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


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

Summary

GlobalData has released its new Country report, “PharmaPoint: Prostate Cancer - Italy 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.

In Italy, prostate cancer is diagnosed in response to symptoms, an abnormal DRE, or an elevated PSA level found during routine screening (EAU, 2012). Routine PSA screening is used less frequently in Italy than in most major markets, similar to the UK. A diagnosis is confirmed using TRUS-guided core needle biopsies, and metastases are detected using a bone scan, CT scan, or Positron Emission Tomography (PET) choline scan. 

Prescribers and KOLs do not expect to see major changes in how prostate cancer is diagnosed over the forecast period, and do not believe the USPSTF recommendation against routine PSA screening will have an impact in Italy.

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 Italy including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in Italy from 2012 to 2022.
  • Analysis of the impact of key events as well the drivers and restraints affecting the Italy 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 Italy
  • Obtain sales forecast from 2012-2022 in Italy
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 Italy 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 106
7.2.6 Alpharadin (radium-223 chloride) 110
7.2.7 Tasquinimod 115
7.2.8 ProstVac (Vaccinia-PSA-TRICOM/Fowlpox-PSA-TRICOM) 119

8 Market Outlook 124
8.1 Italy 124
8.1.1 Forecast 124
8.1.2 Key Events 128
8.1.3 Drivers and Barriers 128

9 Appendix 130
9.1 Bibliography 130
9.2 Abbreviations 143
9.3 Methodology 146
9.4 Forecasting Methodology 146
9.4.1 Number of Prostate Cancer Patients Currently Seeking Treatment 146
9.4.2 Percent Drug-treated Patients 147
9.4.3 Percent Hormone Therapy-Treated Patients 147
9.4.4 Drugs Included in Each Therapeutic Class 147
9.4.5 Launch, Patent and Market Exclusivity Expiry Dates 148
9.4.6 General Pricing Assumptions 149
9.4.7 Individual Drug Assumptions 151
9.4.8 Generic Erosion 160
9.4.9 Pricing of Pipeline Agents 160
9.5 Physicians and Specialists Included in This Study 161
9.6 Survey of Prescribing Physicians 162
9.7 About the Authors 163
9.7.1 Authors 163
9.7.2 Global Head of Healthcare 164
9.8 About GlobalData 165
9.9 Contact Us 165
9.10 Disclaimer 165

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 101
Table 44: Product Profile - Yervoy 102
Table 45: Yervoy SWOT Analysis, 2012 106
Table 46: Product Profile - Orteronel 107
Table 47: Orteronel SWOT Analysis, 2012 110
Table 48: Product Profile - Alpharadin (radium-223 chloride) 111
Table 49: Alpharadin SWOT Analysis, 2012 115
Table 50: Product Profile - Tasquinimod 116
Table 51: Tasquinimod SWOT Analysis, 2012 119
Table 52: Product Profile - ProstVac (Vaccinia-PSA-TRICOM/Fowlpox-PSA-TRICOM) 120
Table 53: ProstVac SWOT Analysis, 2012 123
Table 54: Sales Forecasts ($m) for Prostate Cancer in Italy, 2012-2022 126
Table 55: Key Events Impacting Sales for Prostate Cancer in Italy, 2012-2022 128
Table 56: Prostate Cancer Market in Italy - Drivers and Barriers, 2012 128
Table 57: Key Launch Dates 148
Table 58: Key Patent Expiries and Market Exclusivity Expiries 149
Table 59: Physicians Surveyed, By Country 162
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 Italy by Drug Class, 2012-2022 127