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The pandemic has fueled new market growth and will continue to shape the future of diagnostics

A Look Ahead: Clinical Diagnostics and Cell & Gene Therapies

The pandemic has fueled new market growth and will continue to shape the future of diagnostics

Marwan Alsarraj, MS

Marwan Alsarraj is the biopharma segment manager at Bio-Rad. He has been at the forefront of developing, marketing, and commercializing technologies for the past 15 years in the life science...

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Published:Dec 20, 2021
|3 min read
Marwan Alsarraj, MS, biopharma segment manager at Bio-Rad Laboratories.

COVID-19 has spotlighted the need for quick, accurate, and convenient diagnostics and novel approaches to personalized medicine. But while the pandemic has led to an explosion of innovation in technologies and techniques needed to detect, trace, and stop SARS-CoV-2, it has also spurred a renewed interest and investment in the life science industry. 

For example, the pandemic has created new market drivers that will fuel growth and continue to shape the future of two burgeoning industries: molecular diagnostic development and cell and gene therapy development. 

In this article, we’ll speculate on the nature of this growth in these respective fields.

Clinical diagnostics

The clinical diagnostics market was valued at approximately $63.3 billion in 2020, and it is expected to reach $93.9 billion by 2026. This growth can be attributed to an increased incidence of infectious and chronic diseases and the increasing adoption of automated platforms, such as what we saw with COVID-19.

Implementing ddPCR on a broader scale

Due to the anticipated rise in the frequency of disease outbreaks, and the public’s demand for faster diagnoses, the health care system will demand faster, more sensitive, quantitative, easily scalable testing platforms. qPCR has become the standard technology used for COVID-19 testing, but it has proved inferior where more accurate sensitivity is needed, such as in oncology testing. 

Droplet digital PCR (ddPCR) technology offers enhanced sensitivity. It uses a combination of microfluidics and proprietary surfactant chemistries to divide PCR samples into tens of thousands of water-in-oil droplets and run individual endpoint reactions to quantify the concentration of nucleic acids in a sample. 

ddPCR surpasses the performance of earlier digital PCR techniques by resolving the previous lack of scalable and practical technologies for digital PCR implementation. As a result, implementing ddPCR on a broader scale will increase the reliability of infectious disease testing.

Improving cancer diagnostics

The increasing role of ddPCR as a molecular diagnostic tool will also help feed a rise in demand for faster, more personalized molecular diagnostics for cancer. In recent years, the clinical management of cancer has evolved toward more personalized strategies that require a comprehensive knowledge of the complex molecular features involved in tumor growth and evolution, as well as the development of drug resistance mechanisms leading to disease progression. 

Meanwhile, physicians are discovering that diagnostics and treatment regimens are influenced more by the genetic mutations associated with cancer than the organ in which the first tumor appeared. ddPCR has become one of the most accurate and reliable tools for examining genetic alterations in a wide variety of cancers because of its high sensitivity and specificity. 

ddPCR is currently being applied for absolute allele quantification, rare mutation detection, analysis of copy number variations, DNA methylation, and gene rearrangements in different kinds of clinical samples.

Cell and gene therapies

Oncologists and other physicians are also witnessing a rise in the development of more effective therapies, such as gene therapies for genetic illness and cell therapies for cancer. The cell and gene therapy market is expected to rise from $7.7 billion in 2021 to $13.8 billion by 2026. 

This segment’s high growth rate can be attributed to increasing government funding for cancer research and the increasing number of ongoing cell and gene therapy clinical trials. The FDA predicts that by 2025, they will approve 10–20 cell therapies per year. However, the high operational costs associated with cell and gene therapy manufacturing are expected to restrain the growth of this market to a certain extent.

In addition to a rise in cell therapy approvals, it is predicted that between 200 and 300 cell therapy trials will begin or enter Phase 2 in 2022. 

These markets are expected to grow because of these therapies’ potential in the clinic. For example, cell therapies have the potential to eliminate cancer cells without damaging normal, healthy tissue. Furthermore, cell therapies may provide alternatives when disease does not respond to other more traditional treatments.

In addition, ddPCR is expected to alleviate some operational costs currently holding back clinical trials. Most clinical trials fail in Phase 3 after investors have spent untold amounts of money investigating a therapeutic candidate. Molecular testing tools like ddPCR technology can speed up the “failing” process by offering more sensitive, accurate, and real-time results, helping to reduce costs from the preclinical research phase to FDA approval.

Exciting possibilities to come

The way we tackle some of humankind’s most challenging diseases will continue to evolve. These market drivers and trends bring new and exciting possibilities for clinical diagnostics and cell and gene therapies. As a result, manufacturers, physicians, and patients are learning more every day about their potential to treat various diseases, including cancer and more.