REFERENCE CODE GDHC68PIDR PUBLICATION DATE JANUARY 2014 PROPHYLACTIC HEPATITIS B VIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022

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1 REFERENCE CODE GDHC68PIDR PUBLICATION DATE JANUARY 2014 PROPHYLACTIC HEPATITIS B VIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022

2 Executive Summary Prophylactic HBV Vaccines: Key Metrics in Eight Major Pharmaceutical Markets (8MM) 2012 Pediatric Vaccination Coverage Targeted Population Vaccinated Population 9.1 million 6.3 million Coverage Rate (%) Market Sales US 5EU Japan Canada 8MM Total Pipeline Assessment $528.2m $413.7m $0.2m $17.8m $959.9m Number of vaccines in Phase II III 1 Number of first-in-class vaccines 0 Most Promising Pipeline Drugs Heplisav (Dynavax Technologies) Key events ( ) Launch and endorsement of Hexyon in the 5EU in Launch and endorsement of V419 in the US in Launch and endorsement of V419 in Canada in Launch and endorsement of Heplisav in the US in Launch and endorsement of Heplisav in the 5U and Canada in Market Sales US 5EU Japan Canada 8MM Total Source: GlobalData. Peak-Year Sales $85.6m Level of Impact $735.7m $436.4m $0.2m $19.6m $1,191.9m 5EU = five major European markets (France, Germany, Italy, Spain, UK); 8MM = eight major pharmaceutical markets included in this report (US, 5EU, Japan, Canada) Prophylactic HBV Vaccine Sales Expected to Grow During the Forecast Period GlobalData estimates that, in 2012, the global HBV vaccine market generated over $950m in sales, with the vast majority of vaccine uptake occurring in infants and young children targeted by routine immunization programs in the US, France, Germany, Italy, Spain, and Canada. GlobalData projects the market to experience modest growth through the forecast period, achieving sales of over $1.1 billion by 2022, with a compound annual growth rate (CAGR) of 2.2% from Market growth is expected to be strongest in the US (3.4% CAGR), while growth in the 5EU (0.5% CAGR), Japan (2.8% negative CAGR), and Canada (1.0% CAGR) will be less pronounced. GlobalData expects that some of the most important drivers of global market growth over the next decade will be: The increased preference for pediatric combination vaccines More competition in the pediatric vaccine market The launch of Dynavax Technologies Heplisav for adults An increased emphasis on preventative medicine 2

3 Executive Summary GlobalData believes that notable barriers to growth of the global HBV vaccine market will include: The failed implementation of existing adult immunization recommendations Flawed adult vaccine reimbursement environments Insufficient vaccine knowledge among physicians and patients The shrinking population of adults eligible for vaccination Persistence of vaccine safety concerns Sales for HBV Vaccines by Country, % 15.4% 13.9% 10.3% 6.6% 0.0% 7.3% 0.3% 1.9% 7.2% Source: GlobalData. 0.2% 0.0% 1.6% 5.6% 55.0% 61.7% 2012 Total: $0.96bn United States France Germany Italy Spain United Kingdom Japan Canada 2022 Total: $1.19bn United States France Germany Italy Spain United Kingdom Japan Canada Vaccine Manufacturers Seek to Increase Vaccine Uptake by Developing Pediatric Combination Vaccines and Adult Adjuvanted Vaccines Over the last two decades, the HBV vaccine market has largely been dominated by Big Pharma, with GSK, Merck, and Sanofi as the key players. While GSK and Merck were the first companies to introduce recombinant HBsAgcontaining vaccines in the 1980s, GSK has entrenched itself as the clear market leader, accounting for over 75% of total market sales in Overall, GlobalData expects these major players to maintain their control over the marketplace despite the entrance of a new player, Dynavax Technologies, during the forecast period. Due to the HBV vaccine market s highly competitive nature, both current and future players are employing a variety of strategies to gain patient share in existing and emerging population segments. These corporate strategies include developing more immunogenic vaccines that are targeted at the adult population (Dynavax), the use of combination vaccines to protect infants against HBV (GSK, Merck, and Sanofi), and the development of more convenient HBV vaccine formulations (Merck and Sanofi). In addition to these approaches, GlobalData believes that increasing HBV vaccine uptake and decreasing cost-effectiveness concerns will be issues that all companies must recognize and include in their corporate strategies. 3

4 Executive Summary Company Portfolio Gap Analysis in HBV Vaccines, Strength of Marketed Products High Low Source: GlobalData. Stagnant Players Low Strength of Pipeline Current and Future Players Future Players High Healthcare Providers Clamor for More Immunogenic Adult Vaccines GlobalData classifies the overall level of unmet need in the prophylactic HBV vaccine market as medium, with key opinion leaders (KOLs) from the seven major markets (7MM) and Canada identifying two key unmet needs: vaccines with improved immunogenicity, and increased vaccine uptake, with a specific focus on increasing vaccination coverage rates in at-risk adults. The poor performance of recombinant HBsAg vaccines in non-responders has been welldocumented, and vaccine manufacturers are attempting to address these shortcomings. GSK markets an adjuvanted HBV vaccine in the 5EU, Fendrix, which uses an MPL adjuvant to enhance the immune response. More recently, Dynavax Technologies has been attempting to more effectively vaccinate non-responders with Heplisav, its adjuvanted HBV vaccine candidate, which is in Phase III and preregistration in the US and 5EU, respectively. Clinical trials have demonstrated Heplisav s superior immunogenicity and more convenient dosing regimen, which represent two key advantages over currently marketed products. With Heplisav, Dynavax hopes to address a key clinical unmet need in the treatment landscape, but its commercial success ultimately depends on improving uptake in this segment of the population. GlobalData s primary research has revealed that inadequate hepatitis B vaccination coverage represents one of the most important unmet needs in the global HBV vaccine marketplace. In general, the need for improved vaccine coverage rates is largest outside of routine recommendations, where the vaccination rates for adults with risk factors are poor. Nevertheless, there is still room for improvement even within the context of routine immunization recommendations, which mostly target infants and children. 4

5 Executive Summary In the pediatric segment of the marketplace, companies are leveraging combination vaccines to increase HBV vaccine uptake, while improved dosing regimens are necessary to increase compliance in adults. For both children and adults, companies must ensure that physicians understand immunization recommendations and are able to effectively identify patients. Overall, GlobalData believes that ensuring high coverage rates will be essential to the commercial success of HBV vaccines for the duration of the forecast period. Established Players and New Entrants Must Effectively Address Gaps in Treatment Algorithm to Achieve Commercial Success The lack of a vaccine that effectively protects all adults, especially persons that do not respond to the currently licensed products, is a glaring unmet need in the treatment algorithm and therefore represents an attractive segment of the market for current players and new entrants alike. With its Phase III vaccine candidate, Heplisav, Dynavax Technologies is attempting to exploit this void in the treatment landscape by utilizing a novel adjuvant to induce a stronger immune response in adults with two doses instead of three. The inclusion of HBV in pediatric combination vaccines is another strategy being leveraged by major players in the marketplace, as many countries see these vaccines as more cost-effective and routinely administer them to infants and toddlers. GlobalData projects that the use of combination vaccines in the eight major markets will only increase over the next several years, so utilizing these vaccines to gain market share will remain a sustainable corporate approach for the entire forecast period. The Pipeline, Led by Dynavax s Heplisav, Will Improve Vaccine Effectiveness in Adults and Stimulate Modest Growth in the Market The prophylactic HBV vaccine market is highly mature, with a small pipeline and clinical trial pool that is poised to address key clinical and environmental unmet needs in the US, 5EU, Japan, and Canada. More specifically, the HBV vaccine pipeline, with Dynavax Technologies Heplisav as the sole late-stage product projected to launch during the forecast period, is heavily focused on the development of more-immunogenic adult vaccines and more conveniently formulated combination vaccines. With Heplisav, Dynavax hopes to leverage its superior immunogenicity and dosing regimen to increase HBV vaccine uptake in the adult marketplace. Sanofi Pasteur MSD s fully liquid pediatric combination vaccine, Hexyon, received EMA approval in 2013 and will also be marketed under the name V419 by Merck in the US and Canada, with projected launch dates of 2015 and 2016, respectively. 5

6 Executive Summary GlobalData believes that both of these vaccines, despite targeting distinct segments of the market, will have the potential to stimulate solid growth in the global HBV vaccine marketplace, with peakyear sales for Heplisav and Hexyon/V419 projected to reach $85m and $520m, respectively, during the forecast period. Dynavax must address vaccination coverage rate and vaccine awareness concerns if it wishes to fully exploit this market opportunity. Competitive Assessment of Late-Stage Pipeline Agents and Marketed Products in HBV Vaccines, Commercial Attributes High Low Source: GlobalData. Low Clinical Attributes GSK s Pediarix/ Infanrix Hexa GSK s Fendrix Merck s Recombivax HB Merck s Comvax Kaketsuken s Bimmugen High Merck and Sanofi s Hexyon/V419 GSK s Ambirix/ Twinrix GSK s Engerix-B Dynavax s Heplisav What Do Physicians Think? The KOLs interviewed for this report shared their expert insight into the HBV vaccines market. These KOLs revealed that, while physicians are relatively happy with the performance of the currently marketed vaccines, they realize that there are still glaring weaknesses in the treatment algorithm that must be addressed. They cite increased vaccine immunogenicity in adults as the most important clinical unmet need, and also reveal the need for improved dosing regimens, physician education, and adult immunization strategies. According to the KOLs, combination vaccines are also advantageous for improving vaccination coverage in the pediatric market. Ultimately, KOLs thought that open dialogue between vaccine manufacturers and policymakers is necessary for a vaccine s commercial success in the HBV vaccine market. Yes, I m sure that physicians need to be better educated on how to advise their patients about immunization. OUS key opinion leader, November 2013 A pediatric combination vaccine is more likely to increase vaccine uptake than several vaccines administered separately. OUS key opinion leader, November 2013 I think an ongoing dialogue between policymakers and manufacturers, before vaccines are actually launched, would be beneficial. OUS key opinion leader, October

7 Executive Summary There is a lack of compliance in adults because the series is extended over six months, so it may be difficult to get patients to follow up...the lack of compliance originates from the fact that we cannot get an immune response in less than three doses. US key opinion leader, November 2013 Selectively targeting subgroups within the population has been shown repeatedly for different vaccines to be a very ineffective [immunization] strategy. Doctors and their office staff seemingly have a very hard time in doing that. I mean that s just a fact that s been demonstrated time and time again. US key opinion leader, November 2013 I think there will be a growing trend towards the use of combination vaccines. US key opinion leader, September 2013 A key barrier to increasing vaccine coverage in the adult population is lack of awareness on the part of patients and physicians. US key opinion leader, November 2013 The currently available hepatitis B vaccines require three doses. It would be great to have a vaccine that only requires two doses. I guess it s unreasonable to hope for a vaccine that only requires one [dose], but two doses would be better. US key opinion leader, November 2013 To exploit opportunities, vaccine manufacturers should produce better vaccines, vaccines that have few side effects and are able to raise antibodies levels higher Companies should also be investigating more efficient and cheaper vaccines for development. OUS key opinion leader, November 2013 I think the number one unmet need is the seroconversion problem I would really like a vaccine that induces seroconversion in nearly everybody, if possible everyone I would like a vaccine that would induce in everyone more than 100mIU/mL HBs antibodies. OUS key opinion leader, October 2013 The available hepatitis B vaccines are incredibly safe vaccines, and they are very effective. They are not ideal, there are improvements that we would like to make, and there are also substantial enhancements of hepatitis B immunization programs that are waiting to be undertaken. US key opinion leader, November

8 List of Tables List of Figures Introduction Catalyst Related Reports Upcoming Related Reports Disease Overview Overview Etiology and Pathophysiology Etiology Pathophysiology Symptoms Prognosis Vaccination Recommendations and Coverage Rates Overview US Immunization Recommendations and Policies Vaccination Coverage Clinical Practice France

9 4.3.1 Immunization Recommendations and Policies Vaccination Coverage Clinical Practice Germany Immunization Recommendations and Policies Vaccination Coverage Clinical Practice Italy Immunization Recommendations and Policies Vaccination Coverage Clinical Practice Spain Immunization Recommendations and Policies Vaccination Coverage Clinical Practice UK Immunization Recommendations and Policies Vaccination Coverage Clinical Practice Japan Immunization Recommendations and Policies Vaccination Coverage Clinical Practice

10 4.9 Canada Immunization Recommendations and Policies Vaccination Coverage Clinical Practice Competitive Assessment Overview Strategic Competitor Assessment Product Profiles Monovalent Vaccines Engerix-B Recombivax HB Fendrix Bimmugen Product Profiles Combination Vaccines Infanrix Hexa Pediarix Hexyon Comvax Twinrix Ambirix Opportunity and Unmet Need Overview Increased Vaccine Immunogenicity Unmet Need

11 6.2.2 Gap Analysis Opportunity Increased Vaccination Coverage Rates Unmet Need Gap Analysis Opportunity Increased Patient Awareness Unmet Need Gap Analysis Opportunity Improved Physician Education Unmet Need Gap Analysis Opportunity More Cost-Effective Vaccines Unmet Need Gap Analysis Opportunity Pipeline Assessment Overview Clinical Trial Mapping Clinical Trials by Country Clinical Trials by Phase and Trial Status

12 7.3 Promising Vaccines in Late-Stage Clinical Development Heplisav Promising Vaccines in Early-Stage Clinical Development Current and Future Players Overview Trends in Corporate Strategy Company Profiles GSK Merck Sanofi Kaketsuken Dynavax Technologies Market Outlook Global Markets Forecast Drivers and Barriers Global Issues US Forecast Key Events Drivers and Barriers France Forecast Key Events

13 9.3.3 Drivers and Barriers Germany Forecast Key Events Drivers and Barriers Italy Forecast Key Events Drivers and Barriers Spain Forecast Key Events Drivers and Barriers UK Forecast Key Events Drivers and Barriers Alternative Market Scenario Japan Forecast Drivers and Barriers Canada Forecast

14 9.9.2 Key Events Drivers and Barriers Appendix Bibliography Abbreviations Methodology Forecasting Methodology Patient Populations Targeted for Vaccination Vaccination Coverage Rates Vaccinated Patients Regulatory Approval vs. Advisory Committee Recommendation Vaccines Included Key Launch Dates General Pricing Assumptions Individual Vaccine Assumptions Pricing of Pipeline Vaccines Physicians and Specialists Included in this Study Interviews of Key Opinion Leaders (KOLs) Online Survey of High-Prescribing Physicians (non-kols) About the Authors Analyst Therapy Area Director Global Head of Healthcare

15 10.7 About GlobalData Disclaimer List of Tables Table 1: Modes of HBV Transmission Table 2: HBV Serological Markers and Test Interpretations Table 3: Symptoms of HBV Infection Table 4: HBV Vaccination Advisory Committees by Country Table 5: HBV Immunization Recommendations by Country Table 6: Targeted Age Group(s) for Routine Immunization and Most Administered HBV Vaccines by Country in the Global Markets, Table 7: Targeted Age Group(s) for Routine HBV Immunization in Canada, by Province or Territory, Table 8: Leading Vaccines for HBV, Table 9: Product Profile Engerix-B Table 10: Immunogenicity Profile Engerix-B Table 11: Safety Profile Engerix-B Table 12: Engerix-B SWOT Analysis, Table 13: Global Sales Forecasts ($m) for Engerix-B, Table 14: Product Profile Recombivax HB Table 15: Immunogenicity Profile Recombivax HB Table 16: Safety Profile Recombivax HB Table 17: Recombivax HB SWOT Analysis, Table 18: Global Sales Forecasts ($m) for Recombivax HB, Table 19: Product Profile Fendrix

16 Table 20: Immunogenicity Profile Fendrix Table 21: Safety Profile Fendrix Table 22: Fendrix SWOT Analysis, Table 23: Global Sales Forecasts ($m) for Fendrix, Table 24: Product Profile Bimmugen Table 25: Bimmugen SWOT Analysis, Table 26: Global Sales Forecasts ($m) for Bimmugen, Table 27: Product Profile Infanrix Hexa Table 28: Immunogenicity Profile Infanrix Hexa Table 29: Safety Profile Infanrix Hexa Table 30: Infanrix Hexa SWOT Analysis, Table 31: Global Sales Forecasts ($m) for Infanrix Hexa, Table 32: Product Profile Pediarix Table 33: Immunogenicity Profile Pediarix Table 34: Safety Profile Pediarix Table 35: Pediarix SWOT Analysis, Table 36: Global Sales Forecasts ($m) for Pediarix, Table 37: Product Profile Hexyon Table 38: Immunogenicity Profile Hexyon Table 39: Safety Profile Hexyon Table 40: Hexyon SWOT Analysis, Table 41: Global Sales Forecasts ($m) for Hexyon, Table 42: Product Profile Comvax Table 43: Immunogenicity Profile Comvax

17 Table 44: Safety Profile Comvax Table 45: Comvax SWOT Analysis, Table 46: Global Sales Forecasts ($m) for Comvax, Table 47: Product Profile Twinrix Table 48: Immunogenicity Profile Twinrix Table 49: Safety Profile Twinrix Table 50: Twinrix SWOT Analysis, Table 51: Global Sales Forecasts ($m) for Twinrix, Table 52: Product Profile Ambirix Table 53: Immunogenicity Profile Ambirix Table 54: Safety Profile Ambirix Table 55: Ambirix SWOT Analysis, Table 56: Global Sales Forecasts ($m) for Ambirix, Table 57: Unmet Need and Opportunity in Prophylactic HBV Vaccines Table 58: HBV Vaccines Clinical Trials by Phase and Status, Table 59: HBV Vaccines Phase Pipeline, Table 60: Comparison of Vaccines in Development for HBV, Table 61: Product Profile Heplisav Table 62: Immunogenicity Profile Heplisav Table 63: Safety Profile Heplisav Table 64: Heplisav SWOT Analysis, Table 65: Global Sales Forecasts ($m) for Heplisav, Table 66: Key Companies in the HBV Vaccine Market, Table 67: GSK s HBV Vaccine Portfolio Assessment,

18 Table 68: GSK SWOT Analysis, Table 69: Merck s HBV Vaccine Portfolio Assessment, Table 70: Merck SWOT Analysis, Table 71: Sanofi s HBV Vaccine Portfolio Assessment, Table 72: Sanofi SWOT Analysis, Table 73: Kaketsuken s HBV Vaccine Portfolio Assessment, Table 74: Kaketsuken SWOT Analysis, Table 75: Dynavax Technologies HBV Vaccine Portfolio Assessment, Table 76: Dynavax Technologies SWOT Analysis, Table 77: Global Sales Forecasts ($m) for HBV Vaccines, Table 78: Global HBV Vaccine Market Drivers and Barriers, Table 79: Sales Forecasts ($m) for HBV Vaccines in the United States, Table 80: Key Events Impacting Sales for HBV Vaccines in the United States, Table 81: United States HBV Vaccine Market Drivers and Barriers, Table 82: Sales Forecasts ($m) for HBV Vaccines in France, Table 83: Key Events Impacting Sales for HBV Vaccines in France, Table 84: France HBV Vaccine Market Drivers and Barriers, Table 85: Sales Forecasts ($m) for HBV Vaccines in Germany, Table 86: Key Events Impacting Sales for HBV Vaccines in Germany, Table 87: Germany HBV Vaccine Market Drivers and Barriers, Table 88: Sales Forecasts ($m) for HBV Vaccines in Italy, Table 89: Key Events Impacting Sales for HBV Vaccines in Italy, Table 90: Italy HBV Vaccine Market Drivers and Barriers, Table 91: Sales Forecasts ($m) for HBV Vaccines in Spain,

19 Table 92: Key Events Impacting Sales for HBV Vaccines in Spain, Table 93: Spain HBV Vaccine Market Drivers and Barriers, Table 94: Sales Forecasts ($) for HBV Vaccines in the United Kingdom, Table 95: Key Events Impacting Sales for HBV Vaccines in the United Kingdom, Table 96: United Kingdom HBV Vaccine Market Drivers and Barriers, Table 97: Sales Forecasts ($) for HBV Vaccines in Japan, Table 98: Japan HBV Vaccine Market Drivers and Barriers, Table 99: Sales Forecasts ($) for HBV Vaccines in Canada, Table 100: Key Events Impacting Sales for HBV Vaccines in Canada, Table 101: Canada HBV Vaccine Market Drivers and Barriers, Table 102: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, by Country Table 103: Patient Population(s) Targeted for HBV Vaccination in the Adult Market, by Country Table 104: Key Launch Dates Table 105: High-Prescribing Physicians (non-kols) Surveyed, by Country

20 1.2 List of Figures Figure 1: HBV Structure and the Recombinant Vaccine Development Process Figure 2: Routine HBV Vaccination Coverage (%) in the United States Figure 3: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in the United States, Figure 4: Routine HBV Vaccination Coverage (%) in France Figure 5: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in France, Figure 6: Routine HBV Vaccination Coverage (%) in Germany Figure 7: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Germany, Figure 8: Routine HBV Vaccination Coverage (%) in Italy Figure 9: High-Prescriber Estimation of Pediatric HBV Patient Share in Italy, Figure 10: Routine HBV Vaccination Coverage (%) in Spain Figure 11: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Spain, Figure 12: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in the United Kingdom, Figure 13: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Japan, Figure 14: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Canada, Figure 15: HBV Vaccines Clinical Trials by Country, Figure 16: Competitive Assessment of Late-Stage Pipeline Agents and Marketed Products in HBV Vaccines, Figure 17: Global Sales for HBV Vaccines by Company, Figure 18: Company Portfolio Gap Analysis in HBV Vaccines, Figure 19: Global Sales for HBV Vaccines by Country, Figure 20: Sales for HBV Vaccines in the United States by Vaccine, Figure 21: Sales for HBV Vaccines in France by Vaccine, Figure 22: Sales for HBV Vaccines in Germany by Vaccine,

21 Figure 23: Sales for HBV Vaccines in Italy by Vaccine, Figure 24: Sales for HBV Vaccines in Spain by Vaccine, Figure 25: Sales for HBV Vaccines in the United Kingdom by Vaccine, Figure 26: Sales for HBV Vaccines in Japan by Vaccine, Figure 27: Sales for HBV Vaccines in Canada by Vaccine,

22 Introduction 2 Introduction 2.1 Catalyst The global (7MM and Canada) prophylactic hepatitis B virus (HBV) vaccine market has seen moderate growth over the last several years, primarily due to the effectiveness of routine childhood immunization programs and the strong clinical performance of currently marketed vaccines, such as GSK s Engerix-B, Pediarix/Infanrix Hexa, and Merck s Recombivax HB, in these targeted populations. Despite this success, opportunities still exist for improving the treatment algorithm. The growing popularity of combination vaccines, along with the push for vaccines that achieve higher seroconversion in non-responders, will serve to stimulate modest growth in the marketplace over the forecast period from GlobalData expects the following key factors to contribute to the evolution of the prophylactic HBV vaccine market over the next decade: The maintenance and/or increase of routine HBV vaccination coverage rates in the 7MM and Canada will be essential to the commercial success of these vaccines, as widespread uptake outside of official recommendations is unlikely. GlobalData believes that country-specific immunization recommendations and policy implementation will be an essential metric for determining future vaccine uptake. Our report provides a detailed, primary research-driven analysis of immunization policy at the country level. Vaccines that more effectively protect traditional non-responders, such as patients with chronic kidney disease (CKD) and diabetes mellitus, have the potential to address an area of high unmet need while simultaneously exploiting a largely untapped segment of the HBV vaccine market. For example, Dynavax s Heplisav has showed encouraging results in Phase III clinical studies in the US. Key opinion leaders (KOLs) have indicated to GlobalData that, despite superior clinical performance, the success of vaccines targeting these specific adult populations will depend upon a drastic improvement in current coverage rates. 22

23 Introduction A growing preference for pediatric combination vaccines, particularly in the 5EU, is expected to drive stiff competition between GSK s Infanrix Hexa and Sanofi Pasteur MSD s Hexyon. Vaccine manufacturers will focus much effort on emphasizing the convenience and costeffectiveness of combination vaccines, but their eventual use will depend heavily on how well they fit into country-specific vaccination schedules. Our report includes a thorough competitive assessment of marketed and late-stage pipeline vaccines in the 7MM and Canada, which takes into account both clinical and commercial positioning. GlobalData anticipates that vaccine manufacturers will face an uphill battle in countries that do not currently recommend routine vaccination against HBV, such as the UK and Japan. Despite pressure from patient advocacy and pro-immunization groups, KOLs have indicated that shortterm change to immunization policy appears unlikely. Firms interested in accessing these markets may only target specific at-risk patient populations for the foreseeable future. 2.2 Related Reports GlobalData (2013). PharmaPoint: HIV Therapeutics Global Drug Forecast and Market Analysis to 2022: Event-Driven Update, March, 2013, GDHC41PIDR GlobalData (2013). PharmaFocus: Vaccine Adjuvants in Infectious Disease, March, 2013, GDHC001PFR GlobalData (2013). PharmaPoint: Pediatric Respiratory Syncytial Virus Prophylactics United States Drug Forecast and Market Analysis to 2022, April, 2013, GDHC102PIDR GlobalData (2013). PharmaPoint: HCV Therapeutics Global Drug Forecast and Market Analysis to 2022, May, 2013, GDHC42PIDR GlobalData (2013). PharmaPoint: Dermatophytic Onychomycosis United States Drug Forecast and Market Analysis to 2022, June, 2013, GDHC101PIDR GlobalData (2013). PharmaPoint: Meningococcal Vaccines Global Drug Forecast and Market Analysis to 2022, June 2013, GDHC51PIDR GlobalData (2013). PharmaFocus: Market Access Strategies for Antibiotics Targeting Multidrug-Resistant Gram-Negative Bacteria, August 2013, GDHC004PFR 23

24 Introduction GlobalData (2013). PharmaFocus: HIV R&D Strategies Towards Cure and Prevention, August 2013, GDHC003PFR GlobalData (2013). PharmaPoint: Meningococcal Vaccines Global Drug Forecast and Market Analysis to 2022: Event-Driven Update, August 2013, GDHC61PIDR GlobalData (2013). PharmaPoint: Seasonal Influenza Vaccines Global Drug Forecast and Market Analysis to 2022: Event-Driven Update, September 2013, GDHC67PIDR 2.3 Upcoming Related Reports GlobalData (2014). PharmaPoint: Asthma Therapeutics Global Drug Forecast and Market Analysis to 2022, March 2014, GDHC75PIDR. GlobalData (2014). PharmaPoint: Prophylactic HPV Vaccines Global Drug Forecast and Market Analysis to 2022, February 2014, GDHC84PIDR. 24

25 Appendix 10.7 About GlobalData GlobalData is a leading global provider of business intelligence in the Healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in drug research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has offices in New York, Boston, San Francisco, London, India and Singapore Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData. 302