast period include the following -

• The entry of anti-eosinophilic biologics, including Sanofi and Regeneron's Dupixent, over the forecast period will boost overall COPD sales despite the low patient share that these therapies will acquire. These therapies are only suitable for COPD patients with high levels of eosinophilia, but hold a high price per unit.
• Publication and changes made to the Global Initiative for Chronic Obstructive Lung Diseases (GOLD) guidelines for therapies prescribed to GOLD E patients means an increase in inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) triple therapy use, as advised by the GOLD committee over the forecast period.
• The number of people with COPD and percentage of the drug-treated population will rise across the 7MM over the forecast period due to better awareness of COPD.

Major barriers to growth in the COPD market during the forecast period will include the following:

• The publication of GOLD guidelines and changes in the therapies given to GOLD E patients means there will be a decline in ICS/LABA being prescribed to patients over the forecast period.
• The introduction of an inhaler price cap by several pharmaceutical companies over the forecast period on various bronchodilators will mean overall sales may decrease over the forecast period, as therapies are cheaper.
• There may be low patient compliance to inhaler therapies due to the frequency of administration and dosing.

Key Highlights

• Report deliverables include a PDF report and Excel-based forecast model
• Forecasts includes the 7MM
• Forecasts covers from 2023-2033

Scope

• Overview of COPD - including epidemiology, disease etiology, management and Asthma-COPD Overlap (ACO).
• Topline COPD drugs market revenue, annual cost of therapy, and anticipated sales for major late-stage pipeline drugs.
• Key topics covered include assessment of marketed and pipeline therapies, unmet needs, current and future players and market outlook for the US, 5EU and Japan over the 10-year forecast period.
• Pipeline analysis: Emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
• Analysis of the current and future market competition in the global COPD therapeutics market. Insightful review of the key industry drivers and barriers.

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 7MM COPD therapeutics market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the 7MM COPD therapeutics 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

• About GlobalData

1 Chronic Obstructive Pulmonary Disease: Executive Summary

• 1.1 The COPD market will show steady growth during the forecast period, reaching sales of $30.8 billion in 2033
• 1.2 GSK, AstraZeneca, and Sanofi/Regeneron competing for first place in 2033
• 1.3 COPD remains a market with high unmet need.
• 1.4 Lack of established biomarkers for COPD
• 1.5 Late-stage COPD pipeline therapies to target a niche population.
• 1.6 What do physicians think?

2 Introduction

• 2.1 Catalyst
• 2.2 Related reports
• 2.3 Upcoming related reports

3 Disease Overview

• 3.1 Etiology and pathophysiology
  • 3.1.1 Etiology
  • 3.1.2 Pathophysiology
• 3.2 2016 GOLD classification or staging systems
• 3.3 New 2023 GOLD classification system
  • 3.3.1 US key opinion leader insights
  • 3.3.2 EU key opinion leader insights
  • 3.3.3 Japan key opinion leader insights
• 3.4 Symptoms
• 3.5 Asthma-COPD overlap
  • 3.5.1 Definition of asthma-COPD overlap
  • 3.5.2 Etiology and pathophysiology
  • 3.5.3 Key opinion leader insights on asthma-COPD overlap

4 Epidemiology

• 4.1 Disease background
• 4.2 Risk factors and comorbidities.
• 4.3 Global and historical trends
• 4.4 Forecast methodology.
  • 4.4.1 Sources
  • 4.4.2 Forecast assumptions and methods.
  • 4.4.3 Forecast assumptions and methods: total prevalent cases of COPD - 7MM.
  • 4.4.4 Forecast assumptions and methods: diagnosed prevalent cases of COPD
  • 4.4.5 Forecast assumptions and methods: diagnosed prevalent cases of COPD by severity - GOLD 2016 criteria using mMRC score
  • 4.4.6 Forecast assumptions and methods: diagnosed prevalent cases of COPD by severity - GOLD 2016 criteria using CAT score.
  • 4.4.7 Forecast assumptions and methods: diagnosed prevalent cases of COPD by severity - GOLD 2023 criteria using mMRC/CAT scores.
• 4.5 Epidemiological forecast for COPD
  • 4.5.1 Total prevalent cases of COPD
  • 4.5.2 Diagnosed prevalent cases of COPD
  • 4.5.3 Age-specific diagnosed prevalent cases of COPD
  • 4.5.4 Sex-specific diagnosed prevalent cases of COPD
  • 4.5.5 Diagnosed prevalent cases of COPD by GOLD 2016 criteria using mMRC score
  • 4.5.6 Diagnosed prevalent cases of COPD by GOLD 2016 criteria using CAT score
  • 4.5.7 Diagnosed prevalent cases of COPD by GOLD 2023 criteria using mMRC score
  • 4.5.8 Diagnosed prevalent cases of COPD by GOLD 2023 criteria using CAT score
• 4.6 Discussion
  • 4.6.1 Epidemiological forecast insight
  • 4.6.2 COVID-19 impact
  • 4.6.3 Limitations of the analysis
  • 4.6.4 Strengths of the analysis

5 Disease Management

• 5.1 Diagnosis and treatment overview
• 5.2 US
• 5.3 EU
• 5.4 Japan

6 Current Treatment Options

• 6.1 Overview

7 Unmet Needs and Opportunity Assessment

• 7.1 Overview
• 7.2 Disease-modifying treatments to reverse the progression of COPD
• 7.3 Lack of access and training of spirometry
• 7.4 Biomarkers for COPD
• 7.5 Improved clinical trial design
• 7.6 Earlier diagnosis and recognition

8 R&D Strategies

• 8.1 Overview
  • 8.1.1 Focus on type 2 inflammation with biologics
  • 8.1.2 Focus on treatment of exacerbators
• 8.2 Clinical trials design
  • 8.2.1 Defining the primary endpoints
  • 8.2.2 Innovative trial design
  • 8.2.3 Phenotyping in COPD 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

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
  • 12.2.3 Drivers and barriers
• 12.3 5EU
  • 12.3.1 Forecast
  • 12.3.2 Key events
  • 12.3.3 Drivers and barriers
• 12.4 Japan
  • 12.4.1 Forecast
  • 12.4.2 Key events
  • 12.4.3 Drivers and barriers

13 Appendix

• 13.1 Bibliography
• 13.2 Abbreviations
• 13.3 Methodology
  • 13.3.1 Forecasting methodology
• 13.4 Primary research - key opinion leaders interviewed for this report
  • 13.4.1 Key opinion leaders
• 13.5 Primary research - prescriber survey
• 13.6 About the authors
  • 13.6.1 Analyst
  • 13.6.2 Therapy Area Director
  • 13.6.3 Epidemiologist
  • 13.6.4 Managing Epidemiologist
  • 13.6.5 Vice President of Disease Intelligence and Epidemiology
  • 13.6.6 Global Head of Pharma Research, Analysis, and Competitive Intelligence
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