Granulomatosis With Polyangiitis Market
DelveInsight’s ‘Granulomatosis With Polyangiitis (GPA) – Market Insights, Epidemiology, and Market Forecast – 2030’ report delivers an in-depth understanding of the historical and forecasted epidemiology as well as the market trends of GPA in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
The GPA market report provides current treatment practices, emerging drugs, market share of the individual therapies, current and forecasted GPA market Size from 2018 to 2030, segmented by seven major markets. The report also covers the current GPA treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying market potential.
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Study Period: 2018–2030
Granulomatosis With Polyangiitis: Disease Understanding and Treatment Algorithm
Granulomatosis With Polyangiitis Overview
Granulomatosis With Polyangiitis (GPA, formerly known as Wegener’s granulomatosis) is an autoimmune small-vessel vasculitis that is highly associated with anti-neutrophil cytoplasmic antibodies (ANCA). According to the Chapel Hill criteria (2012), GPA is defined as necrotizing granulomatous inflammation usually involving the upper and lower respiratory tract, and necrotizing vasculitis affecting predominantly small-to-medium vessels (e.g., capillaries, venules, arterioles, arteries, and veins).
Klinger initially described the disease in 1931 as a variant of polyarteritis nodosa and was defined for the first time as a separated syndrome by Friedrich Wegener. Godman and Churg (1954) introduced the term ‘Wegener’s granulomatosis’ and further delineated the clinical and pathological features.
Two phenotypes are distinguished in GPA that are localized and systemic with the possible transition during disease. Typically, patients initially suffer from a limited form that may consist of constitutional symptoms and localized manifestations, such as chronic sinusitis, rhinitis, otitis media, ocular conditions, and/or skin lesions. More serious manifestations may arise in later stages, including pulmonary complications and glomerulonephritis, although the skin, eyes, and heart may also be involved. Classically, the acronym ELK is used to describe the clinical involvement of the ear, nose, and throat (ENT), lungs, and kidneys.
The etiology of GPA is linked to environmental and infectious triggers inciting disease onset in genetically predisposed individuals. Anti-neutrophil cytoplasmic antibodies are pathogenic and play an important role in the pathogenesis of this disease. Pathological processes involved include aberrant epigenetic expression of proteinase-3 on the cell membrane of neutrophils and the formation of antibodies against proteinase-3 (PR3-ANCA). The binding of PR3-ANCA to PR3 activates neutrophils, and there is a release of neutrophilic inflammatory mediators, the formation of neutrophil extracellular traps that lead to complement activation and damage to endothelial cells of small blood vessels.
Diagnosis of GPA is achieved through clinical assessment, serological tests for anti-neutrophil cytoplasmic antibodies (ANCA), and histological analysis. Biopsy, imaging, and laboratory tests are involved. Symptoms of microscopic polyangiitis (MPA), eosinophilic Granulomatosis With Polyangiitis (EGPA), Goodpasture syndrome (GPS), polyarteritis nodosa (PAN), lymphomatous granulomatosis (LyG), and systemic rheumatological disorders can be similar to those of GPA for which differential diagnosis is useful.
The treatment of GPA involves Induction therapy as the first phase, which aims to quickly put the disease into remission and lasts about 3–6 months according to the clinical response, and maintenance therapy as the second phase that lasts 12–24 months to consolidate the remission and limit the risk of relapse. The standard therapy for GPA is a combination of glucocorticoids and cyclophosphamide/ rituximab. Adjuvant therapy and plasma exchange are also involved.
The early diagnosis and specific treatment of GPA are important but difficult to achieve because of the multiplicity of presenting symptoms and unclear histological features. Talking about the pathogenesis of GPA, it has undergone many advances and progressed over the years. Hopefully, this will be translated into the development of new and better therapies for patients.
Granulomatosis With Polyangiitis Diagnosis and Treatment
It covers the details of conventional and current medical therapies and diagnosis available in the Granulomatosis With Polyangiitis market to treat the condition. It also provides country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.
The DelveInsight Granulomatosis With Polyangiitis market report gives a thorough understanding of Granulomatosis With Polyangiitis by including disease definition, symptoms, causes, pathophysiology, and diagnosis. It also provides the treatment algorithms and treatment guidelines for Granulomatosis With Polyangiitis in the US, Europe, and Japan.
Granulomatosis With Polyangiitis Epidemiology
The Granulomatosis With Polyangiitis epidemiology division provides insights about the historical and current patient pool along with the forecasted trend for every seven major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
The disease epidemiology covered in the report provides historical and forecasted Granulomatosis With Polyangiitis epidemiology segmented as the Incident cases of Granulomatosis With Polyangiitis, Gender-specific Cases of Granulomatosis With Polyangiitis and Age-specific Cases of Granulomatosis With Polyangiitis. The report includes the incident scenario of Granulomatosis With Polyangiitis symptoms in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2018 to 2030.
Country-wise Granulomatosis With Polyangiitis Epidemiology
The epidemiology segment also provides the Granulomatosis With Polyangiitis epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
The incident population of Granulomatosis With Polyangiitis in the 7MM countries was estimated to be 7,618 cases in 2020.
Granulomatosis With Polyangiitis Drug Chapters
The drug chapter segment of the Granulomatosis With Polyangiitis report encloses the detailed analysis of Granulomatosis With Polyangiitis marketed drugs and late stage (Phase-III, Phase-II/III, Phase-II, and Phase-I/II) pipeline drugs. It also helps understand the Granulomatosis With Polyangiitis 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.
At present, Rituximab (RTX) is the only drug approved in the United States, Europe and Japan for the treatment of GPA. It is an alternative for cyclophosphamide to induce remission and maybe the first choice for relapsing patients and those refractory to cyclophosphamide. Currently, three RTX biosimilar are approved, i.e., Ruxience (by Pfizer), Riabni (by Amgen), and Truxima (by Teva). RTX has demonstrated efficacy in maintaining remission and preventing future relapses in several retrospective studies. However, it is also associated with major side effects such as a significant risk of hypogammaglobulinemia, infection, lymphopenia, and neutropenia. However, after achieving remission, GPA can recur in significant number of cases. Newer therapies, either alone or in combination, are needed to both improve efficacy, particularly to maintain long term remission and permit reductions in glucocorticoid and immunosuppressive exposure.
Products detail in the report…
Granulomatosis With Polyangiitis emerging drugs
Avacopan (ChemoCentryx) is a first-in-class, orally-administered small molecule that employs a novel, highly targeted mode of action in treating ANCA-associated vasculitis and other complement-driven autoimmune and inflammatory diseases. By precisely blocking the receptor (the C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, Avacopan arrests the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA-associated vasculitis. Avacopan’s selective inhibition of only the C5aR leaves the beneficial C5a pathway through the C5L2 receptor functioning normally. ChemoCentryx is also developing Avacopan to treat patients with C3 glomerulopathy (C3G) and hidradenitis suppurativa (HS). The US Food and Drug Administration (FDA) granted Avacopan orphan-drug designation for ANCA-associated vasculitis and C3G. The European Commission has granted orphan medicinal product designation for Avacopan for the treatment of two forms of ANCA-associated Vasculitis: microscopic polyangiitis (MPA) and GPA (formerly known as Wegener's granulomatosis), as well as for C3G. ChemoCentryx has granted VFMCRP a license for the agent in all countries outside the United States. VFMCRP has granted Kissei a sub-license for the agent in Japan. The company recently submitted a New Drug Application (NDA) to FDA and Marketing Authorization Application (MAA) to the European Medicines Agency. The EMA will review the application under the centralized marketing authorization procedure. If approved, avacopan would receive marketing authorization in all member states of the European Union (EU), as well as in Iceland, Liechtenstein, and Norway. As per the company, drug approval is expected by 2021. Besides, Kissei Pharmaceutical also filed NDA to approve manufacturing and marketing in Japan as a treatment for MPA and GPA.
Vilobelimab (InflaRx GmbH) is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity toward its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. The drug has demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response in pre-clinical studies. Vilobelimab is currently being developed for various indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum, cancer and severe COVID-19. For ANCA-associated vasculitis, the drug is currently in Phase II studies. The main objective of this randomized, double-blind, placebo-controlled study is to evaluate the safety of vilobelimab, as this is the first time the drug is being administered to patients with AAV in the US. Topline results are expected by mid-2021.
Products detail in the report…
Granulomatosis With Polyangiitis Market Outlook
The Granulomatosis With Polyangiitis market outlook of the report builds a detailed comprehension of the historical, current, and forecasted GPA market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers, and demand for better technology.
This segment gives a thorough detail of Granulomatosis With Polyangiitis market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need for the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
According to DelveInsight, the Granulomatosis With Polyangiitis market in the 7MM is expected to change in the study period 2018–2030.
GPA is a chronic relapsing disorder with >50% rate of relapse within 5 years of initial remission. Despite considerable therapeutic progress over the last decades, GPA relapses remain frequent, and maintenance treatment is now the main therapeutic challenge. None of the treatments used is specific to the fundamental auto-immune activation of neutrophils by PR3-ANCA. The most recently used treatment is the application of rituximab, a chimeric monoclonal anti-CD20 antibody that depletes circulating B lymphocytes without specifically targeting those producing ANCA. This depletion is not immediate, with a decrease in ANCA of just 50% after 1 month, and includes several side effects such as the significant risk of hypogammaglobulinemia, infection, lymphopenia, and neutropenia. Therefore, it seems necessary to look for more specific treatments for GPA, which specifically block auto-immune activation of neutrophils by PR3-ANCA. Blocking this interaction could directly neutralize the effector cells more targeted and potentially suppress the inflammatory cascade faster. Herein, the most important aspects of Granulomatosis With Polyangiitis pathophysiology will be reviewed, in addition to evidence for the various treatments.
This section includes a glimpse of the Granulomatosis With Polyangiitis market in the 7MM. The market size of Granulomatosis With Polyangiitis in the seven major markets was found to be USD 58.5 million in 2020.
The United States: Market Outlook
This section provides Granulomatosis With Polyangiitis market size and market size by therapies of Granulomatosis With Polyangiitis in the United States.
The United States accounts for the largest market size of Granulomatosis With Polyangiitis in comparison to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
Treatment is based on a first phase, known as the induction phase, which quickly puts the disease into remission and lasts about 3–6 months according to the clinical response. A second phase, known as the maintenance phase, must then consolidate the remission and limit the relapse risk; it lasts 12–24 months.
The standard therapy for GPA is a combination of glucocorticoids and cyclophosphamide/Rituximab. Rituximab (RTX) is the only drug approved in the United States, Europe and Japan for the treatment of GPA. It is an alternative for cyclophosphamide to induce remission and maybe the first choice for relapsing patients and those refractory to cyclophosphamide. Adjuvant therapy and plasma exchange are also involved.
EU-5 Countries: Market Outlook
The total Granulomatosis With Polyangiitis market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are also mentioned.
Japan Market Outlook
The total Granulomatosis With Polyangiitis market size and market size by therapies of Granulomatosis With Polyangiitis in Japan are also mentioned.
Granulomatosis With Polyangiitis Drugs Uptake
This section focuses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2018–2030. The analysis covers Granulomatosis With Polyangiitis 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 based on market share and size, which again will be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.
Granulomatosis With Polyangiitis Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, and Phase I/II stage. It also analyses Granulomatosis With Polyangiitis key players involved in developing targeted therapeutics.
Major players include Avacopan (ChemoCentryx), Vilobelimab (InflaRx GmbH), Belimumab (GlaxoSmithKline), and Abatacept (Bristol-Myers Squibb), whose key products are expected to get launched in the US market by 20XX.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Granulomatosis With Polyangiitis emerging therapies.
To keep up with current market trends, we take KOLs and SME’s opinion working in the Granulomatosis With Polyangiitis domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps understand and validate current and emerging therapies treatment patterns or Granulomatosis With Polyangiitis market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
We perform Competitive and Market Intelligence analysis of the Granulomatosis With Polyangiitis market by using various Competitive Intelligence tools: 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 GPA, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies
- Comprehensive insight has been provided into the Granulomatosis With Polyangiitis epidemiology and treatment in the 7MM
- Additionally, an all-inclusive account of both the current and emerging therapies for Granulomatosis With Polyangiitis is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
- A detailed review of the Granulomatosis With Polyangiitis market; historical and forecasted, is included in the report, covering drug outreach in the 7MM
- The report provides an edge while developing business strategies by understanding trends shaping and driving the global Granulomatosis With Polyangiitis market
- In the coming years, the Granulomatosis With Polyangiitis 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 Granulomatosis With Polyangiitis R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
- Major players are involved in developing therapies for GPA. The launch of emerging therapies will significantly impact the GPA market
- A better understanding of disease pathogenesis will also contribute to developing novel therapeutics for GPA.
- Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competitor, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities
Granulomatosis With Polyangiitis Report Insights
- Patient Population
- Therapeutic Approaches
- Granulomatosis With Polyangiitis Pipeline Analysis
- Granulomatosis With Polyangiitis Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
Granulomatosis With Polyangiitis Report Key Strengths
- 10-years Forecast
- 7MM Coverage
- Granulomatosis With Polyangiitis Epidemiology Segmentation
- Key Competitors
- Highly Analyzed Market
- Drugs Uptake
Granulomatosis With Polyangiitis Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Market Drivers and Barriers
- What was the Granulomatosis With Polyangiitis Market share (%) distribution in 2018, and how would it look like in 2030?
- What would be the Granulomatosis With Polyangiitis total market Size and market Size by therapies across the 7MM during the forecast period (2018–2030)?
- What are the key findings pertaining to the market across 7MM, and which country will have the largest Granulomatosis With Polyangiitis market Size during the forecast period (2018–2030)?
- At what CAGR, the Granulomatosis With Polyangiitis market is expected to grow in the 7MM during the forecast period (2018–2030)?
- What would be the Granulomatosis With Polyangiitis market outlook across the 7MM during the forecast period (2018–2030)?
- What would be the Granulomatosis With Polyangiitis 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?
- What are the disease risk, burden, and unmet needs of Granulomatosis With Polyangiitis?
- What is the historical Granulomatosis With Polyangiitis patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- What would be the forecasted patient pool of Granulomatosis With Polyangiitis in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- What will be the growth opportunities in the 7MM with respect to the patient population pertaining to Granulomatosis With Polyangiitis?
- Out of all 7MM countries, which country would have the highest incidence of Granulomatosis With Polyangiitis during the forecast period (2018–2030)?
- At what CAGR the population is expected to grow in the 7MM during the forecast period (2018–2030)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
- What are the current options for the treatment of Granulomatosis With Polyangiitis?
- What are the current treatment guidelines for treating Granulomatosis With Polyangiitis in the USA, Europe, and Japan?
- What are the Granulomatosis With Polyangiitis 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 Granulomatosis With Polyangiitis?
- How many therapies are developed by each company for the treatment of Granulomatosis With Polyangiitis?
- How many emerging therapies are in the mid-stage and late stages of development for the treatment of Granulomatosis With Polyangiitis?
- What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Granulomatosis With Polyangiitis 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 Granulomatosis With Polyangiitis and their status?
- What are the key designations that have been granted for the emerging therapies for Granulomatosis With Polyangiitis?
- What are the global historical and forecasted market for Granulomatosis With Polyangiitis?
Reasons to buy
- The report will help in developing business strategies by understanding trends shaping and driving the Granulomatosis With Polyangiitis market
- To understand the future market competition in the Granulomatosis With Polyangiitis market and Insightful review of the key market drivers and barriers.
- Organize sales and marketing efforts by identifying the best opportunities for Granulomatosis With Polyangiitis 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 the Granulomatosis With Polyangiitis market.
- To understand the future market competition in the Granulomatosis With Polyangiitis market.