Microscopic Polyangiitis- Market Insight, Epidemiology and Market Forecast -2030

DelveInsight’s ‘Microscopic Polyangiitis (MPA)-Market Insights, Epidemiology, and Market Forecast–2030’ report deliver an in-depth understanding of the MPA, historical and forecasted epidemiology as well as the MPA market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The MPA market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM MPA market size from 2018 to 2030. The report also covers current MPA treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, and market access, 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: 2018–2030

Microscopic Polyangiitis (MPA) Disease Understanding and Treatment Algorithm

Microscopic Polyangiitis (MPA) Overview

Antineutrophil cytoplasmic autoantibody (ANCA) vasculitis is an autoimmune disease that causes swelling of the blood vessels. Several types of ANCA vasculitis exist due to numerous causes, so patients diagnosed with ANCA vasculitis may display varied symptoms. The ANCA-associated vasculitides (AAV) are three separate conditions, i.e., granulomatosis with polyangiitis (GPA; formerly known as Wegener’s granulomatosis), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA; previously known as Churg–Strauss syndrome [CSS]).

Microscopic polyangiitis (MPA) is a rare autoimmune condition that causes blood vessel inflammation (vasculitis), restricting blood flow and lead to organ damage. The kidneys, lungs, nerves, skin, and joints are the most commonly affected areas of the body. The cause of MPA is unknown, and it is not a contagious condition that does not usually show genetic predisposition and is not a form of cancer. The immune system is thought to play a critical role in the development of MPA. It is believed that the immune system becomes overactive, but it still is not known that what causes this condition. MPA symptoms depend on which blood vessels are involved and what organs in the body are affected. The most common symptoms of MPA include kidney inflammation, weight loss, skin lesions, nerve damage, and fevers.

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Microscopic Polyangiitis (MPA) Diagnosis

MPA can be hard to diagnose, and the symptoms are similar to many other conditions. But, it is vital to receive diagnosis and treatment quickly to prevent permanent organ damage. The variable clinical manifestation of MPA makes the diagnosis difficult. The diagnosis of MPA is based on a combination of clinical, histopathological, and immunological criteria.

MPA diagnosis involves tests including complete blood count, erythrocyte sedimentation rate (ESR), C-reactive protein, urinalysis, serum creatinine, and tests for antineutrophil cytoplasmic antibodies (ANCA). ESR, C-reactive protein levels, and white blood cell and platelet counts are elevated, reflecting systemic inflammation.

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Microscopic Polyangiitis (MPA) Treatment

Treatment of MPA is based on several factors, including disease severity and organ involvement. MPA management can be divided into four phases: identification, induction therapy, maintenance therapy, and long-term management. It is vital to know that remission does not imply the complete absence of symptoms; rather, it is used to convey the absence of symptoms attributable to active vasculitis.

The high levels of adverse effects with current therapies and their failure to induce full remission in all patients or prevent flare have driven a search for newer therapies. These have been immune-suppressive, pooled intravenous immunoglobulin or ‘biological’ agents, including therapeutic antibodies like Mycophenolate mofetil (MMF), Azathioprine, Methotrexate, Leflunomide, Rituximab, Etanercept.

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Microscopic Polyangiitis (MPA) Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of MPA, Gender-Specific Incident Cases of MPA, and Age-Specific Incident Cases of MPA scenario in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2018 to 2030.

Key Findings
• In 2020, the total incident cases of MPA were found out to be 5,196 in the 7MM. As per the estimates by DelveInsight, these cases are expected to decrease at a CAGR of -0.02%, for the study period of 2018–2030. As the major contributor to the incident population are Japan (population growth rate, -0.4%) and Germany (population growth rate, -0.3%) where the population is declining, hence there is a decrease in the incident cases of MPA also.
• As per estimates, Japan had the highest incident cases of MPA (2,280), and among the EU5, Germany had the highest incident cases (1,041), followed by the UK (387), in 2020.
• In 2020, 660 incident cases were observed in the males, whereas 325 incident cases were observed in females in the US.

Microscopic Polyangiitis (MPA)Epidemiology

The epidemiology segment also provides the MPA epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Microscopic Polyangiitis (MPA) Drug Chapters

Microscopic Polyangiitis (MPA) Emerging Drugs

Vilobelimab (IFX-1, CaCP290): InflaRx GmbH

Vilobelimab is an intravenous, 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, the drug 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.

It is currently being developed for various indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis (AAV), Pyoderma Gangraenosum, cancer, and severe COVID 19.

InflaRx recently reported the completion of enrollment in the European Phase II IXCHANGE study of the drug in AAV. Topline data from the randomized, double-blind, placebo-controlled trial with 57 patients are expected by the end of 2021. The drug is also being studied in the US in Phase II IXPLORE study for patients with AAV, and topline results are expected by mid-2021.

Products detail in the report…

Vynpenta (Avacopan, CCX168): ChemoCentryx/Kissei Pharmaceutical/Vifor Pharma

Vynpenta (Avacopan, CCX168) is a potential first-in-class, orally administered complement C5a receptor (C5aR) inhibitor that employs a novel, highly targeted mode of action in the treatment of ANCA vasculitis and other complement-driven autoimmune and inflammatory diseases. The drug precisely blocks a specific receptor (C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils.

Its New Drug Application (NDA) has been accepted for review by the US FDA for AAV with Prescription Drug User Fee Act (PDUFA) goal date in July 2021, and the Marketing Authorization Application (MAA) has been validated by the European Medicines Agency (EMA). Kissei Pharmaceutical also filed NDA for avacopan (CCX168) in Japan.

Products detail in the report…

List to be continued in the report…

Microscopic Polyangiitis (MPA) Market Outlook

MPA is a serious but treatable disease. Treatment is based on several factors, including disease severity and organ involvement. The aim of treatment has been defined in two parts: induction and subsequently maintenance of disease remission. It is important to know that remission does not imply the complete absence of symptoms; rather, it is used to convey the absence of symptoms attributable to active vasculitis. The commonly used immunosuppressive agents in MPA management include cyclophosphamide, rituximab, methotrexate, glucocorticoids, azathioprine, and a few other biological agents. The cornerstone of MPA treatment is corticosteroids, such as prednisone, used in combination with other medications that suppress the immune system and reduce inflammation.

Induction of remission for individuals with the non-severe disease is generally achieved using a combination of glucocorticoids and methotrexate or rituximab alone. For individuals with severe disease, induction using cyclophosphamide with glucocorticoids may be needed. The rituximab versus cyclophosphamide for induction of remission in the AAV trial (RAVE trial) established that comparable results could be achieved using rituximab, especially in individuals experiencing side effects of cyclophosphamide therapy. Typically remission is achieved in most individuals over 2–6 months.

PMDA approved azathioprine and methylprednisolone sodium succinate (Solu-Medrol) for systemic vasculitis (e.g., MPA, Wegener granulomatosis (WG), polyarteritis nodosa, Churg–Strauss syndrome, aortitis syndrome) in May 2011 and August 2014, respectively.

Rituximab (RTX) may represent an important alternative to cyclophosphamide for patients with higher disease activity levels that may not respond adequately to antimetabolite therapies.

Rituxan (rituximab) is a CD20-directed cytolytic antibody indicated for the treatment of GPA and MPA in adult and pediatric patients 2 years of age and older in combination with glucocorticoid indication. The US FDA, EMA, and PMDA have approved Rituxan/MabThera (rituximab) in adults and pediatric patients (US and EU), combined with corticosteroids, as a new medicine for adults with GPA and MPA.

The approvals of biosimilars of rituximab offer the potential for more treatment options and less expensive alternatives, which may pose a threat to novel drug makers. However, some of the critical issues affecting biosimilar uptake involve reimbursement factors and insurance coverage.

Some emerging therapies, such as vilobelimab (IFX-1, CaCP290), Vynpenta (Avacopan, CCX168), etc., are under investigation and might get approved in the forecast period (2021–2030). As per the companies (ChemoCentryx/Kissei Pharmaceutical) developing Vynpenta, it is expected to get approval in 2021.

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Key Findings
• The market size of Microscopic Polyangiitis (MPA) in the 7MM was estimated to be USD 31 million in 2020.
• According to the estimates, in 2020, the highest market size of Microscopic Polyangiitis (MPA) was found in Japan (USD 11 million), followed by the US (USD 10 million).
• The market size of rituximab and steroids in seven major markets was USD 16.1 million and USD 13.4 million in 2020, respectively.

“The current market of MPA is solely dependent on one approved therapy, i.e., rituximab, and several off-labeled therapies. In the off-labeled category, a class like corticosteroids, and immunosuppressive medications are used. People with MPA who have critical organ system involvement are generally treated with corticosteroids combined with another immunosuppressive medication such as cyclophosphamide (Cytoxan) or rituximab (Rituxan). In patients who have less severe MPA, corticosteroids and methotrexate can be used first. The pipeline of MPA is not very robust, and it is estimated that in the forecasted period (2021–2030), two therapies, i.e., avacopan and vilobelimab might get launched.”

The United States Market Outlook

This section provides the total MPA market size and market size by therapies in the United States.

EU-5 Market Outlook

The total MPA 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 MPA market size and market size by therapies in Japan are provided.

Microscopic Polyangiitis (MPA) Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the MPA market or expected to get launched in the market during the study period 2018–2030. The analysis covers the MPA 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 allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Microscopic Polyangiitis (MPA) 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 MPA emerging therapies.

Reimbursement Scenario in Microscopic Polyangiitis (MPA)

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

We perform competitive and market Intelligence analysis of the MPA 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 MPA, explaining its causes, symptoms, pathogenesis, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the MPA epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for MPA is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the MPA 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 MPA market.

Report Highlights
• The robust pipeline with novel MOA and oral ROA, increasing incidence, effectiveness of drugs as both mono and combination therapy will positively drive the MPA market.
• The companies and academics are working to assess challenges and seek opportunities that could influence MPA 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 MPA. The approval of emerging therapies will significantly impact the MPA market.
• 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-competition, 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.

Microscopic Polyangiitis (MPA) Report Insights
• Patient Population
• Therapeutic Approaches
• MPA Pipeline Analysis
• MPA Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Microscopic Polyangiitis (MPA) Report Key Strengths
• 10 Years Forecast
• 7MM Coverage
• MPA Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Microscopic Polyangiitis (MPA) Report Assessment
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions

Market Insights:
• What was the MPA market share (%) distribution in 2018 and how it would look like in 2030?
• What would be the MPA total market size as well as market size by therapies across the 7MM during the forecast period (2021–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest MPA market size during the forecast period (2021–2030)?
• At what CAGR, the MPA market is expected to grow at the 7MM level during the forecast period (2021–2030)?
• What would be the MPA market outlook across the 7MM during the forecast period (2021–2030)?
• What would be the MPA 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 are the disease risk, burdens, and unmet needs of MPA?
• What is the historical MPA patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient pool of MPA at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to MPA?
• Out of the above-mentioned countries, which country would have the highest incident population of MPA during the forecast period (2021–2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2021–2030)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
• What are the current options for the treatment of MPA along with the approved therapy?
• What are the current treatment guidelines for the treatment of MPA in the US and Europe?
• What are the MPA 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 MPA?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of MPA?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the MPA 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 MPA and their status?
• What are the key designations that have been granted for the emerging therapies for MPA?
• What are the 7MM historical and forecasted market of MPA?

Reasons to buy
• The report will help in developing business strategies by understanding trends shaping and driving MPA.
• To understand the future market competition in the MPA market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for MPA 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 MPA market.
• To understand the future market competition in the MPA market.