Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - Market Insight, Epidemiology And Market Forecast - 2032

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - Market Insight, Epidemiology And Market Forecast - 2032

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.

DelveInsight’s “ANCA Associated Vasculitis – Market Insights, Epidemiology and Market Forecast – 2032” 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.

ANCA Associated Vasculitis 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.

Geography Covered

The United States

EU4 (Germany, France, Italy, and Spain)

Japan

Study Period: 2019–2032

ANCA Associated Vasculitis Disease Understanding and Treatment Algorithm

ANCA Associated Vasculitis Overview

ANCA Associated Vasculitis is a rare, potentially life-threatening, and heterogeneous group of rare autoimmune conditions that causes an inflammation of blood vessels with various manifestations, which attacks and injures the kidney, lungs, etc. It includes three main diseases, which are granulomatosis with polyangiitis (GPA), eosinophilic granulomatosis with polyangiitis (EGPA), and microscopic polyangiitis (MPA). ANCA vasculitis may present with constitutional symptoms and symptoms associated with specific organ involvement. The clinical spectrum of ANCA Associated Vasculitis is broad, and hence the presentation can be quite varied, ranging from a skin rash to fulminant multisystem disease.

The exact cause of ANCA Associated Vasculitis is unknown but is probably multifactorial. Several genetic and environmental risk factors have been identified. Triggers for developing ANCA Associated Vasculitis include microbial infections, reactions to certain medications, genetic variations, or exposure to toxins. ANCA Associated Vasculitis often has the presence of circulating autoantibodies (ANCA) that are usually directed against myeloperoxidase (MPO) or proteinase 3 (PR3) antigens.

ANCA Associated Vasculitis Diagnosis

The diagnosis of ANCA Associated Vasculitis is clinical and supported by serological and histological data. The key to diagnosis is prompt recognition of an inflammatory disease pattern when multiple symptoms emerge, especially if more than one organ system is implicated or combined with chronic systemic symptoms. The diagnosis of ANCA Associated Vasculitis is based on ANCA antibody testing detects and measures the amount of these autoantibodies in the blood. Two of the most common ANCAs are the autoantibodies that target the proteins MPO and PR3. These are called pANCAs and cANCAs, respectively. A positive C-ANCA immunofluorescence test or a strongly positive PR3-ANCA or MPO-ANCA ELISA result is highly suspicious for diagnosing ANCA-associated vasculitis.

Blood tests are done to look for abnormal blood counts and an increase in eosinophils, and special antibody testing is called ANCA. Blood tests that detect inflammation include the erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) tests. In patients with EGPA, the complete blood cell count (CBC) with differential typically demonstrates eosinophilia, usually with at least 10% eosinophils (or 5000–9000 eosinophils/µL), and anemia.

In the case of EGPA, commonly found radiographic patterns are lobar or segmental opacity, diffuse interstitial or miliary patterns, migratory infiltrates of the lower lobe or subpleural, hilar, or mediastinal lymphadenopathy, pleural effusion, pulmonary hemorrhage, ground glass opacity, and hyperinflation. Sinonasal CT Scan is the imaging test of choice due to the optimal viewing and discrimination of pneumatic bone, solid bone, and soft tissue offered.

Other tests include EGPA, which can be done to check for specific organ-system involvement: Electrocardiogram (ECG) for cardiac manifestations, gastrointestinal endoscopy for GI bleeding, EMG, and nerve conduction for peripheral neuropathies. If local organ involvement exists, obtaining a biopsy of that organ is most helpful in confirming the diagnosis. Biopsies of the following may be considered: Skin, Lung – Open or video-assisted thoracoscopic biopsy is preferred over transbronchial, renal, etc.

American College of Rheumatology/Vasculitis Foundation Guideline for managing ANCA Associated Vasculitis 2021 guidelines and guidance focus on screening, counseling, prevention, specialized serological tests, and monitoring of untreated patients.

Further details related to country-based variations are provided in the reported

ANCA Associated Vasculitis Treatment

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. Either methotrexate or azathioprine is usually maintenance of remission. Although there is no consensus on the duration of maintenance, it is usually given for 18–24 months to avoid relapse. Additionally, rituximab is recommended to maintain remission in patients with GPA and MPA.

The US ANCA Associated Vasculitis Market over the next few years is expected to change and experience growth substantially, as it will be dominated by the use of TAVNEOS in the GPA and MPA patient pool and NUCALA in EGPA patient segments. We have also anticipated launching an emerging product into the US market. TANVEOS and NUCALA are expected to capture share mainly from rituximab and immunotherapy. NUCALA is expected to peak by 2025 in the US before the generics are expected to enter by 2027.

Notably, most patients had a fairly good survival but disease complications and current treatment-associated toxicity severely hampered their quality of life. The integral agent of ANCA Associated Vasculitis treatment regimen, glucocorticoids, has always put patients at risk of diabetes, hip fracture, etc., in the longer run. Patients who become relapse/refractory for first-line induction remission agents like rituximab and/or immunotherapies have to struggle a lot for effective treatment since very few options are available as treatment agents to opt for. Involvement of the pANCA antibody deteriorates kidney health with the progression of the disease, making patient mortality vulnerable. Moreover, cANCA antibodies are involved in the frequent relapse of the disease. Developing innovative treatment strategies toward an inclusive treatment to arrest disease progress, free from associated toxicities, and a glucocorticoid-free regimen is needed for ANCA Associated Vasculitis treatment. Emerging therapies could fill such gaps in the coming future

ANCA Associated Vasculitis 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 DelveInsight 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.

ANCA Associated Vasculitis 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

TAVNEOS is approved by the FDA as an adjunctive treatment for adults with severe active ANCA-associated vasculitis and is a first-in-class, orally administered small molecule that employs a novel, highly targeted mode of action in complement-driven autoimmune and inflammatory diseases. Moreover, blocking the complement 5a receptor (C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils is presumed to arrest the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA Associated Vasculitis.

In October 2021, the FDA approved TAVNEOS (avacopan) as an adjunctive treatment for adult patients with severe active ANCA Associated Vasculitis, specifically GPA and MPA. In January 2022, the European Commission recently approved TAVNEOS in combination with a rituximab or cyclophosphamide regimen for treating adult patients with severe, active GPA or MPA. In September 2021 received authorization approval in Japan to treat GPA and MPA. Moreover, due to catering larger patient pool of ANCA-associated vasculitis, likely hood of getting a major share is expected.

Note: Detailed current therapies assessment will be provided in the full report of ANCA Associated Vasculitis

Emerging Drugs

FASENRA (benralizumab): AstraZeneca

FASENRA (benralizumab), developed by AstraZeneca, is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis (programmed cell death).

The drug potentially could be the next competitor NUCALA in EGPA patient segments. The drug is being evaluated in Phase III (NCT04157348; MANDARA) clinical trial to compare the efficacy and safety of benralizumab 30 mg vs. mepolizumab 300 mg administered by SC injection in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy. The data is anticipated to complete by the second half of 2023.

The drug is expected to launch by 2024 for EGPA. It is expected that FASENRA to graze shares of NUCALA in the EGPA segments. Still, the probability of getting major shares of EGPA patient segments is less because the chronological performances in the already approved indications are not excellent.

Note: Detailed emerging therapies assessment will be provided in the final report.

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.

ANCA Associated Vasculitis 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.

ANCA Associated Vasculitis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in 2019–2032. For example, for benralizumab, the company runs trials across the 7MM, and for depemokimab, we expect the drug uptake to be fast with a probability-adjusted peak share of 14%, years to the peak is expected to be 5 years from the year of launch for monotherapy.

Further detailed analysis of emerging therapies drug uptake in the report…

ANCA Associated Vasculitis Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisition and merger, licensing, and patent details for ANCA Associated Vasculitis emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts contacted for insights on ANCA Associated Vasculitis evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, drug uptake along with challenges related to accessibility, including Medical/scientific writers, Medical Oncologists and Professors, Pediatric Rheumatologist, ANCA Associated Vasculitis Foundation, and Others.

Delveinsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as MD Anderson Cancer Center, Texas from UT Southwestern Medical Center in Dallas, Cancer Research UK Barts Centre in London, MD Anderson Cancer Center, etc., were contacted. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or ANCA Associated Vasculitis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, administration frequency, administration route, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in ANCA Associated Vasculitis trials, one of the most important primary outcome measures is the ANCA antibody presence confirmed periodically for at least 6 months.

Both EMA and the FDA believe the endpoint in Phase II clinical trials should be tailored to the drug in question, and the benefit should outweigh the risk, allowing subsequent drug development. Given that Birmingham vasculitis activity score (BVAS) is the preferred primary endpoint for Phase III clinical trials. Thus, Phase II trials should look for an early signal of finite treatment efficacy. A decrease in Vasculitis damage index (VDI) was proposed as a clinically meaningful endpoint for Phase II trials.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The risk of ANCA Associated Vasculitis is high in the European population, and in children, prevalence is too low. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), third-party organizations that provide services, and educational programs to aid patients are also present.

HAS uses the ratings of ASMR for improvement in existing therapies and SMR for a new drug. An ASMR rating is assigned based on the drug’s improvement of medical benefit compared to the current standard of care. ASMR I, II, and III mean faster market access with price notification instead of negotiation and consistent price all over Europe, ASMR IV means that the drug is to be priced equal to the comparator, and ASMR V rating means that the drug is to be priced lower than the comparator. However, an SMR rating is given on the product’s medical benefit to determine whether the drug should be reimbursed. A 65–100%, 30%, 15%, and 0% reimbursement is given to drugs with SMR ratings of important, moderate, mild, and insufficient, respectively.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

The report covers a segment of key events, an executive summary, descriptive overview of ANCA Associated Vasculitis, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.

Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.

Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.

A detailed review of the ANCA Associated Vasculitis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.

The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM ANCA Associated Vasculitis market.

ANCA Associated Vasculitis Report Insights

Patient Population

Therapeutic Approaches

ANCA Associated Vasculitis pipeline analysis

ANCA Associated Vasculitis market size and trends

Existing and future market opportunity

ANCA Associated Vasculitis Report Key Strengths

10 years patient based forecast

The 7MM coverage

ANCA Associated Vasculitis epidemiology segmentation

Key cross competition

Attribute analysis

Drugs uptake and key market forecast assumptions

ANCA Associated Vasculitis Report Assessment

Current treatment practices

Unmet needs

Pipeline product profiles

Market attractiveness

Qualitative analysis (SWOT and conjoint analysis)

Key Questions

Market Insights

What was the ANCA Associated Vasculitis total market size, the market size by therapies, market share (%) distribution in 2019, and what would it all look like by 2032? What are the contributing factors for this growth?

How will interferon as a class affect the treatment paradigm in ANCA Associated Vasculitis?

What kind of uptake will benrelizumab witness in ANCA Associated Vasculitis patients in the coming 10 years?

What will be the impact of NUCALA’s expected patent expiry in 2027 (US) and 2026 (EU), respectively?

How will emerging drugs compete with existing therapies such as NUCALA, TAVNEOS, and others in the market?

Which class is going to be the largest contributor by 2032?

What are the pricing variations among different geographies for approved and off-label therapies?

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, burden, and unmet needs of ANCA Associated Vasculitis? What growth opportunities will be across the 7MM for the ANCA Associated Vasculitis patient population?

What is the historical and forecasted ANCA Associated Vasculitis patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?

Why do only limited patients appear with symptoms? Why is the current year diagnosis rate not high?

What factors are affecting the increase in the diagnosis of symptomatic cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

What are the current options to treat ANCA Associated Vasculitis? What are the current guidelines for treating ANCA Associated Vasculitis in the US and Europe?

How many companies are developing therapies to treat ANCA Associated Vasculitis?

How many emerging therapies are in the mid-stage and late stage of development for treating ANCA Associated Vasculitis?

What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?

What are the key designations that have been granted for the emerging therapies for ANCA Associated Vasculitis?

What will be the impact of NUCALA’s expected patent expiry?

What is the cost burden of approved therapies on the patient?

Patient acceptability in terms of preferred treatment options as per real-world scenarios?

What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.

What are the 7MM historical and forecasted market of ANCA Associated Vasculitis?

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.