In-vitro Diagnostics for Cardiology and Neurology Market - Growth Drivers and Challenges
Growth Drivers
- Growing awareness and screening programs: Both medical professionals and patients are becoming more informed about the benefits of early diagnosis in preventing disease progression, which encourages them for routine screening. In this aspect, public health initiatives and government-funded programs are playing a crucial role in spreading awareness of cost-efficient and accessible tests available in the in-vitro diagnostics for cardiology and neurology market. As evidence, the Well-Integrated Screening and Evaluation for WOMen Across the Nation (WISEWOMAN) program provides backing for CVD risk factor assessments and preventive health services for women aged 35-64 living across America.
- Revolution in neurological assessments: IVD detection are currently earning global recognition for enabling early treatment and better outcomes for cognitive neurological conditions, prompting adoption in the in-vitro diagnostics for cardiology and neurology market. Particularly, the accuracy and speed delivered by these testing methods for chronic neurological disorders, including Alzheimer's (AZ) and Parkinson's disease, is settling new avenues for this sector. For instance, in May 2022, the FDA provided recognition to IVD as a minimally invasive testing of AZ by authorizing Lumipulse G Beta-Amyloid Ratio (1-42/1-40) in cerebrospinal fluid (CSF) as the first IVD biomarker.
- Tech-based upgrades in existing pipelines: Current technological breakthrough in the in-vitro diagnostics for cardiology and neurology market include automation and streamlining of assays, platforms, and data interpretation. These upgrades enhance the precision and speed of biomarker identification, where the cohort is further accompanied by the integration of AI and machine learning. Exemplifying the trend, in July 2025, Roche attained CE Mark for its Elecsys pTau181 test to measure phosphorylated Tau (pTau) 181 protein for AZ disease detection. The technology can offer a high negative predictive value (NPV) of 93.8%, along with 83.6% sensitivity. Moreover, such reliable, accessible, and cost-effective advances support future market expansion.
Demographic Trends and Projections in the In-vitro Diagnostics for Cardiology and Neurology Market
Projected Global Cardiovascular Disease Trends and Mortality (2025-2050)
|
Parameter |
Value/Description |
|
Age-standardized cardiovascular prevalence |
Relatively constant (-3.6%) |
|
Age-standardized cardiovascular mortality |
Decreasing (-30.5%) |
|
Age-standardized cardiovascular DALYs |
Decreasing (-29.6%) |
|
Leading cause of cardiovascular deaths in 2050 |
Ischaemic heart disease (20 million deaths) |
|
Main cardiovascular risk factor driving mortality in 2050 |
High systolic blood pressure (18.9 million deaths) |
|
Region with highest age-standardized cardiovascular mortality rate in 2050 |
Central Europe, Eastern Europe, and Central Asia |
|
Mortality rate in this region (2050) |
305 deaths per 100,000 population |
Source: NLM
Comparative Analysis of Commodities Available in the In-vitro Diagnostics for Cardiology and Neurology Market
Performance & Price Characteristics of Cardiac Diagnostic Technologies (2024)
|
Test Type |
Sensitivity |
Specificity |
Cost per Test (in USD) |
|
PrecisionCHD |
0.7 |
0.7 |
850 |
|
Exercise Electrocardiogram (ECG) |
0.5 |
0.6 |
891 |
|
Cardiac Computed Tomography Angiography (CCTA) |
0.9 |
0.7 |
806 |
|
CCTA + Image Processing |
0.9 |
0.8 |
1,556 |
|
Stress echo |
0.8 |
0.8 |
1,740 |
|
Single Photon Emission Computed Tomography (SPECT) |
0.8 |
0.7 |
4,162 |
|
Positron Emission Tomography (PET) |
0.8 |
0.8 |
4,637 |
|
Cardiac Magnetic Resonance Imaging (CMRI) |
0.8 |
0.8 |
1,432 |
|
Angiogram |
1.0 |
1.0 |
9,498 |
Source: NLM
Challenges
- Hurdles related to elongated compliance process: Regulatory hurdles form a considerable barrier to entry for manufacturers in the in-vitro diagnostics for cardiology and neurology market. The time-consuming and expensive process of acquiring approval from different regulatory agencies often causes budget overflow for innovators in this field. Besides, the inflationary development costs of associated products prohibit suppliers from setting comprehensive pricing, fostering a restrictive adoption dynamic among small- and medium-sized laboratories.
In-vitro Diagnostics for Cardiology and Neurology Market Size and Forecast:
|
Base Year |
2025 |
|
Forecast Year |
2026-2035 |
|
CAGR |
9.1% |
|
Base Year Market Size (2025) |
USD 19.8 billion |
|
Forecast Year Market Size (2035) |
USD 43.3 billion |
|
Regional Scope |
|
