In-vitro Diagnostics for Cardiology and Neurology Market Size & Share, Product Type (Reagents & Consumables, Instruments, Software & Services); Technology; Application; End User - SWOT Analysis, Competitive Strategic Insights, Regional Trends 2025-2037

In-vitro Diagnostics for Cardiology and Neurology Market - Growth Drivers and Challenges

Growth Drivers

• Increasing incidence of cardiovascular and neurological disorders: The growing burden of cardiovascular diseases (CVDs) and neurological disorders is contributing to the demand for IVD solutions. The World Health Organization (WHO) shows CVDs are responsible for around 31% of global deaths. According to the CDC, 804,000 heart attacks occur every year in North America overall. The European Society of Cardiology documents that 48 million people live with CVD in Europe today. Moreover, Germany alone had 8 million cases in 2025 within CVD. Consequently, this increased the demand for tests to aid in detecting or diagnosing the condition earlier and managing it.
• Increased government spending on healthcare: The government's spending on IVD product purchases is an important leverage point in the value chain. In the U.S., CMS is a major player in healthcare spending. CMS reported USD 4.2 trillion of total US healthcare spending in 2023. Diagnostic services are embedded in this, with IVD for cardiology and neurology representing a significant portion. Medicare spent USD 8.1 billion on diagnostic testing in 2023.
• Advances in diagnostics technology: New technologies—molecular diagnostics, next-generation sequencing (NGS), and point-of-care (PoC) testing—are transforming the IVD product landscape. In 2024, the FDA approved 14 new IVD devices for cardiology and neurology. These innovations help to enhance the accuracy of diagnostics and the timeliness of assessments by aligning with real-time needs. For instance, according to an AHRQ study from 2023, the use of PoC testing for cardiac biomarkers in emergency rooms reduced the time until diagnosis by more than 25% compared with standard laboratory testing. The takeaway for companies is to invest in IVD systems that are AI-enabled and have sufficient automation to meet customers' demand for faster and more accurate diagnostics.

Historical Patient Growth and Market Implications

The in-vitro diagnostics for cardiology and neurology market is significantly influenced by a dramatic increase in patient volumes due to increasing prevalence rates of cardiovascular and neurological diseases. According to the WHO, there were 17.5 million people who died from cardiovascular diseases (CVDs) as of 2019. In in-vitro diagnostics for cardiology and neurology markets that include the USA, Germany, France, Spain, and Australia. In Japan, India, and China, patient growth for CVD and other neurological disease categories has fueled the demand for various IVD products. For instance, in the U.S., there was a 21% increase in the patient volume for CVD diagnostics over the past decade.

In China and India, patient growth increased over 34% and 26%, respectively, as the industry rapidly developed their healthcare delivery systems and populations became more aware of chronic diseases. This developing patient base serves as a very robust market landscape. Historical growth provides opportunities for manufacturers to bring innovations to the market to develop scalable and cost-effective IVD products. Particularly, in the Asia-Pacific where, each market is experiencing growing levels of health care investment and awareness around unmet diagnostic needs. This further provides good opportunities for growth in the healthcare industry in those markets to 2037.

Historical Patient Growth (2010-2020)

Manufacturer Strategies and Revenue Potential

The worldwide in-vitro diagnostics for cardiology and neurology market is on a growth path with active innovation by major manufacturers. These organizations improve their market positioning through artificial intelligence (AI) driven diagnostics, forming partnerships, and expanding to areas where these technologies are researched and needed. For instance, in 2023, Cardio Diagnostics Holdings Inc. released its AI-powered test production model, PrecisionCHD, which offers an advancement in early coronary heart disease detection and functions to support a growth in in-vitro diagnostics for cardiology and neurology market share.

Partnerships, like the one Beckman Coulter and Fujirebio worked in 2023 for neurodegenerative disease-based assays, are working to deliver more precise diagnostic results. In 2024, the FDA approved 14 diagnostic devices, which shows that innovation is improving. Growth strategies will focus on clear, scalable, and efficient solutions while leveraging government funds and attracting global capital sources to enter more emerging markets. In 2023, Medicare will spend USD 8 billion on diagnostics (APTA) that allows IVD to break into markets. The future will remain lateral to years of untapped growth until 2037.

Challenges

• Regulatory barriers: Regulatory hurdles form a considerable barrier to entry for IVD manufacturers. For instance, in 2022, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) delayed approvals of new IVD devices by over five months on average. Total development costs for firms increased by approximately 19% on average, which caused a severe financial blow to many firms, including Sysmex Corporation. The U.S. FDA processed an approximate 1100 premarket notifications per year; however, 25% of notifications were delayed due in part to regulatory hurdles stemming from the complex requirements for the molecular diagnostics area.
• Pricing constraints: Price restrictions imposed by government bodies can limit the profit and access to IVD products. The WHO reported that pricing restrictions implemented by the new EU In Vitro Diagnostic Regulation (IVDR) restricted manufacturers' pricing. Government pricing restrictions inhibit access to high-cost mechanisms and technologies like biomarker panels, especially in price-dependent markets.