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市場調査レポート
商品コード
1553403
特発性膜性腎症 - 市場の洞察、疫学、市場予測:2032年Idiopathic Membranous Nephropathy Market Insight, Epidemiology, and Market Forecast - 2032 |
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特発性膜性腎症 - 市場の洞察、疫学、市場予測:2032年 |
出版日: 2024年08月01日
発行: DelveInsight
ページ情報: 英文 138 Pages
納期: 1~3営業日
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主要7ヶ国の特発性膜性腎症の市場規模は、2034年までに10億米ドルに達すると予想されます。EU4ヶ国と英国の中で、2023年の市場規模が最も大きいのはドイツで1,000万米ドルとなっています。日本は2034年までに7,000万米ドルに増加すると予想されます。
特発性膜性腎症(IMN)は、主にネフローゼ症候群と関連する糸球体疾患の有病型です。免疫系による糸球体への攻撃が特徴で、著しい蛋白尿、浮腫を引き起こし、腎不全に進行する可能性があります。この疾患は、自己免疫疾患や感染症などの様々な基礎疾患から生じることもあるが、同定可能な二次的原因が見つからない場合は「特発性」と呼ばれます。IMNは一般的に成人、特に中年男性に発症し、泡沫尿、下肢や腹部のむくみ、体液貯留による体重増加などの症状を呈します。
IMNの診断には、臨床評価と臨床検査の組み合わせが必要です。初期評価には通常、蛋白尿を検出するための尿検査が含まれ、蛋白尿はしばしばネフローゼ範囲(3.5g/日以上)にあります。血液検査では腎機能を評価し、ネフローゼ症候群によくみられる低アルブミン血症や脂質異常症の有無を調べます。確定診断は通常、腎生検によって行われ、糸球体に特徴的な変化(毛細血管壁に沿った免疫複合体の沈着など)が認められます。さらに、ホスホリパーゼA2レセプター(PLA2R)などに対する特異的抗体の血清学的検査は、原発性IMNと二次性IMNの鑑別に役立ち、さらなる管理戦略の指針となります。
現在のところ、特発性膜性腎症の特効薬はなく、治療は主に症状の管理と病状の進行予防に重点が置かれています。支持療法としては、浮腫を管理するために利尿薬を使用し、蛋白尿を減少させ腎機能を保護するためにアンジオテンシン変換酵素(ACE)阻害薬またはアンジオテンシンII受容体拮抗薬(ARB)を使用します。支持療法が不十分な場合は、免疫抑制療法が開始されます。これにはコルチコステロイド、シクロホスファミド、自己免疫反応に関与するB細胞を標的とするリツキシマブなどの新しい薬剤が含まれます。しかし、これらの治療の有効性は様々であり、重大な副作用を伴うこともあります。最近の研究から、B細胞を標的とする治療法は有望であり、IMN患者の予後を改善する可能性があることが示唆されています。
当レポートでは、主要7ヶ国における特発性膜性腎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、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 "Idiopathic Membranous Nephropathy (IMN) - Market Insights, Epidemiology and Market Forecast - 2034" report delivers an in-depth understanding of Idiopathic Membranous Nephropathy (IMN), historical and forecasted epidemiology as well as the Idiopathic Membranous Nephropathy (IMN) market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
Idiopathic Membranous Nephropathy (IMN) market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Idiopathic Membranous Nephropathy (IMN) market size from 2020 to 2034. The report also covers current Idiopathic Membranous Nephropathy (IMN) treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.
Idiopathic Membranous Nephropathy (IMN) Overview
Idiopathic Membranous Nephropathy (IMN) is a prevalent form of glomerular disease primarily associated with nephrotic syndrome. It is characterized by the immune system's attack on the glomeruli, leading to significant proteinuria, edema, and potential progression to renal failure. The condition is termed "idiopathic" when no identifiable secondary cause is found, although it can also arise from various underlying conditions, including autoimmune diseases and infections. IMN typically affects adults, particularly middle-aged men, and presents with symptoms such as frothy urine, swelling in the legs and abdomen, and weight gain due to fluid retention.
The diagnosis of IMN involves a combination of clinical evaluation and laboratory tests. Initial assessments typically include urine analysis to detect proteinuria, which is often in the nephrotic range (>3.5 g/day). Blood tests are conducted to evaluate kidney function and check for hypoalbuminemia and dyslipidemia, common in nephrotic syndrome. A definitive diagnosis is usually confirmed through a kidney biopsy, which reveals characteristic changes in the glomeruli, such as immune complex deposition along the capillary walls. Additionally, serological tests for specific antibodies, such as those against the phospholipase A2 receptor (PLA2R), can help differentiate primary IMN from secondary forms, guiding further management strategies.
Further details related to country-based variations in diagnosis are provided in the report
Idiopathic Membranous Nephropathy (IMN) Treatment
Currently, there is no specific cure for IMN, and treatment primarily focuses on managing symptoms and preventing disease progression. Supportive care includes the use of diuretics to manage edema and angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) to reduce proteinuria and protect kidney function. In cases where supportive measures are insufficient, immunosuppressive therapies may be initiated. These include corticosteroids, cyclophosphamide, and newer agents like rituximab, which targets B cells implicated in the autoimmune response. However, the effectiveness of these treatments can vary, and they may carry significant side effects. Recent studies suggest that targeting B cells may offer a promising therapeutic approach, potentially improving outcomes in patients with IMN.
The Idiopathic Membranous Nephropathy (IMN) epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The Idiopathic Membranous Nephropathy (IMN) epidemiology is segmented with detailed insights into total prevalent cases, antigen-specific cases, total treated cases of Idiopathic Membranous Nephropathy (IMN).
Idiopathic Membranous Nephropathy (IMN) Drug Chapter
The drug chapter segment of the Idiopathic Membranous Nephropathy (IMN) report encloses a detailed analysis of Idiopathic Membranous Nephropathy (IMN) marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the Idiopathic Membranous Nephropathy (IMN) pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.
Emerging Drugs
GAZYVA (obinutuzumab): Hoffmann-La Roche
GAZYVA (obinutuzumab) is a humanized and glycoengineered type II anti-CD20 monoclonal antibody with superior in vitro B-cell cytotoxicity than rituximab. Obinutuzumab is directed at a different epitope on CD20 than that recognized by rituximab and can evoke a greater B-cell apoptotic response.
Currently, the drug is in Phase III of development. Roche plans to file a regulatory application for obinutuzumab as a treatment option for membranous nephropathy in or after 2025.
SNP-ACTH (1-39) Gel: Cerium Pharmaceuticals
Cerium has formulated a synthetic porcine ACTH drug substance into a subcutaneous injectable drug product (SNP-ACTH [1-39] Gel). Similar to other synthetic long-acting ACTH products containing highly purified synthetic ACTH peptides, a quantifiable number of ACTH molecules present in a long-acting synthetic ACTH drug product is a clear advantage for optimizing the dosing required to achieve strong response rates in PMN.
The Company has completed its preclinical studies confirming the safety and potency of SNP-ACTH (1-39) Gel and a Phase I clinical trial in healthy subjects, further demonstrating its safety and tolerability. Cerium has engaged with the FDA on its Phase III trial design and outcome measures for a prospective, randomized superiority trial to determine if SNP-ACTH (1-39) Gel is superior to rituximab in inducing a durable remission of proteinuria as a first-line immunosuppressive treatment of moderate to high-risk PMN patients. Cerium is currently enrolling patients in its Phase III clinical trial.
Key players, such as Hoffmann-La Roche, HI-Bio, Cerium Pharmaceuticals, BeiGene and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Idiopathic Membranous Nephropathy (IMN).
This section focuses on the uptake rate of potential 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 players 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.
Further detailed analysis of emerging therapies drug uptake in the report...
Idiopathic Membranous Nephropathy (IMN) Activities
The report provides insights into different therapeutic candidates in Phase III and Phase II stages. 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 Idiopathic Membranous Nephropathy (IMN) emerging therapies.
KOL Views
To keep up with the real-world scenario in current and emerging 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 25+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as University of Minnesota, UCL Centre for Nephrology, University of Washington, Hospital Gregorio Maranon, etc., were contacted. Their opinion helps understand and validate current and emerging treatment patterns of Idiopathic Membranous Nephropathy (IMN). 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.
In efficacy, the trial's primary and secondary outcome measures are evaluated, one of the most important primary outcome measures is change in urinary protein and change in anti-phospholipase A2 receptor (PLA2R) auto-antibody.
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.
Market Access and Reimbursement
The 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.