engerix-b (prophylactic hepatitis b virus vaccines ...the global (7mm and canada) prophylactic...
TRANSCRIPT
REFERENCE CODE GDHC334DFR | PUBLICAT ION DATE JANUARY 2014
ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO
2022
Engerix-B (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market Analysis to 2022 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
The table below provides a summary of the key
metrics for Engerix-B in the 8MM Prophylactic
Hepatitis B Virus (HBV) Vaccines markets during
the forecast period from 2012–2022.
Engerix-B: Key Metrics in the 8MM Prophylactic HBV Vaccines Markets, 2012–2022
2012 Market Sales
US $15.9m
5EU $14.8m
Japan N/A
Canada $1.6m
Total $32.3m
Key Events (2012–2022) Level of Impact
Engerix-B faces stiff competition from combination vaccines in the pediatric market, most notably GSK’s Infanrix Hexa in the 5EU.
↓
2022 Market Sales
US $12.5m
5EU $5.3m
Japan N/A
Canada $1.1m
Global* $18.9m Source: GlobalData 8MM= US, France, Germany, Italy, Spain, UK, Japan and Canada 5EU = France, Germany, Italy, Spain and UK N/A: not available
Sales of Engerix-B in the Prophylactic HBV Vaccines Market
The combined sales of Engerix-B were estimated
at $32.3 million in 2012. By 2022, we project
Engerix-B sales to fall to $18.9 million, with a
negative Compound Annual Growth Rate (CAGR)
of 5.2% over the course of the decade. These
estimates cover the sales in the eight countries
included in this report: the US, France, Germany,
Italy, Spain, the UK, Japan, and Canada.
Key factors contributing to sales of Engerix-B will
include:
The yeast-derived, recombinant HBsAg
antigen makes accidental infection impossible
and thus eliminates the HIV transmission
concerns associated with the plasma-derived,
first-generation HBV vaccines. Physicians are
comfortable with Engerix-B’s strong safety
profile and clinical performance.
Unlike the combination vaccines, Engerix-B
can be given to infants at birth. This expanded
indication gives Engerix-B an advantage over
its competitors in markets that encourage the
administration of the first dose of HBV vaccine
shortly after birth.
Amidst unwarranted public skepticism towards
the ability of the infant immune system to
tolerate combination vaccines, Engerix-B is
seen as a viable option for alternative
vaccination schedules and immunization
skeptics.
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ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
Despite these drivers, the major barrier affecting
the sales of Engerix-B will include:
Engerix-B only protects against HBV, which
puts this vaccine at a competitive
disadvantage. Pediatric combination vaccines,
such as GSK’s Infanrix Hexa, are seen as
more cost-effective and reduce the infant shot
burden because they protect against multiple
diseases.
Engerix-B does not effectively protect all
patients against HBV, and its effectiveness is
especially diminished in adults with renal
insufficiency.
Because there is little differentiation between
Engerix-B and Merck’s Recombivax HB, GSK
must compete for sales in a highly mature
market. Despite Engerix-B’s record as a
reliable vaccine, it fails to differentiate itself
enough from competitors to dominate the
market.
The figure below illustrates the global Engerix-B
sales by region during the forecast period.
Sales for Engerix-B by Region, 2012–2022
49.3%
45.8%
4.9%
2012 Total: $32.3m
US
5EU
Japan
65.9%
28%
6.1%
2022 Total: $18.9m
Source: GlobalData
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ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
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 2013
“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 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 2013
Engerix-B (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market Analysis to 2022 5 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
“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
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Table of Contents
ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO 2022
1 Table of Contents
1 Table of Contents ....................................................................................................................... 6
1.1 List of Tables ...................................................................................................................... 8
1.2 List of Figures ..................................................................................................................... 8
2 Introduction ................................................................................................................................. 9
2.1 Catalyst ............................................................................................................................... 9
2.2 Related Reports ................................................................................................................ 10
2.3 Upcoming Related Reports ............................................................................................... 12
3 Disease Overview ..................................................................................................................... 13
3.1 Overview ........................................................................................................................... 13
3.2 Etiology and Pathophysiology ........................................................................................... 14
3.2.1 Etiology ......................................................................................................................... 14
3.2.2 Pathophysiology ............................................................................................................ 17
3.3 Symptoms ......................................................................................................................... 19
3.4 Prognosis .......................................................................................................................... 21
4 Vaccination Recommendations and Coverage Rates ............................................................... 22
4.1 Overview ........................................................................................................................... 22
5 Competitive Assessment .......................................................................................................... 26
5.1 Overview ........................................................................................................................... 26
5.2 Strategic Competitor Assessment ..................................................................................... 26
6 Engerix-B .................................................................................................................................. 29
6.1 Overview ........................................................................................................................... 29
Engerix-B (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market Analysis to 2022 7 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO 2022
6.2 Immunogenicity ................................................................................................................. 31
6.3 Safety ............................................................................................................................... 32
6.4 SWOT Analysis ................................................................................................................. 33
6.5 Forecast ............................................................................................................................ 34
7 Appendix................................................................................................................................... 35
7.1 Bibliography ...................................................................................................................... 35
7.2 Abbreviations .................................................................................................................... 49
7.3 Methodology ..................................................................................................................... 52
7.4 Forecasting Methodology .................................................................................................. 52
7.4.1 Patient Populations Targeted for Vaccination ................................................................ 53
7.4.2 Vaccination Coverage Rates ......................................................................................... 56
7.4.3 Vaccinated Patients....................................................................................................... 57
7.4.4 Regulatory Approval vs. Advisory Committee Recommendation ................................... 57
7.4.5 General Pricing Assumptions ........................................................................................ 58
7.4.6 Individual Vaccine Assumptions .................................................................................... 59
7.5 Physicians and Specialists Included in this Study ............................................................. 61
7.5.1 Interviews of Key Opinion Leaders (KOLs) .................................................................... 61
7.5.2 Online Survey of High-Prescribing Physicians (non-KOLs)............................................ 63
7.6 About the Authors ............................................................................................................. 64
7.6.1 Analyst .......................................................................................................................... 64
7.6.2 Therapy Area Director ................................................................................................... 64
7.6.3 Global Head of Healthcare ............................................................................................ 65
7.7 About GlobalData .............................................................................................................. 66
Engerix-B (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market Analysis to 2022 8 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO 2022
7.8 Disclaimer ......................................................................................................................... 66
1.1 List of Tables
Table 1: Modes of HBV Transmission .......................................................................................................... 18
Table 2: HBV Serological Markers and Test Interpretations ......................................................................... 19
Table 3: Symptoms of HBV Infection ........................................................................................................... 20
Table 4: HBV Vaccination Advisory Committees by Country ........................................................................ 23
Table 5: HBV Immunization Recommendations by Country ......................................................................... 24
Table 6: Targeted Age Group(s) for Routine Immunization and Most Administered HBV Vaccines by Country
in the Global Markets, 2014 ........................................................................................................... 25
Table 7: Leading Vaccines for HBV, 2014 .................................................................................................... 28
Table 8: Product Profile – Engerix-B ............................................................................................................ 30
Table 9: Immunogenicity Profile – Engerix-B ................................................................................................ 31
Table 10: Safety Profile – Engerix-B .............................................................................................................. 32
Table 11: Engerix-B SWOT Analysis, 2014 .................................................................................................... 33
Table 12: Global Sales Forecasts ($m) for Engerix-B, 2012–2022 .................................................................. 34
Table 13: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, by Country ................. 54
Table 14: Patient Population(s) Targeted for HBV Vaccination in the Adult Market, by Country ...................... 55
Table 15: High-Prescribing Physicians (non-KOLs) Surveyed, by Country ...................................................... 63
1.2 List of Figures
Figure 1: HBV Structure and the Recombinant Vaccine Development Process .............................................. 15
Engerix-B (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market Analysis to 2022 9 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO 2022
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 2012–2022. 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.
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 cost-
effectiveness 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
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ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO 2022
Introduction
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 short-
term 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
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
Engerix-B (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market Analysis to 2022 11 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO 2022
Introduction
GlobalData (2014). PharmaPoint: Prophylactic Hepatitis B Virus Vaccines – Global Drug
Forecast and Market Analysis to 2022: January 2014, GDHC68PIDR
GlobalData (2014). Ambirix (Prophylactic Hepatitis B Virus Vaccines) – Forecast and Market
Analysis to 2022, January 2014, GDHC331DFR
GlobalData (2014). Bimmugen (Prophylactic Hepatitis B Virus Vaccines) – Forecast and
Market Analysis to 2022, January 2014, GDHC332DFR
GlobalData (2014). Comvax (Prophylactic Hepatitis B Virus Vaccines) – Forecast and Market
Analysis to 2022, January 2014, GDHC333DFR
GlobalData (2014). Fendrix (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market
Analysis to 2022, January 2014, GDHC335DFR
GlobalData (2014). Hexyon (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market
Analysis to 2022, January 2014, GDHC337DFR
GlobalData (2014). Infanrix Hexa (Prophylactic Hepatitis B Virus Vaccines) - Forecast and
Market Analysis to 2022, January 2014, GDHC338DFR
GlobalData (2014). Pediarix (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market
Analysis to 2022, January 2014, GDHC339DFR
GlobalData (2014). Recombivax HB (Prophylactic Hepatitis B Virus Vaccines) - Forecast and
Market Analysis to 2022, January 2014, GDHC340DFR
GlobalData (2014). Twinrix (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market
Analysis to 2022, January 2014, GDHC341DFR
GlobalData (2014). Heplisav (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market
Analysis to 2022, January 2014, GDHC336DFR
GlobalData (2014). Prophylactic Hepatitis B Virus Vaccines - US Drug Forecast and Market
Analysis to 2022, January 2014, GDHC214CFR
GlobalData (2014). Prophylactic Hepatitis B Virus Vaccines – 5EU Drug Forecast and Market
Analysis to 2022, January 2014, GDHC215CFR
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ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO 2022
Introduction
GlobalData (2014). Prophylactic Hepatitis B Virus Vaccines - Japan Drug Forecast and Market
Analysis to 2022, January 2014, GDHC216CFR
GlobalData (2014). Prophylactic Hepatitis B Virus Vaccines - Canada Drug Forecast and
Market Analysis to 2022, January 2014, GDHC217CFR
GlobalData (2014). Prophylactic Hepatitis B Virus Vaccines - Current and Future Players,
January 2014, GDHC1028FPR
2.3 Upcoming Related Reports
GlobalData (2014). PharmaPoint: Asthma Therapeutics – Global Drug Forecast and Market
Analysis to 2022, April 2014, GDHC75PIDR.
GlobalData (2014). PharmaPoint: Prophylactic HPV Vaccines – Global Drug Forecast and
Market Analysis to 2022, March 2014, GDHC84PIDR.
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Appendix
ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO 2022
7.7 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.
7.8 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.