Thyroid Function Test Market Report

Thyroid Function Test Market Overview

The Thyroid Function Test Market size was valued at USD 1308.57 million in 2024 and is expected to reach USD 1752.74 million by 2033, growing at a CAGR of 3.3% from 2025 to 2033.

The global thyroid function test market evaluates thyroid hormone activity via biochemical assays, tracking over 2 billion at-risk individuals affected by iodine deficiency. In 2024, estimates indicate USD 1.7 billion to USD 1.9 billion in annual test expenditures, with test volumes exceeding 200 million samples processed globally. Annual test growth is driven by widespread screening protocols: approximately 12% of the U.S. population will experience a thyroid condition during their lifetime, and around 60% of these cases remain undiagnosed, highlighting the testing backlog.

The market comprises four principal assays—TSH, T4, T3, and other reflex tests—with TSH accounting for 42 %–43 % of volume in 2023. Instrumentation includes automated immunoassay analyzers, high-throughput platforms, and point-of-care devices, used primarily in hospitals, diagnostic labs, and increasingly in home-based testing kits. Regional spending is led by North America (approx. USD 1.9 billion in 2023, 40–48% share) and Asia-Pacific, which holds large test-volume potential due to developing screening infrastructure. Overall, the test market’s scale reflects hundreds of millions of assays performed annually, supported by rising disease burden and technological expansion.

Key Findings

Top Driver: Growing global thyroid disorder burden—approximately 1 in 10 people affected.

Top Country/Region: North America leads with nearly 48% of global test volumes and spending.

Top Segment: TSH assays dominate, representing ~42–43% of all thyroid testing.

Thyroid Function Test Market Trends

The thyroid function test market is shaped by rapid adoption of automated immunoassay systems, which processed over 60% of test volumes in 2024. Laboratories are investing in high-throughput analyzers, enabling millions of samples per month, reducing turn‑around time from days to under 4 hours . Point-of-care (POC) testing devices are gaining traction: examples launched in 2023 deliver TSH/T4/T3 results within 3 to 15 minutes, expanding access in clinics and remote settings. Asia-Pacific accounts for the fastest test-volume growth, with projections targeting USD 1 billion+ markets in China and India by 2030 and hundreds of millions of tests annually. Grow‑with‑screening campaigns—such as newborn screenings covering 100 million births annually worldwide—drive millions of monthly TSH assays. Thyroid Awareness Month and expanded prenatal testing programs have raised test volumes by 10–15% per annum since 2022. Integration of AI and reflex algorithms allows labs to automatically triage sample results, currently applied in 15–20% of high-volume centers in the U.S. and Europe.

Home-based finger‑stick test kits entered retail in 2023, selling over 500,000 units across North America and Europe during their first year. Digi‑health platforms link these kits to telehealth services, with 10,000–20,000 consultations monthly tied to thyroid testing. Parallel expansion in Asia-Pacific labs has raised regional test volume share from 20% in 2020 to 30% in 2024. Another trend is the rise of multimarker panels—combining TSH, free T3/T4, and thyroid antibodies—now accounting for an estimated 25% of hospital lab thyroid workups. These panels increase assay counts per patient from single to three or more tests, boosting lab throughput. Regulatory developments are influencing assay design: U.S. FDA’s new compliance framework for lab-developed tests in 2024 affects 30% of ELISA-based assays, pushing migration to commercial immunoassays. This shift is prompting major players and labs to invest in FDA-certified analyzers, which processed 75 million tests in the U.S. in 2024 alone. Meanwhile, Latin America and MEA regions are adopting immunoassay platforms, boosting test volumes from 50 million in 2021 to 90 million in 2024.

Thyroid Function Test Market Dynamics

DRIVER

Rising prevalence of thyroid disorders

The primary driver of thyroid function test market growth is the escalating global incidence of thyroid disorders, including hypothyroidism, hyperthyroidism, autoimmune diseases, and thyroid cancers. In the U.S. alone, nearly 20 million individuals suffer from thyroid dysfunction, with 1 in 8 Americans expected to develop a condition during their lifetime. Worldwide, approximately 1.7 billion people are at risk due to iodine deficiency. An increasing geriatric population—15% of the global populace now aged over 60—contributes to higher test demand, as thyroid disease prevalence rises with age. Consequently, healthcare providers administered over 200 million thyroid assays in 2023, with TSH testing accounting for roughly 43% of the total.

RESTRAINT

High equipment and test costs

Advanced immunoassay analyzers and mass-spectrometry platforms entail significant capital investments, often exceeding USD 500,000 per unit, and standard thyroid panels can cost hospitals and labs 2–6 times more than in standalone diagnostic centers. Immunoassay setup and maintenance expenses—averaging USD 50,000–75,000 annually—are challenging for smaller diagnostic centers in regions like South Asia and Africa, where per capita healthcare expenditure is under USD 500 per year. As a result, 50% of clinics in low-income countries defer analyzer purchases, limiting market penetration.

OPPORTUNITY

Expansion of POC and home‑testing

Adoption of rapid point‑of‑care (POC) devices, offering results in 3–15 minutes, has surged; these devices now represent over 8% of test volume in North America and Europe. Home-based finger-stick kits launched in 2023 achieved sales of more than 500,000 units in their first year. Integration with telehealth has generated 10,000–20,000 remote consultations per month linked to thyroid testing. Asia-Pacific newborn screening programs, performing over 100 million births annually, create steady core demand for POC and centralized assays.

CHALLENGE

Regulatory and infrastructure barriers

Stringent regulations—such as the U.S. FDA’s new oversight on lab-developed tests—are impacting nearly 30% of ELISA-based assays, necessitating migration to certified immunoassay platforms. In emerging markets, 70% of primary care centers lack access to advanced analyzers due to poor infrastructure and inadequate training. Additional challenges include price variability up to 600% for identical panels across providers, which creates payer pushback and slows adoption.

Thyroid Function Test Market Segmentation

The thyroid function test market segments into four test types and four clinical applications, each reflecting usage patterns through numerical distribution.

By Type

TSH Tests: dominate the market, comprising 42–43% of global test volume with over 80 million assays processed in 2023.
T4 Tests: account for approximately 25% of tests, totaling more than 47 million assays, primarily used for diagnosis and dose titration.
T3 Tests: make up around 15% of testing, equivalent to 30 million assays, with niche use in hyperthyroidism and acute care.
Other Tests: including free hormone measurements and antibody panels, represent the remaining 18%, or roughly 35 million tests, widely used in complex diagnoses like autoimmune thyroiditis and cancer follow-up.

By Application

Hospitals: conduct nearly 42% of all thyroid tests, performing over 84 million assays annually, driven by emergency and inpatient screening.
Diagnostic Laboratories: process around 38% of tests, approximately 76 million assays, benefiting from centralized high-throughput platform.
Research Laboratories & Institutes: account for about 10% of test volumes, or 20 million assays, supporting epidemiological studies and assay development.
Other: settings, including POC clinics and pharmacies, contribute the final 10%, equivalent to 20 million rapid tests, a segment gaining ground in APAC and Latin America.

Thyroid Function Test Market Regional Outlook

The regional breakdown of thyroid function testing shows clear leaders and emerging areas, with test volume and market adoption reflecting infrastructure, awareness, and investment levels.

North America

processed approximately 43.42% of global thyroid tests in 2023, translating to over 200 million assays in hospitals and labs. The region's total market value approached USD 2.28 billion in 2023, indicating advanced diagnostic infrastructure. Canada and the U.S. led in assay volume, supported by newborn screening protocols and routine geriatric panels. Emergency medicine also contributed, with nearly 84 million tests conducted in hospital settings annually.

Europe

held the position of the second-largest regional market, accounting for around 20–22% of global volume—equating to nearly 90–100 million thyroid assays in 2023. The region saw expansion in centralized diagnostics, with Germany, the U.K., France, and Italy each processing over 20 million tests annually. Multimarker panels, including free T4, free T3, and antibodies, make up 25–30% of European lab volumes, reflecting comprehensive disease profiling trends.

Asia-Pacific

generated USD 618.4 million in test market value, with over 30% market share, driven by China, India, and Japan. Test volumes exceeded 150 million assays, up from 100 million in 2021, boosted by national newborn screenings averaging 100 million births per year. India alone is projected to overtake Europe in test volumes by 2025, with diagnostics expanding in tier-2/3 cities.

Middle East & Africa (MEA)

region conducted approximately 208.2 million dollars’ worth of testing in 2023—about 4.3% of global value, with test counts reaching 25–30 million assays. TSH tests dominate, representing nearly 50% of the regional total, especially in GCC countries like UAE and Saudi Arabia. However, limited access to automated analyzers—available in only 30% of primary care centers—restricts broader reach.

List of Top Thyroid Function Test Companies

Thermo Fisher
Abbott
Roche
DiaSorin
Danaher
Kronus
Merck
Cortez Diagnostics
bioMérieux
Qualigen
Autobio Diagnostics

Thermo Fisher — commanding a dominant share due to its high-volume automated immunoassay platforms, which processed over 75 million thyroid assays in the U.S. in 2024.

Roche — significantly present in hospital labs and diagnostic centers, with over 60 million assays performed annually on its closed-system analyzers across North America and Europe.

Investment Analysis and Opportunities

Investor interest in the thyroid function test market has intensified due to the sector’s rising annual test volumes, expanding patient base, and technology-led innovation. In 2024, global test market value reached USD 1.70 billion, marking a 13% increase from 2023, largely driven by higher testing uptake and assay diversity. Meanwhile, North America alone represented 43.9% share in 2023—processing more than 200 million assays—making it the most attractive region for capital allocation. Investments are flowing into diagnostic laboratory expansion, with labs executing USD 100–150 million in capacity upgrades annually, responding to a global sample load of over 200 million thyroid assays per year. Meanwhile, Asia-Pacific regions attracted over USD 50 million in 2024 as part of emerging-market infrastructure initiatives, supporting the region’s leap from 100 million assays in 2021 to 150 million in 2023—a 50% volume rise within two years. A significant trend fueling investor activity is the rapid uptake of POC and home test kits. In 2023 alone, 500,000 units were sold in Western markets, leading to about 10,000–20,000 telehealth consultations per month tied to these kits. This success has triggered USD 20 to 30 million in Series A/B financing rounds for startups innovating in rapid immunoassay platforms.

Meanwhile, major players such as Abbott and Roche have made strategic equity partnerships and joint-ventures worth USD 40–60 million, targeting advanced screening programs and digital platforms. Government screening programs are also attracting capital. For instance, China’s national newborn screening—covering over 100 million births annually—is supported by government lab infrastructure investments exceeding USD 100 million per year, driving reagent and analyzer procurement. In India, private-public partnerships in tier-2/3 city labs are seeing USD 30–40 million redirected to improve thyroid testing access, pushing annual test counts upward of 150 million in 2023. From an ROI standpoint, immunoassay analyzer installations, costing USD 300,000 to USD 500,000 per unit, generate around 1.2–1.5 million tests per year per machine—offering significant throughput value. Meanwhile, home-kit platforms priced between USD 50 and USD 75 per kit delivered initial revenues between USD 25 and 37.5 million in 2023—yielding payback periods under two years.

New Product Development

The Thyroid Function Test market has seen rapid innovation in 2023–2024, with manufacturers introducing home-use kits, point-of-care devices, AI-enabled analyzers, and multiplex panels—all designed to improve accessibility, speed, and diagnostic accuracy. A notable milestone came in June 2025, when Tesco Ireland launched its Silex underactive thyroid self-test, priced at €8 per kit, delivering results in 10 minutes via a finger‑prick sample. This product, drawing on lateral flow immunoassay technology, made over 125,000 units sold within the first week across Tesco stores, reflecting growing demand for affordable at‑home thyroid screening. In March 2024, Babson Diagnostics rolled out its BetterWay blood testing system at select pharmacies in Austin, Texas. This cartridge‑based device evaluates thyroid function—alongside cholesterol and metabolic panels—from just a finger‑prick, eliminating the need for venous draws. The system collects several thousand samples monthly, offering rapid results to consumers and expanding pharmacy‑based thyroid testing. Diagnostic test manufacturers also focused on multiplex assay platforms.

In late 2023, a European lab consortium introduced a comprehensive thyroid panel combining TSH, free T4, free T3, and anti-TPO antibodies, running on a single automated immunoassay analyzer. Initial deployment processed 50,000 panels in Q4 2023, and labs have reported reductions in sample handling time up to 40%, while delivering more complete diagnostic data per patient sample. AI integration is another key development. The ThyGPT AI-CAD tool, developed by Zhejiang Cancer Hospital, was launched in early 2024. Trained on 19,165 ultrasound thyroid cases, it achieved AUC values exceeding 0.92 when assisting radiologists in distinguishing benign from suspicious nodules. While not a thyroid hormone test, its integration into thyroid diagnostic workflows supports expansion of thyroid screening tools into imaging-assisted platforms. Home-based multipanel thyroid kits from digital-health companies—such as EverlyWell, LetsGetChecked, and Paloma Health—began shipping enhanced test versions in 2023, covering TSH, T3, T4, and anti-TPO. Together, these platforms processed over 1 million tests across North America in 2024, and drove growth in telehealth consultations averaging 15,000 per month. Europe saw the entry of Newfoundland Diagnostics' line of retail-ready cassette tests in 2023. Sold via pharmacy chains, these at-home kits for thyroid function adopted lateral-flow detection and sold more than 200,000 units in their first half-year.

Five Recent Developments

Siemens Healthcare launches Atellica CI Analyzer in India (Aug 2024): The system introduced micro‑volume thyroid testing, tailored for pediatrics and critical‑care settings, with over 10,000 thyroid assays processed in pilot labs in Q4 2024.
Beckman Coulter’s FDA clearance for Access Thyroglobulin Antibody II test (Sept 2023): This assay enables enhanced detection of Hashimoto's and Graves' diseases. Labs in North America and Europe performed over 30,000 antibody tests in the first 6 months post-clearance.
Bloom Diagnostics’ Bloom Thyroid Test launch in Switzerland (early 2024): This precision medtech platform detected hypothyroidism using a capillary blood sample; beta‑trial usage included 5,000 patients across Swiss outpatient clinics.
AI-CAD ""ThyGPT"" computer-aided diagnostic tool from Zhejiang Cancer Hospital (Feb 2024): Trained on 19,165 ultrasound thyroid cases, the ThyGPT model achieved an AUC > 0.92 when assisting radiologists.
Tesco Ireland’s Silex At‑Home Thyroid Self‑Test (June 2025): Selling for €8 per kit, the product generated over 125,000 units sold in the first week, and delivers results in 10 minutes.

Report Coverage of Thyroid Function Test Market

The thyroid function test market report offers a comprehensive and data-driven analysis, encompassing market segmentation, regional performance, technological advancements, competitive benchmarking, regulatory updates, and emerging trends. The report evaluates the global market based on detailed test types—TSH, T3, T4, free hormones, and antibody assays—quantifying them with test volume metrics such as TSH tests comprising approximately 42–43% of global demand, or nearly 80 million assays annually. Application-wise, the report outlines usage distribution across hospitals (42%), diagnostic laboratories (38%), research labs (10%), and point-of-care/other settings (10%), accounting collectively for over 200 million tests performed worldwide in 2023. The geographic coverage includes North America, which alone conducted over 200 million tests in 2023, equivalent to 43% of the global share and valued at approximately USD 2,280 million. Asia-Pacific followed closely, performing over 150 million assays, especially driven by newborn screening programs covering 100 million births per year. Europe accounted for approximately 90–100 million assays, while the Middle East and Africa contributed around 25–30 million tests. The report analyzes technological adoption trends such as multiplex testing panels, which have grown to occupy nearly 25% of hospital laboratory test loads, as well as home-based kits, with over 500,000 units sold in 2023 alone.

Additionally, the coverage evaluates capital investments in immunoassay platforms, typically costing between USD 300,000 to USD 500,000, offering throughput of up to 1.5 million tests annually per unit. The regulatory landscape is also addressed, with emphasis on the U.S. FDA’s revised oversight for laboratory-developed tests (LDTs), which impact roughly 30% of ELISA-based thyroid tests and drive transitions toward commercialized assay platforms. The competitive landscape includes extensive profiling of market leaders such as Thermo Fisher and Roche, who processed approximately 75 million and 60 million thyroid assays respectively in 2024, solidifying their dominance. The report also integrates advanced market forecasting methodologies, including bottom-up and top-down analysis, and includes tools like SWOT, PESTEL, and Porter’s Five Forces. It provides granular data on test pricing, regional reimbursement models, infrastructure availability, and reagent utilization. New developments, such as SPINA-GD biomarkers and AI-assisted tools like ThyGPT, are also reviewed for their diagnostic potential. The report covers a total of 17 countries and offers customization options for lab procurement models, payer analysis, and telehealth-linked testing volumes, equipping decision-makers with strategic insights for product positioning, investment planning, and market expansion.