甲狀腺眼症(TED)

甲狀腺眼症(TED)與甲狀腺疾病有關，最常發生在凸眼性甲狀腺腫，在患者的約40％中存在。

TED的流行病學資料有限，不過，文件報告一般人口中TED的年度發生率女性每10萬人有16人，男性每10萬人有3人用。

Datamonitor 推定Healthcare，2020年在全球有384,000件TED發生，其數預測至2029年增加到438,000件。

本報告提供全球甲狀腺眼症(TED)市場相關調查，疾病的背景，治療概要，流行病學，成藥與開發平台藥物，臨床試驗趨勢，未滿足需求，及今後預測等相關資料分析。

目錄

內容

概要

要點

疾病的背景

• 定義
• 患者的市場區隔
• 症狀
• 危險因素
• 診斷

治療

• 醫療
• 眼窩放射線治療
• 外科的治療

流行病學

• 甲狀腺疾病中甲狀腺眼症的發生
• 發生率的調查手法

成藥

開發平台藥物

最近的事件和分析師的意見

• 甲狀腺眼症用IMVT-1401(2020年3月30日)
• 甲狀腺眼症用Tepezza(2019年12月13日)
• 甲狀腺眼症用Tepezza(2019年12月11日)

今後主要的活動

主要的法規活動

• Horizon預計，美國的認證後，Tepezza將暢銷

成功的概率

授權及資產取得的交易

• MiRagen以全股份交易收購Viridian

商機

臨床試驗情勢

• 贊助商:各狀態
• 贊助商:各階段
• 最近的活動

參考文件

• 處方資訊

附錄

Thyroid eye disease (TED), also called Graves' ophthalmopathy or orbitopathy, is an autoimmune disorder that causes inflammation in the orbital and retroocular tissues. It generally occurs as a manifestation of Graves' disease, a condition in which the immune system attacks the thyroid gland, commonly affecting the eyes and skin. Although TED is usually found in Graves' hyperthyroidism patients, some patients may have autoimmune euthyroid or hypothyroid thyroiditis. TED is mostly a mild, non-progressive, and self-limiting disease; however, in rare cases it can progress to vision loss. The negative impact of TED on the social and psychological well-being of individuals is an established consequence of the disease.

Key Takeaways

Thyroid eye disease (TED) is associated with thyroid disease, and most commonly occurs in Graves' disease, where it is estimated to be present in ~40% of patients.

Epidemiological data are limited for TED, but it is reported in the literature that annual incidence in the general population is 16 per 100,000 in women and three per 100,000 in men.

Based on these rates, Datamonitor Healthcare estimates that in 2020, there were 384,000 incident cases of TED worldwide, and expects that number to increase to 438,000 incident cases by 2029.

The only approved drug in the TED space is Horizon's Tepezza, which targets insulin-like growth factor-1 receptor. It is currently available as an intravenous formulation.

There are currently no pipeline candidates in development for TED.

The only high-impact upcoming event in the TED space is topline results from Tepezza's Chronic TED trial. The overall likelihood of approval of a Phase I ophthalmology-other asset is 22.8%, and the average probability a drug advances from Phase III is 55%. Drugs, on average, take 8.6 years from Phase I to approval, compared to 8.9 years in the overall ophthalmology space.

The distribution of clinical trials across Phase I-IV indicates that the majority of trials for TED have been in the late phases of development, with 57% of trials in Phase III-IV, and 43% in Phase II.

Horizon Therapeutics has the highest number of completed clinical trials for TED, with three trials.

Horizon Therapeutics leads industry sponsors with the highest overall number of clinical trials for TED.

TABLE OF CONTENTS

CONTENTS

OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

• Definition
• Patient segmentation
• Symptoms
• Risk factors
• Diagnosis

TREATMENT

• Medical treatment
• Orbital radiotherapy
• Surgical treatment

EPIDEMIOLOGY

• Thyroid eye disease occurrence in thyroid disorders
• Incidence methodology

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

• Batoclimab for Thyroid Eye Disease (March 30, 2020)
• Tepezza for Thyroid Eye Disease (December 13, 2019)
• Tepezza for Thyroid Eye Disease (December 11, 2019)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

• With Return Of Tepezza Supply, Horizon Is Ready To Get Back To Business

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

• MiRagen Acquires Viridian In All-Stock Deal

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

• Sponsors by status
• Sponsors by phase

BIBLIOGRAPHY

APPENDIX

LIST OF FIGURES

• Figure 1: Trends in incident cases of thyroid eye disease, 2020-29
• Figure 2: Batoclimab for Thyroid Eye Disease (March 30, 2020): Phase IIa - ASCEND-GO 1
• Figure 3: Key upcoming events in thyroid eye disease
• Figure 4: Probability of success in the ophthalmology-other pipeline
• Figure 5: Clinical trials in thyroid eye disease
• Figure 6: Top 10 drugs for clinical trials in thyroid eye disease
• Figure 7: Top 10 companies for clinical trials in thyroid eye disease
• Figure 8: Thyroid eye disease trials status
• Figure 9: Thyroid eye disease trials sponsors, by phase

LIST OF TABLES

• Table 1: Prevalence of thyroid eye disease in Graves' disease
• Table 2: Incident cases of thyroid eye disease, 2020-29
• Table 3: Marketed drugs for thyroid eye disease
• Table 4: Batoclimab for Thyroid Eye Disease (March 30, 2020)
• Table 5: Tepezza for Thyroid Eye Disease (December 13, 2019)
• Table 6: Tepezza for Thyroid Eye Disease (December 11, 2019)
• Table 7: Historical global sales, by drug ($m), 2016-20
• Table 8: Forecasted global sales, by drug ($m), 2021-25