Market Spotlight: Thyroid Eye Disease (TED)
Market Spotlight: Thyroid Eye Disease (TED)
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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.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
- Description
- Contents
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 20.1%, 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 67% of trials in Phase III–IV, and 33% 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.
CONTENTS
5 OVERVIEW
6 KEY TAKEAWAYS
7 DISEASE BACKGROUND
7 Definition
7 Patient segmentation
9 Symptoms
9 Risk factors
10 Diagnosis
11 TREATMENT
11 Medical treatment
11 Orbital radiotherapy
11 Surgical treatment
13 EPIDEMIOLOGY
13 Thyroid eye disease occurrence in thyroid disorders
13 Incidence methodology
17 MARKETED DRUGS
19 PIPELINE DRUGS
20 RECENT EVENTS AND ANALYST OPINION
20 Batoclimab for Thyroid Eye Disease (March 30, 2020)
23 KEY UPCOMING EVENTS
24 KEY REGULATORY EVENTS
24 With Return Of Tepezza Supply, Horizon Is Ready To Get Back To Business
25 PROBABILITY OF SUCCESS
26 LICENSING AND ASSET ACQUISITION DEALS
26 MiRagen Acquires Viridian In All-Stock Deal
27 REVENUE OPPORTUNITY
28 CLINICAL TRIAL LANDSCAPE
29 Sponsors by status
29 Sponsors by phase
31 BIBLIOGRAPHY
32 APPENDIX
LIST OF FIGURES
16 Figure 1: Trends in incident cases of thyroid eye disease, 2020–29
22 Figure 2: Batoclimab for Thyroid Eye Disease (March 30, 2020): Phase IIa – ASCEND-GO 1
23 Figure 3: Key upcoming events in thyroid eye disease
25 Figure 4: Probability of success in the ophthalmology-other pipeline
28 Figure 5: Clinical trials in thyroid eye disease
28 Figure 6: Top 10 drugs for clinical trials in thyroid eye disease
29 Figure 7: Top 10 companies for clinical trials in thyroid eye disease
29 Figure 8: Thyroid eye disease trials status
30 Figure 9: Thyroid eye disease trials sponsors, by phase
LIST OF TABLES
13 Table 1: Prevalence of thyroid eye disease in Graves’ disease
14 Table 2: Incident cases of thyroid eye disease, 2020–29
18 Table 3: Marketed drugs for thyroid eye disease
20 Table 4: Batoclimab for Thyroid Eye Disease (March 30, 2020)
27 Table 5: Historical global sales, by drug ($m), 2016–20
27 Table 6: Forecasted global sales, by drug ($m), 2021–25
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