ARO-C3와 AMY-101은 현재 C3 사구체증(C3G)과 IgA 신증(IgAN)을 대상으로 한 1단계 시험을 실시했습니다.
C3 보체 억제제 시장 규모는 예측 기간 중(2024-2034년), 복수의 보체조절 이상 질환에 있어서의 새로운 치료법의 상업적 성공이 예상되기 때문에 안정된 성장률로 증가할 것으로 예측됩니다.
C3 보체 억제제 시장 전망
Apellis의 pegcetacoplan이 지도상 위축과 PNH로 승인된 것은 여러 보체 개재성 질환으로 약물을 연구하는 타사에게 바람직한 모범이 되고 있습니다.
또한 C5 억제제는 환자마다 반응이 다르기 때문에 C3는 SOLIRIS 및 ULTOMIRIS와 같은 현재 C5 억제제를 대체하는 강력한 옵션입니다.
또한, PNH와 aHUS는 이미 많은 상시제약 및 신약으로 혼잡하고 있으며, 제네릭 의약품의 진입도 예측되기 때문에 각사는 현재 C3G, IgA-N, 지도상 위축 등의(그러나 이에 한정되지 않는) 다른 보체 조절 장애에 초점을 옮기고 있습니다.
주요 기업 외에 소규모 제약 기업도 현재 RNAi를 기반으로 한 C3 억제제를 연구하고 있으며, 보다 우수한 임상 효과를 가지는 보다 견고한 제품의 제공을 목표로 하고 있습니다.
이 보고서는 C3 보체 억제제의 주요 7개 시장(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본)에 대한 조사 분석을 통해 각 지역 시장 규모와 예측, 현재 치료법, 신약, 미충족 수요(Unmet Needs) 등의 정보를 제공합니다.
목차
제1장 주요 인사이트
제2장 보고서 서문
제3장 C3 보체 억제제 주요 요약
제4장 주요 사건
제5장 시장 예측 조사 방법
제6장 주요 7개 시장 C3 보체 억제제 시장 개요
시장 점유율 분포 : 적응증별(2020년)
시장 점유율 분포 : 적응증별(2034년)
제7장 C3 보체 억제제 : 배경과 개요
서론
C3 보체 억제제의 진화
치료
제8장 표적 환자 집단
주요 조사 결과
전제조건 및 근거 : 주요 7개 시장
주요 7개 시장 역학 시나리오
주요 7개 시장 C3 보체 억제제의 특정 적응증 총 환자 수
주요 7개 시장 C3 보체 억제제의 특정 적응증 총 적격 환자 수
주요 7개 시장 C3 보체 억제제의 특정 적응증 총 치료 환자 수
미국의 역학 시나리오
미국의 C3 보체 억제제의 특정 적응증 총 환자 수
미국의 C3 보체 억제제의 특정 적응증 총 적격 환자 수
미국의 C3 보체 억제제의 특정 적응증 총 치료 환자 수
유럽 4개국 및 영국의 역학 시나리오
유럽 4개국 및 영국의 C3 보체 억제제의 특정 적응증 총 환자 수
유럽 4개국 및 영국의 C3 보체 억제제의 특정 적응증 총 적격 환자 수
유럽 4개국 및 영국의 C3 보체 억제제의 특정 적응증 총 치료 환자 수
일본의 역학 시나리오
일본의 C3 보체 억제제의 특정 적응증 총 환자 수
일본의 C3 보체 억제제의 특정 적응증 총 적격 환자 수
일본의 C3 보체 억제제의 특정 적응증 총 치료 환자 수
제9장 출시된 치료법
주요 경쟁
EMPAVELI/SYFOVRE(pegcetacoplan) : Apellis
제10장 새로운 치료법
주요 경쟁
ARO-C3 : Arrowhead
제11장 C3 보체 억제제 : 주요 7개 시장 분석
주요 조사 결과
시장 전망
주요 시장 예측의 전제조건
주요 7개 시장 C3 보체 억제제 전체 시장 규모
주요 7개 시장 C3 보체 억제제 시장 규모 : 적응증별
미국 시장 규모
미국의 C3 보체 억제제 전체 시장 규모
미국의 C3 보체 억제제 시장 규모 : 적응증별
미국의 C3 보체 억제제 시장 규모 : 치료법별
유럽 4개국 및 영국 시장 규모
유럽 4개국 및 영국의 C3 보체 억제제 전체 시장 규모
유럽 4개국 및 영국의 C3 보체 억제제 시장 규모 : 적응증별
유럽 4개국 및 영국의 C3 보체 억제제 시장 규모 : 치료법별
일본 시장 규모
일본의 C3 보체 억제제 전체 시장 규모
일본의 C3 보체 억제제 시장 규모 : 적응증별
일본의 C3 보체 억제제 시장 규모 : 치료법별
제12장 시장 접근성 및 보험 적용
제13장 SWOT 분석
제14장 KOL의 견해
제15장 미충족 수요(Unmet Needs)
제16장 부록
제17장 DelveInsight 역량
제18장 면책사항
제19장 DelveInsight 정보
KTH
영문 목차
영문목차
Key Highlights:
C3 is a key complement protein, located at the nexus of all complement activation pathways. Extracellular, tissue, cell-derived, and intracellular C3 plays critical roles in the immune response that is dysregulated in many diseases, making it an attractive therapeutic target.
Currently, Apellis' pegcetacoplan is the only C3 inhibitor approved in paroxysmal nocturnal hemoglobinuria (PNH) and geographic atrophy, with brand name EMPAVELI and SYFOVRE, respectively.
A few of the potential emerging C3 complement inhibitors are Arrowhead's ARO-C3 (RNAi based C3 inhibitor), and Amyndas' AMY-101.
Both ARO-C3 and AMY-101 are currently being investigated in a Phase I study for C3 Glomerulopathy (C3G) and IgA Nephropathy (IgAN).
The market size of C3 complement inhibitor is expected to increase at a steady growth rate, owing to anticipated commercial success of emerging and marketed therapies in multiple complement dysregulated disorders during our forecast period (2024-2034).
DelveInsight's "C3 Complement inhibitor - Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the C3 complement inhibitors, historical and forecasted epidemiology, competitive landscape as well as the C3 complement inhibitors market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The C3 complement inhibitors market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM C3 inhibitors market size from 2020 to 2034. The report also covers current C3 inhibitors treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Geography Covered:
The United States
EU4 (Germany, France, Italy, and Spain) and the United Kingdom
Japan
Study Period: 2020-2034
C3 Complement Inhibitors Disease Understanding and Treatment Algorithm
C3 Complement Inhibitors Overview
Three major pathways of complement which are the classical, alternative and lectin pathways converge on complement C3. As the central component among the intricate protein network of the complement system, C3 is associated with diverse immunomodulatory system and biological process that affect human physiology and pathophysiology, thereby representing a 'hot-spot' for current complement-targeted therapeutic intervention. It is the most abundant complement protein which mediates numerous protective effects or pathological effects of complement. C3 plays roles in complement cascade by active fragments or complexes, which are achieved through a panel of enzyme processing procedure. C4b2a is C3 convertase (C3-cleaving enzyme) that triggers the activation in classical (antibody) or lectin (sugar) pathways, whereas in the alternative pathway that is C3bBb.The alternative pathway, triggered by spontaneous hydrolysis of C3 to C3-H2O, also generates C3 convertase (C3(H2O)Bb), leading to C3 cleavage and amplification. The resulting C3b facilitates further complement activation, including the formation of the MAC complex, essential for cell membrane permeation and lysis.
C3 Complement Inhibitors Treatment
Apellis' pegcetacoplan is currently the only approved C3 inhibitor in the complement dysregulation disorder market. On February 17, 2023, FDA approved SYFOVRE (pegcetacoplan) for the treatment of Geographic atrophy secondary to age-related macular degeneration. The FDA previously approved pegcetacoplan (EMPAVELI) as a therapy for adult patients with PNH who are treatment naive and those switching from treatment with SOLIRIS (eculizumab) and ULTOMIRIS (ravulizumab). Pegcetacoplan works by inhibiting C3 to regulate downstream immune response in the complement system. Dysregulated activation of this system can cause both inflammation and damage to motor neurons.
C3 Complement Inhibitors Drug Chapters
The drug chapter segment of the complement inhibitors reports encloses a detailed analysis of complement inhibitors' marketed drugs and late-stage (Phase I and Phase II) pipeline drugs. It also helps understand the complement inhibitors' clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Marketed Drugs
Pegcetacoplan - Apellis
In 2021, EMPAVELI (pegcetacoplan) became the first C3 compliment inhibitor, administered subcutaneously, to be approved by the FDA for the treatment of PNH. Later, in 2023, Apellis launched it under a different brand name, SYFOVRE (pegcetacoplan injection), for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
EMPAVELI is available only through a restricted program under a risk evaluation and mitigation strategy. Meningococcal (a type of bacteria) infections can occur in patients taking Empaveli and can become life-threatening or fatal if not treated early.
Pegcetacoplan binds to C3 and its activation fragment C3b, thereby inhibiting the cleavage of C3 into C3a and C3b, and the downstream effectors of complement activation, leading to regulation of MAC-mediated intravascular haemolysis and C3-mediated extravascular haemolysis.
Emerging Drugs
ARO-C3: Arrowhead
ARO-C3 is designed to reduce production of complement component 3 as a potential treatment for various complement mediated diseases. It uses a technology called RNA interference (RNAi). When a gene is read to produce a protein, the code providing instructions for making the protein is copied into a temporary molecule called messenger RNA. This RNA molecule is then used by other cell machinery components as a template for making the protein.The basic idea behind RNAi therapies such as ARO-C3 is to inactivate the messenger RNA of a specific gene, in order to reduce the amount of protein that is produced.
The ARO-C3 is currently being investigated in a Phase I study involving adult patients with complement-mediated renal disease (C3 Glomerulopathy and IgA Nephropathy).
C3 Complement Inhibitors Market Outlook
The approval of Apellis' pegcetacoplan in Geographic atrophy and PNH has set a positive example for other companies who are investigating their drugs in multiple complement mediated diseases.
Furthermore, since C5 inhibitors are associated with heterogeneous responses among patients, C3 offers a potent alternative to the current C5 inhibitors such as SOLIRIS and ULTOMIRIS.
Also, since PNH and aHUS has already been crowded with a lot of marketed/emerging drugs, and anticipated generic entrants, the companies have now shifted their focus to other complement dysregulation disorders, including but not limited to C3G, IgA-N, and Geographic Atrophy.
Besides major players, small pharma companies are currently exploring RNAi based C3 inhibitors, with an aim to offer a more robust product with better clinical efficacy.
C3 Complement Inhibitors Drugs Uptake
This section focuses on the uptake rate of potential approved and emerging C3 Complement inhibitors expected to be launched in the market during 2020-2034.
C3 Complement Inhibitors Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase III phase II, and phase I. It also analyzes key players involved in developing targeted therapeutics.
The presence of numerous drugs under different stages is expected to generate immense opportunity for C3 Complement Inhibitors market growth over the forecasted period.
Recent Events
The report covers information on collaborations, acquisitions and mergers, licensing, patent details, and recently published results for complement inhibitors emerging therapies.
May 2024 - Apellis Pharmaceuticals has announced positive one-year data from the Phase II NOBLE trial of pegcetacoplan in treating post-transplant recurrence of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). Below are the highlights of the results:
The primary endpoint was met, with a significant proportion of patients showing a reduction in C3c staining after 12 weeks.
Furthermore, 55% of patients, including those with IC-MPGN, showed zero C3c staining intensity, suggesting clearance of C3c deposits
October 2023 - Apellis announced that the FDA has approved the EMPAVELI Injector for PNH patients. The EMPAVELI Injector is the first high-volume (20mL), subcutaneous on-body delivery system, which is developed in collaboration with Enable Injections, based on the enFuse(R) Syringe Transfer System.
KOL Views
To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on C3 complement inhibitors' evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.
DelveInsight's analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 7+ KOLs in the 7MM. We contacted institutes such as Duke University School of Medicine and others.
Their opinion helps understand and validate current and emerging therapy treatment patterns or C3 complement inhibitors market trends. This will support the clients in understanding 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. 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.
Scope of the Report:
The report covers a segment of key events, an executive summary, and a descriptive overview of C3 complement inhibitors, explaining their mechanism, and therapies (current and emerging).
Comprehensive insight into the competitive landscape, forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies that will impact the current landscape.
A detailed review of the C3 complement Inhibitors 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, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM Complement inhibitors market.
C3 complement inhibitors report insights
C3 complement Inhibitors Targeted Patient Pool
Therapeutic Approaches
C3 complement Inhibitors Pipeline Analysis
C3 complement Inhibitors Market Size and Trends
Existing and Future Market Opportunity
C3 complement inhibitors Report Key Strengths
Eleven years Forecast
The 7MM Coverage
Key Cross Competition
Drugs Uptake and Key Market Forecast Assumptions
C3 complement inhibitors Report Assessment
Current Treatment Practices
Unmet Needs
Pipeline Product Profiles
Market Attractiveness
Qualitative Analysis (SWOT)
Key Questions:
What was the C3 complement inhibitors total market size, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
Which drug is going to be the largest contributor in 2034?
Which is the most lucrative market for C3 complement inhibitors?
Which drug accounted for maximum C3 complement inhibitors sales?
What are the pricing variations among different geographies for approved therapies?
How has the reimbursement landscape for C3 complement inhibitors evolved since the first one was approved? Do patients have any access issues that are driven by reimbursement decisions?
What are the risks, burdens, and unmet needs of treatment with C3 complement inhibitors? What will be the growth opportunities across the 7MM for the patient population of C3 complement inhibitors?
What are the key factors hampering the growth of the C3 complement inhibitors market?
What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
What key designations have been granted to the therapies for C3 complement inhibitors?
What is the cost burden of approved therapies on the patient?
Patient acceptability in terms of preferred therapy 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 develop business strategies by understanding the latest trends and changing dynamics driving the C5 complement inhibitors Market.
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 indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges 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. Executive Summary of C3 complement inhibitors
4. Key Events
5. Market Forecast Methodology
6. C3 complement inhibitors Market Overview at a Glance in the 7MM
6.1. Market Share (%) Distribution by Indication in 2020
6.2. Market Share (%) Distribution by Indication in 2034
7. C3 complement inhibitors: Background and Overview
7.1. Introduction
7.2. Evolution of C3 complement inhibitors
7.3. Treatment
8. Target Patient Pool
8.1. Key Findings
8.2. Assumptions and Rationale: 7MM
8.3. Epidemiology Scenario in the 7MM
8.3.1. Total Prevalent Cases in Selected Indications for C3 complement inhibitors in the 7MM
8.3.2. Total Eligible Patient Pool for C3 complement inhibitors in Selected Indications in the 7MM
8.3.3. Total Treated Cases in Selected Indications for C3 Inhibitors in the 7MM
8.4. Epidemiology Scenario in the United States
8.4.1. Total Prevalent Cases in Selected Indications for C3 complement inhibitors in the United States
8.4.2. Total Eligible Patient Pool for C3 complement inhibitors in Selected Indications in the United States
8.4.3. Total Treated Cases in Selected Indications for C3 Inhibitors in the United States
8.5. Epidemiology Scenario in EU4 and the UK
8.5.1. Total Prevalent Cases in Selected Indications for C3 complement inhibitors in EU4 and the UK
8.5.2. Total Eligible Patient Pool for C3 complement inhibitors in Selected Indications in EU4 and the UK
8.5.3. Total Treated Cases in Selected Indications for C3 Inhibitors in EU4 and the UK
8.6. Epidemiology Scenario in Japan
8.6.1. Total Prevalent Cases in Selected Indications for C3 complement inhibitors in Japan
8.6.2. Total Eligible Patient Pool for C3 complement inhibitors in Selected Indications in Japan
8.6.3. Total Treated Cases in Selected Indications for C3 Inhibitors in Japan
9. Marketed Therapies
9.1. Key Competitors
9.2. EMPAVELI/SYFOVRE (pegcetacoplan) : Apellis
9.2.1. Product Description
9.2.2. Other developmental activities
9.2.3. Clinical development
9.2.4. Safety and efficacy
10. Emerging Therapies
10.1. Key Competitors
10.2. ARO-C3 : Arrowhead
10.2.1. Product Description
10.2.2. Other developmental activities
10.2.3. Clinical development
10.2.4. Safety and efficacy
11. C3 complement inhibitors: Seven Major Market Analysis
11.1. Key Findings
11.2. Market Outlook
11.3. Key Market Forecast Assumptions
11.4. Total Market Size of C3 complement inhibitors in the 7MM
11.5. Market Size of C3 complement inhibitors by Indication in the7MM
11.6. The United States Market Size
11.6.1. Total Market Size of C3 complement inhibitors in the United States
11.6.2. Market Size of C3 complement inhibitors by Indication in the United States
11.6.3. Market Size of C3 Complement Inhibitors by Therapies in the United States
11.7. EU4 and the UK Market Size
11.7.1. Total Market Size of C3 Complement Inhibitors in EU4 and the UK
11.7.2. Market Size of C3 Complement Inhibitors by Indication in EU4 and the UK
11.7.3. Market Size of C3 Complement Inhibitors by Therapies in EU4 and the UK
11.8. Japan Market Size
11.8.1. Total Market Size of C3 complement inhibitors in Japan
11.8.2. Market Size of C3 complement inhibitors by Indication in Japan
11.8.3. Market Size of C3 complement inhibitors by Therapies in Japan
12. Market Access and Reimbursement
13. SWOT Analysis
14. KOL Views
15. Unmet Needs
16. Appendix
16.1. Bibliography
16.2. Report Methodology
17. DelveInsight Capabilities
18. Disclaimer
19. About DelveInsight
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