PUBLISHER: Grand View Research | PRODUCT CODE: 1701234
PUBLISHER: Grand View Research | PRODUCT CODE: 1701234
The global companion diagnostics market size is expected to reach USD 15.98 billion by 2030, registering a CAGR of 10.5% from 2025 to 2030, according to a new report by Grand View Research, Inc. Companion diagnostics are specialized tests designed to ensure the safe and effective use of specific therapeutic products by identifying corresponding biomarkers in patients. These tests are predominantly employed in oncology, where they guide clinicians in selecting the most appropriate targeted therapies based on a patient's unique genetic profile. For instance, Foundation Medicine's FOUNDATIONONE CDx analyzes over 300 cancer-related genes, providing critical insights that inform precision cancer treatments across various solid tumors. By identifying key mutations or genetic alterations, companion diagnostics facilitate personalized treatment regimens, thereby improving clinical outcomes and reducing the risk of adverse reactions. This individualized approach to therapy not only enhances patient care but also supports the broader shift towards precision medicine, where treatment strategies are tailored to the genetic makeup of each patient.
Regulatory approvals play a pivotal role in bolstering the companion diagnostics market, particularly in oncology. In August 2022, the U.S. FDA approved Thermo Fisher Scientific Inc.'s Oncomine Dx Target Test, a companion diagnostic designed to identify HER2 (ERBB2) activating mutations-including single nucleotide variants and exon 20 insertions-in non-small cell lung cancer tumors. Such regulatory endorsements validate the clinical utility of these tests and promote their widespread adoption. Additionally, the use of advanced techniques such as Next-Generation Sequencing (NGS) has become integral to companion diagnostics. NGS enables clinicians to evaluate multiple genes simultaneously, thereby providing comprehensive tumor profiling. The Centers for Disease Control and Prevention (CDC) has highlighted that NGS has successfully transitioned from a research tool to a clinically approved method within the past five years, underscoring its growing importance in diagnostic applications.
Technological innovation is a critical driver of growth in the companion diagnostics market. Key industry players are continuously advancing NGS platforms, digital ELISA, and liquid biopsy techniques to improve diagnostic precision and efficiency. Strategic partnerships are further accelerating these developments; for instance, in November 2023, QIAGEN partnered with Element Biosciences to provide NGS workflows for the benchtop sequencer AVITI System, aiming to enhance discovery, reduce costs, and improve turnaround times in genomic research. Similarly, in January 2022, Illumina Inc. collaborated with SomaLogic Operating Co., Inc. to integrate the SomaScan proteomics assay into its high-throughput NGS platforms. These collaborations not only expand the technological capabilities of companion diagnostics but also foster innovation in the development of new testing solutions, ensuring that emerging diagnostic methods keep pace with evolving clinical needs.
The rising prevalence of cancer globally has significantly spurred the adoption of companion diagnostics, as genomic testing offers a detailed insight into tumor biology that is critical for selecting effective treatment protocols. According to data from the American Cancer Society Journal, approximately 1.9 million new cancer cases were reported in the U.S. in 2022, while the World Health Organization (WHO) noted that in the same year, there were 2.26 million new breast cancer cases and 2.21 million new lung cancer cases worldwide. In response to these challenges, novel tests are being developed to detect specific genetic mutations. For example, in August 2020, the U.S. FDA approved Guardant360 CDx, the first liquid biopsy companion diagnostic that employs NGS technology to detect EGFR gene mutations in metastatic non-small cell lung cancer. In October 2023, QIAGEN further strengthened its market position by partnering with Myriad Genetics to develop advanced companion diagnostic solutions for oncology, thereby enhancing personalized treatment strategies and improving patient outcomes.