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한글목차
주요 7개국의 특발성 막성 신증 시장 규모는 2034년까지 10억 달러에 달할 것으로 예상되며, EU 4개국과 영국 중 2023년 시장 규모가 가장 큰 국가는 독일로 1,000만 달러에 달할 것으로 예상됩니다. 일본은 2034년까지 7,000만 달러로 증가할 것으로 예상됩니다.
특발성 막성 신증(IMN)은 주로 신증후군과 관련된 사구체 질환의 유병률입니다. 면역계가 사구체를 공격하는 것이 특징이며, 심각한 단백뇨, 부종을 유발하고 신부전으로 진행될 수 있습니다. 이 질환은 자가면역질환이나 감염 등 다양한 기저질환으로 인해 발생할 수 있지만, 식별 가능한 이차적 원인이 발견되지 않는 경우 '특발성'이라고 하며, 일반적으로 성인, 특히 중년 남성에게 발생하며, 거품뇨, 하체 및 복부 부종, 체액 저류로 인한 체중 증가 등의 증상을 보입니다.
IMN의 진단에는 임상 평가와 임상 검사의 조합이 필요합니다. 초기 평가에는 일반적으로 단백뇨를 검출하기위한 소변 검사가 포함되며, 단백뇨는 종종 신증 범위(3.5g/일 이상)에 있습니다. 혈액 검사는 신장 기능을 평가하고 신증후군에서 흔히 볼 수 있는 저알부민혈증과 이상 지질혈증의 유무를 검사합니다. 확진은 보통 신장 생검을 통해 사구체에 특징적인 변화(모세혈관 벽을 따라 면역복합체 침착 등)를 확인하여 진단을 내릴 수 있습니다. 또한 포스포리파아제 A2 수용체(PLA2R) 등에 대한 특이적 항체 혈청학적 검사는 원발성 IMN과 이차성 IMN을 감별하는 데 도움이 되며, 추가적인 관리 전략의 지침이 될 수 있습니다.
현재 특발성 막성 신증에 대한 특효약은 없으며, 치료는 주로 증상 관리와 병의 진행을 예방하는 데 중점을 두고 있습니다. 지지 요법으로는 이뇨제를 사용하여 부종을 관리하고 안지오텐신 전환 효소(ACE) 억제제 또는 안지오텐신 II 수용체 길항제(ARB)를 사용하여 단백뇨를 감소시키고 신장 기능을 보호합니다. 지지 요법이 불충분한 경우 면역 억제 요법이 시작됩니다. 여기에는 코르티코스테로이드, 사이클로포스파미드, 자가면역 반응에 관여하는 B세포를 표적으로 하는 리툭시맙과 같은 새로운 약물이 포함됩니다. 그러나 이러한 치료의 효과는 다양하며, 심각한 부작용을 동반하기도 합니다. 최근 연구에 따르면, B세포를 표적으로 하는 치료법은 유망하며, IMN 환자의 예후를 개선할 수 있는 가능성을 시사하고 있습니다.
이 보고서는 주요 7개국의 특발성 막성 신증 시장을 조사했으며, 시장 개요와 함께 역학, 환자 동향, 새로운 치료법, 2034년까지 시장 규모 예측, 의료 미충족 수요 등의 정보를 제공합니다.
목차
제1장 주요 인사이트
제2장 보고서 서론
제3장 특발성막성 신증(IMN) 시장 개요
제4장 조사 방법
제5장 IMN 주요 요약
제6장 중요 이벤트
제7장 질환의 배경과 개요
서론
징후와 증상
분류
원인
병태생리학
바이오마커
진단
진단 가이드라인
제8장 치료와 관리
제9장 역학과 환자 인구
주요 조사 결과
전제와 근거 : 주요 7개국
주요 7개국의 막성 신증 총 유병 사례 수
주요 7개국의 특발성 막성 신증 총 유병 사례 수
미국
EU 4개국과 영국
일본
제10장 환자 동향
제11장 새로운 치료법
제12장 시장 분석
주요 조사 결과
시장 전망
결합 분석
주요 시장 예측의 전제조건
주요 7개국의 IMN 전체 시장 규모
주요 7개국의 IMN 시장 규모(치료별)
미국 시장 규모
EU 4개국과 영국 시장 규모
일본 시장 규모
제13장 KOL(Key Opinion Leader)의 견해
제14장 SWOT 분석
제15장 미충족 요구
제16장 시장 접근과 상환
미국
EU 4개국과 영국
일본
제17장 부록
제18장 DelveInsight의 서비스 내용
제19장 면책사항
LSH
영문 목차
영문목차
Key Highlights:
Idiopathic Membranous Nephropathy (IMN) is a significant type of glomerular disease characterized by the presence of large amounts of protein in the urine (nephrotic syndrome) and is primarily an autoimmune condition.
There is currently no specific approved drugs for IMN, and management typically focuses on supportive care.
The market is anticipated to witness a substantial positive shift owing to better uptake of existing drugs, the expected market launch of therapies, and raised awareness.
In 2023, the United States accounts for the largest market size with ~USD 88 million in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
The market of IMN in the 7MM is expected to reach ~USD 1,000 million by 2034.
The total prevalent population of IMN in the 7MM is estimated to be ~71,000 cases in 2023.
In 2023, the US accounted for ~40% of all prevalent cases of IMN in the 7MM, while EU4 and the UK combined accounted for ~35%, and Japan contributed ~25%. This data highlights Japan as the second-largest contributor after US to IMN cases.
Few emerging drugs in pipeline are TNT119, ALPN-303, MOR202, SNP-ACTH (1-39) Gel, GAZYVA, and others.
In October 2023, Human Immunology Biosciences (HI-Bio) announced that the FDA granted Breakthrough Therapy designation (BTD) to felzartamab for the treatment of primary membranous nephropathy.
In June 2023, the US Food and Drug Administration (FDA) granted orphan drug designation (ODD) for corticotrophin (ACTH) porcine (synthetic), otherwise referred to as SNP-ACTH (1-39) gel for the treatment of primary membranous nephropathy (PMN) a rare kidney disease.
In July 2024, Biogen completed its acquisition of Human Immunology Biosciences (HI-Bio). Prior to this, in June 2022, HI-Bio and MorphoSys AG had entered into an equity participation and licensing agreement, under which HI-Bio was tasked with developing and commercializing MorphoSys' anti-CD38 antibody, felzartamab.
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.
Geography Covered:
The United States
EU4 (Germany, France, Italy, and Spain) and the United Kingdom
Japan
Idiopathic Membranous Nephropathy (IMN) Understanding and Treatment Algorithm
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).
In 2023, the US accounted for ~40% of all prevalent cases of IMN in 7MM.
Japan's data suggests a relatively stable trend in the prevalence of IMN over the forecasted period of 2024-2034.
Germany had the highest prevalence of IMN among EU4 and the UK, accounting for ~30% of cases, followed by the UK with ~20%, in 2023.
In 2023, the PLA2R-specific cases in EU4 and the UK contributed ~75% in the 7MM.
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.
Idiopathic Membranous Nephropathy (IMN) Market Outlook
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).
In the 7MM, MOR202 (felzartamab) is expected to garner the largest market revenue of ~USD 500 million by 2034.
Among the EU4 and the UK, Germany accounted for the highest market size of ~USD 10 million in 2023.
Japan is expected to increase to ~USD 70 million by 2034.
In 2023, Rituximab generated a revenue of ~USD 50 million in the 7MM.
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...
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.
Scope of the Report:
The report covers a segment of key events, an executive summary, descriptive overview of Idiopathic Membranous Nephropathy (IMN), explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country specific treatment guidelines.
Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
A detailed review of the Idiopathic Membranous Nephropathy (IMN) 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 in shaping and driving the 7MM Idiopathic Membranous Nephropathy (IMN) market.
What is the growth rate of the 7MM Idiopathic Membranous Nephropathy (IMN) treatment market?
What was the Idiopathic Membranous Nephropathy (IMN) total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
Is there any unexplored patient setting that can open the window for growth in the future?
What are the pricing variations among different geographies for approved and off-label therapies?
How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
What are the current and emerging options for the treatment of Idiopathic Membranous Nephropathy (IMN)?
How many companies are developing therapies for the treatment of Idiopathic Membranous Nephropathy (IMN)?
What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
What are the country-specific accessibility issues of expensive, recently approved therapies?
Reasons to buy:
The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Idiopathic Membranous Nephropathy (IMN) 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.
Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
Identifying strong upcoming 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 of approved therapies, barriers to accessibility of expensive off-label therapies, 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. Idiopathic Membranous Nephropathy (IMN) Market Overview at a Glance
3.1. Market Share (%) Distribution of IMN by Therapies in 2023
3.2. Market Share (%) Distribution of IMN by Therapies in 2034
4. Methodology
5. Executive Summary of IMN
6. Key Events
7. Disease Background and Overview
7.1. Introduction
7.2. Sign and Symptoms
7.3. Classification
7.4. Causes
7.5. Pathophysiology
7.6. Biomarkers
7.7. Diagnosis
7.8. Diagnostic Guidelines
8. Treatment and Management
8.1. Treatment Strategy
8.2. Treatment of secondary MN
8.3. Treatment Guidelines
8.3.1. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases
9. Epidemiology and Patient Population
9.1. Key Findings
9.2. Assumptions and Rationales: 7MM
9.3. Total Prevalent Cases of Membranous Nephropathy in the 7MM
9.4. Total Prevalent Cases of Idiopathic Membranous Nephropathy in the 7MM
9.5. The United States
9.5.1. Total Prevalent Cases of IMN in the US
9.5.2. Antigen-specific cases of IMN in the US
9.5.3. Total Treated Cases of IMN in the US
9.6. EU4 and the UK
9.6.1. Total Prevalent Cases of IMN in EU4 and the UK
9.6.2. Antigen-specific Cases of IMN in EU4 and the UK
9.6.3. Total Treated Cases of IMN in EU4 and the UK
