Dublin, July 21, 2023 (GLOBE NEWSWIRE) -- The "Anti-Neutrophil Cytoplasmic Antibody - Associated Vasculitis - Market Insight, Epidemiology and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.
This report delivers an in-depth understanding of the ANCA Associated Vasculitis, historical and forecasted epidemiology as well as the ANCA Associated Vasculitis market trends in the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, Japan. The market report provides current treatment practices, emerging drugs, market share of the individual therapies, and current and forecasted 7MM ANCA Associated Vasculitis market size from 2019 to 2032. The report also covers current ANCA Associated Vasculitis treatment practice/algorithm and unmet medical needs to curate the best opportunities and assess the market's underlying potential.
Key Highlights
- Anti-neutrophilic cytoplasmic antibody (ANCA) associated vasculitis is a heterogeneous group of rare autoimmune conditions.
- ANCA Associated Vasculitis includes three main diseases, which are granulomatosis with polyangiitis (GPA), eosinophilic granulomatosis with polyangiitis (EGPA), and microscopic polyangiitis (MPA).
- ANCA Associated Vasculitis triggers inflammation of blood vessels with various manifestations.
- Patients suffering from ANCA Associated Vasculitis often have general symptoms initially. As the disease progresses requires multiple specialties like a rheumatologist, pulmonologist, nephrologist, etc., to diagnose the disease, this could be the primary cause of the low diagnosis rate across the 7MM.
- Due to advancements in health care infrastructure and new diagnostic techniques, the tendency toward diagnosis is rising in the US.
- In 2022, the market size of ANCA Associated Vasculitis was highest in the US among the 7MM, accounting for approximately USD 620 million, which is expected to increase by 2032.
- Chemocentryx/Amgen's TAVNEOS (avacopan) approved as an add-on treatment to standard therapy, including glucocorticoids for adult patients with severe active antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis includes GPA and MPA only.
- Treatment for ANCA Associated Vasculitis starts with remission induction, usually done by cyclophosphamide, rituximab, and high-dose steroids. Sometimes with a life-threatening disease or severe kidney involvement, plasma exchange is used along with induction treatment, and the market is currently dominated by rituximab.
- GlaxoSmithKline's NUCALA (mepolizumab) is the first and only FDA-approved treatment for adults with eosinophilic granulomatosis with polyangiitis (EGPA).
- TAVNEOS (avacopan) is progressively entering the ANCA-associated vasculitis market, and the uptake is also fast and expected to cater major market share.
- NUCALA (mepolizumab) is expected to lose patent protection in 2026 in Europe and 2027 in the US.
- Other emerging therapies such as GSK's depemokimab (GSK3511294), AstraZeneca's FASENRA (benralizumab), InflaRx's IFX-1 (vilobelimab) have the potential to create a significant positive shift in the ANCA Associated Vasculitis market size.
Epidemiology
As the market is derived using the patient-based model, the ANCA Associated Vasculitis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, Total Diagnosed Prevalent cases of ANCA-associated vasculitis, Diagnosed Prevalent cases by Type of ANCA-associated vasculitis, Diagnosed Prevalent Cases by Organ Involvement of ANCA associated vasculitis, Diagnosed Prevalent Cases by Antibody Type of ANCA associated vasculitis, Diagnosed Prevalent Cases by Severity of ANCA associated vasculitis, and Total Treated Cases by Type of ANCA associated vasculitis in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, Japan from 2019 to 2032. The total diagnosed prevalent cases of ANCA-associated vasculitis in the 7MM comprised approximately 207,900 cases in 2022 and are projected to increase during the forecasted period.
- The total diagnosed prevalent cases of ANCA-associated vasculitis in the United States were around 70,700 cases in 2022.
- In the 7MM, the United States, EU4, the UK, and Japan accounted for around 34%, 42%, and 24% of the total diagnosed prevalent population share in 2022.
- Among the EU4 countries, Germany accounted for the largest number of ANCA-associated vasculitis cases, followed by the UK, whereas Spain accounted for the lowest number of cases in 2022.
- According to the estimates, Japan had around 23,000, 17,700, and 9,420 diagnosed prevalent cases of MPA, GPA, and EGPA, respectively, in 2022. These cases are projected to increase during the forecasted period.
Drug Chapters
The drug chapter segment of the ANCA-associated vasculitis report encloses a detailed analysis of ANCA-associated vasculitis marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps to understand the ANCA-associated vasculitis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, each drug's advantages and disadvantages, and the latest news and press releases.
Marketed Drugs
- TAVNEOS (avacopan): Chemocentryx/Amgen
Emerging Drugs
- FASENRA (benralizumab): AstraZeneca
Drug Class Insights
Glucocorticoids mainly dominate the existing ANCA Associated Vasculitis treatment, monoclonal antibodies such as rituximab, mepolizumab, and complement C5a receptor antagonists like avacopan and immunotherapies such as cyclophosphamide, azathioprine, methotrexate, etc.
Rituximab was the first monoclonal antibody to be given the go-ahead by US FDA for treating ANCA Associated Vasculitis, especially MPA and GPA. In September 2019, the drug was given pediatric approval for children aged 2 years and older.
NUCALA is the second licensed monoclonal antibody for treating ANCA Associated Vasculitis and is approved for EGPA - recently approved complement C5a receptor antagonists like avacopan for adult patients in GPA and MPA segments.
Moreover, the upcoming treatment landscape is poised to expand further after new classes emerge, such as Interleukin 5 receptor antagonists and other agents in the complement C5a inhibitors and others.
Market Outlook
ANCA Associated Vasculitis treatment in the US is entering a new era with changing dynamics. To this date, few drugs have been approved by the US FDA to treat ANCA Associated Vasculitis: Rituximab, NUCALA, and avacopan. The aforementioned therapies help reduce disease burden and sustainable remission both.
It is worth mentioning that the 2021 American College of Rheumatology/Vasculitis Foundation Guideline for managing antineutrophil cytoplasmic antibody-associated vasculitis presently recommends the treatment recommended for severe GPA/MPA includes remission induction via rituximab, cyclophosphamide along with the reduced dosage of glucocorticoids. For limited (non-severe) GPA/MPA patients, recommended remission induction therapies include glucocorticoids and methotrexate, other immunotherapies. And for the treatment recommended for severe EGPA includes a high dose of oral glucocorticoids or pulse IV and glucocorticoids or rituximab. For limited (non-severe) EGPA patients, recommended therapies include glucocorticoids in combination with mepolizumab, glucocorticoids methotrexate, glucocorticoids and azathioprine, or glucocorticoids and mycophenolate mofetil, and glucocorticoids and rituximab, etc.
The current market has been segmented into different commonly used drugs based on the prevailing treatment pattern across the 7MM, presenting minor variations in the overall prescription pattern. Glucocorticoids (methylprednisolone), Immunotherapies (Cyclophosphamide), TAVNEOS (avacopan), and NUCALA (mepolizumab) are the major drugs that have been covered in the forecast model.
The expected launch of upcoming therapies and greater integration of early patient screening, medication in secondary care and other clinical settings, research on best methods for implementation, and an upsurge in awareness will eventually facilitate the development of effective treatment options. However, there are a few roadblocks regarding the timely diagnosis and treatment of these patients, for instance, entry of generics due to the expiration of the patent protection and increasing healthcare expenses because the current treatment is lifelong. These factors often become a hindrance when adopting newer therapies.
Key players such as new therapies are in development for ANCA Associated Vasculitis, including GlaxoSmithKline (depemokimab), AstraZeneca (benralizumab), and InflaRx (vilobelimab).
- The total market size of ANCA Associated Vasculitis in the 7MM is approximately USD 1,220 million in 2022 and is projected to increase during the forecast period (2023-2032).
- The market size in the 7MM will increase at a CAGR of 6.9% due to increasing awareness of the disease and the launch of the emerging therapy.
- Among EU4 countries, Germany accounts for the maximum market size in 2022, while Spain occupies the bottom of the ladder in 2022.
- By 2032, among all the emerging therapies, the highest revenue is expected to be generated by vilobelimab followed by depemokimab in the 7MM.
Reasons to Buy
- The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the ANCA Associated Vasculitis market.
- Insights on patient burden/disease diagnosis prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
- To understand the existing market opportunity 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 that will help get ahead of competitors.
- Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
- Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
- To understand the perspective of key opinion leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
- Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.
Key Topics Covered
1. Key Insights
2. Report Introduction
3. ANCA Associated Vasculitis Market Overview at a Glance
4. Executive Summary of ANCA Associated Vasculitis
5. Epidemiology and Market Methodology
6. Disease Background and Overview
7. Epidemiology and Patient Population
8. Patient Journey
9. Key Endpoints in ANCA Associated Vasculitis Clinical Trials
10. Marketed Therapies
11. Emerging Therapies
12. Antineutrophil Cytoplasmic Antibody (ANCA)-associated vasculitis (ANCA Associated Vasculitis): The 7MM Analysis
13. Market Access and Reimbursement
14. KOL Views
15. SWOT Analysis
16. Unmet Needs
17. Appendix
A selection of companies mentioned in this report includes:
- GlaxoSmithKline
- AstraZeneca
- InflaRx
For more information about this report visit https://www.researchandmarkets.com/r/xzr211
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