TEPEZZA Market

Key Highlights

• TEPEZZA (teprotumumab) recorded sales of USD 381 million in the first quarter of 2025, following USD 460 million in the fourth quarter of 2024, contributing to a total of USD 1.9 billion in revenue for the full year 2024. TEPEZZA is the first and only approved treatment for thyroid eye disease in the US and Japan.
• In January 2025, at the J.P. Morgan Healthcare Conference, Amgen announced that the company expects regulatory approval of TEPEZZA in Europe in the second half of 2025.
• In September 2024, TEPEZZA was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of active Graves’ orbitopathy. In March 2024, Amgen submitted a marketing authorization application to the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain for TEPEZZA.
• Amgen’s expansion efforts for subcutaneous formulation and its plans for chronic TED represent pivotal moments for TEPEZZA’s continued success. However, the company must keep a close eye on the emerging competition as drugs like VRDN-003, lonigutamab, veligrotug, and linsitinib gain momentum.
• In October 2023, Amgen acquired Horizon Therapeutics for approximately USD 27.8 billion, this acquisition included TEPEZZA for the treatment of active Graves’ orbitopathy, which was originally developed by Horizon Therapeutics.

 

DelveInsight’s report, “TEPEZZA (teprotumumab) Market Size, Forecast, and Drug Insight, 2034” provides comprehensive insights about TEPEZZA in the seven major markets (the United States, EU4 [Germany, France, Italy, and Spain] and the United Kingdom, and Japan) for the study period from 2020 to 2034. The report covers a detailed product profile with information about the product, such as clinical development, safety & efficacy data analysis, product development activities, and competitive landscape. In addition, the report comprises current and future market assessments including the market forecast, SWOT analysis, and analysts’ views.

The report is built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis by our industry experts.

Study Period	2020–2034
Forecast Period	2025–2034
Geographies Covered	US, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan
TEPEZZA (teprotumumab) Company	Amgen
TEPEZZA (teprotumumab) Key Indication	Graves’ orbitopathy (Thyroid Eye Disease)
TEPEZZA (teprotumumab) Key Competitor Companies	Viridian Therapeutics Argenx Hoffmann-La Roche Immunovant, Samsung Biologics, HanAll Biopharma and Roivant Sciences Sling Therapeutics Tourmaline Bio Lassen Therapeutics ACELYRIN
TEPEZZA (teprotumumab) Key Compititor Therapies	Veligrotug  (VRDN-001)  VRDN-003 Efgartigimod PH20 SC ENSPRYNG (satralizumab, RG6168) Batoclimab (IMVT-1401, RVT-1401) Linsitinib Pacibekitug (TOUR006) LASN01 Lonigutamab
TEPEZZA (teprotumumab) Market	Segmented by: Region Indication
Analysis	Competetitive Landscape KOL Views SWOT Analysis Reimbursement Analysts Views

Drug Summary

Amgens’ TEPEZZA, is an insulin-like growth factor 1 receptor (IGF-1R) inhibitor, is a fully human IgG1 monoclonal antibody produced in Chinese hamster ovary (CHO-DG44) cells with a molecular weight of approximately 148 KD.

In January 2020, the US FDA approved TEPEZZA for the treatment of TED after an accelerated Priority Review.

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 Thyroid Eye Disease characterized by a low Clinical Activity Score (CAS). In Japan, Amgen continues to enroll patients with chronic or low CAS Thyroid Eye Disease.

Additionally, the company is also investigating TEPEZZA in Phase III study for treatment of Thyroid Eye Disease via subcutaneous administration.

• In July 2016, TEPEZZA received Breakthrough Therapy designation (BTD) from the US FDA for its potential use in the treatment of Graves’ orbitopathy.
• In April 2015, TEPEZZA received Fast Track Designation (FTD) from the US FDA for its potential use in the treatment of Graves’ orbitopathy.
• TEPEZZA was also granted orphan drug designations (ODD) in the US and Japan.

Further details are provided in the report...

 

Drug Class Insight

IGF-1R Inhibitors

Insulin-like Growth Factor 1 Receptor (IGF-1R) inhibitors represent a targeted therapeutic class designed to block the IGF-1 signaling pathway, a key driver in the pathogenesis of Graves’ orbitopathy. This pathway plays a central role in the activation of orbital fibroblasts, leading to tissue expansion, inflammation, and structural remodeling within the orbital region. By inhibiting IGF-1R, these therapies aim to disrupt the pathological cascade responsible for disease progression, offering a disease-modifying alternative to conventional symptomatic treatments. The mechanism of action involves blocking IGF-1R activation on orbital fibroblasts, thereby reducing the production of pro-inflammatory cytokines and limiting fibroblast proliferation. Additionally, these inhibitors prevent tissue remodeling, orbital fat expansion, and extraocular muscle fibrosis—key factors underlying the disfiguring and function-impairing symptoms of Thyroid Eye Disease. Clinically, this translates into meaningful improvements in proptosis (eye bulging), diplopia (double vision), and inflammation, significantly enhancing patient outcomes and quality of life.

Competitive Landscape

Emerging Competitors of TEPEZZA (Teprotumumab)

Further details are provided in the report...        

 

Market Outlook of TEPEZZA (Teprotumumab)

Thyroid eye disease , also known as Graves' orbitopathy, is a debilitating autoimmune disorder affecting ocular tissues, often linked to thyroid dysfunction. About 50% of Graves' disease patients show thyroid eye disease symptoms, with upper eyelid retraction and proptosis being the most common. While treatment ranges from supportive care to off-label immunotherapies, TEPEZZA remains the only FDA-approved drug specifically indicated for active thyroid eye disease.

TEPEZZA, an IGF-1R inhibitor approved in the US (2020) and Japan (2024), has demonstrated strong efficacy in reducing proptosis and diplopia, with clinical trials showing significant responder rates as early as six weeks. Its targeted mechanism, proven outcomes, and regulatory backing position it as the gold standard in Thyroid Eye Disease treatment, particularly for moderate-to-severe cases.

The company has also been working on a subcutaneous formulation of TEPEZZA, designed to simplify the treatment regimen by reducing the burden of eight infusions that take 60–90 min each. This could be a game-changer for patient adherence. “Improving patient convenience is key to unlocking further growth in the TED market,” said Amgen’s spokesperson. However, if competitors like VRDN-003 can offer at-home auto-injector solutions that last every 4–8 weeks, TEPEZZA’s in-office infusion model may quickly become less appealing.

Veligrotug (VRDN-001), an intravenously administered IGF-1R full antagonist developed by Viridian Therapeutics, is currently in Phase III development. The treatment regimen consists of five infusions, administered 3 weeks apart, with a 30-min infusion time, offering a potentially faster and more convenient alternative to TEPEZZA’s longer infusion sessions.

The Graves’ Orbitopathy treatment landscape is evolving, with investigational therapies such as VRDN-001, batoclimab, and linsitinib showing promise. These emerging therapies target IGF-1R, FcRn, IL-6, or IL-11R, and aim to improve efficacy and patient convenience via subcutaneous or oral routes. However, TEPEZZA’s established profile gives it a competitive edge.

TEPEZZA’s market outlook remains strong, with approximately of USD 1,900 million in 2024 across the 7MM, the US is expected to lead in the forcast period. Despite rising competition, TEPEZZA’s early entry, proven efficacy, and ongoing market expansion reinforce its leadership in Graves’ disease therapy.

 

Further details are provided in the report…

KOL Views for TEPEZZA (teprotumumab)

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. Some of the leaders like MD, PhD, Research Project Manager, Director, and others. Their opinion helps to understand and validate TEPEZZA therapy and market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Delveinsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as the Division of Transplant and Ophthalmology Products, Center for Drug Evaluation and Research, Texas Oculoplastics Consultants, Diabetes-Thyroid and Endocrine Center Shin Koga Hospital, Kellogg Eye Center, Department of Ophthalmology Osaka Kaisei Hospital, etc., were contacted. Their opinion helps understand and validate TEPEZZA drug insight and market trends.

 

Further details are provided in the report...

Market Access and Reimbursement

The United States

Horizon Commercial Copay Program

Horizon is committed to ensuring that patients pay the lowest possible amount for their medications. Eligible patients may qualify for a USD 0 copay, covering both the medication and intravenous infusion costs.

To be eligible for the Horizon Commercial Copay Program, patients must meet the following criteria:

• The prescription cannot be covered, in part or in full, by any government-funded program, including but not limited to Medicare, Medicare Part D, Medicaid, Medigap, VA, CHAMPUS, Department of Defense (DoD), TRICARE, or any state, patient foundation, or other pharmaceutical assistance program.
• The patient must be prescribed a Horizon rare disease medication for an FDA-approved indication, as specified in the prescribing information.
• The patient must reside in the US.

The patient must have commercial insurance and be financially responsible for a portion of the medication and/or infusion costs, if applicable.

 

Further details are provided in the report...

 

Scope of the Report

The report provides insights into the following:

• A comprehensive product overview including the TEPEZZA description, mechanism of action, dosage and administration, and research and development activities in thyroid eye disease.
• Elaborated details on TEPEZZA regulatory milestones and other development activities have been provided in this report.
• The report also highlights the TEPEZZA research and development activities in thyroid eye disease  across the US, EU4 and the UK, and Japan.
• The report contains forecasted sales of TEPEZZA for thyroid eye disease till 2034.
• Comprehensive coverage of the late-stage emerging therapies for thyroid eye disease.
• The report also features the SWOT analysis with analyst views for TEPEZZA in thyroid eye disease.

 

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research, and in-house analysis by DelveInsight’s industry experts. Information and data from secondary sources have been obtained from various printable and non-printable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals, and access to available databases.

TEPEZZA (teprotumumab) Analytical Perspective by DelveInsight

In-depth TEPEZZA (teprotumumab) market assessment

This report provides a detailed market assessment of TEPEZZA for thyroid eye disease  in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This report segment provides forecasted sales data for TEPEZZA.

TEPEZZA (teprotumumab) clinical assessment

The report provides the clinical trial information of TEPEZZA for thyroid eye disease , covering trial interventions, trial conditions, trial status, and start and completion dates.

 

Report Highlights 

• In the coming years, the market scenario for thyroid eye disease is set to change due to the extensive research and incremental healthcare spending worldwide; this would expand the market size to enable drug manufacturers to penetrate more into the market.  
• The companies are developing therapies focusing on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities to influence TEPEZZA dominance.
• Other emerging products for Graves’ orbitopathy  are expected to give tough market competition to TEPEZZA, and the launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones and developmental activities provides the current development scenario of TEPEZZA in Graves’ orbitopathy.
• Our in-depth analysis of the forecasted sales data of TEPEZZA (teprotumumab) will support the clients in decision-making regarding their therapeutic portfolio by identifying the overall scenario of the TEPEZZA in thyroid eye disease.

 

Key Questions

• What are the product type, route of administration, and mechanism of action of TEPEZZA?
• What is the clinical trial status of the study related to TEPEZZA in thyroid eye disease , and the study completion date?
• What are the key collaborations, mergers and acquisitions, licensing, and other activities related to the TEPEZZA development?
• What are the regulatory milestones that TEPEZZA achieved for Graves’ orbitopathy ?
• What is the forecasted market scenario of TEPEZZA for thyroid eye disease ?
• What are the forecasted sales of TEPEZZA  in the7MM, including the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan? 
• What other marketed products are available, and how are these giving competition to TEPEZZA for thyroid eye disease ?
• What other emerging products are available, and how are these giving competition to TEPEZZA for thyroid eye disease ?
• Which are the late-stage emerging therapies under development for treating thyroid eye disease ?