Pipeline and Commercial Insight: Pediatric and Adolescent Vaccines

Published by: Datamonitor

Published: Jul. 23, 2007 - 274 Pages

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor’s insight into the pediatric and adolescent vaccines market

Related reports

Key metrics

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Summary

Market definition for this report

Market size and growth

Vaccines - a rapidly growing pharmaceutical sector

The US dominate global vaccine sales, but main growth opportunities lie in

emerging markets

Pediatric and adolescent vaccines are at the core of the vaccines industry

Market drivers and restrictors

Growing awareness among parents and physicians is the main driver of the

pediatric and adolescent vaccines market

High prices and problems in reaching adolescents could emerge as major

restrictors

Recent approvals

Key players in the childhood and adolescent vaccines market

Merck & Co/Sanofi Pasteur - joint domination

Sanofi Pasteur - influenza, meningitis and DTP as revenue drivers

Sanofi Pasteur MSD - a successful joint venture

Merck & Co - leading in novel, innovative segments including HPV and rotavirus

GSK Biologicals - expanding beyond Europe

Wyeth - it’s all about Prevnar

Novartis Vaccines - hoping for a meningitis blockbuster vaccine

Recommendations and vaccination coverage across the seven major markets

US

Vaccination schedules

Coverage

Japan

Vaccination schedules

Coverage

France

Vaccination schedules

Coverage

Germany

Vaccination schedules

Coverage

Italy

Vaccination schedules

Coverage

Spain

Vaccination schedules

Coverage

UK

Vaccination schedules

Coverage

R&D approach - clinical trials for vaccines

CHAPTER 3 DIPHTHERIA, TETANUS, PERTUSSIS VACCINES - MULTIVALENT COMBINATIONS ON THE RISE

Summary

Epidemiology

Diphtheria

Tetanus

Pertussis

Market opportunity

Currently marketed DTP vaccines

Case Study: GSK versus Sanofi Pasteur

GSK’s DTP franchise - Pediarix and Boostrix as main sales drivers

Sanofi Pasteur’s DTP franchise - lagging behind in combination vaccines

Unmet needs

DTP vaccine pipeline

Globorix - GSK’s contribution for developing countries

CHAPTER 4 MEASLES, MUMPS, RUBELLA, VARICELLA VACCINES - MMR-V COMBINATIONS GAIN POPULARITY

Summary

Epidemiology

Measles

Mumps

Rubella

Varicella

Market opportunity

Currently marketed vaccines

Case study: GSK versus Sanofi/Merck & Co

Merck & Co/Sanofi Pasteur’s MMR and Varicella franchise - building on MMR II

M-M-R II

Varivax

ProQuad

Franchise summary

GSK’s MMR and Varicella franchise - a step behind Merck & Co

Priorix

Varilrix

Priorix Tetra

Franchise summary

Unmet needs

MMR and varicella vaccine pipeline

CHAPTER 5 PNEUMOCOCCAL VACCINES - PREVNAR CONTINUES TO DOMINATE THE FIELD

Summary

Epidemiology

Market opportunity

Currently marketed vaccines

Case study: Prevnar, the first vaccine blockbuster

Vaccine profile

Future opportunities and risks

Prevnar has an acceptable cost-benefit profile and is targeting a growing market

Serotype shift in pneumococcal infections is emerging as a new challenge

Commercial forecast for Prevnar

Unmet needs

S. pneumoniae late-stage pipeline analysis and forecasts

Pipeline summary

13vPnC (Wyeth)

Product overview

Clinical trial data

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor vaccine assessment summary

Synflorix/Streptorix

Product overview

Clinical trial data

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor vaccine assessment

Comparative forecasts

CHAPTER 6 MENINGOCOCCAL VACCINES - MENACTRA’S MONOPOLY UNDER THREAT

Summary

Epidemiology

Market opportunity

Men ACWY - a large untouched childhood market

Men B - huge potential for a universal vaccine

Currently marketed vaccines

N. meningitidis ACWY

N. meningitidis B

Case study: Menactra

Product profile

Clinical data - association with Guillain-Barré syndrome as a hurdle?

Expanding the franchise - Menactra for all age groups

Future opportunities and risks - market leadership under threat

Commercial forecast for Menactra

Unmet needs

Conjugate vaccines against N. meningitidis ACWY for pediatric use are urgently required

Broad-acting vaccines against N. meningitidis B represent a crucial unmet need

N. meningitidis ACWY late-stage pipeline analysis and forecast

Pipeline summary

Men ACWY vaccine (Novartis)

Product overview

Clinical trial data

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor vaccine assessment

GSK-134612

Product overview

Clinical trial data

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor vaccine assessment

Comparative forecasts for Men ACWY vaccines

Hib-MenCY-TT (GSK)

Product overview

Clinical trial data

Marketing factors

Satisfaction of unmet needs

Datamonitor vaccine assessment

MemVac A, C, Y, & W-135 (Transgene Biotek)

Product overview

Clinical trial data

Marketing factors

Satisfaction of unmet needs

Datamonitor vaccine assessment

N. meningitidis B late-stage pipeline analysis and forecast

Pipeline summary

Recombinant meningococcal B vaccine (Novartis)

Product overview

Clinical trial data

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Meningococcal B vaccine (Wyeth)

Product overview

Clinical trial data

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Comparative assessment

CHAPTER 7 HUMAN PAPILLOMAVIRUS VACCINES - A PROMISING NEW MARKET

Summary

Epidemiology

Market opportunity

Currently marketed vaccines

Case study: Gardasil versus Cervarix

Gardasil - first-to-market vaccine for prevention of cervical cancer and genital warts

Product profile

Future challenges and risks

Cervarix - GSK’s runner-up

Product profile

Future challenges and risks

Comparison: Gardasil offers a broader therapeutic spectrum

Commercial forecasts

Unmet needs

HPV vaccine pipeline

CHAPTER 8 ROTAVIRUS VACCINES - ROTATEQ AND ROTARIX HEAD-TO-HEAD

Summary

Epidemiology

Market opportunity

Currently marketed vaccines

Case study: RotaTeq versus Rotarix

New solutions are needed following the withdrawal of Wyeth’s RotaShield

RotaTeq - first-to-market in the US

Rotarix - catching up from Europe

Comparison

Commercial forecasts

Unmet needs

Rotavirus vaccine pipeline

BIBLIOGRAPHY

Literature

APPENDIX

Methodology

Datamonitor forecast methodology

Datamonitor’s patient-based forecasting model

Limitations of the patient-based forecasting model

Datamonitor drug assessment summary

Contributing experts

About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare’s therapy area capabilities

About the Infectious Diseases analysis team

Key therapy team members

Holger Rovini, Head of Respiratory and Infectious Diseases

Hedwig Kresse, Associate Analyst, Infectious Diseases

Disclaimer

Abstract

Introduction

The pediatric and adolescent vaccines market encompasses many different classes. DTP and MMR combinations continue to form the mainstay of childhood immunization; however, their growth potential is limited. The key opportunities lie in novel, innovative additions to established schedules, particularly pneumococcal (Prevnar), conjugated meningococcal (Menactra) and HPV (Gardasil) vaccines.

Scope

Strategic analysis of the pediatric and adolescent vaccines market across the seven major markets and of key companies in the sector Thorough assessment of underlying commercial and clinical influencers shaping the pediatric and adolescent vaccines market Patient-based forecasts for key vaccine classes and products according to recommended vaccination groups and coverage rates in the seven major markets In-depth discussion of novel vaccine pipeline candidates and discussion of their future potential

Highlights

Driven by the launch of novel, high-price vaccines such as Gardasil or RotaTeq, the pediatric and adolescent vaccines market is experiencing a rapid growth. Wyeth's Prevnar has emerged as the first blockbuster vaccine, demonstrating that innovative vaccines can command high prices and yield high revenues in the pediatric vaccines market. The main future opportunities lie in the pneumococcal, meningococcal and HPV vaccine sectors, where there is a large medical need. Particularly a vaccine against infections with N. meningitidis B would have a potentially huge commercial. Key challenges include the reluctance of healthcare providers to pay for increasingly expensive vaccines and the lack of widespread organized vaccination programs for school children and teenagers. With an increasing focus on adolescent vaccines such as Gardasil or Menactra, better ways to reach adolescents for vaccination will have to be found.

Reasons to Purchase

Review clinical and commercial factors driving new product decisions and the strategies of key players in the pediatric and adolescent vaccines market Gain insight through a patient-based forecast and a thorough analysis of marketed and pipeline products as well as case studies in key vaccine classes Understand concerns, unmet needs and future opportunities by learning about the views of key pediatric and adolescent vaccine opinion leaders

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