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OpportunityAnalyzer: Gout - Opportunity Analysis and Forecast to 2018

Summary

GlobalData estimates the 2013 sales for gout at approximately $989m across the 6MM covered in this report. The acute gout segment of the market will double in size over the forecast period, reaching $337m in 2018 at a CAGR of 15%. The chronic gout market, which encompasses urate-lowering and prophylactic anti-inflammatory therapies, will experience even faster growth at a CAGR of 18.8%, and it will more than double in size, reaching over 1.9 billion in 2018. With the current standard of care for gout already encompassing very successful and cheap treatments, the bar for success in the gout market is quite high. As a result, companies are shifting the focus of their research toward more severe gout cases, trying to address the greatest unmet needs. One of the major drivers of the gout market is the growing number of patients suffering from difficult-to-treat gout, for whom the standard therapies are inappropriate due to the presence of comorbidities, unresponsiveness, or intolerance. Targeting this patient niche is the strongest trend in the research and development (R&D) strategies of the gout players.

Highlights

Key Questions Answered

- Although the standard treatments are cheap and effective in most gout patients, there are a growing number of patients for whom the standard therapies are inappropriate. Gout market is still marked by the presence of a number of unmet needs in current treatments. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the gout market?
- The late-stage gout pipeline is sparsely populated; however these drugs in development will be a strong driver of the gout market growth. Which of these drugs will attain high sales revenues during 2013-2018? Which of these drugs will have the highest peak sales at the highest CAGR, and why?
- The more aggressive approach to urate-lowering treatment will increase the patient pool treated with urate-lowering agents and prophylactic anti-inflammatory therapies. How will these changes impact the growth of the future market?

Key Findings

- One of the main drivers of the enormous expansion of the gout market will be the introduction of the novel urate-lowering agents, lesinurad and ulodesine, which will be used as add-on therapies to the current standard of care and target the treatment-failure gout population.
- Another strong driver will be the more aggressive approach to urate-lowering treatment, as recommended by the latest treatment guidelines, which will increase the patient pool treated with urate-lowering agents and prophylactic anti-inflammatory therapy.
- Companies are shifting the focus of their research toward more severe gout cases, trying to address the greatest unmet needs.
- Reasons for inadequate gout treatment include a poor patient understanding of their disease and physician failure to develop targeted treatment plans.

Scope

- Overview of gout, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized gout therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2013 and forecast for five years to 2018.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the gout 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 gout 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

- 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. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the gout therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the gout therapeutics market in 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.
- Track drug sales in the 6MM gout therapeutics market from 2013-2018.
- 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

OpportunityAnalyzer: Gout - Opportunity Analysis and Forecast to 2018
1 Table of Contents

2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 17
2.3 Upcoming Related Reports 17
3 Disease Overview 18
3.1 Etiology and Pathophysiology 19
3.1.1 Etiology 19
3.1.2 Pathophysiology 21
3.2 Symptoms 22
3.3 Risk Factors 23
3.4 Prognosis 23
3.5 Quality of Life 24
4 Epidemiology 25
4.1 Risk Factors and Comorbidities 25
4.2 Global Trends 27
4.2.1 US 29
4.2.2 5EU 29
4.3 Forecast Methodology 30
4.3.1 Sources Used 34
4.3.2 Sources Not Used 38
4.3.3 Forecast Assumptions and Methods 40
4.4 Epidemiological Forecast for Gout (2013-2023) 47
4.4.1 Diagnosed Incidence 47
4.4.2 Diagnosed Prevalence 53
4.5 Discussion 61
4.5.1 Epidemiological Forecast Insight 61
4.5.2 Limitations of the Analysis 62
4.5.3 Strengths of the Analysis 63
5 Current Treatment Options 64
5.1 Overview 64
5.2 Product Profiles 67
5.2.1 Anti-Inflammatory Therapies 67
5.2.2 Urate-Lowering Therapies 86
6 Unmet Needs Assessment and Oppportunity Analysis 103
6.1 Overview 103
6.2 Physician and Patient Awareness of Gout 104
6.2.1 Unmet Needs 104
6.2.2 Gap Analysis 105
6.2.3 Opportunity 106
6.3 Noncompliance to Gout Therapies 106
6.3.1 Unmet Needs 106
6.3.2 Gap Analysis 107
6.3.3 Opportunity 107
6.4 Earlier and More Accurate Diagnosis of Gout 107
6.4.1 Unmet Needs 107
6.4.2 Gap Analysis and Opportunity 108
6.4.3 Opportunity 109
6.5 Efficacious and Safe Treatment of Difficult-to-Treat Gout 109
6.5.1 Unmet Needs 109
6.5.2 Gap Analysis and Opportunity 109
6.5.3 Opportunity 110
7 Research and Development Strategies 111
7.1 Overview 111
7.1.1 Targeting Patients with Refractory Gout - Novel Uricosuric Drugs as Add-On Therapy 111
7.1.2 Targeting Patients with Refractory Gout - PEGylation of Uricase 112
7.1.3 Small Molecules as Inhibitors of the Interleukin-1 Beta Pathway 113
7.1.4 Acquisitions and Licensing 113
7.2 Clinical Trial Design 115
7.2.1 Current Clinical Trial Design 115
7.2.2 Future Clinical Trial Designs 120
8 Pipeline Assessment 122
8.1 Overview 122
8.2 Promising Drugs in Clinical Development 124
8.2.1 Lesinurad (RDEA-594) 125
8.2.2 Ulodesine (BCX4208) 130
8.3 Innovative Early-Stage Approaches 134
9 Pipeline Valuation Analysis 138
9.1 Clinical Benchmark of Key Pipeline Drugs 138
9.2 Commercial Benchmark of Key Pipeline Drugs 140
9.3 Competitive Assessment 141
9.4 Top-Line Five-Year Forecast 144
9.4.1 US 147
9.4.2 5EU 148
10 Appendix 150
10.1 Bibliography 150
10.2 Abbreviations 164
10.3 Methodology 168
10.4 Forecasting Methodology 168
10.4.1 Diagnosed Gout Patients 168
10.4.2 Percent Drug-Treated Patients 169
10.4.3 Drugs Included in Each Therapeutic Class 169
10.4.4 Launch and Patent Expiry Dates 169
10.4.5 General Pricing Assumptions 170
10.4.6 Individual Drug Assumptions 171
10.4.7 Pricing of Pipeline Agents 175
10.5 Physicians and Specialists Included in this Study 176
10.6 About the Authors 178
10.6.1 Analyst 178
10.6.2 Therapy Director - CVMD and Infectious Disease 178
10.6.3 Epidemiologist 179
10.6.4 Global Head of Healthcare 179
10.7 About GlobalData 180
10.8 Disclaimer 180

1.1 List of Tables

Table 1: Risk Factors and Comorbidities for Gout 26
Table 2: Summary of Reported Incidence and Prevalence of Gout in the 6MM* 28
Table 3: American College of Rheumatology Criteria for the Clinical Diagnosis of Gout 31
Table 4: Sources of Gout Incidence Data in 6MM 32
Table 5: Sources of Gout Prevalence Data in 6MM 33
Table 6: Sources of Gout Flare and Tophaceous Gout Data in 6MM 34
Table 7: 6MM, Sources Not Used in the Epidemiological Analysis of Gout 39
Table 8: 6MM, Diagnosed Incident Cases of Gout, Both Sexes, Ages ?20 Years, N, 2013-2023 48
Table 9: 6MM, Age-Specific Diagnosed Incident Cases of Gout, Both Sexes, N (Row %), 2013 49
Table 10: 6MM, Sex-Specific Diagnosed Incident Cases of Gout, Ages ?20 Years, N (Row %), 2013 51
Table 11: 6MM, Diagnosed Prevalent Cases of Gout, Both Sexes, Ages ?20 Years, N, 2013-2023 54
Table 12: 6MM, Age-Specific Diagnosed Prevalent Cases of Gout, Both Sexes, N (Row %), 2013 55
Table 13: 6MM, Sex-Specific Diagnosed Prevalent Cases of Gout, Ages ?20 Years, N (Row %), 2013 57
Table 14: Leading Branded Treatments for Gout 66
Table 15: Nonsteroidal Anti-Inflammatory Drugs SWOT Analysis, 2013 69
Table 16: Product Profile - Colcrys 72
Table 17: Colcrys SWOT Analysis, 2013 74
Table 18: Glucocorticoids SWOT Analysis, 2013 77
Table 19: Product Profile - Ilaris 80
Table 20: Ilaris SWOT Analysis, 2013 82
Table 21: Product Profile - Kineret 84
Table 22: Kineret SWOT Analysis, 2013 85
Table 23: Product Profile - Allopurinol 87
Table 24: Allopurinol SWOT Analysis, 2013 89
Table 25: Product Profile - Uloric 91
Table 26: Uloric SWOT Analysis, 2013 93
Table 27: Uricosuric drugs SWOT Analysis, 2013 97
Table 28: Product Profile - Krystexxa 100
Table 29: Krystexxa SWOT Analysis, 2013 102
Table 30: Unmet Need and Opportunity in Gout 104
Table 31: Examples of Pivotal RCTs of Approved Treatments for Acute Gout 117
Table 32: Examples of Pivotal RCTs of Approved Treatments for Chronic Gout 118
Table 33: Gout - Late Stage Pipeline, 2012 124
Table 34: Product Profile - Lesinurad 127
Table 35: Lesinurad SWOT Analysis, 2013 129
Table 36: Product Profile - Ulodesine 131
Table 37: Ulodesine SWOT Analysis, 2013 133
Table 38: Early-Stage Pipeline Products in Gout 134
Table 39: Clinical Benchmark of Key Pipeline Drugs - Anti-Inflammatory Therapies 138
Table 40: Clinical Benchmark of Key Pipeline Drugs - Urate-Lowering Therapies 139
Table 41: Commercial Benchmark of Key Pipeline Drugs - Anti-Inflammatory Therapies 140
Table 42: Commercial Benchmark of Key Pipeline Drugs - Urate-Lowering Therapies 141
Table 43: Top Line Sales Forecasts ($m) for Gout, 2013-2018 145
Table 44: Key Events Impacting Sales for Gout, 2013-2018 146
Table 45: Gout Market - Drivers and Barriers, 2013-2018 147
Table 46: Key Launch Dates 169
Table 47: Key Patent Expiries 170

1.2 List of Figures

Figure 1: Overview of Purine Metabolism, Leading to Uric Acid Formation 20
Figure 2: Stages of Gout 22
Figure 3: 6MM, Diagnosed Incident Cases of Gout, Both Sexes, Ages ?20 Years, N, 2013-2023 48
Figure 4: 6MM, Age-Specific Diagnosed Incident Cases of Gout, Both Sexes, N, 2013 50
Figure 5: 6MM, Sex-Specific Diagnosed Incident Cases of Gout, Ages ?20 Years, N, 2013 51
Figure 6: 6MM, Age-Standardized Diagnosed Incidence of Gout (Cases per 100,000 Population), Ages ?20 Years, by Sex, 2013 53
Figure 7: 6MM, Diagnosed Prevalent Cases of Gout, Both Sexes, Ages ?20 Years, N, 2013-2023 54
Figure 8: 6MM, Age-Specific Diagnosed Prevalent Cases of Gout, Both Sexes, N, 2013 56
Figure 9: 6MM, Sex-Specific Diagnosed Prevalent Cases of Gout, Ages ?20 Years, N, 2013 57
Figure 10: 6MM, Age-Standardized Diagnosed Prevalence (%) of Gout, Ages ?20 Years, by Sex, 2013 59
Figure 11: 6MM, Number of Gout Flares in the Diagnosed Prevalent Population of Gout, Both Sexes, Ages ?20 Years, N, 2013 and 2023 60
Figure 12: 6MM, Tophaceous Gout Cases in the Diagnosed Prevalent Population of Gout, Both Sexes, Ages ?20 Years, N, 2013 and 2023 61
Figure 13: Mechanisms Targeted by Marketed and Late-Stage Pipeline Drugs 124
Figure 14: Competitive Assessment of the Novel Anti-Inflammatory Agent for Gout, 2013-2018 143
Figure 15: Competitive Assessment of the Late-Stage Pipeline Urate-Lowering Agents for Gout, 2013-2018 144
Figure 16: Sales for the Gout Market, US and 5EU (2013-2018) 146

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