Graves Orbitopathy - Market Insight, Epidemiology And Market Forecast - 2034

Key Highlights:

• According to DelveInsight's estimates, in 2024, there were approximately 1.4 million diagnosed prevalent cases of Graves' orbitopathy in the 7MM. Of these, the United States accounted for 43% of the cases, while EU4 and the UK accounted for nearly 50% and Japan represented 7% of the cases, respectively.
• The Graves' orbitopathy market is set for steady growth from 2025 to 2034, driven by novel therapies such as Veligrotug (VRDN-001), VRDN-003, and Efgartigimod PH20 SC. Rising prevalence associated with smoking, age, hyperthyroidism duration, radioactive iodine use, genetics, and environmental factors like selenium deficiency and stress will further fuel this expansion across the 7MM.
• According to DelveInsight's analysis, the Graves' orbitopathy market in the 7MM was valued at approximately USD 2,060 million in 2024. Over the forecast period from 2025 to 2034, this market is projected to grow at a CAGR of 19.8%.
• Graves' orbitopathy currently has limited treatment options, with TEPEZZA (teprotumumab-trbw) being the only approved therapy. The disease's complex autoimmune mechanisms and diverse clinical presentations make the development of targeted, disease-modifying treatments particularly challenging, leaving a substantial unmet medical need. In clinical practice, off-label approaches such as glucocorticoids and prophylactic corticosteroids are frequently used, but these mainly provide symptomatic relief rather than addressing the underlying disease process.
• Some of the major companies driving innovation in the Graves' orbitopathy market include Viridian Therapeutics, Kissei Pharmaceutical, Hoffmann-La Roche, argenx, Tourmaline Bio, etc., which are actively advancing their pipelines through various clinical trial stages and creating significant growth opportunities.
• Viridian Therapeutics' Veligrotug (VRDN-001), an IGF-1R antibody, is progressing through Phase III development, positioning the asset as a potential key entrant in the Graves' orbitopathy landscape. With a targeted US launch in the second half of 2026, the therapy is expected to broaden treatment options, address unmet needs, and enhance Viridian's competitive position in the market.

DelveInsight's "Graves' Orbitopathy - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Graves' orbitopathy, historical and forecasted epidemiology, as well as the Graves' orbitopathy market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Graves' orbitopathy market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Graves' orbitopathy market size from 2020 to 2034. The report also covers Graves' orbitopathy treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Graves' Orbitopathy Understanding and Treatment Algorithm

Graves' Orbitopathy Overview

Graves' orbitopathy, also known as Thyroid Eye Disease, is the most common extrathyroidal manifestation of Graves' disease and results from autoimmune activity causing orbital inflammation. Autoantibodies, likely targeting a shared protein in the orbit and thyroid, drive this condition, which progresses through an early active stage and a late inactive stage, classified by severity and its impact on vision and quality of life.

Symptoms range from eye irritation, redness, and swelling to advanced complications like optic nerve compression and vision loss. Key risk factors include stress, smoking, and poorly controlled hyperthyroidism, while pathologic changes include glycosaminoglycan deposition, inflammation, fibrosis, and fat accumulation in the orbit, leading to proptosis and impaired ocular motility.

Graves' Orbitopathy Diagnosis

Diagnosing Graves' orbitopathy requires a structured approach combining clinical evaluation, laboratory testing, and imaging. Key clinical signs include lid retraction, proptosis, conjunctival redness, and motility restriction, while history focuses on risk factors like smoking, thyroid disease duration, and prior radioactive iodine treatment. Laboratory tests, including thyroid function (TSH, free T4) and TSH receptor antibodies, confirm autoimmunity and help monitor disease severity. Severity and activity are assessed using scoring systems such as NO SPECS, EUGOGO, VISA, and CAS, with CAS scores =3 at baseline or =4 on follow-up indicating active disease requiring immunomodulatory therapy. Imaging with MRI identifies orbital inflammation, edema, and optic nerve compression, while CT provides anatomical detail for surgical planning. Differential diagnoses include allergic conjunctivitis, myasthenia gravis, orbital myositis, tumors, carotid-cavernous fistula, CPEO, granulomatosis with polyangiitis, and IgG4-related disease, each with distinguishing features. Integrating clinical, laboratory, and imaging data ensures accurate diagnosis, differentiates mimics, guides timely treatment, and reduces the risk of vision-threatening complications.

Graves' Orbitopathy Treatment

The management of Graves' orbitopathy is guided by symptom severity and includes fundamental, medical, and surgical approaches aimed at preventing visual complications, minimizing side effects, and limiting disease progression. Fundamental measures-artificial tears, sunglasses, head elevation, and risk factor control such as smoking cessation-are recommended for all patients. Mild cases may resolve spontaneously or remain stable, though cosmetic concerns can persist. Moderate-to-severe or active disease requires early immunosuppressive therapy. Pharmacologic options include glucocorticoids (first-line anti-inflammatory treatment), mycophenolate mofetil (alone or with steroids), rituximab and tocilizumab (for steroid-refractory cases), and TEPEZZA (teprotumumab-trbw), the only FDA-approved IGF-1R inhibitor. Cyclosporine, mTOR inhibitors, and other agents like methotrexate or anti-TNF therapies are reserved for refractory or experimental use. Surgical interventions-orbital decompression, eye muscle surgery, and eyelid procedures-are typically performed after inflammation subsides to correct functional or aesthetic sequelae. Sight-threatening dysthyroid optic neuropathy requires immediate high-dose intravenous glucocorticoids and urgent decompression if unresponsive. Early diagnosis, risk factor management, and timely medical or surgical therapy are essential to preserve vision, improve function, and enhance quality of life.

Graves' Orbitopathy Epidemiology

As the market is derived using a patient-based model, the Graves' orbitopathy epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by 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, and severity-specific diagnosed prevalent cases of Graves' orbitopathy in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• DelveInsight estimates that in 2024, there were around 7.1 million prevalent cases of Graves' disease across the 7MM, with 3.5 million being diagnosed. This number is projected to rise by 2034.
• In 2024, the US recorded the highest number of diagnosed prevalent cases of Graves' orbitopathy, with approximately 610,000 cases, a figure anticipated to grow over the study period (2020-2034).
• In 2024, Germany reported the highest number of diagnosed prevalent cases of Graves' orbitopathy between the EU4 and the UK, with approximately 155,000 cases, followed by France with around 143,000 cases. In contrast, Spain had the lowest number, with about 123,000 cases.
• In 2024, Japan reported approximately 98,000 diagnosed prevalent cases of Graves' orbitopathy.
• In 2024, the US reported nearly 122,000 diagnosed prevalent cases of Graves' orbitopathy in males and 490,000 cases in females.
• In 2024, the EU4 and the UK reported nearly 195,000 acute cases and 503,000 chronic cases of Graves' orbitopathy.
• In 2024, Japan reported nearly 82,000 mild, 13,000 moderate to severe, and 3,000 most severe/sight-threatening cases of Graves' orbitopathy.

Graves' Orbitopathy Drug Chapters

The drug chapter segment of the Graves' orbitopathy report encloses a detailed analysis of Graves' orbitopathy-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the Graves' orbitopathy clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

TEPEZZA (teprotumumab-trbw): Amgen (Horizon Therapeutics)

TEPEZZA is a fully human IgG1 monoclonal antibody targeting IGF-1R, with a molecular weight of approximately 148 kDa, produced in CHO-DG44 cells. It works by inhibiting IGF-1R signaling in orbital fibroblasts, reducing inflammation and tissue remodeling associated with Graves' orbitopathy.

Emerging Drugs

Veligrotug (VRDN-001): Viridian Therapeutics/Kissei Pharmaceutical

Viridian's lead product candidate, Veligrotug (VRDN-001), is an investigational IV monoclonal antibody that fully antagonizes IGF-1R and is being developed as a potential best-in-class therapy. Clinical data so far indicate that Veligrotug demonstrates strong activity and is generally well tolerated through Week 6; showing promising outcomes compared with the currently approved anti-IGF-1R antibody, although no direct head-to-head trials have been conducted.

• In May 2025, Viridian Therapeutics received US FDA Breakthrough Therapy Designation for Veligrotug in TED, based on robust improvements in diplopia and rapid proptosis response, making it eligible for Priority Review.
• 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, demonstrating long-term durability.

VRDN-003: Viridian Therapeutics/Kissei Pharmaceutical

VRDN-003 is a potential best-in-class SC monoclonal antibody targeting IGF-1R, engineered for an extended half-life. It retains the efficacy of its parent molecule, Veligrotug (VRDN-001), while offering improved patient convenience and potentially enhanced safety.

• Viridian Therapeutics announced that topline data from both trials of VRDN-003 are expected in the first half of 2026, with a Biologics License Application (BLA) submission for TED targeted by year-end 2026.
• In July 2025, Viridian Therapeutics collaborated with Kissei Pharmaceutical, granting Kissei exclusive rights to develop and commercialize Veligrotug and VRDN-003 in Japan. Viridian will receive a USD 70 million upfront payment, up to USD 315 million in milestones, and tiered royalties of 20-35% on net sales.

Efgartigimod PH20 SC: Argenx

Efgartigimod PH20 SC is an investigational drug developed by Argenx for the treatment of TED. It is a fully human antibody fragment designed to target the neonatal Fc receptor (FcRn). By blocking FcRn, it reduces levels of pathogenic IgG autoantibodies. These autoantibodies are believed to play a key role in autoimmune diseases.

• The drug is currently in Phase III proof-of-concept trials for TED. Topline results are expected in the second half of 2026. These studies aim to confirm its efficacy and safety in patients.

Drug Class Insights

Treatment of Graves' orbitopathy involves both supportive care and targeted therapies tailored to disease severity. Supportive measures include ocular lubrication, eye patches, prism correction for diplopia, and head-of-bed elevation to reduce swelling. Pharmacological options comprise glucocorticoids, mycophenolate, rituximab, tocilizumab, teprotumumab, and cyclosporine/mTOR inhibitors, with oral prednisone commonly used and higher doses or intravenous administration reserved for optic nerve compression. Emerging therapies such as VRDN-001, VRDN-003, batoclimab, efgartigimod PH20 SC, ENSPRYNG, LASN01, linsitinib, AMG 732, and lonigutamab are being developed to improve efficacy and address unmet clinical needs.

Efgartigimod PH20 SC and Batoclimab (IMVT-1401; RVT-1401) target FcRn to lower pathogenic IgG autoantibodies in thyroid eye disease. Efgartigimod is a subcutaneous antibody fragment optimized for absorption, while Batoclimab is a subcutaneous monoclonal antibody developed for various IgG-mediated autoimmune diseases. Veligrotug (VRDN-001) and VRDN-003 are IGF-1R inhibitors that reduce proptosis and orbital inflammation, with VRDN-003 offering an extended half-life and flexible dosing. These therapies provide complementary, targeted approaches with distinct mechanisms and pharmacokinetics to improve patient outcomes.

Market Outlook

Graves' orbitopathy treatment strategies are categorized into supportive and targeted approaches, depending on disease severity. Supportive care includes ocular lubrication, eye patches, prism correction for diplopia, and head-of-bed elevation to reduce swelling. Targeted pharmacological therapies include glucocorticoids, mycophenolate, rituximab, tocilizumab, teprotumumab, and cyclosporine/mTOR inhibitors. Corticosteroids, particularly oral prednisone, remain the mainstay, with higher doses or intravenous administration reserved for cases involving optic nerve compression.

TEPEZZA (teprotumumab), an IGF-1R inhibitor, is the first therapy approved for active Graves' orbitopathy. It is a fully human IgG1 monoclonal antibody produced in CHO-DG44 cells (148 kDa). Following US FDA approval in 2020, it gained approval in Japan in 2024, offering a clinically validated, targeted option. Other agents, such as methotrexate, azathioprine, IV immunoglobulins, and anti-TNF therapies (adalimumab, etanercept, infliximab), show limited efficacy compared to biologics like teprotumumab and rituximab.

Currently, TEPEZZA (teprotumumab) remains the only approved therapy for active Graves' orbitopathy, highlighting a major unmet need. Off-label treatments, including glucocorticoids, rituximab, and tocilizumab, demonstrate inconsistent efficacy without regulatory approval, underscoring the importance of developing targeted therapies for severe or refractory cases.

Recent advancements include veligrotug (VRDN-001), VRDN-003, efgartigimod PH20 SC, ENSPRYNG (satralizumab; RG6168), batoclimab, Pacibekitug (TOUR006), Linsitinib, LASN01, and lonigutamab, which aim to improve treatment outcomes and address unmet needs.

• The total market size of Graves' orbitopathy in the 7MM was approximately USD 2,060 million in 2024 and is projected to increase during the forecast period (2025-2034).
• The market size for Graves' orbitopathy in the US was approximately USD 1,980 million in 2024 and is anticipated to increase due to the launch of emerging therapies.
• The total market size of EU4 and the UK was calculated to be approximately USD 75 million in 2024, which was nearly 3.7% of the total market revenue for the 7MM.
• In 2024, Germany dominated the market among EU4 and the UK, generating around USD 17 million. France followed closely with approximately USD 15.4 million, while the UK recorded around USD 15.1 million.
• In 2024, the total market size of Graves' orbitopathy was approximately USD 4.5 million in Japan, which is anticipated to increase during the forecast period (2025-2034).
• Estimates suggest that veligrotug (VRDN-001) is expected to generate approximately USD 1,560 million in the 7MM by 2034.

Graves' Orbitopathy Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034.

Graves' Orbitopathy Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for Graves' orbitopathy.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on Graves' orbitopathy evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the Cedars-Sinai Medical Center, US; Stanford Department of Ophthalmology, US; Johannes Gutenberg University, Germany; Nantes University Hospital, France; University of Insubria, Italy; Navarra Institute for Health Research (IdiSNA), Spain; University of Exeter Medical, UK; and Ito Hospital, Japan; among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Graves' orbitopathy market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician's View

As per the KOLs from the US, "TED starts with orbital and periocular inflammation, progressing to a chronic phase with persistent symptoms. Active TED, marked by a Clinical Activity Score (CAS), involves pain, swelling, redness, proptosis, and, in severe cases, diplopia. In the US, TED prevalence ranges from 0.16% to 0.25%, with higher risk in males, individuals over 65, tobacco users, and those with elevated thyroid autoantibodies."

As per the KOLs from France, "Graves' orbitopathy, the most common extra-thyroid complication of Graves' disease, can be severe and requires multidisciplinary care based on clinical activity and severity. Diagnosis and management should involve an ophthalmologist, endocrinologist, and, if needed, a surgeon specializing in orbital pathologies, such as a maxillofacial surgeon, ENT specialist, or neurosurgeon."

As per the KOLs from Japan, "In Japan, most TED patients are managed conservatively, with few undergoing glucocorticoids, radiotherapy, or surgery, reflecting the predominance of mild or inactive disease. However, with the availability of teprotumumab, there is potential to shift treatment practices by offering an effective option even in cases unresponsive to traditional therapies, underscoring the need for improved disease activity assessment and broader treatment strategies."

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Attribute Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Attribute Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.

Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Amgen by Your Side program

Your Side, providing personalized assistance from prescription to infusion, supports TEPEZZA reimbursement through Amgen. Commercially insured patients may qualify for a USD 0 co-pay, while those with government insurance can seek support via independent foundations. As a specialty therapy, prior insurance approval taking up to 90 days is required, with Patient Access Liaisons guiding the process. Costs vary by insurer; a 70-kg Medicare patient's full regimen is reimbursed at USD 351,574, versus USD 490 for 12 weeks of IV methylprednisolone. Access remains limited, and long-term effects on surgery needs and adverse events are still under investigation.

• TEPEZZA access requires prior insurance approval; Amgen provides dedicated support via Patient Access Liaisons.
• Commercial insurance patients may qualify for zero out-of-pocket costs; government insurance patients rely on independent foundations.
• High treatment cost and variable coverage highlight the need for broader availability to establish TEPEZZA as a first-line therapy.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of Graves' orbitopathy, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Graves' orbitopathy market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Graves' orbitopathy market.

Graves' Orbitopathy report insights

• Patient Population
• Therapeutic Approaches
• Graves' orbitopathy Pipeline Analysis
• Graves' orbitopathy Market Size and Trends
• Existing and Future Market Opportunity

Graves' Orbitopathy report key strengths

• 10 years Forecast
• The 7MM Coverage
• Graves' orbitopathy Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Graves' Orbitopathy report assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Attribute Analysis)

Key Questions:

Market Insights

• What was the total market size of Graves' orbitopathy, the market size of Graves' orbitopathy by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will VRDN-003 affect the treatment paradigm of Graves' orbitopathy?
• How will TEPEZZA (teprotumumab-trbw) compete with other upcoming products and marketed therapies?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of Graves' orbitopathy? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Graves' orbitopathy?
• What is the historical and forecasted Graves' orbitopathy patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest diagnosed prevalent Graves' orbitopathy population during the forecast period (2025-2034)?
• What factors are contributing to the growth of Graves' orbitopathy cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Graves' orbitopathy? What are the current clinical and treatment guidelines for treating Graves' orbitopathy?
• How many companies are developing therapies for the treatment of Graves' orbitopathy?
• How many emerging therapies are in the mid-stage and late stage of development for treating Graves' orbitopathy?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted market of Graves' orbitopathy?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Graves' orbitopathy market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for Graves' orbitopathy, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.