REFERENCE CODE GDHC1013FPR PUBLICAT ION DATE AUGUST 2013 MENINGOCOCCAL VACCINES - CURRENT AND FUTURE PLAYERS

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1 REFERENCE CODE GDHC1013FPR PUBLICAT ION DATE AUGUST 2013 MENINGOCOCCAL VACCINES -

2 Executive Summary Meningococcal Vaccines: Key Metrics in the Nine Major Pharmaceutical Markets 2012 Epidemiology Targeted population Vaccinated population 2012 Market Sales US 5EU Japan Australia Brazil Total Pipeline Assessment 19.3 million 15.5 million $632.1m $170.4m N/A $10.9m $361.7m $1,175.2m Number of vaccines in Phase I II 2 Number of first-in-class vaccines 2 Most Promising Pipeline Vaccines MnB rlp2086 Bexsero Key Events ( ) Introduction of Bexsero in 5EU in 2013 Introduction of Indigenous MenC vaccine in Brazil in 2014 Introduction of Indigenous Heptavalent in Brazil in 2017 Introduction of MnB rlp2086 in US in 2017 Introduction of MnB rlp2086 in 5EU in Market Sales Peak-Year Sales $706.1m N/A Level of Impact US $1, 479.9m 5EU Japan Australia Brazil Total Source: GlobalData $173.4m N/A $12.3m $10.9m $1,676.6m 5EU = five European markets (France, Germany, Italy, Spain, and UK) N/A: Not Applicable Meningococcal Vaccine Sales Expected to Grow During the Forecast Period GlobalData has calculated that the global meningococcal vaccines market, which consists primarily of patients who have been vaccinated according to government-sanctioned routine immunization guidelines, generated close to $1.2 billion in sales in This market is expected to experience modest growth over the next 10 years, with a Compound Annual Growth Rate (CAGR) of 3.6%, and sales are projected to top $1.6 billion by The majority of market growth will take place in the US (8.9% CAGR), which is, and will remain, the largest market for meningococcal vaccines among the countries covered in this report. Growth is expected to be less pronounced across the 5EU and Australia, with CAGRs of 0.2% and 1.2%, respectively. GlobalData expects that some of the most important drivers of global market growth over the next decade will be: The introduction of the first serogroup B vaccines, predominantly in the US The increased coverage rates of existing meningococcal immunization programs Collaborations between vaccine manufacturers and patient advocacy groups The growing populations of targeted age segments, particularly in the US 2

3 Executive Summary GlobalData believes that notable barriers to growth of the global meningococcal vaccines market will include: Cost-effectiveness issues associated with expanding vaccination programs, specifically involving the adoption of serogroup B vaccines into routine vaccination programs Disparate age groups and/or dosing regimens for routine immunization from one country to the next The unpredictable and dynamic epidemiology of meningococcal disease The introduction of indigenous meningococcal vaccines, especially in emerging markets, such as Brazil Global Sales of Meningococcal Vaccines by Region, % 1% 14% 10% 1% 1% 2012 Total: $1.18bn 54% 2022 Total: $1.68bn US 5EU Australia Brazil US 5EU Australia Brazil 88% Source: GlobalData 3

4 Executive Summary Vaccine Manufacturers Concentrate on Unexploited Segments of the Market, as Exemplified by Serogroup B Vaccine Development The meningococcal vaccines market has long been dominated by Big Pharma, with the major players being Sanofi, Novartis, and GlaxoSmithKline (GSK). Sanofi is the clear-cut leader in the marketplace, primarily due to its dominance of the US adolescent market, where its flagship vaccine, Menactra, garners 80% market share, with estimated sales of $500m in The current players are projected to maintain their global market share over the next decade due to limited competition from new players. The market s high level of maturity has sparked a renewed push for the development of vaccines that address areas of the market with unmet need, led by the meningococcal serogroup B (MenB) vaccine space. Both Novartis and Pfizer have invested heavily in serogroup B vaccine research and development (R&D), with the first-in-class vaccines, Bexsero and MnB rlp2086, entering the 5EU and US markets, respectively, over the next few years. Other areas of opportunity for new entrants include immunogenic infant vaccines and vaccines with improved immune response duration. Company Portfolio Gap Analysis in Meningococcal Vaccines, Strength of Marketed Products High Low Source: GlobalData Stagnant Players Low Strength of Pipeline Current and Future Players Future Players High Healthcare Providers Clamour for Cost- Effective Vaccines that Provide Broader Serogroup Coverage GlobalData considers the level of unmet need in the meningococcal vaccines market to be moderate, with key opinion leaders (KOLs) from the nine major markets (9MM) covered in this report (US, 5EU, Japan, Australia, and Brazil) identifying the two major unmet needs: vaccines that offer protection against Neisseria meningitidis serogroup B infections, and more cost-effective vaccines. 4

5 Executive Summary Serogroup B disease (MenB) accounts for the majority of invasive infections in the US, Europe, and Australia, with especially high incidence rates observed in infants and toddlers. Two major players, Novartis and Pfizer, have shown a commitment to addressing this void in disease prevention by investing in the development of Bexsero and MnB rlp2086, respectively. These vaccines will be welcomed by physicians and public health officials, as they fill a gaping void in the treatment algorithm. Nevertheless, the future inclusion of MenB vaccines in routine immunization programs will largely depend upon government cost-effectiveness assessments. As previously mentioned with regard to the MenB vaccines, there is also a general need for more cost-effective meningococcal vaccines. High R&D and manufacturing costs, combined with a lack of generic competitors, have led companies to maintain prohibitively high costs per dose of licensed vaccines, particularly those that protect against multiple serogroups. In a market where government recommendation is critical for commercial success, this need represents a perpetual challenge to the widespread use of all meningococcal vaccines. Companies may seek to address these shortcomings by lowing price points, developing vaccines with reduced dosing regimens, or broadening serogroup coverage. For example, Novartis is seeking to create the first pentavalent meningococcal vaccine, MenABCWY, which is currently in Phase II clinical trials. The Commercial Success of Serogroup B Vaccines Will Hinge on Favorable Cost- Effectiveness Assessments Vaccines that prevent serogroup B disease have been a longstanding void in the treatment algorithm, so the introduction of two of these firstin-class vaccines in the next decade is projected to alter the meningococcal vaccines landscape. While Novartis Bexsero is targeted at the childhood immunization programs of Europe, Pfizer s Phase III vaccine, MnB rlp2086, will offer long-awaited protection for US adolescents. Despite the clear medical need for serogroup B vaccines, the majority of their sales will be heavily dependent upon the willingness of governments to recommend them for routine inoculation. GlobalData predicts that these vaccines have the potential to dominate this segment of the market and, provided they are deemed cost-effective by governments and incorporated into routine vaccination schedules, will be responsible for the majority of global growth over the next decade. 5

6 Executive Summary Serogroup B Vaccines, Increased Coverage Rates Will Stimulate Modest Growth in the Meningococcal Vaccines Market While the meningococcal vaccines pipeline is largely devoid of late-stage products, the greatest clinical unmet need is still likely to be satisfied due to a focus on serogroup B vaccine development. GlobalData therefore anticipates that, along with improved coverage rates of existing routine vaccination programs, global growth in the meningococcal vaccines market will be driven by the addition of these serogroup B vaccines to the treatment landscape, led by the projected inclusion of Pfizer s MnB rlp2086 into the US adolescent immunization program. Novartis Bexsero faces an uphill battle towards inclusion in routine immunization programs due to cost-effectiveness concerns. Despite these concerns, the two new vaccines will enter an untapped segment of the market and have the potential to stimulate rapid growth, while existing vaccines that cover the other four serogroups (A, C, W-135, and Y) will maintain and/or increase their usage levels due to improvements in program coverage rates. Projected peak-year sales for MnB rlp2086 are expected to reach $700m, while Bexsero will be relegated to private-market use if it fails to receive inclusion into routine vaccination programs, particularly in the 5EU. Competitive Assessment of Late-Stage Pipeline Agents in Meningococcal Vaccines, Commercial Attributes High Low GSK s Mencevax Sanofi s Menomune Sanofi s Menactra Novartis Bexsero Novartis Menjugate Nuron Biotech s Meningitec Baxter s NeisVac-C Pfizer s MnB rlp2086 Novartis Menveo GSK s Menitorix Source: GlobalData Low Clinical Attributes High 6

7 Table of Contents 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction Catalyst Related Reports Upcoming Related Reports Market Outlook Global Markets Forecast Drivers and Barriers Global Issues Current and Future Players Overview Trends in Corporate Strategy Company Profiles Sanofi Novartis GlaxoSmithKline Baxter Nuron Biotech Pfizer

8 Table of Contents 5 Appendix Bibliography Abbreviations Methodology Forecasting Methodology Vaccine Coverage Vaccine Approval vs. Routine Schedule Inclusion Vaccines Included Key Launch Dates General Pricing Assumptions Individual Vaccine Assumptions Pricing of Pipeline agents Physicians and Specialists Included in this Study About the Authors Author(s) Reviewer(s) Epidemiologist(s) Global Head of Healthcare About GlobalData Disclaimer

9 Table of Contents 1.1 List of Tables Table 1: Global Sales Forecasts ($m) for Meningococcal Vaccines, Table 2: Global Meningococcal Vaccines Market Drivers and Barriers, Table 3: Key Companies in the Meningococcal Vaccines Market, Table 4: Sanofi s Meningococcal Vaccines Portfolio Assessment, Table 5: Sanofi SWOT Analysis, Table 6: Novartis Meningococcal Vaccines Portfolio Assessment, Table 7: Novartis SWOT Analysis, Table 8: GSK s Meningococcal Vaccines Portfolio Assessment, Table 9: GSK SWOT Analysis, Table 10: Baxter s Meningococcal Vaccines Portfolio Assessment, Table 11: Baxter SWOT Analysis, Table 12: Nuron Biotech s Meningococcal Vaccines Portfolio Assessment, Table 13: Nuron Biotech SWOT Analysis, Table 14: Pfizer s Meningococcal Vaccines Portfolio Assessment, Table 15: Pfizer SWOT Analysis, Table 16: Key Launch Dates Table 17: High-Prescribing Physicians (non-kols) Surveyed, By Country

10 Table of Contents 1.2 List of Figures Figure 1: Global Sales for Meningococcal Vaccines by Region, Figure 2: Company Portfolio Gap Analysis in Meningococcal Vaccines,

11 Introduction 2 Introduction 2.1 Catalyst The global meningococcal vaccines market is mature and has experienced limited growth since the introduction of conjugate vaccines, led primarily by Sanofi s Menactra in the US. The arrival of serogroup B vaccines onto the scene, combined with improved coverage rates of existing programs, is expected to generate modest growth over the forecast period from Below are the key factors that will contribute to this market growth. The introduction of Novartis Bexsero and Pfizer s MnB rlp2086 will provide patients with longawaited protection against serogroup B meningococcal disease. These vaccines will occupy the largest empty segment of the meningococcal vaccines space and will have the potential to revolutionize the treatment landscape. The expansion of routine immunization programs to include serogroup B vaccines will be essential to the commercial success of these vaccines and highlights the importance of government endorsement in ensuring their widespread usage, as the vast majority of meningococcal vaccines are administered to patients within these routine recommendations. The push to improve coverage rates of existing immunization programs will also contribute to market growth, particularly in the US. The cost-effectiveness of meningococcal vaccines will be continuously reassessed by cashstrapped governments, creating opportunities for new and existing manufacturers in a market where vaccine preference and usage level do not always correlate with performance in the clinic or the ability to address unmet need. This point will be particularly important for the incorporation of serogroup B vaccines, such as Novartis Bexsero, into routine vaccination schedules. The entrance of indigenous meningococcal vaccines into emerging markets, such as Brazil, exemplifies the challenges associated with retaining long-term market share in countries that are able to leverage inexpensive manufacturing capacity and buying power to compete with foreign multinational firms. 11

12 Introduction 2.2 Related Reports GlobalData (2013). PharmaFocus: Vaccine Adjuvants in Infectious Disease, March, 2013, GDHC001PR GlobalData (2013). PharmaPoint: Pediatric Respiratory Syncytial Virus Prophylactics United States Drug Forecast and Market Analysis to 2022, April, 2013, GDHC102PIDR GlobalData (2013). PharmaPoint: Dermatophytic Onychomycosis United States Drug Forecast and Market Analysis to 2022, June, 2013, GDHC101PIDR 2.3 Upcoming Related Reports GlobalData (2013). PharmaFocus: HIV R&D Strategies, August 2013, GDHC003PR GlobalData (2013). PharmaFocus: Market Access Strategies for Antibiotics Targeting Multidrug-Resistant Gram-Negative Bacteria, August 2013, GDHC004PR 12

13 Appendix 5.7 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. 5.8 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. 70