市場調査レポート
商品コード
1259767
バセドウ病眼症(悪性眼球突出症)市場 - 市場の洞察、疫学、市場予測:2032年Graves Ophthalmopathy - Market Insight, Epidemiology And Market Forecast - 2032 |
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バセドウ病眼症(悪性眼球突出症)市場 - 市場の洞察、疫学、市場予測:2032年 |
出版日: 受注後更新
発行: DelveInsight
ページ情報: 英文 161 Pages
納期: 2~10営業日
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2022年のバセドウ病眼症(悪性眼球突出症)の市場規模は、主要7ヶ国の中で米国が最も大きく、約19億8,000万米ドルを占めており、2032年までにさらに増加すると予測されています。
当レポートでは、主要7ヶ国におけるバセドウ病眼症(悪性眼球突出症)市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2032年までの市場規模予測、および医療のアンメットニーズなどを提供しています。
Key Highlights:
DelveInsight's"Graves' Ophthalmopathy - Market Insights, Epidemiology and Market Forecast - 2032" report delivers an in-depth understanding of the Graves' Ophthalmopathy, historical and forecasted epidemiology as well as the Graves' Ophthalmopathy market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
Graves' Ophthalmopathy market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Graves' Ophthalmopathy market size from 2019 to 2032. The report also covers current Graves' Ophthalmopathy treatment practice/algorithm and unmet medical needs to curate the best of the opportunities and assess the market's underlying potential.
Study period: 2019-2032
Graves' Ophthalmopathy overview
Graves' ophthalmopathy (GO) 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 GO 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), orbital abnormality.
If the imaging is compatible with Graves' Ophthalmopathy, the finding of elevated TRAb helps make the diagnosis in 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 reported
Graves' Ophthalmopathy treatment
Until 2019, corticosteroids, immunosuppressants, and other biologics, including rituximab and tocilizumab, were the mainstay treatment options for patients with moderate-to-severe acute Graves' Ophthalmopathy and garnered a market size of approximately USD 37 million across the 7MM.
According to the European Group on Graves' Orbitopathy (EUGOGO) clinical practice guidelines 2021, IV methylprednisolone in combination with oral mycophenolate sodium (or mofetil) represents the first-line treatment for moderate-to-severe and acute Graves' Ophthalmopathy, and in the more severe forms of moderate-to-severe and acute Graves' Ophthalmopathy, including constant/inconstant diplopia, severe inflammatory signs and exophthalmos >25 mm, IV methyl-prednisolone at the highest cumulative dose (7.5 g per cycle) as monotherapy represents an additional valid first-line treatment.
Over the next few years, the US Graves' Ophthalmopathy Market is expected to substantially change and experience growth, as an already approved product, TEPEZZA, will dominate it. In contrast, we also anticipate the launch of a second product, batoclimab, in the US market in the coming 2-3 years. Considering that the acute cases of Graves' Ophthalmopathy are the ones that get treated, which is around 20%, we expect the market to expand, especially as safer and more effective therapies enter the market.
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 drug chapter segment of the Graves' Ophthalmopathy report encloses a detailed analysis of Graves' Ophthalmopathy marketed drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps understand Graves' Ophthalmopathy clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
Marketed drugs
TEPEZZA (teprotumumab): Horizon Therapeutics
Insulin-like growth factor I receptor (IGF-IR) is implicated as a potential cause of Graves' Ophthalmopathy, and overexpression of IGF-IR is found in orbital fibroblasts and lymphocytes. Features of Graves' Ophthalmopathy include periorbital edema, proptosis, strabismus, and eyelid retraction, which can progress to vision-threatening complications, such as exposure keratopathy and compression neuropathy. Current management of this condition is not very effective and includes systemic steroids or radiation of the orbit, both of which are associated with significant adverse effects and complications.
TEPEZZA (teprotumumab) is currently the only FDA-approved therapy for treating Graves' Ophthalmopathy. Significant improvements in proptosis, diplopia, and quality of life are noted following its 24-week course of therapy. It is a fully human IgG1 monoclonal antibody directed against the human insulin-like growth factor-1 receptor; the metabolism of teprotumumab has not been fully characterized; however, it is expected to undergo metabolism via proteolysis. It is supplied as a sterile, preservative-free, and white to off-white, lyophilized powder for IV infusions. It significantly improved ptosis, diplopia, CAS score, and quality of life in moderate-to-severe Graves' Ophthalmopathy and showed a favorable safety profile.
It is an exciting, first-in-kind medication that has shown impressive efficacy in reducing proptosis and other complications of Graves' Ophthalmopathy. The amount of reduction in proptosis is similar to that with orbital decompression surgery, which is associated with significant complications, including exacerbation of the inflammation and worsening of the strabismus.
Note: Detailed current therapies assessment will be provided in the full report of Graves' Ophthalmopathy
Emerging drugs
Batoclimab: Immunovant Sciences
Immunovant's first investigational product, batoclimab (IMVT-1401), is a novel, fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn). In nonclinical studies and clinical trials, batoclimab has been observed to reduce IgG antibody levels. High levels of pathogenic IgG antibodies drive a variety of autoimmune diseases, and, as a result, this product candidate has the potential to address a variety of IgG-mediated autoimmune diseases as a self-administered SC injection.
Batoclimab is being evaluated for treating patients with severe autoimmune diseases mediated by pathogenic immunoglobulin G (IgG), including Graves' Ophthalmopathy. In 2019, it was evaluated in an open-label, single-arm Phase IIa clinical trial to treat Graves' Ophthalmopathy. Most subjects (four of seven) evaluated at the end of treatment experienced a =2-point improvement in clinical activity score (CAS). Three of the seven subjects were proptosis responders. Afterward, a Phase IIb trial was initiated and paused in February 2021 due to elevated total cholesterol and low-density lipoprotein ("LDL") levels observed in some trial subjects treated with IMVT-1401. Then later, the company achieved alignment with the FDA Division of Ophthalmology to move forward in Graves' Ophthalmopathy and initiated two Phase III clinical trials to evaluate batoclimab to treat Graves' Ophthalmopathy in the second half of 2022. Top-line results from both Phase III trials are expected to be available by the first half of 2025.
The drug is expected to launch in 2025 for a monotherapy regimen. Being a novel MoA drug, it can be a potential game changer in the treatment landscape of Graves' Ophthalmopathy. The company intends to develop batoclimab as a self-administered subcutaneous injection and fulfill the unmet of an approved drug, like reducing the risk of disease occurrences. This could help people living with Graves' Ophthalmopathy and healthcare providers manage the long-term consequences of Graves' Ophthalmopathy, which include the social burden as well as the risk of developing severe sight-threatening problems.
Note: Detailed emerging therapies assessment will be provided in the final report.
Drug class insights
Treatment of Graves' Ophthalmopathy has evolved from nonspecific immunosuppression to targeted biological therapies. Current medical therapies target the active stage to decrease inflammation, minimize the worsening of functional ocular sequel, and in some cases, improve ocular signs, including proptosis and double vision. The mainstay of treatment for years has been steroids and orbital radiation (ORT). Several biologics have been assessed in recent years: rituximab, tocilizumab, and teprotumumab.
Corticosteroids have been used to treat TED since the 1950s; several studies have demonstrated the superiority of IV over oral steroids. There was a significant improvement in disease severity, activity, and QoL, minimal proptosis, and no significant improvement in diplopia with IV compared with oral steroids. There are limited data regarding the long-term efficacy of IV steroids. Side effects of IV steroids include liver failure and death.
Rituximab is a monoclonal antibody that blocks CD20, expressed in the B lymphocyte. Its fundamental use comes from experience in the hematology-oncology field, where it revolutionized the treatment approach of many lymphoproliferative disorders, as well as in the field of systemic autoimmune diseases. Regarding Graves' Ophthalmopathy, it was speculated that its use could be important, given that it is a disease mediated by antibodies against the TSH receptor. However, it was observed that, with B-cell depletion treatment, the levels of antibodies are not modified, which suggests that the mode of action in this disease should involve T-cell activity modulation.
As the first biological treatment used for Graves' Ophthalmopathy, it is currently recommended by the EUGOGO guidelines to treat patients refractory to steroid treatment.
Tocilizumab is a monoclonal antibody that blocks the interleukin 6 (IL-6) receptor and is used as a biologic drug in the treatment of autoinflammatory diseases and systemic autoimmune diseases, such as rheumatoid arthritis and giant cell arteritis. IL-6 is a ubiquitous protein in the body and is highly involved in controlling the inflammatory response.
Graves' Ophthalmopathy has a relevant role as an inducer of local inflammation concerning the increase in the expression of the thyrotropin receptor in the orbital connective tissue.
Teprotumumab is a humanized monoclonal antibody against the G1 immunoglobulin subclass. It binds to the insulin growth factor 1 (IGF1R) receptor, acting as a powerful inhibitor of the activation of IGF1R signaling, which is over-expressed in orbital fibroblasts and plays a vital role in Graves' Ophthalmopathy inflammation. It is the only drug approved by the US FDA for treating Graves' Ophthalmopathy. It is supplied as a sterile, preservative-free, and white to off-white, lyophilized powder for IV infusions. It significantly improved ptosis, diplopia, CAS score, and quality of life in moderate-to-severe Graves' Ophthalmopathy and showed a favorable safety profile.
Moreover, the upcoming treatment landscape is poised to see further expansion after the emergence of new classes, such as neonatal Fc receptor antagonists, IL17A protein inhibitors, and others.
Graves' Ophthalmopathy treatment in the US is entering a new era with changing dynamics. To this date, only one drug has been approved by the US FDA to treat Graves' Ophthalmopathy: insulin-like growth factor-I receptor antagonist TEPEZZA.
It is worth mentioning that the European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines 2021 recommends IV methylprednisolone in combination with oral mycophenolate sodium (or mofetil) as the first-line treatment for moderate-to-severe and acute Graves' Ophthalmopathy, and in the more severe forms of moderate-to-severe and acute Graves' Ophthalmopathy, including constant/inconstant diplopia, severe inflammatory signs and exophthalmos >25 mm, IV methyl-prednisolone at the highest cumulative dose (7.5 g per cycle) as monotherapy represents an additional valid first-line treatment.
The current market has been segmented into different commonly used drugs based on the prevailing treatment pattern across the 7MM, presenting minor variations in the overall prescription pattern. Corticosteroids, immunosuppressants, neonatal Fc receptor antagonists, IL17A protein inhibitors, Insulin-like growth factor-I receptor antagonists, and others (rituximab, tocilizumab, eye drops, pain killers, supplements like selenium) are the major drug classes that have been covered in the forecast model.
The expected launch of upcoming therapies and greater integration of early patient screening, medication in secondary care and other clinical settings, research on best methods for implementation, and an upsurge in awareness will eventually facilitate the development of effective treatment options. However, there are a few roadblocks regarding the timely diagnosis and treatment of these patients; for instance, since the condition is referred to as a rare indication, the companies are charging premium prices, which often become a hindrance when adopting newer therapies.
Key players such as Immunovant Sciences (batoclimab), Novartis Pharmaceuticals (secukinumab), Viridian Therapeutics (VRDN-001), Sling Therapeutics (linsitinib), Regeneron Pharmaceuticals (aflibercept), ValenzaBio (VB421), and several others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Graves' Ophthalmopathy.
Currently, teprotumumab is the only FDA-approved therapy for the treatment of Graves' Ophthalmopathy; for this reason, research into new drugs is unsurprisingly demanding. A few potential therapies are in the advanced phase for treating Graves' Ophthalmopathy; the rest are in Phase II. It is early to comment on the above-mentioned promising candidate to enter the market during the forecast period (2019-2032); it is safe to assume that the future of this market will depend upon the success of the trial result of these emerging drugs. New players have a huge opportunity to enter the market.
This section focuses on the uptake rate of potential drugs expected to get launched in the market during 2019-2032. For example, batoclimab, being developed by mid-cap company Immunovant Sciences, we expect the drug uptake to be medium-fast with a probability-adjusted peak share of 16%, and years to the peak is expected to be 6 years from the year of launch for monotherapy.
Further detailed analysis of emerging therapies drug uptake in the report…
Graves' Ophthalmopathy Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.
Pipeline development activities
The report covers detailed information on collaborations, acquisition and merger, licensing, and patent details for Graves' Ophthalmopathy emerging therapies.
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 for insights on Graves' Ophthalmopathy evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, drug uptake along with challenges related to accessibility, including Medical/scientific writers, Jules Stein Eye Institute the University of California, Cedars-Sinai Medical Center, Premier Vision Group, and Others.
Delveinsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies and treatment patterns or Graves' Ophthalmopathy market trend. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis, and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, treatment duration and frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in Graves' Ophthalmopathy trials, one of the most important primary outcome measures is reducing proptosis response.
Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
Reimbursement of rare disease therapies can be limited due to lack of supporting policies and funding, challenges of high prices, lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers' concerns about budget impact. The high cost of rare disease drugs usually has a limited impact on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies in the past few years. From a patient perspective, health insurance and payer coverage guidelines surrounding rare disease treatments restrict broad access to these treatments, leaving only a small number of patients who can bypass insurance and pay for products independently.
TEPEZZA (teprotumumab) is an insulin-like growth factor-1 receptor inhibitor (IGF-1R), a fully human IgG1 monoclonal antibody. The mechanism of action of teprotumumab in patients with thyroid eye disease has not been fully characterized. TEPEZZA binds to IGF-1R and blocks its activation and signaling.
Centers for Medicare and Medicaid Services (CMS) has assigned a permanent, product-specific Healthcare Common Procedure Coding System (HCPCS) J-code (J3241) for TEPEZZA (teprotumumab); it is the first and only FDA-approved medicine for the treatment of Graves' Ophthalmopathy. The permanent J-code, which enables reimbursement in all outpatient treatment settings, came into effect in October 2020. In the interim, a temporary C-code (C9061) has been established between July and October for TEPEZZA to support medicare fee-for-service pass-through payment in the hospital outpatient department. Other payers, such as commercial insurers, may also use C9061 in the interim. Commercial insurers use J-codes and government payers to standardize claims submissions and reimbursements for medicines, such as TEPEZZA, administered by a healthcare professional. While not a guarantee of payment, these codes enable timely claims adjudication and processing
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Graves' Ophthalmopathy report insights
Graves' Ophthalmopathy report key strengths
Graves' Ophthalmopathy report assessment
Key Questions
Market insights
Epidemiology insights
Current treatment scenario, marketed drugs, and emerging therapies