Hashimoto Thyroiditis Disease

Published Date : Nov 2023
Category : Autoimmune Diseases
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Autoimmune Disease – Complete Overview of Diagnosis and Treatment Market

Hashimoto's Thyroiditis is an autoimmune disease that destroys thyroid cells by cell and antibody-mediated immune processes. It is the greatest common cause of hypothyroidism in developed countries. The inadequate dietary intake of iodine is the most common cause of hypothyroidism worldwide. This disease is also called chronic autoimmune thyroiditis and chronic lymphocytic thyroiditis. Women are more often affected than men. The female-to-male ratio is about 10:1. According to NCBI, estimated that in females it is 3.5 per 1000 per year while 0.8 per 1000 per year in men.

Symptoms of Hashimoto's disease have not been seen for years. The first sign is often an enlarged thyroid, called a goiter, which causes the front neck to look swollen. A person feels it in the throat, and it is hard to swallow. Although most people don't have any symptoms, and goiters rarely cause pain. Some women having Hashimoto's disease have problems getting pregnant. Hashimoto's disease frequently leads to an underactive thyroid gland (hypothyroidism). Symptoms of an underactive thyroid consist of feeling tired, feeling cold when others do not, constipation, weight gain, and heavier-than-normal menstrual periods.

The pathology of Hashimoto's thyroiditis involves the formation of antithyroid antibodies that attack the thyroid tissue, which causes progressive fibrosis. The diagnosis is often challenging, most common laboratory findings demonstrate raised thyroid-stimulating hormone (TSH) and low levels of free thyroxine (fT4), along with increased antithyroid peroxidase (TPO) antibodies. However, before the course of the disease, patients exhibit signs, symptoms, and laboratory findings of hyperthyroidism. This is because the damage of the thyroid gland cells is intermittent.

The etiology of Hashimoto's disease is not clearly understood. Most patients develop antibodies to various thyroid antigens, the most common is anti-thyroid peroxidase (anti-TPO). Some also form antithyroglobulin (anti-Tg) and TSH receptor-blocking antibodies (TBII). These antibodies attack the thyroid tissue, ultimately leading to inadequate production of thyroid hormone.

Hashimoto's disease is developed through autoimmune origin, with lymphocyte infiltration and fibrosis as characteristic features. The diagnosis of Hashimoto's thyroiditis is based on clinical symptoms correlating with laboratory test results of higher TSH with normal to low thyroxine levels. However, there is little evidence representing the role of antithyroid peroxidase (anti-TPO) antibodies in the pathogenesis of autoimmune thyroid disease (AITD). Anti-TPO antibodies fix complement and, in vitro, it binds and kill thyrocytes. 

Hashimoto thyroiditis occurs at any age but is most often seen in middle-aged women. After age six, Hashimoto is the common cause of hypothyroidism in the US and in those areas of the world where iodine intake is adequate. Women are more affected than men. NCBI conducted twin studies that showed an elevated concordance of autoimmune thyroiditis in monozygotic twins as compared with dizygotic twins. Studies have established concordance rates of 55% in monozygotic twins, compared with only 3% in dizygotic twins. Data suggests that 79% of predisposition is due to genetic factors, allotting 21% to environmental and sex hormone influences. The prevalence of thyroid disease increases with age.

Diagnosis of Hashimoto Thyroiditis:

If a person has symptoms of hypothyroidism, the doctor will do a physical examination and order one or more tests. Tests used to find out whether a person has hypothyroidism and Hashimoto's disease include:

Thyroid Function Test - This blood test tells whether a body has the right amounts of thyroid-stimulating hormone (TSH) and thyroid hormone. A higher level of TSH is a sign of an underactive thyroid. When the thyroid begins to fail, the pituitary gland makes extra TSH to trigger the thyroid to make more thyroid hormone. When the damaged thyroid no longer keeps up, thyroid hormone levels drop below normal.

Free T4 – This blood test is for a hormone made in the thyroid gland that shows how well the thyroid is already working. T4 (thyroxine) is the leading hormone produced by the thyroid gland. Laboratory tests are done to measure the amount of free T4 in blood. A low total T4 or free T4 level in the presence of a higher TSH level confirms the diagnosis of primary hypothyroidism.

Anti-TPO Antibody - Blood test for antibodies that attack the thyroid gland. Having these antibodies in the blood is used to diagnose Hashimoto’s thyroiditis. “TPO” is Thyroid Peroxidase, an important enzyme for the thyroid gland work.

Anti-thyroglobulin Antibody - Blood test for a type of antibody that attacks the thyroid gland. Having these antibodies in the blood is used to diagnose Hashimoto’s thyroiditis.

The presence of anti-thyroid peroxidase and anti-thyroglobulin antibodies diagnose Hashimoto thyroiditis. According to NCBI, 10% of patients are antibody-negative. While anemia is present in 30 to 40% of people. There is decreased glomerular filtration rate (GFR), renal plasma flow, and renal free water clearance with resultant hyponatremia. Creatine kinase is frequently raised. Prolactin levels are sometimes elevated. Increased total cholesterol, LDL, and triglyceride levels occur.

A thyroid ultrasound measures thyroid size, echotexture, and whether thyroid nodules are present; however, it is usually not necessary for diagnosing the condition in the majority.

Diagnostic Market Players



J. Mitra & Co. Pvt. Ltd.

TSH Quanti Microlisa

J. Mitra & Co. Pvt. Ltd.

T4 Quanti Microlisa



Monobind Inc.

AccuBind® ELISA

Biogenix Inc. Pvt.Ltd.



Thyroid Stimulating Hormone (TSH) neonatal

Getein Biotech

TSH Fast Test Kit

MP Biomedicals


LipExoGen Biotech


Ank Cares Pvt. Ltd.

Finecare TSH Test Kit


Treatment of Hashimoto Thyroiditis:

Thyroid hormone replacement therapy is the cornerstone of treatment for hypothyroidism. Titrated levothyroxine sodium taken orally is the preferred medication. It is taken once a day and has a half-life of seven days. To prevent less-than-ideal absorption, it is not administered with calcium or iron supplements, aluminum hydroxide, or proton pump inhibitors. For maximum absorption, it is best taken first thing in the morning on an empty stomach.

The recommended daily dose is between 1.6 and 1.8 mcg/kg, however individual patient dosages may differ. On the other hand, higher dosages of levothyroxine are required in patients with short-bowel syndrome to maintain a euthyroid state, and a 30% increase in thyroxine is required during pregnancy.

A diet that is anti-inflammatory and autoimmune-supportive has little evidence. The underlying reason for the inflammation is related to leaky gut syndrome, which is characterized by an insult to the gut mucosa that permits the penetration of proteins through mucosal transporters that ordinarily prevent them from entering the bloodstream. Antibodies are thought to be generated against the antigens in a reaction akin to molecular mimicry. Sadly, thyroid peroxidase antibody development may result from the antigen's strong structural similarity to the enzyme. The goal of an autoimmune diet is to reduce the intensity of the autoimmune reaction while also repairing the stomach.

Treatment Market Players





Wellona Pharma

Tyrona 100


Thyrox 50


Euthrox 100

AdvaCare Pharma





Clinical Trial Analysis

The importance of clinical trials in the healthcare transition has been highlighted by the government's growing emphasis on comparative effectiveness studies. One of the primary objectives of the healthcare revolution is the use of clinical data, which allows market participants to accurately compare medical therapy.

The table below highlights the study titles of the ongoing clinical trials as well as the stages in which they are being conducted.

Phase 1

Phase 2

Phase 3

Phase 4

A Double-blind, Placebo-controlled, Randomized, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Oral Dose of MYMD1 Capsules in Healthy Male and Female Adult Subjects

Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis: Randomized, Placebo Controlled Clinical Trial

Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis: Open-lable, Randomised, Proof of Concept Study

L-selenomethionine Supplementation in Children and Adolescents with Autoimmune Thyroiditis: a Randomized Blind Placebo-controlled Clinical Trial

A Double-blind, Placebo-controlled, Randomized, First-in-human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Oral Dose of MYMD1 Capsules in Healthy Male Adult Subjects

The Role of Immunomodulatory Treatment in Success of ICSI in Patients Who Have Infertility with Autoimmune Thyroiditis

Phase III Study to Evaluate the Efficacy and Safety of NPB-01 in Patients with Autoimmune Encephalitis Refractory to Steroid Pulse Therapy

Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune Thyroid Disease


A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Potential Effects of the Dietary Supplement Anatabloc on Antithyroid Autoantibodies and Thyroid Function in Autoimmune Thyroiditis

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicentre Basket Study to Evaluate the Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics of Satralizumab in Patients with Anti-N-Methyl-D-Aspartic Acid Receptor (NMDAR) Or Anti-Leucine-Rich Glioma-Inactivated 1 (LGI1) Encephalitis

Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients


Effect of Supplementation of Two Doses of L-selenomethionine (Semet; 80 and 160 mcg) Versus Placebo in Patients with Chronic Autoimmune Thyroiditis (AIT) With Normal Thyroid Function.

A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED)

Randomized Controlled Trial of Preoperative Steroids in Autoimmune Thyroid Disease


Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis: Open-lable, Randomised, Proof of Concept Study

A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED)




For healthcare organizations looking to effectively manage Hashimoto Thyroiditis, DiseaseLandscape Insights (DLI) a healthcare consulting firm is ready to offer a wide range of strategic services to all our stakeholders. Services with a wide range that encompasses conducting market research and analysis to identify trends and opportunities.

Additionally, DLI also provides advice to clients to ensure regulatory compliance on utilizing clinical expertise for evidence-based approaches, developing creative product development strategies, facilitating collaboration with important stakeholders, and more.

DLI services are equipped to navigate clients on the complex landscape of Hashimoto Thyroiditis management and help them make well-informed choices that improve patient outcomes by providing customized recommendations.

Services offered by DLI help the market players to carry out clinical trials for novel medications and therapies easily. Also, it supports patient recruitment, regulatory compliance, and other activities. DLI also provides detailed information about market competitors, growth of the market, and new regulations and rules across the globe to industry players. DLI services assist market participants in gaining a stronger foothold in the Hashimoto Thyroiditis sector.

Vishal SawantBusiness Development

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