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

Pages: 131 Published: May 01, 2013 Report Code: GDHC1094CFR

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GlobalData has released its new Country report, “HCV – UK 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 anticipated drivers of growth in the UK market included increased awareness of HCV, the launch of improved HCV regimens, and advocacy for access to next-generation therapies.

Janssen’s Incivo is the current market leader in the UK. Incivo was among the first DAA HCV therapies launched in the UK. The regimen had an improved efficacy compared with the previous standard of care for HCV GT1, a combination of peginterferon and ribavirin. GlobalData assumes that Incivo’s shorter duration of triple-therapy (i.e., DAA, peginterferon, and ribavirin) compared with Merck’s Victrelis enabled it to outcompete Victrelis for market share. Incivo and Victrelis are both associated with adverse events, which has resulted in HCV-infected patients in the UK deciding to forego therapy in order to await the launch of more-tolerable HCV therapies.

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 UK including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in the UK from 2012-2022.

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

Table of Contents

1Table of Contents5

1.1List of Tables7

1.2List of Figures11

2Introduction12

2.1Catalyst12

2.2Related Reports12

2.3Upcoming Related Reports14

3Disease Overview15

3.1Etiology and Pathophysiology15

3.1.1Etiology15

3.1.2Pathophysiology19

3.1.3Prognosis20

3.2Symptoms20

4Disease Management21

4.1Diagnosis and Referral Overview21

4.2Treatment Overview22

4.3UK25

4.3.1Diagnosis25

4.3.2Clinical Practice26

5Competitive Assessment27

5.1Overview27

5.2Strategic Competitor Assessment27

5.3Product Profiles – Major Brands29

5.3.1Incivek (telaprevir)29

5.3.2Victrelis (boceprevir)34

5.3.3Pegasys (peginterferon alfa-2a)38

5.3.4PegIntron (peginterferon alfa-2b)42

5.3.5Copegus, Rebetol, and Generic Ribavirin46

5.3.6Therapeutic Class: Interferon48

6Opportunity and Unmet Need49

6.1Overview49

6.2Unmet Needs50

6.2.1Unmet Need: Treatment Tolerability50

6.2.2Unmet Need: Efficacy50

6.2.3Unmet Need: Disease Awareness51

6.2.4Unmet Need: Treatment Cost52

6.2.5Unmet Need: Shorter Treatment Duration52

6.2.6Unmet Need: Simplified Treatment Regimens53

6.3Unmet Needs Gap Analysis53

6.4Opportunities54

6.4.1Opportunity: Pan-genotypic HCV Regimen54

6.4.2Opportunity: Treatment of Underrepresented Patient Populations54

6.4.3Opportunity: Involvement of Immune System55

7Pipeline Assessment56

7.1Overview56

7.2Promising Drugs in Clinical Development57

7.2.1Sofosbuvir and Sofosbuvir/Ledipasvir58

7.2.2Simeprevir68

7.2.3ABT-450 plus ABT-267 and ABT-33375

7.2.4Faldaprevir and Faldaprevir plus BI 20712782

7.2.5Daclatasvir and Daclatasvir plus Asunaprevir89

7.2.6Other Drug Classes97

8Market Outlook101

8.1UK101

8.1.1Forecast101

8.1.2Key Events106

8.1.3Drivers and Barriers106

9Appendix109

9.1Bibliography109

9.2Abbreviations118

ALT: Alanine aminotransferase118

9.3Methodology119

9.4Forecasting Methodology119

9.4.1Percent Drug-Treated Patients119

9.4.2Patient Warehousing121

9.4.3Drugs Included in Each Therapeutic Class121

9.4.4Launch and Patent Expiry Dates122

9.4.5General Pricing Assumptions123

9.4.6Individual Drug Assumptions123

9.4.7Generic Erosion125

9.4.8Selection of Pipeline Agents125

9.4.9Pricing of Pipeline Agents126

9.5Physicians and Specialists Included in this Study128

9.6Survey of Prescribing Physicians131

9.7About the Authors132

9.7.1Author132

9.7.2Global Head of Healthcare132

9.8About GlobalData133

9.9Contact Us133

9.10Disclaimer133

1.1

List of Tables

Table 1: Modes of HCV Transmission19

Table 2: Symptoms of Acute and Chronic HCV Infection20

Table 3: HCV Genotypes Present in the 9MM22

Table 4: General Standard of Care by HCV Genotype22

Table 5: Treatment Guidelines for HCV by Country23

Table 6: Most-Prescribed Drugs for HCV by Class in the Global Markets, 201324

Table 7: Leading Treatments for HCV, 201228

Table 8: Product Profile – Incivek30

Table 9: Efficacy of Incivek in Treatment-Naïve Patients (ADVANCE Trial)30

Table 10: Efficacy of Incivek in Treatment-Experienced Patients (REALIZE Trial)31

Table 11: Common Incivek Adverse Drug Reactions32

Table 12: Incivek SWOT Analysis, 201233

Table 13: Product Profile – Victrelis35

Table 14: Victrelis Efficacy in Treatment-Naïve Patients (SPRINT-2 Trial)35

Table 15: Victrelis Efficacy in Treatment-Experienced Patients (RESPOND-2 Trial)36

Table 16: Victrelis SWOT Analysis, 201238

Table 17: Product Profile – Pegasys39

Table 18: Antiviral Efficacy of Peginterferon alfa-2a Compared with Interferon alfa-2b40

Table 19: Pegasys SWOT Analysis, 201242

Table 20: Product Profile – PegIntron43

Table 21: Antiviral Efficacy of Peginterferon alfa-2b Compared with Interferon alfa-2b44

Table 22: PegIntron SWOT Analysis, 201245

Table 23: Effect of Addition of Ribavirin to Peginterferon HCV Therapy47

Table 24: Ribavirin SWOT Analysis, 201248

Table 25: Summary of Minor Therapeutic Classes, 201248

Table 26: Overall Unmet Needs – Current Level of Attainment49

Table 27: Clinical Unmet Needs – Gap Analysis, 201253

Table 28: HCV – Pipeline, 201257

Table 29: Comparison of Therapeutic Classes in Development for HCV, 201258

Table 30: Gilead’s Sofosbuvir Ongoing Clinical Trials of Interest60

Table 31: Product Profile – Sofosbuvir61

Table 32: Sofosbuvir’s Most Common Adverse Effects64

Table 33: Sofosbuvir SWOT Analysis, 201268

Table 34: Janssen’s Simeprevir Ongoing Clinical Trials of Interest69

Table 35: Product Profile – Simeprevir70

Table 36: PILLAR Clinical Trial Results71

Table 37: Adverse Events Observed in PILLAR Clinical Trial72

Table 38: Simeprevir SWOT Analysis, 201275

Table 39: AbbVie’s Combination Therapy Ongoing Clinical Trials of Interest76

Table 40: Product Profile – AbbVie Combination Therapy77

Table 41: AVIATOR Clinical Trial Results77

Table 42: AbbVie Combination Therapy SWOT Analysis, 201281

Table 43: Boehringer Ingelheim’s Faldaprevir Ongoing Clinical Trials of Interest83

Table 44: Product Profile – Faldaprevir84

Table 45: Efficacy of Interferon-Free Faldaprevir Regimen (SOUND-C2 Trial)85

Table 46: Faldaprevir SWOT Analysis, 201289

Table 47: Bristol-Myers Squibb’s Daclatasvir Ongoing Clinical Trials of Interest91

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)97

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 UK, 2012–2022104

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

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

Table 58: Key Launch Dates122

Table 59: Key Patent Expiries122

Table 60: Physicians Surveyed, By Country131

List of Figures

Figure 1: HCV Genome and Polyprotein Composition16

Figure 2: HCV Lifecycle Overview17

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in HCV, 2012–202257

Figure 4: Sales for HCV Therapeutics in the UK by Drug Class, 2012–2022105

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