PharmaPoint: Hepatitis C Virus – Italy Drug Forecast and Market Analysis to 2022

Publisher Name :
Date: 31-May-2013
No. of pages: 132


GlobalData has released its new Country report, “PharmaPoint: Hepatitis C Virus – Italy 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 main drivers of growth of the Italian HCV market are expected to be an increase in HCV awareness and the launch of next-generation HCV therapies.

The current market leader in Italy is Roche’s Pegasys (peginterferon alfa-2a). The current standard of HCV therapy in Italy is a combination of interferon and ribavirin. The less-frequent dosing of peginterferon compared with standard interferon (i.e., once a week compared with three times a week) enabled peginterferon to quickly capture market share. In addition to standard interferon, Pegasys directly competes for market share with Merck’s ViraferonPeg (peginterferon alfa-2b).


  • 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 Italy including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in Italy from 2012-2022.
  • Analysis of the impact of key events as well the drivers and restraints affecting Italy 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 Italy

PharmaPoint: Hepatitis C Virus – Italy Drug Forecast and Market Analysis to 2022

Table Of Contents

1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 9

2 Introduction 10
2.1 Catalyst 10
2.2 Related Reports 10
2.3 Upcoming Related Reports 11

3 Disease Overview 12
3.1 Etiology and Pathophysiology 13
3.1.1 Etiology 13
3.1.2 Pathophysiology 16
3.1.3 Prognosis 17
3.2 Symptoms 17

4 Disease Management 18
4.1 Diagnosis and Referral Overview 18
4.2 Treatment Overview 19
4.3 Italy 22
4.3.1 Diagnosis 22
4.3.2 Clinical Practice 22

5 Competitive Assessment 23
5.1 Overview 23
5.2 Strategic Competitor Assessment 23
5.3 Product Profiles – Major Brands 25
5.3.1 Incivek (telaprevir) 25
5.3.2 Victrelis (boceprevir) 30
5.3.3 Pegasys (peginterferon alfa-2a) 34
5.3.4 PegIntron (peginterferon alfa-2b) 39
5.3.5 Copegus, Rebetol, and Generic Ribavirin 43
5.3.6 Therapeutic Class: Interferon 46

6 Opportunity and Unmet Need 47
6.1 Overview 47
6.2 Unmet Needs 48
6.2.1 Unmet Need: Treatment Tolerability 48
6.2.2 Unmet Need: Efficacy 48
6.2.3 Unmet Need: Disease Awareness 49
6.2.4 Unmet Need: Treatment Cost 50
6.2.5 Unmet Need: Shorter Treatment Duration 50
6.2.6 Unmet Need: Simplified Treatment Regimens 51
6.3 Unmet Needs Gap Analysis 52
6.4 Opportunities 53
6.4.1 Opportunity: Pan-genotypic HCV Regimen 53
6.4.2 Opportunity: Treatment of Underrepresented Patient Populations 53
6.4.3 Opportunity: Involvement of Immune System 54

7 Pipeline Assessment 55
7.1 Overview 55
7.2 Promising Drugs in Clinical Development 56
7.2.1 Sofosbuvir and Sofosbuvir/Ledipasvir 58
7.2.2 Simeprevir 68
7.2.3 ABT-450 plus ABT-267 and ABT-333 76
7.2.4 Faldaprevir and Faldaprevir plus BI 207127 83
7.2.5 Daclatasvir and Daclatasvir plus Asunaprevir 91
7.2.6 Other Drug Classes 99

8 Market Outlook 102
8.1 Italy 102
8.1.1 Forecast 102
8.1.2 Key Events 106
8.1.3 Drivers and Barriers 106

9 Appendix 109
9.1 Bibliography 109
9.2 Abbreviations 117
9.3 Methodology 119
9.4 Forecasting Methodology 119
9.4.1 Percent Drug-Treated Patients 119
9.4.2 Patient Warehousing 120
9.4.3 Drugs Included in Each Therapeutic Class 120
9.4.4 Launch and Patent Expiry Dates 121
9.4.5 General Pricing Assumptions 121
9.4.6 Individual Drug Assumptions 122
9.4.7 Generic Erosion 124
9.4.8 Selection of Pipeline Agents 124
9.4.9 Pricing of Pipeline Agents 125
9.5 Physicians and Specialists Included in this Study 128
9.6 Survey of Prescribing Physicians 130
9.7 About the Authors 131
9.7.1 Author 131
9.7.2 Global Head of Healthcare 131
9.8 About GlobalData 132
9.9 Contact Us 132
9.10 Disclaimer 132

List Of Tables

Table 1: Modes of HCV Transmission 16
Table 2: Symptoms of Acute and Chronic HCV Infection 17
Table 3: HCV Genotypes Present in the 9MM 19
Table 4: General Standard of Care by HCV Genotype 19
Table 5: Treatment Guidelines for HCV by Country 21
Table 6: Most-Prescribed Drugs for HCV by Class in the Global Markets, 2013 21
Table 7: Leading Treatments for HCV, 2012 24
Table 8: Product Profile – Incivek 26
Table 9: Efficacy of Incivek in Treatment-Naïve Patients (ADVANCE Trial) 26
Table 10: Efficacy of Incivek in Treatment-Experienced Patients (REALIZE Trial) 27
Table 11: Common Incivek Adverse Drug Reactions 28
Table 12: Incivek SWOT Analysis, 2012 29
Table 13: Product Profile – Victrelis 30
Table 14: Victrelis Efficacy in Treatment-Naïve Patients (SPRINT-2 Trial) 31
Table 15: Victrelis Efficacy in Treatment-Experienced Patients (RESPOND-2 Trial) 32
Table 16: Victrelis SWOT Analysis, 2012 33
Table 17: Product Profile – Pegasys 35
Table 18: Antiviral Efficacy of Peginterferon alfa-2a Compared with Interferon alfa-2b 36
Table 19: Pegasys SWOT Analysis, 2012 38
Table 20: Product Profile – PegIntron 40
Table 21: Antiviral Efficacy of Peginterferon alfa-2b Compared with Interferon alfa-2b 40
Table 22: PegIntron SWOT Analysis, 2012 42
Table 23: Effect of Addition of Ribavirin to Peginterferon HCV Therapy 44
Table 24: Ribavirin SWOT Analysis, 2012 45
Table 25: Summary of Minor Therapeutic Classes, 2012 46
Table 26: Overall Unmet Needs – Current Level of Attainment 47
Table 27: Clinical Unmet Needs – Gap Analysis, 2012 52
Table 28: HCV – Pipeline, 2012 56
Table 29: Comparison of Therapeutic Classes in Development for HCV, 2012 57
Table 30: Gilead’s Sofosbuvir Ongoing Clinical Trials of Interest 59
Table 31: Product Profile – Sofosbuvir 60
Table 32: Sofosbuvir’s Most Common Adverse Effects 63
Table 33: Sofosbuvir SWOT Analysis, 2012 67
Table 34: Janssen’s Simeprevir Ongoing Clinical Trials of Interest 69
Table 35: Product Profile – Simeprevir 70
Table 36: PILLAR Clinical Trial Results 70
Table 37: Adverse Events Observed in PILLAR Clinical Trial 71
Table 38: Simeprevir SWOT Analysis, 2012 75
Table 39: AbbVie’s Combination Therapy Ongoing Clinical Trials of Interest 77
Table 40: Product Profile – AbbVie Combination Therapy 78
Table 41: AVIATOR Clinical Trial Results 78
Table 42: AbbVie Combination Therapy SWOT Analysis, 2012 82
Table 43: Boehringer Ingelheim’s Faldaprevir Ongoing Clinical Trials of Interest 84
Table 44: Product Profile – Faldaprevir 85
Table 45: Efficacy of Interferon-Free Faldaprevir Regimen (SOUND-C2 Trial) 85
Table 46: Faldaprevir SWOT Analysis, 2012 90
Table 47: Bristol-Myers Squibb’s Daclatasvir Ongoing Clinical Trials of Interest 92
Table 48: Product Profile – Daclatasvir 93
Table 49: Efficacy of Daclatasvir in Treatment-Naïve Patients (COMMAND-1 Trial) 93
Table 50: Daclatasvir and Asunaprevir Quad Therapy Efficacy 94
Table 51: Daclatasvir Triple Therapy Adverse Events 95
Table 52: Daclatasvir SWOT Analysis, 2012 98
Table 53: Comparison of Peginterferon lambda with Peginterferon alfa (EMERGE Trial) 99
Table 54: Efficacy of Alisporivir in Treatment-Naïve HCV GT2/3 Patients (VITAL-1 Trial) 100
Table 55: Sales Forecasts ($m) for HCV in Italy, 2012–2022 104
Table 56: Key Events Impacting Sales for HCV in Italy, 2012 106
Table 57: Italian HCV Market – Drivers and Barriers, 2012 106
Table 58: Key Launch Dates 121
Table 59: Key Patent Expiries 121
Table 60: Physicians Surveyed, By Country 130

List Of Figures

Figure 1: HCV Genome and Polyprotein Composition 13
Figure 2: HCV Lifecycle Overview 14
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in HCV, 2012–2022 56
Figure 4: Sales for HCV Therapeutics in Italy by Drug Class, 2012–2022 105

  • Increase in Surgical Procedures Propelling the Anesthesia Drugs Market
    With increase in surgical operations and invasive medical tests, the market for anesthesia drugs has been growing at a steady pace. Anesthesia drugs can be broadly categorized into two types – general anesthesia drugs and local anesthesia drugs. Anesthetic drugs help in inducing sleep and preventing discomfort and pain during surgical procedures. By 2018, the [...]
  • Water Treatment Chemicals Market to be driven by Increasing Demand from Developing Economies
    The global market for water treatment chemicals is growing at a steady pace with rapid urbanization and high demand from end-users. Water treatment chemicals are used for treating municipal water as well as agricultural wastewater. With higher demand for clean, drinking water with increasing population and increase in the number of industries, the global market [...]
  • Rise in Prevalence of Allergic Diseases Driving the Global Allergy Diagnostics Market
    With rise in the incidences of allergic diseases in the world, the global allergy diagnostics market has also witnessed steady growth. In recent years, there has been an increase in the number of people suffering from different allergies, particularly food allergies and drug allergies. The number of people suffering from asthma has also increased in [...]
  • Global Video Surveillance Market Driven by Increasing Demand for Security
    The global market for video surveillance has been witnessing steady growth with increase in demand for advanced surveillance systems by different law enforcement agencies. Increase in adoption of video surveillance by different sectors such as banking and finance, healthcare, transportation, and retail is one of the major drivers in the market. In 2013, the global [...]
  • Global Empty Capsules Market Driven by Growth in Pharmaceutical Industry
    With rapid growth in the pharmaceutical industry, the market for empty capsules has also grown at a steady pace. Some of the factors which are driving the growth of the empty capsules market are rise in aging population which is increasing the demand for capsule based drugs, technological advancement and increase in demand from the [...]
  • Graft-Versus-Host Disease (GVHD) Treatment Market worth $407 million by 2018
  • The graft-versus-host disease (GVHD) treatment market value will increase from $297 million in 2013 to $407 million by 2018, at a Compound Annual Growth Rate (CAGR) of 6.59%, according to research and consulting firm GlobalData. The company’s latest report* states …

  • Poland Pharmaceutical Industry Growing at 8.3% CAGR to 2020
  • Factors such as the growing elderly population, increasing availability of affordable medicines, and transparent regulatory guidelines will provide the necessary impetus for the growth of the Polish pharmaceutical market, but a decrease in mark-up prices and the country’s stringent drug …

  • Asia-Pacific, Led by China, Drive the Global Methanol Industry
  • China is driving the global methanol industry, with tremendous demand from both its energy and petrochemicals sectors. It accounts for 87.9% of Asia-Pacific’s (APAC) methanol capacity, and 51.9% of the global methanol capacity. Despite a large planned capacity increase in …

  • Diagnostic X-ray Imaging Market worth $4.0 billion by 2020
  • GlobalData estimates that the global diagnostic X-ray imaging market, worth $2.4 billion in 2012, will reach almost $4.0 billion by 2020, increasing at a Compound Annual Growth Rate (CAGR) of 6.7% during the forecast period. Many players are active in …

  • Graft-Versus-Host Disease Market Forecast to 2023
  • Graft-versus-host disease (GVHD) is a common complication of allogeneic hematopoietic stem cell transplantation (HSCT) that occurs when the donated (graft) cells are rejected and attack the host’s cells as foreign. GVHD can progress from mild to severe forms as either …

  • Primary Biliary Cirrhosis – Pipeline Review, H2 2014
    Published: 15-Dec-2014        Price: US $2000 Onwards        Pages: 73
    Global Markets Direct's, ‘Primary Biliary Cirrhosis Pipeline Review, H2 2014', provides an overview of the Primary Biliary Cirrhosis's therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Primary Biliary Cirrhosis, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press relea......
  • Myasthenia Gravis – Pipeline Review, H2 2014
    Published: 10-Dec-2014        Price: US $2000 Onwards        Pages: 93
    Global Markets Direct's, ‘Myasthenia Gravis Pipeline Review, H2 2014', provides an overview of the Myasthenia Gravis's therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Myasthenia Gravis, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key......
  • Sarcoidosis – Pipeline Review, H2 2014
    Published: 10-Dec-2014        Price: US $2000 Onwards        Pages: 61
    Global Markets Direct's, ‘Sarcoidosis Pipeline Review, H2 2014', provides an overview of the Sarcoidosis's therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Sarcoidosis, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved ......
  • Global Active Pharmaceutical Ingredients Market 2015-2019
    Published: 10-Dec-2014        Price: US $3000 Onwards        Pages: 119
    Active pharmaceutical ingredients are the active substances that are used in the manufacture of a drug and have a pharmacological effect. They provide health benefits and play a vital role in disease diagnosis, prevention, and treatment. Active pharmaceutical ingredients may be synthesized either chemically or through biotechnological methods. They are used in a wide range of therapeutic areas such as oncology, respiratory disorders, and rheumatoid arthritis. TechNavio's analysts forecast the......
  • Osteoporosis Drugs Market in the APAC Region 2015-2019
    Published: 3-Dec-2014        Price: US $2500 Onwards        Pages: 73
    Osteoporosis is a disease that reduces of the mass and density of bone, and results in increased risk of fracture. In this disease, the risks related to fracture increases because of the increased permeability of the bones. Often, there are no symptoms observed until the first fracture occurs. Increase in age, low body weight, low sex hormones or menopause, and smoking are some of the risk factors associated with this disease. TechNavio's analysts forecast the Osteoporosis Drugs market in APA......
  • Global Multiple Myeloma Drugs Market 2015-2019
    Published: 3-Dec-2014        Price: US $3000 Onwards        Pages: 115
    Multiple myeloma is a common cancer that affects the plasma cells, a type of white blood cell. It begins in the plasma cells of bone marrow. The primary function of the plasma cells is to combat infections by producing antibodies, which attack germs after recognizing them. In multiple myeloma these plasma cells become malignant, it causes the production of a defective protein, which grows uncontrollably. This protein moves into the bones and cause tumors. Myeloma occurs when the malignant cells ......
  • Global Excipients Market 2014-2018
    Published: 3-Dec-2014        Price: US $2500 Onwards        Pages: 82
    Excipients are pharmacologically inactive substances used in the form of a carrier with the active ingredient of a medication. Excipients help stabilize the active ingredient of a drug for a longer period and are used as a bulking up agent in drug formulations. Excipients are classified primarily based on their product type, functionality, and category. The Global Excipients market is highly fragmented with multiple active vendors. TechNavio's analysts forecast the Global Excipients market to......
  • Replagal-Drug Insights,2014
    Published: 2-Dec-2014        Price: US $1000 Onwards        Pages: 36
    Summary DelveInsight's pharmaceuticals report, "Replagal - Drug Insights, 2014" provides Replagal marketed details and API Manufacturers details across the globe along with the location. In addition, it covers sales estimates for the US, detailed clinical assessment of the drug, patent details, route of synthesis, competitive landscape, and analysis of sales performance during the forecast period (2011-2015). The report also includes SWOT analysis for the drug. This report is built using data......
  • Lymphoma Treatment Drugs Markets in China
    Published: 1-Dec-2014        Price: US $4000 Onwards        Pages: 177
    China's demand for Lymphoma Treatment Drugs has grown at a fast pace in the past decade. In the next decade, both production and demand will continue to grow. The Chinese economy maintains a high speed growth which has been stimulated by the consecutive increases of industrial output, import & export, consumer consumption and capital investment for over two decades. This new study examines China's economic trends, investment environment, industry development, supply and demand, industry capa......
    Value for Money
    We believe in "optimum utilization of available budget and resources". While servicing our clients' (your) market research requirements, we keep the same approach in focus to help you get the best value for your $$s.
    Ever Growing Inventory
    Ranging from the smallest feasible / required data (datasheets, data facts, SWOT analysis, company profiles, etc) to full research reports that help you make decisions, our inventory is updated almost on a daily basis with the latest industry reports from domain experts that track more than 5000 niche sectors.
    One Stop Solution
    Need a custom research report on medical devices market? Require all available business intelligence on 3D printing industry? Exploring F&B sector of a particular country/region? is your one-stop-solution to all market intelligence needs. We not only offer custom research and consulting services, we also "bundle" reports to meet your needs and help you fetch the data analysis you require for your business.
    Dedicated Client Engagement
    Not limited to only "finding" relevant reports for you, our client engagement team dedicates its efforts to understand your "business need" and accordingly maps available research data to help you move forward. Call "your" client engagement executive any time of your day and get your questions answered in order to make the correct business decision.
    Saving Time and Efforts
    Simply share your research requirement details with us and let us do all the hard work to find required intelligence for you. When you add up our "one stop solution" and "dedicated client engagement" services mentioned above, you obviously know the time and effort saving you do by working with us.
    Payment Flexibility
    Working with Fortune 500 organizations, we understand the importance of being flexible for payments. Share your payment terms with us and we will surely match up to them to ensure you get access to required business intelligence data without having to wait for the payment to be done.
    Post-Purchase Research Support
    Have questions after reading a report / datasheet bought through us? Not sure about the methodology used for data available in the research? Talk to us / Share your questions with us and if required, we will connect you with the analyst(s)/author(s) of the report(s) and ensure you get satisfactory answers for the same. Need more data / analysis / report(s) on the topic of your research/project? The team is here for you 24X7 to support you with your post-purchase requirements. Subscription Offers & Packages (Get in touch with us for more details - [email protected] / +1 888 391 5441 )
    • Ad Hoc
    • Pay - as - you - go / Bucket Subscriptions
    • Fixed Cost for #of reports
    • Customize / Personalize as per your needs