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시장보고서
Stakeholder Opinions: Tuberculosis - Development pipeline shows signs of life
| 리서치사 |
Datamonitor |
| 발행일 |
2009년 03월 |
상품코드 |
83797 |
| 페이지 정보 |
128 pages |
| 가격 |
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Abstract
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 of this research
- 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
Research and analysis 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.
Key reasons to purchase this research
- 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
Table of Contents
EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the Tuberculosis market
- Contributing experts
- Related reports
- Upcoming related reports
DISEASE BACKGROUND
- Disease definition
- Etiology and symptomatology
- Pathogenesis
- Management of tuberculosis
- Vaccination
- Combination therapy is used to treat tuberculosis
- 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
- 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
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
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
- Types of vaccines in development
- Pipeline analysis
- AERAS-402/Crucell Ad35 (Aeras and Crucell)
- MVA85A (Aeras, Emergent BioSolutions and the University of Oxford)
- GSK-692342/AS02 (Aeras and GlaxoSmithKline)
- Ag85B and ESAT-6 (Intercell AG/Sanofi Pasteur)
- Future outlook for tuberculosis vaccines
- High-risk groups in seven major markets
- Supplying public and private sectors in developing countries with TB
vaccines
TREATMENT
- Current market overview
- Treatment regimens
- First line drugs
- Fixed dose combinations
- Second-line drugs are required for resistant strains
- 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
- TMC207 (Tibotec/Johnson & Johnson)
- Nitroimidazoles
- SQ109 (Sequella and National Institutes of Health)
BIBLIOGRAPHY
- Journal papers
- Websites
- Other
APPENDIX A
APPENDIX B
TABLES
- Table: Prevalence of tuberculosis in the seven major markets, 2006/2007
- Table: Numbers and rates of newly notified tuberculosis patients in Japan,
2005- 07
- Table: Number of multidrug resistant tuberculosis (MDR-TB )cases estimated
in the top 10 high burden countries
- Table: Summary of commercial Nucleic Acid Amplification Tests (NAAT) for
tuberculosis
- Table: Overview of vaccines in development for prevention and treatment of
tuberculosis, 2009
- Table: Overview of Phase II studies for GSK-692342 in tuberculosis
- Table: Overview of drugs in development for treatment of TB
- Table: Overview of clinical trials for gatifloxacin, 2009
- Table: Clinical development program for moxifloxacin for the treatment of
pulmonary tuberculosis
- Table: Overview of Phase II clinical trials for TMC207, 2009
- Table: Overview of Phase IIa study for PA-824 in tuberculosis
- Table: Overview of Phase II studies for OPC-67683
FIGURES
- Figure: Estimated number of new cases of tuberculosis worldwide by
country, 2006
- Figure: Number of tuberculosis cases and deaths in the US, 1993- 2007
- Figure: Number of tuberculosis cases in the five major European markets,
2002- 06
- Figure: Non-UK born tuberculosis cases by world region of birth in the UK,
2007
- Figure: Total number and rates of newly notified cases of tuberculosis in
Japan, 2005- 07
- Figure: Tuberculosis incidence among the 22 high burden countries in 2006
- Figure: Prevalence of tuberculosis per 100,000 population by region and
sex in India, 2005- 06
- Figure: Prevalence of medically treated tuberculosis in India, 2005- 06
- Figure: Multidrug resistant tuberculosis (MDR-TB) cases in the US, 1993-
2007
- Figure: Cases of primary multidrug resistant tuberculosis (MDR-TB) in
Europe, 2008
- Figure: Estimated HIV prevalence in new tuberculosis cases by country, 2006
- Figure: Geographical distribution of estimated HIV-positive tuberculosis
cases, 2006.
- Figure: Trends in tuberculosis cases in US and foreign-born persons in the
US, 1987- 2007
- Figure: Percentage of tuberculosis cases of foreign origin in Europe, 2006
- Figure: Advantages and disadvantages of laboratory cultures for
tuberculosis testing
- Figure: Advantages and disadvantages of sputum smear microscopy in
tuberculosis testing
- Figure: Advantages and disadvantages of nucleic acid amplification tests
in tuberculosis testing
- Figure: Overview of the drugs commonly used in treatment of tuberculosis,
2007
- Figure: Timeline of tuberculosis therapy, 1950- 2010
- Figure: Distribution of global antituberculosis therapy sales by region,
2007
- Figure: Volume and value of antituberculosis therapies by molecule type,
2003- 07
- Figure: First- and second-line tuberculosis drug market value by country,
2007
- Figure: Drug targets for Mycobacterium tuberculosis
- Figure: The World Health Organization grouping of first and second-line
drugs for the treatment of tuberculosis, 2008
- Figure: Treatment strategies for multidrug-resistant tuberculosis (MDR-TB)
- Figure: Treatment strategies for extensively drug resistant tuberculosis
(XDR-TB)
- Figure: Survival over time in the integrated versus the sequential arms in
the SAPiT trial
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