Progressive Multifocal Leukoencephalopathy Market Insight, Epidemiology and Market Forecast - 2032

This ‘Progressive Multifocal Leukoencephalopathy (PML) - Market Insights, Epidemiology, and Market Forecast - 2032' report deliver an in-depth understanding of the historical and forecasted epidemiology as well as the market trends of Progressive Multifocal Leukoencephalopathy (PML) in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Progressive Multifocal Leukoencephalopathy (PML) market report provides current treatment practices, emerging drugs, market share of the individual therapies, and current and forecasted Progressive Multifocal Leukoencephalopathy (PML) market size from 2019 to 2032 segmented by seven major markets. The report also covers the current Progressive Multifocal Leukoencephalopathy (PML) treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying market potential.

Geographies Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2019-2032

Progressive Multifocal Leukoencephalopathy (PML): Disease Understanding and Treatment Algorithm

Progressive Multifocal Leukoencephalopathy (PML) Overview

Progressive multifocal leukoencephalopathy (PML) is an opportunistic infection caused by the JC virus (JCV), involving infection of white matter (principally oligodendrocytes) and neurons in the brain and leading to irreversible demyelination and neuroaxonal damage.

The immunosuppressive conditions associated with PML are broad and heterogeneous, ranging from HIV-AIDS (relatively common before highly active antiretroviral therapy [HAART] was available) to disease-specific immunosuppressive therapies, including monoclonal antibodies.

The causative agent is the polyomavirus JC which has a tropism for oligodendrocytes. The virus is widespread in up to 85% of the general adult population. Asymptomatic primary infection occurs in childhood, with the virus remaining latent in the kidneys and lymphoid tissue. With profound cellular immunosuppression, the virus reactivates and spreads to the CNS. The most common symptoms include limb weakness, cognitive deficits, speech and visual difficulties, ataxia, seizures, gait, sensory loss, and headache.

PML occurs at an estimated incidence of 0.2 per 100,000 patients with autoimmune diseases who did not have HIV or malignancy and at a very low incidence among patients with rheumatic diseases but can occur even in the absence of HIV or malignancy.

The preferred diagnostic method is cerebral spinal fluid polymerase chain reaction (CSF PCR) to detect JC virus DNA. Stereotactic brain biopsy remains the reference standard for diagnosis.

PML occurs almost exclusively in immunosuppressed patients, including those with AIDS (79%), hematologic malignancies (13%), organ transplants (5%), and autoimmune diseases on immunosuppressive therapy (3%). PML has rarely been reported in patients with occult immunosuppression such as hepatic cirrhosis and renal failure.

There is no specific treatment for JCV. Current treatment strategies are aimed at restoring immune function to improve survival successfully. In HIV-positive patients with PML, ART optimization is the best therapeutic option; in HIV-negative patients, removal or decrease of any potential source of immunosuppression is recommended. However, the prognosis for the majority of PML patients remains poor.

Despite the persistent risk of PML among patients with immunosuppressive conditions and a growing risk of PML among patients treated with immunomodulatory agents, no therapeutics are approved for the treatment of PML. However, the incidence and mortality of PML have decreased since the introduction of HAART, and the restoration of the host adaptive immune response has been shown to prolong survival.

Recently, genetic risk variants in patients with PML have been identified, which might help assess patients at risk, especially in those using immunosuppressant agents. However, outcomes in PML populations remain poor. Therefore, there is still a high unmet need for effective prophylaxis and treatment of PML.

Progressive Multifocal Leukoencephalopathy (PML) Diagnosis and Treatment
It covers the details of conventional and current medical therapies and diagnoses available in the Progressive Multifocal Leukoencephalopathy (PML) market to treat the condition. It also provides the country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.

Progressive Multifocal Leukoencephalopathy (PML) Epidemiology

The Progressive Multifocal Leukoencephalopathy (PML) epidemiology division provides insights into the historical and current patient pool and 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. The report also provides the diagnosed incident patient pool, trends, and assumptions.

Key Findings

The disease epidemiology covered in the report provides historical and forecasted Progressive Multifocal Leukoencephalopathy (PML) epidemiology segmented as the Diagnosed Incident cases of progressive multifocal leukoencephalopathy, Age-specific cases of progressive multifocal leukoencephalopathy, and Incidence of PML based on etiologies of progressive multifocal leukoencephalopathy. The report includes the diagnosed incident scenario of Progressive Multifocal Leukoencephalopathy (PML) symptoms in the 7MM covering the United States, and EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.

Country-wise Progressive Multifocal Leukoencephalopathy (PML) Epidemiology

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

The total diagnosed incidence of Progressive Multifocal Leukoencephalopathy (PML) population in the 7MM countries was estimated to be close to 3,900 cases in 2021.

Progressive Multifocal Leukoencephalopathy (PML) Drug Chapters

The drug chapter segment of the Progressive Multifocal Leukoencephalopathy (PML) report encloses the detailed analysis of Progressive Multifocal Leukoencephalopathy (PML) marketed drugs and late stage (Phase-III, Phase-II/III, Phase-II, and Phase-I/II) pipeline drugs. It also helps understand the Progressive Multifocal Leukoencephalopathy (PML) 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.

Effective treatment for the complete cure for progressive multifocal leukoencephalopathy has not been found. Currently, treatment is guided by efforts made to boost the adaptive immune response, and the methods to achieve this goal vary depending on the clinical setting.

In HIV patients, prompt initiation of HAART is advised. In transplant patients, the use of multiple immunosuppressive therapies may be limited while weighing the risks of graft rejection. In PML induced by natalizumab use, cessation of therapy and resorting to plasma exchange therapy as a means of treatment have been advised. Concerning the treatment of PML IRIS, improvement in neurological status has been observed with the cessation of ART therapy. Certain studies have shown favorable outcomes with steroid treatment. However, cessation of antiretroviral therapy may increase the viral load and lead to antiretroviral resistance. PML IRIS carries a significant risk for mass effect and herniation, and hence glucocorticoids can be utilized in the event of such complications to counter the damage caused by immune reconstitution.

Progressive Multifocal Leukoencephalopathy (PML) Emerging Drugs

To meet the current demands of the patient pool and to counter the unmet needs of the therapeutic market, few drug developers are gradually shifting their attention toward progressive multifocal leukoencephalopathy as a possible indication for new targeted therapies.

A few companies are working on new therapies, such as NeoImmuneTech: (Efineptakin alfa), Inhibikase Therapeutics (kT-01427), Pomonaricerca (PN-JC 1), and others. Currently, there is no development in the mid-stage and late-stage pipeline. However, assets are being investigated in the early Phase I and preclinical trials.

Efineptakin alfa (NT-I7) is a human IL-7 fusion protein that is designed to overcome the key limitations of endogenous IL-7 in infectious diseases and other indications like Glioblastoma. NeoImmuneTech aims to explore the utility of IL-7-based therapeutics in enhancing immune function. The IL-7 domain promotes T cell development which plays a central role in the immune response. The N-terminus of the IL-7 domain is engineered to overcome its structural instability and to enable mass production of NT-I7. The hyFc® domain extends the half-life of IL-7, thereby enhancing bioavailability which provides better potency and stability. The drug is currently in the early Phase I stage of clinical development. The primary outcome will measure the longitudinal change in absolute lymphocyte count over 6 months following study drug administration; while the secondary outcome will measure safety, change in lymphocyte subsets, including CD4, CD8, and CD19 positive cells, and others.

Inhibikase Therapeutics is developing kT-01427 to block the causative virus of PML from replicating in the body. IkT-01427 is an oral, brain-penetrant medication for systemic administration intended to block the entry of the JC virus into the cell, thereby preventing the virus' ability to replicate in the body. It is a new molecular entity developed with the company's RAMP™ technology and is currently in the preclinical phase of development.

Pomonaricerca is developing a fully human monoclonal antibody PN-JC 1. It is an IgG1 molecule endowed with a strong antiviral neutralizing activity. The molecule might be useful in the prophylaxis of natalizumab-induced PML as well as in the therapy of the ouvert disease.

Progressive Multifocal Leukoencephalopathy (PML) Market Outlook

The Progressive Multifocal Leukoencephalopathy (PML) market outlook of the report builds a detailed comprehension of the historical, current, and forecasted Progressive Multifocal Leukoencephalopathy (PML) market trends by analyzing the impact of current therapies on the market, unmet needs, and demand for better technology.

This segment gives a thorough detail of the Progressive Multifocal Leukoencephalopathy (PML) 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, 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 the publisher, the Progressive Multifocal Leukoencephalopathy (PML) market in the 7MM is expected to change in the study period 2019-2032.

Key Findings

This section includes a glimpse of the Progressive Multifocal Leukoencephalopathy (PML) market in the 7MM. In the seven major markets, the Progressive Multifocal Leukoencephalopathy (PML) market size was approximately USD 30 Million in 2021.

The United States: Market Outlook

This section provides the total Progressive Multifocal Leukoencephalopathy (PML) market size and market size by Progressive Multifocal Leukoencephalopathy (PML) therapies in the United States.

Progressive multifocal leukoencephalopathy (PML) caused by JC Virus (JCV) is a rare but frequently fatal disease. It is a severe demyelinating disease of the central nervous system that is caused by the reactivation of the JCV in immunocompromised individuals. The disease is clinically characterized by neurological damage, which includes a variety of symptoms such as loss of vision, sensory loss, trouble walking, speech disturbances, weakness, problems in coordination, etc. PML is also progressive, with other conditions such as HIV, malignancies, chronic inflammatory conditions, and organ transplants. Due to the increased risk of PML in the population, early diagnosis has become of critical importance. Neurologic signs, MRI, and specific detection of JCV by PCR analysis of cerebrospinal fluid are used for the diagnosis.

The United States accounts for the highest market size of Progressive Multifocal Leukoencephalopathy (PML) compared to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.

EU-5 Countries: Market Outlook

The total Progressive Multifocal Leukoencephalopathy (PML) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are also mentioned.

Japan Market Outlook

The total Progressive Multifocal Leukoencephalopathy (PML) market size and market size by therapies of Progressive Multifocal Leukoencephalopathy (PML) in Japan are also mentioned.

Progressive Multifocal Leukoencephalopathy (PML) 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 2019-2032. The analysis covers Progressive Multifocal Leukoencephalopathy (PML) market uptake by drugs, patient uptake by therapies, and sales of each drug.

This helps in understanding the drugs with the most rapid uptake and the 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 the market uptake and in making financial and regulatory decisions.

Progressive Multifocal Leukoencephalopathy (PML) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, and Phase I/II stages. It also analyses Progressive Multifocal Leukoencephalopathy (PML)'s key players involved in developing targeted therapeutics.

Major players include NeoImmuneTech, Inhibikase Therapeutics, Neurimmune, and others whose key products are expected to get launched in the US market by 20XX.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging Progressive Multifocal Leukoencephalopathy (PML) therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the Progressive Multifocal Leukoencephalopathy (PML) 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 Progressive Multifocal Leukoencephalopathy (PML) market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

The publisher performs a Competitive and Market Intelligence analysis of the Progressive Multifocal Leukoencephalopathy (PML) market 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 Progressive Multifocal Leukoencephalopathy (PML), explaining its causes, signs and symptoms, pathophysiology, and currently available therapies
• Comprehensive insight is provided into the Progressive Multifocal Leukoencephalopathy (PML) epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for Progressive Multifocal Leukoencephalopathy (PML) is provided, along with the assessment of new therapies that will impact the current treatment landscape
• A detailed review of the Progressive Multifocal Leukoencephalopathy (PML) 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 Progressive Multifocal Leukoencephalopathy (PML) market

Report Highlights

• In the coming years, the Progressive Multifocal Leukoencephalopathy (PML) 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 Progressive Multifocal Leukoencephalopathy (PML) 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 Progressive Multifocal Leukoencephalopathy (PML). The launch of emerging therapies will significantly impact the Progressive Multifocal Leukoencephalopathy (PML) market.
• A better understanding of disease pathogenesis will also contribute to developing novel therapeutics for Progressive Multifocal Leukoencephalopathy (PML).
• 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.

Progressive Multifocal Leukoencephalopathy (PML) Report Insights

• Patient Population
• Therapeutic Approaches
• Progressive Multifocal Leukoencephalopathy (PML) Pipeline Analysis
• Progressive Multifocal Leukoencephalopathy (PML) Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Progressive Multifocal Leukoencephalopathy (PML) Report Key Strengths

• 11-year Forecast
• 7MM Coverage
• Progressive Multifocal Leukoencephalopathy (PML) Epidemiology Segmentation
• Key Competitors
• Highly Analyzed Market
• Drugs Uptake

Progressive Multifocal Leukoencephalopathy (PML) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness

Key Questions

Market Insights:

• What was the market share (%) distribution, and how would it look in 2032?
• What would be the total market size and market size of Progressive Multifocal Leukoencephalopathy (PML) by therapies across the 7MM forecast period (2019-2032)?
• What are the key findings pertaining to the market across 7MM, and which country will have the largest Progressive Multifocal Leukoencephalopathy (PML) market Size during the forecast period (2019-2032)?
• At what CAGR is the Progressive Multifocal Leukoencephalopathy (PML) market expected to grow in the 7MM forecast period (2019-2032)?
• What would be the Progressive Multifocal Leukoencephalopathy (PML) market outlook across the 7MM forecast period (2019-2032)?
• What would be the Progressive Multifocal Leukoencephalopathy (PML) market growth until 2032 and the resultant market size in 2032?
• How would the 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 Progressive Multifocal Leukoencephalopathy (PML)?
• What is the historical patient pool of Progressive Multifocal Leukoencephalopathy (PML) in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What would be the forecasted patient pool of Progressive Multifocal Leukoencephalopathy (PML) in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What are the major factors that will drive the change in the patient population in XYZ disease during the forecast period (2019-2032)?
• Out of all 7MM countries, which country would have the highest diagnosed incidence of Progressive Multifocal Leukoencephalopathy (PML) during the forecast period (2019-2032)?
• At what CAGR is the population expected to grow in the 7MM during the forecast period (2019-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Progressive Multifocal Leukoencephalopathy (PML)?
• What are the current treatment guidelines for treating Progressive Multifocal Leukoencephalopathy (PML) in the US, Europe, and Japan?
• What are the Progressive Multifocal Leukoencephalopathy (PML) marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?
• How many companies are developing therapies to treat Progressive Multifocal Leukoencephalopathy (PML)?
• How many therapies are developed by each company for the treatment of Progressive Multifocal Leukoencephalopathy (PML)?
• How many emerging therapies are in the mid-stage and late stages of development to treat Progressive Multifocal Leukoencephalopathy (PML)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to the Progressive Multifocal Leukoencephalopathy (PML) 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 for Progressive Multifocal Leukoencephalopathy (PML) and its status?
• Which key designations have been granted for the emerging therapies for Progressive Multifocal Leukoencephalopathy (PML)?
• What are the global historical and forecasted Progressive Multifocal Leukoencephalopathy (PML) markets?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving the Progressive Multifocal Leukoencephalopathy (PML) market
• To understand the future market competition in the Progressive Multifocal Leukoencephalopathy (PML) market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Progressive Multifocal Leukoencephalopathy (PML) in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identifying upcoming solid players in the market will help devise strategies that will help get ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Progressive Multifocal Leukoencephalopathy (PML) market.
• To understand the future market competition in the Progressive Multifocal Leukoencephalopathy (PML) market.