잠복 결핵 감염 진단 시장 : 점유율 분석, 업계 동향 및 통계, 성장 예측(2025-2030년)

According to Mordor Intelligence, the latent tuberculosis infection detection market size stands at USD 1.91 billion in 2025 and is forecast to reach USD 2.53 billion by 2030, reflecting a 5.74% CAGR over the period.

This report is Segmented by Test Method (Tuberculin Skin Test, Interferon-Gamma Release Assays, Other Emerging Tests), Sample Type (Blood, Other), Technology Platform (ELISA-Based IGRA, Chemiluminescence Immunoassay, Fluorescence Immunoassay, and More), End-User (Hospitals, and More), and Geography. The Market Forecasts are Provided in Terms of Value (USD).

Global Latent Tuberculosis Infection Detection Market Trends and Insights

Government-funded LTBI screening mandates

National and state agencies now require routine latent tuberculosis testing for healthcare workers, immunocompromised patients, and immigrants from high-burden regions. The 2024 CDC preventive-service update removed out-of-pocket costs for these tests under the Affordable Care Act, catalyzing stable demand. U.S. states such as Colorado and Rhode Island enforce annual screening rules, and California has rolled out statewide TB risk-assessment tools for hospitals. Comparable policies across the European Union provide a compliance-driven backbone, anchoring consistent test volumes that buffer the latent tuberculosis infection detection market from economic cycles. IGRAs benefit most, given their single-visit workflow and accuracy in BCG-vaccinated cohorts.

Expansion of migrant & refugee health programs

Continued geopolitical instability has heightened TB vigilance among asylum seekers. WHO guidance published in November 2024 recommends structured screening on arrival, prompting adoption of dual active-TB and latent-TB algorithms in Europe, Canada, and Australia. ECDC data show Ukrainian refugees screened in 2023 presented TB notification rates of 16.9 per 100,000, more than double host-country averages. South Korea's pilot IGRA program in immigrants revealed latent infection incidence of 312.5 per 100,000 person-years among untreated IGRA-positive participants, reinforcing the importance of early detection. These findings are accelerating funding for portable IGRA analyzers at border clinics, contributing to latent tuberculosis infection detection market expansion.

Supply shortages of purified protein derivative antigens

Manufacturing bottlenecks periodically constrain tuberculin skin-test availability. Because many LMIC screening programs rely on skin tests for cost reasons, stockouts disrupt surveillance schedules, widen testing backlogs, and erode confidence in routine programs. While shortages often push stakeholders to evaluate IGRA alternatives, transition requires capital investment, creating interim gaps that temper latent tuberculosis infection detection market momentum.

Other drivers and restraints analyzed in the detailed report include:

1. Rising uptake of IGRAs in low-incidence countries
2. Bundled reimbursement for LTBI diagnostics
3. High per-test IGRA cost in LMICs

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

In 2024 the tuberculin skin test retained 54.38% share of the latent tuberculosis infection detection market size, while IGRAs recorded a 9.46% CAGR that will steadily erode the dominance of skin testing. Cost-sensitive public programs continue purchasing skin-test kits, yet operational drawbacks-two-visit workflow and subjective reading-dampen their long-term utility. Developed nations, employer health plans, and immunology clinics increasingly select IGRAs for single-visit accuracy. The WHO 2024 diagnostic pathway places molecular rapid diagnostics at the head of the algorithm, a policy that indirectly favors IGRA confirmation after abnormal radiography.

The latent tuberculosis infection detection market now sees novel biomarker assays entering early commercial pilots. Recombinant antigen cocktails and host-RNA signatures seek to distinguish latent from active infection, a feature that could shorten clinical work-ups. Academic consortia testing T-cell metabolism panels report promising sensitivity, but regulatory approval timelines place widespread rollout beyond 2030.

Blood draws accounted for 62.57% of the latent tuberculosis infection detection market share in 2024, and this format leads growth at 8.52% CAGR to 2030. Venous sampling supports automated IGRA workflows, allows simultaneous chemistry panels, and minimizes inter-reader variability. Rapid plasma separation and microfluidic cartridges now let health posts process samples on site, widening rural reach.

Skin-based tests linger in pediatric and field campaigns where phlebotomy is impractical. Researchers explore saliva and stool matrices to improve diagnosis in HIV-positive and very young cohorts. While early results are encouraging, validation cohorts remain small, keeping these alternatives a niche within the latent tuberculosis infection detection market.

Complete Report Scope:

• By Test Method
  • Tuberculin Skin Test (TST)
  • Interferon-Gamma Release Assays (IGRA)
  • Other Emerging Tests
• By Sample Type
  • Blood
  • Other (e.g., skin)
• By Technology Platform
  • ELISA-based IGRA
  • Chemiluminescence Immunoassay (CLIA)
  • Fluorescence Immunoassay (FIA)
  • Lateral Flow / Point-of-Care Assay
  • Molecular Diagnostics (PCR/NGS)
• By End-user
  • Hospitals
  • Diagnostic Laboratories
  • Public Health Agencies
  • Others
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America controlled 32.49% of latent tuberculosis infection detection market size in 2024, anchored by federal coverage mandates and OSHA compliance testing for healthcare workers. Private insurers uniformly reimburse IGRAs, driving a steady migration from tuberculin skin tests. Canada's immigration physicals incorporate IGRA screening, further solidifying demand.

Asia-Pacific is forecast to expand at 7.52% CAGR through 2030 as India, China, and Indonesia invest in national TB elimination programs that integrate latent infection screening. South Korea's immigrant IGRA pilot confirmed high reactivation risk, nudging regional policymakers toward widespread use of blood-based assays. Deployment of AI-enabled X-ray triage in rural clinics creates fresh referral flows, boosting latent tuberculosis infection detection market test volumes.

Europe maintains substantial share through structured migrant and refugee health checks. Systematic screening of Ukrainian arrivals recorded 1,247 TB cases in 2023, with latent infection detection rates of 16.9 per 100,000 among screened cohorts. Multi-country reimbursement alignment underlines stable procurement of IGRAs, sustaining marketplace resilience. The Middle East, Africa, and South America present long-term upside as economic growth funds laboratory upgrades, although budget constraints and intermittent reagent supply temper near-term latent tuberculosis infection detection market acceleration.

1. QIAGEN
2. Revvity
3. Abbott Laboratories
4. Thermo Fisher Scientific
5. Danaher
6. Bio-Rad Laboratories
7. Hologic
8. SD Biosensor Inc.
9. Beijing Wantai Biological Pharmacy
10. Creative Diagnostics
11. Lionex GmbH
12. Serum Institute of India Pvt Ltd
13. ZeptoMetrix Corp.
14. R-Biopharm
15. GenoScreen SAS
16. Alpha Laboratories Ltd
17. Ansh Labs
18. Arkray
19. Tulip Diagnostics
20. Diasorin SpA

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Government-Funded LTBI Screening Mandates
  • 4.2.2 Expansion Of Migrant & Refugee Health Programs
  • 4.2.3 Rising Uptake Of Igras In Low-Incidence Countries
  • 4.2.4 Bundled Reimbursement For TB/Latent TB Diagnostics
  • 4.2.5 AI-Assisted Triage Tools Boosting Test Demand
  • 4.2.6 Targeted LTBI Control In Immunocompromised Populations
• 4.3 Market Restraints
  • 4.3.1 Supply Shortages Of Purified Protein Derivative (PPD) Antigens
  • 4.3.2 High Per-Test Cost Of IGRAS in LMICs
  • 4.3.3 False-Positive Rates Among BCG-Vaccinated Cohorts
  • 4.3.4 Limited Lab Capacity For High-Throughput ELISA IGRA Analysis
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technology Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size and Growth Forecasts (Value-USD)

• 5.1 By Test Method
  • 5.1.1 Tuberculin Skin Test (TST)
  • 5.1.2 Interferon-Gamma Release Assays (IGRA)
  • 5.1.3 Other Emerging Tests
• 5.2 By Sample Type
  • 5.2.1 Blood
  • 5.2.2 Other (e.g., skin)
• 5.3 By Technology Platform
  • 5.3.1 ELISA-based IGRA
  • 5.3.2 Chemiluminescence Immunoassay (CLIA)
  • 5.3.3 Fluorescence Immunoassay (FIA)
  • 5.3.4 Lateral Flow / Point-of-Care Assay
  • 5.3.5 Molecular Diagnostics (PCR/NGS)
• 5.4 By End-user
  • 5.4.1 Hospitals
  • 5.4.2 Diagnostic Laboratories
  • 5.4.3 Public Health Agencies
  • 5.4.4 Others
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products and Services, and Recent Developments)
  • 6.3.1 QIAGEN N.V.
  • 6.3.2 Revvity
  • 6.3.3 Abbott Laboratories
  • 6.3.4 Thermo Fisher Scientific Inc.
  • 6.3.5 Danaher Corp
  • 6.3.6 Bio-Rad Laboratories Inc.
  • 6.3.7 Hologic Inc.
  • 6.3.8 SD Biosensor Inc.
  • 6.3.9 Beijing Wantai Biological Pharmacy
  • 6.3.10 Creative Diagnostics
  • 6.3.11 Lionex GmbH
  • 6.3.12 Serum Institute of India Pvt Ltd
  • 6.3.13 ZeptoMetrix Corp.
  • 6.3.14 R-Biopharm AG
  • 6.3.15 GenoScreen SAS
  • 6.3.16 Alpha Laboratories Ltd
  • 6.3.17 Ansh Labs
  • 6.3.18 ARKRAY Inc.
  • 6.3.19 Tulip Diagnostics (P) Ltd
  • 6.3.20 Diasorin SpA

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment