TEPEZZA, as the first FDA-approved treatment for thyroid eye disease, marks a major breakthrough in managing TED, addressing a critical medical gap for patients who have long had few treatment alternatives. In addition to helping relieve symptoms, TEPEZZA introduces a novel mechanism of action that may offer the potential to alter the progression of the disease.
New York, USA, Feb. 19, 2025 (GLOBE NEWSWIRE) — TEPEZZA Market Sales on the Rise Due to the Strong Growth Driven by Demand for Thyroid Eye Disease Treatment | DelveInsight
TEPEZZA, as the first FDA-approved treatment for thyroid eye disease, marks a major breakthrough in managing TED, addressing a critical medical gap for patients who have long had few treatment alternatives. In addition to helping relieve symptoms, TEPEZZA introduces a novel mechanism of action that may offer the potential to alter the progression of the disease.
DelveInsight’s “TEPEZZA Market Size, Forecast, and Market Insight Report” highlights the details around TEPEZZA, an insulin-like Growth Factor-1 receptor (IGF-1R) inhibitor. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPEZZA. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Amgen’s TEPEZZA (Teprotumumab-Trbw) Overview
Teprotumumab is a fully human IgG1 monoclonal antibody that inhibits IGF-1R, produced in Chinese Hamster Ovary (CHO-DG44) cells, with a molecular weight of around 148 KD. The full metabolism of teprotumumab has not been completely defined, but it is anticipated to be metabolized through proteolysis. TEPEZZA for injection is provided as a sterile, preservative-free, white to off-white lyophilized powder intended for IV infusions.
Each single-dose vial contains 500 mg of teprotumumab, along with L-histidine (7.45 mg), L-histidine hydrochloride monohydrate (31.8 mg), polysorbate 20 (1 mg), and trehalose dihydrate (946 mg). When reconstituted with 10 mL of sterile water for injection, USP, the final concentration is 47.6 mg/mL, with a pH of 5.5.
The prescribed dosage of TEPEZZA involves an initial intravenous infusion of 10 mg/kg, followed by 20 mg/kg infusions every three weeks for a total of seven additional doses. The exact TEPEZZA mechanism of action in Graves’ Ophthalmopathy remains incompletely understood. However, it binds to IGF-1R, inhibiting its activation and signaling. TEPEZZA generated USD 460 million in sales in the fourth quarter of 2024 and USD 1.9 billion for the full 2024 year.
Currently, TEPEZZA is being tested in Phase III clinical trials for patients with moderate-to-severe active Graves’ orbitopathy and chronic thyroid eye disease with a low Clinical Activity Score (CAS). Furthermore, Amgen is investigating its potential for subcutaneous administration, although it is currently approved only for intravenous use.
Thyroid eye disease is a rare but serious autoimmune condition that affects the eyes, often linked to hyperthyroidism or Graves’ disease. Around 25-50% of people with Graves’ disease develop TED, with women being more commonly affected than men. There were 1.4 million diagnosed prevalent cases of TED in 2023, with the number projected to rise by 2034, as per DelveInsight’s analysis. In the 7MM, the US had the highest number of diagnosed prevalent cases of TED.
Over the next few years, the US thyroid eye disease market is expected to undergo significant transformation and growth, primarily due to the strong presence of the already-approved drug, TEPEZZA. Furthermore, the anticipated launch of a second treatment, batoclimab, within the next 2–3 years is likely to contribute to this expansion. Since only around 20% of TED cases are acute and receive treatment, the market is expected to grow, especially with the introduction of safer and more effective therapies.
In 2023, the TED market size across the seven major markets was valued at USD 2.3 billion, with projections indicating further growth by 2034, according to DelveInsight. This expansion is largely attributed to rising awareness of TED and an increasing prevalence of the disease.
Discover more about the thyroid eye disease market in detail @ Thyroid Eye Disease Market Report
| Drug Name | TEPEZZA (Teprotumumab-Trbw) |
| Molecule type | Monoclonal antibody |
| Developer | Amgen (Horizon Therapeutics) |
| Primary indication | Thyroid Eye Disease |
| Mechanism of action | IGF-1R inhibitor |
| Route of administration | IV |
Learn more about TEPEZZA projected market size for thyroid eye disease @ TEPEZZA Market Potential
Emerging Competitors of TEPEZZA
Key companies such as Immunovant (IMVT-1401 (batoclimab, RVT-1401); IMVT-1402), Viridian Therapeutics (VRDN-001; VRDN-003), Argenx (Efgartigimod PH20 SC), Tourmaline Bio (Pacibekitug), Hoffmann-La Roche (ENSPRYNG), and Sling Therapeutics (Linsitinib), are at the forefront of developing targeted therapies for thyroid disorders. Viridian Therapeutics stands out as the only company developing treatments for both moderate to severe active TED and chronic TED. Meanwhile, Kriya Therapeutics, Septerna, and Crinetics Pharmaceuticals are progressing with earlier-stage products in this area.
Recently, in January 2025, Sling Therapeutics, Inc., a late-stage biopharmaceutical company developing an oral small molecule therapy for thyroid eye disease, announced topline results on the efficacy and safety of linsitinib from the Phase IIb/III LIDS trial in patients with active, moderate to severe TED.
Linsitinib, Sling Therapeutics’ lead candidate, is an oral small molecule taken twice daily and is being clinically developed for TED. It targets the validated IGF-1R pathway and has demonstrated a well-established safety profile, having been studied in over 900 patients across fifteen clinical trials for various diseases.
To know more about the number of competing drugs in development, visit @ TEPEZZA Market Positioning Compared to Other Drugs
Key Regulatory Milestones of TEPEZZA
- In September 2024, TEPEZZA was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of active Graves’ orbitopathy.
- In April 2024, Amgen announced its plans to submit a Marketing Authorization Application (MAA) for teprotumumab to the European Medicines Agency (EMA) in the near future.
- 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.
- In October 2020, Horizon Therapeutics had a manufacturing agreement with Patheon Pharmaceuticals, for the supply of TEPEZZA drug product in Italy. The agreement runs until October 2026, with automatic three-year renewals unless terminated with two years’ notice.
- In January 2020, the US FDA approved TEPEZZA for the treatment of TED after an accelerated Priority Review.
- In July 2016, it received Breakthrough Therapy Designation (BTD) from the US FDA for the same indication. It was also granted Orphan Drug Designations (ODDs) in the US and Japan.
- In April 2015, TEPEZZA received Fast Track Designation (FTD) from the US FDA for its potential use in the treatment of Graves’ orbitopathy.
Dive deeper to get more insight into TEPEZZA’s strengths & weaknesses relative to competitors @ TEPZZA Market Drug Report
TEPEZZA Market Dynamics
The treatment landscape for Graves’ orbitopathy has long relied on corticosteroids, immunosuppressants, and surgical interventions. However, these methods often fail to provide sufficient relief for moderate to severe cases, increasing both treatment complexity and costs. TEPEZZA, a monoclonal antibody, is specifically approved for the treatment of thyroid eye disease, an autoimmune condition causing inflammation and swelling of the eye muscles and surrounding tissues.
As the first FDA-approved therapy for TED, TEPEZZA represents a major advancement, addressing a previously unmet medical need in a patient population with limited treatment options. In addition to symptom relief, TEPEZZA introduces a novel mechanism of action that may alter the disease’s progression.
However, despite its innovative approach, accessibility and cost remain key challenges. While TEPEZZA is currently the only approved therapy for TED, new competitors—including IMVT-1401 (batoclimab), IMVT-1402, VRDN-001 (veligrotug), and Pacibekitug (TOUR006)—are entering the market with potential alternatives. Among them, Viridian Therapeutics stands out as the sole company developing treatments for both moderate to severe active TED and chronic TED. Its veligrotug trials feature a five-dose regimen with fewer infusions and shorter administration times than TEPEZZA, positioning it as a strong competitor.
Looking ahead, the TEPEZZA market will be shaped by factors such as increased physician familiarity, potential label expansions, and emerging competition. Research into alternative IGF-1R inhibitors and new therapeutic approaches for TED, including small-molecule drugs and gene therapies, could introduce competition in the long term. Nevertheless, TEPEZZA’s first-mover advantage, established prescriber base, and strong unmet need in the TED market are expected to sustain its revenue growth in the near future. Strategic pricing, patient access initiatives, and continued investment in clinical research will be crucial in maintaining its dominance in this evolving landscape.
Discover how TEPEZZA is shaping the thyroid eye disease treatment landscape @ TEPEZZA Thyroid Eye Disease
Key Opinion Views on TEPEZZA
“The introduction of TEPEZZA has significantly impacted TED treatment, leading to a reduction in the need for orbital decompression surgeries at their center.”
- Dr. Kikkawa (Ophthalmology Times)
“The patients exhibiting active disease symptoms—such as significant diplopia, proptosis, and a high Clinical Activity Score (CAS)—respond most favorably to TEPEZZA.”
- Dr. Tamhankar (Eyes On Eyecare)
Table of Contents
| 1 | Report Introduction |
| 2 | TEPEZZA: Amgen (Horizon Therapeutics) |
| 2.1 | Product Overview |
| 2.2 | Other Development Activities |
| 2.3 | Clinical Development |
| 2.4 | Clinical Trials Information |
| 2.5 | Safety and Efficacy |
| 2.6 | Product Profile |
| 2.7 | Market Assessment |
| 2.7.1 | The 7MM Analysis |
| 2.7.1.1 | Cost Assumptions and Rebate |
| 2.7.1.2 | Pricing Trends |
| 2.7.1.3 | Analogue Assessment |
| 2.7.1.4 | Launch Year and Therapy Uptake |
| 2.7.2 | The United States Market Analysis |
| 2.7.3 | EU4 and the United Kingdom Market Analysis |
| 2.7.3.1 | Germany |
| 2.7.3.2 | France |
| 2.7.3.3 | Italy |
| 2.7.3.4 | Spain |
| 2.7.3.5 | UK |
| 2.7.4 | Japan Market Analysis |
| 2.8 | Market Drivers |
| 2.9 | Market Barriers |
| 2.10 | SWOT Analysis |
| 3 | Key Cross of Marketed Competitors of TEPEZZA |
| 4 | Key Cross of Emerging Competitors of TEPEZZA |
Related Reports
Graves’ Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Graves’ disease companies, including Amgen (Horizon Therapeutics), Immunovant, Samsung Biologics, HanAll Biopharma, Roivant Sciences, Viridian Therapeutics, Argenx, Hoffmann-La Roche, Sling Therapeutics, Tourmaline Bio, Lassen Therapeutics, ACELYRIN, among others.
Graves’ Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Graves’ disease companies, including Viridian Therapeutics, Immunovant Sciences GmbH, Apitope International NV, Sling Therapeutics, Novartis Pharmaceuticals, among others.
Thyroid Eye Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key TED companies, including Immunovant Sciences, Novartis Pharmaceuticals, Viridian Therapeutics, Sling Therapeutics, Regeneron Pharmaceuticals, ValenzaBio, among others.
Thyroid Eye Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key TED companies, including Viridian Therapeutics, Immunovant Sciences GmbH, Apitope International NV, Sling Therapeutics, Novartis Pharmaceuticals, among others.
Graves Orbitopathy Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Graves orbitopathy companies, including Viridian Therapeutics, Argenx, Hoffmann-La Roche, Immunovant, Samsung Biologics, HanAll Biopharma, Roivant Sciences, Sling Therapeutics, Tourmaline Bio, Lassen Therapeutics, ACELYRIN, among others.
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