PharmaPoint: Chronic Obstructive Pulmonary Disease – Global Drug Forecast and Market Analysis to 2025

Chronic obstructive pulmonary disease (COPD) is a progressive lung disease characterized by an abnormal inflammatory response and airflow obstruction that is not fully reversible. Chronic airflow limitation is caused by both small airway diseases, such as obstructive bronchiolitis, as well as parenchymal destruction, including emphysema. Research suggests that the pathogenesis of COPD involves both genetic and environmental factors. The fourth leading cause of death in the world, COPD progresses slowly and symptoms, including shortness of breath, wheezing, chest tightness, cough, and increased mucous production, worsen over time. Although it is currently unknown if the damage to the airways and lungs can be reversed, treatments and lifestyle changes can help slow the progress of the disease .

GlobalData estimates the 2015 sales for the COPD market at approximately $9.9 billion across the 8MM, encompassing the US, the five major European Union countries (5EU: France, Germany, Italy, Spain, and UK), Japan, and Australia. Over the course of the 10-year forecast period, the COPD market will grow at a Compound Annual Growth Rate (CAGR) of 3.7% across the 8MM. Each of the 8MM are anticipated to grow significantly, recording CAGRs of 3.7%, 5.2%, 4.3%, and 6.6% across the US, 5EU, Japan, and Australia, respectively. At the end of 2025, the US will account for 77.8% of sales across the 8MM, while the 5EU, Japan, and Australia will account for around 19.2%, 2.4%, and 0.7% of sales, respectively. The higher sales numbers for the US can be attributed to the higher prices of pharmaceuticals and the greater diagnosed prevalence of COPD in the region, as well as the anticipated high annual cost of therapy (ACOT) of GSK’s Nucala and AstraZeneca’s benralizumab in the US market.

Key Questions Answered

How will the COPD market landscape in the 8MM (US, France, Germany, Italy, Spain, UK , Japan, and Australia) change from 2015–2025?

What are the most promising late-stage pipeline drugs in COPD?

How do the clinical and commercial attributes of late-stage pipeline therapies compare with one another, and against existing treatment options?

What are the greatest unmet needs in COPD? Will the pipeline drugs fulfil these needs of the market?

What are the largest opportunities in the COPD landscape?

Scope

Overview of COPD, including epidemiology (mMRC and CAT patient population), etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

Topline COPD market revenue from 2015–2025. ACOT and major pipeline product sales in this forecast period are included.

Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting COPD therapeutics sales in the 8MM.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.

Analysis of the current and future market competition in the global COPD 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 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 global COPD therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the 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.

Companies mentioned

AstraZeneca

Boehringer Ingelheim

Chiesi

GSK

Novartis

Sunovion

AstraZeneca

Boehringer Ingelheim

Chiesi

GSK

Novartis

Sunovion

Table of Contents

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

2.1 Sales for COPD ...

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

2.1 Sales for COPD by Country, 2015–2025

2.2 AstraZeneca and GSK in the Spotlight of the COPD Market in 2025

2.3 Despite the Variety of Available Therapies, COPD Remains a Market with High Unmet Needs

2.4 Treatments that Reverse the Progression of COPD Remain Elusive

2.5 COPD Treatment Management Will Change in the Next 10 Years, but Treatment Outcomes Will Not

2.6 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Classification or Staging Systems

4.3 Symptoms

4.4 Asthma-COPD Overlap

4.5 Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast Assumptions and Methods

5.4.3 Total Prevalent Cases

5.4.4 Diagnosed Prevalent Cases

5.4.5 Diagnosed Prevalent Cases of COPD by Severity

5.5 Epidemiological Forecast for COPD (2015–2025)

5.5.1 Total Prevalent Cases of COPD

5.5.2 Age-Specific Total Prevalent Cases of COPD

5.5.3 Sex-Specific Total Prevalent Cases of COPD

5.5.4 Diagnosed Prevalent Cases of COPD

5.5.5 Age-Specific Diagnosed Prevalent Cases of COPD

5.5.6 Sex-Specific Diagnosed Prevalent Cases of COPD

5.5.7 Diagnosed Prevalent Cases of COPD by Severity

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of Analysis

5.6.3 Strengths of Analysis

6 Disease Management

6.1 Diagnosis and Treatment Overview

6.1.1 Diagnosis

6.1.2 Treatment Guidelines and Leading Prescribed Drugs

6.1.3 Clinical Practice

6.2 US

6.3 5EU

6.4 Japan

6.5 Australia

7 Competitive Assessment

7.1 Overview

7.2 Long-Acting Beta2 Agonists

7.2.1 Onbrez Breezhaler (indacaterol maleate)

7.2.2 Serevent Diskus (salmeterol xinafoate)

7.2.3 Striverdi Respimat (olodaterol hydrochloride)

7.2.4 Branded formoterol (formoterol fumarate)

7.2.5 Brovana (arformoterol tartrate)

7.3 Long-Acting Muscarinic Antagonists

7.3.1 Spiriva (tiotropium bromide)

7.3.2 Tudorza Pressair (aclidinium bromide)

7.3.3 Seebri Breezhaler (glycopyrrolate)

7.3.4 Incruse Ellipta (umeclidinium bromide)

7.4 LABA/LAMA Fixed-Dose Combinations

7.4.1 Ultibro Breezhaler (glycopyrrolate + indacaterol maleate)

7.4.2 Anoro Ellipta (umeclidinium bromide + vilanterol trifenatate)

7.4.3 Duaklir Genuair (aclidinium bromide + formoterol fumarate)

7.4.4 Stiolto Respimat (olodaterol hydrochloride + tiotropium bromide)

7.4.5 Bevespi Aerosphere (formoterol fumarate + glycopyrrolate)

7.5 Inhaled Corticosteroids/LABA Fixed-Dose Combinations

7.5.1 Advair Diskus (fluticasone propionate + salmeterol xinafoate)

7.5.2 Symbicort (budesonide + formoterol fumarate)

7.5.3 Breo Ellipta (fluticasone furoate + vilanterol trifenatate)

7.5.4 Fostair (beclomethasone dipropionate + formoterol fumarate)

7.6 Phosphodiesterase Inhibitors

7.6.1 Daliresp (roflumilast)

7.6.2 Other PDE4 Inhibitors

7.7 Short-Acting Beta2 Agonists

7.7.1 Overview

7.8 Short-Acting Muscarinic Antagonists

7.8.1 Overview

7.9 SABA/SAMA Fixed-Dose Combination

7.9.1 Overview

7.10 Off-Label Therapies

7.10.1 Asthma Therapies

7.11 Other Therapeutic Classes

8 Unmet Needs Assessment and Opportunity Analysis

8.1 Overview

8.2 Stakeholders’ Recognition of Symptoms

8.2.1 Unmet Need

8.2.2 Gap Analysis

8.2.3 Opportunity

8.3 Increased Spirometry Access and Training

8.3.1 Unmet Need

8.3.2 Gap Analysis

8.3.3 Opportunity

8.4 Treatment that Reverses Progression of COPD

8.4.1 Unmet Need

8.4.2 Gap Analysis

8.4.3 Opportunity

8.5 Identification of Biomarkers for Phenotype-Specific Treatment

8.5.1 Unmet Need

8.5.2 Gap Analysis

8.5.3 Opportunity

8.6 Insufficient Access to Pulmonary Rehabilitation Services

8.6.1 Unmet Need

8.6.2 Gap Analysis

8.6.3 Opportunity

8.7 Smoking Cessation Programs

8.7.1 Unmet Need

8.7.2 Gap Analysis

8.7.3 Opportunity

9 Pipeline Assessment

9.1 Overview

9.2 Clinical Trial Mapping

9.2.1 Clinical Trials by Class

9.3 Promising Drugs in Clinical Development

9.4 LAMAs

9.4.1 SUN-101 (glycopyrrolate)

9.4.2 Revefenacin

9.5 ICS/LABA/LAMA Fixed-Dose Combinations

9.5.1 CHF-5993 (beclomethasone dipropionate + formoterol fumarate + glycopyrrolate)

9.5.2 PT-010 (budesonide + formoterol fumarate + glycopyrrolate)

9.5.3 FF/UMEC/VI (fluticasone furoate + umeclidinium bromide + vilanterol trifenatate)

9.6 IL-5 Inhibitors

9.6.1 Nucala (mepolizumab)

9.6.2 Benralizumab

9.7 Other Drugs in Development

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Company Profiles

10.3.1 AstraZeneca

10.3.2 Boehringer Ingelheim

10.3.3 Chiesi

10.3.4 GlaxoSmithKline

10.3.5 Novartis

10.3.6 Sunovion

11 Market Outlook

11.1 Global Markets

11.1.1 Forecast Based on mMRC Patient Population

11.1.2 Forecast Based on CAT Patient Population

11.1.3 Drivers and Barriers – Global Issues

11.2 US

11.2.1 Forecast Based on mMRC Patient Population

11.2.2 Key Events

11.2.3 Drivers and Barriers

11.3 5EU

11.3.1 Forecast Based on mMRC Patient Population

11.3.2 Key Events

11.3.3 Drivers and Barriers

11.4 Japan

11.4.1 Forecast Based on mMRC Patient Population

11.4.2 Key Events

11.4.3 Drivers and Barriers

11.5 Australia

11.5.1 Forecast Based on mMRC Patient Population

11.5.2 Key Events

11.5.3 Drivers and Barriers

12 Appendix

12.1 Bibliography

12.2 Abbreviations

12.3 Methodology

12.4 Forecasting Methodology

12.4.1 Diagnosed COPD Patients

12.4.2 Diagnosed Prevalent Cases of COPD by Severity

12.4.3 Percent Drug-Treated Patients

12.4.4 Drugs Included in Each Therapeutic Class

12.4.5 Launch and Patent Expiry Dates

12.4.6 General Pricing Assumptions

12.4.7 Individual Drug Assumptions

12.4.8 Generic Erosion

12.4.9 Pricing of Pipeline Agents

12.5 Primary Research – KOLs Interviewed for this Report

12.5.1 KOLs

12.6 Primary Research – Prescriber Survey

12.7 About the Authors

12.7.1 Analyst

12.7.2 Therapy Area Director

12.7.3 Epidemiologist

12.7.4 Managing Epidemiologist

12.7.5 Global Director of Therapy Analysis and Epidemiology

12.7.6 Global Head of Healthcare

12.8 About GlobalData

12.9 Contact Us

12.10 Disclaimer

List of Tables

Table 1: COPD: Key Metrics in the Eight Major Pharmaceutical Markets

Table 2: GOLD Criteria for the Classification of COPD, 2016

Table 3: Symptoms of ...

Table 1: COPD: Key Metrics in the Eight Major Pharmaceutical Markets

Table 2: GOLD Criteria for the Classification of COPD, 2016

Table 3: Symptoms of COPD

Table 4: Modified MRC Dyspnea Index

Table 5: Common Comorbidities of COPD

Table 6: Risk Factors and Comorbidities for COPD

Table 7: New GOLD 2011 criteria for COPD severity stages

Table 8: Total prevalent cases of COPD for selected years during the forecast period for the 8MM.

Table 9: Age-specific total prevalent cases of COPD for both sexes combined in the 8MM in 2015.

Table 10: Diagnosed prevalent cases of COPD for selected years during the forecast period for the 8MM.

Table 11: Age-specific diagnosed prevalent cases of COPD for both sexes combined in the 8MM in 2015.

Table 12: Treatment Guidelines for COPD

Table 13: Most Prescribed Drugs for COPD by Class in the Global Markets, 2015

Table 14: Country Profile – US, 2015

Table 15: Region Profile – 5EU, 2015

Table 16: Country Profile – Japan, 2015

Table 17: Country Profile – Australia, 2015

Table 18: Leading Treatments for COPD, 2017

Table 19: Product Profile – Onbrez Breezhaler

Table 20: Efficacy of Onbrez Breezhaler in COPD

Table 21: Safety of Onbrez Breezhaler

Table 22: Onbrez Breezhaler SWOT Analysis, 2017

Table 23: Product Profile – Serevent

Table 24: Efficacy of Serevent in COPD

Table 25: Safety of Serevent

Table 26: Serevent SWOT Analysis, 2017

Table 27: Product Profile – Striverdi Respimat

Table 28: Efficacy of Striverdi Respimat in COPD

Table 29: Safety of Striverdi Respimat

Table 30: Striverdi Respimat SWOT Analysis, 2017

Table 31: Overview of the Leading Branded Foroterol Products for COPD Treatment, 2017

Table 32: Efficacy of Formoterol in COPD

Table 33: Safety of Formoterol

Table 34: Branded formoterol SWOT Analysis, 2017

Table 35: Product Profile – Brovana

Table 36: Efficacy of Brovana in COPD

Table 37: Safety of Brovana

Table 38: Brovana SWOT Analysis, 2017

Table 39: Product Profile – Spiriva

Table 40: Efficacy of Spiriva in COPD

Table 41: Spiriva SWOT Analysis, 2017

Table 42: Product Profile – Tudorza Pressair

Table 43: Efficacy of Tudorza Pressair in COPD

Table 44: Safety of Tudorza Pressair

Table 45: Tudorza Pressair SWOT Analysis, 2017

Table 46: Product Profile – Seebri Breezhaler

Table 47: Efficacy of Seebri Breezhaler in COPD

Table 48: Safety of Seebri Breezhaler

Table 49: Seebri Breezhaler SWOT Analysis, 2017

Table 50: Product Profile – Incruse Ellipta

Table 51: Efficacy of Incruse Ellipta in COPD

Table 52: Safety of Incruse Ellipta

Table 53: Incruse Ellipta SWOT Analysis, 2017

Table 54: Product Profile – Ultibro Breezhaler

Table 55: Efficacy of Ultibro Breezhaler in COPD

Table 56: Safety of Ultibro Breezhaler

Table 57: Ultibro Breezhaler SWOT Analysis, 2017

Table 58: Product Profile – Anoro Ellipta

Table 59: Efficacy of Anoro Ellipta in COPD

Table 60: Safety of Anoro Ellipta

Table 61: Anoro Ellipta SWOT Analysis, 2017

Table 62: Product Profile – Duaklir Genuair

Table 63: Efficacy of Duaklir Genuair in COPD

Table 64: Safety of Duaklir Genuair

Table 65: Duaklir Genuair SWOT Analysis, 2017

Table 66: Product Profile – Stiolto Respimat

Table 67: Efficacy of Stiolto Respimat in COPD

Table 68: Safety of Stiolto Respimat

Table 69: Stiolto Respimat SWOT Analysis, 2017

Table 70: Product Profile – Bevespi Aerosphere

Table 71: Efficacy of Bevespi Aerosphere in COPD

Table 72: Bevespi Aerosphere SWOT Analysis, 2017

Table 73: Product Profile – Advair Diskus

Table 74: Efficacy of Advair Diskus in COPD

Table 75: Safety of Advair Diskus

Table 76: Advair Diskus SWOT Analysis, 2017

Table 77: Product Profile – Symbicort

Table 78: Efficacy of Symbicort in COPD

Table 79: Safety of Symbicort

Table 80: Symbicort SWOT Analysis, 2017

Table 81: Product Profile – Breo Ellipta

Table 82: Efficacy of Breo Ellipta in COPD

Table 83: Safety of Breo Ellipta

Table 84: Breo Ellipta SWOT Analysis, 2017

Table 85: Product Profile – Fostair

Table 86: Efficacy of Fostair pMDI in COPD

Table 87: Safety of Fostair pMDI

Table 88: Fostair SWOT Analysis, 2017

Table 89: Product Profile – Daliresp

Table 90: Efficacy of Daliresp in COPD

Table 91: Safety of Daliresp

Table 92: Daliresp SWOT Analysis, 2017

Table 93: Overview of Additional PDE4 Inhibitors for COPD Treatment, 2017

Table 94: Overview of the Leading SABA Therapies for COPD Treatment, 2017

Table 95: Overview of the Leading SABA Therapies for COPD Treatment, 2017

Table 96: Overview of the Leading SABA/SAMA Therapies for COPD Treatment, 2017

Table 97: Summary of Off-Label Asthmatic Therapies Prescribed for COPD, 2015

Table 98: Summary of Minor Therapeutic Classes, 2017

Table 99: Unmet Need and Opportunity in COPD, 2017

Table 100: Key Late-Stage Pipeline Agents for COPD, 2017

Table 101: Product Profile – SUN-101

Table 102: SUN-101 SWOT Analysis, 2017

Table 103: Product Profile – Revefenacin

Table 104: Revefenacin SWOT Analysis, 2017

Table 105: Product Profile – CHF-5993

Table 106: Efficacy of CHF-5993 in COPD

Table 107: Safety of CHF-5993

Table 108: CHF-5993 SWOT Analysis, 2017

Table 109: Product Profile – PT-010

Table 110: PT-010 SWOT Analysis, 2017

Table 111: Product Profile – FF/UMEC/VI

Table 112: Efficacy of FF/UMEC/VI in COPD

Table 113: FF/UMEC/VI SWOT Analysis, 2017

Table 114: Product Profile – Nucala

Table 115: Efficacy of Nucala Versus Placebo in Asthma

Table 116: Safety of Nucala in Asthma

Table 117: Nucala SWOT Analysis, 2017

Table 118: Product Profile – Benralizumab

Table 119: Safety of Benralizumab

Table 120: Benralizumab SWOT Analysis, 2017

Table 121: Drugs in Development for COPD, 2016

Table 122: Key Companies in the COPD Market in the 8MM, 2017

Table 123: AstraZeneca’s COPD Portfolio Assessment, 2017

Table 124: Boehringer Ingelheim’s COPD Portfolio Assessment, 2017

Table 125: Chiesi’s COPD Portfolio Assessment, 2017

Table 126: GSK’s COPD Portfolio Assessment, 2017

Table 127: Novartis’ COPD Portfolio Assessment, 2017

Table 128: Sunovion’s COPD Portfolio Assessment, 2017

Table 129: COPD Market – Global Drivers and Barriers, 2015‒2025

Table 130: Key Events Impacting Sales for COPD in the US, 2015–2025

Table 131: COPD Market – Drivers and Barriers in the US, 2015‒2025

Table 132: Key Events Impacting Sales for COPD in the 5EU, 2015–2025

Table 133: COPD Market – Drivers and Barriers in the 5EU, 2015‒2025

Table 134: Key Events Impacting Sales for COPD in Japan, 2015–2025

Table 135: COPD Market – Drivers and Barriers in Japan, 2015‒2025

Table 136: Key Events Impacting Sales for COPD in Australia, 2015–2025

Table 137: COPD Market – Drivers and Barriers in Australia, 2015‒2025

Table 138: Key Historical and Projected Launch Dates for COPD

Table 139: Key Patent Expiry Dates for COPD

Table 140: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales for COPD by Country, 2015 and 2025

Figure 2: Company Portfolio Gap Analysis in COPD, 2015–2025

Figure 3: Competitive Assessment ...

Figure 1: Global Sales for COPD by Country, 2015 and 2025

Figure 2: Company Portfolio Gap Analysis in COPD, 2015–2025

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in COPD, 2015–2025

Figure 4: Normal Lungs and Lungs with COPD

Figure 5: Etiology of COPD

Figure 6: The Pathogenesis of COPD

Figure 7: Refined ABCD Assessment Tool for COPD, 2017

Figure 8: 8MM, Age-Standardized Total Prevalence of COPD (%), Ages ≥35 Years, 2015

Figure 9: 8MM, Age-Standardized Diagnosed Prevalence of COPD (%), Ages ≥35 Years, 2015

Figure 10: 8MM, Sources Used and Not Used to Forecast Total Prevalent Cases of COPD

Figure 11: 8MM, Sources Used and Not Used to Forecast Diagnosed Prevalent Cases of COPD

Figure 12: 8MM, Sources Used to Forecast the new GOLD 2011 Severity Stages Among the Diagnosed Prevalent Cases of COPD

Figure 13: 8MM, Age-Specific Total Prevalent Cases of COPD, Both Sexes, N, 2015

Figure 14: 8MM, Sex-Specific Total Prevalent Cases of COPD, Both Sexes, N, 2015

Figure 15: 8MM, Age-Specific Diagnosed Prevalent Cases of COPD, Both Sexes, N, 2015

Figure 16: 8MM, Sex-Specific Diagnosed Prevalent Cases of COPD, Both Sexes, N, 2015

Figure 17: 8MM, Diagnosed Prevalent Cases of COPD by the GOLD Severity Stage (Using mMRC), Both Sexes, 2015

Figure 18: 8MM, Diagnosed Prevalent Cases of COPD by the GOLD Severity Stage (Using CAT), Both Sexes, 2015

Figure 19: Pathway to the Diagnosis of COPD

Figure 20: COPD Treatment Algorithm

Figure 21: COPD Therapeutics ‒ Class of Therapy, 2017

Figure 22: COPD – Phase III Pipeline, 2017

Figure 23: Competitive Assessment of Late-Stage Pipeline Agents in COPD, 2015–2025

Figure 24: Global Sales of Branded Products for COPD by Company, 2015 and 2025

Figure 25: Company Portfolio Gap Analysis in COPD, 2015–2025

Figure 26: Global mMRC Sales for COPD by Country, 2015 and 2025

Figure 27: Sales for COPD by Drug Class in the US, 2015 and 2025

Figure 28: Sales for COPD by Drug Class in the 5EU, 2015 and 2025

Figure 29: Sales for COPD by Drug Class in Japan, 2015 and 2025

Figure 30: Sales for COPD by Drug Class in Australia, 2015 and 2025

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