PUBLISHER: MarketsandMarkets | PRODUCT CODE: 2070355
PUBLISHER: MarketsandMarkets | PRODUCT CODE: 2070355
The companion diagnostics market is projected to reach USD 11.57 billion by 2031, from USD 6.31 billion in 2026, with a CAGR of 12.9%. This growth is primarily driven by increasing oncology biomarker testing, expanding approvals of targeted therapies and immunotherapies, and rising pharmaceutical-diagnostic co-development activities.
| Scope of the Report | |
|---|---|
| Years Considered for the Study | 2026-2031 |
| Base Year | 2025 |
| Forecast Period | 2026-2031 |
| Units Considered | Value (USD billion) |
| Segments | Product & Service, Technology, Indication, Sample, End User, Drug Class, Application |
| Regions covered | North America, Europe, Asia Pacific, Latin America, Middle East, Africa |
Market growth is further supported by advancements in molecular diagnostics technologies, such as polymerase chain reaction (PCR), next-generation sequencing (NGS), immunohistochemistry, and in situ hybridization, along with increased demand for personalized treatment selection. However, high development and validation costs, complex regulatory pathways, reimbursement limitations, and variability in biomarker testing infrastructure across regions are expected to restrain market growth to a certain extent.

"Assays, kits & reagents accounted for the largest share of the companion diagnostics market, by product & service, in 2025."
In 2025, assays, kits & reagents accounted for the largest share due to their extensive use in biomarker detection, mutation analysis, therapy selection, and routine molecular testing workflows. Their recurring demand, compatibility with high-throughput testing platforms, and increasing adoption in oncology-focused precision medicine applications continue to support segment growth. Additionally, rising approvals of companion diagnostic assays linked to targeted therapies and immunotherapies are further strengthening the dominance of this segment.
"PCR accounted for a major share of the companion diagnostics market, by technology, in 2025."
In 2025, PCR accounted for a major share due to its high analytical sensitivity, shorter turnaround time, broad clinical adoption, and strong regulatory acceptance in biomarker-driven testing. PCR technologies are widely used for mutation detection and targeted therapy selection across multiple oncology indications. Additionally, growing use of multiplex PCR assays and increasing demand for rapid molecular testing continue to support the segment's leading market position globally.
"Asia Pacific is expected to be the fastest-growing market for companion diagnostics during the forecast period."
During the forecast period, the Asia Pacific region is projected to register the highest CAGR due to increasing cancer incidence, expanding healthcare infrastructure, rising investments in molecular diagnostics, and growing adoption of precision medicine approaches. Growth is further supported by improving access to advanced oncology care, expansion of pharmaceutical clinical trials, and increasing presence of regional and global diagnostic companies across China, Japan, India, South Korea, and Southeast Asia.
Companies Profiled
Research Coverage
This research report categorizes the companion diagnostics market by product & service, technology, indication, sample, end user, drug class, application, and region. The scope of the report covers detailed information regarding the major factors, such as drivers, challenges, opportunities, and restraints, influencing the growth of the protein expression market. A detailed analysis of the key industry players has been done to provide insights into their business overview, product portfolio, key strategies such as product and service approvals and launches, collaborations, partnerships, expansions, agreements, and recent developments associated with the protein expression market. This report covers competitive analysis of top players and upcoming startups in the protein expression market ecosystem.
Key Benefits of Buying this Report
The report will help market leaders and new entrants by providing the closest approximations of revenue numbers for the overall companion diagnostics market and its subsegments. It will also help stakeholders better understand the competitive landscape and gain more insights to position their businesses effectively and develop suitable go-to-market strategies. The report will enable stakeholders to understand the market pulse and provide information on key market drivers, restraints, opportunities, and challenges.