Key Highlights
- Graves' Ophthalmopathy represents a broad spectrum of disease; although the diagnosis is readily apparent in those with severe and active disease, establishing the diagnosis in patients with lesser degrees of Graves' Ophthalmopathy can be challenging, and this may be the primary cause for low diagnosis rate seen across the 7MM since many people go misdiagnosed.
- Graves' Ophthalmopathy is a potentially sight-threatening ocular disease that has puzzled physicians and scientists for nearly two centuries. Its widely quoted incident is 16/100,000 in women and 2.9/100,000 in men. However, these studies are outdated, and no prevalence studies have been reported.
- According to reported literature and primary market research findings, 90% of Graves' Ophthalmopathy cases are generally due to Graves' disease, while the rest are caused due to euthyroid or hypothyroid disorders.
- To estimate the prevalence of Graves' ophthalmopathy, we calculated its occurrence in the prevalent Graves' disease population. Then we scaled up to include Graves' Ophthalmopathy cases caused due to other indications.
- In 2022, the prevalence of Graves' Ophthalmopathy cases were ~2,385,920 in the 7MM, which is expected to rise by 2032.
Geography Covered
- The United States
- EU4 (Germany, France, Italy, and Spain) and the United Kingdom
- Japan
Graves' Ophthalmopathy Disease Understanding and Diagnostic Algorithm
Graves' Ophthalmopathy Overview
Graves' Ophthalmopathy is an autoimmune inflammatory disorder associated with thyroid disease, which affects ocular and orbital tissues. It is also known as Graves' orbitopathy, Graves' eye disease, thyroid eye disease (TED), and thyroid-associated ophthalmopathy. It is the main extrathyroidal manifestation of Graves' disease (GD) and is often disfiguring, significantly impairing the QoL of affected individuals and causing great indirect and direct costs to health systems.Being an immune-mediated inflammatory disorder, it produces expansion of the extraocular muscles and fat in orbit. Edema, accumulation of glycosaminoglycans and collagen, and adipogenesis cause most patients to enlarge both extraocular muscle and orbital adipose tissue, with a predominance of either in some patients.
Graves' Ophthalmopathy Diagnosis
Diagnosis of Graves' Ophthalmopathy is complex because it overlaps symptoms with other diseases, including inflammatory orbitopathy, such as granulomatosis with polyangiitis (GPA, formerly known as Wegener's granulomatosis), allergic conjunctivitis and especially in case euthyroid and hypothyroidism. Although the diagnosis is generally straightforward without additional laboratory or imaging data in thyrotoxic patients with bilateral proptosis, it can be more difficult in euthyroid patients with unilateral proptosis. In these cases, the presence of thyroid autoimmunity, especially the positivity of TSH receptor antibodies (either thyroid-stimulating immunoglobulins [TSI] or thyrotropin-binding inhibitor immunoglobulins [TBII]), is useful in establishing a diagnosis of Graves' Ophthalmopathy. They can also be diagnosed by CT scanning or MRI with special attention to the orbits that may identify an orbital mass lesion, an infiltrative process, idiopathic orbital inflammation (pseudotumor), and orbital abnormality.If the imaging is compatible with Graves' Ophthalmopathy, the finding of elevated TRAb helps diagnose a euthyroid patient. Although the absence of elevated TRAb in this setting does not rule out the diagnosis of Graves' Ophthalmopathy, it makes the diagnosis less likely and necessitates further evaluation and/or observation over time.
The timely and accurate diagnosis of acute Graves' Ophthalmopathy is vital as the natural history of Graves' Ophthalmopathy is such that early intervention in the acute inflammatory phase may improve the long-term outcome. Graves' Ophthalmopathy represents a broad spectrum of disease. Although the diagnosis is readily apparent in those with severe and acute disease, establishing the diagnosis in patients with lesser degrees of Graves' Ophthalmopathy can be challenging. Identifying these patients is important as it is not only those with sight-threatening, acute diseases which benefit from early treatment.
Further details related to country-based variations are provided in the report.
Graves' Ophthalmopathy Epidemiology
The epidemiology of Graves' Ophthalmopathy is not very well studied and understood. Most of the data available over secondary search are of incidence. It has an active inflammatory phase that lasts an average of 3-6 months but may be as long as 3 years, followed by a fibrotic inactive phase. About 1% of patients experience reactivation after a period of inactivity. Therefore, prevalence becomes the better parameter to understand the epidemiology of this disease. Additionally, even though many patients suffer from Graves' Ophthalmopathy, it is referred to as a rare disease because of the difficulty in diagnosing the targeted patient pool.As the market is derived using the patient-based model, the Graves' Ophthalmopathy epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, Prevalent Cases of Graves' Ophthalmopathy, Diagnosed Prevalent Cases of Graves' Ophthalmopathy, Gender-specific Diagnosed Prevalent Cases of Graves' Ophthalmopathy, Diagnosed Prevalent Cases of Graves' Ophthalmopathy, and Moderate-to-severe Drug-treated Cases of Acute Graves' Ophthalmopathy in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2019 to 2032. The total prevalent cases of Graves' Ophthalmopathy in the 7MM comprised approximately 2,386,000 cases in 2022 and are projected to increase during the forecasted period.
- The total prevalent cases of Graves Ophthalmopathy in the United States were around 1,012,000 cases in 2022.
- The US contributed to the largest prevalent population of Graves' Ophthalmopathy, acquiring ~42% of the 7MM in 2022. Whereas Germany accounted for around 13% and Japan accounted for around 8% of the total population share, respectively, in 2022.
- Among EU4 countries, Germany accounted for the largest number of Graves' Ophthalmopathy cases, followed by France, whereas Spain accounted for the lowest number of cases in 2022.
- According to the publisher's estimates, there were around 16,300 cases of acute Graves' Ophthalmopathy and 41,900 cases of chronic Graves' Ophthalmopathy in Japan in 2022. These cases are projected to increase during the forecasted period.
- In the 7MM, approximately 20% of the patient share is attributed to males, whereas only 80% of females suffer from Graves' Ophthalmopathy.
- The diagnosis and treatment rate of Graves' Ophthalmopathy is expected to increase in the coming years due to the increase in expected approvals of several pipeline candidates to treat Graves' Ophthalmopathy, thus leading to an increase in awareness among patients and clinicians.
KOL Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts contacted to understand and validate the patient pool and forecasted trends included Medical/scientific writers, Jules Stein Eye Institute, the University of California, Cedars-Sinai Medical Center, Premier Vision Group, and Others.This analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM.
Scope of the Report
- The report covers a segment of key events, an executive summary, and a descriptive overview of Graves' Ophtalmopathy, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
- Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression has been provided.
- A detailed review of current challenges in establishing diagnosis and diagnosis rate is provided.
Graves' Ophthalmopathy Report Insights
- Patient population
- Prevalence pattern
- Diagnosis rate
- Countrywise epidemiology distribution
Graves' Ophthalmopathy Report Key Strengths
- 10 years forecast
- The 7MM coverage
- Graves' Ophthalmopathy epidemiology segmentation
Graves' Ophthalmopathy Report Assessment
- Epidemiology segmentation
- Current diagnostic practices
- Unmet needs
Key Questions Answered
Epidemiology insights
- What are the disease risk, burdens, and unmet needs of Graves' Ophthalmopathy? What will be the growth opportunities across the 7MM with respect to the patient population of Graves' Ophthalmopathy?
- What is the historical and forecasted Graves' Ophthalmopathy patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
- Even with a large patient pool, why the Graves' Ophthalmopathy receive rare disease benefits?
- Why are only limited patients with symptoms treated? Why is the current year treatment rate not high?
- What factors are affecting the increase in the diagnosis of symptomatic cases?
Reasons to Buy
- The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Graves' Ophthalmopathy market.
- Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
- To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
- To understand the perspective of key opinion leaders around the current challenges with establishing the diagnosis, current diagnosis rate, and treatment-eligible patient pool.
- Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.
Table of Contents
1. Key Insights2. Report Introduction5. Epidemiology and Market Methodology8. KOL Views9. Unmet Needs11. Publisher Capabilities12. Disclaimer13. About the Publisher
3. Graves’ Ophthalmopathy Market Overview at a Glance
4. Executive Summary of Graves’ Ophthalmopathy
6. Disease Background and Overview
7. Epidemiology and Patient Population
10. Appendix
List of Tables
List of Figures