Overview
Global Prostate Cancer Diagnostics Market reached US$ 5.1 billion in 2022 and is expected to reach US$ 11.6 billion by 2030 growing with a CAGR of 11.1% during the forecast period 2023-2030.
Prostate cancer can often be found early by testing prostate-specific antigen (PSA) levels in a man’s blood or digital rectal exam (DRE). According to a study in the United States, the annual screening with PSA and DRE did detect more prostate cancers than in men not screened, but this screening did not lower the prostate cancer death rate.
Early diagnosis of prostate cancer effectively is crucial. Once the staging begins, treating with any available procedure becomes challenging. It is also diagnosed with a prostate biopsy, which removes tissue from the prostate to examine it for cancer cells. Some urologists use MRI and ultrasound technology to achieve a more apparent biopsy target. The PSA blood test is used mainly to screen for prostate cancer in men without symptoms. It’s also one of the first tests done in men suspecting prostate cancer.
Furthermore, the integration of AI in magnetic resonance imaging (MRI), increasing new technologies for improving diagnosis, and rising awareness about early diagnosis among males are the factors that will drive the market in the forthcoming years.
Dynamics
Rising Pipeline products
Several Pipeline products are on the rise as the demand for prostate cancer diagnosis increased in recent years due to the rising incidence of prostate cancer among males. For instance, in 2023, Lantheus is working on the development of 1404, which is a Tc-99m-labeled molecule that binds to PSMA and is used as a SPECT/CT imaging agent to diagnose and detect localized prostate cancer as well as soft tissue and bone metastases. ROTOP has exclusive rights to develop, manufacture, and commercialize 1404 in Europe.
For instance, St Vincent’s Hospital collaborated with Clarity Pharmaceuticals Ltd to conduct phase 2 clinical trials to evaluate Copper-64 SAR Bombesin in PSMA Negative Prostate Cancer. Radiolabeled antagonist analog of bombesin to explore the diagnostic potential of 64Cu-SAR-BBN PET In men with rising PSA and negative PSMA PET. The estimated completion date is June 2024.
Improvements in Diagnosis with the Integration of Artificial Intelligence
Research on AI-assisted prostate cancer diagnosis is also evolving rapidly and has the potential to facilitate all aspects of the current standard diagnostic pathway. Moreover, AI models can help cancer diagnosis by reducing supporting tasks in cancer detection that are labor and experience-intensive, such as prostate gland segmentation, MRI-ultrasound registration, MRI-ultrasound fusion biopsies, and MRI-histopathology registration for developing cancer detection models.
For instance, in March 2023, Qritive introduced QAi Prostate, an advanced artificial intelligence (AI)-powered prostate cancer diagnosis tool. By leveraging advanced machine learning (ML) algorithms, QAi Prostate can accurately identify prostatic adenocarcinoma regions and classify malignant and benign tumor areas in biopsy tissue samples.
Complications related to Biopsy procedures
TRUS biopsy is associated with some risks, including pain, acute urinary retention, haematuria, haematospermia, rectal bleeding, erectile dysfunction, infection, and sepsis. The rising rates of disease and sepsis internationally are of concern. Historically, infection complicated approximately 1% of patients who underwent TRUS biopsy, but this figure has risen to 2–4% in recent years. Men with significant risk factors for sepsis, such as immunocompromise, type 2 diabetes mellitus, recent hospitalization, and COPD (Chronic obstructive pulmonary disease), could be considered for procedures other than TRUS biopsy.

Segment Analysis
The global prostate cancer diagnostics is segmented based on test type, cancer type, stage, end-user, and region.
The Segment Accounted for Approximately 45.3% of the Market Share
Prostate-specific Antigen (PSA) is a protein produced by prostate cells, and the PSA test is performed to diagnose prostate cancer (PCa) in men and for follow-up post-treatment to check if the cancer relapses. PSA testing is essential for detecting prostate cancer, which measures PSA levels in a man’s blood.
Medicare and several private insurers provide coverage for an annual PSA test for all Medicare-eligible men aged 50 and older. PSA testing is gaining popularity among clinicians and hospitals owing to the increasing number of people affected by prostate cancer. For instance, on February 2023, LynxDx, Inc., a developer of innovative diagnostic solutions, is introducing MyProstateScore 2.0 (MPS2), a non-invasive, data-driven, urine prostate cancer screening test that provides highly accurate, stratified risk assessment insights to guide clinical decisions for patients with elevated prostate-specific antigen (PSA) or abnormal digital rectal exam (DRE) findings. Due to increased innovations and advancements in PSA testing is expected to hold the largest market share in the forthcoming period.

Geographical Analysis
North America accounted for Approximately 39.2% of the Market Share in 2022
North America dominates the global prostate cancer diagnostics market, with the United States accounting as the primary contributor. Prostate cancer is one of the most common cancers in American men, which is made apparent by the statistics surrounding it. It affects 1 out of eight men in the U.S. after skin cancer; it is the most common cancer in U.S. men.
American Cancer Society estimated that in 2022, around 268,490 novel cases of prostate cancer were detected. Some of prostate cancers are aggressive, but most of them grow slowly. The number of deaths increases yearly, making prostate cancer the second leading cause of cancer death in men in the United States. Hence, it is considered to have an early diagnosis of the condition.

COVID-19 Impact Analysis
The effects of the pandemic on clinical trials were felt throughout administrative and clinical practices. Clinical trial initiation and recruitment were typically halted at the beginning of the pandemic as infection control measures were implemented. In a March 2021 report, a 60% decrease in new oncology clinical trials during the pandemic was noted, fueling concerns regarding slowing the development of new cancer therapies.
The focus of research and development efforts shifted during the pandemic, with a significant emphasis on developing vaccines and treatments for COVID-19. A major UK-based cancer research charity, Cancer Research UK, halted recruitment in 95% of their clinical trials, both to protect cancer patients and to cope with the redeployment of clinical research staff to support frontline COVID-19-facing healthcare services.
By Test Type

  • Digital Rectal Exam
  • PSA Blood Test
  • Biopsy


o Prostate Biopsy
o Transrectal Biopsy
o Transperineal Biopsy
o Lymph node Biopsy

  • Genetic Testing
  • Imaging Tests


o Transrectal Ultrasound (TRUS)
o Magnetic Resonance Imaging (MRI)
o Nuclear Imaging

  • Others


By Cancer Type

  • Benign Prostate Hyperplasia
  • Prostatic Adenocarcinoma
  • Small Cell Carcinoma
  • Ductal prostate cancer
  • Others


By Stage

  • I
  • II
  • III
  • IV


By End Users

  • Cancer Centers
  • Specialty Clinics
  • Others


By Region

  • North America


o U.S.
o Canada
o Mexico

  • Europe


o Germany
o U.K.
o France
o Spain
o Italy
o Rest of Europe

  • South America


o Brazil
o Argentina
o Rest of South America

  • Asia-Pacific


o China
o India
o Japan
o Australia
o Rest of Asia-Pacific

  • Middle East and Africa


Key Developments

  • In July 2023, BPGb partnered with Grupo Terralpe to Offer AI-Discovered Prostate Cancer Diagnostic Test in Mexico. Through their strategic partnership, Grupo Terralpe will bring the pstateDx test, BPGbio’s novel prostate cancer test to Mexico in an effort to improve clinical decision support for patients with elevated PSA levels who may have prostate cancer.
  • On February 2023, LynxDx, Inc., a developer of innovative diagnostic solutions is introducing MyProstateScore 2.0 (MPS2), a non-invasive, data-driven, urine prostate cancer screening test that provides highly accurate, stratified risk assessment insights to guide clinical decisions for patients with elevated prostate-specific antigen (PSA) or abnormal digital rectal exam (DRE) findings.
  • On March 2023, Novartis Pluvicto was approved by FDA as the first targeted radioligand therapy for the treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer



Competitive Landscape
The major global players in the prostate cancer diagnostics market include Myriad Genetics, Inc., Quanterix Corporation, MDx Health, Siemens Healthineers, F. Hoffman-La Roche AG, OPKO Health, Inc., Thermo Fisher Scientific Inc., Cellanyx Diagnostics Inc., MiR Scientific, and Proteomedix among others.
Why Purchase the Report?

  • To visualize the global prostate cancer diagnostics segmentation based on test type, cancer type, stage, end user, and region, as well as understand key commercial assets and players.
  • Identify commercial opportunities by analyzing trends and co-development.
  • Excel data sheet with numerous data points of prostate cancer diagnostics market-level with all segments.
  • PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
  • Product mapping available as Excel consisting of key products of all the major players.


The global prostate cancer diagnostics market report would provide approximately 53 tables, 54 figures, and 195 Pages.
Target Audience 2023

  • Manufacturers/ Buyers
  • Industry Investors/Investment Bankers
  • Research Professionals
  • Emerging Companies