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OpportunityAnalyzer: Benign Prostatic Hyperplasia - Opportunity Analysis and Forecast to 2024
[Published by Global Data]

Published by Global Data: 08 Sep 2015 | 17096 | In Stock

Introduction

OpportunityAnalyzer: 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 billion across the 7MM (US, Germany, France, Italy, Spain, UK and Japan). The US contributed a significant majority of these sales, generating an estimated .15 billion over the forecast period, ending in 2024. Benign Prostatic Hyperplasia therapeutics sales in the 7MM are expected to grow to .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
for OpportunityAnalyzer: Benign Prostatic Hyperplasia - Opportunity Analysis and Forecast to 2024 [Published by Global Data]

  • 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 α1-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 R&D 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

List Of Tables
in OpportunityAnalyzer: Benign Prostatic Hyperplasia - Opportunity Analysis and Forecast to 2024 [Published by Global Data]

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

List Of Figures, Charts and Diagrams
in OpportunityAnalyzer: Benign Prostatic Hyperplasia - Opportunity Analysis and Forecast to 2024 [Published by Global Data]

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

Additional Details

Publisher

Global Data

Publisher Information

Reference

17096 | GDHC040POA

Number of Pages

174

Report Format

PDF

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