DelveInsight’s “Complement 3 Glomerulopathy Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of Complement 3 Glomerulopathy, historical and forecasted epidemiology as well as Complement 3 Glomerulopathy market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
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Key Takeaways from the Complement 3 Glomerulopathy Market Report
• In October 2024:- Kira Pharmaceuticals- The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with IgAN and C3G. The study will start with enrolling the IgAN cohort. Approximately 42 participants with IgAN will be enrolled in 2 stages: Stage 1 will be used to collect safety, immunogenicity, PK, and PD data to select the optimal biologic dose (OBD) of KP104 for IgAN, as well as to preliminarily explore the effect of KP104 on C3G. Stage 2 will be used to collect safety, immunogenicity, PK, PD, and efficacy data at the OBD dose of KP104 for IgAN and C3G. As soon as the OBD for IgAN is determined, eligible participants with C3G will be enrolled and dosed at the OBD for IgAN for a minimum of 48 weeks for weekly maintenance dosing and a minimum of 47 weeks for biweekly maintenance dosing. Approximately 10 participants with C3G will be enrolled.
• In October 2024:- Novartis Pharmaceuticals- A Multi-center, Single Arm, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Iptacopan in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Who Have Completed a Preceding Iptacopan Phase 3 Study in aHUS. This is a multicenter, single arm, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of iptacopan in participants with aHUS.
• The total Complement 3 Glomerulopathy diagnosed prevalent population in the 7MM was found to be ~5,700 in 2023.
• In Japan, adults are more prevalent in Complement 3 Glomerulopathy compared to pediatrics.
• The leading Complement 3 Glomerulopathy Companies working in the market include ChemoCentryx, Novartis Pharmaceuticals, Omeros Corporation, Apellis Pharmaceuticals, and others.
• Promising Complement 3 Glomerulopathy Pipeline Therapies in the various stages of development include iptacopan, Pegcetacoplan, ARO-C3, and others.
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Complement 3 Glomerulopathy Epidemiology Segmentation in the 7MM
• Total Complement 3 Glomerulopathy Diagnosed Prevalent Population Cases
• Complement 3 Glomerulopathy Age-specific Diagnosed Prevalent Population Cases
• Complement 3 Glomerulopathy Type-specific Diagnosed Prevalent Population Cases
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Complement 3 Glomerulopathy Emerging Drugs
• Iptacopan (LNP023): Novartis Pharmaceuticals
• Pegcetacoplan (APL-2): Apellis Pharmaceuticals
Complement 3 Glomerulopathy Therapeutics Market Landscape
The current Complement 3 Glomerulopathy therapeutic landscape in the United States is driven by current treatment practices, which mainly comprises of off-label treatments. The expected launch of emerging therapies during the forecast period is expected to drive the upcoming market. The upcoming therapies target to slow down the disease progression, which is the current unmet need.
Complement 3 Glomerulopathy Market Outlook
Complement 3 Glomerulopathy, abbreviated as C3 glomerulopathy, refers to a condition characterized by the involvement of a blood protein known as “C3” in the immune system and disease development, alongside damage to the kidney’s glomeruli, denoted by the “G.” This condition encompasses two distinct patterns of damage and inflammation in the glomeruli: dense deposit disease (DDD) and C3 glomerulonephritis (C3GN). When observed under a microscope, the appearance of kidney tissue affected by DDD differs from that affected by C3GN, illustrating the diverse manifestations of this disorder.
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Complement 3 Glomerulopathy Market Size
According to the estimates, the highest market size of C3G was found in the United States and the least was in Spain across the 7MM. Besides, the upcoming therapies of C3G are expected to combat the current unmet needs faced by the patients with C3G and add to the overall growth of the C3G market size.
Complement 3 Glomerulopathy Treatment Market
The optimal Complement 3 Glomerulopathy treatment remains uncertain, lacking a specific therapy that consistently proves effective. Current guidelines primarily draw from case series and observational studies, supplemented by expert opinions. Consequently, treatment strategies are not standardized and often centralized in specialized centers. Generally, all patients diagnosed with C3G should undergo Reno protective measures, including lifestyle adjustments and the use of medications like angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers to manage hypertension and proteinuria. Additionally, lipid-lowering drugs are recommended. However, it’s essential to understand that these medications alone do not ensure protection against progressing to end-stage renal disease but may enhance the efficacy of immunosuppressive therapy.
Complement 3 Glomerulopathy Market Dynamics
The Complement 3 Glomerulopathy market dynamics are expected to shift in the upcoming years. Within the growing C3G market, notable players such as Apellis Pharmaceuticals, ChemoCentryx, and Novartis Pharmaceuticals are prominent contenders. The potential introduction of innovative biomarkers in the near future could shed light on the disease’s pathophysiology, leading to advancements in diagnosis. Various organizations, including WeC3G, the National Kidney Foundation (NKF), the American Society of Nephrology (ASN), the Kidney Disease: International Global Organization (KDIGO), the Japanese Society of Nephrology (JSN), and others, are actively working to disseminate information and raise awareness about this condition.
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Complement 3 Glomerulopathy Drugs Uptake
• Novartis Pharmaceuticals is developing LNP023 (iptacopan), which is an oral small-molecule inhibitor of complement factor B (FB) with potential immunomodulatory activity. Upon administration, FB inhibitor LNP023 binds to FB and prevents the formation of the alternative pathway (AP) C3-convertase (C3bBb). In December 2020, the US FDA granted iptacopan Rare Pediatric Disease (RPD) Designation in C3G. In October 2020, the EMA granted PRIME designation for iptacopan in C3G. The drug has also received orphan drug designation fromthe US FDA and EMA for C3G. In June 2021, Novartis announced positive new interim Phase II data showing investigational iptacopan improved estimated glomerular filtration rate (eGFR) slope and stabilized kidney function in patients with C3G treated with iptacopan. In the same month, the drug entered the Phase III (APPEAR-C3G) stage of clinical development for C3G, with data read-out expected in 2023, and Phase II with data read-out expected in 2025, which will support filings worldwide. In addition, Novartis is planning to file the drug in 2024 so that it can enter the market in near future, thereby meeting the demands of the patients. In November 2021, company announced that that a Phase II study of investigational iptacopan (LNP023) meets primary endpoints in (C3G), significant reductions in proteinuria for patients with C3 glomerulopathy (C3G).
• Apellis’ Pegcetacoplan (Empaveli/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. In October 2020, Sobi and Apellis entered into a collaboration for global co-development and ex-US commercialization of systemic pegcetacoplan in rare diseases with urgent need for new treatments. In December 2018, APL-2 was granted Orphan Drug Designation by the FDA and EMA for the treatment of C3G. It is currently conducting Phase III study (VALIANT) to evaluate the efficacy and safety of pegcetacoplan in patients with C3G and in June 2022, first patient dosed in the VALIANT study. Pegcetacoplan (marketed as Empaveli) is approved in the United States for the treatment of adults with paroxysmal nocturnal Hemoglobinuria.
• Amyndas Pharmaceuticals is developing AMY-101, which is a novel complement C3-targeted therapeutic based on the 3rd-generation compstatin analog Cp40. Compstatins inhibit complement centrally, at the level of C3, and interrupt all downstream pathways of the complement activation cascade. By inhibiting complement centrally, at the level of C3, AMY-101 may prove more effective in treating a wide range of complement-mediated diseases than is possible with partial inhibitors of complement (such as anti-C5 agents) or other C3 inhibitors. Ex vivo data demonstrated that AMY-101 corrects the complement dysregulation that characterizes C3G and constitutes a potentially beneficial treatment strategy. As AMY-101 represents a novel and promising therapeutic option that may offer C3G patients a disease-specific, cost-effective, targeted therapeutic approach, the US FDA and the EMA have each designated AMY-101 an orphan drug for the treatment of C3G. A Phase I trial has been completed and the company has planned a Phase II trial for C3G.
Scope of the Complement 3 Glomerulopathy Market Report
• Coverage- 7MM
• Study Period- 2020-2034
• Complement 3 Glomerulopathy Companies- ChemoCentryx, Novartis Pharmaceuticals, Omeros Corporation, Apellis Pharmaceuticals, and others.
• Complement 3 Glomerulopathy Pipeline Therapies- iptacopan, Pegcetacoplan, ARO-C3, and others.
• Complement 3 Glomerulopathy Market Dynamics: Complement 3 Glomerulopathy Market Drivers and Barriers
Table of Content
1. Key Insights
2. Report Introduction
3. Executive Summary of Complement 3 Glomerulopathy
4. Complement 3 Glomerulopathy Market Overview at a Glance
5. Key Events
6. Complement 3 Glomerulopathy Epidemiology and Market Forecast Methodology
7. Disease Background and Overview
8. Complement 3 Glomerulopathy Treatment
9. Clinical Practice Guideline for the Management of Glomerular Diseases: KDIGO 2021
10. Complement 3 Glomerulopathy Epidemiology and Patient Population
11. Patient Journey
12. Complement 3 Glomerulopathy Emerging Therapies
13. Complement 3 Glomerulopathy (C3G): Seven Major Market Analysis
14. Complement 3 Glomerulopathy Unmet Needs
15. Complement 3 Glomerulopathy SWOT Analysis
16. Complement 3 Glomerulopathy KOL Views
17. Complement 3 Glomerulopathy Market Access and Reimbursement
18. Appendix
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
About Us
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