To date, only two exosome-based diagnostics have gained FDA’s Fast Track Approval. One is Exosome Diagnostics/Bio-Techne’s ExoDx Prostate IntelliScore (EPI) test. The Breakthrough Device Designation was awarded on June 17, 2019. By granting the designation, FDA has acknowledged the need to avoid a painful and invasive prostate biopsy. The second diagnostic was Guardant Health’s Guardant360CDx, approved by the U.S. FDA on August 13, 2020. It is an exosome-based diagnostic that can detect metastatic non-small cell lung cancer (NSCLC).
According to Cancer.Net, in 2023, an estimated 288,300 men in the U.S. were expected to be diagnosed with prostate cancer. Worldwide, an estimated 1,414,259 people were diagnosed with prostate cancer in 2020. The average age at the time of diagnosis is 66 years. It is estimated that 34,700 deaths from this disease occurred in the U.S. in 2023. In 2020, an estimated 375,304 people worldwide died from prostate cancer.
According to Science News, globally each year, more than 1.3 million new cases are diagnosed. When Europe and North America are combined, nearly 2.0 million biopsies are tested every year. The ExoDx prostate test is a urine-based test indicated for men 50 years of age and older with a prostate-specific antigen (PSA) 2-10ng/ml. The test provides a risk score. The test can help reassure a patient to avoid a prostate biopsy or improve patient compliance with physician recommendation. The ExoDx Prostate Test was evaluated in two clinical trials with 1,022 patients and used in more than 30,000 patients since it was first launched. The cost of a test is $760.
Guardant Health’s Guardant360 CDx has been approved for tumor mutation profiling, in patients with any solid cancerous tumor. The test has also been approved as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib). The test offers patients and clinicians a simple, faster blood test to help inform personalized treatment options. The test has been used by more than 7,000 oncologists, and more than 150,000 Guardant360 tests have been performed in the U.S. to date. The cost of a single test is about $4,216.
The two approved exosome-based diagnostics are now generating commercial revenue and a few more diagnostics and therapeutics are expected to reach the market in the next few years. Key factors that are expected to fuel the growth of this market are an increased demand for cancer diagnostics and improvements in exosome technologies as new competitors continue to enter this field. Overall, the global market for exosome diagnostics and therapeutics is anticipated to grow notably by 2030, with a significant six year CAGR of 10.5%.
To learn more about this rapidly expanding market area, view the “The Global Exosome Market – Market Size, Forecast, Trials and Trends.”
