PharmaPoint: Hepatitis C Virus - Global Drug Forecast and Market Analysis to 2022 - Tucson News Now

PharmaPoint: Hepatitis C Virus - Global Drug Forecast and Market Analysis to 2022

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NEW YORK, Feb. 25, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

PharmaPoint: Hepatitis C Virus - Global Drug Forecast and Market Analysis to 2022
http://www.reportlinker.com/p02029809/PharmaPoint-Hepatitis-C-Virus---Global-Drug-Forecast-and-Market-Analysis-to-2022.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication

PharmaPoint: Hepatitis C Virus - Global Drug Forecast and Market Analysis to 2022

Summary

Hepatitis C is a liver infection caused by the hepatitis C virus (HCV) that results in acute or chronic presentation. The disease is often asymptomatic, but infected patients may experience fatigue, joint pain, itchy skin or jaundice. There is no effective vaccine against HCV, so the market is driven by therapeutics. Currently, drug combinations containing pegylated interferon (e.g., Roche's Pegasys and Merck's PegIntron) and ribavirin (e.g., Roche's Copegus and Merck's Rebetol) are used to treat HCV infection. Patients infected with HCV genotype 1 can also have a protease inhibitor added to their combination therapy, such as Merck's Victrelis (boceprevir) or Vertex's Incivek (telaprevir). The entrance of next-generation HCV therapies is expected to fundamentally change the HCV treatment algorithm. GlobalData expects a dramatic shift favoring the uptake of interferon-free regimens due to their more tolerable side-effect profiles and decreased duration of therapy compared with the current standard of care.

Highlights

Key Questions Answered

- What is the fate of Vertex's Incivek and Merck's Victrelis after the launch of next-generation HCV therapies?
- What role, if any, will interferon have in the HCV treatment algorithm over the next decade?
- Is there demand from physicians for new interferon derivatives?
- What metrics do physicians use when evaluating HCV regimens?
- Is pill burden a major unmet need in this indication?
- Which HCV regimen in development are physicians most excited about?
- As direct-acting antivirals (DAAs) overtake the HCV treatment algorithm, is there any need for host-targeting therapies?

Key Findings

- Patient awareness is anticipated to increase in response to government education and screening initiatives.
- Interferon use is predicted to decrease over the next 10 years.
- The launch of next-generation, direct-acting antivirals is expected to streamline the HCV treatment algorithm.
- The approval of more-tolerable HCV therapies is likely to result in patients deciding to undergo treatment (i.e., decrease in the warehouse effect).

Scope

- Overview of hepatitis C virus, including epidemiology, etiology, general symptoms from infection, and national vaccination recommendations and guidelines.
- Annualized hepatitis C therapeutics market revenue, annual cost of vaccination and treatment usage pattern data from 2012 and forecast for nine years to 2022.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the hepatitis C market.
- Pipeline analysis: comprehensive data split across different phases, and emerging trends, specifically interferon-free therapies and fixed-dose combinations.
- Analysis of the current and future market competition in the global hepatitis C therapeutics market. Insightful review of the key industry and governmental 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 hepatitis C therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global hepatitis C market in 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.
- Track drug sales in the global hepatitis C therapeutics market from 2012–2022.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
1 Table of Contents
1 Table of Contents 6
1.1 List of Tables 13
1.2 List of Figures 18
2 Introduction 19
2.1 Catalyst 19
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 25
3.1.3 Prognosis 26
3.2 Symptoms 26
4 Epidemiology 27
4.1 Risk Factors and Comorbidities 27
4.1.1 The Risk of Contracting HCV Is Almost 50 Times Higher Among Injection Drug Users 28
4.1.2 There Is a 10.9-fold Increased Risk of Developing HCV Infection through a Blood Transfusion 29
4.1.3 No Current Preventative Therapy to Reduce Perinatal Transmission 29
4.1.4 Metabolic Syndrome Is a Common Comorbidity in HCV-infected Individuals 29
4.1.5 Chronic Alcoholism Greatly Magnifies the Risk of HCC 30
4.1.6 Hepatitis B Virus and HCV Share Similar Modes of Transmission, Resulting in Co-infections 31
4.1.7 HCV/HIV Co-infection Complicates Treatment Options and Accelerates Liver Damage 31
4.2 Global Trends 32
4.2.1 US 32
4.2.2 5EU 33
4.2.3 Japan 36
4.2.4 Brazil 37
4.2.5 China 37

4.3 Forecast Methodology 38
4.3.1 Sources Used 38
4.3.2 Forecast Assumptions and Methods 42
4.3.3 Forecast Assumptions and Methods (HCV Genotypes) 45
4.3.4 Sources Not Used 48
4.4 Epidemiology Forecast (2012-2022) 49
4.4.1 Total Prevalent Cases of HCV 49
4.4.2 Age-Specific Prevalent Cases of HCV 51
4.4.3 Sex-Specific Prevalent Cases of HCV 54
4.4.4 Age-Standardized Prevalence of HCV 55
4.4.5 HCV Genotype Class Distributions 57
4.5 Discussion 58
4.5.1 Conclusion on Epidemiology Trends 58
4.5.2 Limitations of the Analysis 59
4.5.3 Strengths of the Analysis 59
5 Disease Management 60
5.1 Diagnosis and Referral Overview 60
5.2 Treatment Overview 61
5.3 US 64
5.3.1 Diagnosis 64
5.3.2 Clinical Practice 66
5.4 France 68
5.4.1 Diagnosis 68
5.4.2 Clinical Practice 69
5.5 Germany 70
5.5.1 Diagnosis 70
5.5.2 Clinical Practice 70

5.6 Italy 71
5.6.1 Diagnosis 71
5.6.2 Clinical Practice 72
5.7 Spain 72
5.7.1 Diagnosis 72
5.7.2 Clinical Practice 73
5.8 UK 74
5.8.1 Diagnosis 74
5.8.2 Clinical Practice 75
5.9 Japan 75
5.9.1 Diagnosis 75
5.9.2 Clinical Practice 76
5.10 Brazil 77
5.10.1 Diagnosis 77
5.10.2 Clinical Practice 77
5.11 China 78
5.11.1 Diagnosis 78
5.11.2 Clinical Practice 78
6 Competitive Assessment 79
6.1 Overview 79
6.2 Strategic Competitor Assessment 79
6.3 Product Profiles - Major Brands 81
6.3.1 Incivek (telaprevir) 81
6.3.2 Victrelis (boceprevir) 87
6.3.3 Pegasys (peginterferon alfa-2a) 93
6.3.4 PegIntron (peginterferon alfa-2b) 98
6.3.5 Copegus, Rebetol, and Generic Ribavirin 103

6.3.6 Therapeutic Class: Interferon 107
7 Opportunity and Unmet Need 108
7.1 Overview 108
7.2 Unmet Needs 109
7.2.1 Unmet Need: Treatment Tolerability 109
7.2.2 Unmet Need: Efficacy 109
7.2.3 Unmet Need: Disease Awareness 110
7.2.4 Unmet Need: Treatment Cost 111
7.2.5 Unmet Need: Shorter Treatment Duration 111
7.2.6 Unmet Need: Simplified Treatment Regimens 112
7.3 Unmet Needs Gap Analysis 112
7.4 Opportunities 113
7.4.1 Opportunity: Pan-genotypic HCV Regimen 113
7.4.2 Opportunity: Treatment of Underrepresented Patient Populations 113
7.4.3 Opportunity: Involvement of Immune System 114
8 Pipeline Assessment 115
8.1 Overview 115
8.2 Clinical Trial Mapping 116
8.2.1 Clinical Trials by Country 116
8.3 Clinical Trials by Phase and Trial Status 117
8.4 Promising Drugs in Clinical Development 118
8.4.1 Sofosbuvir and Sofosbuvir/Ledipasvir 119
8.4.2 Simeprevir 132
8.4.3 ABT-450 plus ABT-267 and ABT-333 140
8.4.4 Faldaprevir and Faldaprevir plus BI 207127 148
8.4.5 Daclatasvir and Daclatasvir plus Asunaprevir 157
8.4.6 Vaniprevir 166
8.4.7 Other Drug Classes 172
9 Current and Future Players 175

9.1 Overview 175
9.2 Trends in Corporate Strategy 177
9.3 Company Profiles 178
9.3.1 Merck 178
9.3.2 Roche 180
9.3.3 Vertex 182
9.3.4 Janssen 183
9.3.5 Gilead 185
9.3.6 AbbVie 188
9.3.7 Bristol-Myers Squibb 190
9.3.8 Boehringer Ingelheim 192
9.4 Additional Companies with Promising Drugs 193
9.4.1 Mitsubishi Tanabe 193
9.4.2 GlaxoSmithKline 194
9.4.3 Achillion 195
9.4.4 Scynexis 196
9.4.5 Idenix 196
9.4.6 Presidio 197
10 Market Outlook 199
10.1 Global Markets 199
10.1.1 Forecast 199
10.1.2 Drivers and Barriers - Global Issues 203
10.2 US 207
10.2.1 Forecast 207
10.2.2 Key Events 212
10.2.3 Drivers and Barriers 212
10.3 France 216

10.3.1 Forecast 216
10.3.2 Key Events 221
10.3.3 Drivers and Barriers 221
10.4 Germany 223
10.4.1 Forecast 223
10.4.2 Key Events 228
10.4.3 Drivers and Barriers 228
10.5 Italy 230
10.5.1 Forecast 230
10.5.2 Key Events 234
10.5.3 Drivers and Barriers 234
10.6 Spain 236
10.6.1 Forecast 236
10.6.2 Key Events 240
10.6.3 Drivers and Barriers 240
10.7 UK 242
10.7.1 Forecast 242
10.7.2 Key Events 247
10.7.3 Drivers and Barriers 247
10.8 Japan 249
10.8.1 Forecast 249
10.8.2 Key Events 254
10.8.3 Drivers and Barriers 254
10.9 Brazil 256
10.9.1 Forecast 256
10.9.2 Key Events 260
10.9.3 Drivers and Barriers 260

10.10 China 262
10.10.1 Forecast 262
10.10.2 Key Events 266
10.10.3 Drivers and Barriers 266
11 Appendix 268
11.1 Bibliography 268
11.2 Abbreviations 291
11.3 Methodology 293
11.4 Forecasting Methodology 293
11.4.1 Percent Drug-Treated Patients 293
11.4.2 Patient Warehousing 294
11.4.3 Drugs Included in Each Therapeutic Class 294
11.4.4 Launch and Patent Expiry Dates 295
11.4.5 General Pricing Assumptions 296
11.4.6 Individual Drug Assumptions 296
11.4.7 Generic Erosion 299
11.4.8 Selection of Pipeline Agents 299
11.4.9 Pricing of Pipeline Agents 300
11.5 Physicians and Specialists Included in this Study 303
11.6 Survey of Prescribing Physicians 305
11.7 About the Authors 306
11.7.1 Author 306
11.7.2 Epidemiologist 306
11.7.3 Global Head of Healthcare 307
11.8 About GlobalData 308
11.9 Contact Us 308
11.10 Disclaimer 308

List of Tables

Table 1: Modes of HCV Transmission 25
Table 2: Symptoms of Acute and Chronic HCV Infection 26
Table 3: Risk Factors, Comorbidities, and Complications Associated with Hepatitis C Virus Infection 28
Table 4: 9MM, Sources of HCV Prevalence Data Used for the Forecast 39
Table 5: 9MM, Sources of HCV Genotype Data 39
Table 6: Hepatitis C Virus Genotype Description 45
Table 7: 9MM, Prevalent Cases of HCV, Ages ?15 Years, Men and Women, N (Millions), 2012-2022 50
Table 8: 9MM, Prevalent Cases of HCV, By Age, N (Millions), (Row %), 2012 52
Table 9: 9MM, Prevalent Cases of HCV, by Sex, Ages ?15 Years, N (Row %), 2012 54
Table 10: 9MM, Prevalent Cases of HCV, by Genotypes, Ages ?15 Years, N (Row %), 2012 57
Table 11: HCV Genotypes Present in the 9MM 61
Table 12: General Standard of Care by HCV Genotype 61
Table 13: Treatment Guidelines for HCV by Country 62
Table 14: Most-Prescribed Drugs for HCV by Class in the Global Markets, 2013 63
Table 15: Leading Treatments for HCV, 2012 80
Table 16: Product Profile - Incivek 82
Table 17: Efficacy of Incivek in Treatment-Naïve Patients (ADVANCE Trial) 82
Table 18: Efficacy of Incivek in Treatment-Experienced Patients (REALIZE Trial) 83
Table 19: Common Incivek Adverse Drug Reactions 84
Table 20: Incivek SWOT Analysis, 2012 85
Table 21: Global Sales Forecasts ($m) for Incivek, 2012-2022 87
Table 22: Product Profile - Victrelis 88
Table 23: Victrelis Efficacy in Treatment-Naïve Patients (SPRINT-2 Trial) 88

Table 24: Victrelis Efficacy in Treatment-Experienced Patients (RESPOND-2 Trial) 89
Table 25: Victrelis SWOT Analysis, 2012 91
Table 26: Global Sales Forecasts ($m) for Victrelis, 2012-2022 92
Table 27: Product Profile - Pegasys 94
Table 28: Antiviral Efficacy of Peginterferon alfa-2a Compared with Interferon alfa-2b 95
Table 29: Pegasys SWOT Analysis, 2012 97
Table 30: Global Sales Forecasts ($m) for Pegasys, 2012-2022 98
Table 31: Product Profile - PegIntron 99
Table 32: Antiviral Efficacy of Peginterferon alfa-2b Compared with Interferon alfa-2b 100
Table 33: PegIntron SWOT Analysis, 2012 101
Table 34: Global Sales Forecasts ($m) for PegIntron, 2012-2022 102
Table 35: Effect of Addition of Ribavirin to Peginterferon HCV Therapy 104
Table 36: Ribavirin SWOT Analysis, 2012 105
Table 37: Global Sales Forecasts ($m) for Copegus and Ribavirin, 2012-2022 106
Table 38: Summary of Minor Therapeutic Classes, 2012 107
Table 39: Overall Unmet Needs - Current Level of Attainment 108
Table 40: Clinical Unmet Needs - Gap Analysis, 2012 112
Table 41: HCV - Clinical Trials by Phase and Status, 2012 117
Table 42: HCV - Pipeline, 2012 118
Table 43: Comparison of Therapeutic Classes in Development for HCV, 2012 119
Table 44: Gilead's Sofosbuvir Ongoing Clinical Trials of Interest 121
Table 45: Product Profile - Sofosbuvir 122
Table 46: Sofosbuvir's Most Common Adverse Effects 125
Table 47: Sofosbuvir SWOT Analysis, 2012 129
Table 48: Global Sales Forecasts ($m) for Sofosbuvir and Sofosbuvir/Ledipasvir, 2012-2022 131
Table 49: Janssen's Simeprevir Ongoing Clinical Trials of Interest 133
Table 50: Product Profile - Simeprevir 134
Table 51: PILLAR Clinical Trial Results 134

Table 52: Adverse Events Observed in PILLAR Clinical Trial 135
Table 53: Simeprevir SWOT Analysis, 2012 139
Table 54: Global Sales Forecasts ($m) for Simeprevir, 2012-2022 140
Table 55: AbbVie's Combination Therapy Ongoing Clinical Trials of Interest 141
Table 56: Product Profile - AbbVie Combination Therapy 142
Table 57: AVIATOR Clinical Trial Results 142
Table 58: AbbVie Combination Therapy SWOT Analysis, 2012 146
Table 59: Global Sales Forecasts ($m) for AbbVie Combination Therapy, 2012-2022 147
Table 60: Boehringer Ingelheim's Faldaprevir Ongoing Clinical Trials of Interest 149
Table 61: Product Profile - Faldaprevir 150
Table 62: Efficacy of Interferon-Free Faldaprevir Regimen (SOUND-C2 Trial) 151
Table 63: Faldaprevir SWOT Analysis, 2012 155
Table 64: Global Sales Forecasts ($m) for Faldaprevir and BI 207127, 2012-2022 156
Table 65: Bristol-Myers Squibb's Daclatasvir Ongoing Clinical Trials of Interest 158
Table 66: Product Profile - Daclatasvir 159
Table 67: Efficacy of Daclatasvir in Treatment-Naïve Patients (COMMAND-1 Trial) 159
Table 68: Daclatasvir and Asunaprevir Quad Therapy Efficacy 160
Table 69: Daclatasvir Triple Therapy Adverse Events 161
Table 70: Daclatasvir SWOT Analysis, 2012 164
Table 71: Global Sales Forecasts ($m) for Daclatasvir, Asunaprevir, and Peginterferon Lambda, 2012-2022 165

Table 72: Merck's Vaniprevir Ongoing Clinical Trials of Interest 167
Table 73: Product Profile - Vaniprevir 167
Table 74: Vaniprevir SWOT Analysis, 2012 171
Table 75: Global Sales Forecasts ($m) for Vaniprevir, 2012-2022 172
Table 76: Comparison of Peginterferon lambda with Peginterferon alfa (EMERGE Trial) 172
Table 77: Efficacy of Alisporivir in Treatment-Naïve HCV GT2/3 Patients (VITAL-1 Trial) 174
Table 78: Key Companies in the HCV Market, 2012 176
Table 79: Merck's HCV Portfolio Assessment, 2012 179
Table 80: Merck SWOT Analysis, 2012 179
Table 81: Roche's HCV Portfolio Assessment, 2012 181
Table 82: Roche SWOT Analysis, 2012 181
Table 83: Vertex's HCV Portfolio Assessment, 2012 182
Table 84: Vertex SWOT Analysis, 2012 183
Table 85: Janssen's HCV Portfolio Assessment, 2012 184
Table 86: Janssen SWOT Analysis, 2012 185
Table 87: Gilead's HCV Portfolio Assessment, 2012 187
Table 88: Gilead SWOT Analysis, 2012 187
Table 89: AbbVie's HCV Portfolio Assessment, 2012 189
Table 90: AbbVie SWOT Analysis, 2012 189
Table 91: Bristol-Myers Squibb's HCV Portfolio Assessment, 2012 191
Table 92: Bristol-Myers Squibb SWOT Analysis, 2012 191

Table 93: Boehringer Ingelheim's HCV Portfolio Assessment, 2012 193
Table 94: Boehringer Ingelheim SWOT Analysis, 2012 193
Table 95: Mitsubishi Tanabe's HCV Portfolio Assessment, 2012 194
Table 96: GlaxoSmithKline's HCV Portfolio Assessment, 2012 195
Table 97: Achillion's HCV Portfolio Assessment, 2012 195
Table 98: Scynexis' HCV Portfolio Assessment, 2012 196
Table 99: Idenix's HCV Portfolio Assessment, 2012 197
Table 100: Presidio's HCV Portfolio Assessment, 2012 198
Table 101: Global Sales Forecasts ($m) for HCV, 2012-2022 201
Table 102: HCV Market - Drivers and Barriers, 2013 203
Table 103: Sales Forecasts ($m) for HCV in the US, 2012-2022 210
Table 104: Key Events Impacting Sales for HCV in the US, 2012 212
Table 105: US HCV Market - Drivers and Barriers, 2012 212
Table 106: Sales Forecasts ($m) for HCV in France, 2012-2022 219
Table 107: Key Events Impacting Sales for HCV in France, 2012 221
Table 108: French HCV Market - Drivers and Barriers, 2012 221
Table 109: Sales Forecasts ($m) for HCV in Germany, 2012-2022 226
Table 110: Key Events Impacting Sales for HCV in Germany, 2012 228
Table 111: German HCV Market - Drivers and Barriers, 2012 228
Table 112: Sales Forecasts ($m) for HCV in Italy, 2012-2022 232

Table 113: Key Events Impacting Sales for HCV in Italy, 2012 234
Table 114: Italian HCV Market - Drivers and Barriers, 2012 234
Table 115: Sales Forecasts ($m) for HCV in Spain, 2012-2022 238
Table 116: Key Events Impacting Sales for HCV in Spain, 2012 240
Table 117: Spanish HCV Market - Drivers and Barriers, 2012 240
Table 118: Sales Forecasts ($m) for HCV in the UK, 2012-2022 245
Table 119: Key Events Impacting Sales for HCV in the UK, 2012 247
Table 120: UK HCV Market - Drivers and Barriers, 2012 247
Table 121: Sales Forecasts ($m) for HCV in Japan, 2012-2022 252
Table 122: Key Events Impacting Sales for HCV in Japan, 2012 254
Table 123: Japanese HCV Market - Drivers and Barriers, 2012 254
Table 124: Sales Forecasts ($m) for HCV in Brazil, 2012-2022 258
Table 125: Key Events Impacting Sales for HCV in Brazil, 2012 260
Table 126: Brazilian HCV Market - Drivers and Barriers, 2012 260
Table 127: Sales Forecasts ($m) for HCV in China, 2012-2022 264
Table 128: Key Events Impacting Sales for HCV in China, 2012 266
Table 129: Chinese HCV Market - Drivers and Barriers, 2012 266
Table 130: Key Launch Dates 295
Table 131: Key Patent Expiries 295
Table 132: Physicians Surveyed, By Country 305

1.2 List of Figures
Figure 1: HCV Genome and Polyprotein Composition 22
Figure 2: HCV Lifecycle Overview 23
Figure 3: 9MM, Prevalent Cases of HCV, Ages ?15 Years, Men and Women, N (Millions), 2012-2022 51
Figure 4: 9MM, Prevalent Cases of HCV, by Age, N (Millions), 2012 53

Figure 5: 9MM, Prevalent Cases of HCV, by Sex, N (Millions), 2012 55
Figure 6: 9MM, Age-Standardized Prevalence of HCV, Ages ?15 Years, by Sex, %, 2012 56
Figure 7: HCV Therapeutics - Clinical Trials by Country, 2012 116
Figure 8: Competitive Assessment of Late-Stage Pipeline Agents in HCV, 2012-2022 118
Figure 9: Company Portfolio Gap Analysis in HCV, 2012-2022 176
Figure 10: Global Sales for HCV Therapeutics by Region, 2012-2022 202
Figure 11: Sales for HCV Therapeutics in the US by Drug Class, 2012-2022 211
Figure 12: Sales for HCV Therapeutics in France by Drug Class, 2012-2022 220
Figure 13: Sales for HCV Therapeutics in Germany by Drug Class, 2012-2022 227
Figure 14: Sales for HCV Therapeutics in Italy by Drug Class, 2012-2022 233
Figure 15: Sales for HCV Therapeutics in Spain by Drug Class, 2012-2022 239
Figure 16: Sales for HCV Therapeutics in the UK by Drug Class, 2012-2022 246
Figure 17: Sales for HCV Therapeutics in Japan by Drug Class, 2012-2022 253
Figure 18: Sales for HCV Therapeutics in Brazil by Drug Class, 2012-2022 259
Figure 19: Sales for HCV Therapeutics in China by Drug Class, 2012-2022 265

To order this report: PharmaPoint: Hepatitis C Virus - Global Drug Forecast and Market Analysis to 2022
http://www.reportlinker.com/p02029809/PharmaPoint-Hepatitis-C-Virus---Global-Drug-Forecast-and-Market-Analysis-to-2022.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication

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