Description
Globally, India has the second highest TB burden as per WHO ranking. The country is witnessing a growing demand for advanced tests for early TB diagnosis. This is driving the TB diagnostics market in India and is also creating new opportunities for diagnostic companies with effective platforms. Drug resistance is a particular concern in TB and the demand is high for diagnostic tools that can quickly and accurately diagnose drug resistant TB.
India is witnessing an increase in the uptake of advanced TB diagnostic products. In spite of being a price sensitive market, several expensive diagnostic tests have achieved significant market penetration in India lately. Creative business strategies are being designed and implemented by market players. This is creating an environment where industry players are encouraged to invest in the development of TB diagnostics. This is an important market trend considering the fact that TB had not been one of the major infectious diseases to attract industrial investments.
This price analysis and market intelligence report studies the opportunities offered by India’s TB diagnostics markets. Emerging trends in TB diagnosis, impact of regulations, influence of various initiatives, end-user preferences, and pricing trends of key diagnostic products are studied in detail. The insights derived are presented in clear and lucid manner.
This report offers detailed analysis of the price trends and the factors impacting the pricing of these tools. A particular emphasis is given for PCR-based diagnostic products as these are gaining considerable market shares in this segment. Overall, this report contains:
- An overview of TB diagnostic technologies and trends in India and worldwide
- An overview of various initiatives that are impacting the TB diagnostic practices in India
- An overview of the diagnostic products available in India and their manufacturers
- Detailed product profiles of some of the promising diagnostic products
- An in depth analysis of the diagnostic practices of private and public sector healthcare service providers
- Price trend analysis based on primary research involving around 25 healthcare service providers. The respondents of our survey covered the industry segment from various aspects including public and private healthcare service providers, different geographic locations, urban as well as rural clinics, and big hospitals as well as small diagnostic labs
- Company profiles of most prominent companies in Indian TB diagnostics segment
INTRODUCTION
STUDY GOAL AND OBJECTIVES
RATIONALE FOR THIS STUDY
TARGETED AUDIENCE
MARKET DEFINITION AND SCOPE
INFORMATION SOURCES AND METHODOLOGIES
CUSTOMIZATION OF THIS STUDY
DISCLAIMER
EXECUTIVE SUMMARY
SUMMARY FIGURE: PRICE OF PCR-BASED TESTS IN INDIA – GENEXPERT VS NON-GENEXPERT TESTS *OVERVIEW
TUBERCULOSIS IN INDIA – INCIDENCE AND PREVALENCE
Figure 1: TB Incidence and Prevalence in India, 2010-2013REGION-WISE TB STATISTICS
Figure 2: TB Incidence in India, Region-Wise aKEY GLOBAL INITIATIVES/PROGRAMS FOR TB CONTROL
Table 1: Key Programs Targeting Effective TB Control: India and GlobalKEY TB CONTROL INITIATIVES/PROGRAMS IN INDIA
A. Revised National Tuberculosis Control Program (RNTCP)
B. Initiative for Promoting Affordable, Quality TB tests (IPAQT)
Table 2: WHO-Endorsed TB Diagnostic Tests and Their “Ceiling Prices” under the IPAQT Program
C. Mumbai Mission for TB Control
D. National Stop TB Partnership – Partnership for TB Care and Control (PTCC)
Table 3: The Growth of PTCC from Conceptual Stage to Current Status
E. Project LIGHT
F. Improved Diagnosis of TB and Drug Resistant TB in the Tibetan Refugee Population in India
Table 4: TB Control and Diagnosis in India: Milestone DevelopmentsCLINICAL DIAGNOSIS OF TB: CURRENT STATUS – INDIA AND GLOBAL
Table 5: Diagnostic Tests for Latent and Active TB
Molecular approaches for TB diagnosis
Table 7: Key TB Diagnostics Products in the Market and their Manufacturers*
Table 8: Desirable Characteristics of POC TB Diagnostic Products
Table 9: Tests under Development for TB Diagnosis*PRODUCT PROFILES
TB DIAGNOSTICS DEVELOPED IN COLLABORATION WITH FIND
A. Xpert MTB/RIF
Table 10: Cumulative Number of GeneXpert Instrument Modules and Xpert MTB/RIF Test Cartridges Procured under Concessional Pricing per Year, Globally
B. Genotype MTBDRplus
Figure 3: Annual Manufacturing Capacity and Prices of Genotype MTBDRplus Test
C. BACTEC MGIT SystemsPCR FOR TB DIAGNOSIS: ANALYSIS OF PRICING TRENDS
SELECTION OF STUDY PARTICIPANTS/METHODOLOGY
Table 11: Details of the Laboratories Selected for the StudyPRICES AT WHICH VARIOUS PCR-BASED TB DIAGNOSTIC TESTS ARE OFFERED IN INDIA
IMPACT OF IPAQT INITIATIVE IN IMPROVING AFFORDABILITY OF TB DIAGNOSTICS
Table 12: Price Range of PCR-based Tests – GeneXpert vs Non-GeneXpert tests (USD; Per Test) a
Figure 4: Price of PCR-based Tests in India – GeneXpert vs Non-GeneXpert Tests
Table 13: Number of PCR-Based TB Tests Conducted per Month
Table 14: List of IPAQT Member Laboratories in India a
Figure 5: Number of IPAQT Member Laboratories in Each Region in IndiaCOMPANY PROFILES
COMPANIES OFFERING COMMERCIALIZED PRODUCTS FOR TB DIAGNOSIS
Merck Specialities Private Limited-Genei
(Previously known as Bangalore Genei (India) Private Limited)
bigtec Labs Pvt. Ltd.
Cepheid, Inc.
Table 15: Clinical and Non-Clinical Revenue Shares, 2014
Figure 6: Cepheid Revenue Shares, by Region, 2014
Hain Lifescience GmbH
Table 16: TB diagnostic Products Offered by Hain Lifescience
Professional Biotech Pvt. Ltd./ Genome Diagnostics Pvt. Ltd.
Molbio Diagnostics Pvt. Ltd (A Tulip Group Company)REFERENCES
GLOSSARY
List of Tables
Table 1: Key Programs Targeting Effective TB Control: India and Global
Table 2: WHO-Endorsed TB Diagnostic Tests and Their “Ceiling Prices” under the IPAQT Program
Table 3: The Growth of PTCC from Conceptual Stage to Current Status
Table 4: TB Control and Diagnosis in India: Milestone Developments
Table 5: Diagnostic Tests for Latent and Active TB
Table 6: Advantages and Disadvantages of Selected TB Diagnostics
Table 7: Key TB Diagnostics Products in the Market and their Manufacturers*
Table 8: Desirable Characteristics of POC TB Diagnostic Products
Table 9: Tests under Development for TB Diagnosis*
Table 10: Cumulative Number of GeneXpert Instrument Modules and Xpert MTB/RIF Test Cartridges Procured under Concessional Pricing per Year, Globally
Table 11: Details of the Laboratories Selected for the Study
Table 12: Price Range of PCR-based Tests – GeneXpert vs Non-GeneXpert tests (USD; Per Test) a
Table 13: Number of PCR-Based TB Tests Conducted per Month
Table 14: List of IPAQT Member Laboratories in India a
Table 15: Clinical and Non-Clinical Revenue Shares, 2014
Table 16: TB diagnostic Products Offered by Hain LifescienceList of Figures
Figure 1: TB Incidence and Prevalence in India, 2010-2013
Figure 2: TB Incidence in India, Region-Wise a
Figure 3: Annual Manufacturing Capacity and Prices of Genotype MTBDRplus Test
Figure 4: Price of PCR-based Tests in India – GeneXpert vs Non-GeneXpert Tests
Figure 5: Number of IPAQT Member Laboratories in Each Region in India
Figure 6: Cepheid Revenue Shares, by Region, 2014Companies offering commercialized products for TB diagnosis
- Merck Specialities Private Limited-Genei (Previously known as Bangalore Genei (India) Private Limited)
- bigtec Labs Pvt. Ltd.
- Cepheid, Inc.
- Hain Lifescience GmbH
- Professional Biotech Pvt. Ltd./ Genome Diagnostics Pvt. Ltd
- Molbio Diagnostics Pvt. Ltd (A Tulip Group Company)
