Thyroid Function Test Market Size and Share
Market Overview
| Study Period | 2019 - 2030 |
|---|---|
| Market Size (2025) | USD 1.89 Billion |
| Market Size (2030) | USD 2.47 Billion |
| Growth Rate (2025 - 2030) | 5.53% CAGR |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0. |
|
Thyroid Function Test Market Analysis by Mordor Intelligence
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[1]US Food and Drug Administration, “Laboratory Developed Tests Final Rule,” fda.gov. Price transparency laws and bundled-contract negotiations are shifting volumes toward lower-cost independent laboratories, intensifying competition but expanding patient access.
Key Report Takeaways
- By test type, the TSH assay held 42.86% of thyroid function testing market share in 2024; Anti-TPO/Anti-TG antibody tests are poised for a 7.56% CAGR to 2030.
- By technique, immunoassay methods accounted for 60.23% share of the thyroid function testing market size in 2024, whereas point-of-care tests will grow at an 8.86% CAGR.
- By end user, hospitals captured 41.78% share of the thyroid function testing market size in 2024, while diagnostic laboratories are advancing at an 8.34% CAGR.
- By sample type, serum/plasma captured 72.46% share of the thyroid function testing market size in 2024, while capillary blood (finger-prick) are advancing at an 7.45% CAGR.
- By geography, North America led with 34.89% revenue share in 2024, while Asia-Pacific is projected to expand at a 6.89% CAGR through 2030.
Global Thyroid Function Test Market Trends and Insights
Driver Impact Analysis
| Drivers Impact Analysis | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Rising burden of thyroid disorders | +1.2% | Global; highest in iodine-deficient regions | Medium term (2-4 years) |
| Aging population raises routine screening | +0.9% | North America & Europe, expanding to Asia-Pacific | Long term (≥ 4 years) |
| High-sensitivity 3rd-gen immunoassays | +0.8% | Global; led by developed markets | Short term (≤ 2 years) |
| Government-funded newborn screening | +0.7% | Asia-Pacific core; spreading to emerging markets | Medium term (2-4 years) |
| Direct-to-consumer at-home test kits | +0.6% | North America & Europe; early uptake in urban Asia | Short term (≤ 2 years) |
| AI-driven reflex-testing algorithms | +0.5% | Digitally mature health systems worldwide | Medium term (2-4 years) |
| Source: Mordor Intelligence | |||
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[2]Association of American Medical Colleges, “Physician Workforce Projections 2025-2036,” aamc.org. 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.
High-Sensitivity 3rd-Gen Immunoassays Improve Clinical Utility
Third-generation TSH assays now detect levels below 0.02 mIU/L, enabling confident diagnosis of subclinical disorders and improved therapy monitoring. Enhanced antibodies, signal amplification chemistries, and automated calibration underpin this performance. Studies confirm superior detection of central hypothyroidism and tighter dose titration in replacement therapy. Ongoing R&D into novel detection chemistries keeps competitive pressure high and sustains innovation momentum within the thyroid function testing market.
Government-Funded Newborn & Population Screening Programs
Near-universal congenital hypothyroidism screening in developed nations contrasts with only 29.6% global newborn coverage, pointing to substantial room for expansion [eurothyroid.com]. Thailand’s rural rollout achieved 98.6% coverage and identified one case per 1,208 births, validating scalable models in resource-constrained settings. Switching from T4-first to TSH-first protocols drops false positives to 0.45% and cuts follow-up costs. Government investment secures predictable demand and encourages private-sector laboratory build-outs, enlarging the thyroid function testing market.
Restraints Impact Analysis
| Restraints Impact Analysis | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Complex interpretation & biotin interference | -0.8% | Global; pronounced where supplement use is common | Short term (≤ 2 years) |
| Shortage of endocrinologists | -0.6% | North America & Europe; emerging in Asia-Pacific | Long term (≥ 4 years) |
| Lab-test price compression | -0.5% | North America core; expanding globally | Medium term (2-4 years) |
| Guideline push-back against over-screening | -0.4% | Global; led by evidence-based groups | Medium term (2-4 years) |
| Source: Mordor Intelligence | |||
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[3]Health Canada, “Biotin Interference in Laboratory Testing,” canada.ca. 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.
Shortage Of Endocrinologists Slows Diagnosis & Follow-Up
With only 8,000 US endocrinologists and 40.0% approaching retirement, access gaps worsen outside urban hubs. Training programs add roughly 300 specialists annually—insufficient for surging thyroid and diabetes caseloads. Rural patients often face months-long waits, reducing follow-up compliance and capping potential test volumes despite rising disease incidence. Tele-consultation and AI-driven primary-care support partially mitigate but do not fully offset this restraint on the thyroid function testing market.
Segment Analysis
By Test: TSH Dominance Faces Antibody Test Disruption
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.
Note: Segment shares of all individual segments available upon report purchase
By Technique: Immunoassay Leadership Challenged by POCT Innovation
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.
By Sample Type: Serum Supremacy Yields to Capillary Innovation
Serum and plasma samples still constitute 72.46% of volume, favored for multiparameter panels and regulatory familiarity. Yet capillary blood testing posts a 7.45% CAGR on convenience benefits. Correlation coefficients exceed 0.97 for TSH and free T4 when comparing finger-stick with venous draws, reassuring clinicians of clinical equivalence [endocrinesociety.org]. Dried blood spots streamline newborn programs in remote settings, while smartphone-linked readers transform self-testing into actionable care pathways. As telehealth normalizes, capillary sampling expands overall thyroid function testing market size by recruiting previously undertested populations.
Note: Segment shares of all individual segments available upon report purchase
By End User: Hospital Dominance Shifts Toward Laboratory Efficiency
Hospitals generated 41.78% of 2024 revenue, leveraging integrated electronic records and immediate turnaround for acute care. Nonetheless, their higher cost structure—2-6 times that of independent labs—drives payer migration to central laboratories posting an 8.34% CAGR. Price transparency rules expose variability up to 600% for identical thyroid panels, intensifying the push toward lower-cost channels labcorp. Consolidation among reference labs enhances bargaining power, while specialized thyroid centers adopt mass-spectrometry and AI analytics to carve differentiation. Home-testing providers ride rising consumer engagement and remote-care models, adding new demand strata within the thyroid function testing market.
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.
Competitive Landscape
The thyroid function testing market is moderately consolidated. Abbott, Roche, and Siemens Healthineers leverage broad installed bases, integrated platforms, and service contracts to lock in laboratories. The FDA’s 2024 LDT rule shifts compliance burden toward larger firms with regulatory muscle, potentially thinning smaller outfits. Nonetheless, innovation windows remain: Polaris DX’s EUR 2,250 (USD 2605.9) portable analyzer offers disruptive cost-to-serve economics; HEI Therapeutics progresses patent-protected home-monitoring solutions.
Strategic playbooks center on AI augmentation, mass-spectrometry differentiation, and point-of-care expansion. Midsize vendors pursue geographic partnerships to access fast-growing Asia-Pacific markets, while incumbents bolster menus with calcitonin, antibody, and reflex-algorithm add-ons. Acquisition pipelines target niche assay developers and cloud-analytics specialists, evidencing sustained deal flow even amid rising regulatory costs. Competitive intensity should remain moderate as installed-platform switching barriers and service reliability outweigh pure reagent price in purchasing decisions.
Thyroid Function Test Industry Leaders
-
Abbott
-
Siemens Healthineers
-
Danaher Corporation (Beckman Coulter)
-
F. Hoffmann-La Roche Ltd
-
DiaSorin SpA
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- January 2025: Health Canada issued comprehensive update on biotin interference risks in thyroid function tests, emphasizing mandatory 7-day cessation protocols after documented clinical cases of false results leading to patient mismanagement.
- October 2024: Siemens Healthineers completed verification of the Atellica DL IM1600 analyzer for anti-TPO and anti-TG detection, confirming precision standards for autoimmune thyroid diagnosis.
- August 2024: Labcorp reported hospital thyroid test prices running 2-6 times higher than independent labs, driving payers toward lower-cost channels.
- June 2024: HEI Therapeutics filed a patent on a home monitoring system aimed at personalized hypothyroidism management.
- June 2024: Roche introduced the Elecsys Calcitonin assay for medullary thyroid cancer on the cobas platform.
Research Methodology Framework and Report Scope
Market Definitions and Key Coverage
Our study defines the thyroid function test market as all laboratory-validated in-vitro assays that quantify circulating thyroid-related hormones or antibodies, principally TSH, free or total T4 and T3, and anti-TPO/Tg panels, performed on blood samples within clinical settings worldwide.
(Scope Exclusion) Genetic panels, imaging procedures, and biopsy-based diagnostics that support thyroid cancer work-ups sit outside this estimate.
Segmentation Overview
- By Test
- TSH Test
- Free/Total T4 Test
- Free/Total T3 Test
- Anti-TPO/Anti-TG Antibody Tests
- Other Test
- By Technique
- Immunoassay (CLIA, ELISA, RIA)
- Rapid Point-of-Care Tests
- Mass Spectrometry
- Other Techniques
- By Sample Type
- Serum/Plasma
- Capillary Blood (Finger-prick)
- Dried Blood Spot
- By End User
- Hospital
- Diagnostic Laboratory
- Other End Users
- 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 & Africa
- GCC
- South Africa
- Rest of Middle East & Africa
- South America
- Brazil
- Argentina
- Rest of South America
- North America
Detailed Research Methodology and Data Validation
Primary Research
Mordor analysts interviewed pathologists, lab directors, and procurement leads across North America, Europe, and high-growth Asia-Pacific cities. These conversations tightened assumptions on kit utilization rates, reagent wastage, reimbursement lag times, and expected automation adoption, ensuring secondary findings were fully reconciled.
Desk Research
We gathered foundational numbers from open data troves such as the International Agency for Research on Cancer's thyroid disorder prevalence series, OECD Health Statistics for test volumes per capita, United Nations demo-economic tables, and reimbursement schedules posted by CMS and key European payers. Additional context flowed from trade associations like the American Thyroid Association, peer-reviewed articles in Clinical Chemistry, customs shipment logs visible through Volza, and select listings from D&B Hoovers and Dow Jones Factiva. These sources clarified baseline demand drivers, kit pricing corridors, and cross-border reagent flows.
Our team then scanned annual reports, 10-Ks, and investor decks of major assay suppliers to validate revenue splits by test category and region, giving us realistic average selling prices (ASPs). The sources cited above are illustrative; many more publicly available references informed data collection and sense-checking.
Market-Sizing & Forecasting
A top-down reconstruction starts with country-level test volumes drawn from health ministry registries and private lab disclosures, which are then multiplied by validated ASP ranges. Select bottom-up roll-ups of leading suppliers' reagent revenues serve as guardrails to fine-tune totals. Variables that feed the model include hypothyroidism prevalence, newborn screening mandates, immunoassay kit ASP trends, lab automation penetration, reimbursement tariff revisions, and average turnaround-time targets.
Forecasts to 2030 employ multivariate regression, letting each driver's trajectory, vetted through primary research, shape the CAGR while scenario checks capture policy or technology shocks. Gap pockets in bottom-up estimates are bridged by applying weighted regional margins gleaned from supplier calls.
Data Validation & Update Cycle
Outputs pass three rounds of analyst review, anomaly scans against independent health spending benchmarks, and variance checks versus prior editions. We refresh every twelve months, with interim updates triggered by material regulatory or pricing moves. Before delivery, a final pass ensures clients receive the latest calibrated view.
Why Our Thyroid Function Test Baseline Merits Confidence
Published figures vary because firms choose divergent scopes, price bases, and refresh cadences. Sample inclusions, end-user breadth, and currency conversions often shift totals markedly.
Key gap drivers arise when others blend thyroid screening within broader endocrine baskets, apply list rather than transacted ASPs, or stretch forecasts beyond validated prevalence data. Mordor's study reports only true thyroid function assays, converts revenues at average annual FX rates, and updates annually, which reduces drift.
Benchmark comparison
| Market Size | Anonymized source | Primary gap driver |
|---|---|---|
| USD 1.89 B (2025) | Mordor Intelligence | - |
| USD 5.04 B (2024) | Global Consultancy A | Bundles thyroid tests inside wider endocrine panel and uses list ASPs |
| USD 4.48 B (2024) | Industry Research Group B | Counts rapid self-tests and point-of-care antibody kits outside lab channel |
| USD 1.91 B (2024) | Regional Consultancy C | Applies single-country ASP benchmarks globally with no volume adjustments |
These contrasts show that when scope, pricing realism, and refresh cadence are harmonized, as in Mordor's framework, stakeholders gain a balanced, transparent baseline they can replicate and defend.
Key Questions Answered in the Report
What is the current global thyroid function testing market size?
The thyroid function testing market is valued at USD 1.89 billion in 2025.
Which region is growing fastest?
Asia-Pacific is expanding at a 6.89% CAGR to 2030, driven by newborn screening and rising awareness.
Why are TSH tests still dominant?
Clinical guidelines position TSH as the first-line screen, giving it 42.86% market share in 2024.
How is AI transforming thyroid diagnostics?
AI-driven reflex-testing algorithms automate ordering and interpretation, improving accuracy and easing specialist shortages.
What regulatory change affects laboratories most?
The US FDA’s 2024 rule on laboratory-developed tests introduces significant compliance costs and tighter oversight.
Page last updated on:
