Companion Diagnostics Market By Technology (PCR, NGS, IHC, ISH, Others); By Indication (Oncology, Cardiology, Infectious Diseases, Neurology, Others); By End User (Hospitals & Oncology Centers, Clinical Laboratories, Pharmaceutical & Biotech Companies, Academic Institutes); By Geography, Segment Revenue Estimation, Forecast, 2024–2030

Introduction And Strategic Context

The Global Companion Diagnostics Market will witness a robust CAGR of 13.1 % , valued at $6.4 billion in 2024 , and is expected to appreciate significantly, reaching $14.0 billion by 2030 , confirms Strategic Market Research.

 

Companion diagnostics ( CDx ) are in-vitro diagnostic tests designed to evaluate the compatibility of a specific therapy with a particular patient’s molecular or genetic profile. These tools are crucial for precision medicine , enabling healthcare providers to make more targeted treatment decisions by matching patients with therapies most likely to benefit them. In 2024, the strategic relevance of companion diagnostics is greater than ever due to the rapid expansion of oncology, immunotherapy, and targeted therapies , where patient stratification is vital to both clinical outcomes and reimbursement efficiency.

 

Key macroeconomic and healthcare forces are shaping the market’s dynamics. These include:

• Surging cancer incidence worldwide , with over 20 million new cases expected in 2024, intensifying demand for molecular-based therapy selection.

• The evolution of biomarker discovery technologies , powered by next- gen sequencing (NGS) and liquid biopsy platforms.

• Increasing pressure from regulatory bodies , such as the FDA and EMA, that now often require companion diagnostics for new molecular entities (especially in oncology).

• A shift in healthcare delivery from “one-size-fits-all” to patient-personalized models backed by pharmacogenomics.

• Escalating R&D partnerships between pharmaceutical and diagnostics companies to co-develop drug-diagnostic pairs.
   

The strategic ecosystem of this market includes a diverse group of stakeholders:

• Pharmaceutical companies : seeking to increase the efficacy and market access of their therapies via co-developed CDx .

• Diagnostic developers : building multiplex platforms for real-time patient profiling.

• Regulatory agencies : driving compliance and approving co-labeling of CDx and therapeutic agents.

• Healthcare providers and oncology centers : demanding actionable insights from biomarker-based testing.

• Payers and insurers : increasingly linking reimbursement decisions to biomarker-driven therapeutic alignment.

• Investors and VC firms : focusing on CDx startups and precision medicine ventures due to high return potential.

The global push for personalized care, rising biomarker complexity, and payer scrutiny have elevated companion diagnostics from an optional accessory to a strategic cornerstone of modern therapeutics.

 

Market Segmentation And Forecast Scope

The global companion diagnostics market is categorized based on Technology , Indication , Sample Type , End User , and Geography . Each segment reflects a critical component of how companion diagnostics are developed, integrated, and adopted across therapeutic areas and clinical environments.

 

By Technology

Companion diagnostics employ a variety of molecular and biochemical techniques to deliver precise patient profiling. The major technology types include:

• Polymerase Chain Reaction (PCR)

• Next-Generation Sequencing (NGS)

• In Situ Hybridization (ISH)

• Immunohistochemistry (IHC)

• Others (Gene Expression, Microarrays, etc.)

PCR held the largest share in 2024 , accounting for nearly 38% of global revenue, due to its broad clinical acceptance and regulatory familiarity. However, NGS is the fastest-growing segment, driven by its scalability, multiplexing capacity, and utility in discovering complex biomarker profiles for novel immunotherapies.

NGS-based CDx panels are being rapidly adopted in oncology, especially in non-small cell lung cancer (NSCLC), where multiple biomarkers must be screened simultaneously for effective treatment stratification.

 

By Indication

Companion diagnostics are most relevant in diseases where treatment personalization is crucial, particularly in high-mortality conditions:

• Oncology

• Cardiology

• Neurology

• Infectious Diseases

• Others

Oncology dominates the indication spectrum, accounting for over 65% of market revenue in 2024. This segment includes sub-indications such as breast cancer, colorectal cancer, melanoma, and lung cancer. The increasing prevalence of biomarker-driven oncology drugs such as ALK inhibitors, PD-1 inhibitors, and HER2-targeted agents fuels this dominance.

 

By Sample Type

Companion diagnostics are performed on various biological samples depending on disease type and test availability:

• Tissue Biopsies

• Blood-Based (Liquid Biopsies)

• Saliva/Urine

• Others (CSF, Buccal Swabs)

Tissue samples continue to be the gold standard, but liquid biopsies are witnessing high growth due to their non-invasive nature and potential for real-time monitoring.

 

By End User

Deployment of CDx tools varies across healthcare delivery points:

• Hospitals & Oncology Centers

• Clinical Laboratories

• Pharma & Biotech Companies

• Academic & Research Institutes

Hospitals and specialized cancer centers remain the largest end users due to the need for in-house, rapid diagnostics prior to initiating high-value treatments. Pharma companies also represent a rising share, particularly in early drug development and clinical trial biomarker validation.

 

By Region

The geographical breakdown includes:

• North America

• Europe

• Asia-Pacific

• Latin America

• Middle East & Africa (MEA)

North America leads in 2024, driven by the U.S.'s favorable regulatory environment (FDA CDx mandates), widespread adoption of targeted therapies, and advanced reimbursement frameworks. However, Asia-Pacific is the fastest-growing region through 2030, bolstered by expanding genomic infrastructure in China, Japan, and South Korea.

Overall, the segmentation landscape of the companion diagnostics market reflects a confluence of technological maturity, therapeutic specificity, and healthcare readiness — creating clear white spaces for strategic innovation and regional expansion.

 

Market Trends And Innovation Landscape

The companion diagnostics ( CDx ) market is in the midst of a profound transformation , shaped by fast-evolving technologies, integrated therapy-diagnostic pipelines, and novel approaches to biomarker discovery. Between 2024 and 2030, innovation will not only redefine how CDx tools are developed but also who develops them , and how they are regulated and deployed globally.

 

AI-Powered Biomarker Discovery and Prediction Models

One of the most pivotal trends is the integration of artificial intelligence (AI) and machine learning (ML) in both biomarker identification and diagnostic interpretation. AI algorithms are increasingly being used to mine multi-omics data—genomics, transcriptomics , proteomics, and even radiomics —to discover novel biomarkers and develop predictive companion diagnostics for immunotherapy and rare diseases.

“AI-enabled diagnostics are enabling a shift from single-gene markers to polygenic signatures that better predict drug response,” noted an oncology research head at a leading biotech incubator in Boston.

 

Rise of Multi- Analyte and Panel-Based CDx Platforms

Traditional companion diagnostics were often single-gene, single-drug assays. Today, panel-based CDx platforms —especially those using next-generation sequencing (NGS) —are gaining momentum. These tests can simultaneously screen for dozens of actionable mutations, making them suitable for complex cancer phenotypes and multi-drug regimens .

Emerging CDx panels focus on:

• Tumor mutation burden (TMB)

• Microsatellite instability (MSI)

• PD-L1 expression

• Rare fusion genes (e.g., NTRK)

NGS-based CDx is also enabling pan-cancer approvals , allowing one test to guide therapy across tumor types if the biomarker is present.

 

Liquid Biopsy as a Breakthrough in Non-Invasive CDx

While tissue biopsy remains standard, liquid biopsy-based CDx —especially those analyzing circulating tumor DNA ( ctDNA )—are on the rise. These tools enable:

• Non-invasive, real-time tumor profiling

• Minimal patient discomfort

• Therapy monitoring and resistance detection

Several clinical trials are now incorporating ctDNA as a biomarker for therapy continuation or switch, and regulatory bodies have started to approve liquid biopsy-based CDx for specific drugs.

 

Growth in Pharma–Diagnostic Co-Development Models

Pharmaceutical companies are no longer outsourcing diagnostics late in development. There is a clear trend toward co-developing companion diagnostics and therapies from the early preclinical or Phase I stage. This is especially true for novel immunotherapies, where response rates can vary dramatically by patient genetics or tumor microenvironment.

Co-development benefits include:

• Improved clinical trial success

• Accelerated regulatory approval

• Streamlined market entry

Recent collaborations include joint ventures between top-10 pharma companies and diagnostic startups focusing on modular, scalable CDx platforms.

 

Decentralization of Testing and At-Home Diagnostics

There is growing interest in decentralizing CDx testing , especially for chronic diseases or low-resource settings. This includes:

• Lab-on-a-chip platforms

• Home-based kits with telemedicine interpretation

• Mobile diagnostics integrated into clinical trial ecosystems

“We’re witnessing a future where a cancer patient’s blood sample can be sequenced, analyzed, and matched to a treatment—all without visiting a centralized lab,” commented a product director at a diagnostic device firm in Seoul.

 

Regulatory Evolution Supporting Innovation

Regulatory bodies, especially the FDA and EMA , have increasingly formalized co-labeling procedures for therapies and diagnostics. The U.S. FDA’s guidance on “In Vitro Companion Diagnostic Devices” has established clear pathways for concurrent approval, while Europe's IVDR regulation has begun to harmonize CDx standards across EU nations.

Together, these trends represent a converging frontier where technology, clinical need, and commercial incentive are aligning to make companion diagnostics faster, smarter, more predictive—and more essential than ever.

 

Competitive Intelligence And Benchmarking

The global companion diagnostics market is characterized by a competitive landscape that blends legacy diagnostic giants , emerging molecular platforms , and strategic pharma-diagnostic alliances . Market leadership is being redefined not just by product offerings but by co-development agility , regulatory expertise, and precision-driven innovation.

Below are key players shaping the competitive arena:

 

1. Roche Diagnostics

A global pioneer in companion diagnostics, Roche Diagnostics continues to dominate the space with its integrated drug-diagnostic development through its subsidiary Ventana Medical Systems . The company has co-developed CDx for blockbuster therapies like Herceptin and Alecensa .

• Strategy : Deep alignment with Roche Pharmaceuticals enables synchronized drug/ CDx launches.

• Product Differentiation : Focus on IHC and tissue-based CDx for oncology.

• Global Reach : Strong regulatory track record in both the U.S. and Europe, with expanding markets in Asia-Pacific.

 

2. Thermo Fisher Scientific

Through its Ion Torrent NGS platform , Thermo Fisher Scientific is emerging as a leader in NGS-based companion diagnostics , especially for solid tumors.

• Strategy : Heavy investment in CDx development pipelines with pharma co-partners.

• Product Differentiation : High-throughput sequencing with FDA-approved panels.

• Reach : Expanding footprint in decentralized testing environments via scalable NGS kits.

 

3. Qiagen

Qiagen is known for its PCR and hybrid-capture technologies and has a track record of FDA-cleared companion diagnostics in oncology and infectious disease segments.

• Strategy : Focused on modular, customizable CDx tools that integrate easily into drug pipelines.

• Product Differentiation : Leverages its digital PCR platform for precise biomarker quantification.

• Global Reach : Strong in Europe, gaining regulatory acceleration in the U.S. and Japan.

 

4. Illumina

While primarily known for sequencing hardware, Illumina is actively expanding into the CDx domain via partnerships and clinical validation of its platforms.

• Strategy : Establish NGS as the gold standard for multi-gene CDx tests.

• Product Differentiation : Known for ultra-high accuracy and depth of sequencing.

• Market Position : Currently indirect player but rapidly evolving via joint ventures.

 

5. Agilent Technologies

Agilent has built its CDx strength on companion assays in immuno-oncology , particularly for checkpoint inhibitors.

• Strategy : Deep collaboration with pharma partners to develop IHC-based CDx for PD-L1 and other markers.

• Differentiation : Strong presence in pathology labs and cancer centers.

• Global Penetration : Robust infrastructure in both mature and emerging economies.

 

6. Abbott Laboratories

Abbott is gradually positioning itself in the CDx space, especially in infectious disease and cardiovascular indications.

• Strategy : Capitalizing on existing diagnostic infrastructure to develop niche CDx tools.

• Product Edge : Strong base in point-of-care and molecular diagnostics.

• Growth Focus : Emerging markets and decentralized testing environments.

 

7. Foundation Medicine

A fully owned subsidiary of Roche, Foundation Medicine is at the forefront of comprehensive genomic profiling (CGP) . Its FoundationOne CDx panel is FDA-approved and widely used in clinical oncology.

• Strategy : Offer pan-tumor profiling to support multiple drugs across pharma pipelines.

• Differentiation : End-to-end bioinformatics and interpretation support.

• Presence : Predominantly U.S.-focused but expanding into Europe and Japan.

The competitive battleground is shifting from isolated diagnostic kits to full-service platforms that offer genomic testing, bioinformatics, and regulatory compliance—all in one package. As co-labeling and drug-linked diagnostics become the norm, agility in co-development and real-world data integration will define next-generation market leaders.

 

Regional Landscape And Adoption Outlook

The adoption of companion diagnostics varies significantly across global regions, shaped by regulatory maturity , infrastructure readiness , clinical trial ecosystems , and access to precision therapies . While North America leads in commercial deployment, Asia-Pacific and Europe are rapidly scaling both adoption and innovation, creating a diverse global opportunity map.

 

North America

North America —especially the United States —dominates the companion diagnostics market in 2024, accounting for over 42% of global revenue . The U.S. FDA has formalized regulatory pathways for CDx approvals, with a mandate for companion diagnostics in parallel with new targeted therapy launches . This clear regulatory alignment has enabled rapid market penetration.

Key factors driving U.S. dominance include:

• Robust pharma-diagnostic co-development pipelines originating in Boston, San Francisco, and New Jersey

• Institutional support from the National Cancer Institute (NCI) and the Precision Medicine Initiative

• Comprehensive insurance coverage models from CMS and private payers for FDA-approved CDx assays

• Widespread adoption of NGS-based panels at leading cancer centers and community hospitals

Canada also exhibits a growing CDx market, albeit slower due to provincial reimbursement complexities. However, partnerships with U.S.-based biotech companies are expanding clinical access to advanced diagnostics.

 

Europe

Europe holds the second-largest market share , led by Germany, the UK, and France . The introduction of the In Vitro Diagnostic Regulation (IVDR) across the EU is transforming the companion diagnostics approval and compliance landscape, requiring stronger clinical evidence and co-labeling documentation .

Highlights from Europe include:

• High adoption of IHC and PCR-based CDx for HER2, EGFR, and BRAF markers in public healthcare systems

• Germany's integration of CDx into oncology reimbursement pathways under statutory insurance

• The UK’s Genomic Medicine Service , which is incorporating NGS-based CDx into the NHS system

However, regulatory harmonization delays and fragmented reimbursement policies in southern and eastern Europe slightly hinder pan-European scalability.

 

Asia-Pacific

The Asia-Pacific (APAC) region is the fastest-growing companion diagnostics market , expected to achieve a CAGR of over 15% through 2030. Growth is led by China, Japan, South Korea, and India , where policy, technology investment, and local innovation ecosystems are converging.

• China : Rapid uptake driven by government support under the Healthy China 2030 plan and a flourishing domestic biotech sector focused on CDx co-development.

• Japan : Pioneering reimbursement of NGS-based companion diagnostics; advanced integration into oncology clinical practice.

• South Korea : Home to strong AI-biotech firms developing pan-cancer CDx platforms, particularly in Seoul’s BioCluster .

• India : While still emerging, the private sector is pushing forward CDx adoption in Tier I hospitals and specialty oncology chains.

Multinational pharma and diagnostic firms are increasingly launching Asia-first CDx trials to leverage large patient pools and cost-effective development cycles.

 

Latin America

Adoption in Latin America is nascent but expanding , particularly in Brazil, Mexico, and Argentina . These nations have seen a rise in targeted therapy approvals, leading to increased demand for matching diagnostics.

Challenges:

• Limited lab infrastructure for NGS and molecular testing

• Dependence on imported kits and reagents

• High out-of-pocket costs due to weak reimbursement models

Yet, Brazil’s ANVISA is progressively aligning with international CDx regulations, and several regional cancer centers are building molecular pathology capabilities.

 

Middle East & Africa (MEA)

The MEA region represents the smallest share but holds long-term strategic value , especially in the Gulf Cooperation Council (GCC) countries like Saudi Arabia and the UAE , which are investing heavily in genomic medicine.

• Advanced hospital networks in Dubai, Riyadh, and Abu Dhabi are introducing CDx platforms for oncology patients

• South Africa shows early-stage development through its academic research hubs, but broader adoption remains limited due to infrastructure gaps

The region’s growing investment in healthcare transformation and medical tourism could act as a catalyst for precision diagnostics adoption by the late 2020s.

In summary, North America and Europe currently dominate due to regulatory and reimbursement maturity, while Asia-Pacific offers the highest growth momentum. Latin America and MEA are developing markets with significant white space opportunities for global players willing to localize offerings and build capacity.

 

End-User Dynamics And Use Case

The adoption of companion diagnostics varies widely across end-user categories, depending on clinical infrastructure, technical expertise, and therapeutic focus. Understanding how these stakeholders interact with CDx technologies is crucial for identifying commercial growth pockets and adoption bottlenecks .

 

1. Hospitals and Oncology Centers

 

Hospitals and specialized oncology centers account for the largest share of CDx adoption in 2024. These institutions rely heavily on companion diagnostics to guide high-value treatments—especially in breast cancer, lung cancer, and melanoma.

Key drivers:

• In-house molecular pathology labs

• Direct access to tissue samples from biopsies or surgeries

• Established workflows for integrating diagnostic findings with oncology treatment boards

Large cancer centers often deploy NGS panels or IHC assays directly before initiating treatments like checkpoint inhibitors or kinase-targeted therapies. The rise of multidisciplinary tumor boards has increased the demand for diagnostics that support therapy-matching decisions in real time.

 

2. Clinical Laboratories

 

Independent diagnostic labs and reference labs play a pivotal role in the scaling of CDx testing , especially in community settings where hospitals may lack molecular infrastructure.

• Labs are increasingly offering centralized CDx services , often under partnerships with pharmaceutical companies.

• Use of automated PCR and sequencing platforms allows high-throughput processing.

• Some leading labs are offering turnkey CDx+reporting bundles for oncologists, with therapy recommendations embedded in results.

However, challenges include variability in biomarker interpretation standards , particularly across different regions and lab networks.

 

3. Pharmaceutical and Biotechnology Companies

Pharma and biotech firms are not just end users—they are co-creators in the CDx ecosystem. Companion diagnostics are now integral to clinical trials, helping companies:

• Stratify patients based on response markers

• Design adaptive trials

• Improve approval timelines by aligning diagnostics with therapeutic labeling

Many companies now build CDx partnerships as early as preclinical development, ensuring the diagnostic and therapeutic enter the market as a cohesive solution.

 

4. Academic and Research Institutes

These institutions contribute significantly to biomarker discovery and CDx validation , particularly in rare diseases and novel immunotherapies. While they are not large-scale end users, they play a foundational role in pipeline innovation .

• Leading academic centers are collaborating with CDx developers on prospective biomarker studies

• They often pilot liquid biopsy platforms and next-gen algorithms before commercial rollout

 

Realistic Use Case

A leading tertiary cancer hospital in South Korea integrated an NGS-based CDx panel to identify rare gene fusions in patients with non-small cell lung cancer (NSCLC).

The diagnostic platform was linked to a treatment decision-support tool, allowing oncologists to match patients with targeted therapies like ROS1 and ALK inhibitors. As a result, over 35% of patients were matched to precision therapies that would have otherwise been missed using conventional IHC or PCR methods.

The implementation led to:

• A 22% increase in progression-free survival

• Reduced trial-and-error with first-line drugs

• Improved payer support due to biomarker-confirmed efficacy

This case underscores the procedural value of multi-gene CDx tools in ensuring cost-effective, clinically superior patient outcomes in real-world oncology.

Each end-user group brings unique adoption behaviors, infrastructure needs, and barriers. Market strategies must therefore be tailored— one-size-fits-all deployment models do not succeed in companion diagnostics.

 

Recent Developments + Opportunities & Restraints

Recent Developments (2022–2024)

The companion diagnostics market has witnessed notable regulatory approvals, partnerships, and platform advancements in the past two years, accelerating its commercial trajectory and clinical relevance:

• FDA Approves FoundationOne ® CDx for Rozlytrek ® In mid-2023, the U.S. FDA expanded the approval of Foundation Medicine's FoundationOne CDx test to include use as a companion diagnostic for Rozlytrek ( entrectinib ) for NTRK gene fusion-positive solid tumors.

• Thermo Fisher and Moderna Partner for CDx Development In 2022, Thermo Fisher Scientific entered a collaboration with Moderna to develop a CDx assay for mRNA-based cancer vaccines, signaling growing integration between emerging therapies and diagnostics.

• Roche Launches Digital Pathology CDx Platform In 2023, Roche Diagnostics launched a new AI-powered digital pathology solution aimed at automating PD-L1 expression scoring for use in immunotherapy companion diagnostics.

• Qiagen Expands therascreen ® Portfolio Qiagen received expanded CE-IVD clearance for its therascreen KRAS RGQ PCR Kit in Europe to guide colorectal cancer treatment, further strengthening its leadership in PCR-based CDx .

• Illumina Joins Forces with Janssen for CDx in Hematologic Cancers In late 2023, Illumina announced a strategic alliance with Janssen Pharmaceuticals to develop a broad NGS-based CDx panel for B-cell malignancies.

 

Opportunities

• Expansion into Emerging Markets (Asia-Pacific & LATAM ) As genomic infrastructure improves, there is significant opportunity to localize CDx platforms for large oncology and infectious disease patient pools in countries like India, Brazil, and Indonesia .

• Integration with AI and Digital Biomarkers CDx tools that incorporate AI-based decision support and multi-modal data (imaging + molecular) are expected to gain a competitive edge, particularly in academic hospitals and clinical trials.

• New Indications Beyond Oncology Companion diagnostics are being explored in neurology, cardiology, and autoimmune disorders . For example, CDx -guided treatment of Alzheimer’s or psoriasis represents untapped commercial territory.

 

Restraints

• Complex and Fragmented Regulatory Pathways While some regions (like the U.S. and Japan) have structured CDx regulations, many countries still lack clear approval frameworks , delaying time-to-market and limiting global scale.

• High Cost and Limited Reimbursement The development and clinical validation of CDx are capital-intensive , often exceeding the budgets of small-to-mid-size biotechs . In many markets, reimbursement remains uncertain , especially for NGS-based platforms.

The market’s trajectory will depend on resolving regulatory harmonization and incentivizing payer participation, while capitalizing on new indications and geographic diversification.
 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 6.4 Billion
Revenue Forecast in 2030	USD 14.0 Billion
Overall Growth Rate	CAGR of 13.1% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Units	USD Million, CAGR (2024–2030)
Segmentation	By Technology, By Indication, By End User, By Geography
By Technology	PCR, NGS, IHC, ISH, Others
By Indication	Oncology, Cardiology, Infectious Diseases, Neurology, Others
By End User	Hospitals & Oncology Centers, Clinical Laboratories, Pharmaceutical & Biotech Companies, Academic Institutes
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	U.S., UK, Germany, China, India, Japan, Brazil, South Korea, UAE, South Africa
Market Drivers	Growth in targeted therapies, rise in cancer incidence, AI-enabled biomarker discovery
Customization Option	Available upon request