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Global Companion Diagnostics Market – Growing Preference for Precision Medicine

Companion diagnostics play a major role in advanced healthcare, as it aids in targeting biomarker identification, reducing clinical trial cost, and time to market the product. Also, encouragement from the regulatory bodies such as the U.S Food and Drug Administration (FDA) in terms of providing a defined structure for companion diagnostic development is driving research activities in companion diagnostics.

The global companion diagnostics market size was valued at US$ 2,040.0 million in 2017, and is expected to exhibit a CAGR of 19.5 % over the forecast period (2018–2026).

Figure 1. Global Companion Diagnostics Market Value (US$ Mn), by Region, 2017

Source: Coherent Market Insights Analysis (2019)

Increasing incidences of cancer is expected to propel growth of the global companion diagnostics market

Increasing incidences of cancer cases is expected to drive the global companion diagnostics market growth. For instance, according to GLOBOCAN 2018, around 18.1 million new cancer cases and 9.6 million cancer deaths were recorded worldwide in 2018. Furthermore, according to the same source, in 2018, around 2,093,876 new lung cancer cases were recorded.

Moreover, increasing government initiatives for development of companion diagnostics and therapies used in the treatment of cancer patients is expected to propel growth of global companion diagnostics market. For instance, in 2015, the U.S. government announced the launch of Precision Medicine Initiative, which has led to powerful new discoveries and several new treatments that are tailored for specific characteristic such as person’s genetic makeup or genetic profile of an individual tumor that helps to transform the way of treatment.

However, narrow labelling of companion diagnostics is expected to be the major factor hindering the market growth.

Figure 2. Global Companion Diagnostics Market Share (%), by Application, 2018 and 2026

Source: Coherent Market Insights Analysis (2019)

Increasing cancer cases and presence of well-established manufacturers, which are engaged in providing advanced companion diagnostics in the North America are expected to bolster the market growth

North America holds dominant position in the global companion diagnostics market, owing to presence of well-established manufacturers, which are focused in product approval for offering advanced companion diagnostic. For instance, in June 2018, Agilent Technologies Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay. PD-L1 IHC 22C3 pharmDx is now the first FDA-approved IHC test for determining PD-L1 expression in cervical cancer and is the first FDA-approved companion diagnostic to identify patients with cervical cancer for treatment with KEYTRUDA. Moreover, increasing cancer cases in the region is propelling growth of the market. For instance, according to the National Cancer Institute (NCI), in April 2018, an estimated around 1,735,350 new cancer cases and 609,640 deaths due to cancer in the U.S. were recorded. Moreover, according to the same source, the most common cancers in 2018, were breast cancer, prostate cancer, melanoma, bladder cancer, pancreatic cancer, liver cancer, and other cancers, and the number of new cancer cases reported were around 439.2 per 100,000 men and women per year in the U.S. (based on 2011 to 2015 cases).

Key Players

Major players operating in the global companion diagnostics market include Abbott Laboratories, Agilent Technologies Inc., Danaher Corporation, Qiagen N.V., F. Hoffmann-La Roche AG, bioMerieux S.A., Illumina, Inc., GE Healthcare, Myriad Genetics Inc., and Siemens Healthineers.