Published : May-2017
No. of Pages : 317
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
1.1 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
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
