Market Trends of Companion Diagnostics Industry
This section covers the major market trends shaping the Companion Diagnostics Market according to our research experts:
The Lung Cancer Segment is Expected to Hold a Significant Share in the Market over the Forecast Period
Companion diagnostic tests (CDXs) are considered mandatory in decision-making for treatment with targeted therapies in lung cancer. Patients with lung cancer who receive companion diagnostics as part of their initial treatment have more survival benefits than those who are not tested. Globally, the high incidence rate of non-small cell lung cancer (NSCLC), coupled with the rise in the development of oncology companion diagnostic tests for the disease, is expected to boost the segment's growth. For instance, in August 2022, The U.S. FDA granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients whose tumors have a HER2 (ERBB2) activating mutations (SNVs & Exon 20 Insertion) in non-small cell lung cancer (NSCLC), who may be candidates for ENHERTU (fam-trastuzumab deruxtecan-nxki). ENTER is a precisely engineered HER2-directed antibody-drug conjugate (ADC) jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. In addition, in July 2021, Labcorp launched Therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who are eligible for therapy with LUMAKRAS (sotorasib). This was a novel therapeutic option developed by Amgen.
Moreover, lung cancer is the most common form of cancer. As per Lung Cancer Research Foundation 2022, an estimated 236,740 people were diagnosed with lung cancer in 2022 in the United States, leading to more demand for lung cancer companion diagnostics. This is expected to help the market growth over the forecast period.
Therefore, the factors mentioned above are expected to drive segmental growth in the market during the forecast period.
North America is Expected to Hold a Major Market Share Over the Forecast Period
North America dominated the overall companion diagnostics market, with the United States emerging as a major contributor. The use of companion diagnostics is considered an important treatment decision tool for various oncology drugs, which is also reflected in how the FDA classifies these assays concerning risk. Companion diagnostics clinical trials have come to the forefront in the pharmaceutical industry, despite the COVID-19 pandemic, as it helps to boost the chances of clinical success. The testing kit was in high demand for identifying those infected with SARS-CoV-2. COVID-19 remained the primary focus for diagnostic test makers in terms of research & development. In May 2020, MiraDx set up its lab to provide COVID-19-based test services in the United States. The company claimed that the lab could analyze more than 9,000 tests accurately.
The increasing burden of cancer in the United States is also expected to drive market growth. According to the American Cancer Society, in January 2022, a total of 1.9 million new cancer cases from cancer are expected to occur in the United States by the end of 2022. Moreover, people with chronic conditions are the most frequent users of companion diagnostics in the United States; they drive the market's growth.
Product launches and government clearance by key players are driving the companion diagnostics market growth. For instance, in October 2021, the United States Food and Drug Administration approved Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis), which aids in identifying patients with early breast cancer (EBC) at high risk of disease recurrence. This will further drive the market growth over the forecast period in North America.
Due to the abovementioned factors, North America is expected to hold a significant share of the global companion diagnostics market.
