Press Release   -

Companion Diagnostics Market Accelerates with Strategic Pharma Collaborations and Breakthrough Personalized Therapies

The global market for Companion Diagnostics Market is entering a transformative era as precision medicine gains momentum across therapeutics and diagnostics. According to a report by Vantage Market Research, the market was valued at approximately USD 9.38 billion in 2024 and is projected to reach around USD 31.75 billion by 2035, representing a compound annual growth rate (CAGR) of about 11.75% between 2025 and 2035. This impressive growth reflects the increasing integration of biomarker-driven diagnostics, drug-diagnostic co-development, next-generation sequencing (NGS) and immuno-assays, and an expanding scope from oncology into immunology, infectious disease and rare disorders.

Key Takeaways

1. The global companion diagnostics market is estimated at USD 9.38 billion in 2024.
2. It is projected to grow to USD 31.75 billion by 2035, with a CAGR of approximately 11.75% over the 2025-2035 period.
3. North America currently holds the largest regional share; Asia-Pacific is expected to exhibit the fastest growth.
4. Key growth drivers include expanding use of targeted therapies, increasing regulatory clarity for drug-diagnostic co-approval, growth in NGS & multiplex diagnostics, and rising incidence of chronic diseases.
5. Challenges remain around reimbursement, standardisation of assays, high cost of advanced diagnostics and integration of diagnostics into clinical workflow.

Key Market Trends & Insights

Several critical trends are shaping the companion diagnostics market: firstly, the shift from broad-spectrum therapies to biomarker-guided targeted treatments has elevated the role of CDx in drug development and patient selection. Secondly, NGS-based assays, multiplex panels, liquid biopsies and AI-enabled diagnostic platforms are gaining adoption, enabling precision medicine at scale. Thirdly, regulatory bodies such as U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) are increasingly mandating companion diagnostics alongside new drug approvals, which strengthens CDx demand. Fourthly, whilst oncology remains the core indication, expansion into immunology, neurological, infectious and rare disease indications is creating new growth avenues. Lastly, emerging geographies (Asia-Pacific, Latin America) are catching up rapidly due to increasing healthcare spending, diagnostics infrastructure and awareness.

Market Size & Forecast

According to Vantage Market Research, the global companion diagnostics market size in 2024 is estimated at USD 9.38 billion. Over the period 2025 to 2035, the market is projected to reach approximately USD 31.75 billion, reflecting a CAGR of around 11.75%. This rapid expansion underscores the growing importance of diagnostics in therapeutic decision-making, the rising pipeline of targeted therapies, and increasing global deployment of companion diagnostic solutions.

The companion diagnostics market displays moderate to high concentration, with several major players dominating via broad portfolios of assays, biomarker panels, partnerships with pharmaceutical companies and regulatory expertise. Characteristics of the market include: high R&D intensity (both for assay development and biomarker discovery), strong alignment with pharmaceutical pipelines (CDx often co-developed with drugs), recurring revenue from consumables and reagents, regulatory barriers (device classification, approval pathways), and rapid technology evolution (NGS, digital pathology, AI interpretation). Because CDx often links to specific therapeutic assets, entry requires validated biomarkers, clinical evidence and reimbursement alignment. As a result, leading firms hold strong competitive advantage.

Product & Service Insights

The Companion Diagnostics Market is segmented by product & service into assays, kits & reagents, software & services. Assays and kits dominate due to their crucial role in identifying patients who can benefit from targeted therapies. Software and data analytics solutions are gaining traction as precision medicine advances, enabling integration with digital platforms for real-time diagnostic insights and patient management, enhancing clinical decision-making efficiency across healthcare settings.

Technology Insights

Based on technology, the market includes polymerase chain reaction (PCR), next-generation sequencing (NGS), immunohistochemistry (IHC), in situ hybridization (ISH), and others. PCR remains the most widely used due to its high accuracy, cost-effectiveness, and widespread availability. However, NGS is rapidly expanding as it enables comprehensive genomic profiling, helping clinicians predict therapeutic responses. The growing focus on personalized oncology treatments further drives innovation and adoption across diagnostic laboratories and research institutions.

Indication Insights

The indication segment covers oncology, cardiovascular diseases, infectious diseases, neurological disorders, and others. Oncology holds the largest share as companion diagnostics are primarily used to match cancer patients with targeted therapies, especially in breast, lung, and colorectal cancers. The segment’s growth is driven by an increasing number of FDA-approved CDx tests and partnerships between pharmaceutical companies and diagnostic developers to support precision oncology treatments and enhance patient outcomes.

End Users Insights

By end users, the market is categorized into pharmaceutical & biopharmaceutical companies, reference laboratories, and contract research organizations (CROs). Pharmaceutical and biopharmaceutical firms lead the segment due to their involvement in co-developing targeted therapies alongside diagnostics. Reference laboratories are expanding their footprint through advanced molecular testing capabilities, while CROs support clinical validation and regulatory submissions, contributing to faster commercialization of companion diagnostics in clinical practice.

Regional Insights

North America Companion Diagnostics Market Trends

In North America, the companion diagnostics market leads globally, supported by a mature regulatory framework for CDx co-approval, strong pharmaceutical-diagnostic collaborations, high healthcare expenditure, and the large prevalence of biomarker-driven therapies. The U.S. in particular drives innovation in NGS, liquid biopsy CDx and precision oncology. Private- and public-sector funding for genomics and precision medicine further strengthen this region’s dominance.

Europe Market Companion Diagnostics Trends

Europe is witnessing steady growth in companion diagnostics, driven by regulatory alignment under the EMA, increasing adoption of precision medicine initiatives across major markets (Germany, UK, France), and strong diagnostic laboratory infrastructure. Growth is aided by reimbursement pathways evolving to support CDx, but fragmented regulatory and reimbursement systems across countries can be a limiting factor. Awareness of biomarker-driven therapies is increasing, boosting CDx demand.

Asia Pacific Companion Diagnostics Market Trends

Asia-Pacific is projected to be the fastest-growing region for companion diagnostics, propelled by rapidly increasing healthcare infrastructure, rising incidence of cancer and chronic diseases, expanding genomics ecosystems (China, India, Japan), and scale-up of diagnostics capacity. Although baseline penetration is lower than developed regions, government initiatives, expanding pharmaceutical R&D and diagnostics adoption are catalysing growth. Customized, cost-effective CDx solutions are gaining traction in this region.

Latin America Companion Diagnostics Market Trends

Latin America’s CDx market is emerging and offers meaningful growth opportunities. Drivers include increasing investment in oncology and diagnostics, rising healthcare awareness, and expanding private healthcare networks. However, adoption is constrained by slower reimbursement systems, lower diagnostics penetration, economic volatility and regulatory complexity. As infrastructure and laboratory capacity improve, CDx uptake is expected to accelerate.

Middle East & Africa Companion Diagnostics Market Trends

The Middle East & Africa region is currently at an early stage in adoption of companion diagnostics but is gradually advancing. Growth is driven by increasing investment in healthcare infrastructure, rising prevalence of cancer and chronic disease, and diagnostic capacity expansions in GCC countries. Nevertheless, limitations include low baseline penetration, fragmented regulatory frameworks, and a lack of specialised diagnostic infrastructure. Over time, partnerships, regional investments and rising demand for precision medicine are expected to strengthen CDx adoption.

Top Key Players Companion Diagnostics Market

1. Abbott Laboratories Molecular Inc.
2. Agilent (Dako Denmark A/S)
3. ARUP Laboratories Inc.
4. BioMerieux
5. Danaher Corporation (Leica Microsystems)
6. Foundation Medicine Inc.
7. Myriad Genetics Inc.
8. Roche (Ventana Medical Systems Inc.)
9. Thermo Fisher Scientific (Life Technologies Corporation)
10. QIAGEN N.V.

These companies are cited by Vantage Market Research as leading players in the companion diagnostics market, distinguished by broad assay portfolios, global diagnostic networks, strong collaborations with pharma, and strategic innovation in molecular diagnostics.

Recent Developments

1. In 2025, a pharma-diagnostic collaboration was announced to co-develop companion diagnostics for immuno-oncology therapies, including liquid-biopsy-based CDx for minimal-residual-disease monitoring underscoring expanding CDx beyond traditional solid-tumour biomarker tests.
2. In 2024, a major diagnostics firm announced the launch of a next-generation sequencing (NGS)-based companion diagnostic panel covering multi-gene tumour profiles and linked to multiple pipeline targeted therapies, reinforcing the shift toward multiplex CDx and broader indications.

Market Scope

The Companion Diagnostics Market Report provides an in-depth analysis of market trends, drivers, restraints, opportunities, and challenges shaping the industry from 2024 to 2035. It covers revenue estimates, growth rates, and forecasts across major segments, including product & service, technology, indication, and end users. The study also highlights regional insights, competitive landscape, key company strategies, and recent developments. This comprehensive scope enables stakeholders to understand emerging innovations, regulatory landscapes, and market opportunities influencing global diagnostic advancements.

Market Dynamics

Driver:

A primary driver of the companion diagnostics market is the rapid expansion of precision medicine and targeted therapeutics, which require biomarker-guided tests to match the right patient with the right drug. As pharma pipelines increasingly integrate CDx and regulatory agencies support drug-diagnostic co-approval pathways, the demand for companion diagnostics continues to accelerate.

Restraint:

A key restraint is complex reimbursement pathways and heterogeneous regulatory frameworks across regions, which can delay CDx adoption and limit return on diagnostics investment. Additionally, high cost of advanced molecular diagnostics, infrastructure requirements and need for clinician education hinder faster uptake.

Opportunity:

Significant opportunity lies in expansion of companion diagnostics into non-oncology indications (infectious diseases, immunology, neurology), growing adoption of liquid biopsy and multi-omics CDx, and emerging-market penetration where diagnostics infrastructure is improving. Innovative business models (diagnostic-as-a-service, cloud-based analytics) further open growth pathways.

Challenges:

Key challenges include ensuring clinical and analytical validation of companion diagnostics, interoperability with healthcare systems, data privacy concerns (especially in genomics), integration with therapeutic workflows, and educating stakeholders (physicians, payers) about value of CDx. Moreover, as drug-diagnostic combinations proliferate, maintaining assay quality and regulatory compliance becomes more complex.

Market Segmentation

1. By Product & Service: Assays, Kits & Reagents, Software & Services
2. By Technology: Next-Generation Sequencing, In Situ Hybridization, Immunohistochemistry, Other Technologies
3. By Indication: Cancer, Neurological Disorders, Cardiovascular Disorders, Infectious Diseases, Other Indication
4. By End-Use: Pharmaceutical & Biotechnology Companies, Diagnostic Laboratories, CROs, Reference Laboratories, Others
5. By Region: North America, Europe, Asia Pacific, Latin America, Middle East & Africa

Frequently Asked Questions

1. What is the estimated size of the global companion diagnostics market in 2024?

USD 9.38 billion.

1. What is the projected market size by 2035 and the CAGR from 2025-2035?

Forecast: USD 31.75 billion by 2035; CAGR 11.75%.

1. Which region currently holds the largest share?

North America leads the market.

1. Which region is expected to grow the fastest over the forecast period?

Asia Pacific is projected as the fastest-growing region.

1. Which product/technology segment holds the largest share?

Assays, Kits & Reagents currently dominate the product category.

1. Which indication/application drives the most demand?

Oncology remains the largest indication for CDx.

1. Who are some of the major players in the market?

Abbott Laboratories; Roche Diagnostics; QIAGEN; Thermo Fisher Scientific; Foundation Medicine.

1. What are the primary growth drivers and challenges?

Drivers: Precision medicine expansion, biomarker-based targeted therapies. Challenges: Reimbursement complexity, validation burden, infrastructure cost.