巨細胞性動脈炎（GCA）- 世界市場の考察、疫学、市場予測（2034年）

主なハイライト

• 巨細胞性動脈炎（GCA）または側頭動脈炎は、動脈（血管）の内膜の炎症です。この疾患は自己免疫疾患であると考えられており、身体の免疫系が頭部や脳に血液を供給する側頭動脈を含む血管を攻撃します。
• GCAの他の病名には、頭蓋動脈炎、ホートン病、肉芽腫性動脈炎、老人性動脈炎などがあります。「巨細胞性動脈炎」という用語がよく使われるのは、炎症を起こした側頭動脈の生検を顕微鏡で見ると、しばしば大きな細胞や「巨大な」細胞が見えるためです。
• GCAの症状には主に、体質の症状（体重減少、発熱、疲労、食欲不振、倦怠感）、頭痛、顎跛行、視覚症状、リウマチ性多発筋痛、神経症状、呼吸器症状、頭蓋外症状があります。重篤な合併症としては、失明、大動脈瘤、虚血性脳卒中、心臓発作、末梢動脈疾患などがあります。
• GCAの診断には、血液検査、画像検査、側頭動脈生検（TAB）などの診断検査が利用できます。TABはGCA診断のゴールドスタンダードと考えられています。
• 2023年、米国は主要7市場の中でGCAと診断された発症数がもっとも多いです。
• 米国では、GCAは主に80～89歳の人に発症し、全症例の約42％を占めます。
• 欧州4ヶ国・英国では、臨床症状別の症例数のうち、頭皮の圧痛が2023年にもっとも多く、筋肉痛と原因不明の発熱がそれに続きました。
• ステロイドは、GCAをコントロールし、重篤な合併症を予防するための第一選択薬であり、現在のところ、これに代わる第一選択薬はありません。ステロイド錠は免疫系の活動を鈍らせ、血管の炎症を抑えます。代替の治療法には、従来の疾患修飾性抗リウマチ薬（DMARDs）も含まる可能性があります。
• 生物学的療法と呼ばれる新薬もあります。これらの薬剤は、免疫系の主な細胞を標的として、それらが炎症を引き起こすのを阻止します。米国FDAは近年、このような生物学的療法の1つであるACTEMRA（tocilizumab）をGCA患者の治療法として承認しました。これはその他の治療法が効かない場合にも処方される可能性があります。
• 主要7市場では、米国がもっとも高い市場規模を占め、2023年のGCA市場における市場シェアは欧州4ヶ国・英国、日本と比較して65%近くを占めました。
• 2023年、欧州4ヶ国・英国の中では英国が最大の市場規模を占め、スペインが最小のシェアを占めました。
• RINVOQやCOSENTYXなど、パイプラインにある新治療法は、予測期間（2024年～2034年）にGCAの治療情勢に前向きな変化をもたらすと予測されています。
• Novartis、AbbVie、J&J/MorphoSys AGなどの主要企業が、GCA患者の治療情勢を一変させると予測されています。
• GCA市場の成長は主に、老年人口の増加、心血管障害の有病率の上昇、医療産業における技術の進歩などによって促進されると予測されます。
• 診断の遅れ、GCAの重篤な合併症、経済的負担、疾患に対する正しい理解の欠如などが、GCA市場に打撃を与える見通しです。

GCA市場の見通し

「巨細胞」という用語は、炎症を起こした側頭動脈の生検を顕微鏡で見ると、しばしば大きな、あるいは「巨大な」細胞のように見えることから、この疾患に用いられています。GCAの病因は少し複雑で、現在も広く研究されているが、まだあまりよく分かっていません。現在までに解明されているいくつかの要因には、遺伝的要因（HLAファミリー）、感染性要因、環境要因、免疫反応、T細胞の活性化などがあります。

GCAの治療の主な目的は、患者が失明などの重篤な結果にさらされるのを防ぐことです。GCAを治療するため、医師は毎日40mg～60mgの高用量のコルチコステロイドを処方することがあり、これを3～4週間ほど続けます。その後、患者の状態が改善し始めたら、医師は投与量を減らしていきます。しかし、コルチコステロイドの安全性については常に議論が続いています。コルチコステロイド以外に、疾患修飾性抗リウマチ薬（DMARDs）もGCAの治療に用いられることがあります。一般的に使用されるDMARDsは、methotrexate、leflunomide、azathioprineです。

当レポートでは、巨細胞性動脈炎の主要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 巨細胞性動脈炎（GCA）のエグゼクティブサマリー

• 重要なイベント

第4章 GCA市場の概要

• 主要7市場のGCAの市場シェア分布：治療別（2020）
• 主要7市場のGCAの市場シェア分布：治療別（2034）

第5章 疾患の背景と概要

• イントロダクション
• GCAの原因
• GCAの兆候と症状
• GCAの合併症
• GCAの臨床症状
• GCAの病態生理学
• GCAの発症機序

第6章 GCAの診断

• 診断アルゴリズム
• 診断基準
• 診断検査
• 鑑別診断

第7章 診断ガイドライン

• American College of Rheumatology (ACR) Diagnostic Guidelines for GCA
• European League Against Rheumatism (EULAR) Guidelines for the Diagnosis of GCA
• The British Society for Rheumatology (BSR) and British Health Professionals in Rheumatology (BHPR) Diagnostic Guidelines for GCA
• The French Study Group for Larger Vessel Vasculitis (GEFA) Recommendations for Diagnosis of GCA

第8章 GCAの治療

• GCAの治療アルゴリズム
• コルチコステロイド
• 疾患修飾性抗リウマチ薬（DMARDs）
  • Methotrexate（MTX）
  • Leflunomide
  • Azathioprine

第9章 治療ガイドライン

• American College of Rheumatology Treatment Guidelines for the Management of GCA
• European League Against Rheumatism (EULAR) Guidelines for the Management of GCA
• The British Society for Rheumatology (BSR) and British Health Professionals in Rheumatology (BHPR) Treatment Guidelines for GCA
• The French Study Group for Larger Vessel Vasculitis (GEFA) Recommendations for Management of GCA

第10章 疫学と市場予測の調査手法

第11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GCAの診断された総有病者数
• 米国
• 欧州4ヶ国・英国
• 日本

第12章 ペイシェントジャーニー

第13章 上市済みの治療法

• 主な競合
• ACTEMRA/ROACTEMRA (tocilizumab): Roche

第14章 新治療法

• 主な競合
• RINVOQ (upadacitinib): AbbVie
• COSENTYX (secukinumab): Novartis Pharmaceuticals
• Mavrilimumab: CSL/Kiniksa Pharmaceuticals
• TREMFYA (guselkumab): Johnson & Johnson/MorphoSys AG

第15章 巨細胞性動脈炎（GCA）：市場の分析

• 主な調査結果
• 市場見通し
• コンジョイント分析
• 主な市場予測の前提条件
• 主要7市場のGCAの総市場規模
• 米国の市場規模
• 欧州4ヶ国・英国の市場規模
• 日本の市場規模

第16章 アンメットニーズ

第17章 SWOT分析

第18章 KOLの見解

第19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
• GCAの市場参入と償還

第20章 付録

第21章 DelveInsightのサービス内容

第22章 免責事項

第23章 DelveInsightについて

List of Tables

• Table 1: Summary of GCA Market and Epidemiology (2020-2034)
• Table 2: Revised ACR criteria (rACR) for diagnosis of GCA
• Table 3: Recommendations for Diagnostic testing in GCA
• Table 4: Recommendations Concerning GCA Diagnosis
• Table 5: Recommendations/Statements for Treatment (Medical Management and Surgical Intervention) and Clinical/Laboratory Monitoring in GCA
• Table 6: Recommendations Concerning GCA Management
• Table 7: Total Diagnosed Prevalent Cases of GCA in the 7MM (2020-2034)
• Table 8: Total Diagnosed Prevalent Cases of GCA in the United States (2020-2034)
• Table 9: Subtype-specific Cases of GCA in the United States (2020-2034)
• Table 10: Gender-specific Cases of GCA in the United States (2020-2034)
• Table 11: Age group-specific Cases of GCA in the United States (2020-2034)
• Table 12: Clinical Manifestation-specific Cases of GCA in the United States (2020-2034)
• Table 13: Total Treated Cases of GCA in the United States (2020-2034)
• Table 14: Total Diagnosed Prevalent Cases of GCA in EU4 and the UK (2020-2034)
• Table 15: Subtype-specific Cases of GCA in EU4 and the UK (2020-2034)
• Table 16: Gender-specific Cases of GCA in EU4 and the UK (2020-2034)
• Table 17: Age group-specific Cases of GCA in EU4 and the UK (2020-2034)
• Table 18: Clinical Manifestation-specific Cases of GCA in EU4 and the UK (2020-2034)
• Table 19: Total Treated Cases of GCA in EU4 and the UK (2020-2034)
• Table 20: Total Diagnosed Prevalent Cases of GCA in Japan (2020-2034)
• Table 21: Subtype-specific Cases of GCA in Japan (2020-2034)
• Table 22: Gender-specific Cases of GCA in Japan (2020-2034)
• Table 23: Age group-specific Cases of GCA in Japan (2020-2034)
• Table 24: Clinical Manifestation-specific Cases of GCA in Japan (2020-2034)
• Table 25: Total Treated Cases of GCA in Japan (2020-2034)
• Table 26: Marketed Drug
• Table 27: RINVOQ (upadacitinib), Clinical Trial Description, 2024
• Table 28: Comparison of Emerging Drugs Under Development
• Table 29: RINVOQ (upadacitinib), Clinical Trial Description, 2024
• Table 30: COSENTYX, Clinical Trial Description, 2024
• Table 31: Mavrilimumab, Clinical Trial Description, 2024
• Table 32: TREMFYA, Clinical Trial Description, 2024
• Table 33: Key Market Forecast Assumptions of GCA in the United States
• Table 34: Key Market Forecast Assumptions of GCA in EU4 and the UK
• Table 35: Key Market Forecast Assumptions of GCA in Japan
• Table 36: Total Market Size of GCA in the 7MM, USD million (2020-2034)
• Table 37: Total Market Size of GCA in the US, USD million (2020-2034)
• Table 38: Market Size of GCA by Therapies in the US (2020-2034)
• Table 39: Total Market Size of GCA in EU4 and the UK, USD million (2020-2034)
• Table 40: Market Size of GCA by Therapies in EU4 and the UK, USD million (2020-2034)
• Table 41: Total Market Size of GCA in Japan, USD million (2020-2034)
• Table 42: Market Size of GCA by Therapies in Japan, USD million (2020-2034)
• Table 43: NICE Assessment for GCA Therapies
• Table 44: HAS Assessment for Giant Cell Arteritis Therapies

List of Figures

• Figure 1: Profile of the Head Showing the GCA in the Human Body
• Figure 2: Brief Description of GCA
• Figure 3: Causes of GCA
• Figure 4: Symptoms of GCA
• Figure 5: Complications of GCA
• Figure 6: Clinical Manifestations Involved in GCA
• Figure 7: Pathophysiology of GCA
• Figure 8: Diagnostic Algorithm for Evaluation of Suspected GCA
• Figure 9: Diagnostic Tests involved in GCA
• Figure 10: Preoperative Appearance of a Patient With a Prominent Left Superficial Temporal Artery
• Figure 11: "Halo-sign" on Temporal and Axillary Arteries
• Figure 12: Cranial Involvement Pattern
• Figure 13: Sagittal PET (A, B), Coronal PET and Fused PET/CT (C-F), and Axial PET (G-I)
• Figure 14: Biopsy in a Patient
• Figure 15: Treatment Algorithm of GCA
• Figure 16: Total Diagnosed Prevalent Cases of GCA in the 7MM
• Figure 17: Total Diagnosed Prevalent Cases of GCA in the United States (2020-2034)
• Figure 18: Subtype-specific Cases of GCA in the United States (2020-2034)
• Figure 19: Gender-specific Cases of GCA in the United States (2020-2034)
• Figure 20: Age group-specific Cases of GCA in the United States (2020-2034)
• Figure 21: Clinical Manifestation-specific Cases of GCA in the United States (2020-2034)
• Figure 22: Total Treated Cases of GCA in the United States (2020-2034)
• Figure 23: Total Diagnosed Prevalent Cases of GCA in EU4 and the UK (2020-2034)
• Figure 24: Subtype-specific Cases of GCA in EU4 and the UK (2020-2034)
• Figure 25: Gender-specific Cases of GCA in EU4 and the UK (2020-2034)
• Figure 26: Age group-specific Cases of GCA in EU4 and the UK (2020-2034)
• Figure 27: Clinical Manifestation-specific Cases of GCA in EU4 and the UK (2020-2034)
• Figure 28: Total Treated Cases of GCA in EU4 and the UK (2020-2034)
• Figure 29: Total Diagnosed Prevalent Cases of GCA in Japan (2020-2034)
• Figure 30: Subtype-specific Cases of GCA in Japan (2020-2034)
• Figure 31: Gender-specific Cases of GCA in Japan (2020-2034)
• Figure 32: Age group-specific Cases of GCA in Japan (2020-2034)
• Figure 33: Clinical Manifestation-specific Cases of GCA in Japan (2020-2034)
• Figure 34: Total Treated Cases of GCA in Japan (2020-2034)
• Figure 35: Total Market Size of GCA in the 7MM (2020-2034)
• Figure 36: Total Market Size of GCA in the US (2020-2034)
• Figure 37: Market Size of GCA by Therapies in the US (2020-2034)
• Figure 38: Total Market Size of GCA in EU4 and the UK (2020-2034)
• Figure 39: Market Size of GCA by Therapies in EU4 and the UK (2020-2034)
• Figure 40: Total Market Size of GCA in Japan (2020-2034)
• Figure 41: Market Size of GCA by Therapies in Japan (2020-2034)
• Figure 43: Health Technology Assessment
• Figure 44: Reimbursement Process in Germany
• Figure 45: Reimbursement Process in France
• Figure 46: Reimbursement Process in Italy
• Figure 47: Reimbursement Process in Spain
• Figure 48: Reimbursement Process in the United Kingdom
• Figure 49: Reimbursement Process in Japan

Key Highlights:

• Giant Cell Arteritis (GCA) or "Temporal Arteritis" is an inflammation of the lining of the arteries (blood vessels). The disease is believed to be an autoimmune disease in which the body's immune system attacks the blood vessels, including the temporal arteries, which supply blood to the head and the brain.
• Other names of GCA include arteritis cranialis, Horton's disease, granulomatous arteritis, and arteritis of the aged. The term "Giant cell Arteritis" is often used because when one looks at biopsies of the inflamed temporal arteries under a microscope, one often sees large or "giant" cells.
• GCA symptoms mainly include constitutional symptoms (weight loss, fever, fatigue, anorexia, and malaise), headache, jaw claudication, visual symptoms, polymyalgia rheumatica, neurological symptoms, respiratory symptoms, and extracranial symptoms. Serious complications may include blindness, aortic aneurysm, ischemic stroke, heart attack, and peripheral artery disease.
• Several diagnostic tests are available to diagnose the GCA, which may involve blood tests, imaging tests, and temporal artery biopsy (TAB). TAB is considered a "Gold standard" in the diagnosis of the GCA.
• In 2023, the United States accounted for the highest number of diagnosed incident cases of GCA in the 7MM.
• In the United States, GCA primarily affects individuals aged 80-89 years, constituting approximately ~42% of the total cases.
• Among the EU4 and the UK, out of all clinical manifestation-specific cases, scalp tenderness accounted for the highest number of cases, followed by myalgia and fever of unknown origin in 2023.
• Steroids are the first line of treatment to get GCA under control and prevent any serious complications, and currently, there is no alternative first line of treatment available. Steroid tablets slow down the activity of the immune system and reduce the inflammation in blood vessels. Alternative treatments may also include conventional disease-modifying anti-rheumatic drugs (DMARDs).
• There are also some newer drugs available called biological therapies; these drugs target key cells within the immune system to stop them from causing inflammation. The US FDA has recently approved one such biological treatment, ACTEMRA (tocilizumab), for the treatment of people with GCA. It can also be prescribed if other treatments have not worked.
• In the 7MM, the United States accounted for the highest market size, with nearly 65% of the market share of the GCA market as compared to EU4 and the UK and Japan in 2023.
• In 2023, among EU4 and the UK, the UK accounted for the largest market size, while Spain accounted for the smallest share.
• Emerging therapies in the pipeline, including RINVOQ and COSENTYX, are expected to bring a positive shift in the GCA treatment landscape during the forecast period (2024-2034).
• Key players like Novartis, AbbVie, and J&J/MorphoSys AG are expected to transform the treatment landscape for GCA patients.
• The growth of the GCA market is expected to be mainly driven by the growing geriatric population, the rise in the prevalence of cardiovascular disorders, technological advancements in the healthcare industry, etc.
• Delays in diagnosis, serious complications of GCA, economic burden, and lack of proper understanding of the disease will be going to hit the GCA market.

Report Summary

• The report offers extensive knowledge regarding the epidemiology segments (by region, diagnosed prevalent cases of GCA, subtype-specific cases, gender-specific cases, age-specific cases, clinical manifestation-specific cases, and total treated cases) and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies such as RINVOQ, COSENTYX and the elaborative profiles of late and mid-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the GCA market, providing an in-depth examination of its historical and projected market size (2020-2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM GCA market.

Market

Various key players, such as Novartis, AbbVie, J&J/MorphoSys AG, and others, are involved in developing therapies for GCA. The expected launch of emerging therapies and other treatments will lead to a significant increase in the market size during the forecast period [2024-2034].

• In 2023, the total market size of GCA was around USD 960 million, which is expected to increase by 2034 during the study period (2020-2034) in the 7MM.
• Among the 7MM, the United States accounted for the highest market size in 2023, followed by the United Kingdom for GCA.
• During the forecast period (2024-2034), pipeline candidates such as COSENTYX, RINVOQ and TREMFYA are expected to drive the rise in GCA market size.
• By 2034, RINVOQ (upadacitinib) is expected to garner the largest market share in the 7MM.

GCA Drug Chapters

The section dedicated to drugs in the GCA report provides an in-depth evaluation of pipeline drugs (Phase III and Phase II) related to GCA.

The drug chapters section provides valuable information on various aspects related to clinical trials of GCA, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting GCA.

Marketed Therapies

ACTEMRA/ROACTEMRA (tocilizumab): Roche

ACTEMRA/ROACTEMRA (tocilizumab) is a first-in-class anti-IL-6 receptor (aIL-6R) therapy. IL-6 is believed to play a key role in activating the inflammatory pathway that contributes to the signs and symptoms of RA and other inflammatory autoimmune conditions. ACTEMRA/ROACTEMRA binds to the IL-6 receptor and blocks the inflammatory protein IL-6. This improves joint pain and swelling from arthritis and other symptoms caused by inflammation. It is also approved for the treatment of pediatric juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), GCA, and CAR-T cell-induced cytokine release syndrome (CRS).

In September 2017, Roche announced that the European Commission (EC) approved ACTEMRA/ROACTEMRA (tocilizumab) for the treatment of giant cell arteritis (GCA). ACTEMRA/ROACTEMRA is the first therapy approved for the treatment of GCA in Europe. The European approval was based on the outcome of the Phase III GiACTA study, which showed that a weekly dose of ACTEMRA/ROACTEMRA, initially combined with a 6-month steroid taper, significantly increased the proportion of patients achieving sustained remission at one year compared to a six-month steroid taper given alone.

In November 2018, Roche announced that the US FDA approved ACTPen 162 mg/0.9 mL, a single-dose prefilled autoinjector for ACTEMRA (tocilizumab), as an additional formulation for adult patients with giant cell arteritis (GCA).

Note: Detailed assessment will be provided in the final report of GCA.

Emerging Therapies

RINVOQ (upadacitinib): AbbVie

RINVOQ (upadacitinib) is an orally administered selective and reversible Janus kinase (JAK) inhibitor; proinflammatory cytokines use immune signaling networks, such as the JAK-STAT pathway, to communicate with the cell nucleus. When dysregulated, these signals increase the inflammatory response, leading to cycles of chronic inflammation, presenting as pain, swelling, and progressive joint destruction. It is approved in the United States, Japan, and the European Union. RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs), is being developed by Abbvie.

JAKs are intracellular enzymes that transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs), which modulate intracellular activity, including gene expression. RINVOQ modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs. Currently, RINVOQ is in the Phase III stage of clinical development for GCA.

COSENTYX (secukinumab): Novartis Pharmaceuticals

COSENTYX (secukinumab) is an injectable fully human monoclonal antibody that specifically inhibits interleukin-17A (IL-17A), a cytokine involved in several immunological diseases, and is being developed by Novartis Pharmaceuticals. It is approved in the US and EU to treat patients with moderate-to-severe plaque psoriasis, adults with active ankylosing spondylitis (AS), adults with active non-radiographic axial spondyloarthritis (nr-axSpA), and adults with active psoriatic arthritis (PsA).

Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.

The company has completed one Phase II study, and it is currently in the Phase III stage of clinical development for the treatment of Giant Cell Arteritis. The study (NCT04930094) has been initiated and started recruiting participants.

GCA Market Outlook

The term "Giant Cell" is used for the disease because when one looks at the biopsies of the inflamed temporal arteries under a microscope, it often appear as large or "giant" cells. The etiological factors of GCA are a bit complex and still being widely researched, but yet it is not very well understood. Several factors that are understood till now may include genetic factors (HLA family), infectious or environmental factors, immune responses, and T-cell activation.

The main goal of the treatment of GCA is to prevent the patients from getting exposed to severe consequences of the disease, such as blindness. To treat GCA, doctors may prescribe a high dose of corticosteroids, between 40 mg and 60 mg every day, which is continued for around 3-4 weeks. If the patient's condition starts to improve after that, the doctor will start reducing the dose. Although, there has always been a continuous discussion on the safety profile of corticosteroids. Other than corticosteroids, disease-modifying anti-rheumatic drugs (DMARDs) are also used sometimes to treat GCA. DMARDs that are commonly used are methotrexate, leflunomide, and azathioprine.

Currently, there is just one therapy that is approved in the 7MM for the treatment of GCA, which includes Chugai Pharmaceuticals/Roche's ACTEMRA/ROACTEMRA (tocilizumab).

Productive pharmacologic options for managing the most prevalent and most disabling phases of GCA are minimal. Treatments that work in this disorder are scarce; therefore, new treatments are desperately needed. Some companies like Novartis (COSENTYX; secukinumab), AbbVie (RINVOQ; upadacitinib), and J&J/MorphoSys AG (TREMFYA; guselkumab) have initiated clinical trials that investigate new treatment options.

In a nutshell, a few potential therapies are being investigated for the management of GCA. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market during the forecast period (2024-2034), it is safe to assume that the future of this market is bright. Eventually, the drug shall create a significant difference in the landscape of GCA in the coming years. The treatment space is expected to experience a positive impact in the coming years owing to the improvement in the rise of healthcare spending across the world.

Further details are provided in the report.

GCA Disease Understanding and Treatment

GCA Overview

Giant Cell Arteritis (GCA), or "Temporal Arteritis," is an inflammation of the lining of the arteries (blood vessels). GCA most commonly affects arteries in the head, especially those in the temples. For this reason, GCA is sometimes also called temporal arteritis. In GCA, the temporal arteries, which course along the sides of the head just in front of the ears (to the temples), can become inflamed. The inflammation causes the arteries to narrow down, resulting in poor blood flow.

GCA is classified as a large-vessel vasculitis but also involves medium and small arteritis, particularly the superficial temporal arteritis- hence it is termed temporal arteritis. Along with this, GCA most commonly affects the ophthalmic, occipital, vertebral, posterior ciliary, and proximal vertebral arteries. Medium- and large-sized vessels that may be involved include the aorta and the carotid, subclavian, and iliac arteries.

The etiology of GCA is a bit complex and is still being widely researched. Genetic and environmental factors (such as infections) are thought to play important roles. Because it is rare in people under age 50, its development could be linked to the aging process also.

Among genetic factors, certain genes with Human Leukocyte Antigen (HLA) class I and class II regions, specifically HLA-DRB1*04, DRW6, and DR3, are associated with susceptibility to GCA. In environmental factors, a variety of different infectious stimuli have also been implicated, including Chlamydia pneumoniae, varicella virus, and parvovirus B19.

After the initial trigger, a dual immune response begins. One involves a systemic inflammatory reaction, and the other is a maladaptive, antigen-specific immune response. The systemic inflammatory reaction results from the over-activation of the innate acute phase response: a non-antigen-driven, non-adaptive defense mechanism to overall stress and injury. This response is mediated by IL-6, produced by circulating macrophages, neutrophils, and monocytes. IL-6 levels are correlated with the intensity of the immune response and other acute-phase reactants such as C-reactive proteins, haptoglobin, fibrinogen, and complement.

The combination of these reactants under the systemic inflammatory reaction leads to the general signs of inflammation seen in GCA, such as fevers, chills, sweats, myalgias, anorexia, and weight loss. The antigen-specific immune response damages the arterial walls and results in the focal ischemic complications seen in GCA. The combination of these two processes results in systemic inflammatory syndrome and arteritis, respectively.

Further details are provided in the report.

GCA Diagnosis

Since 1990, the mainstay of GCA diagnosis was predicated on fulfilling 3/5 of the America College of Rheumatology's criteria, namely: age of onset =50 years, new onset of localized headache, temporal artery tenderness or decreased pulse, elevated ESR = 50 mm/h and predominance of mononuclear cell infiltrates or a granulomatous inflammation with multinucleate giant cells on TAB.

While a clinical presentation of headache, jaw claudication, scalp tenderness, fever, and other systemic symptoms and serum markers are together highly suggestive of the disease, diagnosis can be challenging in those cases in which classic symptoms are lacking.

No test can confirm the presence of GCA. To help the doctor reach a diagnosis, the doctor will observe the symptoms and note down the medical history of the patient. The doctors can also conduct a physical examination, partly focusing on the arteries in the temples, and if the patient has GCA, the arteries may feel hard or tender.

Then, the patients are required to go through some testing procedures. Typically, if a doctor suspects the GCA, the first tests ordered are blood tests looking for inflammation. These may include Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) blood tests; high levels of either signify inflammation suggesting GCA.

Imaging tests may also help pinpoint GCA as well. A specialized ultrasound can be performed in some medical centers to evaluate for inflammation of the temporal arteries and the large arteries in the upper chest. Other types of imaging studies may also be performed if the doctor suspects inflammation in the aorta (in the chest) or its branches in the chest and upper extremities.

While blood tests and imaging are helpful, there is one test often prized above all others. The gold-standard test for GCA has traditionally been a temporal artery biopsy showing active inflammation of the temporal artery. If a doctor recommends a patient that they should have a temporal artery biopsy, this generally means they have a high level of suspicion for GCA.

Further details related to country-based variations are provided in the report.

GCA Treatment

The main goal of the treatment of GCA is to prevent the patients from getting exposed to severe consequences of the disease, such as blindness. The main treatment for GCA consists of a high dose of a corticosteroid drug such as prednisone, and immediate treatment is necessary to prevent the patient from vision loss or a stroke. The doctor is most likely to start the medication even before confirming the diagnosis with a biopsy.

Alternative treatments may also include conventional disease-modifying anti-rheumatic drugs (DMARDs), including:

• Methotrexate
• Leflunomide
• Azathioprine
• Mycophenolate mofetil

These drugs can slow down the immune system, which can be misfiring in people who have autoimmune diseases.

Some newer drugs are also available called biological therapies; these drugs target key cells within the immune system to stop them from causing inflammation. The FDA has recently approved one such biological treatment, ACTEMRA (tocilizumab), for the treatment of people with GCA. It can also be prescribed if other treatments have not worked.

Further details related to treatment and management are provided in the report.

GCA Epidemiology

The GCA epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by diagnosed prevalent cases, subtype-specific cases, gender-specific cases, age-specific cases, clinical manifestation-specific and treated cases in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In 7MM, the United States accounted for the highest number of diagnosed prevalent cases of GCA, which is 54.0% of the diagnosed prevalent cases of GCA in 2023.
• In the US, among the subtype-specific cases of GCA, classic cranial GCA cases were highest, followed by extracranial GCA (large-vessel GCA) cases in 2023.
• Among the EU4 and the UK, the United Kingdom accounted for the highest number of GCA cases, followed by France, whereas Spain accounted for the lowest number of GCA cases.
• In 2023, as far as clinical manifestation-specific cases are concerned, scalp tenderness accounted for the highest number of cases in Japan. These cases are anticipated to increase by 2034.

KOL Views

To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of GCA, including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

Our team of analysts at DelveInsight connected with more than 10 KOLs across the 7MM. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the GCA market, which will assist our clients in analyzing the overall epidemiology and market scenario.

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, frequency of administration, designation, 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. Based on these, the overall efficacy is evaluated.

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 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

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

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.

GCA Report Insights

• Patient Population
• Therapeutic Approaches
• GCA Market Size and Trends
• Existing Market Opportunity

GCA Report Key Strengths

• Eleven-year Forecast
• The 7MM Coverage
• GCA Epidemiology Segmentation
• Key Cross Competition

GCA Report Assessment

• Current Treatment Practices
• Reimbursements
• Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)

Key Questions:

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in GCA management recommendations?
• Would research and development advances pave the way for future tests and therapies for GCA?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of GCA?
• What kind of uptake will the new therapies witness in the coming years in GCA patients?

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Giant Cell Arteritis (GCA)

• 3.1. Key Events

4. GCA Market Overview at a Glance

• 4.1. Market Share by Therapies (%) Distribution of GCA in 2020 in the 7MM
• 4.2. Market Share by Therapies (%) Distribution of GCA in 2034 in the 7MM

5. Disease Background and Overview

• 5.1. Introduction
• 5.2. Causes of GCA
• 5.3. Signs and Symptoms of GCA
• 5.4. Complications of GCA
• 5.5. Clinical Manifestations of GCA
• 5.6. Pathophysiology of GCA
• 5.7. Pathogenesis of GCA

6. Diagnosis of GCA

• 6.1. Diagnostic Algorithm
  • 6.1.1. Journal of Medical Case Reports Diagnostic Algorithm
• 6.2. Diagnostic Criteria
• 6.3. Diagnosis Tests
  • 6.3.1. Physical Examination
  • 6.3.2. Blood Tests
    • 6.3.2.1. Erythrocyte Sedimentation Rate (ESR) Test
    • 6.3.2.2. C-reactive Protein (CRP) Test
  • 6.3.3. Imaging Tests
    • 6.3.3.1. Ultrasound for GCA Diagnosis
    • 6.3.3.2. Magnetic Resonance Imaging (MRI) for GCA Diagnosis
    • 6.3.3.3. Computed Tomography Angiography (CTA) for GCA Diagnosis
    • 6.3.3.4. Fluorodeoxyglucose (18F-FDG) - Positron Emission Tomography (PET)/Computed Tomography (CT) for GCA Diagnosis
  • 6.3.4. Temporal Artery Biopsy (TAB)
• 6.4. Differential Diagnosis

7. Diagnostic Guidelines

• 7.1. American College of Rheumatology (ACR) Diagnostic Guidelines for GCA
• 7.2. European League Against Rheumatism (EULAR) Guidelines for the Diagnosis of GCA
• 7.3. The British Society for Rheumatology (BSR) and British Health Professionals in Rheumatology (BHPR) Diagnostic Guidelines for GCA
• 7.4. The French Study Group for Larger Vessel Vasculitis (GEFA) Recommendations for Diagnosis of GCA

8. Treatment of GCA

• 8.1. Treatment Algorithm of GCA
• 8.2. Corticosteroids
• 8.3. Disease-modifying Anti-rheumatic Drugs (DMARDs)
  • 8.3.1. Methotrexate (MTX)
  • 8.3.2. Leflunomide
  • 8.3.3. Azathioprine

9. Treatment Guidelines

• 9.1. American College of Rheumatology Treatment Guidelines for the Management of GCA
• 9.2. European League Against Rheumatism (EULAR) Guidelines for the Management of GCA
• 9.3. The British Society for Rheumatology (BSR) and British Health Professionals in Rheumatology (BHPR) Treatment Guidelines for GCA
• 9.4. The French Study Group for Larger Vessel Vasculitis (GEFA) Recommendations for Management of GCA

10. Epidemiology and Market Forecast Methodology

11. Epidemiology and Patient Population

• 11.1. Key Findings
• 11.2. Assumptions and Rationale
• 11.3. Total Diagnosed Prevalent Cases of GCA in the 7MM
• 11.4. The United States
  • 11.4.1. Total Diagnosed Prevalent Cases of GCA in the United States
  • 11.4.2. Subtype-specific Cases of GCA in the United States
  • 11.4.3. Gender-specific Cases of GCA in the United States
  • 11.4.4. Age group-specific Cases of GCA in the United States
  • 11.4.5. Clinical Manifestation-specific Cases of GCA in the United States
  • 11.4.6. Total Treated Cases of GCA in the United States
• 11.5. EU4 and the UK
  • 11.5.1. Total Diagnosed Prevalent Cases of GCA in EU4 and the UK
  • 11.5.2. Subtype-specific Cases of GCA in EU4 and the UK
  • 11.5.3. Gender-specific Cases of GCA in EU4 and the UK
  • 11.5.4. Age group-specific Cases of GCA in EU4 and the UK
  • 11.5.5. Clinical Manifestation-specific Cases of GCA in EU4 and the UK
  • 11.5.6. Total Treated Cases of GCA in EU4 and the UK
• 11.6. Japan
  • 11.6.1. Total Diagnosed Prevalent Cases of GCA in Japan
  • 11.6.2. Subtype-specific Cases of GCA in Japan
  • 11.6.3. Gender-specific Cases of GCA in Japan
  • 11.6.4. Age group-specific Cases of GCA in Japan
  • 11.6.5. Clinical Manifestation-specific Cases of GCA in Japan
  • 11.6.6. Total Treated Cases of GCA in Japan

12. Patient Journey

13. Marketed Therapies

• 13.1. Key Cross Competition
• 13.2. ACTEMRA/ROACTEMRA (tocilizumab): Roche
  • 13.2.1. Drug Description
  • 13.2.2. Regulatory Milestones
  • 13.2.3. Other Developmental Activities
  • 13.2.4. Pivotal Clinical Trial
    • 13.2.4.1. Summary of Pivotal Trial
  • 13.2.5. Ongoing Current Pipeline Activity
    • 13.2.5.1. Clinical Trials Information

14. Emerging Therapies

• 14.1. Key Cross Competition
• 14.2. RINVOQ (upadacitinib): AbbVie
  • 14.2.1. Drug Description
  • 14.2.2. Other Developmental Activities
  • 14.2.3. Clinical Development
    • 14.2.3.1. Clinical Trials Information
• 14.3. COSENTYX (secukinumab): Novartis Pharmaceuticals
  • 14.3.1. Drug Description
  • 14.3.2. Other Developmental Activities
  • 14.3.3. Clinical Development
    • 14.3.3.1. Clinical Trials Information
  • 14.3.4. Safety and Efficacy
• 14.4. Mavrilimumab: CSL/Kiniksa Pharmaceuticals
  • 14.4.1. Drug Description
  • 14.4.2. Other Developmental Activities
  • 14.4.3. Clinical Development
    • 14.4.3.1. Clinical Trials Information
  • 14.4.4. Safety and Efficacy
• 14.5. TREMFYA (guselkumab): Johnson & Johnson/MorphoSys AG
  • 14.5.1. Drug Description
  • 14.5.2. Other Developmental Activities
  • 14.5.3. Clinical Development
    • 14.5.3.1. Clinical Trials Information

15. Giant Cell Arteritis (GCA): Market Analysis

• 15.1. Key Findings
• 15.2. Market Outlook
• 15.3. Conjoint Analysis
• 15.4. Key Market Forecast Assumptions
• 15.5. Total Market Size of GCA in the 7MM
• 15.6. United States Market Size
  • 15.6.1. Total Market Size of GCA in the United States
  • 15.6.2. Market Size of GCA by Therapies in the United States
• 15.7. EU4 and the UK Market Size
  • 15.7.1. Total Market Size of GCA in EU4 and the UK
  • 15.7.2. Market Size of GCA by Therapies in EU4 and the UK
• 15.8. Japan Market Size
  • 15.8.1. Total Market Size of GCA in Japan
  • 15.8.2. Market Size of GCA by Therapies in Japan

16. Unmet Needs

17. SWOT Analysis

18. KOL Views

19. Market Access and Reimbursement

• 19.1. United States
  • 19.1.1. Centre for Medicare and Medicaid Services (CMS)
• 19.2. EU4 and the UK
  • 19.2.1. Germany
  • 19.2.2. France
  • 19.2.3. Italy
  • 19.2.4. Spain
  • 19.2.5. United Kingdom
• 19.3. Japan
  • 19.3.1. MHLW
• 19.4. Market Access and Reimbursement of GCA
  • 19.4.1. Patient Access Program
  • 19.4.2. The National Institute for Health and Care Excellence (NICE): UK
  • 19.4.3. Haute Autorite de Sante (HAS): France

20. Appendix

• 20.1. Bibliography
• 20.2. Report Methodology

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight