The Graves' orbitopathy market is undergoing rapid change, driven by advancements in targeted treatments. TEPEZZA (teprotumumab-trbw) remains the only approved therapy, providing significant clinical improvements and enhancing quality of life. New therapies in late-stage development, including VRDN-001, VRDN-003, and efgartigimod PH20 SC, are showing potential by targeting the IGF-1R and FcRn pathways to alleviate proptosis, orbital inflammation, and pathogenic IgG autoantibodies.
LAS VEGAS, Oct. 2, 2025 /PRNewswire/ -- DelveInsight's Graves' Orbitopathy Market Insights report includes a comprehensive understanding of current treatment practices, Graves' orbitopathy emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Graves' Orbitopathy Market Summary
- The market size for Graves' orbitopathy was found to be USD 2.1 billion in the leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] in 2024.
- The United States accounted for the largest Graves' orbitopathy treatment market size, approximately 96% of the total market size in the 7MM in 2024, compared to other major markets, including the EU4 countries, the United Kingdom, and Japan.
- According to DelveInsight analysis, there were approximately 1.4 million diagnosed prevalent cases of Graves' orbitopathy in the 7MM in 2024, with the number projected to rise by 2034.
- Leading Graves' orbitopathy companies developing emerging therapies, such as Viridian Therapeutics, Kissei Pharmaceutical, argenx, Hoffmann-La Roche, Immunovant Sciences, HanAll Biopharma, Samsung Biologics, Sling Therapeutics, Tourmaline Bio, Lassen Therapeutics, Alumis (ACELYRIN), and others, are developing new Graves' orbitopathy treatment drugs that can be available in the Graves' orbitopathy market in the coming years.
- The promising Graves' orbitopathy therapies in clinical trials include Veligrotug (VRDN-001), VRDN-003, Efgartigimod PH20 SC, ENSPRYNG (satralizumab; RG6168), Batoclimab (IMVT-1401; RVT-1401), Linsitinib, Pacibekitug (TOUR006), LASN01, Lonigutamab, and others.
Discover the new Graves' orbitopathy treatment @ Graves' Orbitopathy Treatment Market
Key Factors Driving the Growth of the Graves' Orbitopathy Market
Rising Graves' Orbitopathy Prevalence
According to DelveInsight analysis, there were approximately 1.4 million diagnosed prevalent cases of Graves' orbitopathy in the 7MM in 2024, with the number projected to rise by 2034. In 2024, the US reported that the highest cases were mild, followed by moderate-to-severe cases, and sight-threatening cases of Graves' orbitopathy, and these numbers are anticipated to rise throughout the forecast period from 2025 to 2034. The disproportionately higher prevalence of early-stage cases across all categories underscores the impact of increased disease awareness, earlier symptom recognition, and advancements in diagnostic tools.
Role of Standardized Diagnostic Tools
Enhanced awareness and standardized tools like VISA and EUGOGO aid early Graves' orbitopathy diagnosis, enabling timely interventions to prevent severe progression.
TEPEZZA: Only Approved TED Drug
With TEPEZZA as the only approved therapy, there is a significant market opportunity for new treatments targeting underlying mechanisms like autoimmunity and offering novel routes of administration in Graves' orbitopathy.
Graves' Orbitopathy Competitive Landscape
The Graves' orbitopathy clinical trial landscape is highly competitive, with late-stage candidates such as Viridian Therapeutics/Kissei Pharmaceutical's Veligrotug (VRDN-001), VRDN-003, argenx's efgartigimod PH20 SC, Immunovant Sciences/HanAll Biopharma/Samsung Biologics's batoclimab, Sling Therapeutics' Linsitinib, Tourmaline Bio's Pacibekitug, and others, showing promise as disease-modifying, steroid-sparing therapies to improve outcomes in moderate-to-severe TED.
Graves' Orbitopathy Market Analysis
Graves' orbitopathy currently has few treatment options, with Amgen'sTEPEZZA (teprotumumab-trbw) being the only therapy formally approved. The disease's complex autoimmune processes and varied clinical manifestations make the development of targeted, disease-modifying treatments particularly difficult, resulting in a significant unmet medical need.
Available pharmacological interventions include glucocorticoids, mycophenolate, rituximab, tocilizumab, teprotumumab, and cyclosporine/mTOR inhibitors. Oral prednisone is commonly used, while higher doses or intravenous administration are typically reserved for cases involving optic nerve compression.
Emerging therapies such as Efgartigimod PH20 SC and Batoclimab (IMVT-1401; RVT-1401) target FcRn to reduce pathogenic IgG autoantibodies in thyroid eye disease. Efgartigimod is a subcutaneous antibody fragment designed for optimized absorption, whereas Batoclimab is a subcutaneous monoclonal antibody developed for multiple IgG-mediated autoimmune disorders. IGF-1R inhibitors, including Veligrotug (VRDN-001) and VRDN-003, decrease proptosis and orbital inflammation, with VRDN-003 providing an extended half-life and flexible dosing. Collectively, these therapies offer complementary, targeted strategies with unique mechanisms and pharmacokinetic profiles to enhance patient outcomes.
Graves' Orbitopathy Competitive Landscape
The Graves' orbitopathy treatment landscape is becoming increasingly competitive, with multiple promising candidates advancing through various stages of development. Key investigational therapies include Viridian Therapeutics/Kissei Pharmaceutical's Veligrotug (VRDN-001) and VRDN-003, argenx's Efgartigimod PH20 SC, Immunovant Sciences/HanAll Biopharma/Samsung Biologics' Batoclimab (IMVT-1401), and others.
Viridian's lead intravenous (IV) monoclonal antibody candidate, Veligrotug (VRDN-001), is being developed as a potential best-in-class therapy for thyroid eye disease (TED). Clinical data through Week 6 demonstrate strong efficacy and good tolerability, though no direct comparisons with the approved anti-IGF-1R antibody have been conducted. Veligrotug is being studied in two global Phase III trials: THRIVE (NCT05176639) for active TED and THRIVE-2 (NCT06021054) for chronic TED. Long-term results from THRIVE show that 70% of patients maintained a proptosis response at Week 52. Regulatory filings include a planned US BLA submission in 2H 2025 and an anticipated EU MAA submission in 1H 2026, with a US launch targeted for 2H 2026. The FDA granted Breakthrough Therapy Designation in May 2025 due to the rapid response to proptosis and durable improvement in diplopia, making veligrotug eligible for Priority Review.
Viridian's VRDN-003 is a potential best-in-class subcutaneous (SC) monoclonal antibody targeting IGF-1R. It shares the same binding domain as veligrotug (VRDN-001). Still, it has been engineered for a longer half-life, aiming to maintain IV veligrotug's clinical efficacy while offering improved patient convenience and potentially better safety through SC administration. Viridian began two global Phase III trials in August 2024: REVEAL-1 for active TED and REVEAL-2 for chronic TED. Topline results from both studies are expected in the first half of 2026, with a BLA submission targeted for the end of 2026 and a potential launch for both active and chronic TED in 2027.
argenx's Efgartigimod PH20 SC is a fully human antibody fragment designed to inhibit FcRn, reducing pathogenic IgG autoantibodies implicated in autoimmune diseases, including TED. It is currently in Phase III proof-of-concept trials, with topline results expected in 2H 2026. The subcutaneous PH20 formulation improves drug absorption and patient convenience.
Immunovant Sciences' Batoclimab is a fully human monoclonal antibody that targets FcRn, reducing IgG antibody levels. Elevated IgG antibodies drive many autoimmune diseases, and batoclimab is being developed as a self-administered SC injection. Phase III data for TED are anticipated in 2H 2025, with additional indications under investigation.
The anticipated launch of these emerging therapies are poised to transform the Graves' orbitopathy market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Graves' orbitopathy market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about the Graves' orbitopathy drugs @ Graves' Orbitopathy Drugs Market
Recent Developments in the Graves' Orbitopathy Market
- In September 2025, Novartis agreed to acquire Tourmaline Bio for USD 48 per share in cash, valuing the company at about USD 1.4 billion, with closing expected in the fourth quarter of 2025.
- In July 2025, Viridian partnered with Kissei Pharmaceutical for the exclusive development and commercialization of veligrotug and VRDN-003 in Japan, with an upfront payment of USD 70 million, up to USD 315 million in milestone payments, and tiered royalties ranging from 20% to 35% on net sales.
What is Graves' Orbitopathy?
Graves' orbitopathy, also called thyroid eye disease (TED), is an autoimmune inflammatory disorder of the orbit that most commonly occurs in patients with Graves' disease. However, it can also present in individuals with chronic thyroiditis who are euthyroid or hypothyroid. The condition involves remodeling of orbital tissues, marked by enlargement of extraocular muscles and fat, which leads to characteristic eye symptoms. Its pathogenesis is primarily driven by immune responses against the thyroid-stimulating hormone receptor (TSH-R), with TSH-R autoantibodies strongly associated with disease activity and severity.
Graves' Orbitopathy Epidemiology Segmentation
The Graves' orbitopathy epidemiology section provides insights into the historical and current Graves' orbitopathy patient pool and forecasted trends for the leading markets. The US had the highest number of diagnosed prevalent cases of Graves' orbitopathy, with approximately 610K cases in 2024. This figure is expected to increase by 2034. In the same year, the US represented about 72% of chronic and around 28% of acute diagnosed prevalent cases of Graves' orbitopathy.
The Graves' orbitopathy treatment market report proffers epidemiological analysis for the study period 2020-2034 in the leading markets, segmented into:
- Total Prevalent Cases of Graves' Disease
- Total Diagnosed Prevalent Cases of Graves' Disease
- Total Diagnosed Prevalent Cases of Graves' Orbitopathy
- Gender-specific Diagnosed Prevalent Cases of Graves' Orbitopathy
- Chronicity-specific Diagnosed Prevalent Cases of Graves' Orbitopathy
- Severity-specific Diagnosed Prevalent Cases of Graves' Orbitopathy
Graves' Orbitopathy Market Report Metrics | Details |
Study Period | 2020-2034 |
Coverage | 7MM [The United States, the EU4 (Germany, France, Italy, and Spain) , the United Kingdom, and Japan]. |
Graves' Orbitopathy Market CAGR | 19.8 % |
Graves' Orbitopathy Market Size in 2024 | USD 2.1 Billion |
Key Graves' Orbitopathy Companies | Viridian Therapeutics, Kissei Pharmaceutical, argenx, Hoffmann-La Roche, Immunovant Sciences, HanAll Biopharma, Samsung Biologics, Sling Therapeutics, Tourmaline Bio, Lassen Therapeutics, Alumis (ACELYRIN), and others |
Key Graves' Orbitopathy Therapies | Veligrotug (VRDN-001), VRDN-003, Efgartigimod PH20 SC, ENSPRYNG (satralizumab; RG6168), Batoclimab (IMVT-1401; RVT-1401), Linsitinib, Pacibekitug (TOUR006), LASN01, Lonigutamab, and others |
Scope of the Graves' Orbitopathy Market Report
- Therapeutic Assessment: Graves' Orbitopathy current marketed and emerging therapies
- Graves' Orbitopathy Market Dynamics: Key Market Forecast Assumptions of Emerging Graves' Orbitopathy Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, Graves' Orbitopathy Market Access and Reimbursement
Download the report to understand who's the best in Graves' orbitopathy treatment industry @ Graves' Orbitopathy Disease Market
Table of Contents
1 | Graves' Orbitopathy Market Key Insights |
2 | Graves' Orbitopathy Market Report Introduction |
3 | Graves' Orbitopathy Market Overview at a Glance |
3.1 | Clinical Landscape Analysis (By Phase, RoA, and Molecule Type) |
3.2 | Market Share (%) Distribution of Graves' Orbitopathy by Therapies in 2024 |
3.3 | Market Share (%) Distribution of Graves' Orbitopathy by Therapies in 2034 |
4 | Executive Summary |
5 | Key Events |
5.1 | Upcoming Key Catalysts |
5.2 | Key Transactions and Collaborations |
5.3 | News Flow |
6 | Disease Background and Overview |
6.1 | Introduction |
6.2 | Graves' Orbitopathy Types |
6.3 | Graves' Orbitopathy Signs and Symptoms |
6.4 | Graves' Orbitopathy Causes and Risk Factors |
6.5 | Graves' Orbitopathy Grading |
6.6 | Graves' Orbitopathy Pathophysiology |
6.7 | Graves' Orbitopathy Biomarkers |
6.8 | Graves' Orbitopathy Diagnosis |
6.9 | Graves' Orbitopathy Treatment |
6.10 | Diagnosis and Treatment Guidelines |
7 | Graves' Orbitopathy Epidemiology and Market Forecast Methodology |
8 | Graves' Orbitopathy Epidemiology and Patient Population |
8.1 | Key Findings |
8.2 | Assumptions and Rationale |
8.2.1 | Total Prevalent Cases of Graves' Disease |
8.2.2 | Total Diagnosed Prevalent Cases of Graves' Disease |
8.2.3 | Total Prevalent Cases of Graves' Orbitopathy Among Graves' Disease |
8.2.4 | Gender-specific Cases of Graves' Orbitopathy |
8.2.5 | Chronicity-specific Cases of Graves' Orbitopathy |
8.2.6 | Severity-Specific Cases of Graves' Orbitopathy |
8.2.7 | Treated Cases of Graves' Orbitopathy |
8.3 | Total Diagnosed Prevalent Cases of Graves' Orbitopathy in the 7MM |
8.4 | The US |
8.5 | EU4 and the UK |
8.6 | Japan |
9 | Graves' Orbitopathy Patient Journey |
10 | Marketed Graves' Orbitopathy Drugs |
10.1 | TEPEZZA (teprotumumab-trbw): Amgen (Horizon Therapeutics) |
10.1.1 | Product Description |
10.1.2 | Regulatory Milestones |
10.1.3 | Other Developmental Activities |
10.1.4 | Summary of Pivotal Trials |
10.1.5 | Ongoing Clinical Development Activity |
10.1.6 | Analyst View |
List to be continued in the final report…… | |
11 | Emerging Graves' Orbitopathy Drugs |
11.1 | Key Cross Competition |
11.2 | Veligrotug (VRDN-001): Viridian Therapeutics/Kissei Pharmaceutical |
11.2.1 | Product Description |
11.2.2 | Other Development Activities |
11.2.3 | Clinical Development |
11.2.3.1 | Clinical Trials Information |
11.2.4 | Safety and Efficacy |
11.2.5 | Analyst Views |
11.3 | VRDN-003: Viridian Therapeutics/Kissei Pharmaceutical |
11.4 | Efgartigimod PH20 SC: argenx |
11.5 | ENSPRYNG (satralizumab; RG6168): Hoffmann-La Roche |
11.6 | Batoclimab (IMVT-1401; RVT-1401): Immunovant Sciences/HanAll Biopharma/Samsung Biologics |
11.7 | Linsitinib: Sling Therapeutics |
11.8 | Pacibekitug (TOUR006): Tourmaline Bio |
11.9 | LASN01: Lassen Therapeutics |
11.10 | Lonigutamab: Alumis (ACELYRIN) |
List to be continued in the final report…… | |
12 | Graves' Orbitopathy Market- 7MM Market Analysis |
12.1 | Key Findings |
12.2 | Key Graves' Orbitopathy Market Forecast Assumptions |
12.3 | Graves' Orbitopathy Market Outlook |
12.4 | Attribute Analysis |
12.5 | Total Market Size of Graves' Orbitopathy in the 7MM |
12.6 | Total Market Size of Graves' Orbitopathy by Therapies in the 7MM |
12.7 | Market Size of Graves' Orbitopathy in the US |
12.7.1 | Total Market Size of Graves' Orbitopathy in the US |
12.7.2 | Total Market Size of Graves' Orbitopathy by Therapies in the US |
12.8 | Market Size of Graves' Orbitopathy in EU4 and the UK |
12.9 | Market Size of Graves' Orbitopathy in Japan |
13 | Key Opinion Leaders' Views on Graves' Orbitopathy |
14 | Graves' Orbitopathy Market Unmet Needs |
15 | Graves' Orbitopathy Market SWOT Analysis |
16 | Graves' Orbitopathy Market Access and Reimbursement |
16.1 | The United States |
16.2 | EU4 and the UK |
16.3 | Japan |
16.4 | Graves' Orbitopathy Market Access and Reimbursement |
17 | Acronyms and Abbreviations |
18 | Bibliography |
19 | Graves' Orbitopathy Market Report Methodology |
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