Graves’ Ophthalmopathy Market Forecast Analysis 2034: Clinical Trial, Pipeline, FDA Approvals and companies by DelveInsight

Graves’ Ophthalmopathy Market

The Graves’ Ophthalmopathy (Thyroid Eye Disease) market was valued at approximately USD 2.6 billion in 2023 across the 7MM and is projected to grow steadily through 2034. This condition, a common extrathyroidal manifestation of Graves’ disease, affects nearly 1 million individuals in the United States alone and can become vision-threatening in about 5% of cases.

Despite its prevalence, the disease remains significantly underdiagnosed, largely due to low awareness among physicians and its often asymptomatic early stages. The United States accounts for the highest number of diagnosed cases within the 7MM, while among European countries, Germany leads in prevalence, with France and Spain reporting comparatively fewer cases.

Treatment strategies for Graves’ Ophthalmopathy depend on disease severity and include supportive care, pharmacological interventions, and surgical procedures. Corticosteroids are commonly used in the short term, particularly following radioactive iodine therapy, while botulinum toxin may provide temporary relief for specific symptoms like dysthyroid strabismus. Historically, therapeutic options were limited, especially for chronic cases where surgery was often the only viable solution.

The treatment landscape has evolved significantly with the introduction of targeted therapies. Amgen’s TEPEZZA (teprotumumab), launched in 2020 as the first approved therapy for thyroid eye disease, generated nearly USD 2 billion in revenue in 2023, marking a major breakthrough in this rare disease segment. Pipeline advancements are also promising, with Tourmaline Bio advancing TOUR006 into Phase IIb trials following IND approval, highlighting its long-acting profile and strong IL-6 targeting capability. Additionally, ACELYRIN has reported encouraging early-stage results for lonigutamab, a subcutaneous anti-IGF-1R therapy.

Emerging players such as Immunovant Sciences and Viridian Therapeutics are expected to further reshape the market with innovative treatment approaches. As research progresses, especially in chronic disease management, there is increasing emphasis on understanding patient quality of life and integrating patient-reported outcomes into clinical development. Overall, the evolving therapeutic landscape and ongoing clinical advancements present substantial growth opportunities in the Graves’ Ophthalmopathy market.

DelveInsight’s “Graves’ Ophthalmopathy Market Insights, Epidemiology, and Market Forecast 2034” report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the Graves’ Ophthalmopathy market size, share, trends, and growth opportunities in the seven major markets (7MM) (i.e., the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom and Japan).

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Graves’ Ophthalmopathy Market Key Facts

• The total Graves’ Ophthalmopathy market size in the 7MM was approximately USD 2.6 billion in 2023.
• Among EU4 countries, Germany accounted for the maximum Graves’ Ophthalmopathy market size in 2025.
• There are several promising Graves’ Ophthalmopathy drugs in the pipeline, including VRDN-001 (Viridian Therapeutics) and IMVT-1401 (Immunovant Sciences GmbH), among others, expected to hit the market in the near future.
• The total prevalent cases of Graves Ophthalmopathy in the United States were around 1,012,000 cases in 2022.
• In the 7MM, approximately 20% of the patient share is attributed to males, whereas only 80% of females suffer from Graves’ Ophthalmopathy.
• Teprotumumab (Tepezza): Teprotumumab, an FDA-approved treatment for thyroid eye disease, has shown promising results. In a phase 2 trial, it was found to reduce eye protrusion by more than two millimeters in over 70% of patients. Subsequently, a phase 3 trial (OPTIC) further validated its safety and efficacy.
• Atorvastatin and IvGCs Combination: A recent phase 2 randomized clinical trial explored the combination of atorvastatin (a statin) and intravenous glucocorticoids (ivGCs) for moderate-to-severe active Graves’ Ophthalmopathy. Although initial results were positive, a longer phase 3 trial is needed to establish its effectiveness.
• In April 2026, Amgen (NASDAQ: AMGN) announced positive topline results from a Phase 3 trial of TEPEZZA (teprotumumab-trbw) administered by subcutaneous injection via an on-body injector (OBI) in participants with moderate-to-severe active Thyroid Eye Disease (TED). TEPEZZA OBI provides comparable efficacy to, and builds upon the success of, intravenous (IV) TEPEZZA, the first and only medicine approved for the treatment of TED, which has now treated more than 25,000 patients worldwide.
• In April 2026, Tourmaline Bio, Inc. announced results of a Multicenter Phase 2b Randomized, Double-Masked, Placebo-Controlled Dose-Ranging Study of TOUR006 in Participants With Thyroid Eye Disease
• In September 2025, Viridian Therapeutics, Inc. announced that enrollment is complete in REVEAL-1 and REVEAL-2, Phase III clinical trials for VRDN-003 in patients with active and chronic TED, respectively.
• In August 2025, Alumis announced that the US Food and Drug Administration has granted Fast Track Designation to lonigutamab for the treatment of thyroid eye disease (TED).
• In July 2025, Viridian Therapeutics, Inc. announced that it had entered into an exclusive collaboration and license agreement with Kissei Pharmaceutical Co., Ltd. to develop and commercialize VRDN-003 in Japan.
• In May 2025, Alumis Inc. announced that it had completed its merger with ACELYRIN, Inc. Each ACELYRIN stockholder will receive 0.4814 shares of Alumis common stock for each share of ACELYRIN common stock owned.
• In April 2025, VelaVigo Bio announced its second out-licensing agreement of a first-in-class asset to Ollin Biosciences, Inc., granting Ollin an exclusive license to develop, manufacture and commercialize VBS-102 globally (excluding Greater China).
• In January 2025, Sling Therapeutics, Inc announced results of 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)

Graves’ Ophthalmopathy Overview

Graves’ ophthalmopathy is a complex orbital inflammatory disease that can be sight-threatening, debilitating, and disfiguring. Graves’ ophthalmopathy, also known as thyroid eye disease (TED), is named after Robert J. Graves, an Irish physician who first described thyrotoxicosis in a woman presenting with goitre, rapid heartbeat, and exophthalmos.

Graves’ ophthalmopathy affects eye muscles, eyelids, tear glands, and fatty tissues behind the eye to become inflamed. This can cause the eyes and eyelids to become red, swollen, and uncomfortable, and the eyes can be pushed forward (‘staring’ or ‘bulging’ eyes). Untreated thyroid dysfunction (hyper- or hypothyroidism) is associated with the development and progression of Graves’ ophthalmopathy. Smoking is the strongest risk factor associated with Graves’ ophthalmopathy.

According to NORD, the exact prevalence (i.e., the number of people who have a disorder in a specific population at a specific time) of Graves’ ophthalmopathy is not known but is estimated to be 16 per 100,000 women in the general population, and 2.9 per 100,000 men in the general population.

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Graves’ Ophthalmopathy Market

The market outlook section of the report helps to build a detailed comprehension of the historical, current and forecasted Graves’ Ophthalmopathy market size by analyzing the impact of current and emerging pipeline therapies. It also thoroughly assesses the market drivers & barriers, unmet needs, and emerging technologies set to impact the market dynamics.

The report gives complete detail of the Graves’ Ophthalmopathy market trend for each marketed drug and mid & late-stage pipeline therapies by evaluating their impact based on the annual cost of therapy, their Mechanism of Action (MOA), Route of Administration (ROA), molecule types, competition with other therapies, brand value, and their impact on the market.

Graves’ Ophthalmopathy Epidemiology Assessment

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 to recognize the causes of current and forecasted epidemiology trends by exploring numerous studies and research. The epidemiology section also provides a detailed analysis of diagnosed and prevalent patient pool, future trends, and views of key opinion leaders.

The Report Covers the Graves’ Ophthalmopathy Epidemiology, Segmented as –

• Total Prevalent cases of Graves’ ophthalmopathy in 7MM [2020–2034
• Gender-specific cases of Graves’ ophthalmopathy in 7MM [2020–2034]
• Severity-Specific Cases of Graves’ ophthalmopathy in 7MM [2020–2034]
• Age-specific cases of Graves’ ophthalmopathy in 7MM [2020–2034]

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Graves’ Ophthalmopathy Drugs Uptake and Pipeline Development Activities

The drug uptake section focuses on the uptake rate of potential drugs recently launched in the Graves’ Ophthalmopathy market or expected to be launched during the study period. The analysis covers the Graves’ Ophthalmopathy 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 the drugs based on market share.

The report also covers the Graves’ Ophthalmopathy pipeline development activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyses recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

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Graves’ Ophthalmopathy Therapeutics Analysis

Several major pharma and biotech giants are developing therapies for Graves Ophthalmopathy. Currently, Novartis is leading the therapeutics market with its Graves Ophthalmopathy drug candidates in the most advanced stage of clinical development.

Leading Companies in the Graves Ophthalmopathy Therapeutics Market Include:

• Novartis
• Harbour BioMed
• Viridian Therapeutics, Inc.
• Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Sling Therapeutics, Inc.
• ValenzaBio
• Argenx
• HanAll Biopharma
• Immunovant Sciences
• Novartis
• Viridian Therapeutics
• And Many Others

Graves Ophthalmopathy Therapies Covered in the Report Include:

• Tepezza (teprotumumab) : Horizon Therapeutics
• Secukinumab: Novartis
• Batoclimab (HBM9161): Harbour BioMed
• TEPEZZA (teprotumumab): Horizon Therapeutics
• Batoclimab: Immunovant Sciences
• VRDN-001: Viridian Therapeutics
• Linsitinib : Sling Therapeutics
• And Many More

The Report Covers the In-depth Assessment of the Emerging Drugs & Key Companies. Download the Sample Report to Learn More @ https://www.delveinsight.com/sample-request/graves-ophthalmopathy-market

Table of Content (TOC)

1. Key Insights
2. Executive Summary
3. Graves’ Ophthalmopathy Competitive Intelligence Analysis
4. Graves’ Ophthalmopathy Market Overview at a Glance
5. Graves’ Ophthalmopathy Disease Background and Overview
6. Graves’ Ophthalmopathy Patient Journey
7. Graves’ Ophthalmopathy Epidemiology and Patient Population (In the US, EU5, and Japan)
8. Graves’ Ophthalmopathy Treatment Algorithm, Current Treatment, and Medical Practices
9. Graves’ Ophthalmopathy Unmet Needs
10. Key Endpoints of Graves’ Ophthalmopathy Treatment
11. Graves’ Ophthalmopathy Marketed Products
12. Graves’ Ophthalmopathy Emerging Drugs and Latest Therapeutic Advances
13. Graves’ Ophthalmopathy Seven Major Market Analysis
14. Attribute Analysis
15. Graves’ Ophthalmopathy Market Outlook (In US, EU5, and Japan)
16. Graves’ Ophthalmopathy Access and Reimbursement Overview
17. KOL Views on the Graves’ Ophthalmopathy Market
18. Graves’ Ophthalmopathy Market Drivers
19. Graves’ Ophthalmopathy Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer

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