Thyroid Function Tests Market

Market Overview

The thyroid function tests market was estimated at USD 1417.3 million in 2019 and is expected to grow with a CAGR of 6.0%.

Thyroid function tests (TFTs) are standard blood tests performed to examine thyroid function. TFTs may be requested if a patient suffers from hyperthyroidism (overactive thyroid) or hypothyroidism (underactive thyroid) or monitoring either thyroid suppression or hormone replacement therapy effectiveness. A TFT panel generally includes assays for thyroid hormones, such as thyroid-stimulating hormone (TSH, thyrotropin) and thyroxin (T4), and triiodothyronine (T3), depending on the local laboratory policy.

First-generation TSH assays were carried out by radioimmunoassay and introduced in 1965. TSH radioimmunoassay had variations and improvements, but their use declined as a new immunometric assay technique became available in the mid-1980s. The modern techniques were more accurate, leading to the second, third, and even fourth-generation TSH assay, with each generation having ten times greater functional sensitivity than the last. 

Market Dynamics

TSH immunometric assay of the fourth generation has been established for research usage. Currently, third-generation TSH assays are more demanding in the market. In the U.S., TSH testing is usually performed with automated platforms using advanced forms of the immunometric assay. However, there are no international standards available for thyroid-stimulating hormone measurement. The free thyroxine index (Fti) is considered to be a reliable indicator of thyroid status in the presence of plasma protein binding abnormalities. However, this test is rarely employed as now reliable free thyroxine, and free triiodothyronine assays are readily available.

Rising Cases of Thyroid Gland Disorders to Prompt the Need for Effective Thyroid Diagnostics

The increasing prevalence of thyroid disorders, such as hypothyroidism and hyperthyroidism, and surging cases of autoimmune diseases, such as Grave’s disease, (which is the major risk factor for thyroid disorder), prompts the need for effective thyroid function tests. The World Health Organization (WHO) and the American Association of Clinical Endocrinologists (AACE) have reported that the cases of thyroid disorders are rapidly increasing, further driving the demand for novel and effective thyroid diagnostics to predict better treatment options.  The WHO estimated that thyroid disorders such as hypothyroidism, hyperthyroidism, and goiter are common conditions affecting more than 750 million people across the globe.

The Journal of Clinical Endocrinology and Metabolism also projected that thyroid dysfunction (i.e. hypothyroidism) is the leading endocrine disorder and accounts for around 30% to 40% of the total endocrine patients. Therefore, increasing the prevalence of thyroid disorders drives the demand for thyroid function tests such as TSH, T3, and T4. As per the Endocrine Society, about 140 hypothyroidism and ten hyperthyroidism cases are reported among every 1,000 individuals in the U.S. every year.

Diabetic, Obese, and Cardiovascular Patients Be Highly Susceptible to Thyroid Disorder

The risk of developing hypothyroidism and hyperthyroidism is higher in obese, diabetic, and cardiovascular patients. For instance, the study 'Prevalence of Hypothyroidism in Patients With Type 2 Diabetes Mellitus and Hypertension in India’ reported that in March 2019, the prevalence of hypothyroidism in patients with type 2 diabetes mellitus, hypertension, and type 2 diabetes mellitus + hypertension was 24.8%, 33.5%, and 28.9%, respectively.  

In July 2013, the Journal of Clinical Endocrinology and Metabolism published a cross-sectional study on 27,097 volunteers over 40 years of age with a body mass index of more than 30.0 kg/m2 to investigate the risk of hypothyroidism among the obese population. The clinical findings of the study reinforced that thyroid dysfunction is associated with significant changes in body weight, and represents a risk to obese and overweight people. A report issued by the Annals of International Medicine in the International Journal indicated that hypothyroidism currently accounts for more than 60% of cardiovascular cases, such as myocardial infarction and ischemic heart disease.

Segmental Analysis

Growing Popularity of TSH Tests among the Physicians to Drive the Segment Growth

The TSH tests segment holds the highest market share on account of its growing popularity among physicians as a preliminary screening test for the detection of thyroid disorders. This test can be performed at a negligible cost, which further facilitates cost-effective disease screening and possesses very low to no risk in taking the blood test. The test determines whether the thyroid gland is functioning properly.   

Hospitals: Leading Market Contributing Segment

The hospital segment holds the largest market share on account of the increasing rate of public healthcare awareness campaigns organized to educate people about the hazardous effects of the thyroid. Rising number of hospital settings, especially in developing regions, fosters segment growth. Several hospitals are adopting thyroid function tests in pregnant women since any abnormality in thyroid functioning may affect the development of the baby, further driving the market growth.

Impact of covid-19

On March 11, 2020, the World Health Organization (WHO) declared the emergence of the COVID-19 pandemic. The pandemic is projected to pose serious diagnostic and therapeutic challenges for healthcare practitioners and patients for thyroid function tests as hospitals and diagnostic centers have suspended or limited biochemical testing. Apart from this, staff and resource unavailability in hospitals can cause diagnostic difficulties for patients with new thyroid dysfunctions, further hampering the market growth.

Regional Analysis

The U.S. and Canada to Spearhead North America’s Thyroid Function Test Market

North America dominates the thyroid function testing market as the region possesses advanced healthcare infrastructure in countries such as the U.S. and Canada. The growing prevalence of thyroid dysfunction and rising spending power drives the regional market growth. As per the American Thyroid Association (ATA), more than 20 million Americans suffered from thyroid disorder in 2017, of which about 60% of people lived with an undiagnosed thyroid disorder. Similarly, the statistics published by the Thyroid Foundation of Canada in 2015 suggests that one in every 1,700 children in Canada are affected by congenital hypothyroidism. This shows the potential demand for thyroid diagnostics and therapeutics in the coming years.

Low Cost of Thyroid Function Test to Drive Asia-Pacific’s Market Growth

Asia-Pacific’s thyroid function test market is projected to grow with the highest CAGR during the forecast period as the region houses a large patient population suffering from thyroid disorder. Increasing disposable income and improving healthcare infrastructure in emerging countries such as China and India provides an impetus to regional market growth.

As per the study 'Trends in the Incidence of Thyroid Cancer in INDIA,' presented in the Journal of Clinical Oncology in May 2018, the incidence rate of thyroid cancer in India rose from 2.4 to 3.9 in women and 0.9 to 1.3 in men, a relative increase of 62% and 48% in 2013/14 and 2014/15, respectively.  Apart from this, the low cost of thyroid function test bolsters the market growth; for instance, the average price of thyroid test in any NABL accredited labs is about USD 3.51 to USD 7.

Recent Developments

• In May 2018, Interpace Diagnostics Group entered into an agreement with the Vanderbilt University Medical Center (VUMC), which will enable all physicians in the Vanderbilt system to gain access to both ThyGeNEXT(R) and ThyraMIR(R) for patients with thyroid disorders. ThyGeNEXT(R) and ThyraMIR(R) are molecular diagnostic tests for detecting mutations in thyroid cells.
• In April 2020, Veracyte, Inc. launched the Afirma Xpression Atlas (XA) test, which can detect novel and rare gene alterations through RNA sequencing. The product is expected to be promising in the thyroid cancer diagnostics market as it can help in the decision-making process of targeted therapy for thyroid cancer.

Thyroid Function Tests Market Segmentation

By Type

• TSH Tests
• T4 Tests
•  T3 Tests

By End-User

• Hospitals
• Diagnostic Laboratories
• Research Laboratories and Institutes

By Region 

• North America
• Europe
• Asia-Pacific
• South America
• The Middle East and Africa