Advantages of companion diagnostics, the growing need for targeted therapy, the rising importance of personalized medicine, the increasing global incidence of cancer, and the ever-increasing application areas of companion diagnostics are driving the growth of the global companion diagnostics industry. The increasing demand for next-generation sequencing, the growing significance of companion diagnostics in drug development, and the rising number of clinical trials are the major factors driving the growth of this market.
[333 Pages Report] The companion diagnostics market is expected to reach USD 6.8 billion by 2025 from USD 3.7 billion in 2020, at a CAGR of 12.9% during the forecast period of 2020 to 2025.
COVID-19 Impact on the Global Companion Diagnostics Market
The companion diagnostics market includes major Tier I and II companies like Roche Diagnostics, Agilent Technologies, Qiagen, Thermo Fisher, and Abbott Laboratories. These suppliers have their manufacturing facilities spread across various countries across Asia Pacific, Europe, North America, South America, and RoW. The lockdown and restrictions related to social distancing implemented in these COVID-19 countries had negatively affected the supply chain of these products.
Drivers: Growing need for targeted therapy
With advances in genetic sequencing and genomics, it is now widely believed that drugs can work differently in different individuals. A better understanding of the genetic characteristics or biomarkers of an individual can promote the practice of administering “the right drug, at the right time, at the right dose, for the right person.” Pharmaceutical and biopharmaceutical companies are continuously attempting to implement patient-selection diagnostic frameworks in the earlier stages of drug development to provide targeted therapies to the right candidate. This further supports the growth of the companion diagnostics market.
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Restrains: High cost of companion diagnostics tests
The high initial cost puts these tests out of reach of a large portion of end users—particularly those in developing countries—in spite of providing assured returns on investment. This prompts end users such as pharma companies, reference laboratories, hospitals, and CROs, which perceive the usage of such diagnostic tests as a burden on their budgets, to opt for third-party companion diagnostic services.
Opportunities: Increasing demand for next-generation sequencing
NGS-based companion diagnostic tests aim to unlock molecular information from each patient’s tumor genome to guide treatment decisions for cancer therapies. Next-generation sequencing detects multiple biomarkers for multiple drug therapies in a shorter time frame as compared to other sequencing techniques. The use of NGS panels for biomarker measurement in one test has the potential to help in the treatment of many different types of cancers.
Challenges:Shortage of trained professionals
Companion diagnostic testing is a complex and technical process that demands well-trained resources. The knowledge of companion diagnostic technologies is vital for effectively carrying out tests. CDx assays are sensitive to the quantity and purity of the samples used, and small deviations can lead to erroneous and variable inferences. In addition, different types of assays, kits, tests, and software & services are used in companion diagnostics; this increases the cost of production. Hence, it is mandatory that all laboratories and setups be well-versed with these technologies.
Polymerase chain reaction (PCR) segment to account for the largest share of the companion diagnostics market, by technology, in 2019
The polymerase chain reaction segment is expected to dominate the companion diagnostics market in 2019. The large share of this segment can be attributed to the ease of use and widespread availability of PCR kits & reagents in companion diagnostic testing, growing applications of PCR in the high-throughput detection of mutants with a limited or low allele frequency of genes, and high turnaround time of PCR as compared to other technologies.
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Pharmaceutical & biopharmaceutical companies are estimated to be the largest end-users of companion diagnostics in 2019
Pharmaceutical & biopharmaceutical companies are expected to account for the largest share of the companion diagnostics market in 2019. The large share of this segment can majorly be attributed to the extensive usage of companion diagnostics in these industries owing to their growing prominence in drug development and the increasing importance of companion diagnostic biomarkers. The increasing demand for personalized medicine as well as the high demand for targeted therapies for various diseases and disorders are also expected to drive the demand and uptake of companion diagnostics among pharmaceutical & biopharmaceutical companies.
Asia Pacific market to witness the highest growth during the forecast period
The Diagnostic biomarker Market in the APAC is estimated to grow at the highest CAGR during the forecast period. The high incidence of cancer, increasing proteomics & genomics research, growing research funding, rising investments by pharmaceutical and biotechnology companies, and growing awareness about personalized therapeutics in several APAC countries are expected to drive the growth of the APAC market.
The companion diagnostics market is dominated by a few globally established players such as Roche Diagnostics, Agilent Technologies, Qiagen, Thermo Fisher, and Abbott Laboratories.
The major market players include F. Hoffmann-La Roche AG (Switzerland), Agilent Technologies, Inc. (US), QIAGEN N.V. (Germany), Abbott Laboratories, Inc. (US), Almac Group (UK), Danaher Corporation (US), Illumina, Inc. (US), bioMérieux SA (France), Myriad Genetics, Inc., (US), Sysmex Corporation (Japan), Thermo Fisher Scientific Inc. (US), Abnova Corporation (Taiwan), Guardant Health, Inc. (US), Icon Plc (Ireland), Biogenex Laboratories, Inc. (US).
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