Digital PCR Market: Opportunities & Challenges

The Digital PCR Market is estimated to grow to USD 6,270.9 million by 2024 from USD 4,113.3 million in 2019, at a CAGR of 8.8%. Factors such as the rising incidences of target infectious diseases and genetic disorders; continuous technological advancements in PCR technologies; increasing investments, funds, and grants; increasing use of biomarker profiling for disease diagnostics; and successful completion of the Human Genome Project are driving the growth of this market. However, the high instrument costs—especially that of dPCR—and the technical limitations of PCR have restricted their greater use.

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How growing market penetration in emerging countries is affecting the Digital PCR/Real-Time PCR market?

Emerging markets are expected to offer significant growth opportunities, led by the rising incidence of infectious and chronic diseases as well as increasing R&D initiatives to develop innovative genomic techniques such as qPCR and dPCR. Growth will be supported by the expansion of healthcare infrastructure, increase in healthcare expenditure, and reducing procedural costs for qPCR-based & dPCR-based disease diagnosis in emerging countries. Emerging countries are witnessing rapid modernization in healthcare facilities and the expansion of healthcare infrastructure. This factor is contributing to the growing demand for clinical diagnostic procedures among diagnostic laboratories, which is resulting in the increased sales of clinical qPCR and dPCR products.

Moreover, to meet the growing demand for qPCR and dPCR products in emerging markets, prominent reagent manufacturers are strategically focusing on inorganic strategies (such as partnerships and collaborations) to strengthen their distribution networks and enhance their manufacturing capabilities. For instance, as of February 2017, ~1,022 biotechnology-based start-ups are active in India, with a total investment of USD 2.8 billion (INR 18,700 crore) during 2012–2016 (Source: Association of Biotechnology Led Enterprises, India).

Moreover, increasing competition in mature markets is affecting the revenue growth of global players; this will prompt them to focus on emerging markets for generating additional revenue.

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How is the adoption and implementation of MIQE guidelines affecting the Digital PCR/Real-Time PCR market?

Currently, the use of qPCR and dPCR techniques is unregulated globally, which has made end users reluctant to use qPCR and dPCR products in genomic analysis and disease diagnosis. This is mainly due to a non-uniform consensus that exists for the method by which qPCR/dPCR experiments should be conducted, to obtain quality results in a time-bound manner. However, there have been attempts to develop guidelines that can streamline and define the minimum requirements needed to carry a qPCR/dPCR-based genomic procedure in a scientific manner with efficient data generation and interpretation.

In this regard, the Minimum Information for the Publication of Quantitative Real-time PCR Experiments (MIQE) guidelines were published in the Journal of Clinical Chemistry (April 2009). This included directions for researchers to develop a robust qPCR-based experiment and the evaluation of generated data. However, the main challenge for its universal adoption and acceptance includes tedious preparation and considerations needed prior to performing the actual PCR procedure. These considerations pertain to sample storage conditions, reactant quality, and extraction method, among other factors.

These factors have restrained the adoption of MIQE guidelines among researchers, which is evident from the fact that, in 2013, only 7% of the published qPCR-based research papers cited MIQE guidelines (Source: The International Journal of Life Science Methods). This underscores the huge trust deficit among researchers that currently exists globally for adopting qPCR and dPCR techniques in genomic analysis. This is a significant challenge to the future growth of the qPCR and dPCR technology, including instruments and reagents, globally.

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