BCG Unresponsive NMIBC Market to Register Sustainable Growth During the Study Period (2020-2034) | DelveInsight

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


Study Period



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


BCG Unresponsive NMIBC Key Insights


BCG Unresponsive NMIBC Report Introduction


BCG Unresponsive NMIBC Overview at a Glance


BCG Unresponsive NMIBC Executive Summary


BCG Unresponsive NMIBC Key Events


Epidemiology and Market Forecast Methodology


Disease Background and Overview


BCG Unresponsive NMIBC Treatment and Management


BCG Unresponsive NMIBC Guidelines


BCG Unresponsive NMIBC Epidemiology and Patient Population


Patient Journey


Key Endpoints in BCG Unresponsive NMIBC 


BCG Unresponsive NMIBC Marketed Drugs


BCG Unresponsive NMIBC Emerging Drugs


7MM BCG Unresponsive NMIBC Market Analysis


Market Access and Reimbursement


KOL Views


Unmet Needs


SWOT Analysis




DelveInsight Capabilities




About DelveInsight

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