Molecular Diagnostics for Cancer Grows, Fueled by NGS-based Testing
Cancer diagnostics is a highly dynamic field that consists of various types of platforms. Molecular diagnostics platforms are increasingly becoming popular as they enable accurate diagnosis as well as prognosis evaluation, which are important for treatment decisions. In 2019, the market for molecular cancer diagnostics, including histology and assays, reached $1,600 million, increasing 11.5% over roughly $1,435 million in 2018. For 2020, growth is expected to remain relatively stable driving the market to $1,770 million for the year. Roche leads the market for oncology but Illumina comes in second, a testament to the increasing use of next-generation sequencing systems. The report can be found at: https://kaloramainformation.com/product/molecular-cancer-diagnostics-market/
The potential of molecular diagnostic tools was initially recognized by onco-hematologists during the 1980s based on the observation that specific chromosomal translocations may significantly aid the diagnosis of various types of leukemia and lymphoma. Later, the emergence of user-friendly molecular methods such as PCR has opened up practical applications that helped multiple approaches for cancer diagnosis and treatments. DNA sequencing is increasingly employed in cancer molecular diagnostics. PCR is the initial step used in isolating and amplifying specific regions of the genome, known as amplicons, before moving to sequencing of these regions, which are then compared with reference sequences to identify mutations.
Expectations for molecular diagnostics in cancer include the introduction of more biofluid-based (e.g. blood, urine) samples and tests indicated for cancer detection and monitoring. However, the current market remains largely composed of tissue-based tests, companion assays, and tests for the prognosis and diagnosis of specific cancer types.
The Cancer Genome Atlas (TCGA), a large-scale collaboration initiated and supported by the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI), has offered significant insights by generating data across various cancer types. TCGA concluded the most elaborate cross-cancer analysis undertaken in cancer research, namely the ‘PanCancer Atlas Project’ in April 2018, which received over $300 million funding. The project included analysis of all TCGA exome data by the Multi-Center Mutation-Calling in Multiple Cancers (MC3) network that interpreted data from over 10,000 tumor samples from 33 most prevalent forms of cancers. In a related research paper published in Cell (M. H. Bailey et. al, vol 173, P371-385 published on April 5, 2018), the authors reported the identification of 299 cancer driver genes by analyzing PanCancer data by applying PanSoftware. There are only a few targeted cancer therapies available today but over 800 oncology drugs are in development, many of which are designed to target specific mutations. With the emergence of new targeted therapies, there is a growing need for new companion diagnostic tests.
Rapid uptake of NGS is expected to have significant influence on cancer diagnostics and cancer management. NGS allows comprehensive description of germ-line DNA, analysis of somatic mutations, RNA profiles of naturally occurring tumors, etc. However, clinical integration of these advancements is expected to take a while. Even the integration of straightforward assays such as EGFR mutation or BRCA1/2 took several years and still many related issues are being studied. Hence, clinical medicine may not benefit significantly from the increasing numbers of novel candidate markers immediately due to the long time needed for clinical validation of molecular cancer diagnostics methods. Still, the demand for single gene genomics is expected to grow in cancer diagnostics, mainly in advanced markets such as the USA.
Promising innovation is evident in other relatively established markets as well, such as PCR and ISH. For instance, PCR-based molecular cancer diagnostics segment is being revolutionized by high-sensitivity technologies such as emulsion PCR including digital droplet PCR (ddPCR) and advanced separation reagents. ISH-based cancer assays are covered under the molecular histology application in the report.
There are several growth opportunities in the molecular cancer diagnostics market including:
• Global market to experience this strong level growth through the next five years.
• Increasing use of NGS technologies and liquid biopsy methods; reduction in PCR-based testing in developed markets
• Asia fastest growing market.
• Latin America continues to gain momentum but still slower than global average
• United States will remain largest market
Kalorama’s report Molecular Cancer Diagnostics reviews the current makeup of the molecular diagnostics market in cancer including its notable products and geographical segmentation. The report also reviews expected developments such as technology and product introduction. Expectations for molecular diagnostics in cancer include the introduction of more biofluid-based (e.g. blood, urine) samples and tests indicated for cancer detection and monitoring. However, the current market remains largely composed of tissue-based tests, companion assays, and tests for the prognosis and diagnosis of specific cancer types. Some of the most significant developments in this field that may have an impact in shaping cancer diagnostics and treatment management are assessed throughout the report. The report includes statistical information for cancers by type on a global level.
All market data pertains to the global market at the manufacturers’ level. The base year for data is 2019 with projections for 2020 and a forecasted market through 2025. Competitive analysis is provided for estimated and published data gathered for the 2019 year. The forecasted market analysis is based on product availability, cancer indications and sales of products expected to reach market by 2025, competitive trends, product marketing, cancer epidemiology, and demographic trends.
Information for this report were gathered using both primary and secondary research including comprehensive research of secondary sources such as company reports and literature; government documents and databases; research journals and reports; and general medical and business journals.
Primary research methods included telephone interviews and email correspondence with company representatives, researchers, government representatives, and physicians. These interviews were conducted with the purpose of capturing the perspectives from industry participants on the market opportunity and current trends. This was the basis of formulating forecast models and for confirming early findings related to market potential. Secondary research included billing databases and pricing charts.
Kalorama’s report is available at: https://kaloramainformation.com/product/molecular-cancer-diagnostics-market/
