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 accelerate at CAGR of 13.1%, climbing from $6.4 billion in 2024 to $14.0 billion by 2030, driven by NGS, liquid biopsy, biomarker testing, precision medicine, oncology, as highlighted by 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.

 

Comprehensive Market Snapshot

• The Global Companion Diagnostics Market will accelerate at a CAGR of 13.1%, climbing from $6.4 billion in 2024 to $14.0 billion by 2030.

• The USA Companion Diagnostics Market will register a healthy 12.7% CAGR, expanding from $2.0 billion in 2024 to approximately $4.1 billion by 2030.

• The Europe Companion Diagnostics Market will grow at a 10.6% CAGR, expanding from $1.7 billion in 2024 to approximately $3.1 billion by 2030.

• The APAC Companion Diagnostics Market will grow at a robust 15.0% CAGR, expanding from $1.2 billion in 2024 to approximately $2.8 billion by 2030.

 

Market Segmentation Insights

By Technology

• Polymerase Chain Reaction (PCR) accounted for approximately 38% of the total market share in 2024, driven by its widespread clinical adoption, cost efficiency, and entrenched regulatory acceptance across routine biomarker testing.

• Next-Generation Sequencing (NGS) represented nearly 27% of market revenue, supported by increasing use of multi-gene panels and tumor profiling in precision oncology.

• Immunohistochemistry (IHC) held about 18% share, reflecting its continued relevance in protein-expression–based biomarker validation.

• In Situ Hybridization (ISH) contributed approximately 11%, particularly in gene amplification and rearrangement detection.

• Other technologies (including gene-expression profiling and microarrays) accounted for the remaining 6%, largely in research-driven and niche clinical applications.

By Indication

• Oncology remained the dominant indication, accounting for approximately 65% of market revenue in 2024, as companion diagnostics are structurally linked to targeted therapies and immuno-oncology drugs.

• Infectious Diseases represented nearly 11% of the market, supported by precision-guided antiviral and antimicrobial treatment strategies.

• Cardiology accounted for around 9%, reflecting growing interest in pharmacogenomic-guided cardiovascular therapies.

• Neurology contributed approximately 7%, driven by emerging biomarker-based approaches in neurodegenerative and rare neurological disorders.

• Other indications collectively held about 8%, spanning autoimmune, metabolic, and rare disease applications.

By End User

• Hospitals & Oncology Centers accounted for approximately 44% of total market revenue in 2024, driven by point-of-care decision-making needs prior to initiating high-cost targeted therapies.

• Clinical Laboratories represented nearly 34%, supported by centralized testing models, high-throughput workflows, and reimbursement optimization.

• Pharmaceutical & Biotech Companies held about 15% share, reflecting rising use of companion diagnostics in clinical trials, label expansion, and lifecycle management.

• Academic & Research Institutes accounted for approximately 7%, primarily focused on translational research and early biomarker discovery.

Regional Insights

• North America accounted for the largest market share at approximately 42% in 2024, supported by formal FDA companion diagnostic requirements, strong oncology drug pipelines, and advanced reimbursement frameworks.

• Asia-Pacific is expected to expand at the fastest CAGR during 2024–2030, driven by expanding genomic testing capacity, rising cancer incidence, and increasing CDx adoption alongside new drug approvals.

 

Strategic Questions Driving the Next Phase of the Global Companion Diagnostics Market

1. What testing modalities, biomarker classes, and drug–diagnostic pairings are explicitly included within the companion diagnostics market, and which molecular tests fall outside the CDx regulatory definition?

2. How does the companion diagnostics market differ structurally from adjacent molecular diagnostics, laboratory-developed tests (LDTs), and broad genomic screening markets?

3. What is the current and forecasted size of the global companion diagnostics market, and how is value distributed across key technologies, indications, and regions?

4. How is revenue allocated between single-analyte assays, multiplex panels, and comprehensive genomic profiling solutions, and how is this mix expected to evolve?

5. Which therapeutic areas (e.g., oncology, infectious diseases, cardiology, neurology) account for the largest and fastest-growing CDx revenue pools?

6. Which CDx segments generate disproportionate economic value due to pricing, regulatory lock-in, or drug-label exclusivity rather than testing volume alone?

7. How does demand differ across early-stage screening, treatment-selection testing, and resistance or relapse monitoring applications?

8. How are companion diagnostics positioned across first-line, later-line, and combination therapy decision pathways, and how is this positioning changing over time?

9. What role do test frequency, re-testing rates, and longitudinal biomarker monitoring play in driving recurring CDx revenue?

10. How do disease prevalence, biomarker incidence rates, and access to molecular testing infrastructure shape demand across CDx segments?

11. What clinical adoption barriers—such as tissue availability, turnaround time, or test complexity—limit penetration of specific companion diagnostic platforms?

12. How do reimbursement policies, payer evidence requirements, and value-based pricing models influence realized CDx revenues across regions?

13. How strong is the current and mid-term CDx development pipeline, and which emerging biomarkers or mechanisms of action are likely to create new testing categories?

14. To what extent will new CDx approvals expand the eligible treated population versus intensify competition within existing biomarker-defined segments?

15. How are advances in assay sensitivity, multiplexing, and liquid biopsy technologies improving clinical utility and adoption of companion diagnostics?

16. How will drug patent expirations and label expansions affect the lifecycle value and competitive positioning of associated companion diagnostics?

17. What role will alternative testing strategies—such as broad NGS panels or reflex testing—play in displacing single-drug companion diagnostics?

18. How are diagnostic developers and pharmaceutical partners aligning co-development, regulatory, and commercialization strategies to defend or grow CDx market share?

19. Which geographic markets are expected to outperform global growth in companion diagnostics adoption, and which technology or indication segments are driving this momentum?

20. How should diagnostic developers, pharma partners, and investors prioritize platforms, biomarkers, and regions to maximize long-term value creation in the CDx ecosystem?

 

Segment-Level Insights and Market Structure

The Companion Diagnostics (CDx) Market is organized around technology platforms, clinical indications, biological sample types, and end-user environments, reflecting how diagnostics are co-developed with targeted therapies and operationalized within real-world treatment pathways. Unlike volume-driven laboratory testing markets, CDx value creation is anchored in regulatory linkage to drugs, clinical decision criticality, and treatment-enabling utility. Each segment therefore contributes differently to revenue durability, competitive positioning, and long-term growth potential.

 

Technology Insights

Polymerase Chain Reaction (PCR)

PCR-based companion diagnostics represent the most established and operationally mature segment of the market. These assays are commonly used for detecting well-defined genetic alterations with high sensitivity and rapid turnaround. From a market perspective, PCR benefits from deep clinical familiarity, relatively low infrastructure requirements, and predictable regulatory pathways. As a result, this segment continues to generate stable revenue tied to mature targeted therapies, even as innovation shifts toward more complex platforms.

Next-Generation Sequencing (NGS)

NGS constitutes the most transformative and fastest-evolving technology segment within the CDx market. Its ability to interrogate multiple biomarkers simultaneously makes it especially valuable in disease settings characterized by molecular heterogeneity, particularly oncology. Commercially, NGS tests command higher per-assay value and play a strategic role in consolidating multiple drug-linked diagnostics into a single platform. Over time, NGS is expected to reconfigure the market from single-biomarker testing toward comprehensive genomic profiling.

In Situ Hybridization (ISH)

ISH-based companion diagnostics occupy a specialized position, primarily supporting detection of gene amplifications and chromosomal rearrangements. These assays are often deployed when spatial genomic context is clinically relevant. While narrower in scope compared with PCR or NGS, ISH remains strategically important in select drug-diagnostic pairings and continues to serve as a confirmatory or complementary technology within precision-medicine workflows.

Immunohistochemistry (IHC)

IHC represents a critical technology for protein-expression–based companion diagnostics. These assays are tightly integrated into pathology workflows and are valued for their visual interpretability and direct correlation with tissue morphology. From a market standpoint, IHC maintains durable relevance due to its role in guiding therapy eligibility where expression thresholds, rather than genetic alterations alone, determine treatment decisions.

Other Technologies (Gene Expression, Microarrays, etc.)

Other molecular platforms, including gene-expression profiling and microarrays, form a smaller but strategically exploratory segment of the market. Their use is more prevalent in translational research, early clinical development, or niche applications. While limited in current commercial scale, these technologies contribute to upstream biomarker discovery and may inform future CDx innovation cycles.

 

Indication Insights

Oncology

Oncology represents the dominant indication for companion diagnostics, driven by the widespread adoption of biomarker-defined therapies and immuno-oncology agents. In this segment, CDx tests are directly embedded into treatment selection and reimbursement decisions, making them indispensable rather than optional. From a market perspective, oncology CDx benefits from frequent label expansions, multi-line testing requirements, and strong regulatory alignment with drug approvals.

Cardiology

Cardiology-focused companion diagnostics form a smaller but emerging segment, primarily linked to pharmacogenomics and precision dosing strategies. Adoption is influenced by the pace at which molecular stratification is integrated into cardiovascular treatment guidelines. While growth is more measured compared with oncology, this segment reflects increasing interest in individualized therapy beyond cancer.

Neurology

Neurology represents an early-stage but strategically important indication segment. Companion diagnostics in this area are tied to complex disease biology and evolving therapeutic pipelines. Market contribution remains modest today, but future expansion is expected as biomarker-driven therapies advance in neurodegenerative and rare neurological disorders.

Infectious Diseases

Infectious disease CDx applications focus on identifying molecular markers that guide targeted antimicrobial or antiviral therapy. This segment is shaped by the need for precision in resistance detection and treatment optimization. While smaller in absolute revenue, it offers growth potential linked to antimicrobial stewardship and precision-guided treatment strategies.

Other Indications

Other indications encompass a range of autoimmune, metabolic, and rare diseases where targeted therapies are emerging. These applications are currently limited in scale but represent potential long-term expansion areas as biomarker-based drug development broadens beyond traditional strongholds.

 

Sample Type Insights

Tissue Biopsies

Tissue-based testing remains the reference standard for many companion diagnostics, particularly in oncology. These samples provide high analytical confidence and enable multiple testing modalities from a single specimen. From a market standpoint, tissue biopsies continue to underpin the majority of approved CDx claims, anchoring current revenue streams.

Blood-Based (Liquid Biopsies)

Liquid biopsy–based companion diagnostics represent one of the most dynamic growth segments. Their non-invasive nature and ability to capture real-time molecular changes make them attractive for both initial therapy selection and disease monitoring. Commercially, liquid biopsies are reshaping testing pathways by expanding access and reducing procedural burden.

Saliva and Urine

Saliva- and urine-based samples occupy a niche position, offering convenience and patient comfort in specific use cases. While not broadly adopted across all CDx indications, they reflect ongoing efforts to simplify sample collection and decentralize testing where clinically appropriate.

Other Samples (CSF, Buccal Swabs)

Other biological samples are used in specialized clinical contexts, such as central nervous system disorders or rare diseases. These sample types contribute marginally to overall market revenue but are essential for addressing specific diagnostic challenges.

 

End-User Insights

Hospitals & Oncology Centers

Hospitals and specialized oncology centers are the primary end users of companion diagnostics. These settings integrate CDx testing directly into treatment decision workflows, often under time-sensitive conditions. Their central role in initiating high-value therapies makes them the largest contributors to CDx utilization and revenue.

Clinical Laboratories

Clinical laboratories serve as the operational backbone for companion diagnostics, particularly for complex molecular assays requiring scale and standardization. From a market perspective, this segment supports broad geographic access and high-throughput testing, reinforcing its importance in the CDx ecosystem.

Pharmaceutical & Biotech Companies

Pharma and biotech companies represent a distinct end-user segment focused on CDx use in drug development, clinical trials, and label expansion strategies. Although not volume-driven, this segment is strategically critical, as it shapes future approvals and long-term market expansion.

Academic & Research Institutes

Academic and research institutions contribute primarily to early biomarker discovery and translational research. While their direct revenue contribution is limited, their influence on future CDx innovation and clinical validation is substantial.

 

Segment Evolution Perspective

The companion diagnostics market is transitioning from single-purpose, drug-specific tests toward platform-based, multi-use diagnostic ecosystems. Established segments continue to anchor current clinical practice, while advanced technologies, novel sample types, and expanding indications are redefining how value is generated. As precision medicine deepens across therapeutic areas, the balance of revenue and strategic importance across segments is expected to shift accordingly.

 

Table: Key Approved Companion Diagnostics and Major CDx Platforms

CDx Product / Platform	Company (Developer / Manufacturer)	Development Status	Target / Biomarker Focus + Example Linked Therapy/Use
FoundationOne CDx (tissue broad NGS CDx)	Foundation Medicine, Inc. (Roche)	FDA-approved CDx (PMA: P170019 + supplements)	Broad multi-gene solid tumor profiling; example FDA-linked uses include MET exon 14 skipping for capmatinib (Tabrecta) and FGFR2 fusions/rearrangements for pemigatinib (Pemazyre).
FoundationOne Liquid CDx (plasma broad NGS CDx)	Foundation Medicine, Inc. (Roche)	FDA-approved CDx (PMA: P190032 + supplements)	Plasma NGS for actionable alterations; example FDA-linked use includes ROS1 fusions (and NTRK1/2/3 fusions) for entrectinib (Rozlytrek).
Guardant360 CDx (plasma NGS CDx)	Guardant Health, Inc.	FDA-approved CDx (PMA: P200010 + indication expansions)	cfDNA NGS; example FDA-linked uses include KRAS G12C for sotorasib (Lumakras) and ERBB2 activating mutations for fam-trastuzumab deruxtecan (ENHERTU).
Oncomine Dx Target Test (tissue NGS CDx; Ion platform)	Life Technologies Corporation (Thermo Fisher Scientific)	FDA-approved CDx (PMA: P160045 + supplements)	Tissue NGS CDx; example FDA-linked uses include ROS1 fusions for crizotinib (Xalkori) and EGFR exon 20 insertions for amivantamab (Rybrevant).
PD-L1 IHC 22C3 pharmDx	Dako North America, Inc. (Agilent)	FDA-approved CDx (PMA: P150013 + supplements)	PD-L1 protein expression scoring; example FDA-linked use includes PD-L1 expression thresholds used to guide cemiplimab (Libtayo) in NSCLC.
PD-L1 IHC 28-8 pharmDx	Dako North America, Inc. (Agilent)	FDA-approved CDx (PMA: P150025 + supplements)	PD-L1 protein expression; example FDA-linked use includes PD-L1 tumor cell staining thresholds for nivolumab (Opdivo) + ipilimumab (Yervoy) in NSCLC.
Ventana PD-L1 (SP142) Assay	Ventana Medical Systems, Inc. (Roche)	FDA-approved CDx (PMA: P160002 + supplements)	PD-L1 protein expression (indication-specific scoring); example FDA-linked use includes atezolizumab (Tecentriq) in urothelial carcinoma and NSCLC with specified cutoffs.
Ventana PD-L1 (SP263) Assay	Ventana Medical Systems, Inc. (Roche)	FDA-approved CDx (PMA: P160046 + supplements)	PD-L1 protein expression; example FDA-linked uses include atezolizumab (Tecentriq) (NSCLC, TC ≥1%) and cemiplimab (Libtayo) (NSCLC, TC ≥50%).
Ventana ALK (D5F3) CDx Assay	Ventana Medical Systems, Inc. (Roche)	FDA-approved CDx (PMA: P140025 + supplements)	IHC detection of ALK protein expression; example FDA-linked use includes selecting ALK therapy such as alectinib (Alecensa) in NSCLC.
Vysis ALK Break Apart FISH Probe Kit	Abbott Molecular Inc.	FDA-approved CDx (PMA: P110012 + supplements)	FISH detection of ALK gene rearrangements; example FDA-linked uses include crizotinib (Xalkori) and later ALK inhibitors (via PMA supplements).
therascreen EGFR RGQ PCR Kit	QIAGEN Manchester, Ltd.	FDA-approved CDx (PMA: P120022 + supplements)	PCR detection of EGFR exon 19 deletions / L858R; example FDA-linked use includes dacomitinib (Vizimpro) in NSCLC.
cobas EGFR Mutation Test v2	Roche Molecular Systems, Inc.	FDA-approved CDx (PMA: P120019 + supplements; plus separate PMA entries for specific claims)	Tissue/plasma EGFR testing; example FDA-linked use includes afatinib (Gilotrif) selection using exon 19 del/L858R (and other claim-specific entries on the FDA table).
cobas 4800 BRAF V600 Mutation Test	Roche Molecular Systems, Inc.	FDA-approved CDx (PMA: P110020 + supplements)	BRAF V600E (±V600K) detection; example FDA-linked use includes vemurafenib (Zelboraf) in melanoma.
therascreen BRAF V600E RGQ PCR Kit	QIAGEN GmbH	FDA-approved CDx (PMA: P190026)	PCR detection of BRAF V600E; example FDA-linked use includes encorafenib (Braftovi) + cetuximab (Erbitux) in colorectal cancer.
therascreen PIK3CA RGQ PCR Kit	QIAGEN GmbH	FDA-approved CDx (PMA: P190004; listed alongside P190001 on FDA table)	PCR detection of PIK3CA mutations; example FDA-linked use includes alpelisib (Piqray) in breast cancer.
BRACAnalysis CDx	Myriad Genetic Laboratories, Inc.	FDA-approved CDx (PMA: P140020 + supplements)	Germline BRCA1/2; example FDA-linked uses include multiple tumor types/labels such as olaparib (Lynparza) (table includes pancreatic and mCRPC entries, among others).
therascreen FGFR RGQ RT-PCR Kit	QIAGEN Manchester Ltd.	FDA-approved CDx (PMA: P180043)	FGFR3 mutations + FGFR3–TACC3 fusions; example FDA-linked use includes erdafitinib (Balversa) in urothelial cancer.
Abbott RealTime IDH2	Abbott Molecular, Inc.	FDA-approved CDx (PMA: P170005)	PCR detection of IDH2 mutations; example FDA-linked use includes enasidenib (Idhifa) in AML.

 

Key Recent Developments

Roche Diagnostics

• Breakthrough Device Designation for AI-enabled VENTANA TROP2 RxDx assay (USA)
  Roche received FDA Breakthrough Device Designation for an AI-powered VENTANA TROP2 companion diagnostic intended to support patient selection for datopotamab deruxtecan (Dato-DXd) in non-small cell lung cancer—highlighting the market’s shift toward digital pathology + algorithmic scoring as CDx complexity rises.

• FDA approval of VENTANA MET (SP44) RxDx Assay paired to telisotuzumab vedotin (Emrelis) (USA)
  Roche announced FDA approval of the VENTANA MET (SP44) RxDx Assay as the companion diagnostic tied to AbbVie’s telisotuzumab vedotin (Emrelis) launch pathway in NSCLC—reinforcing MET as a commercially relevant biomarker where assay standardization matters for uptake.

• HER2 testing expansion aligned to Enhertu + pertuzumab first-line metastatic breast cancer (USA)
  With FDA’s December 15, 2025 decision for Enhertu + pertuzumab, FDA also approved the PATHWAY anti-HER2/neu (4B5) and HER2 Dual ISH DNA Probe Cocktail as companion diagnostics—tightening the link between therapy label expansion and HER2 IHC/ISH test demand in high-volume metastatic settings.

Thermo Fisher Scientific

• Oncomine Dx Target Test approved as CDx for HER2 (ERBB2) TKD mutations (USA)
  On Nov 19, 2025, FDA approved Oncomine Dx Target Test as the companion diagnostic to detect HER2 (ERBB2) tyrosine kinase domain activating mutations in non-squamous NSCLC patients eligible for sevabertinib (Hyrnuo)—a clear example of how NGS CDx continues to expand beyond the “classic” EGFR/ALK set.

• Oncomine Dx Express Test cleared/approved as CDx for EGFR exon 20 insertion therapy (USA)
  Thermo Fisher highlighted FDA approval of its Oncomine Dx Express Test as a companion diagnostic supporting sunvozertinib (ZEGFROVY) in NSCLC—showing continued momentum for faster, streamlined NGS workflows designed for routine hospital-lab adoption.

Guardant Health

• Guardant360 CDx paired to Lilly’s imlunestrant (Inluriyo) in ESR1-mutated breast cancer (USA)
  Guardant announced FDA approval of Guardant360 CDx as the companion diagnostic for selecting patients for imlunestrant—strengthening the role of liquid-biopsy CDx in hormone receptor–positive metastatic breast cancer where rapid, minimally invasive biomarker detection can accelerate treatment decisions.

• Guardant360 CDx approval as CDx for Inluriyo (Japan)
  Guardant’s Japan business reported regulatory approval of Guardant360 CDx as a companion diagnostic for Inluriyo, underscoring the continued “globalization” of CDx labels (and the operational advantage of platforms already validated across regions).

QIAGEN

• Therascreen KRAS RGQ PCR Kit tied to KRAS G12C mCRC combination regimen (USA)
  QIAGEN’s therascreen KRAS RGQ PCR Kit received FDA approval as a companion diagnostic aligned with the sotorasib (Lumakras) + panitumumab (Vectibix) regimen in KRAS G12C–mutated metastatic colorectal cancer—elevating KRAS G12C testing relevance outside lung cancer into a larger CRC treatment pool.

Illumina

• FDA approval of TruSight Oncology Comprehensive with CDx claims (USA)
  Illumina announced FDA approval of TruSight Oncology Comprehensive as a distributable CGP IVD that includes companion diagnostic claims—supporting decentralization of CDx-quality NGS away from purely central labs and into more localized testing environments.

Tempus

• National launch of FDA-approved xT CDx (USA)
  Tempus announced the national launch of its FDA-approved xT CDx (648-gene) test, positioning it as broadly orderable with CDx claims—another indicator that competitive intensity is rising among “CGP-as-CDx” platforms (panel breadth + turnaround + evidence packages).

Pillar Biosciences

• OncoReveal CDx PMA supplement approval for pan-cancer tumor profiling (USA)
  Pillar announced FDA approval of its oncoReveal CDx pan-cancer solid tumor assay PMA supplement for broader tumor profiling on Illumina MiSeq Dx—showing how smaller platform players are expanding beyond single-biomarker CDx into multi-gene profiling footprints.

 

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