Acute Ischemic Stroke: Global Drug Forecast and Market Analysis to 2027

GlobalData
184 Pages - GLDATA66164
$10,995.00

Summary

Stroke is caused by the interruption of the blood supply to the brain, usually because a cerebral blood vessel ruptures and bleeds (hemorrhagic stroke) or is blocked by a clot (ischemic stroke), which obstructs blood flow and oxygen and nutrients from reaching the brain, causing death of the local brain tissue (infarction). Stroke is a leading cause of disability and death worldwide and a common cause of dementia, associated with significant social and economic impact. The acute ischemic stroke (AIS) market is about to enter an exciting phase over the next decade with novel therapies entering the market that are designed to improve stroke outcome. The arrival of three novel neuroprotective agents (NA-1, BIIB093, and 3K3A-APC) and one stem cell therapy (MultiStem) are aimed at improving clinical outcome post-stroke when given in the acute phase of stroke, along with Activase or endovascular treatment (EVT) or both. One stem cell therapy, SB623, is designed to reduce disability in patients with chronic stroke, potentially given years after the initial event.

GlobalData estimates that sales of drugs in the AIS market (including TIA) were approximately $7.2B in 2017 in the 8MM. The US was the largest market, with sales of $3.4B, representing 47% of all sales from the 8MM. The highest-selling drug in the market was Roche’s Activase (alteplase), which generated sales of $1.2B in the 8MM in 2017.

Key Questions Answered

- What are the key drivers of significant growth of the AIS market?
- What are the pricing and reimbursement prospects for the upcoming novel therapies?
- What is the market potentials of drugs developed for the treatment of AIS, and would they fulfil the greatest unmet needs in this space?
- How will key patent expiries of novel anticoagulants (NOACs) impact sales of current and launching therapies in AIS?
- Will there be opportunities remaining after the launch of late pipeline drugs in AIS?

Scope

- Overview of AIS, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized AIS therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2012 and forecast for ten years to 2022.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the AIS therapeutics market.
- 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 AIS 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 AIS therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global AIS therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing 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
Roche
Boehringer Ingelheim
Bristol-Myers Squibb
Janssen
Daiichi Sankyo
AstraZeneca
ZZ Biotech
NoNO Inc.
Biogen
Athersys
SanBio

'

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 7
2 Acute Ischemic Stroke: Executive Summary 8
2.1 AIS Market Forecast to Reach $10.6B by 2027 9
2.2 The AIS Late-Stage Pipeline Focus on Improving Stroke Outcome 11
2.3 Current Treatments Leave High Level of Unmet Need in the AIS Market 14
2.4 Opportunities Will Remain for New Entrants 15
2.5 Late-Stage Pipeline Drugs Entering the AIS Market Will Be a Key Driver of Growth 16
2.6 What Do Physicians Think? 17
3 Introduction 21
3.1 Catalyst 21
3.2 Related Reports 22
4 Disease Overview 23
4.1 Etiology and Pathophysiology 23
4.1.1 Etiology 24
4.1.2 Pathophysiology 26
4.2 Classification or Staging Systems 29
5 Epidemiology 33
5.1 Disease Background 33
5.2 Risk Factors and Comorbidities 34
5.3 Global and Historical Trends 35
5.4 Forecast Methodology 39
5.4.1 Sources 39
5.4.2 Forecast Assumptions and Methods 44
5.5 Epidemiological Forecast for AIS (2017-2027) 57
5.5.1 First-Ever Diagnosed Incident Cases of AIS 57
5.5.1 Age-Specific First-Ever Diagnosed Incident Cases of AIS 59
5.5.2 Sex-Specific First-Ever Diagnosed Incident Cases of AIS 60
5.5.3 Recurrent Diagnosed Incident Cases of AIS 60
5.5.4 First-Ever Diagnosed Incident Cases of AIS by TOAST Subtype 61
5.5.5 Diagnosed Prevalent Cases of AIS 62
5.5.6 Age-Specific Diagnosed Prevalent Cases of AIS 63
5.5.7 Sex-Specific Diagnosed Prevalent Cases of AIS 64
5.5.8 AIS Mortality 65
5.6 Discussion 66
5.6.1 Epidemiological Forecast Insight 66
5.6.2 Limitations of Analysis 67
5.6.3 Strengths of Analysis 67
6 Disease Management 69
6.1 Diagnosis and Treatment Overview 69
6.1.1 AIS 69
6.1.2 TIA 79
6.2 Treatment Guidelines 81
6.3 US 82
6.4 5EU 86
6.5 Japan 91
6.6 China 95
7 Competitive Assessment 98
7.1 Overview 98
8 Unmet Needs and Opportunity Assessment 105
8.1 Overview 105
8.2 Safer and More Effective Thrombolysis 108
8.3 Effective Therapies to Improve Clinical Outcome 109
8.4 Long-Term Compliance with Secondary Stroke Prevention Therapies 112
8.5 Access to Rapid Diagnosis and Acute Treatment 114
9 Pipeline Assessment 118
9.1 Overview 118
9.2 Promising Drugs in Clinical Development 122
9.2.1 Neuroprotective Agents 123
9.2.2 Stem Cell Therapies 125
10 Current and Future Players 128
10.1 Overview 128
10.2 Trends in Corporate Strategy 130
10.3 Roche Portfolio Assessment 131
10.4 Boehringer Ingelheim Portfolio Assessment 132
10.5 Bristol-Myers Squibb Portfolio Assessment 132
10.6 Janssen Portfolio Assessment 132
10.7 Daiichi Sankyo Portfolio Assessment 133
10.8 AstraZeneca Portfolio Assessment 133
10.9 ZZ Biotech Portfolio Assessment 133
10.10 NoNO Inc. Portfolio Assessment 133
10.11 Biogen Portfolio Assessment 134
10.12 Athersys Portfolio Assessment 135
10.13 SanBio Portfolio Assessment 135
11 Market Outlook 136
11.1 Global Markets 136
11.1.1 Forecast 136
11.1.2 Drivers and Barriers - Global Issues 139
11.2 US 139
11.2.1 Forecast 139
11.2.2 Key Events 142
11.2.3 Drivers and Barriers 142
11.3 5EU 143
11.3.1 Forecast 143
11.3.2 Key Events 145
11.3.3 Drivers and Barriers 145
11.4 Japan 146
11.4.1 Forecast 146
11.4.2 Key Events 148
11.4.3 Drivers and Barriers 148
11.5 China 149
11.5.1 Forecast 149
11.5.2 Key Events 151
11.5.3 Drivers and Barriers 151
12 Appendix 152
12.1 Bibliography 152
12.2 Abbreviations 166
12.3 Methodology 171
12.3.1 Forecasting Methodology 171
12.3.2 Diagnosed Patients 171
12.3.3 Percent Drug-Treated Patients 171
12.3.4 Drugs Included in Each Therapeutic Class 172
12.3.5 Launch and Patent Expiry Dates 173
12.3.6 General Pricing Assumptions 174
12.3.7 Individual Drug Assumptions 175
12.3.8 Generic Erosion 176
12.3.9 Pricing of Pipeline Agents 176
12.4 Primary Research - KOLs Interviewed for This Report 177
12.4.1 KOLs 177
12.4.2 Primary Research - Prescriber Survey 178
12.5 About the Authors 179
12.5.1 Analyst 179
12.5.2 Therapy Area Director 179
12.5.3 Epidemiologist 180
12.5.4 Managing Epidemiologist 180
12.5.5 Global Director of Therapy Analysis and Epidemiology 181
12.5.6 Global Head and EVP of Healthcare Operations and Strategy 182
12.6 About GlobalData 183
12.7 Contact Us 183
12.8 Disclaimer 184

1.1 List of Tables
Table 1: AIS: Key Metrics in the 8MM 8
Table 2: TOAST Classification of Subtypes of AIS 31
Table 3: Risk Factors and Comorbidities for AIS 34
Table 4: Evaluation of Patients with Suspected Acute Ischemic Stroke or Transient Ischemic Attack 70
Table 5: Criteria for Thrombolysis Using Activase in Patients with AIS 73
Table 6: ABCD2 Score Used for Risk of Stroke Assessment 79
Table 7: Treatment Guidelines for AIS and TIA 81
Table 8: Country Profile - US 84
Table 9: Country Profile - 5EU 90
Table 10: Country Profile - Japan 95
Table 11: Country Profile - China 97
Table 12: Leading Treatments for AIS and TIA, 2018 104
Table 13: Roche’s AIS/TIA Portfolio Assessment, 2018 131
Table 14: Boehringer Ingelheim’s AIS Portfolio Assessment, 2018 132
Table 15: Bristol-Myers Squibb’s AIS Portfolio Assessment, 2018 132
Table 16: Janssen’s AIS Portfolio Assessment, 2018 132
Table 17: Daiichi Sankyo’s AIS Portfolio Assessment, 2018 133
Table 18: AstraZeneca’s AIS Portfolio Assessment, 2018 133
Table 19: ZZ Biotech’s AIS Portfolio Assessment, 2018 133
Table 20: NoNO Inc.’s AIS Portfolio Assessment, 2018 134
Table 21: Biogen’s AIS Portfolio Assessment, 2018 134
Table 22: Athersys’ AIS Portfolio Assessment, 2018 135
Table 23: SanBio’s AIS Portfolio Assessment, 2018 135
Table 24: AIS Market - Global Drivers and Barriers, 2017-2027 139
Table 25: Key Events Impacting Sales for AIS and TIA in the US, 2017-2027 142
Table 26: AIS Market - Drivers and Barriers in the US, 2017-2027 142
Table 27: Key Events Impacting Sales for AIS in the 5EU, 2017-2027 145
Table 28: AIS Market - Drivers and Barriers in the 5EU, 2017-2027 145
Table 29: Key Events Impacting Sales for AIS in Japan, 2017-2027 148
Table 30: AIS Market - Global Drivers and Barriers in Japan, 2017-2027 148
Table 31: Key Events Impacting Sales for AIS in China, 2017-2027 151
Table 32: AIS Market - Global Drivers and Barriers in China, 2017-2027 151
Table 33: Key Historical and Projected Launch Dates for AIS 173
Table 34: Key Historical and Projected Patent Expiry Dates for AIS 173
Table 35: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 178

1.2 List of Figures
Figure 1: Global Sales Forecast by Country for AIS in 2017 and 2027 11
Figure 2: Analysis of the Company Portfolio Gap in AIS During the Forecast Period 14
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents That GlobalData Expects to Be Licensed for the Treatment of AIS During the Forecast Period 17
Figure 4: Main Types and Processes of Acute Ischemic Stroke (AIS) and Its Management 26
Figure 5: Stroke-Induced Neuronal Cell Death and Therapeutic Targets of Pipeline Candidates 29
Figure 6: 8MM, Age-Standardized First-Ever Diagnosed Incidence of AIS, Men, Ages ≥18 Years, 2007-2027 36
Figure 7: 8MM, Age-Standardized First-Ever Diagnosed Incidence of AIS, Women, Ages ≥18 Years, 2007-2027 37
Figure 8: 8MM, Age-Standardized Diagnosed Prevalence of AIS, Men, Ages ≥18 Years, 2007-2027 38
Figure 9: 8MM, Age-Standardized Diagnosed Prevalence of AIS, Women, Ages ≥18 Years, 2007-2027 38
Figure 10: Sources Used and Not Used for First-Ever Diagnosed Incident Cases of AIS 40
Figure 11: Sources Used and Not Used for Recurrent Diagnosed Incident Cases of AIS 41
Figure 12: Sources Used and Not Used for First-Ever Diagnosed Incident Cases of AIS by TOAST Subtype 42
Figure 13: Sources Used and Not Used for Diagnosed Prevalent Cases of AIS 43
Figure 14: Sources Used and Not Used for AIS Mortality 44
Figure 15: 8MM, First-Ever Diagnosed Incident Cases of AIS, Men and Women, Ages ≥18 Years, 2017 58
Figure 16: 8MM, Age-Specific First-Ever Diagnosed Incident Cases of AIS, Men and Women, 2017 59
Figure 17: 8MM, Sex-Specific First-Ever Diagnosed Incident Cases of AIS, Ages ≥18 Years, 2017 60
Figure 18: 8MM, Recurrent Diagnosed Incident Cases of AIS, Ages ≥18 Years, Men and Women, 2017 61
Figure 19: 8MM, First-Ever Diagnosed Incident Cases of AIS by TOAST Subtype, Ages ≥18 Years, Men and Women, 2017 62
Figure 20: 8MM, Diagnosed Prevalent Cases of AIS, Men and Women, Ages ≥18 Years, 2017 63
Figure 21: 8MM, Age-Specific Diagnosed Prevalent Cases of AIS, Men and Women, 2017 64
Figure 22: 8MM, Sex-Specific Diagnosed Prevalent Cases of AIS, Ages ≥18 Years, 2017 65
Figure 23: 8MM, AIS Mortality, Ages ≥18 Years, Men and Women, 2017-2027 66
Figure 24: Acute Ischemic Stroke Management 78
Figure 25: Transient Ischemic Attack Management 80
Figure 26: Unmet Needs and Opportunities in AIS and TIA 107
Figure 27: Overview of the Development Pipeline in AIS and TIA 122
Figure 28: Key Phase II/III Trials for the Promising Pipeline Agents That GlobalData Expects to Be Licensed for AIS or TIA or Both in the 8MM During the Forecast Period 126
Figure 29: Competitive Assessment of the Late-Stage Pipeline Agents That GlobalData Expects to Be Licensed for the Treatment of AIS During the Forecast Period 127
Figure 30: Analysis of the Company Portfolio Gap in AIS and TIA During the Forecast Period 130
Figure 31: Global (8MM) Sales Forecast by Country for AIS and TIA Combined in 2017 and 2027 138
Figure 32: Sales Forecast by Class for AIS and TIA Combined in the US in 2017 and 2027 141
Figure 33: Sales Forecast by Class for AIS and TIA Combined in the 5EU in 2017 and 2027 144
Figure 34: Sales Forecast by Class for AIS and TIA Combined in Japan in 2017 and 2027 147
Figure 35: Sales Forecast by Class for AIS and TIA Combined in China in 2017 and 2027 150

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