Graves' Disease Market Intelligence: Epidemiology Analysis and Therapeutic 

DelveInsight's comprehensive report on "Graves' Disease Market Insights, Epidemiology, and Market Forecast-2034" delivers extensive understanding of Graves' Disease, encompassing historical and projected epidemiology alongside market dynamics in the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.

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Key Highlights from the Market Report

• In December 2025, Sanofi announced a Phase 2, 2-arm investigation to measure rilzabrutinib treatment effect and safety at dose 1 or rilzabrutinib dose 2 in participants with Graves' disease, with and without Graves' orbitopathy, aged 18 years or older.

• In December 2025, Immunovant Sciences GmbH initiated an investigation to assess IMVT-1402 efficacy, safety, and tolerability in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment. The primary objective of this study is to evaluate IMVT-1402 efficacy versus placebo as assessed by T3 (total triiodothyronine [T3] or free triiodothyronine [FT3]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.

• Among the 7MM, the US accounted for approximately 48%, EU4 and the UK for 46%, and Japan for 6% of the total prevalent cases of Graves' disease in 2023.

• As per DelveInsight estimates, there were approximately 3,720,200 diagnosed prevalent cases of Graves' disease in the 7MM in 2023.

• In 2023, the manifestation of Graves' disease in the US showed that Graves' Ophthalmopathy captured the highest case numbers, i.e., approximately 584,400 cases.

• In 2023, the gender-specific diagnosed prevalent cases of Graves' disease in Japan were approximately 80,450 cases for males and approximately 321,800 cases for females.

• Key pharmaceutical developers include Amgen (Horizon Therapeutics), Immunovant, Samsung Biologics, HanAll Biopharma, Roivant Sciences, Viridian Therapeutics, Argenx, Hoffmann-La Roche, Sling Therapeutics, Tourmaline Bio, Lassen Therapeutics, ACELYRIN and others.

• Notable therapies comprise linsitinib, Batoclimab, Teprotumumab, VRDN-001 10 mg/kg, Satralizumab, IBI311, and others.

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Understanding Graves' Disease

Graves' disease represents an autoimmune disorder and the most common cause of hyperthyroidism, characterized by the overproduction of thyroid hormones due to the presence of thyroid-stimulating immunoglobulins that activate the thyroid-stimulating hormone (TSH) receptor. This excessive hormone secretion leads to a hypermetabolic state, resulting in symptoms such as weight loss, heat intolerance, palpitations, anxiety, tremors, and fatigue, along with a diffusely enlarged thyroid gland (goiter).

Epidemiological Insights

The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides detailed analysis of the diagnosed patient pool and future trends.

Graves' Disease Epidemiology Segmentation:

• Graves' Disease Gender-specific Cases

• Total Graves' Disease Prevalent Cases

• Graves' Disease Age Group-specific Cases

• Total Graves' Disease Treated Cases

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Therapeutic Landscape and Pipeline Development

The drugs uptake section focuses on the rate of uptake of potential drugs recently launched in the Graves' Disease market or expected to launch during the study period. The analysis covers Graves' Disease market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares drugs based on market share.

The report also covers Graves' Disease Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Key Graves' Disease Therapies and Companies:

• linsitinib: Sling Therapeutics, Inc.

• Batoclimab: Immunovant Sciences GmbH

• Teprotumumab: Amgen

• VRDN-001 10 mg/kg: Viridian Therapeutics Inc.

• Satralizumab: Hoffmann-La Roche

Market Outlook

There are three main treatments for Graves' disease: ATD medications, thyroidectomy, and radioactive iodine therapy. ATD medications prevent the biosynthesis of thyroid hormone by blocking iodide, the salted or reduced form of iodine, from interacting with thyroglobulin, thus diminishing the amount of hormone produced. Methimazole is the most widely used ATD medication, with a long half-life and low side effects. Another is carbimazole which has been approved in European countries but is not approved in the United States. It is an inactive drug that is metabolized in the blood into active methimazole thus it is less potent. And the last is propylthiouracil, which is the least potent of the available antithyroid medications. Approved in the United States and Europe, propylthiouracil is the initial treatment choice during the first trimester of pregnancy because of low placental transfer. Propylthiouracil was, for many years, the first-choice ATD in both the USA and South America. But now the American Thyroid Association (ATA) recommends Methimazole over Propylthiouracil. Methimazole is used in most European countries and Japan, whereas carbimazole is mainly used in the UK.

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Marketed Graves' Disease Therapeutics

TEPEZZA (Teprotumumab-Trbw): Amgen (Horizon Therapeutics) Teprotumumab, an insulin-like Growth Factor-1 receptor (IGF-1R) inhibitor, represents a fully human IgG1 monoclonal antibody produced in Chinese hamster (CHO-DG44) cells with a molecular weight of approximately 148 KD. In January 2020, the US FDA approved TEPEZZA for treating TED after an accelerated Priority Review. Recently, in September 2024, the drug was approved by Japan's Ministry of Health, Labour, and Welfare (MHLW) for treating active Graves' orbitopathy. Additionally, in April 2024, Amgen announced its plans to submit a Marketing Authorization Application (MAA) for teprotumumab to the European Medicines Agency (EMA) in the near future. TEPEZZA is currently under investigation in Phase III clinical trials for patients with moderate-to-severe active Graves' orbitopathy as well as those with chronic TED characterized by a low Clinical Activity Score (CAS). Additionally, Amgen is exploring its potential for subcutaneous administration.

Emerging Graves' Disease Therapeutics

IMVT-1401 (batoclimab, RVT-1401): Immunovant, Samsung Biologics, HanAll Biopharma, and Roivant Sciences Immunovant's first investigational product, batoclimab (IMVT-1401), represents a novel, fully human monoclonal antibody targeting the neonatal FcRn. In nonclinical studies and clinical trials, batoclimab has been observed to reduce IgG antibody levels. High levels of pathogenic IgG antibodies drive a variety of autoimmune diseases, and, as a result, this product candidate has the potential to address a variety of IgG-mediated autoimmune diseases as a self-administered SC injection. Currently, batoclimab is being developed as a low-volume SC injection for treating a variety of IgG-mediated autoimmune disorders, including myasthenia gravis, TED, chronic inflammatory demyelinating polyneuropathy, and Graves' disease. The drug is currently in Phase III developmental stage. Recently, in September 2024, Immunovant received Investigational New Drug (IND) clearance from the US FDA for IMVT-1402 in Graves' disease patients who remain hyperthyroid despite treatment with antithyroid drugs. Furthermore, Immunovant plans to initiate clinical trials of IMVT-1402 in a total of ten indications by March 2026.

VRDN-001 (veligrotug): Viridian Therapeutics Viridian's lead product candidate, VRDN-001, represents a differentiated monoclonal antibody targeting Insulin-like Growth Factor-1 Receptor (IGF-1R), a clinically and commercially validated target for treating Graves' ophthalmopathy. In preclinical studies, VRDN-001 had shown to be a full antagonist of IGF-1R, with complete receptor blockade than other anti-IGF-1R antibodies, including the only approved Graves' Ophthalmopathy therapy. Currently, the drug is being evaluated in various Phase III trials for treating Graves' ophthalmopathy. According to a corporate presentation published in November 2024, the potential PDUFA date and launch of veligrotug are expected in 2H 2026.

Report Scope

• Geographic Coverage: 7MM

• Study Period: 2020-2034

• Featured Companies: Amgen (Horizon Therapeutics), Immunovant, Samsung Biologics, HanAll Biopharma, Roivant Sciences, Viridian Therapeutics, Argenx, Hoffmann-La Roche, Sling Therapeutics, Tourmaline Bio, Lassen Therapeutics, ACELYRIN and others

• Pipeline Therapies: linsitinib, Batoclimab, Teprotumumab, VRDN-001 10 mg/kg, Satralizumab, IBI311, and others

• Therapeutic Assessment: Current marketed and emerging therapies

• Market Dynamics: Market drivers and barriers

• Competitive Intelligence: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

• Additional Coverage: Unmet Needs, KOL's views, Analyst's views, Market Access and Reimbursement

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Table of Contents

1. Graves' Disease Market Report Introduction

2. Executive Summary for Graves' Disease

3. SWOT analysis of Graves' Disease

4. Graves' Disease Patient Share (%) Overview at a Glance

5. Graves' Disease Market Overview at a Glance

6. Graves' Disease Disease Background and Overview

7. Graves' Disease Epidemiology and Patient Population

8. Country-Specific Patient Population of Graves' Disease

9. Graves' Disease Current Treatment and Medical Practices

10. Graves' Disease Unmet Needs

11. Graves' Disease Emerging Therapies

12. Graves' Disease Market Outlook

13. Country-Wise Graves' Disease Market Analysis (2020-2034)

14. Graves' Disease Market Access and Reimbursement of Therapies

15. Graves' Disease Market Drivers

16. Graves' Disease Market Barriers

17. Graves' Disease Appendix

18. Graves' Disease Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

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