Predictive Biomarkers Market

The predictive biomarkers market is expected to reach USD 14.69 billion by 2030, from USD  8.49 billion in 2025, reporting a CAGR of 11.6% between 2025 and 2030. The growth of the predictive biomarkers market is due to several key factors, including the rising adoption of targeted therapies and immunotherapies and the integration of biomarkers into clinical trial design.

Several key players in the predictive biomarkers market include Thermo Fisher Scientific Inc. (US), QIAGEN (Germany), F. Hoffmann La Roche Ltd (Switzerland), Bio Rad Laboratories, Inc. (US), Merck KGaA (Germany), Abbott (US), PacBio (US), Illumina, Inc. (US), among others. Companies in this space are adopting expansion strategies to strengthen their global footprint and advance their technology portfolios. In July 2025, QIAGEN’s Therascreen KRAS RGQ PCR kit was approved by the FDA as a companion diagnostic for KRAZATI (adagrasib) in NSCLC, giving the company eleven PCR-based CDx indications, and it continues to expand its Therascreen portfolio for multiple targeted therapies.

To know about the assumptions considered for the study download the pdf brochure

Thermo Fisher Scientific (US)

The Oncomine portfolio and Genexus sequencing system from Thermo Fisher Scientific position Thermo Fisher Scientific as a prominent player in the predictive biomarkers market, enabling comprehensive genomic and protein-based risk assessment on a single platform for clinical laboratories. The portfolio encompasses key predictive markers for solid tumors and hematologic malignancies, enabling oncologists to estimate treatment response, toxicity risk, and minimal residual disease within a single workflow. The integration of sample-to-report automation, fast turnaround times, and pharma partnerships for companion diagnostics makes it easier for hospitals and regional laboratories to bring these advanced predictive tests in-house, rather than relying solely on external reference labs.

QIAGEN (Germany)

QIAGEN has become an important player in the predictive biomarkers market by pairing its Therascreen companion diagnostic kits with a growing menu of NGS and digital PCR assays tailored for targeted therapies. Its tests cover key predictive mutations and fusions in lung, colorectal, and hematologic cancers, enabling clinicians to identify responders, track resistance, and guide therapy switches with high sensitivity from limited samples. Seamless sample-to-insight workflows established regulatory approvals, and co-development deals with biopharma make it straightforward for hospital and reference labs to deploy validated predictive testing as part of routine precision oncology.

F. Hoffmann-La Roche Ltd (Switzerland)

Roche is a key player in the predictive biomarkers market because many of its Cobas and VENTANA tests are referenced directly in drug labels, serving as the tools doctors use to determine who should receive a particular targeted therapy. Clinicians rely on these assays to assess HER2, EGFR, BRAF, and other markers that indicate whether a treatment is likely to be effective or harmful, turning complex molecular data into clear “yes/no” answers at the bedside. Behind the scenes, Roche’s teams work with oncologists, pathologists, and pharma partners to expand these companion diagnostics to new tumor types and indications, so more patients can be matched to effective therapies with confidence rather than by trial and error.

Market Ranking

Thermo Fisher Scientific, QIAGEN, and Roche collectively cover the full spectrum of predictive biomarkers, each contributing distinct insights. Thermo Fisher focuses on NGS-based companion diagnostics, such as its Oncomine Dx portfolio and broad CDx partnerships, for example, with AstraZeneca, enabling multi-gene panels that read numerous predictive biomarkers at once and are co-developed alongside targeted drugs so tests can launch in parallel with the approval of therapies. QIAGEN, in turn, concentrates on highly targeted, regulated PCR-based therascreen assays such as EGFR, KRAS, PIK3CA, and PITX2 that return fast, mutation-specific "yes/no" answers from small samples, allowing clinicians to predict response or resistance to EGFR inhibitors, PI3K-targeted drugs, or particular chemotherapy regimens in solid tumors. Roche then anchors many of these predictive biomarkers directly into routine pathology and drug labels using its VENTANA IHC and cobas molecular CDx portfolio, with assays such as PD-L1 (SP263) and the VENTANA MMR RxDx Panel, so that markers like PD-L1 expression or MMR deficiency explicitly determine eligibility for checkpoint inhibitors and other targeted therapies.

Related Reports:

Predictive Biomarkers Market by Product & Service (Consumable, Software), Technology (NGS, PCR), Disease (Cancer, Infectious), Application (Clinical Diagnostics) -Forecast to 2030

Contact:
Mr. Rohan Salgarkar
MarketsandMarkets™ INC.
1615 South Congress Ave.
Suite 103, Delray Beach, FL 33445
USA : 1-888-600-6441
sales@marketsandmarkets.com