North America Cancer Tissue Diagnostics Market to 2027 - Regional Analysis and Forecasts by Test Type and Country

The North America cancer tissue diagnostics market is expected to reach US$ 1,587.38 Mn in 2027 from US$ 923.79 Mn in 2018. This market is projected to grow at a growth rate of 6.5% from 2019-2027.

The growth of the cancer tissue diagnostics market is primarily attributed to growing cancer prevalence in North American region and new product launches & FDA approvals. However, lack of reimbursement policies for cancer diagnosis is likely to pose a negative impact on the market growth. On the other hand, growing medical tourism in Mexico is likely to have a positive impact on the growth of the North America cancer tissue diagnostics market in the coming years.

Personalize medicine is a new approach relatively and is expanding significantly in the healthcare sector. It enables a medical practitioner to select treatment based on a patient's genetic profile. This approach not only minimizes harmful side effects but also leads to successful result within a short period. Cancer personalize medicine involves the study of individuals genetic makes up for tumor growth. By studying the patient's genetic make-up, an oncologist may customize the treatment depending on the patient's genetic mutations. In the US, attempts are made to integrate personalized medicine into healthcare practices. In the United States, The Precision Medicine Initiative (PMI) is a research endeavor, which involves the National Institutes of Health (NIH) and various other research centers. The initiative has been created to analyze a person's genetics, environment, and lifestyle to determine a suitable approach for the prevention or treatment of disease. The PMI was launched during the fiscal year 2016, approximately $130 million were allocated to NIH to establish a large-scale research participant group, called a cohort. Nearly $70 million was given to the National Cancer Institute to conduct studies in cancer genomics as part of PMI for Oncology. These initiatives are expected to increase awareness regarding personalized medicine during the forecast period.

Moreover, the companies namely, Agilent Technologies Inc., Thermo Fisher Scientific, Inc., Cancer Genetics Inc. and F. Hoffmann-La Roche Ltd. have received approvals in the cancer tissue diagnostics market. Some of the recent approvals are mentioned below.

Table 1. Recent Approvals For Cancer Tissue Diagnostics in the Market
Month & Year Company Description
June, 2019 Agilent Technologies Inc. Agilent Technologies Inc. received the U.S. Food and Drug Administration (FDA) approval for its PD-L1 IHC 22C3 pharmDx assay. The assay is approved to aim in identifying patients with head and neck squamous cell carcinoma (HNSCC) for treatment with KEYTRUDA (pembrolizumab), anti-PD-1 therapy manufactured by Merck.

October, 2018 Thermo Fisher Scientific, Inc. Thermo Fisher Scientific received CE mark for its Oncomine Dx Target Test. The approval has enabled the company to offer NGS testing and precision oncology across the globe.

April, 2018 Cancer Genetics Inc. Cancer Genetics, Inc. received special 510(k) approval from the FDA for its Tissue of Origin test (TOO) that follows modifications made to test reagents and software.

June, 2017 F. Hoffmann-La Roche Ltd. Roche received approval for the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer.

August, 2016 Agilent Technologies Inc. Dako, Agilent received the CE mark for cancer therapy. The new companion diagnostic assay reveals that the patient with advanced non-small cell lung cancer (NSCLC) will respond to KEYTRUDA(r) (pembrolizumab), an anti-PD-1 therapy.

In 2018, the immunohistochemical tests segment held a largest market share of 57.84% of the cancer tissue diagnostics market, by test type. This segment is also expected to dominate the market in 2027 owing to the low cost of the procedure. Higher acceptance of the method for diagnosis purpose. Moreover, the technique is easily accessible, and growth in number of products based on technology. Additionally, the rising prevalence of cancer is a major factor for the growth of the diagnostic tests.

Some of the major primary and secondary sources for cancer tissue diagnostics included in the report are, World Health Organization (WHO), Canadian Institutes of Health Research (CIHR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and National Institute for Health among others.