Graves’ Orbitopathy Market to Grow from USD 2.06 Billion at a CAGR of 19.8% Through 2034
(Albany, US), September 14, 2026, DelveInsight’s “Graves’ Orbitopathy Market Insights, Epidemiology, and Market Forecast 2034” report offers an in-depth understanding of Graves’ orbitopathy, historical and forecasted epidemiology, as well as the market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
To know in detail about the Graves’ orbitopathy market outlook, drug uptake, treatment scenario, and epidemiology trends, click here: https://www.delveinsight.com/report-store/graves-orbitopathy-market
Some of the Key Facts of the Graves’ Orbitopathy Market Report
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In May 2025, Viridian Therapeutics received US FDA Breakthrough Therapy Designation for Veligrotug (VRDN-001) in thyroid eye disease (TED), based on robust improvements in diplopia and rapid proptosis response.
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In May 2025, Viridian Therapeutics reported that 70% of patients in the Phase III THRIVE trial who achieved a proptosis response with Veligrotug at Week 15 maintained it at Week 52.
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In July 2025, Viridian Therapeutics collaborated with Kissei Pharmaceutical, granting Kissei exclusive rights to develop and commercialize Veligrotug and VRDN-003 in Japan, with Viridian receiving a USD 70 million upfront payment and up to USD 315 million in milestones.
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Viridian Therapeutics is targeting a Biologics License Application (BLA) submission for VRDN-003 in TED by year-end 2026, with topline data from both pivotal trials expected in the first half of 2026.
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Argenx’s Efgartigimod PH20 SC is currently in Phase III proof-of-concept trials for TED, with topline results expected in the second half of 2026.
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Veligrotug (VRDN-001) is targeting a US launch in the second half of 2026, positioning it as a potential key entrant in the Graves’ orbitopathy landscape.
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According to DelveInsight’s analysis, the Graves’ orbitopathy market size in the 7MM was valued at approximately USD 2,060 million in 2024 and is projected to grow at a CAGR of 19.8% during the forecast period through 2034.
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The United States accounted for the largest Graves’ orbitopathy market share among the 7MM, with revenue of approximately USD 1,980 million in 2024.
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The total diagnosed prevalent cases of Graves’ orbitopathy across the 7MM were estimated at approximately 1.4 million in 2024.
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Within the EU4 and the UK, Germany accounted for the highest number of diagnosed prevalent cases, with approximately 155,000 cases reported in 2024.
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Graves’ orbitopathy is closely linked with Graves’ disease; DelveInsight estimated around 7.1 million prevalent cases of Graves’ disease across the 7MM in 2024, with 3.5 million being diagnosed.
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Currently, TEPEZZA (teprotumumab-trbw) remains the only approved therapy for active Graves’ orbitopathy, while a wave of IGF-1R antibodies and FcRn inhibitors advance through late-stage development to address this substantial unmet need.
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Key Graves’ Orbitopathy Companies: Amgen (Horizon Therapeutics), Viridian Therapeutics, Kissei Pharmaceutical, argenx, Tourmaline Bio, Immunovant Sciences, HanAll Biopharma, Samsung Biologics, Sling Therapeutics, Hoffmann-La Roche, and other emerging market players.
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Key Graves’ Orbitopathy Therapies: TEPEZZA (teprotumumab-trbw), Veligrotug (VRDN-001), VRDN-003, Efgartigimod PH20 SC, ENSPRYNG (satralizumab), Batoclimab, Pacibekitug (TOUR006), Linsitinib, LASN01, lonigutamab, and other emerging therapies.
Graves’ Orbitopathy Overview
Graves’ orbitopathy, also known as Thyroid Eye Disease (TED), is the most common extrathyroidal manifestation of Graves’ disease, resulting from autoimmune activity that causes orbital inflammation, tissue remodeling, and, in advanced cases, vision-threatening complications.
The condition progresses through an early active inflammatory stage and a later inactive fibrotic stage, with severity classified using scoring systems such as NO SPECS, EUGOGO, VISA, and the Clinical Activity Score (CAS).
Diagnosis relies on a structured combination of clinical evaluation, thyroid function and autoantibody testing, and orbital imaging (MRI or CT) to confirm autoimmunity, assess disease activity, and rule out differential diagnoses such as orbital myositis or IgG4-related disease.
Get a free sample for the Graves’ Orbitopathy Market Forecast, Size & Share Analysis Report.
Graves’ Orbitopathy Epidemiology
The Graves’ orbitopathy epidemiology section provides insights into the historical and current patient pool and forecasted trends across the seven major markets (7MM): the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan for the study period 2020–2034.
Graves’ Orbitopathy Epidemiology Segmentation
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Total Prevalent Cases of Graves’ Disease
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Total Diagnosed Prevalent Cases of Graves’ Disease
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Total Diagnosed Prevalent Cases of Graves’ Orbitopathy
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Gender-specific Diagnosed Prevalent Cases of Graves’ Orbitopathy
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Chronicity-specific Diagnosed Prevalent Cases of Graves’ Orbitopathy
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Severity-specific Diagnosed Prevalent Cases of Graves’ Orbitopathy
Download the report to understand which factors are driving Graves’ orbitopathy epidemiology trends.
Graves’ Orbitopathy Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of potential Graves’ orbitopathy drugs expected to launch during the forecast period 2025–2034, covering peak performance, factors affecting growth years, patient uptake by therapy, and anticipated sales.
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Drug uptake in Graves’ orbitopathy is expected to be led by Veligrotug (VRDN-001) following its anticipated 2026 US launch, driven by strong Phase III efficacy data, Breakthrough Therapy Designation, and the convenience benefits it may offer relative to the current standard of care.
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Emerging candidates such as VRDN-003 and Efgartigimod PH20 SC are expected to see gradual, sustained adoption as subcutaneous administration options and FcRn-targeted mechanisms broaden the treatment paradigm beyond IGF-1R inhibition alone.
The report also covers Graves’ Orbitopathy Pipeline Development: https://www.delveinsight.com/report-store/graves-orbitopathy-market
Graves’ Orbitopathy Marketed and Late-Stage Therapies and Key Companies
Currently, the landscape is anchored by a single approved biologic focused on active disease, with a deep late-stage pipeline of IGF-1R and FcRn-targeted candidates poised to expand options for moderate-to-severe patients.
Graves’ Orbitopathy Marketed Therapies
TEPEZZA (teprotumumab-trbw): Amgen (Horizon Therapeutics)
A fully human IgG1 monoclonal antibody targeting IGF-1R, produced in CHO-DG44 cells (~148 kDa), administered via IV infusion. It works by inhibiting IGF-1R signaling in orbital fibroblasts, reducing inflammation and tissue remodeling associated with Graves’ orbitopathy. Approved in the US (2020) and Japan (2024).
Graves’ Orbitopathy Emerging Therapies
Veligrotug (VRDN-001): Viridian Therapeutics/Kissei Pharmaceutical
An investigational IV monoclonal antibody that fully antagonizes IGF-1R, in Phase III development and positioned as a potential best-in-class therapy with a targeted US launch in the second half of 2026.
VRDN-003: Viridian Therapeutics/Kissei Pharmaceutical
A potential best-in-class subcutaneous monoclonal antibody targeting IGF-1R, engineered for an extended half-life, retaining the efficacy of Veligrotug while offering improved convenience.
Efgartigimod PH20 SC: argenx
An investigational subcutaneous antibody fragment targeting the neonatal Fc receptor (FcRn) to reduce pathogenic IgG autoantibody levels, currently in Phase III proof-of-concept trials for TED.
Discover more about therapies set to shape the Graves’ orbitopathy market share.
Graves’ Orbitopathy Market Drivers
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Rising prevalence of Graves’ disease and its extrathyroidal manifestations.
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Advancements in targeted biologics, including IGF-1R and FcRn-directed therapies.
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Strong late-stage pipeline and increasing R&D investment from multiple sponsors.
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Regulatory momentum, including Breakthrough Therapy Designation for lead candidates.
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Growing physician and patient awareness of disease-modifying treatment options.
Graves’ Orbitopathy Market Barriers
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Reliance on a single approved therapy (TEPEZZA) for active disease.
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High cost of biologic treatment and complex prior-authorization requirements.
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Limited efficacy of off-label options such as corticosteroids and immunosuppressants.
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Diagnostic complexity due to overlapping presentations with other orbital conditions.
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Variable reimbursement and access pathways across the 7MM.
Scope of the Graves’ Orbitopathy Market Report
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Study Period: 2020–2034
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Forecast Period: 2025–2034
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Coverage: 7MM (United States, EU4 [Germany, France, Italy, and Spain], the United Kingdom, and Japan)
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Key Graves’ Orbitopathy Companies: Amgen (Horizon Therapeutics), Viridian Therapeutics, Kissei Pharmaceutical, argenx, Tourmaline Bio, Immunovant Sciences, HanAll Biopharma, Samsung Biologics, Sling Therapeutics, Hoffmann-La Roche, and other emerging market players.
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Key Graves’ Orbitopathy Therapies: TEPEZZA (teprotumumab-trbw), Veligrotug (VRDN-001), VRDN-003, Efgartigimod PH20 SC, ENSPRYNG (satralizumab), Batoclimab, Pacibekitug (TOUR006), Linsitinib, LASN01, lonigutamab, and other emerging therapies.
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Therapeutic Assessment: Comprehensive analysis of currently marketed and emerging Graves’ orbitopathy therapies.
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Market Dynamics: Detailed evaluation of market drivers, barriers, opportunities, and challenges.
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Competitive Intelligence Analysis: SWOT analysis, attribute analysis, cost assumptions and pricing analogues, reimbursement landscape, and competitive benchmarking.
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Additional Coverage: Unmet needs, KOL insights, market access strategies, and reimbursement analysis across the 7MM.
About DelveInsight
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