
Tuberculosis Diagnostics Test Market, Opportunity, Growth Drivers, Industry Trend Analysis and Forecast, 2025-2034
Description
The Global Tuberculosis Diagnostics Test Market was valued at USD 2.4 billion in 2024 and is estimated to grow at a CAGR of 5.6% to reach USD 4.1 billion by 2034. The growth is driven by rising TB incidence in low- and middle-income countries, increasing government screening initiatives, and the global push toward early detection and drug-resistant TB control. Tuberculosis diagnostics involve a range of tests aimed at identifying active or latent TB infections, which are crucial for timely treatment and the containment of disease spread. The growing burden of multidrug-resistant TB (MDR-TB) has intensified the need for accurate, rapid, and cost-effective diagnostic solutions across the healthcare ecosystem.
Increasing investments from global health bodies like the WHO, the Global Fund, and the Stop TB Partnership are reinforcing diagnostics infrastructure, particularly in high-burden countries. The WHO’s End TB Strategy and national TB elimination programs are further accelerating the deployment of new diagnostic tools, including molecular assays and advanced culture methods. The integration of digital tools, artificial intelligence, and telemedicine into TB diagnostics is also enhancing case detection, especially in remote or resource-limited areas.
The Tuberculosis Diagnostics Test Market is primarily segmented by test type, with molecular diagnostics leading in 2024, generating USD 880 million. Molecular diagnostics are favored for their speed and high accuracy in detecting Mycobacterium tuberculosis DNA and rifampicin resistance. Techniques such as GeneXpert MTB/RIF and Truenat are being widely adopted in both developed and developing regions due to their point-of-care suitability and WHO endorsement. Continuous innovations in nucleic acid amplification tests (NAATs), coupled with global funding support, are strengthening the role of molecular platforms in early TB diagnosis and treatment monitoring.
By modality, laboratory-based testing (non-POCT) dominated the market in 2024, accounting for USD 1.56 billion. Despite the growing availability of point-of-care solutions, centralized laboratory testing remains essential due to its broad test menu, higher throughput, and superior accuracy in complex cases. Reference laboratories and large diagnostic centers continue to rely on culture tests, microscopy, and molecular platforms for comprehensive TB diagnostics. The expansion of lab-based infrastructure, supported by public-private partnerships and global health initiatives, is expected to sustain demand for high-volume, lab-based TB screening solutions.
Among end users, pathological laboratories held the largest market share in 2024, generating USD 1.79 billion. These labs play a critical role in TB diagnosis and monitoring by offering a range of test formats, including smear microscopy, culture, and molecular testing. The increasing collaboration between public health departments and private pathology labs has enhanced testing capacity and improved case notification rates. Moreover, the accreditation and quality control frameworks adopted by pathological labs ensure standardization and reliability in test results, which is vital for managing TB at scale.
The Asia Pacific Tuberculosis Diagnostics Test Market led the global landscape in 2024 with a valuation of USD 67.3 million, driven by a high disease burden, increasing awareness, and government-led TB eradication campaigns. Countries like India, China, Indonesia, and the Philippines are aggressively expanding diagnostic outreach through national health programs, mobile testing units, and subsidized screening initiatives. Investments in laboratory infrastructure and the adoption of WHO-recommended diagnostic technologies are further boosting market growth across the region. Asia Pacific’s strong focus on drug-resistant TB surveillance and cross-border TB control cooperation is solidifying its leadership in global TB diagnostics efforts.
Major players in the tuberculosis diagnostics test market, including F. Hoffmann-La Roche Ltd., Danaher Corporation, Thermo Fisher Scientific Inc., Qiagen N.V., and Hologic Inc., are strengthening their market position through strategic partnerships, portfolio expansions, and product innovations. These companies are actively involved in developing rapid molecular diagnostic platforms, enhancing test sensitivity and affordability, and integrating digital diagnostics into TB screening programs. Strategic collaborations with governments and NGOs, along with investments in high-burden regions, are enabling these players to address the unmet need for accessible and accurate TB testing worldwide.
Increasing investments from global health bodies like the WHO, the Global Fund, and the Stop TB Partnership are reinforcing diagnostics infrastructure, particularly in high-burden countries. The WHO’s End TB Strategy and national TB elimination programs are further accelerating the deployment of new diagnostic tools, including molecular assays and advanced culture methods. The integration of digital tools, artificial intelligence, and telemedicine into TB diagnostics is also enhancing case detection, especially in remote or resource-limited areas.
The Tuberculosis Diagnostics Test Market is primarily segmented by test type, with molecular diagnostics leading in 2024, generating USD 880 million. Molecular diagnostics are favored for their speed and high accuracy in detecting Mycobacterium tuberculosis DNA and rifampicin resistance. Techniques such as GeneXpert MTB/RIF and Truenat are being widely adopted in both developed and developing regions due to their point-of-care suitability and WHO endorsement. Continuous innovations in nucleic acid amplification tests (NAATs), coupled with global funding support, are strengthening the role of molecular platforms in early TB diagnosis and treatment monitoring.
By modality, laboratory-based testing (non-POCT) dominated the market in 2024, accounting for USD 1.56 billion. Despite the growing availability of point-of-care solutions, centralized laboratory testing remains essential due to its broad test menu, higher throughput, and superior accuracy in complex cases. Reference laboratories and large diagnostic centers continue to rely on culture tests, microscopy, and molecular platforms for comprehensive TB diagnostics. The expansion of lab-based infrastructure, supported by public-private partnerships and global health initiatives, is expected to sustain demand for high-volume, lab-based TB screening solutions.
Among end users, pathological laboratories held the largest market share in 2024, generating USD 1.79 billion. These labs play a critical role in TB diagnosis and monitoring by offering a range of test formats, including smear microscopy, culture, and molecular testing. The increasing collaboration between public health departments and private pathology labs has enhanced testing capacity and improved case notification rates. Moreover, the accreditation and quality control frameworks adopted by pathological labs ensure standardization and reliability in test results, which is vital for managing TB at scale.
The Asia Pacific Tuberculosis Diagnostics Test Market led the global landscape in 2024 with a valuation of USD 67.3 million, driven by a high disease burden, increasing awareness, and government-led TB eradication campaigns. Countries like India, China, Indonesia, and the Philippines are aggressively expanding diagnostic outreach through national health programs, mobile testing units, and subsidized screening initiatives. Investments in laboratory infrastructure and the adoption of WHO-recommended diagnostic technologies are further boosting market growth across the region. Asia Pacific’s strong focus on drug-resistant TB surveillance and cross-border TB control cooperation is solidifying its leadership in global TB diagnostics efforts.
Major players in the tuberculosis diagnostics test market, including F. Hoffmann-La Roche Ltd., Danaher Corporation, Thermo Fisher Scientific Inc., Qiagen N.V., and Hologic Inc., are strengthening their market position through strategic partnerships, portfolio expansions, and product innovations. These companies are actively involved in developing rapid molecular diagnostic platforms, enhancing test sensitivity and affordability, and integrating digital diagnostics into TB screening programs. Strategic collaborations with governments and NGOs, along with investments in high-burden regions, are enabling these players to address the unmet need for accessible and accurate TB testing worldwide.
Table of Contents
162 Pages
- Chapter 1 Methodology
- 1.1 Market segmentation
- 1.2 Market definitions
- 1.3 Research design
- 1.4 Market size estimates and calculations
- 1.4.1 Approach 1: Company share analysis
- 1.4.2 Approach 2: Secondary-based approach
- 1.4.3 Approach 3: Parent market analysis
- 1.4.4 Approach 4: Prevalence based approach
- 1.5 Key trends for market estimates
- 1.6 Forecast model
- 1.7 Primary research & validation
- 1.7.1 Primary sources
- 1.7.2 Data mining sources
- 1.7.2.1 Paid sources
- 1.7.2.2 Public sources
- Chapter 2 Executive Summary
- 2.1 Industry 360° synopsis, 2021 - 2034
- 2.2 Test type trends
- 2.3 Modality trends
- 2.4 End use trends
- 2.5 Regional trends
- Chapter 3 Tuberculosis Diagnostics Test Market Industry Insights
- 3.1 Industry ecosystem analysis
- 3.2 Industry impact forces
- 3.2.1 Growth drivers
- 3.2.1.1 Rising burden of tuberculosis globally`
- 3.2.1.2 Advancement in tuberculosis diagnostics techniques
- 3.2.1.3 Increasing awareness and screening programs regarding tuberculosis
- 3.2.1.4 Surge in point-of-care testing (POCT)
- 3.2.2 Industry pitfalls and challenges
- 3.2.2.1 Limited sensitivity and specificity
- 3.2.2.2 Stringent regulatory scenario
- 3.3 Growth potential analysis
- 3.3.1 By test type
- 3.3.3 By end use
- 3.4 Technological landscape
- 3.5 Regulatory landscape
- 3.5.1 U.S.
- 3.5.2 Europe
- 3.6 Trump administration tariff analysis
- 3.6.1 Impact on trade
- 3.6.1.1 Trade volume disruptions
- 3.6.1.2 Country-wise response
- 3.6.2 Industry impact
- 3.6.2.1 Supply-side impact (Cost of manufacturing)
- 3.6.2.1.1 Price volatility in key materials
- 3.6.2.1.2 Supply chain restructuring
- 3.6.2.1.3 Production cost implications
- 3.6.2.2 Demand-side impact (Cost to Consumers)
- 3.6.2.2.1 Price transmission to end markets
- 3.6.2.2.2 Market share dynamics
- 3.6.2.2.3 Consumer response patterns
- 3.6.3 Strategic industry responses
- 3.6.3.1 Supply chain reconfiguration
- 3.6.3.2 Pricing and product strategies
- 3.6.3.3 Policy engagement
- 3.6.4 Outlook and future considerations
- 3.7 Future market trends
- 3.8 Comparative analysis of PPD vs IGRAs
- 3.9 Pricing analysis, 2024
- 3.10 Porter's analysis
- 3.11 PESTEL analysis
- Chapter 4 Competitive Landscape, 2024
- 4.1 Introduction
- 4.1.1 Abbott Laboratories
- 4.1.2 Becton, Dickinson and Company
- 4.1.3 Danaher Corporation (Cepheid)
- 4.1.4 F. Hoffmann-La Roche Ltd.
- 4.2 Company market share analysis
- 4.3 Competitive analysis of major market players
- 4.4 Competitive positioning matrix
- 4.5 Strategic outlook matrix
- Chapter 5 Tuberculosis Diagnostics Test Market, By Test Type
- 5.1 Radiographic method
- 5.2 Diagnostic laboratory methods
- 5.2.1 Microscopy
- 5.2.2 Culture-based techniques
- 5.2.3 Serological tests
- 5.3 Molecular diagnostics
- 5.3.1 Polymerase chain reaction (PCR)
- 5.3.2 Nucleic acid amplification tests (NAAT)
- 5.3.3 GeneXpert MTB/RIF
- 5.4 Detection of latent infection
- 5.4.1 Tuberculin skin test (TST)/ Purified protein derivative (PPD)
- 5.4.1.1 First-generation PPD-based TSTs
- 5.4.1.2 New-generation skin tests with recombinant antigens
- 5.4.2 Interferon-gamma release assays (IGRAs)
- 5.4.2.1 ELISA-based IGRAs
- 5.4.2.2 ELISPOT-based IGRAs
- 5.4.2.3 Point-of-care IGRAs
- 5.5 Cytokine detection assays
- 5.6 Detection of drug resistance (DST)
- 5.7 Phage assay
- 5.8 Other test types
- Chapter 6 Tuberculosis Diagnostics Test Market, By Modality
- 6.1 Point of care testing (POCT)
- 6.2 Laboratory-based testing (Non-POCT)
- Chapter 7 Tuberculosis Diagnostics Test Market, By End Use
- 7.1 Pathological laboratories
- 7.2 Other end users
- Chapter 8 Tuberculosis Diagnostics Test Market, By Region
- 8.1 Asia Pacific
- 8.2 North America
- 8.3 Europe
- 8.4 Latin America
- 8.5 Middle East and Africa
- Chapter 9 Company Profile
- 9.1 Abbott Laboratories
- 9.1.1 Financial data
- 9.1.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.1.2 Product landscape
- 9.1.3 SWOT analysis
- 9.2 Anhui Zhifei Longcom Biopharmaceutical Co., Ltd
- 9.2.1 Financial data
- 9.2.1.1 Sales revenue, 2020-2023 (USD Million)
- 9.2.2 Product landscape
- 9.2.3 Strategic outlook
- 9.2.4 SWOT analysis
- 9.3 Becton, Dickinson and Company
- 9.3.1 Financial data
- 9.3.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.3.2 Product landscape
- 9.3.3 Strategic outlook
- 9.3.4 SWOT analysis
- 9.4 bioMerieux SA
- 9.4.1 Financial data
- 9.4.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.4.2 Product landscape
- 9.4.3 Strategic outlook
- 9.4.4 SWOT analysis
- 9.5 Danaher Corporation (Cepheid)
- 9.5.1 Financial data
- 9.5.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.5.2 Product landscape
- 9.5.3 Strategic outlook
- 9.5.4 SWOT analysis
- 9.6 F. Hoffmann-La Roche Ltd.
- 9.6.1 Financial data
- 9.6.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.6.2 Product landscape
- 9.6.3 Strategic outlook
- 9.6.4 SWOT analysis
- 9.7 Generium Pharmaceuticals
- 9.7.1 Financial data
- 9.7.2 Product landscape
- 9.7.3 SWOT analysis
- 9.8 Hain Lifescience GmbH
- 9.8.1 Financial data
- 9.8.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.8.2 Product landscape
- 9.8.3 Strategic outlook
- 9.8.4 SWOT analysis
- 9.9 Hologic, Inc.
- 9.9.1 Financial data
- 9.9.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.9.2 Product landscape
- 9.9.3 SWOT analysis
- 9.10 Japan BCG Laboratory
- 9.10.1 Financial data
- 9.10.2 Product landscape
- 9.10.3 SWOT analysis
- 9.11 NIPRO
- 9.11.1 Financial data
- 9.11.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.11.2 Product landscape
- 9.11.3 SWOT analysis
- 9.12 Oxford Immunotec
- 9.12.1 Financial data
- 9.12.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.12.2 Product landscape
- 9.12.3 Strategic outlook
- 9.12.4 SWOT analysis
- 9.13 QIAGEN N.V.
- 9.13.1 Financial data
- 9.13.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.13.2 Product landscape
- 9.13.3 Strategic outlook
- 9.13.4 SWOT analysis
- 9.14 Sanofi
- 9.14.1 Financial data
- 9.14.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.14.2 Product landscape
- 9.14.3 SWOT analysis
- 9.15 Siemens Healthineers AG
- 9.15.1 Financial data
- 9.15.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.15.2 Product landscape
- 9.15.3 Strategic outlook
- 9.15.4 SWOT analysis
- 9.16 Thermo Fisher Scientific, Inc.
- 9.16.1 Financial data
- 9.16.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.16.2 Product landscape
- 9.16.3 Strategic outlook
- 9.16.4 SWOT analysis
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