The study of biomarkers is crucial for the development of diagnostics; therefore it is crucial to understand in detail the evolution of the various classes of biomarkers from their analysis in research to their utility as starting materials for diagnostics development. We have sought to understand the qualitative and quantitative trends operative in the various classes of biomarkers that are positioned to be utilized in the development of diagnostics in the future. The following presents a snapshot of the data from these market analyses that we have been performing on an ongoing and continual basis. The data presented in this report were collected in January 2016.
Comparison of the Growth of the Various Classes of Cancer Biomarkers
Figures 1A, 1B, and 1C present the growth of the various classes of cancer biomarkers as viewed by publication rates, which is an excellent bottom-up measure of the market size of a given class of biomarkers.
The various components of Figure 1 illustrate the growth, albeit at different paces, of the multiple emerging classes of cancer biomarkers. LncRNAs as well as exosomes are among the fastest-growing classes as assessed by four-year CAGR of the publications databases. Our illustration of this space demonstrates a continuum of biomarker classes that are emerging and evolving based on research data, validation data, and ultimately clinical utility data.
In this manner, the cancer biomarkers space en bloc represents a pipeline that is fueled from the front end with many analyte classes, and as these entities traverse the pipeline they undergo triage. A bottom-up analysis of the field accurately documents this evolution of the space.
We also present the four-year compound annual growth rate (CAGR) of selected cancer biomarker classes. A summary is presented in Figure 2. The CAGR data illustrates the relative growth of the various classes presented.
As can be observed from Figure 2, Liquid Biopsy is by far the fastest-growing term in the publications database.
Qualitative Trends in Cancer Biomarker Publications
The growth of the numbers of publications and their relative CAGRs is a good measure to assess the quantitative evolution of the cancer biomarkers space, but these metrics alone do not provide a picture of the space as it evolves—for example, what types of cancer are being targeted by a given biomarker class, or which technology platform is being deployed to interrogate the biomarker class in question. These are important issues to consider as we seek to track the evolution of the marketplace for the various cancer biomarker classes.
We therefore performed an analysis of the qualitative nature of each of the cancer biomarker classes we have studied by capturing the titles of all the publications of each biomarker class (en bloc capture) and then displayed these into a word cloud format. The relative size of each word derived from the publication titles is proportional to the abundance of that word in the publication database. The data are presented in Figures 3A through 3H.
These word clouds could be viewed as infographics as they provide a schematic representation of the biomarker class and the sizes of the various words, each of which is indicative of abundance and representation in the publications database. We believe this provides an effective bottom-up picture.
Circulating Cancer Biomarkers Drive Precision Medicine
We have sought to provide data, both quantitative and qualitative in nature, to characterize the landscape of emerging molecular analytes, many of which are in the running to be most promising of the next-generation of diagnostic entities. Many of these expanding biomarker classes consist of circulating biomarkers; that is, they are found in biological fluids and therefore have the potential to be harvested in a minimally invasive manner for the development of liquid biopsies.
Therein lays the future opportunity. As oncologists, we liken it to performing a tissue biopsy: You are only viewing one part of the tumor and acquiring one perspective on the disease. On the other hand, when you perform a biofluid biopsy you get a snapshot of the entire tumor and therefore can identify variants and mutations that may be at extremely low abundance, but which may contribute to the tumor’s virulence and potential metastatic progression.
The eventual successful deployment of cancer precision medicine requires the following elements:
Clinical validation and utility of biomarkers associated tightly with a particular disease class
Ability to capture the cancer biomarkers that represent in toto the disease (In the case of metastatic disease it is impossible to perform traditional biopsies to capture all the metastatic lesions and a biofluid biopsy approach is the most realistic alternative to capture the biomarkers from the various metastatic lesions.)
Targeted therapeutics that address the molecular lesion (mutation) associated with disease manifestation, progression, or sequelae (In this manner, the knowledge of the cancer biomarker represented in the disease drives decision making vis-à-vis the therapeutic entity that must be applied.)
A means to monitor efficacy of the therapeutic. Here again a biofluid-based biomarker capture approach enables longitudinal disease monitoring over time as a means to address treatment efficacy and if any adjustments are required to the therapeutic or combinations thereof.
We have presented up-to-date data analyzing the cancer biomarkers market landscape with the goal of providing not only quantitative trends in the space but also a picture of this landscape as it rapidly evolves. We believe that the drive toward personalized precision medicine will accelerate the rate of evolution of the cancer biomarkers space. The most suitable and robust molecular entities will be the ones that prevail and traverse closer to clinical deployment. Already liquid biopsies based on circulating biomarkers are being launched, and we believe that 2016 will see even more new circulating cancer biomarker–based diagnostic tests.
Select Biosciences’ upcoming conference on Circulating Biomarkers brings all the stakeholders from academia as well as industry together to focus on the various classes of circulating biomarkers primarily addressing the cancer space, including CTCs, cell-free DNA, and exosomes/extracellular vesicles. Combined, these represent the leading edge of the cancer circulating biomarkers space and potential analytes for future development of minimally invasive diagnostics.