Hepatitis C Virus – United States Drug Forecast and Market Analysis to 2022

Pages: 135 Published: May 01, 2013 Report Code: GDHC1089CFR

GlobalData has released its new Country report, “HCV – US Drug Forecast and Market Analysis to 2022”. 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.

The projected drivers of market growth include increased patient awareness of HCV, broader HCV screening recommendations, the shift in American medicine toward preventative care, and the launch of next-generation HCV therapies.

Vertex’s Incivek is the current market leader. It was among the first DAA HCV therapies launched in the US. Incivek’s improved efficacy over the previous standard of care (i.e., peginterferon and ribavirin combination therapy) in the treatment of the most prevalent HCV genotype in the US, HCV GT1, enabled the drug to quickly capture the market. The adverse events associated with Incivek therapy, such as life-threatening skin reactions, and the slow-progressing nature of HCV, has resulted in many patients deciding to forego treatment in order to wait for the launch of a more-tolerable HCV regimen.

Scope

Overview of the HCV 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 2012-2022.

Analysis of the impact of key events as well the drivers and restraints affecting the US HCV 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 HCV

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 drug performance

Obtain sales forecast for drugs from 2012-2022 in the US

Table of Contents

1Table of Contents1

1.1List of Tables3

1.2List of Figures3

2Executive Summary4

2.1Sales for HCV in the US4

2.2What Do the Physicians Think?6

3Introduction7

3.1Catalyst7

3.2Related Reports7

3.3Upcoming Related Reports8

4Disease Overview9

4.1Etiology and Pathophysiology9

4.1.1Etiology9

4.1.2Pathophysiology12

4.1.3Prognosis13

4.2Symptoms13

5Disease Management14

5.1Diagnosis and Referral Overview14

5.2Treatment Overview15

5.3US18

5.3.1Diagnosis18

5.3.2Clinical Practice20

6Competitive Assessment22

6.1Overview22

6.2Strategic Competitor Assessment22

6.3Product Profiles – Major Brands25

6.3.1Incivek (telaprevir)25

6.3.2Victrelis (boceprevir)30

6.3.3Pegasys (peginterferon alfa-2a)34

6.3.4PegIntron (peginterferon alfa-2b)39

6.3.5Copegus, Rebetol, and Generic Ribavirin43

6.3.6Therapeutic Class: Interferon46

7Opportunity and Unmet Need46

7.1Overview46

7.2Unmet Needs47

7.2.1Unmet Need: Treatment Tolerability47

7.2.2Unmet Need: Efficacy47

7.2.3Unmet Need: Disease Awareness48

7.2.4Unmet Need: Treatment Cost49

7.2.5Unmet Need: Shorter Treatment Duration49

7.2.6Unmet Need: Simplified Treatment Regimens50

7.3Unmet Needs Gap Analysis51

7.4Opportunities52

7.4.1Opportunity: Pan-genotypic HCV Regimen52

7.4.2Opportunity: Treatment of Underrepresented Patient Populations52

7.4.3Opportunity: Involvement of Immune System53

8Pipeline Assessment53

8.1Overview53

8.2Promising Drugs in Clinical Development54

8.2.1Sofosbuvir and Sofosbuvir/Ledipasvir56

8.2.2Simeprevir66

8.2.3ABT-450 plus ABT-267 and ABT-33374

8.2.4Faldaprevir and Faldaprevir plus BI 20712781

8.2.5Daclatasvir and Daclatasvir plus Asunaprevir89

8.2.6Other Drug Classes97

9Market Outlook99

9.1US99

9.1.1Forecast99

9.1.2Key Events104

9.1.3Drivers and Barriers105

10Appendix109

10.1Bibliography109

10.2Abbreviations119

10.3Methodology121

10.4Forecasting Methodology121

10.4.1Percent Drug-Treated Patients121

10.4.2Patient Warehousing122

10.4.3Drugs Included in Each Therapeutic Class122

10.4.4Launch and Patent Expiry Dates123

10.4.5General Pricing Assumptions124

10.4.6Individual Drug Assumptions124

10.4.7Generic Erosion126

10.4.8Selection of Pipeline Agents126

10.4.9Pricing of Pipeline Agents127

10.5Physicians and Specialists Included in this Study130

10.6Survey of Prescribing Physicians132

10.7About the Authors133

10.7.1Author133

10.7.2Global Head of Healthcare133

10.8About GlobalData134

10.9Contact Us134

10.10Disclaimer134

List of Tables

Table 1: Modes of HCV Transmission13

Table 2: Symptoms of Acute and Chronic HCV Infection14

Table 3: HCV Genotypes Present in the 9MM16

Table 4: General Standard of Care by HCV Genotype16

Table 5: Treatment Guidelines for HCV by Country18

Table 6: Most-Prescribed Drugs for HCV by Class in the Global Markets, 201318

Table 7: Leading Treatments for HCV, 201225

Table 8: Product Profile – Incivek27

Table 9: Efficacy of Incivek in Treatment-Naïve Patients (ADVANCE Trial)27

Table 10: Efficacy of Incivek in Treatment-Experienced Patients (REALIZE Trial)28

Table 11: Common Incivek Adverse Drug Reactions29

Table 12: Incivek SWOT Analysis, 201230

Table 13: Product Profile – Victrelis31

Table 14: Victrelis Efficacy in Treatment-Naïve Patients (SPRINT-2 Trial)32

Table 15: Victrelis Efficacy in Treatment-Experienced Patients (RESPOND-2 Trial)32

Table 16: Victrelis SWOT Analysis, 201233

Table 17: Product Profile – Pegasys36

Table 18: Antiviral Efficacy of Peginterferon alfa-2a Compared with Interferon alfa-2b37

Table 19: Pegasys SWOT Analysis, 201239

Table 20: Product Profile – PegIntron41

Table 21: Antiviral Efficacy of Peginterferon alfa-2b Compared with Interferon alfa-2b41

Table 22: PegIntron SWOT Analysis, 201243

Table 23: Effect of Addition of Ribavirin to Peginterferon HCV Therapy44

Table 24: Ribavirin SWOT Analysis, 201246

Table 25: Summary of Minor Therapeutic Classes, 201247

Table 26: Overall Unmet Needs – Current Level of Attainment47

Table 27: Clinical Unmet Needs – Gap Analysis, 201252

Table 28: HCV – Pipeline, 201255

Table 29: Comparison of Therapeutic Classes in Development for HCV, 201256

Table 30: Gilead’s Sofosbuvir Ongoing Clinical Trials of Interest57

Table 31: Product Profile – Sofosbuvir59

Table 32: Sofosbuvir’s Most Common Adverse Effects62

Table 33: Sofosbuvir SWOT Analysis, 201266

Table 34: Janssen’s Simeprevir Ongoing Clinical Trials of Interest67

Table 35: Product Profile – Simeprevir69

Table 36: PILLAR Clinical Trial Results69

Table 37: Adverse Events Observed in PILLAR Clinical Trial70

Table 38: Simeprevir SWOT Analysis, 201274

Table 39: AbbVie’s Combination Therapy Ongoing Clinical Trials of Interest75

Table 40: Product Profile – AbbVie Combination Therapy77

Table 41: AVIATOR Clinical Trial Results77

Table 42: AbbVie Combination Therapy SWOT Analysis, 201280

Table 43: Boehringer Ingelheim’s Faldaprevir Ongoing Clinical Trials of Interest82

Table 44: Product Profile – Faldaprevir84

Table 45: Efficacy of Interferon-Free Faldaprevir Regimen (SOUND-C2 Trial)84

Table 46: Faldaprevir SWOT Analysis, 201289

Table 47: Bristol-Myers Squibb’s Daclatasvir Ongoing Clinical Trials of Interest90

Table 48: Product Profile – Daclatasvir92

Table 49: Efficacy of Daclatasvir in Treatment-Naïve Patients (COMMAND-1 Trial)92

Table 50: Daclatasvir and Asunaprevir Quad Therapy Efficacy93

Table 51: Daclatasvir Triple Therapy Adverse Events94

Table 52: Daclatasvir SWOT Analysis, 201297

Table 53: Comparison of Peginterferon lambda with Peginterferon alfa (EMERGE Trial)98

Table 54: Efficacy of Alisporivir in Treatment-Naïve HCV GT2/3 Patients (VITAL-1 Trial)99

Table 55: Sales Forecasts ($m) for HCV in the US, 2012–2022103

Table 56: Key Events Impacting Sales for HCV in the US, 2012106

Table 57: US HCV Market – Drivers and Barriers, 2012106

Table 58: Key Launch Dates124

Table 59: Key Patent Expiries124

Table 60: Physicians Surveyed, By Country133

List of Figures

Figure 1: Sales for HCV in the US, 2012 – 20226

Figure 2: HCV Genome and Polyprotein Composition10

Figure 3: HCV Lifecycle Overview11

Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in HCV, 2012–202255

Figure 5: Sales for HCV Therapeutics in the US by Drug Class, 2012–2022105

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