갑상선 기능 검사 시장 : 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The thyroid function testing market size is valued at USD 1.89 billion in 2025 and is projected to reach USD 2.47 billion by 2030, posting a CAGR of 5.53% during the forecast period.

Rising global thyroid disease prevalence, an expanding elderly population, and the spread of newborn screening programs anchor this growth. Technology integration-especially high-sensitivity third-generation immunoassays, emerging mass-spectrometry methods, and AI-guided reflex-testing algorithms-elevates diagnostic accuracy while easing the workload created by endocrinologist shortages that affect 70% of US counties. Regulatory changes such as the US FDA's 2024 framework for laboratory-developed tests introduce higher compliance costs yet promise greater standardization. Price transparency laws and bundled-contract negotiations are shifting volumes toward lower-cost independent laboratories, intensifying competition but expanding patient access.

Global Thyroid Function Test Market Trends and Insights

Rising Burden of Thyroid Disorders

Hypothyroidism prevalence reaches 11% in India versus 2-4.6% in Western nations, underscoring geographic differences in iodine sufficiency, genetics, and environmental exposures. Subclinical hyperthyroidism affects 4.4% of US adolescents, highlighting an undiagnosed cohort that fuels screening programs. Growing autoimmune thyroid disease awareness expands demand for antibody panels alongside traditional hormone measures. Earlier detection reduces downstream cardiovascular and cognitive complications, giving payers economic incentives to broaden screening coverage. Collectively these forces underpin steady expansion of the thyroid function testing market.

Aging Population Raises Routine Screening Volumes

Population aging, especially among women older than 60, correlates with higher hypo- and hyperthyroidism rates. A projected US physician shortfall of up to 86,000 by 2036, with endocrinology among the hardest-hit specialties, is accelerating adoption of automated platforms and primary-care-based testing pathways. Insurer reimbursement for preventive screening pushes thyroid panels into routine checkups, transforming test ordering from reactive to proactive. Digitally enabled population-health initiatives further scale testing volumes, reinforcing long-term growth in the thyroid function testing market.

Complex Interpretation & Biotin Interference Issues

High-dose biotin supplements distort immunoassay results in up to 10% of tested patients, forcing laboratories to impose 7-day cessation windows that delay diagnosis. Interference varies by platform, complicating harmonization across hospital networks. Additionally, hormone-binding protein shifts in pregnancy and critical illness demand nuanced interpretation, prompting some primary-care clinicians to limit ordering, which tempers near-term gains for the thyroid function testing market.

Other drivers and restraints analyzed in the detailed report include:

1. High-Sensitivity 3rd-Gen Immunoassays Improve Clinical Utility
2. Government-Funded Newborn & Population Screening Programs
3. Shortage Of Endocrinologists Slows Diagnosis & Follow-Up

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

Segment Analysis

The TSH assay held a 42.86% slice of the thyroid function testing market in 2024, reflecting guideline preference for a sensitive first-line screen. Anti-TPO and Anti-TG antibody assays, while smaller in absolute volume, are expanding at 7.56% CAGR as autoimmune thyroiditis recognition accelerates. Turbo TSI bioassays cut turnaround time from days to hours, and point-of-care antibody kits deliver actionable results inside 10 minutes. Emerging mass-spectrometry panels gain favor in complex cases, promising higher specificity and lower interference, thereby broadening the thyroid function testing market.

Free/total T4 assays remain indispensable for dose titration and differential diagnosis, whereas free/total T3 holds a niche role given low prevalence of isolated T3 toxicosis. Specialized markers-thyroglobulin for differentiated thyroid cancer follow-up and calcitonin for medullary carcinoma-provide incremental revenues but do not materially shift overall thyroid function testing market size. AI-based pattern-recognition tools now help clinicians interpret multi-analyte profiles, reducing diagnostic ambiguity and encouraging wider antibody-panel adoption.

Immunoassays controlled 60.23% of 2024 revenues, leveraging automated chemiluminescent and ELISA platforms that process thousands of samples per shift. Growth continues but moderates as decentralized care models fuel an 8.86% CAGR for point-of-care formats. Lateral-flow strips using gold nanoshells cut TSH detection thresholds to 0.16 µIU/mL, matching lab-grade sensitivity. Digital immunoassays provide cloud-connected results for remote monitoring, widening the thyroid function testing market.

Mass spectrometry adoption rises within reference labs seeking unparalleled specificity, especially for free hormones where protein binding skews immunoassays. Fluorescence polarization and electrochemiluminescence remain specialty tools in research. COVID-19 heightened appreciation for rapid, minimally attended diagnostics, a behavioral shift sustaining post-pandemic uptake of portable devices and reshaping investment priorities across the thyroid function testing industry.

The Thyroid Function Test Market Report is Segmented by Test (TSH Test, Free/Total T4 Test, Free/Total T3 Test, and More), Technique (Immunoassay, Rapid Point-Of-Care Tests, and More), Sample Type (Serum/Plasma, and More), End User (Hospital, Diagnostic Laboratory, Other End Users, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America retained the largest regional share at 34.89% in 2024, propelled by broad insurance coverage, high disease awareness, and sophisticated lab infrastructure. Endocrinologist shortages in 70% of US counties, however, risk pockets of under-service, prompting wider deployment of AI triage tools and tele-endocrinology consults. Price-benchmarking regulations spur health systems to reroute non-urgent panels to independent labs, altering channel mix but sustaining overall thyroid function testing market growth.

Asia-Pacific is the fastest-growing arena at 6.89% CAGR. India's 11% hypothyroidism prevalence signals a substantial screening opportunity [ijmedicine.com]. China's rising thyroid cancer incidence and large population base fuel volume, while Japan's rapidly aging society drives routine monitoring. Government-backed newborn screening expansions in Thailand and elsewhere demonstrate near-universal coverage feasibility, unlocking predictable volumes and elevating regional thyroid function testing market size. Regulatory heterogeneity and reimbursement gaps remain challenges, yet digital health investments and public-private lab partnerships offset barriers.

Europe shows steady but slower expansion, anchored by universal health systems and stringent clinical guidelines. Budget constraints encourage centralized procurement and bundled contracts, favoring cost-efficient suppliers. Regulatory realignment post-Brexit adds complexity, yet established quality standards sustain clinician confidence. Middle East & Africa and South America emerge as longer-term growth pockets as healthcare infrastructure matures. Mobile testing units and telehealth platforms help overcome geographic obstacles, extending reach of the thyroid function testing market into underserved locales.

1. Abbott Laboratories
2. Zhengzhou Autobio Co., Ltd.
3. bioMerieux
4. Danaher
5. DiaSorin
6. Roche
7. Qualigen, Inc.
8. QuidelOrtho
9. Siemens Healthineers
10. Thermo Fisher Scientific
11. Werfen
12. Boditech Med
13. Ortho Clinical Diagnostics
14. Mindray Bio-Medical Electronics
15. Randox Laboratories
16. Tosoh
17. Diazyme Laboratories
18. Sysmex
19. PerkinElmer
20. IBL-America
21. Sekisui Diagnostics
22. Euroimmun

Additional Benefits:

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

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & 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 Rising Burden of Thyroid Disorders
  • 4.2.2 Aging Population Raises Routine Screening Volumes
  • 4.2.3 High-Sensitivity 3rd-Gen Immunoassays Improve Clinical Utility
  • 4.2.4 Government-Funded Newborn & Population Screening Programs
  • 4.2.5 Direct-To-Consumer At-Home Test Kits & Tele-Lab Services
  • 4.2.6 AI-Driven Reflex-Testing Algorithms Increase Test Orders
• 4.3 Market Restraints
  • 4.3.1 Complex Interpretation & Biotin Interference Issues
  • 4.3.2 Shortage Of Endocrinologists Slows Diagnosis & Follow-Up
  • 4.3.3 Lab Test Price Compression from Bundled Contracts
  • 4.3.4 Guideline Push-Back Against Over-Screening & Over-Treatment
• 4.4 Regulatory Landscape
• 4.5 Porter's Five Forces Analysis
  • 4.5.1 Bargaining Power of Suppliers
  • 4.5.2 Bargaining Power of Buyers/Consumers
  • 4.5.3 Threat of New Entrants
  • 4.5.4 Threat of Substitute Products
  • 4.5.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts

• 5.1 By Test
  • 5.1.1 TSH Test
  • 5.1.2 Free/Total T4 Test
  • 5.1.3 Free/Total T3 Test
  • 5.1.4 Anti-TPO/Anti-TG Antibody Tests
  • 5.1.5 Other Test
• 5.2 By Technique
  • 5.2.1 Immunoassay (CLIA, ELISA, RIA)
  • 5.2.2 Rapid Point-of-Care Tests
  • 5.2.3 Mass Spectrometry
  • 5.2.4 Other Techniques
• 5.3 By Sample Type
  • 5.3.1 Serum/Plasma
  • 5.3.2 Capillary Blood (Finger-prick)
  • 5.3.3 Dried Blood Spot
• 5.4 By End User
  • 5.4.1 Hospital
  • 5.4.2 Diagnostic Laboratory
  • 5.4.3 Other End Users
• 5.5 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 & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & 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, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Abbott
  • 6.3.2 Zhengzhou Autobio Co., Ltd.
  • 6.3.3 bioMrieux SA
  • 6.3.4 Danaher Corporation (Beckman Coulter)
  • 6.3.5 DiaSorin SpA
  • 6.3.6 F. Hoffmann-La Roche Ltd
  • 6.3.7 Qualigen, Inc.
  • 6.3.8 QuidelOrtho Corporation
  • 6.3.9 Siemens Healthineers
  • 6.3.10 Thermo Fisher Scientific Inc.
  • 6.3.11 Werfen
  • 6.3.12 Boditech Med Inc.
  • 6.3.13 Ortho Clinical Diagnostics
  • 6.3.14 Mindray Bio-Medical Electronics
  • 6.3.15 Randox Laboratories
  • 6.3.16 Tosoh Corporation
  • 6.3.17 Diazyme Laboratories
  • 6.3.18 Sysmex Corporation
  • 6.3.19 PerkinElmer Inc.
  • 6.3.20 IBL-America
  • 6.3.21 Sekisui Diagnostics
  • 6.3.22 Euroimmun AG

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment