Companion Diagnostics for Oncology Market: Driving Personalized Cancer Care

The Companion Diagnostics for Oncology Market is growing rapidly as cancer care increasingly shifts toward precision and personalized medicine. According to Straits Research, the global market size was valued at USD 4.46 billion in 2024 and is projected to grow from USD 5.48 billion in 2025 to an impressive USD 28.27 billion by 2033, registering a CAGR of 22.77% during the forecast period.

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Key Market Insights

North America dominated the market with a 44% share in 2024, thanks to advanced healthcare infrastructure and strong adoption of personalized medicine. The assays, kits, and reagents segment led the market with a 66.1% share in 2024, fueled by technological advancements and increasing availability of high-quality test kits. By technology, polymerase chain reaction (PCR) held the leading position in 2024 and is expected to expand at a CAGR of 20.27%, while breast cancer diagnostics accounted for the highest share in 2024 and is forecasted to grow at a CAGR of 22.82% due to its rising global prevalence.

Market Drivers

Rising Preference for Personalized Medicine

Personalized medicine is revolutionizing cancer care. With genetic testing at the forefront, healthcare providers are using companion diagnostics to tailor therapies based on specific biomarkers. Regulatory bodies like the FDA are actively collaborating with drug and device makers to accelerate the adoption of these diagnostics, further boosting demand.

Increasing Global Incidence of Cancer

The rising number of cancer cases worldwide directly fuels the adoption of companion diagnostics. For instance, the American Cancer Society estimated 1.8 million new cases in the U.S. in 2020 and around 3.9 million new cases in Europe in 2018, highlighting the urgent need for targeted solutions.

Market Restraints

Lack of Reimbursement in Developing Regions

Despite the promise of companion diagnostics, growth is hampered in developing regions due to complex reimbursement systems, insufficient funding, and the high cost of advanced tests such as NGS-based CDx.

Market Opportunities

Entry of Market Players into Emerging Economies

Emerging markets such as Africa and Asia present untapped opportunities due to their growing cancer burden. For example, the African region recorded over 1 million new cancer cases in 2018, creating strong demand for advanced diagnostic solutions despite economic challenges.

Regional Insights

Americas: Largest market, supported by high cancer prevalence, rising R&D, and genomic database initiatives. Projected to grow at a CAGR of 20.92%.
Europe: Fastest-growing region with a CAGR of 23.38%, driven by targeted therapy research, favorable reimbursement, and strong presence of key players.
Asia-Pacific: Expected to grow rapidly due to rising cancer cases in India, China, and Japan, alongside growing investments in personalized therapeutics.
Middle East & Africa: Moderate growth anticipated, supported by increasing cancer awareness, hospital expansion, and healthcare investment.

Segmental Highlights

Products and Services: Assays, kits, and reagents dominate with a projected CAGR of 24.10%.
Technology: PCR leads today, but next-generation sequencing (NGS) is gaining momentum.
Indication: Breast cancer holds the largest share with rapid adoption of advanced diagnostic techniques.
End-User: Pharmaceutical and biopharmaceutical companies lead adoption, with regulators increasingly requiring CDx integration in drug development.

Key Players

According to Straits Research, the major players in the global companion diagnostics for oncology market include:

Qiagen N.V.
F. Hoffmann La Roche Ltd
Agilent Technologies
Thermo Fisher Scientific
Abbott
Amoy Diagnostics
BioMérieux SA
Archerdx
Illumina, Inc.
Foundation Medicine, Inc.

Recent Developments

January 2023: Foundation Medicine partnered with Karyopharm Therapeutics to develop FoundationOne®CDx as a companion diagnostic for selinexor in endometrial cancer.
January 2023: QIAGEN and Helix launched an exclusive partnership to advance next-generation sequencing companion diagnostics in hereditary diseases.

About Us

Straits Research is a leading global market intelligence and consulting firm, dedicated to delivering actionable insights and in-depth analysis across a wide range of industries. Our mission is to empower organizations, investors, and decision-makers with reliable data, strategic guidance, and forward-looking perspectives to help them thrive in a rapidly evolving business landscape.