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 <18 with 440 cases, respectively, in 2017.
• In the EU5 countries, the diagnosed prevalence of Complement 3 Glomerulopathy (C3G) was found to be maximum in Germany with 820 cases, followed by France with 685 cases in 2017. While, the least number of cases were found in Spain, with 496 cases in 2017.
• In Japan, the diagnosed prevalence of Complement 3 Glomerulopathy (C3G) was found to be 912 in 2017.

Country Wise- Complement 3 Glomerulopathy (C3G) Epidemiology
The epidemiology segment also provides the Complement 3 Glomerulopathy (C3G) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
Complement 3 Glomerulopathy (C3G) Drug Chapters
The drug chapter segment of the Complement 3 Glomerulopathy (C3G) report encloses the detailed analysis of Complement 3 Glomerulopathy (C3G) marketed drugs and mid and late stage pipeline drugs. It also helps to understand the Complement 3 Glomerulopathy (C3G) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.
Complement 3 Glomerulopathy (C3G) Emerging Drugs
Danicopan (ACH-4471/ALXN2040): Alexion Pharmaceuticals
Danicopan (ACH-4471/ ALXN2040) is an investigational, oral, factor D inhibitor, which is designed to treat rare diseases associated with the complement alternative pathway. The drug acts by selectively inhibiting the binding of complement factor C3b from complementing factor D, triggering downstream activation of the AP-mediated terminal pathway. The company expects to publish the interim data of its phase II clinical developmental trial for the treatment of C3G in the second quarter of 2020. The company is also expecting to complete danicopan phase II C3G studies and target global regulatory discussions in 2020 itself. Currently, the phase II C3G trial is being held in the United States and the United Kingdom.
Product details in the report…
Narsoplimab (OMS721): Omeros Corporation
Narsoplimab is a human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. The lectin pathway is one of the principal pathways of complement and is activated primarily by tissue damage and microbial infection. Importantly, inhibition of MASP-2 does not appear to interfere with the classical complement pathway, a critical component of the acquired immune response to infection. This novel, proprietary drug is designed to prevent complement-mediated inflammation and endothelial damage while leaving intact the respective functions of the other pathways of innate immunity. The drug is currently being assessed in a phase II trial for C3G. In addition to potential intravenous administration, Omeros plans to commercialize OMS721 for one or more therapeutic indications as a subcutaneous injection and is also developing small-molecule inhibitors of MASP-2. Based on requests from treating physicians, the company has established a compassionate-use program for OMS721, which is active in both the US and Europe.
Product details in the report…
Pegcetacoplan (APL-2): Apellis Pharmaceuticals
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. The company believes that this approach can regulate uncontrolled or excessive complement activation that occurs in several debilitating diseases, including those within hematology, ophthalmology, and nephrology. As per the company’s research, the drug has the potential to be a best-in-class and first-in-class treatment that may address the limitations of existing treatment options or provide a treatment option where today there is none. The company plans to disclose the strategy and timing for further clinical development of pegcetacoplan for patients with cold agglutinin disease (CAD) and C3G in the second quarter of 2020. Currently, the drug is being evaluated in phase II clinical developmental trial for patients with C3G.
Product details in the report…
LNP023 (TBD): Novartis Pharmaceuticals
Novartis Pharmaceuticals is developing LNP023, 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). This limits the cleavage of C3 to the active fragment C3b and may prevent C3b-mediated extravascular hemolysis in certain complement-driven disorders such as C3G, paroxysmal nocturnal hemoglobinuria (PNH), etc. Currently, the drug is in phase II stage of clinical development for C3G. In addition, Novartis is planning to file the drug in 2023 so that it can enter the market in near future, thereby meeting the demands of the patients.
Product details in the report…
Complement 3 Glomerulopathy (C3G) Market Outlook
According to the National Kidney Foundation (NKF), C3G stands for complement 3 glomerulopathy. The “C3” refers to a blood protein that plays a key role in normal immunity and in the development of this disease whereas the “G” is for glomerulopathy, meaning damage to the glomeruli in the kidney. In addition, C3G includes dense deposit disease (DDD) and C3 glomerulonephritis (C3GN), which represent the two different patterns of damage and inflammation in the glomeruli. In other words, the damage and inflammation in the kidney tissue in DDD look different from that in C3GN when seen under a microscope.
Since there are no approved therapies for C3G, the market is mainly dominated by the use of off-label prescription drugs. Treatments for C3G include Immunosuppressant, Steroids, Renin–angiotensin–aldosterone system Inhibitors (RAAS), and other Supportive therapies (also including Antibody regimens: Eculizumab and Rituximab).
However, the current emerging market of C3G possesses an intermediate pipeline. There are no emerging therapies in their phase III developmental stage; however, a few potential emerging players are investigating their product candidates in phase II clinical developmental stage, namely, Alexion Pharmaceuticals (Danicopan), Omeros Corporation (Narsoplimab), Apellis Pharmaceuticals (Pegcetacoplan), and Novartis Pharmaceuticals (LNP023 (TBD)). Other actively developing early stage players are Amyndas Pharma and Visterra Inc.
Key Findings
This section includes a glimpse of the Complement 3 Glomerulopathy (C3G) 7MM market.
• The market size of Complement 3 Glomerulopathy (C3G) in the seven major markets is estimated to be USD 40.6 Million in 2017.
• The United States accounts for the largest market size of C3G, in comparison to EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
• Among the EU5 countries, Germany had the highest market size with USD 3.6 Million in 2017, while Spain had the lowest market size of Complement 3 Glomerulopathy (C3G) with USD 2.2 Million in 2017.
• The Japan C3G market accounted for USD 3.0 Million in 2017, which is expected to increase during the forecast period of 2020–2030.
The United States Market Outlook
This section provides the total Complement 3 Glomerulopathy (C3G) market size and market size by therapies in the United States.
EU-5 Market Outlook
The total Complement 3 Glomerulopathy (C3G) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
Japan Market Outlook
The total Complement 3 Glomerulopathy (C3G) market size and market size by therapies in Japan are provided.
Complement 3 Glomerulopathy (C3G) Drugs Uptake
This section focusses on the rate of uptake of the potential drugs recently launched in the Complement 3 Glomerulopathy (C3G) market or expected to get launched in the market during the study period 2017–2030. The analysis covers Complement 3 Glomerulopathy (C3G) market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Complement 3 Glomerulopathy (C3G) Development Activities
The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for Complement 3 Glomerulopathy (C3G) emerging therapies.
Competitive Intelligence Analysis
We perform competitive and market Intelligence analysis of the Complement 3 Glomerulopathy (C3G) market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
• The report covers the descriptive overview of Complement 3 Glomerulopathy (C3G), explaining its causes, signs and symptoms, pathogenesis and currently available therapies.
• Comprehensive insight has been provided into the Complement 3 Glomerulopathy (C3G) epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Complement 3 Glomerulopathy (C3G) are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of Complement 3 Glomerulopathy (C3G) market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Complement 3 Glomerulopathy (C3G) market.
Report Highlights
• In the coming years, Complement 3 Glomerulopathy (C3G) market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Complement 3 Glomerulopathy (C3G) R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• As per DelveInsight’s analysis, Complement 3 Glomerulopathy (C3G) can be divided into two types, namely, Dense Deposit Disease (DDD) and C3 glomerulonephritis (C3GN).
• The report also encompasses another major segment, i.e., Age-specific Diagnosed Prevalent Population of Complement 3 Glomerulopathy (C3G), wherein various age groups have been considered, such as <18, 18–50 and >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)?
Reasons to buy
• The report will help in developing business strategies by understanding trends shaping and driving the Complement 3 Glomerulopathy (C3G).
• To understand the future market competition in the asprgillosis market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Complement 3 Glomerulopathy (C3G) in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for Complement 3 Glomerulopathy (C3G) market.
• To understand the future market competition in the Complement 3 Glomerulopathy (C3G) market.