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 set to grow at a strong 8.3% CAGR, rising from $4.9 billion in 2024 to $8.4 billion by 2030, driven by advanced cardiac biomarkers, neurodegenerative blood tests, and expanding diagnostic infrastructure, according to Strategic Market Research.

 

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.

 

Comprehensive Market Snapshot

• The Global In Vitro Diagnostics (IVD) in Cardiology and Neurology Market is projected to grow at a compelling CAGR of 8.3%, increasing from USD 4.9 billion in 2024 to reach approximately USD 8.4 billion by 2030.

• The USA In Vitro Diagnostics (IVD) in Cardiology and Neurology Market, accounting for 32% of global revenue, will register a healthy 8.1% CAGR, expanding from USD 1.57 billion in 2024 to approximately USD 2.50 billion by 2030, supported by strong adoption of biomarker-based diagnostics, advanced cardiac panels, and neurodegenerative disease testing.

• The Europe In Vitro Diagnostics (IVD) in Cardiology and Neurology Market, representing 24% market share, is expected to grow at a 6.4% CAGR, rising from USD 1.18 billion in 2024 to nearly USD 1.71 billion by 2030, driven by aging demographics, expanding stroke and cardiovascular screening programs, and regulatory-backed diagnostic standardization.

• The APAC In Vitro Diagnostics (IVD) in Cardiology and Neurology Market, holding 17% of the global market, will be the fastest growing region at a 10.0% CAGR, expanding from USD 0.83 billion in 2024 to around USD 1.48 billion by 2030, fueled by rising cardiovascular disease burden, improving healthcare infrastructure, and rapid expansion of diagnostic laboratories across China, India, and Southeast Asia.

 

Market Segmentation Insights

By Technology Type

• Molecular Diagnostics held the largest market share of approximately 32% in 2024, reflecting growing reliance on genetic, proteomic, and blood-based biomarkers for stroke risk assessment and inherited cardiac condition screening, corresponding to an estimated market value of around USD 1.57 billion.

• Immunoassays accounted for about 26% of the market in 2024, valued at approximately USD 1.27 billion, supported by their routine use in cardiac marker testing such as troponin, BNP, and NT-proBNP across emergency and inpatient settings.

• Clinical Chemistry represented nearly 18% share in 2024, translating to an estimated market value of around USD 0.88 billion, driven by high test volumes for lipid panels, electrolyte monitoring, and metabolic risk assessment.

• Hematology-based assays captured approximately 12% of the global market in 2024, with a value of about USD 0.59 billion, reflecting their role in coagulation testing, inflammatory markers, and stroke-related risk profiling.

• Point-of-Care Testing (POCT) accounted for roughly 12% share in 2024, valued at around USD 0.59 billion, and is projected to grow at the fastest CAGR of 10.1% during 2024–2030, driven by demand for rapid cardiac enzyme testing and decentralized neurology diagnostics in emergency and rural care environments.

 

By Disease Indication

• Cardiovascular Diseases represented the dominant disease segment with approximately 64% market share in 2024, supported by routine diagnostic use in emergency triage, acute coronary syndrome management, heart failure monitoring, and post-PCI follow-up, corresponding to an estimated market value of around USD 3.14 billion.
  Within cardiology, Acute Coronary Syndrome (ACS) and Heart Failure together accounted for the majority of testing volumes due to continuous reliance on biomarker-based decision making in hospital settings.

• Neurological Disorders accounted for the remaining 36% share in 2024, valued at approximately USD 1.76 billion, and are expected to grow at a faster pace through 2030 as blood-based diagnostics for Alzheimer’s disease, stroke, and neurodegenerative conditions gain clinical validation.
  Among neurology indications, Alzheimer’s disease and stroke diagnostics are emerging as high-growth subsegments, driven by innovations in neurofilament light chain (NfL), tau protein, and beta-amyloid blood testing, signaling a structural shift toward earlier and less invasive neurological diagnosis.

 

By End User

• Hospitals accounted for the largest share of approximately 58% in 2024, reflecting integrated laboratory infrastructure, high emergency testing volumes, and centralized cardiology and neurology care delivery, with an estimated market value of around USD 2.84 billion.

• Diagnostic Laboratories represented about 24% of the market in 2024, valued at approximately USD 1.18 billion, supported by centralized testing for molecular diagnostics, batch immunoassays, and reference-based neurology panels.

• Neurology and Cardiology Clinics captured roughly 12% share in 2024, translating to an estimated value of around USD 0.59 billion, and are expected to grow steadily as outpatient disease management and precision diagnostics adoption increase.

• Academic & Research Institutes accounted for the remaining 6% of the market in 2024, valued at approximately USD 0.29 billion, driven by biomarker discovery programs, clinical trials, and translational research in neurodegeneration and cardiovascular disease.

 

Strategic Questions Driving the Next Phase of the Global IVD in Cardiology and Neurology Market

1. What diagnostic technologies, test categories, and disease applications are explicitly included within the cardiology and neurology IVD market, and which diagnostic modalities or adjacent services remain out of scope?

2. How does the cardiology and neurology IVD market differ structurally from adjacent diagnostics markets such as oncology IVD, infectious disease testing, genetic screening, and digital health diagnostics?

3. What is the current and forecasted size of the global IVD market in cardiology and neurology, and how is market value distributed across major technology platforms and disease categories?

4. How is revenue allocated between centralized laboratory testing, near-patient diagnostics, and point-of-care testing (POCT), and how is this mix expected to evolve over the forecast period?

5. Which disease areas—such as acute coronary syndrome, heart failure, stroke, Alzheimer’s disease, and neurodegenerative disorders—represent the largest and fastest-growing diagnostic revenue pools?

6. Which diagnostic segments generate disproportionately higher margins relative to test volumes, particularly in advanced biomarker assays and molecular diagnostics?

7. How does diagnostic demand differ across acute, chronic, and preventive care settings, and how does this influence test selection and utilization patterns?

8. How are diagnostic pathways evolving across emergency, inpatient, outpatient, and long-term monitoring settings in cardiology and neurology care?

9. What role do testing frequency, repeat testing, and long-term disease monitoring play in driving recurring revenue across specific IVD segments?

10. How are disease prevalence, aging populations, earlier diagnosis initiatives, and access to diagnostic infrastructure shaping demand across cardiology and neurology testing markets?

11. What clinical validation hurdles, regulatory constraints, or reimbursement limitations restrict adoption of novel biomarkers in cardiology and neurology diagnostics?

12. How do pricing pressures, reimbursement variability, and payer cost-containment strategies influence revenue realization across different IVD technologies and care settings?

13. How robust is the current diagnostic development pipeline, and which emerging biomarkers or assay platforms are likely to create new testing segments?

14. To what extent will pipeline diagnostics expand the tested patient population versus intensify competition within established cardiology and neurology test categories?

15. How are advances in assay sensitivity, automation, multiplexing, and sample minimization improving diagnostic accuracy, turnaround time, and clinician adoption?

16. How will patent expirations, platform commoditization, and standardization impact competitive dynamics across core cardiology and neurology IVD segments?

17. What role will low-cost assays, local manufacturing, and alternative platforms play in driving price competition and access expansion, particularly in emerging markets?

18. How are leading diagnostic companies aligning their cardiology and neurology portfolios to balance high-volume routine testing with premium precision diagnostics?

19. Which geographic markets are expected to outperform global growth in cardiology and neurology IVD adoption, and which disease or technology segments are driving this regional acceleration?

20. How should diagnostic developers, healthcare providers, and investors prioritize specific technologies, disease areas, and regions to maximize long-term value creation in the global IVD cardiology and neurology market?

 

Segment-Level Insights and Market Structure - IVD in Cardiology and Neurology Market

The IVD in cardiology and neurology market is structured around distinct diagnostic technology platforms, disease-driven testing needs, and care delivery settings, each reflecting differences in clinical urgency, testing frequency, and decision-making impact. Unlike therapy markets, value in this market is shaped by test complexity, turnaround time, clinical criticality, and repeat utilization, particularly in acute and chronic cardiovascular and neurological conditions. Together, these segments define how diagnostic value is created, scaled, and sustained across healthcare systems.

 

Technology Type Insights

Immunoassays

Immunoassays represent a cornerstone technology in cardiology and neurology diagnostics due to their reliability, scalability, and compatibility with automated laboratory systems. These assays are widely used for routine and emergency testing, including cardiac markers such as troponin, BNP/NT-proBNP, and inflammatory indicators relevant to stroke risk assessment. From a market perspective, immunoassays generate consistent testing volumes and stable revenue streams, as they are embedded into standard diagnostic protocols across hospitals and reference laboratories. Ongoing enhancements in assay sensitivity and multiplexing are reinforcing their relevance in both acute care and longitudinal monitoring.

Molecular Diagnostics

Molecular diagnostics constitute the most innovation-intensive segment within the market, enabling detection of genetic, proteomic, and disease-specific biomarkers that are not accessible through conventional testing. In cardiology, these platforms support inherited cardiac condition screening and risk stratification, while in neurology they are increasingly applied to neurodegenerative disease research and early diagnosis. Commercially, molecular diagnostics command higher per-test value and play a disproportionate role in margin generation. As clinical validation expands and testing costs decline, molecular platforms are expected to transition from specialized use toward broader clinical integration.

Clinical Chemistry

Clinical chemistry assays support foundational diagnostic workflows by providing metabolic, lipid, and electrolyte profiling essential to cardiovascular risk evaluation and neurological disease management. These tests are typically high-volume and low-complexity, making them integral to baseline patient assessment and chronic disease monitoring. Although they carry lower unit pricing compared to advanced diagnostics, their sheer testing frequency ensures continued relevance. Advances in analyzer automation and workflow integration are improving efficiency while preserving their role as a diagnostic entry point.

Hematology-Based Assays

Hematology assays play a supporting yet critical role, particularly in coagulation testing, inflammation assessment, and stroke-related diagnostics. These assays contribute valuable contextual data that complements cardiology and neurology decision-making, especially in acute and peri-procedural settings. While not the primary driver of innovation, hematology testing remains essential for comprehensive diagnostic evaluation, reinforcing its position as a steady contributor to overall market value.

Point-of-Care Testing (POCT)

Point-of-care testing represents the most dynamic technology segment, driven by the need for rapid diagnostic decisions in emergency, ambulatory, and resource-limited settings. POCT enables near-patient assessment of cardiac enzymes and select neurological markers, significantly reducing time to treatment initiation. From a market standpoint, this segment is characterized by rapid adoption, expanding test menus, and growing relevance in decentralized care models. Continued improvements in device accuracy and connectivity are expected to further accelerate POCT penetration.

 

Disease Indication Insights

Cardiovascular Diseases

Cardiovascular conditions form the dominant diagnostic demand base within the market, supported by continuous testing needs across emergency triage, inpatient management, and long-term disease monitoring. Acute coronary syndrome, heart failure, and arrhythmia management rely heavily on biomarker-driven diagnostics to guide treatment decisions. The high prevalence of cardiovascular disease and the clinical imperative for rapid risk stratification ensure sustained test volumes and recurring utilization across healthcare settings.

Neurological Disorders

Neurological diagnostics represent a rapidly evolving segment, transitioning from symptom-driven evaluation toward biomarker-supported diagnosis. Historically constrained by limited laboratory markers, this segment is now benefiting from advances in blood-based testing for neurodegenerative and cerebrovascular conditions. Alzheimer’s disease, stroke, and other chronic neurological disorders are emerging as strategic growth areas, as earlier diagnosis and disease monitoring become clinically feasible. This shift is redefining the role of IVD in neurology from supportive to decision-enabling.

 

Segment Evolution Perspective

The IVD in cardiology and neurology market is evolving from a volume-driven diagnostic model toward a value- and precision-oriented ecosystem. Established technologies continue to anchor routine clinical workflows, while advanced molecular and point-of-care platforms are reshaping how and where diagnostics are delivered. Simultaneously, the expanding role of neurology diagnostics is diversifying revenue streams beyond traditional cardiovascular testing. Together, these shifts are redefining segment priorities and influencing how diagnostic value is distributed across the market over the forecast period.

 

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.

 

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