Increased breast pump market innovation, competition after Affordable Care Act

Key takeaways:

• ACA policies to improve maternal health care access led to significant increases in breast pump premarket notifications and patents.
• By 2020, the yearly mean number of patents significantly decreased.

The Affordable Care Act introduced policies to increase access to maternal health care that were associated with a rise in innovation and competition in the breast pump market, according to a research letter published in JAMA.

“The Patient Protection and Affordable Care Act (ACA), enacted in March 2010, required employers to provide employees who are breastfeeding a reasonable break time and appropriate location to express milk,” Oluwarantimi Adetunji, PhD, from the Office of the Assistant Secretary for Planning and Evaluation at HHS, and colleagues wrote. “A second provision, which became effective in August 2012, required all new insurance policies to provide coverage for preventive services, including breast pumps and lactation care, with no cost sharing.”

Adetunji and colleagues evaluated whether ACA policies to increase breast pump and lactation care access were associated with breast pump market innovations by assessing changes from 1994 to 2021 for the number of patent filings and the number of 510(k) premarket notifications for breast pumps in the U.S. Researchers obtained data on patent filings from the PatentsView dataset and the U.S. Patent and Trademark Office and obtained data on premarket notifications from the Premarket Notification 510(k) dataset from the FDA.

From 1994 to 2021, there were 136 premarket notifications and 403 patent filings for breast pumps. Of the 136 premarket notifications, 89% were for new breast pumps, the researchers wrote. Before the ACA, 80% of firms submitted a premarket notification for the first time compared with 86.4% of firms after the ACA policies were enacted.

Researchers observed no significant changes in premarket notifications and patent trends from 1994 to 2010. However, after the ACA policies in 2010, researchers observed an increase from 3.13 to 7.17 (P = .01) in the yearly mean number of premarket notifications for breast pumps and an increase from 9.5 to 20.92 (P = .02) in the yearly mean number of patents.

By 2020, the yearly mean number of breast pump patents decreased by 26.73 (P < .001).

“This study’s findings suggest there has been an increase in innovation and competition in the breast pump market after ACA,” the researchers wrote. “In contrast, the potential market size for breast pumps, proxied by U.S. births, decreased over the same period.”