The BCG unresponsive NMIBC market is anticipated to
witness a substantial positive shift owing to better uptake of
existing drugs, the expected market launch of photodynamic therapy
and non-viral gene therapy, and raised awareness.
LAS VEGAS, July 3, 2024 /PRNewswire/ --
DelveInsight's BCG Unresponsive NMIBC Market
Insights report includes a comprehensive understanding of
current treatment practices, BCG unresponsive NMIBC 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 BCG Unresponsive NMIBC Market
Report
- According to DelveInsight's analysis, the market size for BCG
unresponsive NMIBCs is expected to grow significantly by
2034.
- 30% to 50% of cases involving non-muscle-invasive
bladder cancer (NMIBC) do not respond to Bacillus Calmette-Guérin
(BCG) treatment.
- Leading BCG unresponsive NMIBC companies such as
Johnson & Johnson, enGene, and others are developing
novel BCG unresponsive NMIBC drugs that can be available in the BCG
unresponsive NMIBC market in the coming years.
- The promising BCG unresponsive NMIBC therapies in the
pipeline include TAR-200 (RIS/gemcitabine plus cetrelimab),
EG-70, and others.
- In April 2024, the
FDA approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln)
in combination with Bacillus Calmette-Guérin (BCG) for the
treatment of patients with BCG-unresponsive, non-muscle invasive
bladder cancer (NMIBC) with carcinoma in situ, with or without
papillary tumors. ANKTIVA, is first-in-class interleukin-15 agonist
immunotherapy for NMIBC.
- In December 2023, Johnson
& Johnson announced that the FDA had granted TAR-200
Breakthrough Therapy Designation (BTD) for the potential future
treatment of patients with Bacillus Calmette-Guérin
(BCG)-unresponsive high-risk non-muscle-invasive bladder cancer
(HR-NMIBC), who were ineligible for or elected not to undergo
radical cystectomy (surgical removal of the bladder).
Discover which therapies are expected to grab the major BCG
unresponsive NMIBC market share @ BCG Unresponsive NMIBC
Market Report
BCG Unresponsive NMIBC Overview
BCG unresponsive non-muscle invasive bladder cancer (NMIBC) is a
condition where bladder cancer does not adequately respond to
Bacillus Calmette-Guérin (BCG) therapy, a common intravesical
treatment for this type of cancer. The causes of BCG
unresponsiveness can be multifaceted, including intrinsic
resistance of the cancer cells to BCG, inadequate immune response
by the patient, or improper administration of the therapy. Symptoms
of NMIBC include blood in the urine (hematuria), frequent
urination, urgency, and painful urination. As the disease
progresses without effective treatment, these symptoms may worsen.
Diagnosis involves a combination of methods such as urine cytology,
cystoscopy, and biopsy, often supplemented by imaging studies like
CT scans or MRIs to assess the extent and grade of the tumor.
Identifying BCG unresponsiveness typically requires monitoring
tumor recurrence or progression after multiple cycles of BCG
therapy, often necessitating a multidisciplinary approach to
explore alternative treatments.
BCG Unresponsive NMIBC Epidemiology Segmentation
The BCG unresponsive NMIBC epidemiology section provides
insights into the historical and current BCG unresponsive NMIBC
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 BCG unresponsive NMIBC market report proffers
epidemiological analysis for the study period 2020–2034 in the 7MM
segmented into:
- BCG Unresponsive NMIBC Incident Cases
- BCG Unresponsive NMIBC Age-specific Cases
- BCG Unresponsive NMIBC Gender-specific Cases
- BCG Unresponsive NMIBC Risk factor- specific Cases
- BCG Unresponsive NMIBC Line-wise Treated Case
BCG Unresponsive NMIBC Treatment Market
BCG-unresponsive non-muscle-invasive bladder cancer poses a
significant clinical challenge due to its resistance to standard
BCG immunotherapy, which is typically the first-line treatment.
This condition arises when patients fail to respond adequately or
experience disease recurrence despite undergoing BCG therapy.
Managing BCG-unresponsive NMIBC requires careful consideration of
alternative treatment options, such as intravesical chemotherapy,
immunotherapy with checkpoint inhibitors, or even radical
cystectomy in severe cases. The decision-making process involves
balancing the risk of disease progression with potential treatment
side effects, emphasizing the need for personalized care plans
tailored to each patient's specific clinical characteristics and
preferences.
Research into novel therapies for BCG-unresponsive NMIBC
continues to evolve, aiming to improve outcomes and quality of life
for affected individuals. Clinical trials exploring different
immunotherapeutic agents targeted therapies, and combination
approaches offer hope for more effective treatment strategies. The
challenge lies in selecting the most appropriate therapy based on
tumor characteristics, patient health status, and previous
treatment responses, highlighting the importance of
multidisciplinary collaboration among urologists, oncologists, and
researchers to advance the field and optimize patient care.
To know more about BCG unresponsive NMIBC treatment guidelines,
visit @ BCG Unresponsive NMIBC Management
BCG Unresponsive NMIBC Pipeline Therapies and Key
Companies
Some of the drugs in the BCG unresponsive NMIBC pipeline include
TAR-200 (RIS/gemcitabine plus cetrelimab) (Johnson &
Johnson), EG-70 (enGene), and others.
TAR-200 is an innovative investigational system
designed to provide a sustained local release of gemcitabine into
the bladder, ensuring prolonged drug exposure. Cetrelimab, an
investigational PD-1 monoclonal antibody, is being studied for the
treatment of bladder cancer, prostate cancer, melanoma, and
multiple myeloma, and is currently in Phase II trials.
In December 2023, Johnson &
Johnson announced that the FDA had granted Breakthrough Therapy
Designation (BTD) to TAR-200 for the potential treatment of
patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk
non-muscle-invasive bladder cancer (HR-NMIBC) who are either
ineligible for or have chosen not to undergo radical cystectomy
(bladder removal surgery).
EG-70 (detalimogene voraplasmid) is an innovative,
non-viral gene therapy currently under investigation for treating
high-risk, NMIBC with carcinoma in situ (CIS) that does not respond
to BCG treatment. EG-70 is designed to activate both the innate and
adaptive immune systems within the bladder, aiming to trigger a
coordinated immune response to eliminate tumors.
The therapy has shown promising efficacy and safety in patients
with BCG-unresponsive, high-risk NMIBC CIS, achieving high complete
response rates and demonstrating good tolerability. It is presently
being evaluated in Phase I/II clinical trials.
The anticipated launch of these emerging therapies for BCG
unresponsive NMIBC 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 BCG unresponsive NMIBC market landscape,
offering new standards of care and unlocking opportunities for
medical innovation and economic growth.
Discover more about BCG unresponsive NMIBC drugs in
development @ BCG Unresponsive NMIBC Clinical
Trials
BCG Unresponsive NMIBC Market Dynamics
The market dynamics of BCG unresponsive NMIBC are driven by
several critical factors. Firstly, the increasing incidence of
bladder cancer globally necessitates effective treatment
options for patients who do not respond to or cannot tolerate BCG
therapy. Secondly, advancements in diagnostic techniques
have improved early detection rates, highlighting the need for
alternative therapies when BCG fails. Additionally, regulatory
approvals and ongoing clinical trials for novel immunotherapies
and targeted agents underscore a growing pipeline of potential
treatments, promising new options in a historically challenging
therapeutic area.
Furthermore, potential therapies are being investigated for the
treatment of BCG unresponsive NMIBC, and it is safe to predict that
the treatment space will significantly impact the BCG unresponsive
NMIBC 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 BCG unresponsive
NMIBC market in the 7MM.
However several factors may impede the growth of the BCG
unresponsive NMIBC market. Key challenges include the lack of
alternative therapies with proven efficacy comparable to BCG,
limited understanding of tumor biology leading to inadequate
patient stratification, and regulatory complexities in approving
novel treatments. Additionally, the high variability in patient
responses to existing therapies underscores the urgent need for
personalized medicine approaches and innovative clinical trial
designs. Addressing these barriers is crucial to improving
outcomes and quality of life for patients grappling with
BCG-unresponsive NMIBC.
Moreover, BCG unresponsive NMIBC treatment poses a
significant economic burden and disrupts patients' overall
well-being and QOL. Furthermore, the BCG unresponsive
NMIBC 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 BCG unresponsive NMIBC market
growth.
BCG Unresponsive
NMIBC 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 BCG Unresponsive
NMIBC Companies
|
Dompé Farmaceutici
S.p.A, Claris Biotherapeutics, Inc. ReGenTree, LLC,
and others
|
Key Pipeline BCG Unresponsive NMIBC Therapies
|
rhNGF, RGN-259,
CSB-001, and others
|
Scope of the BCG Unresponsive NMIBC Market
Report
- Therapeutic Assessment: BCG Unresponsive
NMIBC current marketed and emerging therapies
- BCG Unresponsive NMIBC Market
Dynamics: Key Market Forecast Assumptions of Emerging BCG
Unresponsive NMIBC Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis
and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, BCG Unresponsive
NMIBC Market Access and Reimbursement
Download the report to understand which factors are driving BCG
unresponsive NMIBC market trends @ BCG Unresponsive
NMIBC Market Trends
Table of Contents
1.
|
BCG Unresponsive
NMIBC Key Insights
|
2.
|
BCG Unresponsive
NMIBC Report
Introduction
|
3.
|
BCG Unresponsive NMIBC
Overview at a Glance
|
4.
|
BCG Unresponsive
NMIBC Executive Summary
|
5
|
BCG Unresponsive
NMIBC Key Events
|
6
|
Epidemiology and Market
Forecast Methodology
|
6.
|
Disease Background and
Overview
|
7.
|
BCG Unresponsive
NMIBC Treatment and
Management
|
8.
|
BCG Unresponsive NMIBC
Guidelines
|
9.
|
BCG Unresponsive
NMIBC Epidemiology and Patient
Population
|
10.
|
Patient
Journey
|
11.
|
Key Endpoints in BCG
Unresponsive NMIBC
|
12.
|
BCG Unresponsive NMIBC
Marketed Drugs
|
13.
|
BCG Unresponsive
NMIBC Emerging Drugs
|
14.
|
7MM BCG Unresponsive NMIBC 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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