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市場調査レポート
商品コード
1632493
抗糸球体基底膜(抗GBM)市場 - 市場の洞察、疫学、市場予測:2034年Anti-Glomerular Basement Membrane (Anti-GBM) - Market Insights, Epidemiology, and Market Forecast - 2034 |
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抗糸球体基底膜(抗GBM)市場 - 市場の洞察、疫学、市場予測:2034年 |
出版日: 2025年01月01日
発行: DelveInsight
ページ情報: 英文 200 Pages
納期: 2~10営業日
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抗糸球体基底膜(抗GBM)の市場規模は米国が主要7ヶ国中最大で、2023年には約1,550万米ドルに達しました。抗GBMは超希少かつ非常に重篤な疾患であり、年間100万人あたり約1~1.5人が罹患します。多くの患者が腎機能を失い、慢性透析や腎移植を必要とします。一般的に、20~30歳の若年層と60歳以上の2つの年齢層に罹患します。患者の大部分(80~90%)は急速に進行する糸球体腎炎を呈します。一方、40~60%の患者は肺出血を併発し、ごく少数の患者は孤立性肺疾患を呈します。標準治療は血漿交換と高用量のグルココルチコイドおよびシクロホスファミドの併用です。
主要7ヶ国では、米国が抗GBM症の罹患者数で最も多く、2023年には500例を超えます。EU4ヶ国と英国では、2023年にドイツが最多の罹患者数を占め、次いでフランスでした。抗GBM治療薬は承認されていないため、抗GBM治療薬に対するアンメットニーズは高いものとなっています。
抗GBM疾患は、腎臓と肺に炎症を引き起こすまれではありますが重篤な自己免疫疾患です。抗GBM病は腎臓だけに発症することもありますが、腎臓と肺の両方に発症する場合はグッドパスチャー症候群と呼ばれます。抗GBM病では、免疫系が誤って肺や腎臓を攻撃する「抗GBM抗体」を作り、臓器の出血や炎症を引き起こします。また、腎臓のろ過構造(糸球体)の炎症(糸球体腎炎)や肺への過剰な出血(肺出血)が特徴的です。
抗GBM病の診断は通常、血液検査による抗GBM抗体の同定によります。多くの場合、腎臓が侵されていることを証明するために腎生検(注射針で腎臓の組織を採取する)が必要となります。また、腎臓に抗GBM抗体が沈着していることを示すことで、診断が確定することもあります。肺が侵されているかどうかを確認するために、X線やCTスキャンなどの検査が行われることもあります。患者さんの血清中の抗GBM抗体については、間接免疫蛍光法、あるいは可能であれば遺伝子組換え型またはヒトNC-1α3を用いた直接酵素結合免疫吸着法(ELISA法)で検査します。これらの抗体の存在は診断を確定します。
治療には血漿交換と呼ばれるプロセスが必要で、機械を使って血液中から抗GBM抗体を除去します。これは多くの場合、2週間毎日行われます。さらに、ステロイドやシクロホスファミドなどの免疫抑制剤を使用して、炎症を抑え、さらなる抗体産生を阻止します。治療は通常、診断が下されてから6ヵ月間続けられます。
当レポートでは、主要7ヶ国における抗糸球体基底膜(抗GBM)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、2034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。
DelveInsight's "Anti-glomerular Basement Membrane (Anti-GBM) Disease Market Insight, Epidemiology and Market Forecast - 2034" report delivers an in-depth understanding of Anti-glomerular Basement Membrane (anti-GBM) Disease, historical and forecasted epidemiology as well as the Anti-glomerular Basement Membrane (anti-GBM) Disease market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
Anti-glomerular Basement Membrane (Anti-GBM) Disease market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM anti-glomerular Basement Membrane (Anti-GBM) Disease market size from 2020 to 2034. The report also covers current anti-glomerular Basement Membrane (Anti-GBM) Disease treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.
Anti-GBM Treatment Market
Anti-glomerular Basement Membrane (Anti-GBM) Disease Overview, Country-Specific Treatment Guidelines and Diagnosis
Anti-GBM disease is a rare but serious autoimmune disease that causes inflammation in the kidneys and lungs. Anti-GBM disease may affect only the kidneys; however, when it causes both kidney and lung disease, it is called Goodpasture's syndrome. In anti-GBM disease, the immune system mistakenly makes "anti-GBM antibodies" that attack the lungs and kidneys, leading to bleeding and inflammation in the organs. It is also characterized by the inflammation of the filtering structures (glomeruli) of the kidneys (glomerulonephritis) and excessive bleeding into the lungs (pulmonary hemorrhaging).
The diagnosis of anti-GBM disease usually relies on a blood test to identify anti-GBM antibodies. Often a kidney biopsy (taking a small sample of kidney tissue with a needle) is required to demonstrate that the kidneys are involved. This may also confirm the diagnosis, by showing deposition of anti-GBM antibodies in the kidney. Other tests such as X-rays or CT scans are often used to show if the lungs are involved. Patients are tested for serum anti-GBM antibodies by indirect immunofluorescence testing or, when available, direct enzyme-linked immunosorbent assay (ELISA) with recombinant or human NC-1 alpha3. The presence of these antibodies confirms the diagnosis.
Anti-glomerular Basement Membrane (Anti-GBM) Disease Treatment
Treatment requires a process called plasma exchange, which involves using a machine to remove anti-GBM antibodies from the bloodstream. This is often done daily for 2 weeks. In addition, immunosuppressive drugs such as steroids and cyclophosphamide, are used to suppress inflammation and stop further antibody production. Treatment usually continues for 6 months after the diagnosis is made.
The anti-GBM disease epidemiology chapter in the report provides historical as well as forecasted epidemiology in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034. The anti-GBM disease epidemiology is segmented with detailed insights into total incident cases of anti-GBM disease and age-specific incident cases of anti-GBM disease.
Anti-glomerular Basement Membrane (Anti-GBM) Disease Drug Chapter
The drug chapter segment of the anti-GBM disease market report encloses a detailed analysis of anti-GBM disease pipeline drugs. It also deep dives into the anti-GBM disease pivotal clinical trial details, expected market approvals, patent details, the latest news, and recent deals and collaborations.
Emerging Anti-GBM Drugs
IDEFIRIX (Imlifidase/HMed-IdeS): Hansa Biopharma
Imlifidase is a unique intravenous antibody-cleaving enzyme originating from Streptococcus pyogenes. It specifically targets IgG and inhibits IgG-mediated immune response and is being developed by Hansa Biopharma for the treatment of transplant rejection and rare IgG-mediated autoimmune conditions. Using imlifidase is a novel approach to eliminate pathogenic IgG. It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their reactivity within hours after intravenous administration. In 2018, Hansa Biopharma was granted orphan drug designation for imlifidase for anti-GBM antibody disease in both Europe and the US. The drug is currently in Phase III.
The GOOD-IDES-02 Phase III study in anti-GBM disease has now enrolled more than 70 percent of patients and the company is expecting to complete enrollment and deliver data in 2025.
There is a high unmet need for new therapies for the treatment of anti-GBM disease, which is apparent by the unavailability of any approved drugs in the anti-GBM disease market. Nevertheless, recently some developmental activities have been initiated toward the management of anti-GBM disease. Treatment opportunities are likely to evolve as for the first time, some exciting therapy, is heading down the pipeline. At present, key players such as Hansa Biopharma (imlifidase) have commenced clinical trials that investigate new treatment options for the management of anti-GBM disease.
This section focuses on the uptake rate of potential Anti-GBM drugs expected to be launched in the market during 2024-2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key Anti-GBM companies evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.
Anti-glomerular Basement Membrane (Anti-GBM) Disease Activities
The Anti-GBM market report provides insights into different therapeutic candidates in different stages. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The Anti-GBM market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for anti-GBM disease emerging therapies.
Anti-GBM KOL Views
To keep up with the real-world scenario in current and emerging Anti-GBM market trends, we take opinions from key industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.
DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of anti-GBM disease. 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 gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
Conjoint Analysis analyzes multiple approved and 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.
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 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.
Anti-GBM Market Access and Reimbursement
The Anti-GBM market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used 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.
Scope of the Anti-GBM Market Report