Companion Diagnostics in Oncology

Published On: October 2022

A companion diagnostic is a device of in vitro medical equipment that offers data necessary for the safe and efficient use of a matching medication or biological product. This diagnostic procedure aids a medical expert in determining whether a given therapeutic product would benefit patients and offset any possible serious dangers or adverse effects.


The prevalence of cancer is rising worldwide, which raises public awareness and the need for tailored therapies. There have been many prospects for applications in indications including cancer, cardiovascular, and neurological problems because corporations are increasing their cooperation for better biomarkers and diagnostics to concentrate on cost regulations.


By 2027, the companion diagnostics market is expected to register a CAGR of 20.29%, reaching USD 8.08 billion.


It is now well-accepted that medications can interact differently with different people because of genetic sequencing and genomics advancements. Giving "the correct drug, at the right time, at the right dose, for the right person" can be advanced with a greater understanding of a person's genetic traits or biomarkers. To give focused therapeutics to the appropriate candidate, pharmaceutical and biopharmaceutical companies continuously work to adopt patient-selection diagnostic frameworks in the early stages of drug development. This helps the companion diagnostics market share increase even more.


Companion diagnostic tests based on next-generation sequencing (NGS) attempt to unlock molecular information from each patient's tumor genome to advise cancer therapy treatment decisions. NGS's multiple technological developments also give market companies an immediate competitive advantage over players who offer other technologies like ICH, PCR, and ISH. While immunotherapy has been proven effective in cancer treatment, its high cost has limited patient access. Instead, doctors may decide that combining medicines is the best option, which might extend the treatment from five months to more than three years. In this scenario, the higher the cost, the longer the period. As a result, the market for companion diagnostics is projected to be hampered by the high price of immuno-oncology medicines.


The high expense of immunotherapy has restricted overall patient access even though it has shown tremendous promise in cancer treatment. The course of treatment could be increased from five months to over three years if doctors decide that it is beneficial to combine medicines. In this instance, the cost increases as the duration increases. Additionally, tailored immunotherapies are expensive.


The companion diagnostics market has been divided into categories based on technology, indication, products & services, and end users.


The discovery of new biomarkers for various conditions, the rise in demand for personalized medicine with increased awareness in emerging economies, the increased number of unmet needs for the treatment of cancer, and the surge in R&D of targeted therapies are the main factors driving the growth of the global companion diagnostics market.


Demand growth is also anticipated to be fuelled by increasing product approvals from major international companies. Pharmaceutical and biopharmaceutical companies are actively working to combine patient-selection diagnostic frameworks and provide the best applicant for targeted therapies in the early stages of drug development. This serves as additional support for the companion diagnostics industry's growth. Next-generation sequencing uncovers several biomarkers for numerous medication therapies in less time than other sequencing techniques. The evaluation of biomarkers using NGS panels in a single test has the potential to aid in the treatment of a variety of cancer types.


Globally, the Americas, Europe, Asia-Pacific, and the Middle East & Africa regions make up the global companion diagnostics market.


Due to ongoing technical developments targeted at creating companion diagnostic tests for novel indications like neurology and infectious disorders, North America holds the most significant worldwide market share. The FDA's risk classification of these procedures reflects that companion diagnostics is a critical treatment decision tool for various cancer medicines. Despite the COVID-19 outbreak, companion diagnostics clinical trials have gained prominence in the pharmaceutical sector because they increase the likelihood of clinical success. The testing kit has been in high demand for locating SARS-CoV-2-affected people. Diagnostic tests' development continues to focus on the new coronavirus primarily.


Several local and international businesses operate in the very competitive companion diagnostics market. Abbott Laboratories Inc., Agilent Technologies Inc., F. Hoffmann-La Roche Ltd, Biomerieux SA, and Qiagen NV are significant companies boosting the market's expansion. Other key players include Siemens Healthcare, Thermo Fisher Scientific Inc., Danaher Corporation (Beckman Coulter Inc.), Almac Group, and Illumina Inc.


The key companies are implementing various growth tactics, including product launches, acquisitions, and partnerships, to expand the companion diagnostics market globally. For instance, Bayer AG and ArcherDX Inc. collaborated to develop and market companion diagnostics (CDx) for Vitrakvi based on next-generation sequencing (NGS) in May 2020. (larotrectinib).


The onset of the COVID-19 pandemic has altered how medical treatment is provided globally. Many hospitals and departments have been re-profiled for treating patients with COVID-19 because of the increasing demand brought on by the rising rate of hospitalization of COVID-19 patients. Curfews and lockdowns caused by the COVID-19 outbreak forced many diagnostic and therapeutic operations to be canceled or delayed globally, including up to 2.3 million cancer surgeries, per one study.


This report dives through the information about the past, present, and future state of the companion diagnostic market. The key strategies used by participants in the worldwide companion diagnostics market segment included acquisitions, alliances, growth, and product releases.