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Urothelial Carcinoma Diagnostics Market

Bladder cancer across the globe is a primary factor driving the urothelial carcinoma diagnostics market

Urothelial Carcinoma Diagnostics Market by Product (Reagent and Kits, Instruments)

Urothelial Carcinoma Diagnostics Market Outlook (2023 to 2033)

The Global revenue from the Urothelial Carcinoma Diagnostics Market was about US$ 1.4 Billion in 2022, with the global market expected to grow at a CAGR of 10.9% to reach a valuation of around US$ 4.3 Billion by the end of 2033.

Market Size (2023)

US$ 1.5 Billion

Projected Market Value (2033)

US$ 4.3 Billion

Global Market Growth Rate (2023 to 2033)

10.9% CAGR

Market Share of Top 5 Countries


As assessed by Persistence Market Research, reagents and kits held a market share of around 72.1% in the global market, in 2022. Overall, urothelial carcinoma diagnostics market sales account for approximately 1.8% of revenue share in the global clinical diagnostics market, which was valued at around US$ 74.3 Billion in 2022.

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Sales Analysis of Market from 2015 to 2022 Vs Market Outlook for 2023 to 2033

The global market recorded a historic CAGR of 9.6% in the last 7 years from 2015 to 2022. Urothelial carcinoma is a condition where the bladder lining's urothelial cells alter and grow abnormally, eventually forming a mass known as a tumour. The most typical kind of bladder cancer is this one. Tumors in the ureter, urethra, and renal pelvis are also rather common in people with bladder cancer.

An issue arises when bladder tumours spread to deeper bladder layers and become difficult to treat. Blood in the urine, pain, irritation in the bladder, changes in urination patterns, edema, night sweats, weight loss, and fever are among the common signs of urothelial cancer.

Enhanced diagnosis of diverse cancer patients is made possible by better understanding of certain cancer biomarkers, which is fuelling potential growth for diagnostic companies.

In situ hybridization, biopsy, and cystoscopy are some of the most modern diagnostics utilised for the detection and progression of urothelial carcinoma. The identification of potential cancer biomarkers has increased because of technical advancements in the field of biotechnology.

  • Few specialised biomarker tests for urothelial cancer diagnosis are UroVysion, bladder tumour antigen, NMP-22, ImmunoCyt/uCyt+, CxBladder, and Xpert Bladder Cancer.

The global market is likely to show high growth over the coming years at a CAGR of 10.9% and reach a global market size of US$ 4.3 Billion by 2033.

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How Can the Global Market Grow?

“Increased Awareness of Early Urothelial Cancer Screening.”

  • According to World Cancer Research Fund International, the tenth most frequent cancer in the world is bladder cancer. For both men and women, it ranks as the sixth most frequent malignancy. In 2020, there were more than 573,000 new bladder cancer cases.

By receiving a late diagnosis of a malignancy with a strong tendency for metastasis, the relatively high mortality rate associated with urothelial carcinoma can be addressed. If discovered in its early stages, the benign tumour can be substantially eliminated permanently with surgical interlineation, but if it has progressed to other organs, the prognosis for urothelial carcinoma is dismal, with an estimated average survival time of 6–8 months.

  • The demand for better diagnostic tests for urothelial cancer is being directly driven by the increased risk of acquiring urothelial cancer from benign lesions.

A favourable environment for market expansion is anticipated to be created in the near future by rising biomedical research using clinical oncology molecular diagnosis. Recently, cancer biomarkers and immunotherapies have been developed using clinical oncology molecular diagnostic tests. As a result, the market for urothelial carcinoma diagnostics is anticipated to rise due to the rising incidence of cancer.

There has been a lot of interest in clinical molecular diagnostics for cancer in recent years. In order to increase urothelial cancer screening programmes with the aid of the government, numerous clinical development initiatives are being implemented in a number of nations. As a result, the patient with urothelial carcinoma receives early diagnosis and screening.

  • For instance, the Plan of Health China 2030, published by the State Council in October 2016, states that by 2030, the Chinese healthcare market is expected to reach approximately US$ 2 trillion. The urothelial cancer diagnostic market is anticipated to see development prospects due to the health sector, which includes biomedical research.

In order to capture the largest portion of the industry and increase their footprint in the untapped market, the top firms are also developing diagnostic companions in numerous areas with high prevalence rates.

  • For instance, Thermo Fisher Scientific and Janssen reached a deal in March 2020 to co-develop companion diagnostics for cancer. Thermo Fisher Scientific and Hengrui Therapeutics, Inc. also inked a companion diagnostic agreement in August 2020.
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Can the Market Growth Be Affected in Any Way?

Lack of Skilled Professionals.

One significant issue that is anticipated to impede the growth of the market for urothelial carcinoma diagnostics is the lack of competent laboratory personnel. In addition, diagnostic laboratories use cutting-edge technology and automate operations; their ability to expand is constrained by a dearth of qualified personnel who are conversant in molecular techniques. The number of new students graduating from clinical laboratory programs is continually falling, which is impeding market expansion even though the demand for medical laboratory experts is rising.

The testing, identification, and implementation of biomarkers in any molecular diagnostic are issues connected with the discovery of biomarkers that are anticipated to impede the market's expansion for urothelial carcinoma diagnostics.

In order to identify and evaluate biomarkers, there are a number of difficulties related to clone evolution and tumor heterogeneity that must be overcome. Although comprehensive molecular, including metabolomics and proteomics, could aid in the discovery of new predictive biomarkers, their implementation in routine clinical practice has been constrained by critical errors of data reliability between multiple platforms and analogous difficulties of analytical validation.

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Country-wise Insights

Why is the United States Market Booming?

“Increasing Prevalence of Bladder Cancer”

The United States accounted for around 86.9% market share in the North America market in 2022. The regional dominance is attributed to growing research and development efforts and a developed healthcare system. The existence of numerous biologics and biopharmaceutical firms is another factor that has contributed to the urothelial carcinoma diagnostics market's size and stellar growth.

  • In the United States, there are approximately 81,180 new cases of bladder cancer in 2022 (61,700 in men and 19,480 in women), according to the American Cancer Society's January 2022 statistics.

Therefore, the need for bladder cancer detection and treatment is anticipated to rise as its prevalence rises, supporting the market's expansion.

Will the Germany Be a Lucrative Market for Urothelial Carcinoma Diagnostics?

“Rise in Awareness of Bladder Cancer”

The Germany market held around 30.7% market share of the Europe market in 2022. The primary factor influencing the market in the region is the rising prevalence of bladder cancer.

  • With around 628,519 new cases expected in 2020 for both women and men, or roughly 5.6% of all cases, bladder cancer ranks fifth among the most frequently diagnosed cancer types, according to Globocan estimates.

The regional market is expanding as a result of rising awareness of the disease and its treatments. Other factors influencing the expansion of the market under study include rising knowledge of bladder disorders, the medicines that are available, and advancements in the creation of new drugs.

How is China Emerging as a Prominent Market?

“Increasing Product Approvals”

China held a market share of about 46.7% of the East Asia market in 2022. The rising incidence of bladder cancer and the advent of new diagnostic and therapeutic techniques are to blame for the regional domination.

  • For instance, bladder cancer is being treated with new drugs. For the treatment of locally advanced or metastatic urothelial carcinoma, the China National Medical Products Administration (NMPA) licensed the anti-PD-1 antibody Tislelizumab in 2020. These factors are therefore expected to stimulate market growth.

Category-wise Insights

Which Product is Driving Demand within the Global Market?

“Specificity of Some Reagents and Kits”

The reagents and kits segment held around 72.1% share of the total market in 2022. Today, it is understood that changes in a number of cellular functions cause urothelial cancer. The use of molecular testing to accurately detect the disease's presence, forecast the behavior of specific tumors, and recommend prospective targeted therapies will be crucial in the care of bladder cancer patients in the future. This specificity of reagents and kits are responsible for segment growth.

Which Test is Widely Adopted for the Production of Urothelial Carcinoma Diagnostics?

“Technological Advancements”

Molecular diagnostic tests held around 43.8% share of the total market in 2022. Early urological cancer identification is essential for effective patient management and treatment. A key advancement would be the development of molecular assays that can reliably identify disease or that can supplement existing methods of evaluation.

The use of such molecular assays on non-invasively obtained body fluids would ideally allow for the identification of at-risk patients as well as asymptomatic screening, disease recurrence tracking, and treatment response monitoring. These objectives are coming into focus because of the development of advanced proteomics and genomics technologies and the related bioinformatics field. These affirmatory factors are responsible for segment growth.

Which End User Propels the Global Sales in the Market?

“Increasing Hospital Facilities Globally”

The hospitals segment held a share of about 46.3% in 2022, within the global market. The growth of hospitals around the world is to blame for the segment's domination. For instance, as per the Organization for Economic Co-operation and Development data, there were around total 6,090 hospitals in the United States, in 2019.

Also, medical tourism has increased on a global scale. With a growth in medical tourism, hospitals should offer higher-quality healthcare services. The aforementioned causes are anticipated to cause the hospitals segment to grow significantly during the projection period.

Competition Landscape

The market for diagnostics, therapies, and treatments for bladder cancer has a few significant players and is moderately competitive. F. Hoffmann-La Roche Ltd., Novartis, and Pfizer are the principal players on the market. To increase their market shares, the companies now operating in the industry concentrate on new product developments, business expansions, the discovery of new markets, and advancements in their core competencies.

Some key instances of development include:

  • In April 2022, Pfizer invested USD 25 million in stock in Zentalis Pharmaceuticals, Inc. to assist in its global development capabilities.
  • In June 2022, Roche unveiled an HPV self-sampling solution, which enables patients to perform HPV screening in the presence of a healthcare provider. It also predicted that this would increase the company's selection of cancer screening products.

Similarly, the team at Persistence Market Research has tracked recent developments related to companies in the urothelial carcinoma diagnostics market, which are available in the full report.

Urothelial Carcinoma Diagnostics Industry Report Scope



Forecast Period

2023 to 2033

Historical Data Available for

2015 to 2022

Market Analysis

USD Million for Value

Key Countries Covered

  • United States
  • Canada
  • Brazil
  • Argentina
  • Mexico
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Nordic Countries
  • India
  • Thailand
  • Malaysia
  • Indonesia
  • China
  • Japan
  • South Korea
  • Australia
  • New Zealand
  • Türkiye
  • GCC countries
  • North Africa
  • South Africa

Key Market Segments Covered

  • Product
  • Test
  • End User
  • Region

Key Companies Covered

  • Roche Holding
  • Illumina
  • IDL Biotech
  • Agilent Technologies
  • Olympus Corporation
  • Philips Healthcare
  • Abbott Molecular
  • Bio-Rad Laboratories, Inc.
  • Thermo Fisher Scientific, Inc. (Qiagen N.V.)
  • Danaher Corporation (Cepheid)
  • GE Healthcare

Report Coverage

  • Market Forecast
  • Competition Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives

Customization & Pricing

Available upon Request

Key Segments Covered in Urothelial Carcinoma Diagnostics Industry Research


  • Reagent and Kits
  • Instruments


  • Urinalysis Test
  • Molecular Diagnostic Test
  • Biomarker Test
    • Immuno-Histochemical Assay Test
    • In Situ Hybridization Test
    • Biopsy
    • Cell-Based Test
  • Imaging Test
  • Cytoscopy
  • Ureteroscopy

End User:

  • Hospitals
  • Diagnostic Laboratories
  • Research and Academic Institutes
  • Clinical Research Organizations


  • North America
  • Latin America
  • Europe
  • South Asia
  • East Asia
  • Oceania
  • Middle East and Africa

- Companies Covered in This Report -

  • GE Healthcare
  • Roche Holding
  • Illumina
  • IDL Biotech
  • Agilent Technologies
  • Olympus Corporation
  • Philips Healthcare
  • Abbott Molecular
  • Bio-Rad Laboratories, Inc.
  • Thermo Fisher Scientific, Inc. (Qiagen N.V.)
  • Danaher Corporation (Cepheid)

- Frequently Asked Questions -

The global market is currently valued at around US$ 1.4 Billion in 2022.

The global market is estimated to reach around US$ 1.5 Billion in 2023.

The global market expected to be valued at around US$ 4.3 Billion by the end of 2033.

Sales of the market are set to witness growth at a CAGR of 10.9% between 2023 and 2033.

Demand for the global market increased at a 9.6% CAGR from 2015 – 2022.

The U.S., Germany, China, the U.K., and Canada account for most demand within the market, currently holding around 55.7% market share.

The U.S. accounts for around 86.9% share of the North American market in 2022.

The China market held a share of about 46.7% in the East Asia urothelial carcinoma diagnostics market in 2022.

The Germany market held around 30.7% market share of the Europe market in 2022.

Roche Holding, Illumina, IDL Biotech, Agilent Technologies, Olympus Corporation, Philips Healthcare, Abbott Molecular, Bio-Rad Laboratories, Inc., Thermo Fisher Scientific, Inc., Qiagen N.V., Danaher Corporation (Cepheid) and GE Healthcare are the leading players in the global market.

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