GlobalData analysts indicate that US tariffs, introduced under the Trump administration, are disrupting global supply chains and posing a risk to the rapidly expanding cardiovascular device market, especially pulsed field ablation (PFA) systems, which are predominantly manufactured overseas.
Over the past year, PFA devices have seen rapid uptake in electrophysiology, offering patients shorter procedure times, better safety, and enhanced clinical outcomes. Market leaders such as Boston Scientific’s FARAPULSE, Medtronic’s PulseSelect, and Johnson & Johnson’s VARIPULSE have significantly benefitted.
GlobalData forecasts the US PFA device market to be worth $535.9 million in 2024, growing at an aggressive 31.65% CAGR through 2034. Despite this, GlobalData warns that tariff-driven cost increases might force manufacturers to choose between absorbing tariffs or raising prices, potentially slowing growth.
Since PFA systems rely on globally sourced components, the 10–125% tariffs (varying by country of origin) complicate manufacturing economics. With PFA still approved in only a few countries, pricing flexibility is limited. Higher costs may shift hospital preferences toward cheaper alternatives, undermining PFA momentum.
GlobalData extends its warning to other medical device categories, such as in vitro diagnostics (IVD) and semiconductor-dependent systems, which are similarly exposed to tariff-linked cost increases. Over half of medical devices rely on chips and electronics—tariffs on semiconductors could drive up consumer and healthcare system costs.
US med-tech lobby groups—including Medtronic, Johnson & Johnson, and Abbott are calling for tariff exemptions, arguing that prolonged trade tensions may disrupt care delivery and increase patient costs. Meanwhile, healthcare systems are reportedly stockpiling essential devices in anticipation of rising tariffs and supply interruptions
Tariffs could prompt manufacturers to relocate production to the US or absorb additional costs, both of which impact unit economics and time to market. However, shifting supply chains is time-consuming and requires complex regulatory re-approvals-potentially dampening innovation.
GlobalData emphasizes that in high-growth segments like PFA, supply chain disruptions and rising manufacturing costs threaten to dampen future growth trajectories. Healthcare providers may pivot toward more cost-effective technologies if pricing remains strained.
Despite a booming US cardiovascular device market—highlighted by PFA’s $535.9M valuation and 31.7% CAGR—the imposition of tariffs introduces a notable brake on expansion. With rising costs, potential price hikes, supply chain volatility, and regulatory hurdles, manufacturers and providers face critical decisions. Exemptions and strategic shifts in production are possible mitigants, but the full impact on innovation, affordability, and patient access remains uncertain.
(Input from various sources)
(Rehash/Sakshi Thakar/MSM)