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Stakeholder Opinions: Tuberculosis - Development pipeline shows signs of life

Published by: Datamonitor

Published: Mar. 20, 2009 - 122 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE
About the Infectious Diseases and Respiratory pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
Scope of the analysis
Datamonitor insight into the Tuberculosis market
Contributing experts
Related reports
Upcoming related reports
CHAPTER 2 DISEASE BACKGROUND
Disease definition
Etiology and symptomatology
Mycobacterium tuberculosis
Pathogenesis
Management of tuberculosis
Vaccination
Combination therapy is used to treat tuberculosis
The DOTS programme has improved treatment outcomes in many high burden countries
Industry interest in the antituberculosis therapy market has remained low
Public-private partnerships to drive future drug and vaccine development
Epidemiological trends
US
Europe
Japan
Epidemiological trends in Brazil, Russia, India and China and rest of the world
India
China and Asia Pacific
Russia
Brazil
Drug resistant tuberculosis is a growing problem in high burden countries
HIV epidemic fueling a rise in tuberculosis cases
The immigrant population in US and Europe is at high risk
CHAPTER 3 PRESENTATION AND DIAGNOSIS
Presentation
Culture and microscopy form the mainstay of tuberculosis diagnosis
Cost and access to newer technologies limits uptake in high-burden countries
Diagnosis of latent tuberculosis infection
Tuberculin skin test (TST)
Interferon-gamma release assays
Diagnosis of active tuberculosis infections
Laboratory cultures
Sputum smear microscopy
Nucleic-acid amplification tests
Serology
Drug susceptibility tests
Solid media
Liquid media
CHAPTER 4 VACCINATION
The immune response against tuberculosis
The current vaccine against tuberculosis: Bacillus Calmette-Guerin
BCG vaccine efficacy is highly variable
The duration of protection has not been determined
BCG vaccination is most commonly practiced in high-burden countries
Mycobacterial antigens for vaccine development
Challenges associated with vaccine development
Safety
HIV infection
Late-stage clinical trials
Immunization strategies
Prime-boost vaccination strategy
Types of vaccines in development
Live mycobacterial vaccines
Subunit and DNA vaccines
Pipeline analysis
AERAS-402/Crucell Ad35 (Aeras and Crucell)
Phase II
Phase I
Datamonitor comments
MVA85A (Aeras, Emergent BioSolutions and the University of Oxford)
Phase II
Phase I
GSK-692342/AS02 (Aeras and GlaxoSmithKline)
Phase II
Ag85B and ESAT-6 (Intercell AG/Sanofi Pasteur)
Phase I
Future outlook for tuberculosis vaccines
High-risk groups in seven major markets
Supplying public and private sectors in developing countries with TB vaccines
CHAPTER 5 TREATMENT
Current market overview
Treatment regimens
First line drugs
Rifamycins
Isoniazid
Pyrazinamide
Ethambutol
Fixed dose combinations
Second-line drugs are required for resistant strains
Treating multi drug resistant organisms
Duration of treatment for MDR-TB and XDR-TB is substantially longer
Directly Observed Therapy, Short Course (DOTS) programme
Payment for drugs and services
Treatment for HIV infected patients
Antiretroviral therapy
Drug-drug interactions and toxicity
Immune reconstitution inflammatory syndrome (IRIS)/paradoxical reactions
Sequencing of treatments
Challenges associated with tuberculosis drug development
Complex pathobiology of Mycobacterium tuberculosis
Development of drug combinations
Long duration of studies
Unmet needs
Multidrug-resistant and extensively drug resistant tuberculosis
Increasing patient compliance
Tackling latent tuberculosis infection
Pipeline analysis
Fluoroquinolones
Gatifloxacin (Bristol-Myers Squibb and Kyorin Pharmaceuticals)
Moxifloxacin (Bayer and Schering Plough)
Datamonitor comments
TMC207 (Tibotec/Johnson & Johnson)
Drug overview
Clinical trials
Datamonitor comments
Nitroimidazoles
PA-824 (Chiron PathoGenesis and TB Alliance)
OPC-67683 (Otsuka Pharmaceuticals)
SQ109 (Sequella and National Institutes of Health)
Drug overview
Clinical trials
BIBLIOGRAPHY
Journal papers
Websites
Other
APPENDIX A
Contributing experts
APPENDIX B
About Datamonitor
About Datamonitor Healthcare
About the Infectious Diseases and Respiratory analysis team
List of Tables
Table 1: Prevalence of tuberculosis in the seven major markets, 2006/2007
Table 2: Numbers and rates of newly notified tuberculosis patients in Japan, 2005-07
Table 3: Number of multidrug resistant tuberculosis (MDR-TB )cases estimated in the top 10 high burden countries
Table 4: Summary of commercial Nucleic Acid Amplification Tests (NAAT) for tuberculosis
Table 5: Overview of vaccines in development for prevention and treatment of tuberculosis, 2009
Table 6: Overview of Phase II studies for GSK-692342 in tuberculosis
Table 7: Overview of drugs in development for treatment of TB
Table 8: Overview of clinical trials for gatifloxacin, 2009
Table 9: Clinical development program for moxifloxacin for the treatment of pulmonary tuberculosis
Table 10: Overview of Phase II clinical trials for TMC207, 2009
Table 11: Overview of Phase IIa study for PA-824 in tuberculosis
Table 12: Overview of Phase II studies for OPC-67683
List of Figures
Figure 1: Estimated number of new cases of tuberculosis worldwide by country, 2006
Figure 2: Number of tuberculosis cases and deaths in the US, 1993-2007
Figure 3: Number of tuberculosis cases in the five major European markets, 2002-06
Figure 4: Non-UK born tuberculosis cases by world region of birth in the UK, 2007
Figure 5: Total number and rates of newly notified cases of tuberculosis in Japan, 2005-07
Figure 6: Tuberculosis incidence among the 22 high burden countries in 2006
Figure 7: Prevalence of tuberculosis per 100,000 population by region and sex in India, 2005-06
Figure 8: Prevalence of medically treated tuberculosis in India, 2005-06
Figure 9: Multidrug resistant tuberculosis (MDR-TB) cases in the US, 1993-2007
Figure 10: Cases of primary multidrug resistant tuberculosis (MDR-TB) in Europe, 2008
Figure 11: Estimated HIV prevalence in new tuberculosis cases by country, 2006
Figure 12: Geographical distribution of estimated HIV-positive tuberculosis cases, 2006.
Figure 13: Trends in tuberculosis cases in US and foreign-born persons in the US, 1987-2007
Figure 14: Percentage of tuberculosis cases of foreign origin in Europe, 2006
Figure 15: Advantages and disadvantages of laboratory cultures for tuberculosis testing
Figure 16: Advantages and disadvantages of sputum smear microscopy in tuberculosis testing
Figure 17: Advantages and disadvantages of nucleic acid amplification tests in tuberculosis testing
Figure 18: Overview of the drugs commonly used in treatment of tuberculosis, 2007
Figure 19: Timeline of tuberculosis therapy, 1950-2010
Figure 20: Distribution of global antituberculosis therapy sales by region, 2007
Figure 21: Volume and value of antituberculosis therapies by molecule type, 2003-07
Figure 22: First- and second-line tuberculosis drug market value by country, 2007
Figure 23: Drug targets for Mycobacterium tuberculosis
Figure 24: The World Health Organization grouping of first and second-line drugs for the treatment of tuberculosis, 2008
Figure 25: Treatment strategies for multidrug-resistant tuberculosis (MDR-TB)
Figure 26: Treatment strategies for extensively drug resistant tuberculosis (XDR-TB)
Figure 27: Survival over time in the integrated versus the sequential arms in the SAPiT trial

Abstract

Introduction

Tuberculosis is a major cause of illness and death worldwide, but despite 14.4 million prevalent cases, 9.2 million new cases and 1.7 million deaths in 2006, the small and rapidly declining burden of disease in the seven major markets has limited drug and vaccine development activities until recently.

Scope
  • An overview of the epidemiological trends in the seven major markets and rest of world
  • Discussion of the diagnostic methods for latent and active infection
  • A review of current treatment regimens and antibiotic agents in development for TB
  • An assessment of vaccines in development for TB and the immunization strategies being investigated
Highlights

Drug developers and research foundations are trialling several novel vaccines and therapeutic strategies for the prevention and treatment of TB. Immunization approaches used include boosting the old BCG vaccine in order to provide better, lasting protection; new vaccines to prevent adult pulmonary TB; and immunotherapeutic vaccines.

In 2007 the global TB market was worth approximately $300 million, expanding at a modest CAGR of 2.2% from 2004-2007. Given the low incidence of TB in the seven major markets, they only accounted for around 40% of total sales; the majority of revenues (60%) was achieved in the rest of world which includes the majority of the high burden countries.

The most significant commercial opportunity exists in second line therapy, since the drugs currently used in this setting suffer from greater toxicity and less efficacy compared to first-line agents. Drugs that reduce the duration of therapy and are active against drug resistant TB have a strong chance of gaining significant commercial success.

Reasons to Purchase
  • Understand the current TB market dynamics and future commercial opportunities
  • Examine unmet needs in the TB vaccines and antibiotics market and the extent to which pipeline products are addressing these
  • Identify the key vaccines and antibiotics in development for TB and their likely positioning
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