甲状腺眼症治療薬の需要増加を受け、TEPEZZAの市場売上が急増 | DelveInsight

TEPEZZA stands out as the pioneering FDA-approved medication for thyroid eye disease (TED), revolutionizing treatment by filling a significant void for patients with limited options. Beyond alleviating symptoms, it employs a unique mechanism that could potentially modify the disease's course.

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

As the inaugural FDA-endorsed therapy for TED, TEPEZZA represents a transformative development in TED management, tackling a longstanding therapeutic shortfall for affected individuals. It not only eases symptoms but also features an innovative action pathway with the possibility of influencing disease advancement.

DelveInsight’s “TEPEZZA Market Size, Forecast, and Market Insight Report” delves into TEPEZZA, an inhibitor of the insulin-like growth factor-1 receptor (IGF-1R). The report covers product details, patent information, and competitive therapies (both available and in development) for TEPEZZA. It also presents historical and projected sales data from 2020 to 2034 across the 7MM (United States, EU4—Germany, France, Italy, Spain—the United Kingdom, and Japan).

Amgen’s TEPEZZA (Teprotumumab-Trbw) Overview

Teprotumumab is a fully human IgG1 monoclonal antibody that blocks IGF-1R, manufactured in Chinese Hamster Ovary (CHO-DG44) cells, with a molecular weight of approximately 148 kDa. Its full metabolic pathway is not fully elucidated, but it is expected to break down via proteolysis. TEPEZZA is supplied as a sterile, preservative-free, white to off-white lyophilized powder for intravenous infusions.

Each vial contains 500 mg of teprotumumab, plus excipients: L-histidine (7.45 mg), L-histidine hydrochloride monohydrate (31.8 mg), polysorbate 20 (1 mg), and trehalose dihydrate (946 mg). Reconstituting with 10 mL of sterile water for injection yields a concentration of 47.6 mg/mL at pH 5.5.

The recommended dosing starts with an initial 10 mg/kg IV infusion, followed by 20 mg/kg every three weeks for seven more doses. While the precise mechanism in Graves’ ophthalmopathy is not entirely clear, it binds to IGF-1R to prevent activation and signaling. TEPEZZA achieved USD 460 million in Q4 2024 sales and USD 1.9 billion for the full year 2024.

Currently, TEPEZZA is under Phase III evaluation for moderate-to-severe active Graves’ orbitopathy and chronic TED with low Clinical Activity Score (CAS). Amgen is also exploring subcutaneous delivery, though IV administration is the only approved route.

TED is a rare yet severe autoimmune disorder impacting the eyes, frequently associated with hyperthyroidism or Graves’ disease. Approximately 25-50% of Graves’ disease patients develop TED, with higher prevalence in women. In 2023, there were 1.4 million diagnosed prevalent cases globally, expected to increase by 2034 per DelveInsight. The US leads in diagnosed cases within the 7MM.

In the coming years, the US TED market is poised for substantial growth and change, fueled by TEPEZZA's established presence. The upcoming introduction of batoclimab in 2-3 years should further drive expansion. With only about 20% of TED cases being acute and treated, the market is set to expand through safer, more effective options.

The TED market across the 7MM reached USD 2.3 billion in 2023, with growth anticipated through 2034, driven by heightened awareness and rising incidence.

Explore the thyroid eye disease market further @ Thyroid Eye Disease Market Report-https://www.delveinsight.com/report-store/tepezza-market-size-forecast-and-market-insight?utm_source=apac&utm_medium=promotion&utm_campaign=kkpr

Learn more about TEPEZZA's projected market potential for thyroid eye disease @ TEPEZZA Market Potential-https://www.delveinsight.com/report-store/tepezza-market-size-forecast-and-market-insight?utm_source=apac&utm_medium=promotion&utm_campaign=kkpr

Emerging Competitors for TEPEZZA

Leading firms like 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 advancing targeted treatments for thyroid conditions. Viridian Therapeutics uniquely develops therapies for both moderate-to-severe active TED and chronic TED. Meanwhile, Kriya Therapeutics, Septerna, and Crinetics Pharmaceuticals are advancing early-stage candidates.

In January 2025, Sling Therapeutics announced topline data from the Phase IIb/III LIDS trial for linsitinib in active, moderate-to-severe TED patients.

Linsitinib, Sling's primary asset, is an oral small molecule administered twice daily, targeting the IGF-1R pathway with a proven safety record from over 900 patients in 15 trials across various conditions.

For details on competing drugs in development, visit @ TEPEZZA Market Positioning Compared to Other Drugs-https://www.delveinsight.com/report-store/tepezza-market-size-forecast-and-market-insight?utm_source=apac&utm_medium=promotion&utm_campaign=kkpr

Key Regulatory Milestones for TEPEZZA

• September 2024: Approved by Japan's MHLW for active Graves’ orbitopathy.
• April 2024: Amgen plans to file an MAA with the EMA soon.
• October 2023: Amgen acquired Horizon Therapeutics for ~USD 27.8 billion, gaining TEPEZZA for active Graves’ orbitopathy.
• October 2020: Horizon partnered with Patheon for TEPEZZA supply in Italy until October 2026, with renewal options.
• January 2020: FDA approval for TED via accelerated Priority Review.
• July 2016: Granted Breakthrough Therapy Designation by FDA; also Orphan Drug status in US and Japan.
• April 2015: Fast Track Designation from FDA for Graves’ orbitopathy.

Gain deeper insights into TEPEZZA's strengths and weaknesses vs. competitors @ TEPEZZA Market Drug Report-https://www.delveinsight.com/report-store/tepezza-market-size-forecast-and-market-insight?utm_source=apac&utm_medium=promotion&utm_campaign=kkpr

TEPEZZA Market Dynamics

TED treatment has historically depended on corticosteroids, immunosuppressants, and surgery, often inadequate for severe cases, complicating care and raising costs. TEPEZZA, a monoclonal antibody, is approved for TED, an autoimmune issue causing eye muscle and tissue inflammation.

As the first FDA-approved TED therapy, it addresses an unmet need. Its novel mechanism may alter disease progression.

Challenges include accessibility and cost. While TEPEZZA is the sole approved option, newcomers like IMVT-1401 (batoclimab), IMVT-1402, VRDN-001 (veligrotug), and Pacibekitug (TOUR006) are emerging. Viridian Therapeutics uniquely targets both active and chronic TED, with veligrotug's five-dose regimen offering fewer infusions and shorter times than TEPEZZA.

Future market trends will involve physician adoption, label extensions, and competition. Long-term rivals may include other IGF-1R inhibitors, small molecules, and gene therapies. TEPEZZA's early entry, prescriber loyalty, and market need should support revenue growth. Pricing strategies, access programs, and R&D will be vital for sustained leadership.

See how TEPEZZA influences TED treatment @ TEPEZZA Thyroid Eye Disease-https://www.delveinsight.com/report-store/tepezza-market-size-forecast-and-market-insight?utm_source=apac&utm_medium=promotion&utm_campaign=kkpr

Key Opinion Views on TEPEZZA

“TEPEZZA has markedly changed TED care, reducing orbital decompression surgeries at our facility.”

— Dr. Kikkawa (Ophthalmology Times)

“Patients with active disease—severe diplopia, proptosis, and high CAS—show the best responses to TEPEZZA.”

— Dr. Tamhankar (Eyes On Eyecare)

Table of Contents

1. Report Introduction
2. TEPEZZA: Amgen (Horizon Therapeutics)
3. 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
4. Key Cross of Marketed Competitors of TEPEZZA
5. Key Cross of Emerging Competitors of TEPEZZA

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