PharmaPoint: Prostate Cancer - United States Drug Forecast and Market Analysis to 2022


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162pages

GlobalData

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Summary

GlobalData has released its new Country report, “PharmaPoint: Prostate Cancer - United States Drug Forecast and Market Analysis to 2022”. The recent approvals of second-line metastatic castration-resistant prostate cancer (mCRPC) therapies like J&J’s Zytiga (abiraterone acetate) and Medivation/Astellas’ Xtandi (enzalutamide) will drive strong market growth over the next decade. 

These safe and orally administered treatments will provide safety and convenience benefits over the current standard of care, chemotherapy with docetaxel, while prolonging the overall survival of patients with mCRPC. The December 12, 2012 FDA approval of Zytiga for the added indication of chemotherapy-naïve mCRPC marks the onset of a new treatment paradigm for the disease, in which chemotherapy is relegated to second-line therapy and beyond. For patients with earlier-stage prostate cancer, androgen deprivation therapy with LHRH agonists and first-generation antiandrogens remains the standard of care for suppressing testosterone levels and temporarily controlling the disease.

US prescribers widely use routine PSA screening to diagnose prostate cancer, as well as a DRE. GlobalData’s primary research shows that the majority of patients treated by urologists and medical oncologists in the US in 2011 were diagnosed or monitored using PSA screening. 

The diagnosis is confirmed and the cancer is staged following a TRUS-guided multiple-core needle biopsy, and any metastases are diagnosed using a bone scan or Computed Tomography (CT) scan (NCCN, 2012). Most prescribers surveyed intend to decrease their use of routine PSA screening to diagnose prostate cancer in asymptomatic patients in response to the recent USPSTF recommendation against it (see Section 5.2.2). While GlobalData predicts that the use of routine PSA screening will slightly decrease, we still believe that it will be the primary tool used in the diagnosis of prostate cancer over the forecast period, as there are currently no better, cost-effective options available.

Scope
  • Overview of RA, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in the US from 2012 to 2022.
  • Analysis of the impact of key events as well the drivers and restraints affecting the US Prostate cancer market.
Reasons to buy
  • Understand and capitalize by identifying products that are most likely to ensure a robust return
  • Stay ahead of the competition by understanding the changing competitive landscape for Prostate cancer
  • Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
  • Make more informed business decisions from insightful and in-depth analysis of Prostate cancer drug performance in the US
  • Obtain sales forecast from 2012-2022 in The US
Table of Contents

1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 8

2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 9
2.3 Upcoming Related Reports 11

3 Disease Overview 12
3.1 Etiology and Pathophysiology 12
3.1.1 Etiology 12
3.1.2 Pathophysiology 12
3.1.3 Prognosis 13
3.1.4 Quality of Life 14
3.2 Symptoms 14

4 Disease Management 15
4.1 Diagnosis and Referral Overview 15
4.2 Treatment Overview 17
4.2.1 Conservative Management Strategies 21
4.2.2 Localized Treatments 22
4.2.3 Hormone Therapy 23
4.2.4 Drug Therapies 25
4.3 US 26
4.3.1 Diagnosis 26
4.3.2 Clinical Practice 26

5 Competitive Assessment 28
5.1 Overview 28
5.2 Strategic Competitor Assessment 29
5.3 Product Profiles - Major Brands, Hormone Therapies 32
5.3.1 Zoladex (goserelin acetate) 32
5.3.2 Lupron Depot (leuprolide acetate) 35
5.3.3 Eligard (leuprolide acetate) 39
5.3.4 Trelstar (triptorelin acetate) 42
5.3.5 Firmagon (degarelix) 45
5.3.6 Casodex (bicalutamide) 48
5.4 Product Profiles - Major Brands, Chemotherapies 52
5.4.1 Taxotere (docetaxel) 52
5.4.2 Jevtana (cabazitaxel) 55
5.5 Product Profiles - Major Brands, Therapeutic Vaccines 59
5.5.1 Provenge (sipuleucil-T) 59
5.6 Product Profiles - Major Brands, Targeted Therapies 64
5.6.1 Zytiga (abiraterone acetate) 64
5.6.2 Xtandi (enzalutamide) 68
5.7 Product Profiles - Major Brands, Bone Therapies 72
5.7.1 Xgeva (denosumab) 72
5.7.2 Zometa (zoledronic acid) 75
5.8 Other Marketed Hormone and Drug Therapies 78

6 Opportunity and Unmet Need 79
6.1 Overview 79
6.2 Efficacy at Prolonging Overall Survival 80
6.3 Safety 80
6.4 Mitigation of Symptoms 81
6.5 Cost 81
6.6 Convenient Routes of Administration 81
6.7 Accurate Diagnostic Tests and Surveillance Tools 82
6.8 Unmet Needs Gap Analysis 82
6.9 Opportunity: Targeting Early-Stage, Hormone-Sensitive Prostate Cancer 84

7 Pipeline Assessment 85
7.1 Overview 85
7.2 Promising Drugs in Clinical Development 86
7.2.1 Cabozantinib 88
7.2.2 Custirsen Sodium 92
7.2.3 Sprycel (dasatinib) 97
7.2.4 Yervoy (ipilimumab) 101
7.2.5 Orteronel 105
7.2.6 Alpharadin (radium-223 chloride) 109
7.2.7 Tasquinimod 114
7.2.8 ProstVac (Vaccinia-PSA-TRICOM/Fowlpox-PSA-TRICOM) 118

8 Market Outlook 122
8.1 United States 122
8.1.1 Forecast 122
8.1.2 Key Events 125
8.1.3 Drivers and Barriers 125

9 Appendix 128
9.1 Bibliography 128
9.2 Abbreviations 141
9.3 Methodology 143
9.4 Forecasting Methodology 143
9.4.1 Number of Prostate Cancer Patients Currently Seeking Treatment 143
9.4.2 Percent Drug-treated Patients 144
9.4.3 Percent Hormone Therapy-Treated Patients 144
9.4.4 Drugs Included in Each Therapeutic Class 144
9.4.5 Launch, Patent and Market Exclusivity Expiry Dates 145
9.4.6 General Pricing Assumptions 146
9.4.7 Individual Drug Assumptions 148
9.4.8 Generic Erosion 157
9.4.9 Pricing of Pipeline Agents 157
9.5 Physicians and Specialists Included in This Study 159
9.6 Survey of Prescribing Physicians 159
9.7 About the Authors 160
9.7.1 Authors 160
9.7.2 Global Head of Healthcare 161
9.8 About GlobalData 162
9.9 Contact Us 162
9.10 Disclaimer 162

Table 1: Stage Distribution of Prostate Cancer at Diagnosis in Selected Major Markets 13
Table 2: Global Variations in Recommendations on Routine PSA Screening 15
Table 3: Most Commonly Followed Treatment Guidelines for Prostate Cancer, 2012 18
Table 4: Most Commonly Prescribed Drugs for Prostate Cancer by Class in the Global Markets, 2012 20
Table 5: Leading Treatments for Prostate Cancer, 2012 31
Table 6: Product Profile - Zoladex 33
Table 7: Zoladex SWOT Analysis, 2012 35
Table 8: Product Profile - Lupron Depot 36
Table 9: Lupron Depot SWOT Analysis, 2012 38
Table 10: Product Profile - Eligard 40
Table 11: Eligard SWOT Analysis, 2012 42
Table 12: Product Profile - Trelstar 43
Table 13: Trelstar SWOT Analysis, 2012 45
Table 14: Product Profile - Firmagon 46
Table 15: Firmagon SWOT Analysis, 2012 48
Table 16: Product Profile - Casodex 49
Table 17: Casodex SWOT Analysis, 2012 51
Table 18: Product Profile - Taxotere 53
Table 19: Taxotere SWOT Analysis, 2012 55
Table 20: Product Profile - Jevtana 56
Table 21: Jevtana SWOT Analysis, 2012 58
Table 22: Product Profile - Provenge 59
Table 23: Provenge SWOT Analysis, 2012 63
Table 24: Product Profile - Zytiga 65
Table 25: Zytiga SWOT Analysis, 2012 67
Table 26: Product Profile - Xtandi 69
Table 27: Xtandi SWOT Analysis, 2012 71
Table 28: Product Profile - Xgeva 73
Table 29: Xgeva SWOT Analysis, 2012 75
Table 30: Product Profile - Zometa 76
Table 31: Zometa SWOT Analysis, 2012 78
Table 32: Summary of Other Marketed Hormone and Drug Therapies, 2012 78
Table 33: Overall Unmet Needs, Hormone-Sensitive Prostate Cancer - Current Level of Attainment 79
Table 34: Overall Unmet Needs, CRPC - Current Level of Attainment 80
Table 35: Clinical Unmet Needs - Gap Analysis, 2012 83
Table 36: Prostate Cancer - Phase III Pipeline, 2012 86
Table 37: Comparison of Therapeutic Classes in Development for Prostate Cancer, 2012 86
Table 38: Product Profile - Cabozantinib 88
Table 39: Cabozantinib SWOT Analysis, 2012 92
Table 40: Product Profile - Custirsen Sodium 93
Table 41: Custirsen Sodium SWOT Analysis, 2012 96
Table 42: Product Profile - Sprycel 97
Table 43: Sprycel SWOT Analysis, 2012 100
Table 44: Product Profile - Yervoy 101
Table 45: Yervoy SWOT Analysis, 2012 105
Table 46: Product Profile - Orteronel 106
Table 47: Orteronel SWOT Analysis, 2012 109
Table 48: Product Profile - Alpharadin (radium-223 chloride) 110
Table 49: Alpharadin SWOT Analysis, 2012 113
Table 50: Product Profile - Tasquinimod 114
Table 51: Tasquinimod SWOT Analysis, 2012 117
Table 52: Product Profile - ProstVac (Vaccinia-PSA-TRICOM/Fowlpox-PSA-TRICOM) 118
Table 53: ProstVac SWOT Analysis, 2012 121
Table 54: Sales Forecasts ($m) for Prostate Cancer in the United States, 2012-2022 123
Table 55: Key Events Impacting Sales for Prostate Cancer in the US, 2012-2022 125
Table 56: Prostate Cancer Market in the US - Drivers and Barriers, 2012-2022 125
Table 57: Key Launch Dates 145
Table 58: Key Patent Expiries and Market Exclusivity Expiries 146
Table 59: Physicians Surveyed, By Country 159
Figure 1: General Treatment Algorithm for Prostate Cancer, 2012 19
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Prostate Cancer, 2012-2022 87
Figure 3: Sales for Prostate Cancer in the United States by Drug Class, 2012-2022 124