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Stakeholder Opinions: Tuberculosis - Development pipeline shows signs of life

Healthcare

Publication Date March 2009
Publisher Datamonitor
Product Type Report
Pages 122
ISBN Number not applicable
Product Code DAT01752

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£1,320.00
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Summary

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

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