U.S. Prostate Cancer Testing Market - A Country Analysis: Focus on Type of Biomarker, Application, End User, and Region - Analysis and Forecast, 2022-2030

U.S. Prostate Cancer Testing Market - A Country Analysis: Focus on Type of Biomarker, Application, End User, and Region - Analysis and Forecast, 2022-2030

U.S. Prostate Cancer Testing Market Industry Overview

The U.S. prostate cancer testing market is anticipated to reach $1,901.6 million in 2030 from $544.1 million in 2021, with a CAGR of 14.7%, during the forecast period 2022-2030. The growth in the U.S. prostate cancer testing market is expected to be driven by high investments in the field of cancer research and the rising prevalence of prostate cancer in U.S. In addition, the focus of business leaders is establishing a deep understanding to address the unmet needs in clinical research to understand the prostate cancer market.

Market Lifecycle Stage

The U.S. prostate cancer testing market is in progressing phase. PSA screening or testing in a general population has increased the incidence of prostate cancer in recent decades. In addition, prostate cancer testing is essential in precision medicine because it assures the safe and successful use of tailored therapies. The majority of the companies in the U.S. prostate cancer testing market provide biomarker tests that are urine, blood, and tissue-based, as well as testing services. Furthermore, applications of prostate cancer testing are primarily clinical and research.

Impact

One of the main reasons for the expansion of the prostate cancer testing market in the upcoming years is the rise in prostate cancer cases. Prostate cancer is the second most frequent disease diagnosed in men, and its frequency is rising across the globe. Prostate cancer is thought to be diagnosed in one million additional cases worldwide each year. Due to an aging population, growing urbanization, and accompanying lifestyle changes, the overall incidence of prostate cancer has increased over the past few decades.

Impact of COVID-19

During the coronavirus disease 2019 (COVID-19) pandemic, a number of disease models issued warnings about an excess of cancer fatalities brought on by missed cancer screenings as a result of the general population's quarantine and a lack of healthcare resources. The COVID-19 pandemic has had a negative impact on early diagnosis in the specific case of prostate cancer, the second most common cancer in men, by reducing participation in screening programs and on time from diagnostic testing to surgery/radiotherapy, which may translate into a worse prostate-cancer-specific death rate in the coming years. Additionally, in other areas, including Florida, state governments disallowed non-essential healthcare services.

Significant reductions in cancer screenings were seen in the early stages of the COVID-19 pandemic. According to a research paper published in January 2022 by the University of Florida, screenings for prostate cancer were reduced by 74%. Due to these screening figures, there may have been thousands more cancer deaths in the U.S. than were registered.

For instance, prostate-specific antigen (PSA) testing rates and the identification of several urological malignancies, including prostate cancer, have been found to be declining in significantly afflicted populations. Several Australian urologists worry that men with possibly curable prostate cancer may have missed their chance for a cure due to low screening test uptake during the lockdowns of 2020. According to a research paper published by BMC Urology in June 2022, a total of 4,048,099 PSA tests and 118,328 prostate biopsies were performed in Australia over the six years of data analysis. In the years 2019 and 2020, 68,429 prostate magnetic resonance imaging (MRI) were performed. Between 2015 and 2019, there were, on average, 19,573 prostate biopsies and 678,082 PSA testing performed per year.

Market Segmentation:

Segmentation 1: by Biomarker Type

• Initial Evaluation: Prostate-Specific Antigen (Total PSA, Free PSA)
• Pre-Biopsy/Post-Negative Biopsy Testing
• Post-Biopsy Tissue Testing

Based on biomarker type, the pre-biopsy test in the U.S. prostate cancer testing market is expected to be dominated by the biomarker type segment. This is due to the increasing popularity of prostate cancer testing and rising awareness related to prostate cancer testing.

Segmentation 2: by Application

• Diagnostics Biomarkers
• Prognostics Biomarkers

Based on application, the U.S. prostate cancer testing market is dominated by the diagnostics biomarkers segment owing to the rising R&D activity focused on the development of prostate cancer testing. The diagnosis of prostate cancer has developed a new molecular-based diagnostics technology. To detect clinically relevant cancer upon diagnosis, several tools or therapeutic options are required to improve the patient’s quality of life.

Segmentation 3: by End User

• Cancer Research Institutes
• Diagnostic Laboratories
• Hospitals and Clinics
• Ambulatory Surgical Center (ASCs)
• Others

As of 2021, the U.S. prostate cancer testing market (by end user) was dominated by ambulatory surgical centers (ASCs), holding a 28.55% market share with a market value of $155.3 million.

Segmentation 4: by Region

• Northeast U.S.
• Midwest U.S
• South U.S.
• West U.S.

The TAM of the pre-biopsy/post-negative biopsy testing segment is expected to grow at a CAGR of 4.5% during the forecast period 2022-2030 in the South U.S. prostate cancer testing market. Several established diagnostics manufacturers in this region who are focusing on expanding their portfolios in prostate cancer testing and are collaborating with service providers and pharmaceutical giants to co-market prostate cancer testing solutions with its complementary precision medicine solutions. Moreover, the U.S. government is currently undertaking several initiatives to develop tests for cancer and provide funds to new start-ups in the cancer diagnostics field.

Recent Developments in the U.S. Prostate Cancer Testing Market

• In September 2022, Veracyte, Inc. announced the publishing of data in the Journal of the National Cancer Institute to demonstrate the company’s decipher prostate genomic classifier may help identify African American men with early, localized prostate cancer who are most likely to harbor more aggressive disease.
• In August 2019, BioReference Laboratories, Inc. announced the selection by The IPA Association of America (TIPAAA) as its provider of laboratory services and to assist with data analytics for its members’ patients. The agreement is designed to enhance patient care and offers collaborative health management tools to TIPAAA members, which includes more than 667 medical organizations in 39 states. The members can have convenient access to BioReference’s comprehensive laboratory testing menu, including routine and specialty tests, as well as the 4Kscore for detecting aggressive prostate cancer.
• In June 2021, Thermo Fisher Scientific announced submissions open for the Oncomine Clinical Research Grant program to support clinical research projects in oncology. The grant aims to provide funding for high-quality molecular profiling studies focusing on the impact of immune-based treatments for cancer patients.

Demand - Drivers and Limitations

The following are the demand drivers for the U.S. prostate cancer testing market:

• Rising Prevalence of Prostate Cancer in the U.S.
• Increasing Number of Prostate Cancer Screening and Testing
• Government Initiatives Related to Prostate Cancer

The market is expected to face some limitations due to the following challenges:

• High Probability of False Positives during Prostate Cancer Testing
• Clinical Gaps Related to Prostate Cancer Testing

How can this report add value to an organization?

Workflow/Innovation Strategy: The workflow segment helps the reader understand the two prostate cancer testing, i.e., initial evaluation: prostate-specific antigen (total PSA, free PSA), pre-biopsy/post-negative biopsy testing, post-biopsy tissue testing, which further aid in diagnosis. Moreover, the study provides the reader with a detailed understanding of the different applications of prostate cancer testing in clinical and research applications.

Growth/Marketing Strategy: Prostate cancer testing is being used for both research and clinical application. Various companies are providing urine and blood, and tissue-based biomarkers that aid in the diagnosis, which is also the key strategy for market players to excel in the current prostate cancer testing market.

Competitive Strategy: Key players in the U.S. prostate cancer testing market are analyzed and profiled in the study, including manufacturers who are involved in new product launches, acquisitions, expansions, and strategic collaborations. Moreover, a detailed competitive benchmarking of the players operating in the U.S. prostate cancer testing market has been done to help the reader understand how players stack against each other, presenting a clear market landscape. Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.

Key Market Players and Competition Synopsis

The companies that are profiled have been selected based on inputs gathered from primary experts and analyzing company coverage, product portfolio, and market penetration.

Key Companies Profiled:

• Abbott.
• Abcam plc.
• Agilent Technologies, Inc.
• Bio-Techne. (ExoDx)
• Cleveland Diagnostics, Inc.
• Danaher. (Beckman Coulter, Inc.)
• Exact Sciences Corporation
• F. Hoffmann-La Roche Ltd (FOUNDATION MEDICINE, INC.)
• H.U. Group Holdings, Inc. (Fujeribio)
• mdxhealth.
• Siemens Healthcare GmbH
• Myriad Genetics, Inc.
• NeoGenomics Laboratories.
• OPKO Health, Inc. (GenPath)
• Veracyte, Inc.

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