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.

The global companion diagnostics market is projected to reach USD 7.3 billion by 2024 from USD 3.5 billion in 2019, at a CAGR of 15.7%.

The extractables/leachables testing services 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.

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.

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Geographical Region Covered in Companion Diagnostics Market

The companion diagnostics 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.

Leading Companies in Companion Diagnostics Market

The prominent players operating in the global companion diagnostics market are 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), and Guardant Health, Inc. (US).

F. Hoffmann-La Roche AG is one of the leading providers of companion diagnostics across the globe. It provides a comprehensive portfolio of companion diagnostic products for pharmaceutical companies and research institutes. With a strong brand name and extensive geographic coverage in more than 180 countries, Roche has a well-established presence in the companion diagnostics market. In the companion diagnostics market, the company focuses on strategies, such as product launches & approvals, to increase its presence. With regard to this, the company launched the VENTANA HER2 Dual ISH companion diagnostic test in May 2019. This test will provide Roche’s CDx customers with a product for the detection of the HER2 biomarker in breast & gastric cancer, thus supporting pharmaceuticals in developing personalized medicines and targeted therapies. In line with launching innovative products, Roche invests a significant amount of its sales revenue in R&D. In 2018, it invested approximately 20% of its sales revenue in R&D activities. These investments enable the company to extend its technological capabilities and provide superior-quality products, thereby helping the firm achieve long-term growth.

Agilent Technologies is another leading provider of comprehensive companion diagnostics for to pharmaceutical companies, reference laboratories, hospitals, and other medical academic centers. The company offers robust companion diagnostic assays & kits where the products are based majorly on immunohistochemistry (IHC) and in-situ hybridization (ISH) technologies. The company provides companion diagnostic products to the end-users through its strong distribution network across the globe. Agilent’s business strategy includes product launches and approvals for new therapeutic areas. For instance, in April 2019, Agilent received an expanded FDA approval for its companion diagnostic assay, PD-L1 IHC 22C3 pharmDx, in non-small cell lung cancer (NSCLC) for first-line treatment with KEYTRUDA, a targeted anti-PD-1 therapy manufactured by Merck and Co. However, the company could also focus on other strategies such as partnerships & agreements and acquisitions to further strengthen its position in the market.

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