| Study Period | 2019 - 2030 |
| Base Year For Estimation | 2024 |
| Forecast Data Period | 2025 - 2030 |
| Historical Data Period | 2019 - 2023 |
| CAGR | 5.00% |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
North America Bladder Cancer Therapeutics and Diagnostics Market Analysis by Mordor Intelligence
The North America Bladder Cancer Therapeutics and Diagnostics Market is expected to register a CAGR of 5% during the forecast period.
- The COVID-19 pandemic significantly impacted the North American bladder cancer therapeutics and diagnostics market. For instance, as per the updates from American Urological Association's May 2022, during the peak of the COVID-19 pandemic, more than a quarter of patients with bladder cancer experienced care delays in the United States. 76,984 (27.2%) patients reported that their treatment was changed, delayed, or canceled due to the pandemic, including bladder cancer (27.5%).
- As a result of the pandemic, the market for bladder cancer therapeutics and diagnostics has been significantly impacted. However, the sector has been recovering since restrictions were lifted, resulting in the return of the normal pre-pandemic demand levels for therapeutic and diagnostic procedures. Thus, the North American bladder cancer therapeutics and diagnostics market is expected to grow over the forecast period.
- Factors driving the market growth include increasing awareness of bladder diseases and available therapies, an increase in the burden of bladder cancer, and innovations in drug development. For instance, as per the American Cancer Society's report of 2023, about 82.3 thousand cases of bladder cancer are expected to be reported in the United States in 2023 (62.4 thousand in men and 19.9 thousand in women).
- Furthermore, a study published by MDPI in January 2023 stated that a general hospital in Mexico reported a median age at diagnosis of bladder cancer is 62.5 years with a predominance of male patients. Furthermore, it also stated that a prevalence of 36% of cases was reported for patients with muscle-invasive bladder cancer (MIBC). Hence, with the growing burden of bladder cancer, the demand for its diagnosis and treatment is expected to increase, thereby boosting the market growth.
- Additionally, various strategies adopted by the key market players, such as product launches and mergers and acquisitions, are anticipated to drive the market over the forecast period. For instance, in August 2021, Merck's anti-PD-1 therapy, KEYTRUDA, was approved for treating patients with locally advanced or metastatic urothelial carcinoma eligible for platinum-containing chemotherapy in the United States.
- Additionally, in December 2022, Astellas Pharma Inc., Seagen Inc., and Merck reported that the U.S. FDA had accepted priority review supplemental Biologics License Applications (sBLAs) for PADCEV (enfortumab vedotin-ejfv) and KEYTRUDA (pembrolizumab) for the use of these two agents in combination for the treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC) who are not eligible to receive cisplatin-containing chemotherapy.
- Therefore, the factors mentioned above are collectively attributed to the growth of the studied market growth over the forecast period. However, the rise in the number of patent expirations and the asymptomatic nature of the disease are the major factors restraining the market's growth.
North America Bladder Cancer Therapeutics and Diagnostics Market Trends and Insights
Immunotherapy is Expected to Hold a Significant Share Over the Forecast Period
- Immunotherapy is a therapy that uses drugs to suppress or stimulate the immune system to help the body fight against infection, cancer, and other diseases. It relates to biological therapy for cancer treatment to boost the body's natural defenses to fight cancer. The advantages of immunotherapy over chemotherapy in a bladder cancer patient and product launches by the key market players drive the segment.
- For instance, according to an article published by WebMD LLC, in December 2022, Bacillus Calmette-Guérin (BCG) immunotherapy was approved by the United States Food and Drug Administration (US FDA) for primary carcinoma therapy in situ (CIS) of the bladder. BCG replaced cystectomy as the treatment of choice for CIS. BCG therapy also reduces the risk of recurrence, and ongoing maintenance therapy with BCG reduces the risk of progression in patients with high-grade non-muscle invasive bladder cancer (NMIBC). The advantage of immunotherapy on bladder cancer is expected to drive the segment demand over the forecast period.
- Various strategies adopted by the key market players support segment growth over the forecast period. For instance, in December 2022, US FDA approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating (cannot multiply in human cells) adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Such development is expected to drive the growth of the market. Therefore, all factors above are expected to post the segment growth over the forecast period.
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United States is Expected to Hold a Significant Share of the Market Over the Forecast Period
- The United States holds a significant share due to the high prevalence of bladder cancer, the growth of its therapeutics and diagnostics in the country, and the presence of many companies. According to Cancer.Net Editorial Board, in March 2023, in the United States, men are three to four times more likely than women to be diagnosed with bladder cancer.
- Furthermore, according to an article published by Healthline Media, in December 2022, in the United States, bladder cancer was around the sixth most common cancer overall in 2022, with approximately 81,180 new cases.
- On average, people with bladder cancer are about 77.1% as likely as those without it to live for at least five years after their diagnosis. According to the same source, in the United States, white people were reported to be more likely to receive a bladder cancer diagnosis than African Americans or Hispanic Americans. Thus, the high prevalence of bladder cancer and the growth of its therapeutics and diagnostics in the country is anticipated to increase the demand for it, thereby propelling the market growth.
- Additionally, various strategies adopted by the key market players support the market growth in the United States over the forecast period. For instance, in August 2021, the United States Food and Drug Administration (US FDA) approved nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the adjuvant treatment of urothelial carcinoma (UC), a type of bladder cancer.
- Additionally, in February 2022, Astellas Pharma Inc. and Seagen Inc. reported preliminary findings from Cohort H of the EV-103 study, which tests PADCEV (enfortumab vedotin-jeff) as a monotherapy in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based treatment. Thus, all factors above are expected to boost the market growth in the United States over the forecast period.
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Competitive Landscape
The North America bladder cancer therapeutics and diagnostics market is moderately concentrated in nature due to the presence of companies operating in North America. The competitive landscape includes an analysis of companies including AstraZeneca PLC, Bristol-Myers Squibb, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, GlaxoSmithKline PLC, Novartis AG, Pfizer Inc., Sanofi SA, Johnson & Johnson (Janssen Pharmaceutical), among others.
North America Bladder Cancer Therapeutics and Diagnostics Industry Leaders
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Bristol-Myers Squibb Company
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AstraZeneca PLC
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GlaxoSmithKline plc
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Johnson & Johnson (Janssen Pharmaceutical)
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F. Hoffmann-La Roche Ltd
- *Disclaimer: Major Players sorted in no particular order
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Recent Industry Developments
- July 2022: The United States Food and Drug Administration (FDA) agreed to review ImmunityBio's Biologics License Application (BLA) for N-803 in patients with or without Ta or T1 illness who have non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS).
- July 2022: Nanostics Inc. launched a prospective clinical study designed to validate a novel and minimally invasive bladder cancer diagnostic test, ClarityDX Bladder, using its ClarityDX diagnostic platform in partnership with the University of Alberta's Alberta Prostate Cancer Research Initiative (APCaRI) and DynaLIFE Medical Labs.
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North America Bladder Cancer Therapeutics and Diagnostics Market Report Scope
As per the scope of the report, bladder cancer arises from the epithelial lining of the urinary bladder. It is the ninth most common cancer worldwide, with the highest recurrence rate of any malignancy. Over the past ten years, bladder cancer has gradually developed, with a massive void of unmet needs.
The North America bladder cancer therapeutics and diagnostics market is segmented by product (therapeutics (chemotherapy, immunotherapy, and other therapeutics), and diagnostics (cystoscopy, bladder ultrasound, urinalysis, and other diagnostics)), cancer type (transitional cell bladder cancer, squamous cell bladder cancer, and other cancer types), and geography (United States, Canada, and Mexico).
The report offers the value (in USD) for the above segments.
By Product
| Therapeutics | Chemotherapy |
| Immunotherapy | |
| Other Therapeutics | |
| Diagnostics | Cystoscopy |
| Bladder Ultrasound | |
| Urinalysis | |
| Other Diagnostics |
By Cancer Type
| Transitional Cell Bladder Cancer |
| Squamous Cell Bladder Cancer |
| Other Cancer Types |
Geography
| North America | United States |
| Canada | |
| Mexico |
| By Product | Therapeutics | Chemotherapy |
| Immunotherapy | ||
| Other Therapeutics | ||
| Diagnostics | Cystoscopy | |
| Bladder Ultrasound | ||
| Urinalysis | ||
| Other Diagnostics | ||
| By Cancer Type | Transitional Cell Bladder Cancer | |
| Squamous Cell Bladder Cancer | ||
| Other Cancer Types | ||
| Geography | North America | United States |
| Canada | ||
| Mexico | ||
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Key Questions Answered in the Report
What is the current North America Bladder Cancer Therapeutics and Diagnostics Market size?
The North America Bladder Cancer Therapeutics and Diagnostics Market is projected to register a CAGR of 5% during the forecast period (2025-2030)
Who are the key players in North America Bladder Cancer Therapeutics and Diagnostics Market?
Bristol-Myers Squibb Company, AstraZeneca PLC, GlaxoSmithKline plc, Johnson & Johnson (Janssen Pharmaceutical) and F. Hoffmann-La Roche Ltd are the major companies operating in the North America Bladder Cancer Therapeutics and Diagnostics Market.
What years does this North America Bladder Cancer Therapeutics and Diagnostics Market cover?
The report covers the North America Bladder Cancer Therapeutics and Diagnostics Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the North America Bladder Cancer Therapeutics and Diagnostics Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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North America Bladder Cancer Therapeutics and Diagnostics Market Report
Statistics for the 2025 North America Bladder Cancer Therapeutics and Diagnostics market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. North America Bladder Cancer Therapeutics and Diagnostics analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
