TEPEZZA Market Sales on the Rise Due to Strong Growth Driven by Demand for Thyroid Eye Disease Treatment

TEPEZZA (teprotumumab) continued its strong commercial performance, generating USD 381 million in sales in the first quarter of 2025, following USD 460 million in the last quarter of 2024. The drug achieved a total annual revenue of USD 1.9 billion in 2024.

Key regulatory milestones include approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) in September 2024 for active Graves’ orbitopathy, and a marketing authorization application submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom in March 2024. During the January 2025 J.P. Morgan Healthcare Conference, Amgen announced it expects European approval in the second half of 2025.

Despite its continued success and leadership in the TED market, TEPEZZA faces emerging competition from new investigational therapies such as VRDN-003, lonigutamab, veligrotug, and linsitinib, which could reshape the future treatment landscape. Amgen’s ongoing clinical innovation and global regulatory initiatives remain central to maintaining TEPEZZA’s dominant position and growth trajectory.

DelveInsight Business Research LLP, a leading strategic business consulting and market research organization, announces the release of its latest report, “TEPEZZA Market Size, Forecast, and Market Insight Report.” The comprehensive report provides an in-depth assessment of TEPEZZA (Teprotumumab-trbw), the first and only approved therapy for Thyroid Eye Disease (TED). The analysis highlights robust sales growth, evolving market dynamics, and a promising outlook for the drug’s continued global expansion.

For a comprehensive analysis of TEPEZZA sales trends, pipeline therapies, and market insights, Download the Full Report Here.

TEPEZZA has been a game-changing innovation in the management of thyroid eye disease-an autoimmune condition historically underserved by effective therapies. Since its launch, TEPEZZA has not only mitigated the debilitating symptoms associated with TED but also introduced a novel mechanism targeting disease progression itself.

Breakthrough Innovation in TED Treatment

Approved by the U.S. Food and Drug Administration (FDA) in January 2020 under Priority Review and Breakthrough Therapy Designation, TEPEZZA became the first and only medication to gain regulatory approval for TED. The therapy is a fully human monoclonal antibody that inhibits the insulin-like growth factor-1 receptor (IGF-1R), a key pathway implicated in TED pathogenesis.

Unlike broad immunosuppression-an approach that has dominated treatment for years-TEPEZZA offers a targeted therapeutic route. The drug helps reduce inflammation, swelling, and proptosis while improving diplopia (double vision). Its novel biologic profile has made it a preferred choice among physicians managing moderate to severe active TED.

According to DelveInsight’s report, TEPEZZA’s success lies in its ability to address a deep unmet need among patients who have long relied on corticosteroids and surgery, therapies that often yield suboptimal results or lead to complications.

TEPEZZA Market Performance and Growth Highlights

Amgen, following its 2023 acquisition of Horizon Therapeutics for approximately USD 27.8 billion, has accelerated TEPEZZA’s global commercialization strategy. TEPEZZA generated USD 460 million in Q4 2024 and approximately USD 1.9 billion for the full year 2024, demonstrating sustained confidence among prescribers and patients.

DelveInsight’s analysis projects continued expansion, driven by the increasing prevalence of TED and rising clinician awareness. In 2023, the total TED market across the seven major markets (7MM: United States, EU4, United Kingdom, and Japan) was valued at USD 2.3 billion, with forecasts indicating significant growth through 2034. Within this, TEPEZZA remains a leading contributor due to its first-mover advantage and robust clinical data.

The U.S. remains the largest market for TEPEZZA, attributed to higher diagnosis rates and greater acceptance of biologic therapies. The report anticipates TEPEZZA’s sales momentum to rise further in Europe and Japan following regulatory milestones achieved in 2024.

Expanding Global TEPEZZA Regulatory Approvals and Pipeline Advancements

In September 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) granted TEPEZZA approval for the treatment of active Graves’ orbitopathy. Meanwhile, Amgen has announced plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), marking a major step toward EU market entry.

For detailed analysis of TEPEZZA’s regulatory landscape and pipeline, Download the Regulatory Insights.

These regulatory advances complement a growing body of clinical evidence. TEPEZZA is currently in Phase III trials for both moderate-to-severe active TED and chronic disease manifestations, further solidifying its place as a cornerstone therapy. Additionally, Amgen is investigating a subcutaneous formulation designed to enhance patient convenience compared to its existing intravenous (IV) form.

This strategic pipeline diversification underscores Amgen’s long-term commitment to expanding the adoption and accessibility of TEPEZZA across both acute and chronic patient populations.

Understanding Thyroid Eye Disease and Market Drivers

Thyroid Eye Disease is a rare autoimmune disorder linked to Graves’ disease, characterized by inflammation, eye bulging (proptosis), orbital pain, and reduced vision. Between 25% and 50% of individuals with Graves’ disease develop some degree of TED. According to DelveInsight estimates, there were 1.4 million diagnosed prevalent cases of TED in 2023, with prevalence expected to rise by 2034 due to increasing disease awareness and improved diagnosis rates.

DelveInsight notes that only about 20% of TED patients-those with active, moderate-to-severe disease-receive targeted therapy today. This considerable untapped patient pool represents a significant growth avenue for TEPEZZA and upcoming competitor products.

As awareness of the disease improves, coupled with earlier diagnosis and more inclusive health coverage, market expansion is forecasted to accelerate steadily across major regions.

 

TEPEZZA Composition, Mechanism, and Administration

Each single-dose vial of TEPEZZA for injection contains 500 mg of teprotumumab, alongside excipients including L-histidine, L-histidine hydrochloride monohydrate, polysorbate 20, and trehalose dihydrate. When reconstituted with sterile water, the solution achieves a final concentration of 47.6 mg/mL at a pH of 5.5.

The standard dosing regimen includes an initial infusion of 10 mg/kg, followed by infusions of 20 mg/kg every three weeks for seven additional doses. The therapy’s mechanism-binding and inhibiting IGF-1R-disrupts pro-inflammatory signaling pathways that cause the pathological remodeling of orbital tissues.

While its precise metabolic pathway remains under study, TEPEZZA’s proteolytic metabolism is consistent with large-molecule biologics, and its efficacy profile continues to show strong reproducibility across patient subgroups.

 

TEPEZZA Competitive Landscape: A Growing Field

Although TEPEZZA currently leads the TED treatment market, emerging competitors are reshaping the competitive landscape. Key late-stage contenders include:

• Immunovant: IMVT-1401 (batoclimab) and IMVT-1402
• Viridian Therapeutics: VRDN-001 and VRDN-003
• Argenx: Efgartigimod PH20 SC
• Tourmaline Bio: Pacibekitug
• Sling Therapeutics: Linsitinib
• Hoffmann-La Roche: ENSPRYNG

Viridian Therapeutics stands out as the only company pursuing therapies for both active and chronic TED, positioning it as a formidable challenger in upcoming market phases. Meanwhile, Sling Therapeutics recently announced positive topline results from its Phase IIb/III LIDS trial, evaluating linsitinib, an oral small molecule targeting the IGF-1R pathway. With over 900 patients studied across fifteen prior trials, linsitinib’s favorable safety outcomes suggest potential differentiation in oral administration convenience.

The expanding competitive arena indicates that TEPEZZA’s long-term market performance will rely on strategic innovations such as alternative delivery routes, value-based pricing, and lifecycle management investments.

 Discover in-depth profiles of TEPEZZA and competitors by Accessing the Competitive Landscape Report.

TEPEZZA Expert Insights and Clinical Impact

Clinical specialists emphasize TEPEZZA’s transformational effect on treatment paradigms.
According to Dr. Kikkawa (Ophthalmology Times), “The introduction of TEPEZZA has significantly impacted TED treatment, leading to a reduction in the need for orbital decompression surgeries at their center.” Similarly, Dr. Tamhankar (Eyes On Eyecare) highlighted that “Patients exhibiting active disease symptoms-such as significant diplopia, proptosis, and high Clinical Activity Scores-respond most favorably to TEPEZZA.”

These endorsements underline growing physician confidence in the drug’s real-world outcomes and its capacity to change clinical algorithms for TED management.

 

TEPEZZA Market Challenges and Opportunities Ahead

Despite being a clinical success, TEPEZZA faces ongoing challenges related to pricing, reimbursement, and accessibility. High biologic infusion costs have limited patient uptake in certain regions, emphasizing the need for continued innovation in affordability and administration models.

Moreover, increased competition from investigational biologics and small molecules could apply downward pressure on market share. Nevertheless, TEPEZZA’s strong efficacy, established prescriber familiarity, and continued expansion into new markets underpin its sustainability.

DelveInsight projects that with strategic partnerships, patient access programs, and continued research investment, TEPEZZA can maintain its leadership position well into the next decade.

 

TEPEZZA Future Outlook: Sustained Momentum Through 2034

The future of the TED market appears robust and evolving, with TEPEZZA positioned as its cornerstone therapy. DelveInsight forecasts significant revenue expansion through 2034, supported by:

• Growing TED incidence and diagnosis rates
• Expanding geographic approvals
• Broader physician awareness and confidence in biologic therapies
• Increasing R&D into related IGF-1R-driven disorders
• Greater competition fostering innovation and market outreach

Amgen’s continued commitment to addressing thyroid-associated ophthalmopathy underlines its vision for expanding patient access and therapeutic innovation.