Cancer Diagnostics Market

The global cancer burden is significant with an estimated 43.8 million people living with cancer, 18.1 million new cases and 9.6 million deaths in 2018.[1] The incidence of cancer is expected to rise to 29.4 million new cases by 2040 due to population aging and growth.4 The most commonly diagnosed cancers worldwide were lung cancer, breast cancer, colorectal cancer, prostate and stomach cancer in 2018. Cancer is a leading cause of premature death with the highest burdens in China, Europe and North America. In the USA, more than 1,735,350 diagnoses of cancer were estimated in 2018, causing more than 609, 640 deaths. The cancer burden can be reduced by improved prevention, early detection, availability of cancer screening programs and effective treatment to improve patient outcomes and reduce mortality.

The development of ‘omics’ technologies has led to the field of precision oncology, which comprises tailoring treatment regimens to the molecular characteristics of each patient’s tumour. The current gold standard for diagnosis and molecular profiling of tumours typically involves the use of tissue biopsies. Given their invasive nature, tissue biopsies are associated with many limitations, including patient risk, sample preparation, sensitivity and accuracy, procedural costs and incompatibility for clinical longitudinal monitoring. Furthermore, a significant limitation of tissue biopsies is that they fail to capture intra-tumoral and inter-metastatic genetic heterogeneity, further impacting the accuracy of the test.

BARD1’s approach using liquid biopsies (blood tests) have a great potential to overcome these existing sampling limitations. Blood is a rich source of tumor-associated biomarkers, which can be isolated from several biosources. These include the cell fraction, encompassing leucocytes, circulating tumor cells (CTC), and circulating endothelial cells (CEC), and the supernatant (plasma and serum) fraction, which contains extracellular vesicles (EV), cell-free DNA (cfDNA) and RNA (cfRNA), proteins and metabolites, and tumor-educated platelets (TEP). These are illustrated below:

 

The tumor circulome comprises all the tumor-derived elements circulating in the bloodstream that can be used, directly or indirectly, as a source of cancer biomarkers. It includes circulating tumor proteins, circulating tumor (ct)DNA, circulating tumor cells (CTCs), tumor-derived extracellular vesicles (EVs) and their constituents, circulating tumor (ct)RNAs and tumor-educated platelets (TEPs). Source: De Rubis et al, Trends in Pharmacological Sciences, 2019; 40:172-186.

Each biomarker has potential for blood-based cancer diagnostics, companion diagnostics, prognostics, and therapy selection and monitoring. Liquid biopsies may thus enable:

  1. early detection of cancer (screening),
  2. prognostication by providing information about stage and spread of the disease,
  3. identification of new targets for personalized treatment,
  4. pre-treatment therapy response prediction,
  5. early therapy response monitoring and “real-time” assessment of treatment effectiveness,
  6. selection of cancer treatment with the highest likelihood of success, and
  7. early detection of recurrence of the disease.

 

The Company has a marketed product for bladder cancer and development programs for the detection of ovarian, breast, prostate and lung cancer.

Bladder Cancer is among the more commonly occurring cancers. It ranks tenth in worldwide absolute incidence: sixth in men and seventeenth in women[2]. Worldwide approximately 550,000 cases were diagnosed in 2018 with almost 425,000 in males and over 125,000 in females1. In 2018 approximately 200,000 patients died from Bladder Cancer1. Globally the Age Standardized Incidence Rate (ASR) for mortality among males is 3.2 per 100,000 per year versus 0.9 per 100,000 per year among females.

Ovarian cancer was the seventh most common cancer in women, the leading cause of gynaecological cancer death and was responsible for 5% of all female cancer deaths worldwide with 295,414 new cases and 184,799 deaths in 2018.4 There is currently no screening test recommended for ovarian cancer, which is often diagnosed at a late-stage after symptoms have occurred resulting in a poor 5-year survival rate of only 47%.[3]

Breast cancer is the second most commonly diagnosed cancer and leading cause of cancer death in women worldwide with 2.1 million new cases and 626,679 deaths in 2018. Breast cancer has good 5-year survival rates of approximately 90% due to mammography screening, increased awareness and improved treatments.

Prostate cancer is the second most frequent cancer diagnosis made in men and the fifth leading cause of death worldwide. Based on GLOBOCAN 2018 estimates, 1,276,106 new cases of prostate cancer were reported worldwide in 2018, with higher prevalence in the developed countries. Differences in the incidence rates worldwide reflect differences in the use of diagnostic testing. Prostate cancer incidence and mortality rates are strongly related to the age with the highest incidence being seen in elderly men (> 65 years of age). African-American men have the highest incidence rates and more aggressive type of prostate cancer compared to White men.

Lung cancer is the most commonly diagnosed cancer and leading cause of cancer death worldwide with 2.1 million new cases and 1.8 million deaths in 2018. Lung cancer has poor survival rates of 19% due to late-stage detection with either no screening program or low-dose computed tomography (LDCT) screening offered for high-risk smokers in some countries. The potential for a lung cancer screening test is large.

Early detection of cancer before it has spread (metastasised) can increase the 5-year survival rate up to 89% for ovarian cancer, 99% for breast cancer and 55% for lung cancer.

Cancer 5-year survival rates

There is a clear unmet need for non-invasive, accurate and reliable diagnostic tests for early detection of cancer to improve patient outcomes, save lives and reduce healthcare costs.

The global liquid biopsy market size was expected to reach US$ 5.96 billion by 2030, according to Grand View Research, Inc. While tissue biopsies have been the standard for cancer diagnoses, their highly invasive nature, frequently associated complications and high cost have been of significant concern. Liquid biopsies, in which body fluids such as serum, plasma and urine are tested for the presence of cancer-associated biomarkers offer a less invasive approach. The key to expanding the use of liquid biopsy is to discover and develop biomarkers that are highly sensitive and specific for the cancer they are associated with. No blood tests are currently approved for early detection of ovarian, breast or lung cancers.

BARD1 autoantibody tests are targeting the large global market opportunity that exists for accurate, reliable and affordable liquid biopsy tests which are less invasive and more convenient alternatives to current tissue biopsy and imaging methods (such as ultrasound for ovarian cancer, mammography for breast cancer and low-dose computed tomography for lung cancer) that suffer cost, convenience, safety and other limitations.

 

Incidence, mortality and market potential for cancer screening tests

Note: dollar amounts are in USD.

The Company’s tests have the potential to detect cancer earlier, improve patient outcomes, save lives and reduce healthcare costs.

[1] WHO. 2018.

[2] Ferlay J et al (2018) Global cancer observatory: cancer today. Available from: https://gco.iarc.fr/today. Accessed date 01 May 2019

[3] ACS 2017.