市場調査レポート
商品コード
1108663
進行性多巣性白質脳症市場 - 市場の洞察、疫学、市場予測:2032年Progressive Multifocal Leukoencephalopathy Market Insight, Epidemiology And Market Forecast - 2032 |
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進行性多巣性白質脳症市場 - 市場の洞察、疫学、市場予測:2032年 |
出版日: 2022年07月01日
発行: DelveInsight
ページ情報: 英文 116 Pages
納期: 1~3営業日
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主要7ヶ国における進行性多巣性白質脳症の市場規模は、2021年に3,000万米ドルとなりました。
当レポートでは、主要7ヶ国における進行性多巣性白質脳症市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2019~2032年の市場規模予測、および医療のアンメットニーズなどを提供しています。
DelveInsight's, '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
Study Period: 2019-2032
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.
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.
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.
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.
Products detail in the report…
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.
Products detail in the report…
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 DelveInsight, 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.
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.
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.
The total Progressive Multifocal Leukoencephalopathy (PML) market size and market size by therapies of Progressive Multifocal Leukoencephalopathy (PML) in Japan are also mentioned.
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
We perform 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.
Key Questions
Market Insights:
Epidemiology Insights:
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies: