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

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


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Executive Summary

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

Summary

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.



Read More



Contact Us:
Ken Research
Ankur Gupta, Head Marketing & Communications

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1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 8

1.2 List of Figures 11

2 Executive Summary 12

2.1 Sales for COPD by Country, 2015-2025 13

2.2 AstraZeneca and GSK in the Spotlight of the COPD Market in 2025 15

2.3 Despite the Variety of Available Therapies, COPD Remains a Market with High Unmet Needs 16

2.4 Treatments that Reverse the Progression of COPD Remain Elusive 17

2.5 COPD Treatment Management Will Change in the Next 10 Years, but Treatment Outcomes Will Not 17

2.6 What Do Physicians Think? 18

3 Introduction 21

3.1 Catalyst 21

3.2 Related Reports 21

4 Disease Overview 22

4.1 Etiology and Pathophysiology 22

4.1.1 Etiology 23

4.1.2 Pathophysiology 24

4.2 Classification or Staging Systems 27

4.3 Symptoms 28

4.4 Asthma-COPD Overlap 31

4.5 Quality of Life 32

5 Epidemiology 33

5.1 Disease Background 33

5.2 Risk Factors and Comorbidities 34

5.3 Global and Historical Trends 36

5.4 Forecast Methodology 38

5.4.1 Sources 40

5.4.2 Forecast Assumptions and Methods 42

5.4.3 Total Prevalent Cases 43

5.4.4 Diagnosed Prevalent Cases 46

5.4.5 Diagnosed Prevalent Cases of COPD by Severity 49

5.5 Epidemiological Forecast for COPD (2015-2025) 51

5.5.1 Total Prevalent Cases of COPD 51

5.5.2 Age-Specific Total Prevalent Cases of COPD 52

5.5.3 Sex-Specific Total Prevalent Cases of COPD 54

5.5.4 Diagnosed Prevalent Cases of COPD 54

5.5.5 Age-Specific Diagnosed Prevalent Cases of COPD 55

5.5.6 Sex-Specific Diagnosed Prevalent Cases of COPD 57

5.5.7 Diagnosed Prevalent Cases of COPD by Severity 57

5.6 Discussion 59

5.6.1 Epidemiological Forecast Insight 59

5.6.2 Limitations of Analysis 60

5.6.3 Strengths of Analysis 60

6 Disease Management 62

6.1 Diagnosis and Treatment Overview 62

6.1.1 Diagnosis 62

6.1.2 Treatment Guidelines and Leading Prescribed Drugs 63

6.1.3 Clinical Practice 67

6.2 US 68

6.3 5EU 70

6.4 Japan 73

6.5 Australia 74

7 Competitive Assessment 76

7.1 Overview 76

7.2 Long-Acting Beta2 Agonists 77

7.2.1 Onbrez Breezhaler (indacaterol maleate) 78

7.2.2 Serevent Diskus (salmeterol xinafoate) 84

7.2.3 Striverdi Respimat (olodaterol hydrochloride) 88

7.2.4 Branded formoterol (formoterol fumarate) 93

7.2.5 Brovana (arformoterol tartrate) 97

7.3 Long-Acting Muscarinic Antagonists 101

7.3.1 Spiriva (tiotropium bromide) 101

7.3.2 Tudorza Pressair (aclidinium bromide) 108

7.3.3 Seebri Breezhaler (glycopyrrolate) 112

7.3.4 Incruse Ellipta (umeclidinium bromide) 118

7.4 LABA/LAMA Fixed-Dose Combinations 122

7.4.1 Ultibro Breezhaler (glycopyrrolate + indacaterol maleate) 123

7.4.2 Anoro Ellipta (umeclidinium bromide + vilanterol trifenatate) 128

7.4.3 Duaklir Genuair (aclidinium bromide + formoterol fumarate) 133

7.4.4 Stiolto Respimat (olodaterol hydrochloride + tiotropium bromide) 137

7.4.5 Bevespi Aerosphere (formoterol fumarate + glycopyrrolate) 142

7.5 Inhaled Corticosteroids/LABA Fixed-Dose Combinations 145

7.5.1 Advair Diskus (fluticasone propionate + salmeterol xinafoate) 146

7.5.2 Symbicort (budesonide + formoterol fumarate) 151

7.5.3 Breo Ellipta (fluticasone furoate + vilanterol trifenatate) 156

7.5.4 Fostair (beclomethasone dipropionate + formoterol fumarate) 160

7.6 Phosphodiesterase Inhibitors 164

7.6.1 Daliresp (roflumilast) 164

7.6.2 Other PDE4 Inhibitors 170

7.7 Short-Acting Beta2 Agonists 170

7.7.1 Overview 170

7.8 Short-Acting Muscarinic Antagonists 171

7.8.1 Overview 171

7.9 SABA/SAMA Fixed-Dose Combination 172

7.9.1 Overview 172

7.10 Off-Label Therapies 173

7.10.1 Asthma Therapies 173

7.11 Other Therapeutic Classes 174

8 Unmet Needs Assessment and Opportunity Analysis 177

8.1 Overview 177

8.2 Stakeholders' Recognition of Symptoms 179

8.2.1 Unmet Need 179

8.2.2 Gap Analysis 180

8.2.3 Opportunity 181

8.3 Increased Spirometry Access and Training 181

8.3.1 Unmet Need 181

8.3.2 Gap Analysis 183

8.3.3 Opportunity 183

8.4 Treatment that Reverses Progression of COPD 183

8.4.1 Unmet Need 183

8.4.2 Gap Analysis 184

8.4.3 Opportunity 185

8.5 Identification of Biomarkers for Phenotype-Specific Treatment 185

8.5.1 Unmet Need 185

8.5.2 Gap Analysis 186

8.5.3 Opportunity 187

8.6 Insufficient Access to Pulmonary Rehabilitation Services 187

8.6.1 Unmet Need 187

8.6.2 Gap Analysis 188

8.6.3 Opportunity 188

8.7 Smoking Cessation Programs 189

8.7.1 Unmet Need 189

8.7.2 Gap Analysis 190

8.7.3 Opportunity 190

9 Pipeline Assessment 191

9.1 Overview 191

9.2 Clinical Trial Mapping 191

9.2.1 Clinical Trials by Class 191

9.3 Promising Drugs in Clinical Development 192

9.4 LAMAs 195

9.4.1 SUN-101 (glycopyrrolate) 195

9.4.2 Revefenacin 199

9.5 ICS/LABA/LAMA Fixed-Dose Combinations 203

9.5.1 CHF-5993 (beclomethasone dipropionate + formoterol fumarate + glycopyrrolate) 203

9.5.2 PT-010 (budesonide + formoterol fumarate + glycopyrrolate) 209

9.5.3 FF/UMEC/VI (fluticasone furoate + umeclidinium bromide + vilanterol trifenatate) 212

9.6 IL-5 Inhibitors 216

9.6.1 Nucala (mepolizumab) 216

9.6.2 Benralizumab 222

9.7 Other Drugs in Development 226

10 Current and Future Players 228

10.1 Overview 228

10.2 Trends in Corporate Strategy 231

10.3 Company Profiles 232

10.3.1 AstraZeneca 232

10.3.2 Boehringer Ingelheim 235

10.3.3 Chiesi 238

10.3.4 GlaxoSmithKline 239

10.3.5 Novartis 242

10.3.6 Sunovion 243

11 Market Outlook 245

11.1 Global Markets 245

11.1.1 Forecast Based on mMRC Patient Population 245

11.1.2 Forecast Based on CAT Patient Population 249

11.1.3 Drivers and Barriers-Global Issues 250

11.2 US 250

11.2.1 Forecast Based on mMRC Patient Population 250

11.2.2 Key Events 254

11.2.3 Drivers and Barriers 255

11.3 5EU 255

11.3.1 Forecast Based on mMRC Patient Population 255

11.3.2 Key Events 258

11.3.3 Drivers and Barriers 259

11.4 Japan 259

11.4.1 Forecast Based on mMRC Patient Population 259

11.4.2 Key Events 262

11.4.3 Drivers and Barriers 263

11.5 Australia 263

11.5.1 Forecast Based on mMRC Patient Population 263

11.5.2 Key Events 266

11.5.3 Drivers and Barriers 267

12 Appendix 268

12.1 Bibliography 268

12.2 Abbreviations 285

12.3 Methodology 289

12.4 Forecasting Methodology 289

12.4.1 Diagnosed COPD Patients 290

12.4.2 Diagnosed Prevalent Cases of COPD by Severity 291

12.4.3 Percent Drug-Treated Patients 293

12.4.4 Drugs Included in Each Therapeutic Class 293

12.4.5 Launch and Patent Expiry Dates 295

12.4.6 General Pricing Assumptions 297

12.4.7 Individual Drug Assumptions 298

12.4.8 Generic Erosion 308

12.4.9 Pricing of Pipeline Agents 308

12.5 Primary Research-KOLs Interviewed for this Report 310

12.5.1 KOLs 310

12.6 Primary Research-Prescriber Survey 313

12.7 About the Authors 314

12.7.1 Analyst 314

12.7.2 Therapy Area Director 314

12.7.3 Epidemiologist 314

12.7.4 Managing Epidemiologist 315

12.7.5 Global Director of Therapy Analysis and Epidemiology 316

12.7.6 Global Head of Healthcare 316

12.8 About GlobalData 317

12.9 Contact Us 317

12.10 Disclaimer 317

1.2 List of Figures

Figure 1: Global Sales for COPD by Country, 2015 and 2025 14

Figure 2: Company Portfolio Gap Analysis in COPD, 2015-2025 16

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in COPD, 2015-2025 18

Figure 4: Normal Lungs and Lungs with COPD 22

Figure 5: Etiology of COPD 24

Figure 6: The Pathogenesis of COPD 26

Figure 7: Refined ABCD Assessment Tool for COPD, 2017 28

Figure 8: 8MM, Age-Standardized Total Prevalence of COPD (%), Ages ?35 Years, 2015 37

Figure 9: 8MM, Age-Standardized Diagnosed Prevalence of COPD (%), Ages ?35 Years, 2015 38

Figure 10: 8MM, Sources Used and Not Used to Forecast Total Prevalent Cases of COPD 40

Figure 11: 8MM, Sources Used and Not Used to Forecast Diagnosed Prevalent Cases of COPD 41

Figure 12: 8MM, Sources Used to Forecast the new GOLD 2011 Severity Stages Among the Diagnosed Prevalent Cases of COPD 42

Figure 13: 8MM, Age-Specific Total Prevalent Cases of COPD, Both Sexes, N, 2015 53

Figure 14: 8MM, Sex-Specific Total Prevalent Cases of COPD, Both Sexes, N, 2015 54

Figure 15: 8MM, Age-Specific Diagnosed Prevalent Cases of COPD, Both Sexes, N, 2015 56

Figure 16: 8MM, Sex-Specific Diagnosed Prevalent Cases of COPD, Both Sexes, N, 2015 57

Figure 17: 8MM, Diagnosed Prevalent Cases of COPD by the GOLD Severity Stage (Using mMRC), Both Sexes, 2015 58

Figure 18: 8MM, Diagnosed Prevalent Cases of COPD by the GOLD Severity Stage (Using CAT), Both Sexes, 2015 59

Figure 19: Pathway to the Diagnosis of COPD 63

Figure 20: COPD Treatment Algorithm 65

Figure 21: COPD Therapeutics ? Class of Therapy, 2017 192

Figure 22: COPD-Phase III Pipeline, 2017 193

Figure 23: Competitive Assessment of Late-Stage Pipeline Agents in COPD, 2015-2025 194

Figure 24: Global Sales of Branded Products for COPD by Company, 2015 and 2025 230

Figure 25: Company Portfolio Gap Analysis in COPD, 2015-2025 231

Figure 26: Global mMRC Sales for COPD by Country, 2015 and 2025 249

Figure 27: Sales for COPD by Drug Class in the US, 2015 and 2025 253

Figure 28: Sales for COPD by Drug Class in the 5EU, 2015 and 2025 257

Figure 29: Sales for COPD by Drug Class in Japan, 2015 and 2025 261

Figure 30: Sales for COPD by Drug Class in Australia, 2015 and 2025 265

1.1 List of Tables

Table 1: COPD: Key Metrics in the Eight Major Pharmaceutical Markets 12

Table 2: GOLD Criteria for the Classification of COPD, 2016 28

Table 3: Symptoms of COPD 29

Table 4: Modified MRC Dyspnea Index 30

Table 5: Common Comorbidities of COPD 30

Table 6: Risk Factors and Comorbidities for COPD 35

Table 7: New GOLD 2011 criteria for COPD severity stages 39

Table 8: Total prevalent cases of COPD for selected years during the forecast period for the 8MM. 52

Table 9: Age-specific total prevalent cases of COPD for both sexes combined in the 8MM in 2015. 53

Table 10: Diagnosed prevalent cases of COPD for selected years during the forecast period for the 8MM. 55

Table 11: Age-specific diagnosed prevalent cases of COPD for both sexes combined in the 8MM in 2015. 56

Table 12: Treatment Guidelines for COPD 66

Table 13: Most Prescribed Drugs for COPD by Class in the Global Markets, 2015 66

Table 14: Country Profile-US, 2015 70

Table 15: Region Profile-5EU, 2015 72

Table 16: Country Profile-Japan, 2015 74

Table 17: Country Profile-Australia, 2015 75

Table 18: Leading Treatments for COPD, 2017 77

Table 19: Product Profile-Onbrez Breezhaler 79

Table 20: Efficacy of Onbrez Breezhaler in COPD 80

Table 21: Safety of Onbrez Breezhaler 82

Table 22: Onbrez Breezhaler SWOT Analysis, 2017 83

Table 23: Product Profile-Serevent 84

Table 24: Efficacy of Serevent in COPD 85

Table 25: Safety of Serevent 87

Table 26: Serevent SWOT Analysis, 2017 87

Table 27: Product Profile-Striverdi Respimat 89

Table 28: Efficacy of Striverdi Respimat in COPD 90

Table 29: Safety of Striverdi Respimat 91

Table 30: Striverdi Respimat SWOT Analysis, 2017 92

Table 31: Overview of the Leading Branded Foroterol Products for COPD Treatment, 2017 94

Table 32: Efficacy of Formoterol in COPD 95

Table 33: Safety of Formoterol 96

Table 34: Branded formoterol SWOT Analysis, 2017 96

Table 35: Product Profile-Brovana 98

Table 36: Efficacy of Brovana in COPD 99

Table 37: Safety of Brovana 100

Table 38: Brovana SWOT Analysis, 2017 100

Table 39: Product Profile-Spiriva 103

Table 40: Efficacy of Spiriva in COPD 105

Table 41: Spiriva SWOT Analysis, 2017 107

Table 42: Product Profile-Tudorza Pressair 109

Table 43: Efficacy of Tudorza Pressair in COPD 110

Table 44: Safety of Tudorza Pressair 111

Table 45: Tudorza Pressair SWOT Analysis, 2017 112

Table 46: Product Profile-Seebri Breezhaler 114

Table 47: Efficacy of Seebri Breezhaler in COPD 115

Table 48: Safety of Seebri Breezhaler 117

Table 49: Seebri Breezhaler SWOT Analysis, 2017 117

Table 50: Product Profile-Incruse Ellipta 119

Table 51: Efficacy of Incruse Ellipta in COPD 120

Table 52: Safety of Incruse Ellipta 121

Table 53: Incruse Ellipta SWOT Analysis, 2017 122

Table 54: Product Profile-Ultibro Breezhaler 124

Table 55: Efficacy of Ultibro Breezhaler in COPD 125

Table 56: Safety of Ultibro Breezhaler 127

Table 57: Ultibro Breezhaler SWOT Analysis, 2017 127

Table 58: Product Profile-Anoro Ellipta 129

Table 59: Efficacy of Anoro Ellipta in COPD 130

Table 60: Safety of Anoro Ellipta 132

Table 61: Anoro Ellipta SWOT Analysis, 2017 132

Table 62: Product Profile-Duaklir Genuair 134

Table 63: Efficacy of Duaklir Genuair in COPD 135

Table 64: Safety of Duaklir Genuair 136

Table 65: Duaklir Genuair SWOT Analysis, 2017 137

Table 66: Product Profile-Stiolto Respimat 138

Table 67: Efficacy of Stiolto Respimat in COPD 139

Table 68: Safety of Stiolto Respimat 140

Table 69: Stiolto Respimat SWOT Analysis, 2017 141

Table 70: Product Profile-Bevespi Aerosphere 143

Table 71: Efficacy of Bevespi Aerosphere in COPD 144

Table 72: Bevespi Aerosphere SWOT Analysis, 2017 145

Table 73: Product Profile-Advair Diskus 147

Table 74: Efficacy of Advair Diskus in COPD 148

Table 75: Safety of Advair Diskus 149

Table 76: Advair Diskus SWOT Analysis, 2017 150

Table 77: Product Profile-Symbicort 152

Table 78: Efficacy of Symbicort in COPD 153

Table 79: Safety of Symbicort 154

Table 80: Symbicort SWOT Analysis, 2017 155

Table 81: Product Profile-Breo Ellipta 157

Table 82: Efficacy of Breo Ellipta in COPD 158

Table 83: Safety of Breo Ellipta 159

Table 84: Breo Ellipta SWOT Analysis, 2017 159

Table 85: Product Profile-Fostair 161

Table 86: Efficacy of Fostair pMDI in COPD 162

Table 87: Safety of Fostair pMDI 163

Table 88: Fostair SWOT Analysis, 2017 163

Table 89: Product Profile-Daliresp 165

Table 90: Efficacy of Daliresp in COPD 167

Table 91: Safety of Daliresp 168

Table 92: Daliresp SWOT Analysis, 2017 169

Table 93: Overview of Additional PDE4 Inhibitors for COPD Treatment, 2017 170

Table 94: Overview of the Leading SABA Therapies for COPD Treatment, 2017 171

Table 95: Overview of the Leading SABA Therapies for COPD Treatment, 2017 172

Table 96: Overview of the Leading SABA/SAMA Therapies for COPD Treatment, 2017 173

Table 97: Summary of Off-Label Asthmatic Therapies Prescribed for COPD, 2015 174

Table 98: Summary of Minor Therapeutic Classes, 2017 176

Table 99: Unmet Need and Opportunity in COPD, 2017 178

Table 100: Key Late-Stage Pipeline Agents for COPD, 2017 195

Table 101: Product Profile-SUN-101 196

Table 102: SUN-101 SWOT Analysis, 2017 198

Table 103: Product Profile-Revefenacin 200

Table 104: Revefenacin SWOT Analysis, 2017 202

Table 105: Product Profile-CHF-5993 204

Table 106: Efficacy of CHF-5993 in COPD 205

Table 107: Safety of CHF-5993 207

Table 108: CHF-5993 SWOT Analysis, 2017 208

Table 109: Product Profile-PT-010 210

Table 110: PT-010 SWOT Analysis, 2017 211

Table 111: Product Profile-FF/UMEC/VI 213

Table 112: Efficacy of FF/UMEC/VI in COPD 214

Table 113: FF/UMEC/VI SWOT Analysis, 2017 215

Table 114: Product Profile-Nucala 218

Table 115: Efficacy of Nucala Versus Placebo in Asthma 219

Table 116: Safety of Nucala in Asthma 220

Table 117: Nucala SWOT Analysis, 2017 221

Table 118: Product Profile-Benralizumab 223

Table 119: Safety of Benralizumab 224

Table 120: Benralizumab SWOT Analysis, 2017 225

Table 121: Drugs in Development for COPD, 2016 226

Table 122: Key Companies in the COPD Market in the 8MM, 2017 229

Table 123: AstraZeneca's COPD Portfolio Assessment, 2017 234

Table 124: Boehringer Ingelheim's COPD Portfolio Assessment, 2017 237

Table 125: Chiesi's COPD Portfolio Assessment, 2017 239

Table 126: GSK's COPD Portfolio Assessment, 2017 241

Table 127: Novartis' COPD Portfolio Assessment, 2017 243

Table 128: Sunovion's COPD Portfolio Assessment, 2017 244

Table 129: COPD Market-Global Drivers and Barriers, 2015?2025 250

Table 130: Key Events Impacting Sales for COPD in the US, 2015-2025 254

Table 131: COPD Market-Drivers and Barriers in the US, 2015?2025 255

Table 132: Key Events Impacting Sales for COPD in the 5EU, 2015-2025 258

Table 133: COPD Market-Drivers and Barriers in the 5EU, 2015?2025 259

Table 134: Key Events Impacting Sales for COPD in Japan, 2015-2025 262

Table 135: COPD Market-Drivers and Barriers in Japan, 2015?2025 263

Table 136: Key Events Impacting Sales for COPD in Australia, 2015-2025 266

Table 137: COPD Market-Drivers and Barriers in Australia, 2015?2025 267

Table 138: Key Historical and Projected Launch Dates for COPD 295

Table 139: Key Patent Expiry Dates for COPD 296

Table 140: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 313

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