甲状腺眼症 - 市場考察、疫学、市場予測（2034年）

主なハイライト

• 2023年、主要7市場の診断された甲状腺眼症の患者数は推定約150万人でした。このうち米国が44%、欧州4ヶ国・英国が約49%、日本が7%を占めています。
• 甲状腺眼症市場は安定した成長が予測され、2024年～2034年のCAGRは堅調に推移すると予測されます。この主要7市場全体での拡大は、VRDN-001、VRDN-003、lonigutamab、efgartigimod PH20などの革新的な治療薬の導入によって促進されます。さらに、喫煙、年齢、甲状腺眼症の罹患期間、放射性ヨード治療、遺伝、セレン欠乏症やストレスなどの環境要素などの要因に影響される甲状腺眼症の患者の増加が、市場成長をさらに後押しすると見られます。
• 主要7市場の甲状腺眼症の市場規模は、2023年に約23億4,060万米ドルと推定されました。2024年～2034年の予測期間にCAGRで17.7%の成長が見込まれます。
• 甲状腺眼症は治療オプションが限られており、承認されている薬剤はTEPEZZAのみです。甲状腺眼症は複雑な自己免疫疾患であり、臨床症状も多様であるため、標的を絞った疾患修飾療法の開発は困難であり、より効果的な治療法に対するアンメットニーズは大きいです。
• Viridian Therapeutics、ACELYRIN、Argenx、Immunovant Sciencesなどは、甲状腺眼症市場における技術革新を促進し、大きな成長機会を創出するため、さまざまな臨床試験段階を経て自社アセットの開発を進めています。
• 米国のViridian TherapeuticsのVRDN-003（IGF-1R抗体）は現在フェーズ3臨床開発段階にあり、は2026年末までに甲状腺眼症治療薬として生物製剤承認申請（BLA）を行う予定です。

市場見通し

甲状腺眼症の治療戦略は、疾患の重症度に応じて支持的アプローチと特異的アプローチに分けられます。支持療法には、眼球潤滑、眼帯、複視に対するプリズム矯正、腫脹を軽減するための頭部挙上などが含まれます。薬理学的治療には、グルココルチコイド、ミコフェノール酸、rituximab、ocilizumab、teprotumumab、シクロスポリン/mTOR阻害薬が含まれます。副腎皮質ステロイド、特に経口プレドニゾンが主流で、視神経圧迫には高用量または静脈内投与が用いられます。

IGF-1R阻害薬であるTEPEZZA（teprotumumab）は、チャイニーズハムスター卵巣（CHO-DG44）細胞で産生された分子量148kDaの完全ヒトIgG1モノクローナル抗体として、2020年に米国FDAの承認を取得しました。2024年、日本の厚生労働省が活動性甲状腺眼症を適応症として承認し、世界的に使用が拡大しました。methotrexate、azathioprine、免疫グロブリン静注療法、抗腫瘍壊死因子療法（adalimumab、etanercept、infliximabなど）といった他の治療法は、teprotumumabやrituximabのような生物学的製剤に比べ、限られた有効性しか示しません。

現在、TEPEZZAは活動性甲状腺眼症に対して承認された唯一の治療法であり、大きなアンメットニーズを浮き彫りにしています。グルココルチコイド、rituximab、tocilizumabなどの適応外治療は、有効性に一貫性がなく、この疾患に対する承認はありません。このギャップは、特に重症患者や難治性患者に対する、標的を絞った効果的な治療法の必要性を強調しています。

近年の進歩としては、VRDN-001、VRDN-003、batoclimab、efgartigimod PH20 SC、ENSPRYNG（satralizumab、RG6168）、LASN01、linsitinib、AMG 732（旧HZN-280）、lonigutamab（抗IGF-1R）などがあり、治療成績の改善とアンメットニーズへの対応を目指しています。

• 主要7市場の甲状腺眼症の総市場規模は、2023年に約23億4,060万米ドルであり、予測期間（2024年～2034年）に拡大する見込みです。
• 米国の甲状腺眼症の市場規模は、2023年に約21億1,450万米ドルであり、新治療法の上市により増加が予測されます。
• 欧州4ヶ国・英国の総市場規模は2023年に約2億370万米ドルと推計され、主要7市場の総市場収益の9%近くを占めました。
• 2023年、欧州4ヶ国・英国の中でドイツが市場を独占し、約4,540万米ドルを創出しました。フランスが約4,180万米ドルで僅差で続き、英国は約4,080万米ドルを記録しました。
• 2023年、日本の甲状腺眼症眼症の総市場規模は約2,230万米ドルであり、予測期間（2024年～2034年）に拡大が見込まれます。
• VRDN-003は、2034年までに主要7市場で約14億7,310万米ドルを創出すると予測されます。

当レポートでは、甲状腺眼症の主要7市場（米国、ドイツ、スペイン、イタリア、フランス、英国、日本）について調査分析し、各地域の市場規模、現在の治療法、アンメットニーズ、新薬などの情報を提供しています。

目次

第1章 重要考察

第2章 レポートのイントロダクション

第3章 市場の概要

• 甲状腺眼症の市場シェアの分布（2020年）
• 甲状腺眼症の市場シェアの分布（2034年）

第4章 疫学と市場予測の調査手法

第5章 エグゼクティブサマリー

第6章 重要な出来事

第7章 疾患の背景と概要

• イントロダクション
• 種類
• 兆候と症状
• 原因と危険因子
• 段階分け
  • NOSPECS分類
  • VISA分類
  • EUGOGO分類
• 病態生理学
• バイオマーカー
• 診断
  • 鑑別診断
• 現在の治療法
  • 治療ガイドライン
  • 治療アルゴリズム

第8章 ペイシェントジャーニー

第9章 疫学と患者人口

• 主な調査結果
• 前提条件と根拠
• 主要7市場の甲状腺眼症の診断された患者の総数
• 米国
• 欧州4ヶ国・英国
• 日本

第10章 上市済み薬品

• TEPEZZA（Teprotumumab-Trbw）：Amgen（Horizon Therapeutics）

第11章 新薬

• 主な競合
• VRDN-001（veligrotug）：Viridian Therapeutics
• VRDN-003：Viridian Therapeutics
• Efgartigimod PH20 SC：Argenx
• ENSPRYNG（satralizumab, RG6168）：Hoffmann-La Roche
• IMVT-1401（batoclimab、RVT-1401）：Immunovant、Samsung Biologics、HanAll Biopharma、Roivant Sciences
• Linsitinib：Sling Therapeutics
• Pacibekitug（TOUR006）：Tourmaline Bio
• LASN01：Lassen Therapeutics
• Lonigutamab：ACELYRIN

第12章 甲状腺眼症：市場の分析

• 主な調査結果
• 主な市場予測の前提条件
  • コストの想定とリベート
  • 価格動向
  • アナログの評価
  • 上市年と治療の普及
• 市場見通し
• 属性分析
• 主要7市場の甲状腺眼症の総市場規模
• 主要7市場の甲状腺眼症の総市場規模：治療法別
• 米国の甲状腺眼症の市場規模
  • 米国の甲状腺眼症の総市場規模
  • 米国の甲状腺眼症の総市場規模：治療法別
• 欧州4ヶ国・英国の甲状腺眼症の市場規模
  • 欧州4ヶ国・英国の甲状腺眼症の総市場規模
  • 欧州4ヶ国・英国の甲状腺眼症の総市場規模：治療法別
• 日本の甲状腺眼症の市場規模
  • 日本の甲状腺眼症の総市場規模
  • 日本の甲状腺眼症の総市場規模：治療法別

第13章 KOLの見解

第14章 SWOT分析

第15章 アンメットニーズ

第16章 市場参入と償還

• 米国
• 欧州4ヶ国・英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • 英国
• 日本

第17章 付録

第18章 DelveInsightのサービス内容

第19章 免責事項

第20章 DelveInsightについて

List of Tables

• Table 1: Summary of Epidemiology and Market (2020-2034)
• Table 2: Key Events for Idiopathic Inflammatory Myositis
• Table 3: A Bridged Classification Of Eye Changes Of Graves' Disease
• Table 4: NO SPECS modified classification
• Table 5: VISA Inflammatory Index (I)
• Table 6: Protocol to assess the severity of Graves' ophthalmopathy (EUGOGO)
• Table 7: EUGOGO Classification of the Severity of the Ophthalmopathy
• Table 8: Total Diagnosed Prevalent Cases of Graves' Orbitopathy in the 7MM (2020-2034)
• Table 9: Total Diagnosed Prevalent Cases of Graves' Orbitopathy in the US (2020-2034)
• Table 10: Gender-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in the US (2020-2034)
• Table 11: Chronicity-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in the US (2020-2034)
• Table 12: Severity-specific Diagnosed Prevalent Cases of Acute Graves' Orbitopathy in the US (2020-2034)
• Table 13: Total Diagnosed Prevalent Cases of Graves' Orbitopathy in EU4 and the UK (2020-2034)
• Table 14: Gender-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in EU4 and the UK (2020-2034)
• Table 15: Chronicity-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in EU4 and the UK (2020-2034)
• Table 16: Severity-specific Diagnosed Prevalent Cases of Acute Graves' Orbitopathy in EU4 and the UK (2020-2034)
• Table 17: Total Diagnosed Prevalent Cases of Graves' Orbitopathy in Japan (2020-2034)
• Table 18: Gender-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in Japan (2020-2034)
• Table 19: Chronicity-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in Japan (2020-2034)
• Table 20: Severity-specific Diagnosed Prevalent Cases of Acute Graves' Orbitopathy in Japan (2020-2034)
• Table 21: TEPEZZA (teprotumumab), Clinical Trials Description, 2024
• Table 22: Efficacy Results in Patients with Graves' Ophthalmopathy in Studies 1 and 2
• Table 23: Comparison of Emerging Drugs for Treatment
• Table 24: VRDN-001 (veligrotug), Clinical Trials Description, 2024
• Table 25: VRDN-003, Clinical Trials Description, 2024
• Table 26: Efgartigimod (PH20 SC), Clinical Trials Description, 2024
• Table 27: ENSPRYNG (satralizumab, RG6168), Clinical Trial Description, 2024
• Table 28: IMVT-1401 (batoclimab, RVT-1401), Clinical Trials Description, 2024
• Table 29: Linsitinib, Clinical Trials Description, 2024
• Table 30: TOUR006, Clinical Trials Description, 2024
• Table 31: LASN01, Clinical Trials Description, 2024
• Table 32: Lonigutamab, Clinical Trials Description, 2024
• Table 33: Key Market Forecast Assumption of Graves' Orbitopathy in the US
• Table 34: Key Market Forecast Assumption of Graves' Orbitopathy in EU4 and the UK
• Table 35: Key Market Forecast Assumption of Graves' Orbitopathy in Japan
• Table 36: Total Market Size of Graves' Orbitopathy in the 7MM, in USD Million (2020-2034)
• Table 37: Total Market Size of Graves' Orbitopathy by Therapies in the 7MM, in USD Million (2020-2034)
• Table 38: Total Market Size of Graves' Orbitopathy in the US, in USD Million (2020-2034)
• Table 39: Total Market Size of Graves' Orbitopathy by Therapies in the US, in USD Million (2020-2034)
• Table 40: Total Market Size of Graves' Orbitopathy in EU4 and the UK, in USD Million (2020-2034)
• Table 41: The Market Size of Graves' Orbitopathy by Therapies in EU4 and the UK, in USD Million (2020-2034)
• Table 42: Total Market Size of Graves' Orbitopathy in Japan, in USD Million (2020-2034)
• Table 43: Total Market Size of Graves' Orbitopathy by Therapies in Japan, in USD Million (2020-2034)
• Table 44: NHI Pricing for Graves' Orbitopathy Therapies

List of Figures

• Figure 1: Risk Factors for the Development and Progression of Graves' Ophthalmopathy
• Figure 2: CAS Assessment
• Figure 3: Pathophysiology of Graves' Ophthalmopathy
• Figure 4: Algorithm for the Therapeutic Approach
• Figure 5: Patient Journey
• Figure 6: Total Diagnosed Prevalent Cases of Graves' Orbitopathy in the 7MM (2020-2034)
• Figure 7: Total Diagnosed Prevalent Cases of Graves' Orbitopathy in the US (2020-2034)
• Figure 8: Gender-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in the US (2020-2034)
• Figure 9: Chronicity-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in the US (2020-2034)
• Figure 10: Severity-specific Diagnosed Prevalent Cases of Acute Graves' Orbitopathy in the US (2020-2034)
• Figure 11: Total Diagnosed Prevalent Cases of Graves' Orbitopathy in EU4 and the UK (2020-2034)
• Figure 12: Gender-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in EU4 and the UK (2020-2034)
• Figure 13: Chronicity-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in EU4 and the UK (2020-2034)
• Figure 14: Severity-specific Diagnosed Prevalent Cases of Acute Graves' Orbitopathy in EU4 and the UK (2020-2034)
• Figure 15: Total Diagnosed Prevalent Cases of Graves' Orbitopathy in Japan (2020-2034)
• Figure 16: Gender-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in Japan (2020-2034)
• Figure 17: Chronicity-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in Japan (2020-2034)
• Figure 18: Severity-specific Diagnosed Prevalent Cases of Acute Graves' Orbitopathy in Japan (2020-2034)
• Figure 19: Total Market Size of Graves' Orbitopathy in the 7MM, in USD Million (2020-2034)
• Figure 20: Total Market Size of Graves' Orbitopathy by Therapies in the 7MM, in USD Million (2020-2034)
• Figure 21: Total Market Size of Graves' Orbitopathy in the US, in USD Million (2020-2034)
• Figure 22: Total Market Size of Graves' Orbitopathy by Therapies in the US, in USD Million (2020-2034)
• Figure 23: Total Market Size of Graves' Orbitopathy in EU4 and the UK, in USD Million (2020-2034)
• Figure 24: Total Market Size of Graves' Orbitopathy by Therapies in EU4 and the UK, in USD Million (2020-2034)
• Figure 25: Total Market Size of Graves' Orbitopathy in Japan, in USD Million (2020-2034)
• Figure 26: Total Market Size of Graves' Orbitopathy by Therapies in Japan, in USD Million (2020-2034)
• Figure 27: SWOT Analysis
• Figure 28: Unmet Needs
• Figure 29: HTA
• Figure 30: Reimbursement Process in Germany
• Figure 31: Reimbursement Process in France
• Figure 32: Reimbursement Process in Italy
• Figure 33: Reimbursement Process in Spain
• Figure 34: Reimbursement Process in the United Kingdom
• Figure 35: Reimbursement Process in Japan

Key Highlights:

• According to DelveInsight's estimates, in 2023, there were approximately 1.5 million diagnosed prevalent cases of Graves' orbitopathy in the 7MM. Of these, the United States accounted for 44% of the cases, while EU4 and the UK accounted for nearly 49% and Japan represented 7% of the cases, respectively.
• The Graves' orbitopathy market is projected to see consistent growth, with a robust compound annual growth rate (CAGR) anticipated from 2024 to 2034. This expansion across the 7MM will be driven by the introduction of innovative therapies, including VRDN-001, VRDN-003, lonigutamab, and efgartigimod PH20, among others. Furthermore, increasing cases of Graves' orbitopathy, influenced by factors such as smoking, age, the duration of hyperthyroidism, radioactive iodine treatment, genetics, and environmental elements like selenium deficiency and stress, will further support the market's growth.
• According to DelveInsight's analysis, the Graves' orbitopathy market in the 7MM was valued at approximately USD 2,340.6 million in 2023. Over the forecast period from 2024 to 2034, this market is projected to grow at a CAGR of 17.7%.
• Graves' orbitopathy has limited treatment options, with TEPEZZA as the only approved drug. The disease's complex autoimmune nature and varied clinical manifestations make developing targeted, disease-modifying therapies challenging, leaving a significant unmet need for more effective treatments.
• Viridian Therapeutics, ACELYRIN, Argenx, and Immunovant Sciences, among others are progressing their assets through various clinical trial phases, driving innovation in the Graves' orbitopathy market and creating significant growth opportunities.
• Viridian Therapeutics' VRDN-003, an IGF-1R antibody, is currently in Phase III clinical development, with a Biologics License Application (BLA) submission for Graves' orbitopathy treatment expected by the end of 2026 in the US.

DelveInsight's "Graves' Orbitopathy - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Graves' orbitopathy, historical and forecasted epidemiology, as well as the Graves' orbitopathy market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Graves' orbitopathy market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Graves' orbitopathy market size from 2020 to 2034. The report also covers Graves' orbitopathy treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Graves' Orbitopathy Understanding and Treatment Algorithm

Graves' orbitopathy overview

Graves' orbitopathy, also known as Thyroid Eye Disease, is the most common extrathyroidal manifestation of Graves' disease and results from autoimmune activity causing orbital inflammation. Autoantibodies, likely targeting a shared protein in the orbit and thyroid, drive this condition, which progresses through an early active stage and a late inactive stage, classified by severity and its impact on vision and quality of life.

Symptoms range from eye irritation, redness, and swelling to advanced complications like optic nerve compression and vision loss. Key risk factors include stress, smoking, and poorly controlled hyperthyroidism, while pathologic changes include glycosaminoglycan deposition, inflammation, fibrosis, and fat accumulation in the orbit, leading to proptosis and impaired ocular motility.

Graves' orbitopathy diagnosis

Diagnosing Graves' orbitopathy may involve imaging studies such as CT scans or MRI to detect changes in the eye muscles, along with blood tests to evaluate thyroid hormone levels and antibodies for abnormalities.

Graves' orbitopathy treatment

The management of Graves' orbitopathy varies based on symptom severity and includes medical, surgical, and fundamental treatments aimed at reducing visual complications, minimizing side effects, and preventing disease progression or recurrence. While no preventive therapy exists, corticosteroids administered for three months may reduce orbitopathy risks following radioactive iodine therapy. Botulinum toxin can temporarily address dysthyroid strabismus during the acute phase.

Graves' Orbitopathy Epidemiology

As the market is derived using a patient-based model, the Graves' orbitopathy epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of Graves' orbitopathy, gender-specific diagnosed prevalent cases of Graves' orbitopathy, chronicity-specific diagnosed prevalent cases of Graves' orbitopathy, and severity-specific diagnosed prevalent cases of acute Graves' orbitopathy in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• DelveInsight estimates that in 2023, there were around 7.1 million prevalent cases of Graves' disease across the 7MM, with 3.7 million being diagnosed. This number is projected to rise by 2034.
• In 2023, the US recorded the highest number of diagnosed prevalent cases of Graves' orbitopathy, with approximately 643 thousand cases, a figure anticipated to grow over the study period (2020-2034).
• In 2023, Germany reported the highest number of diagnosed prevalent cases of Graves' orbitopathy among the EU4 and the UK, with approximately 162 thousand cases, followed by France with around 149 thousand cases. In contrast, Spain had the lowest number, with about 128 thousand cases.
• In 2023, Japan reported approximately 102 thousand diagnosed prevalent cases of Graves' orbitopathy.
• In 2023, the US reported nearly 129 thousand diagnosed prevalent cases of Graves' orbitopathy in males and 514 thousand cases in females.
• In 2023, the EU4 and the UK reported nearly 204 thousand acute cases and 523 thousand chronic cases of Graves' orbitopathy.
• In 2023, Japan reported nearly 20 thousand mild, 7 thousand moderate to severe, and 14 hundred sight-threatening cases of acute Graves' orbitopathy.

Graves' Orbitopathy Drug Chapters

The drug chapter segment of the Graves' orbitopathy report encloses a detailed analysis of Graves' orbitopathy-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the Graves' orbitopathy 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-Trbw): Amgen (Horizon Therapeutics)

TEPEZZA, an IGF-1R inhibitor and fully human IgG1 monoclonal antibody produced in CHO-DG44 cells, has a molecular weight of approximately 148 kDa. It is currently being studied in Phase III trials for moderate-to-severe active Graves' orbitopathy and chronic Thyroid Eye Disease (TED) with a low Clinical Activity Score (CAS). Amgen is also investigating the potential for subcutaneous administration. TEPEZZA has received Breakthrough Therapy and Fast Track designations from the US FDA for Graves' orbitopathy treatment, along with orphan drug designations in both the US and Japan. It has regulatory approval in the US and Japan for active Graves' orbitopathy. In April 2024, Amgen announced plans to submit a Marketing Authorization Application for teprotumumab to the European Medicines Agency.

Emerging Drugs

VRDN-003: Viridian Therapeutics

VRDN-003 is a subcutaneously administered anti-IGF-1R antibody in development for TED, designed to have a longer half-life and act as a full IGF-1R antagonist. It shares the same binding domain as VRDN-001 and targets the clinically validated IGF-1R inhibition mechanism. Viridian launched two Phase III trials, REVEAL-1 and REVEAL-2, for active and chronic TED, respectively, evaluating VRDN-003 administered every 4 or 8 weeks versus placebo. Topline data is expected in 2026, with a BLA submission by year-end. Positive results from the THRIVE-2 trial further support confidence in VRDN-003's success announced in December 2024.

Efgartigimod PH20 SC: Argenx

Efgartigimod PH20 SC, an investigational drug developed by Argenx, is designed to treat TED. This fully human antibody fragment targets the neonatal Fc receptor (FcRn), blocking its function to reduce pathogenic immunoglobulin G (IgG) autoantibodies, which are implicated in autoimmune diseases.

Currently in Phase III proof-of-concept development for TED, the subcutaneous formulation (PH20 SC) is intended to enhance the drug's dispersion and absorption, potentially improving both efficacy and patient convenience.

Lonigutamab: ACELYRIN

Lonigutamab is an SC-delivered humanized IgG1 monoclonal antibody targeting IGF-1R for the treatment of TED. ACELYRIN recently concluded a positive end-of-Phase II meeting with the US FDA, aligning on critical elements of the Phase III program, including trial size, endpoints, and dose selection. A webcast will be held in early 2025 to review the Phase II results and FDA feedback.

In August 2024, despite strong clinical performance of izokibep, ACELYRIN shifted its focus to lonigutamab, resulting in a 33% workforce reduction. The company plans to initiate Phase IIb/III trials in late 2024, with Phase III starting in 2025 and topline results expected in 2026.

Drug Class Insights

Treatment for Graves' orbitopathy includes supportive measures and specific therapies based on disease severity. Supportive care consists of ocular lubrication, eye patches, prism correction for diplopia, and head-of-bed elevation to alleviate swelling. Pharmacological treatments include glucocorticoids, mycophenolate, rituximab, tocilizumab, teprotumumab, and cyclosporine/mTOR inhibitors. Oral prednisone is commonly used, with higher doses or intravenous administration for optic nerve compression. Emerging therapies, such as VRDN-001, VRDN-003, batoclimab, efgartigimod PH20 SC, ENSPRYNG, LASN01, linsitinib, AMG 732, and lonigutamab, aim to enhance treatment outcomes and address unmet needs.

Batoclimab (IMVT-1401) and efgartigimod PH20 SC target the neonatal Fc receptor (FcRn) to reduce pathogenic IgG autoantibodies. Batoclimab, a fully human monoclonal antibody, is delivered as a subcutaneous injection and developed for various IgG-mediated autoimmune diseases, including Graves' disease. Efgartigimod, a human antibody fragment, is also available in subcutaneous form and designed to improve dispersion and absorption, focusing on thyroid eye disease. Both therapies aim to reduce IgG levels, with differences in formulation and pharmacokinetics offering potential patient convenience benefits.

Market Outlook

Graves' orbitopathy treatment strategies are divided into supportive and specific approaches, based on disease severity. Supportive care includes ocular lubrication, eye patches, prism correction for diplopia, and head-of-bed elevation to reduce swelling. Pharmacological treatments involve glucocorticoids, mycophenolate, rituximab, tocilizumab, teprotumumab, and cyclosporine/mTOR inhibitors. Corticosteroids, especially oral prednisone, are the mainstay, with higher doses or intravenous administration used for optic nerve compression.

TEPEZZA (teprotumumab), an IGF-1R inhibitor, gained US FDA approval in 2020 as a fully human IgG1 monoclonal antibody produced in Chinese hamster ovary (CHO-DG44) cells, with a molecular weight of 148 kDa. In 2024, Japan's Ministry of Health, Labour, and Welfare (MHLW) approved it for active Graves' orbitopathy, expanding its global use. Other treatments, such as methotrexate, azathioprine, intravenous immunoglobulins, and anti-tumor necrosis factor therapies (e.g., adalimumab, etanercept, infliximab), show limited efficacy compared to biological agents like teprotumumab and rituximab.

Currently, TEPEZZA is the only approved therapy for active Graves' orbitopathy, highlighting a major unmet need. Off-label treatments like glucocorticoids, rituximab, and tocilizumab have inconsistent efficacy and no regulatory approval for this condition. This gap emphasizes the need for targeted, effective therapies, especially for severe or refractory cases.

Recent advancements include VRDN-001, VRDN-003, batoclimab, efgartigimod PH20 SC, ENSPRYNG (satralizumab, RG6168), LASN01, linsitinib, AMG 732 (formerly HZN-280), and lonigutamab (anti-IGF-1R), which aim to improve treatment outcomes and address unmet needs.

• The total market size of Graves' orbitopathy in the 7MM was approximately USD 2,340.6 million in 2023 and is projected to increase during the forecast period (2024-2034).
• The market size for Graves' orbitopathy in the US was approximately USD 2,114.5 million in 2023 and is anticipated to increase due to the launch of emerging therapies.
• The total market size of EU4 and the UK was calculated to be approximately USD 203.7 million in 2023, which was nearly 9% of the total market revenue for the 7MM.
• In 2023, Germany dominated the market among EU4 and the UK, generating around USD 45.4 million. France followed closely with approximately USD 41.8 million, while the UK recorded around USD 40.8 million.
• In 2023, the total market size of Graves' orbitopathy was approximately USD 22.3 million in Japan which is anticipated to increase during the forecast period (2024-2034).
• Estimates suggest that VRDN-003 is expected to generate approximately USD 1,473.1 million in the 7MM by 2034.

Graves' orbitopathy Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034.

Graves' orbitopathy Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for Graves' orbitopathy.

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' orbitopathy evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the Cedars-Sinai Medical Center, US, Stanford Department of Ophthalmology, US, Center for Drug Evaluation and Research, US, Johannes Gutenberg University, Germany, Nantes University Hospital, France, University of Insubria, Italy, Hospital Universitario y Politecnico La Fe, Spain, University Hospitals Bristol NHS Foundation Trust, UK, and Ito Hospital, Shibuya-ku, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Graves' orbitopathy market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician's View

As per the KOLs from the US, Thyroid Eye Disease (TED) starts with orbital and periocular inflammation, progressing to a chronic phase with persistent symptoms. Active TED, marked by a Clinical Activity Score (CAS), involves pain, swelling, redness, proptosis, and, in severe cases, diplopia. In the US, TED prevalence ranges from 0.16% to 0.25%, with higher risk in males, individuals over 65, tobacco users, and those with elevated thyroid autoantibodies.

As per the KOLs from France, Graves' orbitopathy, the most common extra-thyroid complication of Graves' disease, can be severe and requires multidisciplinary care based on clinical activity and severity. Diagnosis and management should involve an ophthalmologist, endocrinologist, and, if needed, a surgeon specializing in orbital pathologies, such as a maxillofacial surgeon, ENT specialist, or neurosurgeon.

As per the KOLs from Japan, despite its impact on social and psychological well-being, epidemiological data on TED in Japan is limited. Current estimates suggest a prevalence of 24.65-37.58 per 100,000 people, highlighting a potential gap in awareness and diagnosis within the population.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT 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 emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.

Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. 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 and designation, 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

Horizon Commercial Copay Program

Horizon is committed to ensuring that patients pay the lowest possible amount for their medications. Eligible patients may qualify for a USD 0 copay, covering both the medication and intravenous infusion costs.

To be eligible for the Horizon Commercial Copay Program, patients must meet the following criteria:

• The prescription cannot be covered, in part or in full, by any government-funded program, including but not limited to Medicare, Medicare Part D, Medicaid, Medigap, VA, CHAMPUS, Department of Defense (DoD), TRICARE, or any state, patient foundation, or other pharmaceutical assistance program.
• The patient must be prescribed a Horizon rare disease medication for an FDA-approved indication, as specified in the prescribing information.
• The patient must reside in the US.
• The patient must have commercial insurance and be financially responsible for a portion of the medication and/or infusion costs, if applicable

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of Graves' orbitopathy, 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, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Graves' orbitopathy market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Graves' orbitopathy market.

Graves' orbitopathy report insights

• Patient Population
• Therapeutic Approaches
• Graves' orbitopathy Pipeline Analysis
• Graves' orbitopathy Market Size and Trends
• Existing and Future Market Opportunity

Graves' orbitopathy report key strengths

• 11 years Forecast
• The 7MM Coverage
• Graves' orbitopathy Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Graves' orbitopathy report assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Attribute Analysis)

Key Questions:

Market Insights

• What was the total market size of Graves' orbitopathy, the market size of Graves' orbitopathy by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will VRDN-003 affect the treatment paradigm of Graves' orbitopathy?
• How will TEPEZZA compete with other upcoming products and marketed therapies?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of Graves' orbitopathy? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Graves' orbitopathy?
• What is the historical and forecasted Graves' orbitopathy patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest diagnosed prevalent Graves' orbitopathy population during the forecast period (2024-2034)?
• What factors are contributing to the growth of Graves' orbitopathy cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Graves' orbitopathy? What are the current clinical and treatment guidelines for treating Graves' orbitopathy?
• How many companies are developing therapies for the treatment of Graves' orbitopathy?
• How many emerging therapies are in the mid-stage and late stage of development for treating Graves' orbitopathy?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted market of Graves' orbitopathy?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Graves' orbitopathy 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.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for Graves' orbitopathy, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Graves' Orbitopathy in 2020
• 3.2. Market Share (%) Distribution of Graves' Orbitopathy in 2034

4. Epidemiology and Market Forecast Methodology

5. Executive Summary

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Types
• 7.3. Signs and Symptoms
• 7.4. Causes and Risk Factors
• 7.5. Grading
  • 7.5.1. NOSPECS Classification
  • 7.5.2. VISA Classification
  • 7.5.3. EUGOGO Classification
• 7.6. Pathophysiology
• 7.7. Biomarkers
• 7.8. Diagnosis
  • 7.8.1. Differential Diagnosis
• 7.9. Current Treatment Practices
  • 7.9.1. Treatment Guidelines
    • 7.9.1.1. Clinical Practice Guidelines for the Medical Management of Graves' Orbitopathy: European Group on Graves' Orbitopathy (EUGOGO) (2021)
    • 7.9.1.2. Management of Thyroid Eye Disease: A Consensus Statement by the American Thyroid Association and the European Thyroid Association
  • 7.9.2. Treatment Algorithm

8. Patient Journey

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale
• 9.3. Total Diagnosed Prevalent Cases of Graves' Orbitopathy in the 7MM
• 9.4. The US
  • 9.4.1. Total Diagnosed Prevalent Cases of Graves' Orbitopathy in the US
  • 9.4.2. Gender-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in the US
  • 9.4.3. Chronicity-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in the US
  • 9.4.4. Severity-specific Diagnosed Prevalent Cases of Acute Graves' Orbitopathy in the US
• 9.5. EU4 and the UK
  • 9.5.1. Total Diagnosed Prevalent Cases of Graves' Orbitopathy in EU4 and the UK
  • 9.5.2. Gender-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in EU4 and the UK
  • 9.5.3. Chronicity-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in EU4 and the UK
  • 9.5.4. Severity-specific Diagnosed Prevalent Cases of Acute Graves' Orbitopathy in EU4 and the UK
• 9.6. Japan
  • 9.6.1. Total Diagnosed Prevalent Cases of Graves' Orbitopathy in Japan
  • 9.6.2. Gender-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in Japan
  • 9.6.3. Chronicity-specific Diagnosed Prevalent Cases of Graves' Orbitopathy in Japan
  • 9.6.4. Severity-specific Diagnosed Prevalent Cases of Acute Graves' Orbitopathy in Japan

10. Marketed Drugs

• 10.1. TEPEZZA (Teprotumumab-Trbw): Amgen (Horizon Therapeutics)
  • 10.1.1. Product Description
  • 10.1.2. Product Profile
  • 10.1.3. Regulatory Milestone
  • 10.1.4. Other Developmental Activities
  • 10.1.5. Clinical Trials Information
  • 10.1.6. Safety and Efficacy

List to be continued in the final report.

11. Emerging Drugs

• 11.1. Key Cross Competition
• 11.2. VRDN-001 (veligrotug): Viridian Therapeutics
  • 11.2.1. Drug Description
  • 11.2.2. Drug Profile
  • 11.2.3. Other Development Activities
  • 11.2.4. Clinical Trials Information
  • 11.2.5. Safety and Efficacy
  • 11.2.6. Analysts' View
• 11.3. VRDN-003: Viridian Therapeutics
  • 11.3.1. Drug Description
  • 11.3.2. Drug Profile
  • 11.3.3. Other Development Activities
  • 11.3.4. Clinical Trials Information
  • 11.3.5. Analysts' View
• 11.4. Efgartigimod PH20 SC: Argenx
  • 11.4.1. Drug Description
  • 11.4.2. Drug Profile
  • 11.4.3. Clinical Trials Information
  • 11.4.4. Analysts' View
• 11.5. ENSPRYNG (satralizumab, RG6168): Hoffmann-La Roche
  • 11.5.1. Drug Description
  • 11.5.2. Drug Profile
  • 11.5.3. Other Developmental Activities
  • 11.5.4. Clinical Trials Information
  • 11.5.5. Analysts' View
• 11.6. IMVT-1401 (batoclimab, RVT-1401): Immunovant, Samsung Biologics, HanAll Biopharma, and Roivant Sciences
  • 11.6.1. Drug Description
  • 11.6.2. Drug Profile
  • 11.6.3. Other Developmental Activities
  • 11.6.4. Clinical Trials Information
  • 11.6.5. Safety and Efficacy
  • 11.6.6. Analysts' View
• 11.7. Linsitinib: Sling Therapeutics
  • 11.7.1. Drug Description
  • 11.7.2. Drug Profile
  • 11.7.3. Clinical Trials Development
  • 11.7.4. Analysts' View
• 11.8. Pacibekitug (TOUR006): Tourmaline Bio
  • 11.8.1. Drug Description
  • 11.8.2. Drug Profile
  • 11.8.3. Other Development Activities
  • 11.8.4. Clinical Trials Information
  • 11.8.5. Analysts' View
• 11.9. LASN01: Lassen Therapeutics
  • 11.9.1. Drug Description
  • 11.9.2. Drug Profile
  • 11.9.3. Other Development Activities
  • 11.9.4. Clinical Trials Information
  • 11.9.5. Safety and efficacy
  • 11.9.6. Analysts' View
• 11.10. Lonigutamab: ACELYRIN
  • 11.10.1. Drug Description
  • 11.10.2. Drug Profile
  • 11.10.3. Other development activities
  • 11.10.4. Clinical Trials Information
  • 11.10.5. Safety and efficacy
  • 11.10.6. Analysts' View

List to be continued in the final report.

12. Graves' Orbitopathy: Market Analysis

• 12.1. Key Findings
• 12.2. Key Market Forecast Assumptions
  • 12.2.1. Cost Assumptions and Rebates
  • 12.2.2. Pricing Trends
  • 12.2.3. Analogue Assessment
  • 12.2.4. Launch Year and Therapy Uptake
• 12.3. Market Outlook
• 12.4. Attribute Analysis
• 12.5. Total Market Size of Graves' Orbitopathy in the 7MM
• 12.6. Total Market Size of Graves' Orbitopathy by Therapies in the 7MM
• 12.7. Market Size of Graves' Orbitopathy in the US
  • 12.7.1. Total Market Size of Graves' Orbitopathy in the US
  • 12.7.2. Total Market Size of Graves' Orbitopathy by Therapies in the US
• 12.8. Market Size of Graves' Orbitopathy in EU4 and the UK
  • 12.8.1. Total Market Size of Graves' Orbitopathy in EU4 and the UK
  • 12.8.2. Total Market Size of Graves' Orbitopathy by Therapies in EU4 and the UK
• 12.9. Market Size of Graves' Orbitopathy in Japan
  • 12.9.1. Total Market Size of Graves' Orbitopathy in Japan
  • 12.9.2. Total Market Size of Graves' Orbitopathy by Therapies in Japan

13. Key Opinion Leaders' Views

14. SWOT Analysis

15. Unmet Needs

16. Market Access and Reimbursement

• 16.1. The United States
  • 16.1.1. Centre for Medicare & Medicaid Services (CMS)
• 16.2. In EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. The United Kingdom
• 16.3. Japan
  • 16.3.1. MHLW

17. Appendix

• 17.1. Bibliography
• 17.2. Acronyms and Abbreviations
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight