The BK virus infection market is expanding due to increased awareness and advancements in diagnostic technologies. Rising kidney transplant procedures and the subsequent need for effective treatments and management of BK virus in immunocompromised patients are driving market growth.

LAS VEGAS, July 4, 2024 /PRNewswire/ -- DelveInsight's BK Virus Infection Market Insights report includes a comprehensive understanding of current treatment practices, BK virus infection emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Takeaways from the BK Virus Infection Market Report

• According to DelveInsight's analysis, the market size for BK virus infection is expected to grow significantly by 2034.
• BKV infections generally occur in patients, who undergo transplantation or surgical procedures. Viral infections after renal transplantation have emerged as an important cause of allograft loss. It affects about 15% of renal transplant recipients in the first post-transplant year and lacks an effective prophylaxis strategy.
• Leading BK virus infection companies such as Memo Therapeutics, Vera Therapeutics, SymBio Pharmaceuticals, and others are developing novel BK virus infection drugs that can be available in the BK virus infection market in the coming years.
• The promising BK virus infection therapies in the pipeline include AntiBKV, MAU868, SyB V-1901, and others.
• In December 2023, AlloVir announced that it has discontinued its three Phase III posoleucel studies following separate, pre-planned DSMB futility analyses concluding the studies were unlikely to meet their primary endpoints. The company will  prioritize capital preservation and review strategic options

Discover which therapies are expected to grab the major BK virus infection market share @ BK Virus Infection Market Report

BK Virus Infection Overview

The BK virus (BKV) is a member of the polyomavirus family and is highly prevalent in the general population, often remaining latent in the kidneys. Infection typically occurs in childhood, but it remains asymptomatic in most individuals. Reactivation of the BK virus is usually associated with immunosuppressed states, such as in organ transplant recipients, particularly kidney and bone marrow transplants. This reactivation can lead to significant clinical conditions, including BK virus nephropathy, which is a leading cause of renal dysfunction and transplant failure.

Causes of BK virus reactivation include immunosuppressive therapy, which is administered to prevent organ rejection but can inadvertently reduce the body's ability to control latent viral infections. This immunosuppression creates an environment where the virus can multiply unchecked.

Symptoms of BK virus infection vary depending on the site and severity of the infection. In the case of BK virus nephropathy, symptoms may include reduced kidney function, which can manifest as elevated creatinine levels, and signs of urinary tract involvement such as hematuria (blood in the urine). General symptoms may also include fever and fatigue, although these are less specific.

Diagnosis of BK virus infection involves several approaches. Detection of viral DNA in the blood or urine through polymerase chain reaction (PCR) testing is a common method. A urine cytology test can also reveal the presence of decoy cells, which are indicative of BK virus infection. In cases of suspected BK virus nephropathy, a kidney biopsy may be performed to confirm the diagnosis and assess the extent of kidney damage.

BK Virus Infection Epidemiology Segmentation

The BK virus infection epidemiology section provides insights into the historical and current BK virus infection patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.

The BK virus infection market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Total Number of Kidney Transplant Cases, Hematopoietic Stem Cell Transplant (HSCT)
• Total Incident Cases of BKV Infections
• Total Cases of BKV Infection by Viral Genotype
• Treatable Cases of BKV Infection 

BK Virus Infection Treatment Market 

The aim of treating BKV replication is to eradicate the virus while maintaining as much kidney function as possible. Treatment strategies for BKV infections are derived from research involving kidney and bone marrow transplant patients. Since BKV infection results from the reactivation of a dormant virus in an immunocompromised environment, the primary approach is to reduce immunosuppression. Monitoring BK viral load and adjusting immunosuppression in response to BKV replication has been shown to enhance graft survival in kidney transplant patients, according to non-randomized trials.

BK-specific T-cell therapy and vaccines are becoming potential methods for managing and preventing BK infection. However, achieving a consistently effective and lasting treatment for BK infection is still challenging. Furthermore, there is a lack of randomized, controlled trials that offer strong evidence to back certain management strategies. Therefore, it is essential to conduct studies that can provide the necessary evidence to determine the best management practices for BK infection after transplantation. Such studies could shape the future of BK management by reducing treatment side effects and improving both graft and patient survival.

To know more about BK virus infection treatment guidelines, visit @ BK Virus Infection Management 

BK Virus Infection Pipeline Therapies and Key Companies

Some of the drugs in the pipeline include AntiBKV (Memo Therapeutics), MAU868 (Vera Therapeutics), SyB V-1901  (SymBio Pharmaceuticals), and others.

AntiBKV is a BK virus-neutralizing antibody derived from humans, used to treat BK virus infection following renal transplantation. This antibody features high virus neutralization capabilities, picomolar affinity, and an optimal safety profile due to its human origin and well-defined viral target. It received Fast Track Designation from the US FDA in May 2023.

In June 2023, Memo Therapeutics started pivotal Phase II/III trials for treating BKV infection in renal transplant patients. The Phase II portion is a randomized, placebo-controlled trial aimed at evaluating AntiBKV's therapeutic efficacy in 60 renal transplant patients with BK viremia. The primary endpoint is the proportion of participants with no detectable BKV. Data from Phase II is expected in the first half of 2025.

MAU868 is a powerful human monoclonal antibody (immunoglobulin G, IgG1/λ isotype subclass) that neutralizes all four BKV serotypes. It targets a specific conformational epitope on the viral capsid protein VP1, which is crucial for the virus's attachment and infection of new cells. Vera has an exclusive global license from Amplyx Pharmaceuticals, a subsidiary of Pfizer, for the development and commercialization of MAU868 across all indications. The final results of the Phase II clinical trial comparing MAU868 to a placebo indicated that MAU868 was well tolerated and significantly reduced BK viral activity over 36 weeks in kidney transplant patients with BK viremia. Based on feedback from the FDA regarding the Phase 2 trial, we are exploring strategies for further development, including a potential new clinical trial.

SyB V-1901 (BCV) is anticipated to be an effective treatment for a wide range of dsDNA virus infections, including BK Virus. It boasts a higher antiviral activity compared to cidofovir and other antiviral drugs. BCV is expected to be a potent multi-antiviral agent with a lower risk of causing nephrotoxicity or myelosuppression, serious side effects associated with other antiviral drugs like cidofovir. A Phase II clinical trial is currently underway for patients with post-kidney transplant BK virus infection and is projected to conclude in February 2025.

The anticipated launch of these emerging therapies for BK virus infection are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the BK virus infection market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

Discover more about BK virus infection drugs in development @ BK Virus Infection Clinical Trials 

BK Virus Infection Market Dynamics

The dynamics of the BK virus infection market are expected to change in the coming years. The BKV infection market may benefit from a growing understanding of the disease epidemiology and treatment options, with marketed drugs and emerging therapies offering potential solutions for managing the infection. Increased research and development activities contribute to the advancement of treatment options, and several organizations are actively working to provide information and awareness of this rare and devastating disorder. Although current treatment options for BKV infection are very few, this opens a platform for new therapies to boost the market.

Furthermore, potential therapies are being investigated for the treatment of BK virus infection, and it is safe to predict that the treatment space will significantly impact the BK virus infection market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the BK virus infection market in the 7MM.

However several factors may impede the growth of the BK virus infection market. Balancing immunosuppression to prevent organ rejection while controlling BKV is challenging, as treatment for BKV infection focuses on managing symptoms and improving the quality of life, with no cure found to date. Novel therapies might have improved outcomes and survival but have off-target effects, including the risk of bacterial, viral, and fungal infections. There is a paucity of randomized, controlled trials to provide high-level evidence to support certain management strategies since the disease is very rare, and therefore, very few patients are available even for clinical trials.

Moreover, BK virus infection treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the BK virus infection market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the BK virus infection market growth.

Scope of the BK Virus Infection Market Report

• Therapeutic Assessment: BK Virus Infection current marketed and emerging therapies
• BK Virus Infection Market Dynamics: Key Market Forecast Assumptions of Emerging BK Virus Infection Drugs and Market Outlook
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL's views, Analyst's views, BK Virus Infection Market Access and Reimbursement

Download the report to understand which factors are driving BK virus infection market trends @ BK Virus Infection Market Trends

Table of Contents

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