Cardiotoxicity Screening Market Size and Companies (2026-2035)

Revenue, 2025

USD 3.21 Billion

Forecast, 2035

USD 9.61 Billion

CAGR, 2026-2035

11.58%

Report Coverage

Global

Cardiotoxicity Screening Market Trends for 2026

The global cardiotoxicity screening market size was estimated at USD 3.21 billion in 2025 and is predicted to increase from USD 3.59 billion in 2026 to approximately USD 9.61 billion by 2035, expanding at a CAGR of 11.58% from 2026 to 2035.

Across the globe, rising cases of cardiac diseases and the expanding need for early phase detection are propelling the demand for advanced cardiotoxicity screening solutions. Besides this, several companies are leveraging 3D biomarker models and modern AI platforms to meet the stringent regulatory guidelines.

Key Takeaways

• Cardiotoxicity screening market to crossed USD 3.59 billion by 2026.
• Market projected at USD 9.61 billion by 2035.
• CAGR of 11.58% expected in between 2026 to 2035.
• North America registered dominance in the market in 2025.
• Asia Pacific is expected to be the fastest-growing region during the forecast period.
• By assay/test type, the hERG (Kv11.1) binding and patch-clamp assays segment dominated the market in 2025.
• By assay/test type, the multi-electrode array (MEA) with iPSC-cardiomyocytes segment is expected to grow rapidly in the studied years.
• By modality/approach, the in vitro (cell and tissue-based) segment was dominant in the cardiotoxicity screening market in 2025.
• By modality/approach, the in silico/computational (simulation, PBPK-QT models) segment is expected to witness the fastest growth during 2026-2035.
• By product and service type, the assay kits, reagents, and ready-to-use cells (iPSC-cardiomyocytes, dyes, media) segment led the market in 2025.
• By product and service type, the contract testing services/CRO screening programs segment is expected to grow at a rapid CAGR in the upcoming years.
• By end user, the pharmaceutical and biotechnology companies (in-house screening) segment dominated the market in 2025.
• By end user, the CROs/safety and toxicology service providers segment is expected to register rapid expansion during the forecast period.

What are the Prominent Breakthroughs in Cardiotoxicity Screening?

The application of a vital safety assessment process for finding drugs or chemicals affecting the heart, which results in arrhythmia and minimal contraction, is referred to as cardiotoxicity screening. This cardiotoxicity screening market is driven by the growing number of cancer cases, which need cardiotoxic therapies, with the incorporation of stricter regulatory safety guidelines. Extensive advances encompass Zebrafish models, which have a major role in the detection of myocardial apoptosis & heart rate modification. Also, researchers are fostering microfluidic heart-on-a-chip solutions, such as BioFlux.

What is the Key Role of AI in the Cardiotoxicity Screening Market?

Specifically, AI has a substantial role in early detection, such as AI supports the analysis of standard 12-lead ECGs to find subclinical left ventricular dysfunction, & also detects risks weeks before traditional echocardiograms show a lowering in ejection fraction, like the AI-CTRCD model. Moreover, at AHA 2025, AI-SCREEN-CA software was rolled out, which utilises deep learning on echocardiographic loops to determine cardiac amyloidosis (CA) early, detecting 17% of suspected, high-risk incidences.

Trends & Future Outlook of the Cardiotoxicity Screening Market

Strengthening Novelty in Biomarkers & Risk Stratification

Recently, the firms validated certain newer biomarker panels for prior detection of cardiotoxicity in cancer patients, for which individualized risk scoring systems, like PREVENT equations, are being employed to identify high-risk individuals.

Surging Microphysiological Systems (MPS)

The market is focusing on using "organ-on-a-chip" technology to model interactions between diverse cell types, including cardiomyocytes, endothelial cells, fibroblasts & vascular flow.

Emphasis on Mechanistic Assays

Researchers are evolving assays to emphasise non-electrophysiological pathways, such as mitochondrial dysfunction, metabolic perturbations, and structural damage.

Quick Facts Table

Segmentation Analysis

Assay/Test Type Insights

Which Assay/Test Type Registered Dominance in the Cardiotoxicity Screening Market in 2025?

In 2025, the hERG (Kv11.1) binding and patch-clamp assays segment led the market. Its significant benefit is the estimation of the risk of drug-induced QT interval prolongation and Torsades de Pointes (TdP), which leads to fatal ventricular arrhythmia. A current aim at modeling dynamic, state-dependent binding of drug-hERG interactions is impacting the overall progression. Recently, XGBoost-ISE Mapping launched, which integrates XGBoost with Isometric Stratified Ensemble (ISE) mapping to facilitate strong predictions for hERG liability.

Multi-Electrode Array (MEA) with iPSC-Cardiomyocytes

The multi-electrode array (MEA) with iPSC-cardiomyocytes segment will witness rapid growth. This is an immersive, non-invasive, and high-throughput approach used to assess cardiotoxicity in drug development. Whereas iPSCs enable the generation of patient-specific, or even disease-specific, cardiomyocytes, such as those with Long QT syndrome. Alongside, a latest study showed closed-loop "traveling wave" (TW) systems unified with MEAs, which utilise rapid electrical pacing to bolster the sarcomeric and functional maturation of the cells.

Modality/Approach Insights

How did the In Vitro (Cell and Tissue-Based) Segment Lead the Market in 2025?

The in vitro (cell and tissue-based) segment dominated the cardiotoxicity screening market in 2025. It is mainly propelled by the rising requirement for more precise, affordable, and ethical options to animal testing in drug development. Ongoing innovations include 3D bio-printed cardiac tissues, which use decellularized extracellular matrix (dECM) hydrogels as bio-ink, for mimicking the complex 3D anisotropic structure of the human heart.

In Silico/Computational (Simulation, PBPK-QT Models)

The in silico/computational (simulation, PBPK-QT models) segment will expand rapidly. Particular adoption of in-silico screening enables the detection of adverse effects during the discovery stage, which prevents expenditures on toxic molecules & clinical trials. However, validated PBPK models are assisting in establishing "virtual populations" for future anticipation of drug exposure and improvement in dosing regimens for actual clinical trials. Recently, the QSP-PBPK-TD platform for anti-tumor drugs was developed by connecting the PBPK model with Quantitative Systems Pharmacology (QSP) and Toxicology Dynamics (TD).

Product and Service Type Insights

Which Product and Service Type Dominated the Cardiotoxicity Screening Market in 2025?

In 2025, the assay kits, reagents, and ready-to-use cells (iPSC-cardiomyocytes, dyes, media) segment registered dominance in the market. Kits, like the EarlyTox Cardiotoxicity Kit, support measuring intracellular calcium flux, mitochondrial membrane potential, and general cytotoxicity. This segment also encompasses calcium-sensitive dyes, like FLIPR Calcium 5, & specialized media, such as MyoMax. Additionally, axocells confirmed against the Comprehensive in vitro Pro-arrhythmia Assay (CiPA) compound panel for high-throughput electrophysiology & calcium imaging.

Contract Testing Services/CRO Screening Programs

Moreover, the contract testing services/CRO screening programs segment is anticipated to expand fastest. It is primarily fueled by CRO’s inexpensive, specialized, high-throughput in vitro and in vivo screening services for lowering drug attrition rates. They are emphasizing the use of sophisticated human-induced pluripotent stem cell-derived cardiomyocyte (hiPSC-CM) technologies, 3D cardiac organoids, and AI-powered predictive modeling to raise safety assessments.

End User Insights

Which End User Led the Cardiotoxicity Screening Market in 2025?

The pharmaceutical and biotechnology companies (in-house screening) segment was dominant in the market. Players, like Novartis, Pfizer, Inc., etc., are highly involved in the development of cardioprotective drugs and assessing existing drugs for preventing heart damage. Nowadays, companies are promoting modern machine learning, including graph neural networks trained on the FDA’s Drug-Induced Cardiotoxicity Risk (DICTRank) dataset.

CROs/Safety and Toxicology Service Providers

The CROs/safety and toxicology service providers segment will witness rapid expansion. Specifically, they explore in vitro & in vivo testing, and also, advanced cardiac imaging and high-throughput screening tools. Alongside, CROs are widely leveraging the Comprehensive in vitro Proarrhythmia Assay (CiPA), mandating strong, early-phase cardiac safety assessments to avoid late-stage failures. The latest approach is "Cardiotox Screen" panels for evaluating both structural and functional endpoints from a single cell population.

Regional Insights

How did North America Dominate the Market in 2025?

North America captured the biggest share of the cardiotoxicity screening market, due to the stricter regulatory safety requirements, a rise in oncology-related cardiac risks, and increased R&D investment in drug development. Also, the region is spurring novel projects, especially the Jackson Laboratory (JAX), which is fostering "CARDIOVERSE," by using stem cell-based systems (iPSC-CMs) and AI to develop virtual hearts, or "digital twins" of cardiac tissue.

U.S. Market Trends

The U.S. was a major contributor in this regional market, as recently the FDA initiated formalizing its plan to phase out mandatory animal testing for some drugs, which supports manufacturers in submitting safety data derived from NAMs. The U.S. is increasingly bolstering ML solutions to Electrocardiograms (ECGs) for detecting subclinical structural heart diseases & estimating prospective heart failure.

Raising R&D Investments and Transformative Models are Fueling the Asia Pacific

Asia Pacific is predicted to witness the fastest growth in the cardiotoxicity screening market. A prominent catalyst is continuous investment in drug discovery, mainly in China, Japan, and India, which is driven by the need for early-stage in-vitro cardiotoxicity testing. However, Singapore & across Asian researchers are broadly adopting 3D human heart tissue, which is developed from stem cells, for new oncology and cardiovascular drug evolutions.

India Market Trends

India is emphasizing preventive cardiac care through youth screening campaigns, which include mandatory early, regular screening for at-risk individuals, like lipid profiles, ECG, and stress tests, even for young adults. Also, they are stepping towards uniting cardiovascular specialists into cancer care teams for tracking chemotherapy-induced cardiac damage.

Promoting Digital Health & Research Studies are Supporting Europe

Europe is anticipated to expand significantly in the market, as it is focusing on the widespread adoption of wearable devices, like the Garmin Venu SQ and Polar H10 sensor. These devices are encouraging consistent monitoring of older, multimorbid breast cancer patients to find cardiotoxicity before it becomes clinically evident.

UK Market Trends

Moreover, the UK researchers found a set of 29 intracellular ceramides, which act as a predictive metabolic signature for structural cardiotoxicity, and further enable early detection of damage in cardiac microtissues.

Key Players' Offerings in the Cardiotoxicity Screening Market

SWOT Analysis

Strengths

• The cardiotoxicity screening market offers early detection of subclinical damage, increased predictive value, comprehensive risk-assessments, etc.
• Also, it mitigates expensive failures in late-stage clinical trials, lowering economic losses and minimizing the number of toxic substances that reach the market.

Weaknesses

• Certain cell models limit structural features, such as T-tubules and a 3D environment, which restrict their ability to precisely estimate how a drug will affect a mature, functioning human heart.

Opportunities

• Leaders will encourage the progression of AI-enabled tools to boost ECG, echocardiography, and cardiac MRI, which enables rapid, more accurate identification of subclinical, therapy-induced cardiac dysfunction.
• Researchers will execute multi-channel assays and in silico simulations to evaluate proarrhythmic liability, lowering reliance on traditional QT studies.

Threat

• Exploration of robust, early-stage screening methods, like human-induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs), needs greater spending on innovative technologies and infrastructure.

What are the Key Developments in the Cardiotoxicity Screening Market?

• In January 2026, Cellistic introduced three novel GMP manufacturing platforms to foster iPSC-derived cell therapies across immuno-oncology and regenerative medicine.
• In September 2025, Ncardia launched Ncyte NHP-C vCardiomyocytes to offer a scalable, ethical, and translational tool for cross-species cardiac studies.

Segment Covered in the Report

By Assay/Test Type

• hERG (Kv11.1) Binding and Patch-Clamp Assays
• Automated Patch Clamp (APC)
• Multi-Electrode Array (MEA) with iPSC-Cardiomyocytes
• Calcium-Flux and Optical Electrophysiology Assays
• In vivo Telemetry/Conscious ECG Studies (rodent, dog, non-rodent)
• In Silico Predictive Modeling and QSAR/CiPA Workflows

By Modality/Approach

• In Vitro (cell and tissue-based)
• In Vivo (animal telemetry, ECG)
• In Silico/Computational (simulation, PBPK-QT models)

By Product and Service Type

• Assay Kits, Reagents and Ready-to-use Cells (iPSC-cardiomyocytes, dyes, media)
• Instrumentation and Platforms (MEA systems, APC rigs, patch amplifiers)
• Contract Testing Services/CRO Screening Programs
• Software and Predictive Analytics (QTc algorithms, pro-arrhythmia AI)
• Consulting, Validation, and Regulatory Support

By End User

• Pharmaceutical and Biotechnology Companies (in-house screening)
• CROs/Safety and Toxicology Service Providers
• Academic and Research Institutes
• Regulatory Bodies and Translational Consortia
• Instrument and Reagent Suppliers (internal R&D use)

By Region 

• North America
  • U.S.
  • Canada 
  • Mexico 
  • Rest of North America
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Europe 
  • Western Europe 
    • Germany 
    • Italy
    • France
    • Netherlands
    • Spain
    • Portugal 
    • Belgium
    • Ireland
    • UK 
    • Iceland 
    • Switzerland
    • Poland
    • Rest of Western Europe
  • Eastern Europe 
    • Austria
    • Russia & Belarus 
    • Türkiye
    • Albania 
    • Rest of Eastern Europe 
• Asia Pacific
  • China 
  • Taiwan
  • India 
  • Japan 
  • Australia and New Zealand
  • ASEAN Countries (Singapore, Malaysia)
  • South Korea 
  • Rest of APAC 
• MEA 
  • GCC Countries
    • Saudi Arabia 
    • United Arab Emirates (UAE)
    • Qatar 
    • Kuwait 
    • Oman 
    • Bahrain 
  • South Africa
  • Egypt 
  • Rest of MEA