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.
BK Virus Infection
Market Report Metrics
|
Details
|
Study Period
|
2020–2034
|
Coverage
|
7MM [the United States,
the EU4 (Germany, France, Italy, and Spain) and the United Kingdom,
and Japan].
|
Key BK Virus Infection
Companies
|
Memo Therapeutics, Vera
Therapeutics, SymBio Pharmaceuticals, and others
|
Key Pipeline BK Virus Infection Therapies
|
AntiBKV, MAU868, SyB
V-1901, and others
|
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
1.
|
BK Virus
Infection Key Insights
|
2.
|
BK Virus
Infection Report
Introduction
|
3.
|
BK Virus Infection
Overview at a Glance
|
4.
|
BK Virus
Infection Executive
Summary
|
5
|
BK Virus
Infection Key Events
|
6
|
Epidemiology and Market
Forecast Methodology
|
6.
|
Disease Background and
Overview
|
7.
|
BK Virus
Infection Treatment and
Management
|
8.
|
BK Virus Infection
Guidelines
|
9.
|
BK Virus
Infection Epidemiology and Patient
Population
|
10.
|
Patient
Journey
|
11.
|
Key Endpoints in BK
Virus Infection
|
12.
|
BK Virus Infection
Marketed Drugs
|
13.
|
BK Virus
Infection Emerging
Drugs
|
14.
|
7MM BK Virus Infection Market Analysis
|
15.
|
Market Access and
Reimbursement
|
16.
|
KOL Views
|
17.
|
Unmet Needs
|
18.
|
SWOT
Analysis
|
19.
|
Appendix
|
20.
|
DelveInsight
Capabilities
|
21.
|
Disclaimer
|
22.
|
About
DelveInsight
|
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