Hashimoto's Thyroiditis market size was ~USD 1,450 million, as per DelveInsight | TNF Pharmaceuticals, and others 07-02-2025 12:08 PM CET | Health & Medicine Press release from: DelveInsight Business Research LLP
DelveInsight's new report on "Hashimoto's Thyroiditis - Market Insights, Epidemiology, and Market Forecast-2034" provides an in-depth analysis of the disease, historical and forecasted epidemiology, and market trends in the US, EU5 (Germany, Spain, Italy, France, UK), and Japan.
Emerging therapies like Isomyosamine (MYMD-1) from TNF Pharmaceuticals are poised to drive market growth.
Key Facts from the Report:
Hashimoto's Thyroiditis Overview An autoimmune disorder causing hypothyroidism, with risks of cardiovascular issues and cancers. Forms include classic, fibrous, IgG4-related, juvenile, and Hashitoxicosis. Triggers: immune treatments, iodine excess, vitamin D deficiency. Genetic factors (HLA, CTLA-4, PTPN22) and epigenetics play roles. Symptoms: fatigue, weight gain, cognitive issues.
Market Outlook Management focuses on LT4 for hormonal balance; combination LT4/T3 for persistent symptoms. Immunomodulatory therapies targeting autoimmune mechanisms are emerging. Early intervention is key, but unmet needs persist for better symptom control.
After an extensive search of clinical trial registries and public sources on interventional therapeutic trials specifically targeting Hashimoto’s Thyroiditis where a Japanese, Korean, or Taiwanese company is listed as sponsor or co‑sponsor, there is no clear evidence of such trials (Phase 1–3) conducted by companies from Japan, South Korea, or Taiwan that are focused on Hashimoto’s Thyroiditis itself.
Most interventional clinical research related to thyroid autoimmunity in registries involves thyroid eye disease (TED) or other autoimmune indications (e.g., myasthenia gravis) rather than Hashimoto’s Thyroiditis (HT) per se. A widely reported drug in this space, batoclimab (HBM9161 / HL161), is being developed by a Korean company (in partnership/licensing) for autoimmune conditions such as TED but not directly for Hashimoto’s Thyroiditis as a primary indication in registered Phase 2/3 trials.
Batoclimab (Anti‑FcRn monoclonal antibody) is developed by HanAll Biopharma Co., Ltd. (Korea), with a global development program. It is a fully human monoclonal antibody that targets the neonatal Fc receptor (FcRn) to accelerate IgG degradation, potentially reducing pathogenic autoantibodies in autoimmune diseases. Batoclimab is under Phase 2/3 development for certain autoimmune diseases (e.g., myasthenia gravis, TED), but no registered Phase 1–3 clinical trial specifically for Hashimoto’s Thyroiditis as the primary indication could be identified in major registries. The Phase 3 study is being conducted in active Thyroid Eye Disease (TED), which is an autoimmune condition often associated with Graves’ Disease rather than Hashimoto’s Thyroiditis itself. Batoclimab’s mechanism is IgG modulation, which is relevant in autoimmune conditions but not directly registered for Hashimoto’s Thyroiditis treatment.
There are interventional studies exploring adjuvant therapies (e.g., vitamin D supplementation) involving Hashimoto’s Thyroiditis, but these are typically not sponsored by Japanese, Korean, or Taiwanese companies, often Phase 2 or exploratory, and involve non‑patented supplements or biomarkers, not linked to proprietary drug development programs from the region’s biopharma sector. For example, NCT05871957 is a Vitamin D adjuvant study in Hashimoto’s Thyroiditis patients (not drug‑company sponsored).
After reviewing available data, HanAll Biopharma Co., Ltd. (South Korea) is developing Batoclimab (HBM9161 / HL161) for autoimmune diseases (e.g., TED) in Phase 2/3, with FcRn inhibition (IgG reduction) as the mechanism, but no registered Hashimoto’s Thyroiditis‑specific trial; active trials focus on TED & other autoimmune conditions. No clear Japanese or Taiwanese pharmaceutical company is listed as sponsor/co‑sponsor for Phase 1–3 HT trials in registries.
Batoclimab received Orphan Drug Designation in Japan for active Thyroid Eye Disease (a related autoimmune thyroid condition) — suggesting regulatory recognition of an autoimmune target in the region. There are no major regulatory updates specific to trial‑sponsored Hashimoto’s Thyroiditis therapeutics by Japan/Korea/Taiwan companies in public clinical trial registries or recent press.
At present, based on publicly available clinical trial registries and company disclosures, there are no Phase 1–3 interventional clinical trials sponsored or co‑sponsored by Japanese, Korean, or Taiwanese companies that explicitly target Hashimoto’s Thyroiditis as the primary indication. There are relevant autoimmune therapy programs (e.g., batoclimab) from Korean companies targeting related autoimmune pathology, but not registered for Hashimoto’s Thyroiditis per se. Observational or adjunctive studies exist but lack proprietary drug development backing from regional biotech/pharma companies.
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Related report
Hashimoto's Thyroiditis - Epidemiology Forecast - 2034
DelveInsight’s “Hashimoto’s Thyroiditis Epidemiology Forecast – 2034” report delivers an in-depth understanding of Hashimoto’s Thyroiditis, historical and forecasted epidemiology of Hashimoto’s Thyroiditis in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. The leading Hashimoto Thyroiditis Companies developing potential therapies include - TNF Pharmaceuticals, Pfizer, Merck KGaA, AbbVie Inc., Takeda Pharmaceutical Company Ltd., and Novartis AG, and others.
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