In Vitro Diagnostics in Cardiology and Neurology Market By Technology Type (Immunoassays, Molecular Diagnostics, Clinical Chemistry, Hematology, Point-of-Care Testing); By Disease Indication (Cardiovascular Diseases, Neurological Disorders); By End User (Hospitals, Diagnostic Laboratories, Specialty Clinics, Academic & Research Institutes); By Region (North America, Europe, Asia Pacific, Latin America, Middle East & Africa), Segment Revenue Estimation, Forecast, 2024–2030.

Introduction And Strategic Context

The Global In Vitro Diagnostics ( IVD ) In Cardiology And Neurology Market is projected to grow at a compelling CAGR of 8.3% from $4.9 billion in 2024 to reach approximately $8.4 billion by 2030 , confirms Strategic Market Research. This dynamic segment of the broader IVD space is rapidly evolving due to the mounting demand for early detection, precision diagnostics, and personalized therapeutic pathways in two of the most fatal and resource-intensive disease areas globally: cardiovascular disorders and neurological conditions .

 

IVD technologies—ranging from molecular assays and immunoassays to point-of-care testing kits—play a pivotal role in identifying biomarkers, managing disease progression, and informing treatment strategies. In the context of cardiology, they’re indispensable in detecting conditions like acute coronary syndromes, myocardial infarctions, and heart failure . In neurology, IVD applications are gaining traction in areas such as Alzheimer’s disease, multiple sclerosis, and neurodegenerative biomarker profiling .

 

From a strategic lens, the 2024–2030 period will be shaped by four macro forces:

• Epidemiological transition : Aging populations across North America, Europe, and parts of Asia Pacific are driving a surge in cardiovascular and neurodegenerative disease incidence.

• Biomarker innovation : The emergence of blood-based biomarkers for stroke, dementia, and subclinical cardiac events is expanding the utility of IVD.

• Policy incentives : Health systems are incentivizing early diagnostics as a cost-containment and outcome-optimization tool, especially under value-based care models.

• Digital integration : Connectivity between IVD systems and electronic health records (EHRs) is enabling real-time clinical decision support in high-acuity settings.

 

Key ecosystem stakeholders in this market include:

• IVD OEMs and diagnostic innovators : Leading manufacturers and emerging biotech developers.

• Hospitals and specialized clinics : Primary buyers and users of diagnostic panels.

• Academic and research institutions : Driving assay validation and biomarker discovery.

• Regulatory agencies : Setting evolving standards for clinical use and validation.

• Investors and venture capitalists : Funding early-stage diagnostics, especially in neurology.

• Public health organizations : Advocating for national screening programs and public access to testing.

IVD solutions in cardiology and neurology are no longer peripheral—they’re becoming central to proactive, data-driven healthcare strategies across geographies.

 

Market Segmentation And Forecast Scope

The in vitro diagnostics (IVD) in cardiology and neurology market is segmented across four critical axes: by technology type , by disease indication , by end user , and by region . This framework reflects both the clinical diversity and the operational models of diagnostic deployment in these two high-burden specialties.

By Technology Type

The market is broadly categorized into:

• Immunoassays

• Molecular Diagnostics

• Clinical Chemistry

• Hematology -based assays

• Point-of-Care Testing (POCT)

Among these, molecular diagnostics represented nearly 32% of the market share in 2024 , driven by rising adoption of genetic and proteomic markers in both stroke prediction and inherited cardiac condition screening. Meanwhile, point-of-care testing is projected to be the fastest-growing segment (CAGR: 10.1%), primarily due to the demand for rapid cardiac enzyme tests (e.g., Troponin I/T, BNP) in emergency settings and decentralized neurology assessments in rural or under-resourced environments.

 

By Disease Indication

Segmented into:

Cardiovascular Diseases

• Acute Coronary Syndrome (ACS)

• Heart Failure

• Arrhythmias

Neurological Disorders

• Alzheimer’s Disease

• Epilepsy

• Stroke

• Parkinson’s Disease

• Multiple Sclerosis

Cardiology remains dominant in revenue terms, driven by routine use of IVD in emergency triage , risk stratification , and post-PCI monitoring . However, neurology is emerging as a strategic growth frontier. With no definitive lab tests for many neurodegenerative diseases until recently, innovations in neurofilament light chain ( NfL ), tau protein, and beta-amyloid blood testing are opening up a new diagnostic era.

 

By End User

Includes:

• Hospitals

• Diagnostic Laboratories

• Neurology and Cardiology Clinics

• Academic & Research Institutes

Hospitals account for the majority of diagnostic test volumes due to integrated labs and emergency testing infrastructure. However, specialty clinics and academic centers are gaining momentum, especially in adopting next-generation biomarker assays for clinical trials and precision medicine programs.

 

By Region

The global market is segmented into:

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East & Africa (MEA)

North America led the global market in 2024 due to a combination of early tech adoption, robust reimbursement systems , and a high disease burden . That said, Asia Pacific is expected to witness the highest CAGR during 2024–2030, propelled by rapid diagnostics infrastructure expansion, rising chronic disease incidence, and supportive government screening initiatives—particularly in China, India, and South Korea.

The convergence of high-impact diseases with rapidly advancing IVD capabilities is creating a unique multi-dimensional growth trajectory across all segments of this market.

 

Market Trends And Innovation Landscape

The IVD in cardiology and neurology market is undergoing a meaningful transformation, shaped by a convergence of biomarker discovery, AI-powered analytics, and patient-centric testing paradigms. The industry is shifting from conventional diagnostic panels to integrated, precision-driven platforms that enable earlier detection, deeper disease characterization, and continuous monitoring.

1. Biomarker Innovation and Diagnostic Specificity

One of the most significant trends is the explosion of biomarker research , particularly in neurology. Blood-based tests for Alzheimer’s disease , once considered impractical, are now moving closer to routine clinical use. Biomarkers like phosphorylated tau (p-tau), beta-amyloid, and neurofilament light ( NfL ) have gained significant clinical validation. On the cardiology front, refinements in troponin assays , NT- proBNP , and high-sensitivity C-reactive protein ( hs -CRP) are allowing for earlier and more precise cardiovascular risk stratification.

“We're witnessing a shift where biomarkers are no longer just diagnostic—they’re prognostic and therapeutic indicators,” notes a molecular pathologist at a Boston-based medical research center .

 

2. Rise of AI and Digital IVD Platforms

Artificial intelligence is increasingly embedded in IVD workflows—especially in neurology, where pattern recognition , cognitive trajectory prediction , and longitudinal data modeling are essential. In cardiology, AI-integrated diagnostics are enhancing ECG interpretation , risk scoring from lab parameters , and decision support for intervention timing . Furthermore, cloud-based platforms are enabling real-time data transmission from POCT devices to EMRs, enabling better integration into care pathways.

 

3. Miniaturization and Point-of-Care (POC) Expansion

Miniaturized diagnostics have become indispensable for rapid cardiac care. The launch of compact, handheld troponin testing kits and portable NT- proBNP readers allows emergency teams to make decisions in under 15 minutes. Similarly, home-based cognitive assessment kits integrated with saliva or blood biomarker collection are under pilot in parts of the EU and Japan. These POC solutions are not only improving diagnostic turnaround but also reducing the burden on tertiary care systems.

 

4. Integration with Genomic and Multi-Omics Platforms

Advanced IVD players are exploring multi-omics diagnostics , combining proteomics, genomics, and transcriptomics for more nuanced insights—especially in stroke subtyping and epilepsy phenotyping. In cardiology, genetic risk scoring for atherosclerosis or arrhythmias is entering mainstream screening panels.

This systems-level diagnostic view is becoming critical as comorbid conditions blur traditional disease boundaries in elderly and high-risk populations.

 

5. Collaborations and Licensing Agreements

The industry is increasingly collaborative. In the last 24 months, several strategic tie-ups have been announced between neurodiagnostics startups and pharma companies , aiming to create companion diagnostics for disease-modifying therapies (DMTs) in Alzheimer’s and Parkinson’s. Similarly, cardiology IVD makers are licensing algorithms from medtech startups to enhance predictive modeling .

 

6. Pipeline Technologies and Liquid Biopsy for Brain Health

A niche but promising frontier is liquid biopsy for neuro-oncology and brain health monitoring . Leveraging ctDNA and exosomal RNA in plasma, startups are working on early detection assays for glioblastoma and neuroinflammatory conditions —potentially changing how neurological disease progression is surveilled .

Innovation in this market is no longer linear—it’s networked, data-rich, and precision-focused. The next wave of diagnostic tools will not just tell if a patient is sick—they’ll help predict who will be, and how to prevent it.

 

Competitive Intelligence And Benchmarking

The IVD in cardiology and neurology market is moderately consolidated, with a mix of established diagnostics giants and niche innovators competing across product breadth, assay sensitivity, geographic coverage, and disease-specific capabilities. While cardiology IVD is dominated by long-established players, the neurology space is drawing agile biotech firms focused on biomarker development and high-specificity assays.

Key Players in the Market

1. Roche Diagnostics With one of the most expansive global footprints in molecular and immunodiagnostics, Roche remains a market leader in cardiac marker assays—especially Troponin T , NT- proBNP , and hs -CRP . The company has made strategic strides in neurology through its Elecsys ® platform , enabling semi-automated testing of Alzheimer’s-related biomarkers across select markets.

 

2. Abbott Laboratories Abbott’s i -STAT and ARCHITECT platforms are cornerstones of point-of-care and lab-based cardiology diagnostics worldwide. The company also maintains a growing focus on neurovascular risk assessment tools , although its neurology segment is less diversified than cardiology.

 

3. Siemens Healthineers A strong presence in cardiac diagnostics via ADVIA Centaur and Atellica systems has positioned Siemens as a preferred vendor for high-throughput hospital labs. The firm has recently expanded its neurodegeneration biomarker panels, integrating phospho-tau181 and amyloid beta detection into its automated platforms.

 

4. Quanterix Corporation A specialized player focused on ultrasensitive Simoa ® assays , Quanterix is leading the neurology IVD frontier. Their assays detect neurofilament light chain ( NfL ) at unprecedented sensitivity—making them highly valuable in multiple sclerosis monitoring , Alzheimer’s research , and concussion studies . They partner with major pharma for biomarker validation in CNS trials.

 

5. Thermo Fisher Scientific While best known for molecular diagnostics and lab tools, Thermo Fisher has strategically entered neurodiagnostics through acquisitions and partnerships aimed at translational neuroscience applications. Their strength lies in custom assay development and platform integration across genomics and proteomics.

 

6. Fujirebio (a H.U. Group company) Fujirebio has long-standing expertise in Alzheimer’s diagnostics , offering CSF and plasma-based tau and amyloid assays . The company is steadily shifting toward blood-based neurology panels , and is particularly active in Asia and Europe, where demand for non-invasive cognitive diagnostics is expanding.

 

7. BioMérieux Traditionally strong in infectious disease diagnostics, BioMérieux is positioning itself in neuro-infectious diagnostics and has recently explored biosensor-based assays for stroke and meningitis detection.

 

Strategic Differentiation Approaches

• Product Breadth vs. Specialization : Giants like Roche and Abbott leverage platform uniformity and test menu expansion, while firms like Quanterix and Fujirebio pursue ultra-niche, high-specificity assays .

• Geographic Expansion : Siemens and Thermo Fisher are leading in lab connectivity and automation in emerging markets, especially Southeast Asia and the Middle East.

• Innovation Partnerships : Several players have entered academic and pharmaceutical co-development agreements to fast-track Alzheimer’s and cardiac failure test commercialization.

• Digital Diagnostics Integration : Players like Abbott and Roche are embedding AI into test interpretation engines, which is especially relevant for emergency decision-making and long-term neurological tracking.

The competitive battleground is bifurcating: while traditional players race to digitize and automate cardiology diagnostics, the neurology space is heating up with biomarker breakthroughs, niche partnerships, and assay miniaturization.

 

Regional Landscape And Adoption Outlook

The adoption and evolution of IVD technologies in cardiology and neurology vary considerably across regions, shaped by healthcare infrastructure, reimbursement frameworks, disease prevalence, and innovation ecosystems. While North America and Europe continue to lead in both market share and technological maturity, the Asia Pacific region is poised for accelerated growth through 2030, propelled by systemic healthcare reforms and expanding diagnostics capacity.

North America

The United States remains the largest single market for IVD in cardiology and neurology, thanks to its integrated hospital networks , aggressive investment in neurodegeneration research , and payer support for cardiac marker testing . The country leads globally in:

• Routine use of high-sensitivity troponin and BNP/NT- proBNP testing in emergency departments

• Inclusion of Alzheimer’s blood biomarkers in ongoing clinical trials

• Rapid point-of-care test (POCT) adoption, particularly in ambulatory and rural settings

Canada also showcases strong uptake, especially in academic centers and publicly funded stroke networks , although reimbursement timelines can be longer than in the U.S.

“The convergence of diagnostics and digital health in U.S. emergency rooms is setting the tone for global cardiology workflows,” says a director at a Boston-based diagnostics firm.

 

Europe

Europe’s position is underscored by strong public health screening programs , especially for stroke and dementia risk in countries like Germany, the UK, and the Netherlands. The EU’s regulatory environment (IVDR) is stricter, but it has also spurred innovation in evidence-based biomarker testing . Germany leads in automated cardiac assay deployment, while the UK’s National Health Service (NHS) is piloting Alzheimer’s blood tests in memory clinics.

Key characteristics include:

• Early neurology biomarker trial adoption (notably in Sweden and France)

• High integration of IVD with national electronic medical record systems

• Region-wide push for early-onset dementia diagnostics

 

Asia Pacific

Asia Pacific is the fastest-growing region for IVD in cardiology and neurology, projected to expand at over 10% CAGR through 2030 . Several drivers are converging here:

• Rising incidence of cardiovascular and neurodegenerative disorders due to aging and urbanization

• Large-scale government investment in diagnostics infrastructure (e.g., India's National Health Mission, China’s Healthy China 2030)

• Accelerated approvals for novel assays in Japan and South Korea

 

China is making notable strides, with domestic players entering the neurology IVD space and leveraging AI for population-scale screening. Japan , long a leader in neurodegenerative care, is actively adopting blood-based Alzheimer’s diagnostics in both hospital and home settings.

 

Latin America

Adoption is slower but steadily rising in countries like Brazil , Mexico , and Argentina . The main challenges include:

• Uneven public-private healthcare access

• Limited access to high-cost molecular tests

• Heavy reliance on central laboratories over POCT

However, increasing burden of non-communicable diseases and public awareness campaigns are beginning to drive demand, especially in urban centers .

 

Middle East & Africa (MEA)

Still in nascent stages, MEA's market for IVD in cardiology and neurology is defined by:

• Fragmented access to diagnostics

• High dependency on imports for high-sensitivity assays

• Pockets of excellence—like UAE and Saudi Arabia , which are investing in digitized cardiology centers and Alzheimer’s preparedness programs

The region presents white space opportunities , particularly in low-cost POCT for cardiovascular risk , and regional partnerships for neuro-lab capacity building .

Each region reflects a distinct trajectory—mature markets focus on precision and digital integration, while emerging economies prioritize access, affordability, and public health alignment.

 

End-User Dynamics And Use Case

The utility of in vitro diagnostics (IVD) in cardiology and neurology extends across a diverse spectrum of healthcare settings—from emergency departments and intensive care units to outpatient neurology clinics and academic research centers . Each end user segment adopts and integrates IVD tools based on clinical urgency, diagnostic throughput, available infrastructure, and reimbursement landscape.

Hospitals and Emergency Departments

Hospitals, especially tertiary care centers , are the largest consumers of cardiology-related IVD. These institutions rely heavily on high-sensitivity troponin , BNP , CK-MB , and other cardiac marker panels for early diagnosis of myocardial infarctions, heart failure, and perioperative cardiac risk. Large hospitals typically use automated analyzers capable of handling high volumes with rapid turnaround times—crucial for critical care triaging.

In neurology, hospitals increasingly use CSF and blood-based biomarker panels to support differential diagnosis in patients presenting with cognitive decline , acute neurological events , or suspected neuroinflammation .

 

Diagnostic Laboratories

Both standalone and hospital-attached labs are central to batch-processing of molecular assays , multiplex neurology panels , and longitudinal biomarker testing . Reference labs particularly handle specialized neurodegeneration panels —such as phospho-tau/amyloid beta quantification —which are not yet available in all clinical facilities.

These centers are often first adopters of emerging technologies due to their centralized infrastructure, accreditation mandates , and partnerships with pharma for clinical trials .

 

Cardiology and Neurology Clinics

Cardiology clinics are adopting portable analyzers and desktop POCT devices that enable real-time risk assessment—especially useful in post-discharge monitoring and high-risk outpatient visits . For instance, point-of-care BNP testing is increasingly being used to monitor patients with chronic heart failure without requiring hospitalization .

Neurology clinics, on the other hand, are slower adopters due to the historical lack of validated IVD tools. However, this is changing rapidly with the commercialization of blood-based Alzheimer’s diagnostics , enabling memory clinics to complement cognitive tests with biomarker-based confirmation.

 

Academic and Research Institutions

These institutions play a pivotal role in assay development, clinical validation , and biomarker discovery , especially in neurology. Centers of excellence across the U.S., Germany, Japan, and South Korea have published landmark studies validating plasma neurofilament light chain ( NfL ) and amyloid ratios in diverse populations.

They also serve as early access nodes for experimental assays and are essential for understanding disease heterogeneity and treatment response in neurology and complex cardiovascular conditions.

 

Real-World Use Case

A tertiary neurology center in South Korea recently piloted a point-of-care Alzheimer’s risk assessment workflow combining a digital cognitive battery with a blood-based beta-amyloid assay. Over 1,000 patients were screened in under 4 months, with over 65% of confirmed early-stage cases identified without CSF sampling. This streamlined early referral to clinical trials and reduced unnecessary imaging costs by 38%.

The center has since reported plans to integrate additional neuroinflammatory biomarkers for real-time triage of cognitive complaints—a model being studied for replication in the Netherlands and Canada.

End users are not only deploying IVDs for disease identification—they are redefining diagnostic workflows to prioritize speed, accuracy, and preventive insights.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Past 2 Years)

1. FDA Clearance for Alzheimer’s Blood Test In 2023, the U.S. FDA granted Breakthrough Device Designation to an innovative blood-based test for Alzheimer’s disease, which quantifies phospho-tau 217 and amyloid beta with high clinical concordance to PET imaging and CSF results. This milestone is expected to trigger reimbursement pathways and broaden access to early dementia diagnostics.

 

2. Roche’s Launch of Advanced Troponin T hs Assay Roche Diagnostics introduced a next-gen high-sensitivity Troponin T assay with improved analytical precision for ruling in/out acute myocardial infarction within 1 hour of ED admission. This aligns with evolving ESC and ACC guidelines that favor rapid rule-out protocols.

 

3. Siemens Healthineers Partnerships in Asia Siemens expanded its strategic footprint in the Asia Pacific region by partnering with major hospital chains in India and Singapore to deploy the Atellica platform for neurology and cardiology biomarker testing, targeting faster diagnosis and laboratory automation.

 

4. Quanterix Simoa NfL Validated in MS Progression Studies A major 2024 clinical study validated Quanterix’s NfL assay as a predictive marker for disease activity and progression in multiple sclerosis (MS). Several neurology clinics across Europe have integrated it into their longitudinal disease-monitoring protocols.

 

5. Abbott Introduces AI-Driven POCT Interface Abbott released a new AI-powered software layer integrated into its i -STAT Alinity device, allowing clinicians to receive interpretive guidance alongside real-time test results—particularly relevant for complex cardiology cases in emergency settings.

 

Opportunities

1. Acceleration of Neurodegeneration Screening Programs As healthcare systems prepare for the societal burden of dementia, there is rising interest in national Alzheimer’s screening programs , especially in Europe and Asia. IVD players have an opportunity to position scalable, blood-based biomarker panels as front-line screening tools.

2. Emergence of Home and Mobile Testing Ecosystems The miniaturization of cardiac and cognitive biomarker platforms opens the door to home-based monitoring kits , especially for post-stroke rehabilitation, mild cognitive impairment (MCI) tracking, and chronic heart failure.

3. Companion Diagnostics for Neurotherapeutics As disease-modifying therapies (DMTs) for Alzheimer’s and Parkinson’s move through clinical trials, the need for diagnostic confirmation prior to treatment will boost demand for validated neurology IVD assays.

 

Restraints

1. Regulatory Complexity and Reimbursement Lag While technological breakthroughs are accelerating, reimbursement approval cycles for neurology diagnostics—particularly blood-based Alzheimer’s tests—remain slow in many countries, delaying widespread adoption.

2. Capital Intensity and Skill Gap Deploying high-throughput or multiplexed diagnostics, especially in lower-resource settings, demands significant capital investment and trained personnel , limiting accessibility outside major healthcare centers .

The landscape is full of momentum, but true scalability will depend on thoughtful integration, policy alignment, and affordability—especially in neurology, where diagnostic inertia has long impeded progress.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 4.9 Billion
Revenue Forecast in 2030	USD 8.4 Billion
Overall Growth Rate	CAGR of 8.3% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Technology Type, By Disease Indication, By End User, By Geography
By Technology Type	Immunoassays, Molecular Diagnostics, Clinical Chemistry, Hematology, POCT
By Disease Indication	Cardiovascular Diseases (ACS, HF, Arrhythmia), Neurological Disorders (Alzheimer’s, Stroke, MS, etc.)
By End User	Hospitals, Diagnostic Laboratories, Clinics, Academic & Research 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, etc.
Market Drivers	- Rising chronic disease burden - Expansion of neurology biomarkers - Growth in decentralized diagnostics
Customization Option	Available upon request