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Opportunity Analyzer: Benign Prostatic Hyperplasia - Opportunity Analysis and Forecast to 2024

Summary

GlobalData estimates the 2014 sales for the benign prostatic hyperplasia (BPH) therapeutics market at approximately $2 billion across the 7MM (US, Germany, France, Italy, Spain, UK and Japan). The US contributed a significant majority of these sales, generating an estimated $1.15 billion over the forecast period, ending in 2024. Benign Prostatic Hyperplasia therapeutics sales in the 7MM are expected to grow to $4.5 billion at a Compound Annual Growth Rate (CAGR) of 8.23%. The majority of sales in the 7MM in 2024 will come from the US, which will represent 65% of the market; with sales in the 5EU corresponding to 24%, while the remaining 12% in sales is attributable to Japan. The major driver for this growth across the 7MM will be the launch of NX-1207, a direct prostatic injection, which represents a first-in-class therapy for the treatment of moderate-to- severe BPH.

Highlights

Key Questions Answered

- Overall, the greatest unmet need in the BPH space is the issue with hard to treat symptoms such as nocturia and the presence of sexual adverse effects that are common with BPH medications. There are other prominent unmet needs highlighted by the Key Opinion Leaders (KOLs). What are these? Will the pipeline drugs fulfil these unmet needs of the market?
- The 10-year forecast period will mark the launch of three pipeline BPH drugs. How will the sales of the existing drugs be impacted? Which of the pipeline drugs will have the highest peak sales at the highest CAGR, and why?
- Four BPH therapies will face patent expiration during the forecast period resulting in a therapy area dominated by generics. How will this affect the market size? How will pharmaceutical companies be affected and how can they hope to profit in this environment?

Key Findings

- The major driver for growth in the BPH market during the forecast period will be the launch of three pipeline therapies which each represent an improvement over currently available medications in their own right. KOLs believe that the launch of NX-1207, PRX302 and Vesomni will considerably change the treatment algorithm for patients with BPH.
- There are substantial unmet needs in the BPH area which need to be addressed. Targeting any of these unmet needs represents significant opportunities for investment in the area.
- KOLs believe that BPH is an underappreciated disease and that there is the potential for momentous growth in the field.

Scope

- Overview of BPH, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized BPH therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the BPH 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 BPH 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 BPH therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the BPH 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 7MM BPH therapeutics market from 2014-2024.
- 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

Opportunity Analyzer: Benign Prostatic Hyperplasia - Opportunity Analysis and Forecast to 2024
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 12
1.2 List of Figures 14
2 Introduction 15
2.1 Catalyst 15
2.2 Related Reports 15
3 Disease Overview 16
3.1 Etiology and Pathophysiology 16
3.1.1 Etiology 16
3.1.2 Pathophysiology 20
3.2 Symptoms and Diagnosis 21
3.3 Quality of Life 25
4 Epidemiology 27
4.1 Disease Background 27
4.2 Risk Factors and Comorbidities 28
4.3 Global Trends 28
4.3.1 US 28
4.3.2 5EU 29
4.3.3 Japan 29
4.4 Forecast Methodology 29
4.4.1 Sources Used 30
4.4.2 Sources Not Used 31
4.4.3 Forecast Assumptions and Methods - Diagnosed Prevalent Cases 32
4.5 Epidemiological Forecast for BPH (2014-2024) 33
4.5.1 Diagnosed Prevalent Cases of BPH 33
4.5.2 Age-Specific Diagnosed Prevalent Cases of BPH 35
4.5.3 Diagnosed Prevalent Cases of BPH by Severity Using IPSS Criteria 36
4.5.4 Age Standardized Diagnosed Prevalence of BPH (%) 37
4.6 Discussion 38
4.6.1 Epidemiological Forecast Insight 38
4.6.2 Limitations of the Analysis 39
4.6.3 Strengths of the Analysis 39
5 Current Treatment Options 40
5.1 Overview 40
5.2 Product Profiles of Major BPH Brands 41
5.2.1 Flomax 41
5.2.2 Rapaflo 47
5.2.3 Uroxatral 53
5.2.4 Other ?1-adrenoceptor antagonists 58
5.2.5 Finasteride 59
5.2.6 Avodart 66
5.2.7 Jalyn/Duodart 73
5.2.8 Cialis 79
5.2.9 Antimuscarinics 85
5.2.10 Phytotherapy 87
5.2.11 Medical Devices and Surgical Treatment 88
6 Unmet Needs Assessment and Oppportunity Analysis 90
6.1 Overview 90
6.2 There are No Effective Drugs for the Treatment of Nocturia 91
6.2.1 Unmet need 91
6.2.2 Gap Analysis 92
6.2.3 Opportunity 92
6.3 Sexual Adverse Effects Encountered Frequently in Patients Receiving BPH Medication 93
6.3.1 Unmet need 93
6.3.2 Gap Analysis 94
6.3.3 Opportunity 95
6.4 There is a Lack of Patient Awareness of BPH 95
6.4.1 Unmet Need 95
6.4.2 Gap Analysis 96
6.4.3 Opportunity 97
6.5 There are No Accurate Techniques for the Early Detection of BPH 97
6.5.1 Unmet Need 97
6.5.2 Gap Analysis 98
6.5.3 Opportunity 98
6.6 There are No Drugs that Target the Cause of BPH 99
6.6.1 Unmet Need 99
6.6.2 Gap Analysis 100
6.6.3 Opportunity 100
6.7 Physician Education about BPH is Poor 100
6.7.1 Unmet Need 100
6.7.2 Gap Analysis 101
6.7.3 Opportunity 102
7 RandD Strategies 103
7.1 Overview 103
7.1.1 Eliminating Sexual Adverse Effects 103
7.1.2 Novel Route of Administration 104
7.1.3 Secondary Indications 104
7.1.4 Targeting Patient Subgroups 105
7.1.5 Licensing Agreements and Other Partnerships 105
7.2 Clinical trial design 106
7.2.1 Current Clinical Trials 106
7.2.2 Future Clinical Trials 110
8 Pipeline Assessment 112
8.1 Overview 112
8.2 Promising Drugs in Clinical Development 113
8.2.1 NX-1207 113
8.2.2 PRX302 120
8.2.3 Vesomni 126
8.3 Innovative Early-stage Approaches 130
9 Pipeline Valuation Analysis 135
9.1 Clinical Benchmark of Key Pipeline Drugs 135
9.2 Commercial Benchmark of Key Pipeline Drugs 137
9.3 Competitive Assessment 139
9.4 Top Line Ten Year Forecast 140
9.4.1 US 143
9.4.2 5EU 145
9.4.3 Japan 146
9.4.4 Drivers and Barriers 148
10 Appendix 149
10.1 Bibliography 149
10.2 Abbreviations 160
10.3 Methodology 163
10.4 Forecasting Methodology 163
10.4.1 Diagnosed BPH patients 163
10.4.2 Percent of Drug-treated Patients 164
10.4.3 Drugs Included in Each Therapeutic Class 164
10.4.4 Launch and Patent Expiry Dates 165
10.4.5 General Pricing Assumptions 166
10.4.6 Individual Drug Assumptions 166
10.4.7 Generic Erosion 168
10.4.8 Pricing of Pipeline agents 169
10.5 Physicians and Specialists Included in this Study 170
10.6 About the Authors 171
10.6.1 Author 171
10.6.2 Therapy Area Director 171
10.6.3 Epidemiologist 172
10.6.4 Global Head of Healthcare 172
10.7 About GlobalData 173
10.8 Disclaimer 173

1.1 List of Tables
Table 1: Symptoms of Benign Prostatic Hyperplasia 22
Table 2: The International Prostate Symptoms Score (IPSS) 23
Table 3: Risk Factors and Comorbidities for BPH 28
Table 4: 7MM, Sources of Epidemiological Data Used in the Forecast for BPH Diagnosed Prevalence Data 30
Table 5: 7MM, Diagnosed Prevalent Cases of BPH, Ages ?40 Years, Men (N), 2014-2024 34
Table 6: 7MM, Age-Specific Diagnosed Prevalent Cases of BPH, Ages ?40 Years, Men, N (Row %), 2014 35
Table 7: Leading Treatments for BPH 41
Table 8: Product Profile - Flomax 44
Table 9: Flomax SWOT Analysis, 2015 46
Table 10: Product Profile - Rapaflo 49
Table 11: Rapaflo SWOT Analysis, 2015 52
Table 12: Product Profile - Uroxatral 55
Table 13: Uroxatral SWOT Analysis, 2015 57
Table 14: Product Profile - Proscar 62
Table 15: Proscar SWOT Analysis, 2015 65
Table 16: Product Profile - Avodart 69
Table 17: Avodart SWOT Analysis, 2015 72
Table 18: Product Profile - Jalyn 76
Table 19: Jalyn SWOT Analysis, 2015 78
Table 20: Product Profile - Cialis 82
Table 21: Cialis SWOT Analysis, 2015 84
Table 22: Overall Unmet Needs - Current Level of Attainment 91
Table 23: Clinical Trial Design of Key Marketed and Pipeline Drugs for Benign Prostatic Hyperplasia 107
Table 24: Inclusion and Exclusion Criteria Common in BPH Clinical Trials 109
Table 25: Benign Prostatic Hyperplasia - Late Stage Pipeline, 2015 113
Table 26: Product Profile - NX-1207 116
Table 27: NX-1207 SWOT Analysis, 2015 119
Table 28: Product Profile - PRX302 123
Table 29: PRX302 SWOT Analysis, 2015 125
Table 30: Product Profile - Vesomni 128
Table 31: Vesomni SWOT Analysis, 2015 130
Table 32: Early-stage Pipeline Products in Benign Prostatic Hyperplasia 134
Table 33: Clinical Benchmark of Key Pipeline Drugs 136
Table 34: Commercial Benchmark of Key Pipeline Drugs 138
Table 35: Top Line Sales Forecasts ($m) for Benign Prostatic Hyperplasia, 2014-2024 142
Table 36: Key Events That Will Impact Sales for Benign Prostatic Hyperplasia, 2014-2024 143
Table 37: Benign Prostatic Hyperplasia Market - Drivers and Barriers, 2014-2024 148
Table 38: Key Launch Dates 165
Table 39: Key Patent Expiries 165

1.2 List of Figures
Figure 1: A Graphical Representation of the Role of DHT in the Prostate 17
Figure 2: A Schematic Illustration of How an Imbalance of DHT Levels in the Prostate Disrupts the Growth Cycle 18
Figure 3: The Complex Relationship Between Neuroregulatory Factors and Benign Prostatic Hyperplasia 19
Figure 4: Anatomy of a Prostate Gland 20
Figure 5: The Management Protocol for Benign Prostatic Hyperplasia 25
Figure 6: 7MM, Diagnosed Prevalent Cases of BPH, Ages ?40 Years, Men (N), 2014-2024 34
Figure 7: 7MM, Age-Specific Diagnosed Prevalent Cases of BPH, Ages ?40 years, Men (N), 2014 36
Figure 8: 7MM, Severity Profile of Diagnosed Prevalent Cases of BPH, Ages ?40 years, Men (N), 2014 37
Figure 9: 7MM, Age Standardized Prevalence of BPH, Ages ?40 years, Men (%), 2014 38
Figure 10: The NO/cGMP Pathway 80
Figure 11: Mechanism of Action of PRX302 121
Figure 12: Competitive Assessment of Late-stage Pipeline Agents in Benign Prostatic Hyperplasia, 2014-2024 139
Figure 13: Sales for the Benign Prostatic Hyperplasia Market in the 7MM, 2014-2024 142
Figure 14: Global Sales of Benign Prostatic Hyperplasia Drugs by Region, 2014 and 2024 147

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