ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES ...The global (7MM and Canada) prophylactic...

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.



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



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.”


“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.”


“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.”


“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.”




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.”


“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.”


“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


Table of Contents


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


Table of Contents


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


Table of Contents


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



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



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



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


GlobalData (2014). Fendrix (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market


GlobalData (2014). Hexyon (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market


GlobalData (2014). Infanrix Hexa (Prophylactic Hepatitis B Virus Vaccines) - Forecast and


GlobalData (2014). Pediarix (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market


GlobalData (2014). Recombivax HB (Prophylactic Hepatitis B Virus Vaccines) - Forecast and


GlobalData (2014). Twinrix (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market


GlobalData (2014). Heplisav (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market


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




Introduction

GlobalData (2014). Prophylactic Hepatitis B Virus Vaccines - Japan Drug Forecast and Market


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.


Appendix


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.

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