Companion Diagnostics Market Size | Forecast & Global Trends 2025

Q: What is the Companion Diagnostics Market size?

The market was valued at USD 6.5 billion in 2024 and is projected to reach USD 16.2 billion by 2031, growing at a CAGR of 14.1%.

Q: Which diseases are primarily targeted by companion diagnostics?

Oncology remains the dominant area, especially for breast, lung, and colorectal cancers, followed by autoimmune and infectious diseases.

Q: How are regulations impacting market growth?

Agencies like the FDA and EMA are encouraging co-approval of diagnostics with therapeutics, fostering market standardization and growth.

Q: What technological innovations are shaping this market?

NGS-based tests, AI-powered biomarker analysis, and lab-on-a-chip platforms are revolutionizing test speed, accuracy, and scalability.

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Code: MTA4346

Publication Date: Jun 2025

What is the Companion Diagnostics Market Size?

According to 6Wresearch internal database and industry insights, the Global Companion Diagnostics Market was valued at approximately USD 6.5 billion in 2024 and is expected to surpass USD 16.2 billion by 2031, exhibiting a CAGR of 14.1%.

The market growth is driven by the increasing adoption of personalized medicine, rising demand for targeted cancer therapies, and regulatory encouragement for biomarker-driven drug development.

Key Growth Drivers of the Companion Diagnostics Market

Rising prevalence of cancer and chronic genetic conditions.
Increasing approvals of targeted therapies and associated diagnostics.
Advancements in genomics and biomarker discovery.
Collaboration between diagnostic companies and pharmaceutical manufacturers.
Supportive regulatory landscape encouraging precision medicine.
Growing demand for non-invasive, accurate diagnostic tools.

Companion Diagnostics Market Trends

The Companion Diagnostics Market is expected to undergo significant transformation with the integration of next-generation sequencing (NGS), artificial intelligence (AI) for biomarker analysis, and the emergence of multiplex diagnostic platforms that can detect multiple targets simultaneously. An even more recent trend is to shift towards a co-developing type of paradigm where companion diagnostics will be developed along with a specific therapy and will increase the specificity of treatment and shorten regulatory pathways.

This market is diversifying to non-oncology diseases like auto diseases, infectious diseases, and cardiovascular diseases, creating additional opportunities in precision medicine. Regulatory agencies in key markets are focusing on allowing companion diagnostics in the initial stages of the clinical trials so that safer and more efficient therapeutics will be achieved. Additionally, technological advancements are enabling faster turnaround times, reduced costs, and greater accessibility, which are crucial for broader clinical adoption and improved patient outcomes.