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Opportunity Analyzer: Genital Herpes - Opportunity Analysis and Forecasts to 2023

Summary

Genital herpes (GH) is a life-long viral infection of the genitalia and urogenital tract. It is one of the most common sexually transmitted infections (STIs) and is a leading cause of genital ulcers around the world. Patients with GH can suffer from recurring episodes of symptom outbreaks, which usually involve painful ulcerations. The prevalence of GH in the seven major pharmaceutical markets (7MM) covered in this report (US, France, Germany, Italy, Spain, UK, and Japan) has been increasing, and GH is beginning to be viewed as a significant global public health problem, especially because the infection can assist the transmission of human immunodeficiency virus 1 (HIV-1).

There is currently no effective preventative vaccine or cure for GH, and the treatment landscape is dominated by generic nucleoside analogues. Despite the effectiveness of these drugs in managing the symptoms in the majority of patients, the lack of treatment alternatives and the shortcomings of the current treatments have stimulated investments in new treatment options for this vast patient population.

For the purposes of this report, GlobalData defines the GH market to include sales of GH-specific medication in patients 18 years and older. GlobalData expects the market to experience moderate growth that is primarily driven by the uptake of novel therapies - led by Agenus’s HerpV and Genocea’s GEN-003 - in the US and 5EU (France, Germany, Italy, Spain and UK).

Highlights

Key Questions Answered

- Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the GH marketplace. Will the leading pipeline agents fulfil these unmet needs during the forecast period (2013-2023)?
- What research and development (R&D) strategies will companies leverage to compete in the future GH marketplace?
- Which patient population(s) are most likely to be targeted for GH -specific product development?
- What clinical and commercial factors are likely to influence GH uptake in the US, 5EU and Japan?

Key Findings

- GlobalData projects the GH market in the US, 5EU and Japan to grow from approximately $490m in 2013 to $668m in 2023, at a compound annual growth rate (CAGR) of 3.1%. This growth across the 7MM will primarily be driven by the launch of pipeline agents, especially the therapeutic vaccines in the US and 5EU, while continued generic erosion across the 7MM, particularly in the 5EU and Japan, is expected to curtail market growth over the forecast period.
- While pipeline agents have the potential to address some of the unmet needs in the GH treatment, available data do not demonstrate that they will be able to fully address these issues, according to interviewed KOLs.
- GlobalData anticipates that opportunities centered on the development of therapeutic and/or prophylactic vaccines, as well as antivirals with novel MOAs, will exist for current and future players in the GH marketplace for the duration of the forecast period.

Scope

- Overview of GH, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
- Topline GH market revenue from 2013-2023. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the genital herpes market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products. An interactive clinical and commercial analyzer tool is available.
- Analysis of the current and future market competition in the global genital herpes 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.
- Develop business strategies by understanding the trends shaping and driving the global genital herpes market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the genital herpes market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- 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: Genital Herpes - Opportunity Analysis and Forecasts to 2023
1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 14
1.2 List of Figures 17
2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 19
2.3 Upcoming Related Reports 20
3 Disease Overview 21
3.1 Etiology and Pathophysiology 21
3.1.1 Etiology 21
3.1.2 Pathophysiology 23
3.2 Quality of Life 26
3.3 Symptoms 27
3.4 Disease Management 28
3.4.1 Diagnosis 28
3.4.2 Antiviral Therapy 31
3.4.3 Management of GH in Specific Patient Populations 34
3.4.4 Supportive Measures 37
4 Epidemiology 39
4.1 Disease Background 39
4.2 Risk Factors and Comorbidities 40
4.3 Global Trends 42
4.4 Forecast Methodology 43
4.4.1 Sources Used 44
4.4.2 Sources Not Used 50
4.4.3 Forecast Assumptions and Methods 51
4.5 Epidemiological Forecast of GH (2013-2023) 61
4.5.1 Diagnosed Incident Cases of GH 61
4.5.2 Diagnosed Incident Cases of GH Segmented by Strain 63
4.5.3 Diagnosed Incident Cases of GH Segmented by Sex 65
4.5.4 Number of Persons Diagnosed with Herpes Simplex Virus-1 GH Experiencing Recurrences During the First Year of Diagnosis 67
4.5.5 Number of Persons Diagnosed with Herpes Simplex Virus-2 GH Experiencing Recurrences During the First Year of Diagnosis 68
4.5.6 Diagnosed Prevalent Cases of Herpes Simplex Virus-1 Only GH 69
4.5.7 Diagnosed Prevalent Cases of Herpes Simplex Virus-2 Only GH 71
4.5.8 Diagnosed Prevalent Cases of Herpes Simplex Virus-1 and Herpes Simplex Virus-2 Co-infection GH 72
4.6 Discussion 74
4.6.1 Epidemiological Forecast Insight 74
4.6.2 Limitations of the Analysis 74
4.6.3 Strengths of the Analysis 75
5 Current Treatment Options 77
5.1 Overview 77
5.2 Product Profiles - Antivirals 80
5.2.1 Acyclovir 80
5.2.2 Valacyclovir 85
5.2.3 Famciclovir 90
5.2.4 Other Marketed Products 96
6 Unmet Needs Assessment and Opportunity Analysis 101
6.1 Overview 101
6.2 Unmet Needs Analysis 105
6.2.1 Unmet Need: Novel Treatment Options That Reduce GH Transmission and Recurrence 105
6.2.2 Unmet Need: Therapies with More Convenient Dosing Schedules 108
6.2.3 Unmet Need: Safe and Efficacious Therapeutic Interventions for Difficult-to-Treat Patient Populations 110
6.2.4 Unmet Need: Increased Public Awareness and Acceptance of GH 111
6.2.5 Unmet Need: Improved Physician Education on the Importance of Proactively Diagnosing and Treating GH 113
6.3 Opportunity Analysis 114
6.3.1 Opportunity: Develop Therapeutic GH Vaccines 114
6.3.2 Opportunity: Develop Prophylactic GH Vaccines 117
6.3.3 Opportunity: Develop Novel Antiviral Treatments that Possess Novel Mechanisms of Action 120
6.3.4 Opportunity: Leverage Novel Diagnostic Tools alongside Public Awareness Initiatives to Improve GH Diagnosis Rates 122
7 Research and Development Strategies 124
7.1 Overview 124
7.2 Technological Approaches to Vaccine Development 125
7.2.1 Vaccine Antigen Selection 125
7.2.2 Selection of Adjuvants and Co-stimulants 128
7.2.3 Prioritizing Therapeutic Vaccines that Target Herpes Simplex Virus-2 130
7.3 Development of Antivirals that Possess Novel Mechanisms of Action 131
7.4 Collaboration, Licensing, and Partnerships 133
7.5 Clinical Trial Design 134
7.5.1 Current Clinical Trial Design 134
7.5.2 Selection and Enrollment of Clinical Trial Participants 138
7.5.3 Efficacy Endpoint Selection 140
7.5.4 Genital Swabbing Test 143
8 Pipeline Assessment 145
8.1 Overview 145
8.2 Promising Products in Clinical Development 146
8.2.1 Amenamevir 146
8.2.2 HerpV 153
8.2.3 GEN-003 157
8.3 Promising Products in Early-Stage Clinical Development 164
8.3.1 VCL-HB01 and VCL-HM01 165
8.3.2 HSV529 166
8.3.3 HSV-2 DNA Vaccine 168
8.3.4 Brincidofovir 169
8.3.5 G103 169
8.3.6 Pritelivir 169
8.4 Other Innovative Approaches 170
8.4.1 Vaccines in Preclinical Development 171
8.4.2 Other Products in Preclinical Development 172
9 Pipeline Valuation Analysis 173
9.1 Clinical Benchmark of Key Pipeline Drugs 173
9.2 Commercial Benchmark of Key Pipeline Drugs 176
9.3 Competitive Assessment 178
9.4 Top Line Five Year Forecast 181
9.4.1 US 185
9.4.2 5EU 185
9.4.3 Japan 186
10 Appendix 187
10.1 Bibliography 187
10.2 Abbreviations 206
10.3 Methodology 210
10.4 Forecasting Methodology 210
10.4.1 Diagnosed GH Patients 210
10.4.2 Drug-Treated GH Patients 211
10.4.3 Drugs Included in Each Therapeutic Class 211
10.4.4 Launch and Patent Expiry Dates 211
10.4.5 General Pricing Assumptions 212
10.4.6 Individual Drug Assumptions 213
10.4.7 Pricing of Pipeline Agents 217
10.5 Primary Research — Key Opinion Leaders Interviewed for this Report 218
10.6 Primary Research — Prescriber Survey 219
10.7 About the Authors 220
10.7.1 Author 220
10.7.2 Epidemiologist 220
10.7.3 Therapy Area Director 221
10.7.4 Global Head of Healthcare 221
10.8 About GlobalData 222
10.9 Disclaimer 222

1.1 List of Tables
Table 1: Symptoms of GH 28
Table 2: Laboratory-Based Diagnostic Tests for HSV Infection 30
Table 3: Recommended Antiviral Regimens for the Management of GH in Immunocompetent Patients 33
Table 4: Recommended Antiviral Regimens for the Management of GH in Immunocompromised Patients 35
Table 5: Risk Factors and Comorbidities for GH 41
Table 6: Sources of Epidemiological Data Used for the Forecast of the Diagnosed Incident Cases of GH in the 7MM 44
Table 7: Sources of Epidemiological Data Used for the Forecast of the Total Prevalent Cases of HSV-1 Infections in the 7MM 45
Table 8: Sources of Epidemiological Data Used for the Forecast of the Total Prevalent Cases of HSV-2 Infection in the 7MM 45
Table 9: Sources of Epidemiological Data Used for the Forecast of the Total Prevalent Cases of HSV-1 and HSV-2 Co-infections in the 7MM 46
Table 10: Sources of Epidemiological Data Used for the Forecast of the Diagnosis Rate of HSV-1 Only GH in the 7MM 46
Table 11: Sources of Epidemiological Data Used for the Forecast of the Diagnosis Rate of HSV-2 Only GH in the 7MM 47
Table 12: Sources of Epidemiological Data Used for the Forecast of the Diagnosis Rate of HSV-1 and HSV-2 Co-infection GH in the 7MM 47
Table 13: 7MM, Sources Not Used in the Epidemiological Analysis of GH 51
Table 14: 7MM, Diagnosed Incident Cases of GH, Both Sexes, Ages ?18 Years, Select Years 2013-2023 62
Table 15: 7MM, Diagnosed Incident Cases of GH Segmented by Strain, Both Sexes, Ages ?18 Years, 2013 64
Table 16: 7MM, Diagnosed Incident Cases of GH Segmented by Sex, Ages ?18 Years, N (Row %) 2013 66
Table 17: 7MM, Number of Persons Diagnosed with HSV-1 Experiencing Recurrences During the First Year of Diagnosis, Both Sexes, Ages ?18 Years, 2013 68
Table 18: 7MM, Number of Persons Diagnosed with HSV-2 Experiencing Recurrences During the First Year of Diagnosis, Both Sexes, Ages ?18 Years, 2013 69
Table 19: 7MM, Diagnosed Prevalent Cases of HSV-1 Only GH, Both Sexes, Ages ?18 Years, N, Select Years, 2013-2023 70
Table 20: 7MM, Diagnosed Prevalent Cases of HSV-2 Only GH, Both Sexes, Ages ?18 Years, N, Select Years, 2013-2023 71
Table 21: 7MM, Diagnosed Prevalent Cases of HSV-1 and HSV-2 Co-infection GH, Both Sexes, Ages ?18 Years, Select Years, 2013-2023 73
Table 22: Leading Treatments for GH 79
Table 23: Product Profile — Acyclovir 81
Table 24: Summary of Key Clinical Trials of Acyclovir 82
Table 25: Result from a Clinical Trial with Oral Acyclovir 82
Table 26: Result from a Clinical Trial with Oral Acyclovir 83
Table 27: Acyclovir SWOT Analysis, 2014 85
Table 28: Product Profile — Valacyclovir 86
Table 29: Summary of Key Clinical Trials of Valacyclovir 87
Table 30: Valacyclovir SWOT Analysis, 2014 90
Table 31: Product Profile — Famciclovir 92
Table 32: Summary of Key Clinical Trials of Famciclovir 93
Table 33: Famciclovir SWOT Analysis, 2014 96
Table 34: Other Drugs Used to Treat HSV Infections 100
Table 35: Overall Unmet Needs — Current Level of Attainment 103
Table 36: Collaboration and Partnership in the Development of GH Vaccines 134
Table 37: Key Clinical Trials of Pipeline Antiviral Treatments 135
Table 38: Key Clinical Trials of Pipeline Vaccines 137
Table 39: Late-Stage Pipeline for GH, 2014 146
Table 40: Product Profile — Amenamevir 148
Table 41: Amenamevir — Key Efficacy End Point Result in a Phase II Clinical Trial 150
Table 42: Amenamevir SWOT Analysis, 2014 152
Table 43: Product Profile - HerpV 155
Table 44: HerpV SWOT Analysis, 2014 157
Table 45: Product Profile — GEN-003 160
Table 46: GEN-003 - Clinical Data from a Phase I/IIa Clinical Trial 162
Table 47: GEN-003 - Clinical Data from a Phase II Dose Optimization Clinical Trial 163
Table 48: GEN-003 SWOT Analysis, 2014 164
Table 49: Early-stage Pipeline for GH, 2014 165
Table 50: Preclinical and Discovery Stage Vaccines for GH 171
Table 51: Preclinical and Discovery Stage Non-vaccine Products for GH 172
Table 52: Clinical Benchmarking of Key Marketed and Pipeline Antivirals 174
Table 53: Clinical Benchmarking of Key Pipeline Vaccines 175
Table 54: Commercial Benchmarking of Key Marketed and Pipeline Products 177
Table 55: Top Line Sales Forecasts ($m) for GH, 2013-2023 181
Table 56: Key Events Impacting Sales for GH, 2013-2023 184
Table 57: GH Market — Drivers and Barriers, 2013-2023 184
Table 58: Key Historical and Projected Launch Dates 211
Table 59: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 219

1.2 List of Figures
Figure 1: HSV Virion Structure 22
Figure 2: 7MM, Diagnosed Incident Cases of GH, Both Sexes, Ages ?18 Years, Select Years, 2013-2023 63
Figure 3: Diagnosed incident Cases of GH Segmented by Strain, Both Sexes, Ages ?18 Years, 2013 65
Figure 4: 7MM, Diagnosed Incident Cases of GH Segmented by Sex, Ages ?18 Years, 2013 67
Figure 5: 7MM, Diagnosed Prevalent Cases of HSV-1 Only GH, Both Sexes, Ages ?18 Years, N, 2013-2023 70
Figure 6: 7MM, Diagnosed Prevalent Cases of HSV-2 Only GH, Both Sexes, Ages ?18 Years, N, 2013-2023 72
Figure 7: 7MM, Diagnosed Prevalent Cases of HSV-1 and HSV-2 Co-infection GH, Both Sexes, Ages ?18 Years, Select Years, 2013-2023 73
Figure 8: Competitive Assessment of Late-stage Pipeline Agents for GH, 2013-2023 180
Figure 9: Sales for GH by Region, 2013-2023 183

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