비근침윤성 방광암 치료 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the non-muscle invasive bladder cancer treatment market size is projected to be USD 3.14 billion in 2025, USD 3.56 billion in 2026, and reach USD 7.5 billion by 2031, growing at a CAGR of 16.04% from 2026 to 2031.

This report is Segmented by Therapy (BCG, Chemotherapy, Immunotherapy, Gene Therapy, Device-Assisted Intravesical), Route of Administration (Intravesical, Systemic), Disease Stage (Ta, T1, CIS), End User (Hospitals, Specialty Clinics, Ascs), and Geography (North America, Europe, Asia-Pacific, MEA, South America). Market Forecasts are Provided in Value (USD).

Global Non-muscle Invasive Bladder Cancer Treatment Market Trends and Insights

Approvals Expanding BCG-Unresponsive Care

A wave of FDA and EMA clearances for nadofaragene firadenovec, ANKTIVA, and pembrolizumab is redefining the salvage pathway for patients who cannot mount a durable response to BCG. ANKTIVA's IL-15 superagonism amplifies natural-killer cell infiltration, delivering a 62% 12-month complete response rate in the pivotal QUILT 3.032 study, twice the historical benchmark for single-agent chemotherapy. Ferring's adenoviral p53 gene therapy addresses the TP53 mutation burden that drives 50% of high-grade tumors, while Breakthrough Therapy status for CG Oncology's cretostimogene signals growing regulatory confidence in oncolytic platforms. Collectively, these approvals cut the lag between BCG failure and next-line therapy from 18 months to less than 6 months, mitigating the progression window that historically forced early cystectomy.

BCG Supply Constraints Accelerating Alternatives Adoption

Chronic shortages have prompted the American Urological Association to recommend gene therapy or checkpoint inhibitors as first-line options when BCG is unavailable. UroGen Pharma reported a 140% year-over-year jump in Jelmyto prescriptions during Q1 2025, underscoring a structural reordering of the treatment algorithm as physicians substitute earlier chemotherapeutic recourse for BCG-reliant pathways. Merck's recombinant BCG, engineered in yeast to generate 15-fold higher yields, entered Phase II trials in 2024 and is on course for a 2027 launch, yet capacity gaps will persist until then. The shortfall is already funneling treatment-naive patients into alternatives once reserved for salvage, permanently lifting baseline demand for immunotherapy.

High Cost Versus Legacy Intravesical Chemo and BCG

Nadofaragene lists at USD 189,000 per course, while a six-week BCG induction costs USD 3,500-5,000 and generic mitomycin USD 400 per instillation, leaving a 30-fold price chasm that sparks payer pushback. Medicare covers gene therapy only after BCG failure and high-grade histology, excluding intermediate-risk Ta patients who make up 60% of incident cases. Outcomes-based contracts in the U.K. and Germany oblige manufacturers to rebate 40% of therapy cost if complete response is not achieved at 12 months, throttling early uptake. In India and Brazil, where out-of-pocket spending exceeds 50%, many patients default to generic chemotherapy or proceed directly to cystectomy.

Other drivers and restraints analyzed in the detailed report include:

1. Aging Incidence Base and High NMIBC Share of Bladder Cancer
2. Device-Assisted Intravesical Therapy Adoption
3. Limited Durability and Retreatment Burden

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Chemotherapy accounted for 45.09% of non-muscle invasive bladder cancer treatment market share in 2025, anchored by mitomycin and gemcitabine. Yet immunotherapy is set to grow at 18.19% CAGR through 2031, reflecting earlier-line use of checkpoint inhibitors and IL-15 agonists. BCG therapy remains first-line for high-risk disease, but capacity limits crimp growth. Gene therapy commands a premium that translates into outsized revenue. Device-assisted hyperthermia systems logged 22% year-over-year gains in 2025, as European centers adopted Combat Medical's BRS.

Immunotherapy's ascent hinges on long-term data. Keynote-057 36-month readouts due in 2026 will determine if checkpoint blockade can forestall muscle invasion. Real-world nivolumab response rates trail clinical trials, revealing a gap between controlled and community settings. Gene therapy's single-dose convenience resonates with frail elders, yet certification bottlenecks limit clinic participation. Chemotherapy will persist in low-income regions where biologic pricing remains prohibitive, but its growth is slowing as patent cliffs erode pricing power.

Intravesical delivery represented 55.14% of non-muscle invasive bladder cancer treatment market size in 2025 and is projected to expand at an 18.14% CAGR through 2031. TAR-200 condenses six catheterizations into a single cystoscopic insertion, freeing clinic slots and nursing capacity. RTGel extends mitomycin contact time sixfold, enabling weekly schedules that fit community practice. Systemic PD-1 inhibitors serve multifocal disease and patients unable to catheterize, but carry higher immune-related adverse-event risk. Oral PD-1 inhibitors in Phase II target non-catheterizable cohorts but must clear durability and safety hurdles before displacing intravesical standards.

The route split is increasingly biology-driven. Tumors with high PD-L1 expression trend toward systemic therapy, while papillary Ta disease favors resurfacing-focused intravesical options. Cold-chain requirements tilt gene therapy toward accredited centers, whereas sustained-release devices need only room-temperature storage, broadening their geographic reach.

Geography Analysis

North America generated 45.35% of 2025 revenue, anchored by the United States' spending on NMIBC therapies. Broad Medicare coverage, rapid FDA approvals, and high disposable incomes underpin adoption of premium biologics and devices. Yet payer pressure is mounting; outcomes-based contracts and site-of-service differentials are already nudging therapy into physician offices.

Europe captured a significant share of 2025 revenue, led by Germany, France, and the United Kingdom. EMA's PRIME designation slashed launch timelines for nadofaragene, but divergent health-technology assessments create patchwork access. Germany granted full reimbursement in 2025, while France imposed a three-year registry, delaying uptake. Shared-service HIVEC consortia and expanded compassionate-use checkpoints in Spain illustrate Europe's pragmatic drive to balance innovation with cost containment.

Asia-Pacific is the breakout region, forecast to grow at an 18.3% CAGR through 2031. China's November 2024 approval of pembrolizumab for BCG-unresponsive CIS, combined with domestic PD-1 biosimilars priced at USD 8,000 annually, is democratizing access. India's 2025 mitomycin generic slashed per-vial prices to INR 12,000 (USD 145), expanding uptake in tier-2 cities. Japan's aging cohort and universal insurance position it as the region's second-largest market, but PMDA demands for local trials delay novel entrants. South Korea's 40% price cut for pembrolizumab in 2025 and Australia's 2026 TAR-200 approval round out an APAC region embracing both cost-effective generics and high-value sustained-release devices.

1. Asieris Pharmaceuticals
2. AstraZeneca
3. Bristol-Myers Squibb
4. CG Oncology
5. Combat Medical
6. F. Hoffmann-La Roche (Roche)
7. Ferring Pharmaceuticals
8. ImmunityBio, Inc.
9. Johnson & Johnson
10. Merck
11. Pfizer
12. UroGen Pharma

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Approvals Expanding BCG-Unresponsive Care (Gene Therapy, IL-15, PD-1)
  • 4.2.2 BCG Supply Constraints Accelerating Alternatives Adoption
  • 4.2.3 Aging Incidence Base and High NMIBC Share of Bladder Cancer
  • 4.2.4 Device-Assisted Intravesical Therapy (HIVEC/EMDA) Adoption
  • 4.2.5 Drug-Device Sustained-Release Platforms
  • 4.2.6 Manufacturing Scale-Up (Gene Therapy, rBCG) De-Bottlenecking Access
• 4.3 Market Restraints
  • 4.3.1 High Cost Vs. Legacy Intravesical Chemo/BCG
  • 4.3.2 Limited Durability/Retreatment Burden in Some Therapies
  • 4.3.3 Complex Biologics Manufacturing and Cold-Chain Constraints
  • 4.3.4 Capital/Staff Needs for Hyperthermia/EMDA Devices Slow Uptake
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Industry Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Therapy
  • 5.1.1 BCG therapy
  • 5.1.2 Chemotherapy
  • 5.1.3 Immunotherapy
  • 5.1.4 Gene therapy
  • 5.1.5 Device-assisted intravesical
• 5.2 By Route of administration
  • 5.2.1 Intravesical
  • 5.2.2 Systemic (IV/Oral)
• 5.3 By Disease Stage
  • 5.3.1 Ta (non-invasive papillary)
  • 5.3.2 T1 (lamina propria)
  • 5.3.3 Carcinoma in situ (CIS)
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Specialty Clinics
  • 5.4.3 Ambulatory Surgical Centers
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 France
    • 5.5.2.3 United Kingdom
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 South Korea
    • 5.5.3.5 Australia
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles {(includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)}
  • 6.3.1 Asieris Pharmaceuticals
  • 6.3.2 AstraZeneca
  • 6.3.3 Bristol-Myers Squibb
  • 6.3.4 CG Oncology
  • 6.3.5 Combat Medical
  • 6.3.6 F. Hoffmann-La Roche (Roche)
  • 6.3.7 Ferring Pharmaceuticals
  • 6.3.8 ImmunityBio, Inc.
  • 6.3.9 Johnson & Johnson (Janssen)
  • 6.3.10 Merck & Co.
  • 6.3.11 Pfizer Inc.
  • 6.3.12 UroGen Pharma

7 Market Opportunities & Future Outlook

• 7.1 White-space & unmet-need assessment