MENINGOCOCCAL VACCINES - CURRENT AND …Meningococcal Vaccines Market While the meningococcal...

REFERENCE CODE GDHC1013FPR | PUBLICAT ION DATE AUGUST 2013

MENINGOCOCCAL VACCINES - CURRENT AND FUTURE PLAYERS

Meningococcal Vaccines - Current and Future Players 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.


Executive Summary

Meningococcal Vaccines: Key Metrics in the Nine Major Pharmaceutical Markets

2012 Epidemiology

Targeted population 19.3 million

Vaccinated population 15.5 million

2012 Market Sales

US $632.1m

5EU $170.4m

Japan N/A

Australia $10.9m

Brazil $361.7m

Total $1,175.2m

Pipeline Assessment

Number of vaccines in Phase I–II 2

Number of first-in-class vaccines 2

Most Promising Pipeline Vaccines Peak-Year Sales

MnB rLP2086 $706.1m

Bexsero N/A

Key Events (2012–2022) Level of Impact

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 2018 ↑

2022 Market Sales

US $1, 479.9m

5EU $173.4m

Japan N/A

Australia $12.3m

Brazil $10.9m

Total $1,676.6m Source: GlobalData 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 2012. 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

2022. 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



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, 2012–2022

54%

14%

1%

31%

US

5EU

Australia

Brazil

2012 Total: $1.18bn

88%

10%1% 1%

US

5EU

Australia

Brazil

2022 Total: $1.68bn

Source: GlobalData



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 2012. 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, 2012–2022

Strength of Pipeline

Low High

Hig

hLo

w

Stre

ngth

of M

arke

ted

Pro

duct

s

Current and Future Players

Future Players

Stagnant Players

Source: GlobalData

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.



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 first-

in-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.



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, 2012–2022

Clinical AttributesLow High

Hig

hLo

wCom

mer

cial

Attr

ibut

es

Sanofi’s Menactra

Pfizer’sMnB rLP2086

Novartis’Bexsero

Novartis’Menveo

Novartis’Menjugate

Nuron Biotech’sMeningitec

Baxter’sNeisVac-C

Sanofi’sMenomune

GSK’sMencevax

GSK’sMenitorix

Source: GlobalData



Table of Contents

1 Table of Contents

1 Table of Contents .......................................................................................................................... 7

1.1 List of Tables............................................................................................................................ 9

1.2 List of Figures ........................................................................................................................ 10

2 Introduction ................................................................................................................................. 11

2.1 Catalyst .................................................................................................................................. 11

2.2 Related Reports ..................................................................................................................... 12

2.3 Upcoming Related Reports .................................................................................................... 12

3 Market Outlook ............................................................................................................................ 13

3.1 Global Markets ....................................................................................................................... 13

3.1.1 Forecast ......................................................................................................................... 13

3.1.2 Drivers and Barriers – Global Issues............................................................................... 17

4 Current and Future Players ......................................................................................................... 21

4.1 Overview ................................................................................................................................ 21

4.2 Trends in Corporate Strategy ................................................................................................. 25

4.3 Company Profiles ................................................................................................................... 27

4.3.1 Sanofi ............................................................................................................................. 27

4.3.2 Novartis .......................................................................................................................... 31

4.3.3 GlaxoSmithKline ............................................................................................................. 35

4.3.4 Baxter ............................................................................................................................. 38

4.3.5 Nuron Biotech ................................................................................................................. 40

4.3.6 Pfizer .............................................................................................................................. 42



Table of Contents

5 Appendix ..................................................................................................................................... 44

5.1 Bibliography ........................................................................................................................... 44

5.2 Abbreviations ......................................................................................................................... 48

5.3 Methodology .......................................................................................................................... 50

5.4 Forecasting Methodology ....................................................................................................... 50

5.4.1 Vaccine Coverage .......................................................................................................... 51

5.4.2 Vaccine Approval vs. Routine Schedule Inclusion........................................................... 51

5.4.3 Vaccines Included........................................................................................................... 52

5.4.4 Key Launch Dates .......................................................................................................... 53

5.4.5 General Pricing Assumptions .......................................................................................... 54

5.4.6 Individual Vaccine Assumptions ...................................................................................... 55

5.4.7 Pricing of Pipeline agents ............................................................................................... 62

5.5 Physicians and Specialists Included in this Study................................................................... 63

5.6 About the Authors .................................................................................................................. 67

5.6.1 Author(s) ......................................................................................................................... 67

5.6.2 Reviewer(s) .................................................................................................................... 67

5.6.3 Epidemiologist(s) ............................................................................................................ 68

5.6.4 Global Head of Healthcare .............................................................................................. 69

5.7 About GlobalData ................................................................................................................... 70

5.8 Disclaimer .............................................................................................................................. 70



Table of Contents

1.1 List of Tables

Table 1: Global Sales Forecasts ($m) for Meningococcal Vaccines, 2012–2022............................................. 15

Table 2: Global Meningococcal Vaccines Market – Drivers and Barriers, 2012–2022 ..................................... 17

Table 3: Key Companies in the Meningococcal Vaccines Market, 2012 .......................................................... 24

Table 4: Sanofi’s Meningococcal Vaccines Portfolio Assessment, 2012 ......................................................... 29

Table 5: Sanofi SWOT Analysis, 2012 ........................................................................................................... 30

Table 6: Novartis’ Meningococcal Vaccines Portfolio Assessment, 2012 ........................................................ 33

Table 7: Novartis SWOT Analysis, 2012 ........................................................................................................ 34

Table 8: GSK’s Meningococcal Vaccines Portfolio Assessment, 2012 ............................................................ 36

Table 9: GSK SWOT Analysis, 2012 .............................................................................................................. 37

Table 10: Baxter’s Meningococcal Vaccines Portfolio Assessment, 2012 ....................................................... 39

Table 11: Baxter SWOT Analysis, 2012 ......................................................................................................... 39

Table 12: Nuron Biotech’s Meningococcal Vaccines Portfolio Assessment, 2012 ........................................... 41

Table 13: Nuron Biotech SWOT Analysis, 2012 ............................................................................................. 41

Table 14: Pfizer’s Meningococcal Vaccines Portfolio Assessment, 2012 ........................................................ 43

Table 15: Pfizer SWOT Analysis, 2012 .......................................................................................................... 43

Table 16: Key Launch Dates .......................................................................................................................... 53

Table 17: High-Prescribing Physicians (non-KOLs) Surveyed, By Country ..................................................... 66



Table of Contents

1.2 List of Figures

Figure 1: Global Sales for Meningococcal Vaccines by Region, 2012–2022 ................................................... 16

Figure 2: Company Portfolio Gap Analysis in Meningococcal Vaccines, 2012–2022 ....................................... 24



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 2012–2022. 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 long-

awaited 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 cash-

strapped 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.



Introduction

2.2 Related Reports

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: 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, GDHC003PFR

GlobalData (2013). PharmaFocus: Market Access Strategies for Antibiotics Targeting

Multidrug-Resistant Gram-Negative Bacteria, August 2013, GDHC004PFR



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.

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