![]() |
市場調査レポート
商品コード
1415501
免疫複合体膜性増殖性糸球体腎炎(IC-MPGN) - 市場考察、疫学、市場予測(2034年)Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) - Market Insights, Epidemiology, and Market Forecast - 2034 |
||||||
カスタマイズ可能
|
免疫複合体膜性増殖性糸球体腎炎(IC-MPGN) - 市場考察、疫学、市場予測(2034年) |
出版日: 2024年01月24日
発行: DelveInsight
ページ情報: 英文 99 Pages
納期: 1~3営業日
|
当レポートでは、免疫複合体膜性増殖性糸球体腎炎(IC-MPGN)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。
DelveInsight's "Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), historical and forecasted epidemiology as well as Immune Complex Membranoproliferative Glomerulonephritis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The Immune Complex Membranoproliferative Glomerulonephritis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Immune Complex Membranoproliferative Glomerulonephritis market size from 2020 to 2034. The report also covers current Immune Complex Membranoproliferative Glomerulonephritis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2020-2034.
Membranoproliferative glomerulonephritis (MPGN) is a kidney disorder involving inflammation and kidney cell changes. It is a form of glomerulonephritis caused by an abnormal immune response.
MPGN has previously been used as an umbrella term to describe a spectrum of hypocomplementemic glomerular diseases, which are a rare cause of end-stage kidney disease (ESKD). More recently, MPGN has been reclassified into two diseases: immune-complex MPGN (IC-MPGN) and C3 glomerulopathy (C3G) based on immunofluorescence findings in kidney biopsies: predominant or exclusive C3 deposits in C3G and combined immunoglobulins and complement deposits in IC-MPGN.
To diagnose MPGN, several tests are typically conducted including a Urine test, Blood test, Glomerular Filtration Rate (GFR) test, Kidney biopsy, and Genetic testing. These tests collectively aid in confirming the diagnosis of MPGN, determining its specific class, understanding the extent of kidney involvement, and guiding healthcare providers in formulating the most effective treatment plan based on the underlying causes and characteristics of the disease
To date, there has not been a specific treatment devised to cure the indication completely. Besides, the market for IC-MPGN lacks approved drugs and is dominated by the use of off-label prescription medications. These include immunosuppressants, corticosteroids, renin-angiotensin-aldosterone system Inhibitors (RAAS), and other supportive therapies.
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by a total diagnosed prevalent population of Immune Complex Membranoproliferative Glomerulonephritis, gender-specific diagnosed prevalent population of Immune Complex Membranoproliferative Glomerulonephritis, and age-specific diagnosed prevalent population of Immune Complex Membranoproliferative Glomerulonephritis in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom and Japan from 2020 to 2034.
The drug chapter segment of the Immune Complex Membranoproliferative Glomerulonephritis report encloses a detailed analysis of the marketed and the late-stage (Phase III and Phase II) pipeline drug. Furthermore, the current key players for emerging drugs and their respective drug candidates include Novartis Pharmaceuticals (iptacopan) and Apellis Pharmaceuticals (pegcetacoplan). The drug chapter also helps understand the Immune Complex Membranoproliferative Glomerulonephritis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.
Iptacopan is an investigational, first-in-class, orally administered factor B inhibitor of the alternative complement pathway, targeting one of the key drivers of CDRDs8-10. It is the most advanced asset in the Novartis nephrology pipeline and has the potential to become the first targeted therapy to delay progression to dialysis in C3G9. Discovered at the Novartis Institutes for BioMedical Research, iptacopan is currently in development for several CDRDs where significant unmet needs exist, including Immune Complex Membranoproliferative Glomerulonephritis. Currently, the drug is being investigated in Phase III of the clinical development.
Novartis intends to seek regulatory approval for the drug by 2026, with the preliminary findings from the Phase III APPARENT trials expected to be available by the same year.
Apellis' Pegcetacoplan (APL-2) is an investigational, targeted C3 inhibitor designed to regulate excessive complement activation, which can lead to the onset and progression of many serious diseases. It is a15-amino acid cyclic peptide conjugated to each end of a linear polyethylene glycol molecule that binds to C3 and C3b, directly preventing activation of C3, C5, and the alternative pathway. Pegcetacoplan (marketed as EMPAVELI) is approved in the United States for the treatment of adults with paroxysmal nocturnal hemoglobinuria.
In October 2020, the company initiated the Phase II (NOBLE) trial in up to 12 patients with post-kidney transplant recurrence of C3G or Immune Complex Membranoproliferative Glomerulonephritis. In September 2021, the first patients dosed in the NOBLE trial. In June 2022, the first patient was dosed in the VALIANT Phase III study investigating pegcetacoplan in C3G or Immune Complex Membranoproliferative Glomerulonephritis. Currently, the drug is evaluated in a Phase III trial for Immune Complex Membranoproliferative Glomerulonephritis patients.
Note: Detailed emerging therapies assessment will be provided in the final report.
Renin-angiotensin-aldosterone system inhibitors: Angiotensin receptor blocker (ARB) and angiotensin-converting enzyme (ACE) inhibitors both are used to treat hypertension in C3G. Combination use of RAAS inhibitors showed higher efficiency compared with monotherapy and was associated with a higher incidence of adverse events.
Immunosuppressants: Corticosteroids, calcineurin inhibitors, corticosteroids in combination with mycophenolate mofetil (MMF), and others are used for the treatment of C3G. Among all nonspecific immunosuppressive therapies, MMF-based treatment is promising compared with others concerning clinical remission and renal survival.
Complement inhibitors are the primary class in the emerging pipeline for C3G therapy. Complement inhibitors Pegcetacoplan and Iptacopan perform well in C3G in terms of safety and effectiveness.
Note: Detailed insights will be provided in the final report.
Immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN) is an ultrarare, chronic, and progressive nephropathy, which is characterized by significant immunoglobulin deposition and is assumed to involve dysregulation of both the classical and alternative pathways of complement (AP).
Immune Complex Membranoproliferative Glomerulonephritis lacks approved medications, creating a significant demand for treatments addressing the root cause. Kidney failure, necessitating dialysis or transplantation, can occur within 5-10 years of diagnosis. Current strategies involve supportive measures with or without traditional immunosuppression, showing limited effectiveness in slowing disease progression. Considering the diseases' pathophysiology, a logical approach involves targeted complement inhibition.
The utilization of off-label prescription medications predominantly characterizes the market. Immune Complex Membranoproliferative Glomerulonephritis treatments encompass immunosuppressants, steroids, inhibitors of renin-angiotensin-aldosterone system (RAAS), and other supportive therapies like calcineurin inhibitors, additional immunosuppressive agents, and antibodies.
The current evolving landscape of Immune Complex Membranoproliferative Glomerulonephritis treatment exhibits a mid-level pipeline. Two promising therapies, Iptacopan (Novartis Pharmaceutical) and Pegcetacoplan (Apellis Pharmaceuticals), are in the advanced Phase III developmental stage.
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034, which depends on the competitive landscape, safety, efficacy data, and 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. Iptacopan is an oral small-molecule inhibitor of complement factor B with potential immunomodulatory activity. Novartis intends to seek regulatory approval for the drug by 2026. The drug is expected to launch in the US in 2027.
The report provides insights into therapeutic candidates in Phase III and II. It also analyzes key players involved in developing targeted therapeutics.
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Immune Complex Membranoproliferative Glomerulonephritis emerging therapies.
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 contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, nephrologists, Consultant Nephrologists, and Honorary Associate Professor at University Hospitals of Leicester NHS Trust, and others.
DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapy treatment patterns or Immune Complex Membranoproliferative Glomerulonephritis market trends.
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. 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.
The report provides detailed insights on the country-wise accessibility and reimbursement 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.
The development of drugs targeting the complement system is picking up speed, but it comes with several challenges. While the general role of complement in the body is acknowledged, how it contributes to disease and its impact on pathogenesis remains unclear. The complement system is intricate, comprising numerous pathways with regulatory functions. Even if one pathway is blocked, the system can adapt by "redirecting" to another, using regulatory mechanisms to safeguard the body from pathogens. This adaptability poses a challenge in achieving the desired clinical effects of complement inhibitors.
Developing drugs that can successfully block the complement pathway presents a significant challenge. This encompasses choosing appropriate indications, screening potential targets within the complement system, and determining drug types (such as monoclonal antibodies, small molecules, peptides, etc.). When discussing reimbursement for complement inhibitors, there is a possibility that drugs being researched for Immune Complex Membranoproliferative Glomerulonephritis might receive reimbursement in certain countries without encountering obstacles, especially when the same drugs are already reimbursed for other indications.