Complement 3 Glomerulopathy (C3G) - Market Insights, Epidemiology and Market Forecast– 2030

DelveInsight’s ‘Complement 3 Glomerulopathy (C3G) - Market Insights, Epidemiology and Market Forecast– 2030’ report delivers an in-depth understanding of the Complement 3 Glomerulopathy (C3G), historical and forecasted epidemiology as well as the Complement 3 Glomerulopathy (C3G) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The Complement 3 Glomerulopathy (C3G) market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Complement 3 Glomerulopathy (C3G) market size from 2017 to 2030. The report also covers current Complement 3 Glomerulopathy (C3G) treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Geography Covered
• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2017–2030
Complement 3 Glomerulopathy (C3G) Disease Understanding and Treatment Algorithm
Complement 3 Glomerulopathy (C3G) Overview
The term complement 3 glomerulopathy (C3G) was adopted by expert consensus in 2013 to define a group of rare kidneys diseases driven by dysregulation of the complement cascade. The major features of C3G include high levels of protein in the urine (proteinuria), blood in the urine (hematuria), reduced amounts of urine, low levels of protein in the blood, and swelling in several areas of the body.
C3G is a type of glomerular disease, characterized by predominant C3 complement component (C3) deposits in the glomeruli in the absence of a significant amount of immunoglobulin and without deposition of C1q and C4. The accumulation of C3 without a significant amount of classical or lectin complement component in the glomeruli suggests dysregulation of the alternative complement pathway as the underlying pathogenetic mechanism. This finding, in the absence or near absence of immunoglobulin deposits in a patient with the classic clinical features of glomerulonephritis, is the single diagnostic criterion. The rarity of C3G makes it challenging to derive precise incidence and prevalence of the indication; however, several small cohort studies have generated estimates of limited reliability.
The term C3G includes dense deposit disease (DDD) and C3 glomerulonephritis (C3GN), which are the two patterns of damage and inflammation in the glomeruli. In other words, the damage and inflammation in the kidney tissue in DDD appear different from that in C3GN when observed under a microscope. People with DDD generally present at a younger age (childhood or adolescence) compared to people with C3GN (adulthood).
The classification and nomenclature of this indication have drastically evolved over the years. Therefore, it is crucial to know the history of the naming system for C3G because some patients who were diagnosed with the disease before the new classification proposed in 2013 were introduced to know their disease by a different name. Before 2013, a portion of C3G patients carried the diagnosis of “membranoproliferative glomerulonephritis (MPGN)” or “mesangio proliferative glomerulonephritis.” These same patients are now referred to as C3G patients based on the microscopic appearance of their glomeruli and the new definition of the disease.
Dysregulation of the complement alternative pathway, driven by acquired and/or genetic defects, plays a pathogenetic role in C3G. The most common acquired drivers of C3G are the C3 nephritic factors (C3NeFs), heterogeneous autoantibodies that stabilize the C3 convertase, C3bBb. Although present in many different disease conditions and reported in normal individuals, most DDD patients (80–85%) and many C3GN patients (∼50%) develop these autoantibodies, which prolong convertase half-life and promote fluid-phase AP dysregulation. In both DDD and C3GN, the profile of serological complement biomarkers is consistent with over-activity of the AP and terminal pathway (TP).

Complement 3 Glomerulopathy (C3G) Diagnosis
In most of the cases, diagnosis of C3G requires a renal biopsy and careful review of light microscopy, immunofluorescence and electron microscopy. Broadly, C3G is defined as the predominant staining of C3 on immunofluorescence (IF) when compared to immunoglobulin (intensity >2 orders of magnitude). C3G is classified by electron microscopy findings into DDD or C3GN, depending on the presence or absence of dense osmiophilic intramembranous deposits.
Light microscopy identifies diverse patterns of glomerular injury that include MPGN, and detect additional features such as crescentic disease or markers of chronic disease such as interstitial fibrosis and tubular atrophy.
However, the various diagnostic tests opted for establishing a C3G diagnosis are as follows:
• Urine test: A urine test identifies if the patient presents with protein and blood in the urine.
• Blood test: A blood test identifies if complement proteins are normal and if wastes are building up in the blood.
• Glomerular filtration rate (GFR): A blood test is required to know how well the patients’ kidneys are filtering the wastes from the body.
• Kidney biopsy: In this test, a tiny piece of the kidney is removed with a special needle, and looked at under special microscopes. The kidney biopsy may show lots of breakdown products of C3, without other proteins, in the glomeruli, which usually means C3G.
Complement 3 Glomerulopathy (C3G) Treatment
Optimal treatment for C3G has not been established yet since no treatment has proven effective and beneficial for C3G. Recommendations have only been deducted from case series and observational studies and are mostly based on expert opinion. As a consequence, its treatment has not been standardized and is concentrated in centers of expertise.
All patients diagnosed with C3G should be treated with renoprotective measures, including lifestyle advice, an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker to control hypertension and proteinuria, and lipid-lowering treatment. Such medication alone has not been shown to protect against progression to end-stage renal disease but may improve the protective effect of immunosuppressive medication.
Due to the absence of approved treatment/therapies for C3G as well as therapies that can attack the cause of C3G, treatment regimen focuses on slowing the process of kidney damage from C3G. This treatment regimen may include corticosteroids (often called “steroids”), immunosuppressive drugs, ACE inhibitors and ARBs, diet changes and complement inhibitors.
• Corticosteroids: Corticosteroids are used to inhibit the immune system of the patient from attacking the glomeruli.
• ACE inhibitors and ARBs: These are blood pressure that can reduce protein loss and control blood pressure.
• Immunosuppressant: Such medications inhibit the function of the immune system, which is responsible for the kidney damage in C3G.
• Change in diet: Some diet changes may be needed, such as reducing salt (sodium) and protein in the food choices to lighten a load of wastes on the kidneys.
Complement inhibitors: There is high interest in the possibility that drugs that inhibit the complement system might become an effective treatment for C3G. However, no anti-complement agent has been approved for use in C3G.
Complement 3 Glomerulopathy (C3G) Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Population of Complement 3 Glomerulopathy (C3G), Type-specific Diagnosed Prevalent Population of Complement 3 Glomerulopathy (C3G) and Age-specific Diagnosed Prevalent Population of Complement 3 Glomerulopathy (C3G) in the 7MM market covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2017 to 2030.
Key Findings
This section provides glimpse of the Complement 3 Glomerulopathy (C3G) epidemiology in the 7MM.
• The total diagnosed prevalent population of Complement 3 Glomerulopathy (C3G) in the seven major markets was found to be 8,175 in 2017.
• The diagnosed prevalent cases of Complement 3 Glomerulopathy (C3G), in the United States, were found to be 3,967 in 2017.
• It was found that in the United States, the number of cases of DDD and C3GN was 1,349 and 2,619, respectively, in 2017.
• Age-specific data for C3G suggests that in the United States the highest and the lowest number of cases of DDD were found in the age group of 18–50 with 830 cases and age-group >50 with 243 cases, respectively, in 2017, while the highest and the lowest number of cases of C3GN were found in the age group of 18–50 with 1,705 cases and age-group 50. It has been found that the diagnosed prevalence of both DDD and C3GN has been found maximum in the 18–50 age group.
• Expected Launch of potential therapies, Danicopan (Alexion Pharmaceuticals), Narsoplimab (Omeros Corporation), Pegcetacoplan (Apellis Pharmaceuticals) and LNP023 (Novartis Pharmaceuticals), may increase the market size in the coming years, assisted by an increase in diagnosed prevalent population of Complement 3 Glomerulopathy (C3G).
• The current treatment of Complement 3 Glomerulopathy (C3G) is mainly dominated by the use of off-label therapies, which includes Immunosuppressant, Steroids, Renin–angiotensin–aldosterone system Inhibitors (RAAS) and Other Supportive Therapies (also including Antibody regimens: Eculizumab and Rituximab).
Complement 3 Glomerulopathy (C3G) Report Insights
• Patient Population
• Therapeutic Approaches
• Complement 3 Glomerulopathy (C3G) Pipeline Analysis
• Complement 3 Glomerulopathy (C3G) Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies
Complement 3 Glomerulopathy (C3G) Report Key Strengths
• Eleven Years Forecast
• 7MM Coverage
• Complement 3 Glomerulopathy (C3G) Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake
Complement 3 Glomerulopathy (C3G) Report Assessment
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
Key Questions
Market Insights:
• What was the Complement 3 Glomerulopathy (C3G) market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the Complement 3 Glomerulopathy (C3G) total market size as well as market size by therapies across the 7MM during the forecast period (2020–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Complement 3 Glomerulopathy (C3G) market size during the forecast period (2020–2030)?
• At what CAGR, the Complement 3 Glomerulopathy (C3G) market is expected to grow at the 7MM level during the forecast period (2020–2030)?
• What would be the Complement 3 Glomerulopathy (C3G) market outlook across the 7MM during the forecast period (2020–2030)?
• What would be the Complement 3 Glomerulopathy (C3G) market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights:
• What is the disease risk, burden and unmet needs of Complement 3 Glomerulopathy (C3G)?
• What is the historical Complement 3 Glomerulopathy (C3G) patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
• What would be the forecasted patient pool of Complement 3 Glomerulopathy (C3G) at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Complement 3 Glomerulopathy (C3G)?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Complement 3 Glomerulopathy (C3G) during the forecast period (2020–2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2020–2030)?
Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
• What are the current options for the treatment of Complement 3 Glomerulopathy (C3G) along with the approved therapy?
• What are the current treatment guidelines for the treatment of Complement 3 Glomerulopathy (C3G) in the US and Europe?
• What are the Complement 3 Glomerulopathy (C3G) marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of Complement 3 Glomerulopathy (C3G)?
• How many therapies are developed by each company for the treatment of Complement 3 Glomerulopathy (C3G)?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Complement 3 Glomerulopathy (C3G)?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Complement 3 Glomerulopathy (C3G) therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Complement 3 Glomerulopathy (C3G) and their status?
• What are the key designations that have been granted for the emerging therapies for Complement 3 Glomerulopathy (C3G)?
• What are the 7MM historical and forecasted market of Complement 3 Glomerulopathy (C3G)?
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• To understand the future market competition in the Complement 3 Glomerulopathy (C3G) market.