Wearable Pregnancy Devices Market - Growth Drivers and Challenges
Growth Drivers
- Rising maternal age and pregnancy complexity: The market is experiencing a potential growth as the maternal age has shifted to the advanced maternal age with a high risk. According to a report by the National Vital Statistics Reports, March 2025, there was a decline of 4% in the birth rate for females 15 to 19 years of age from 2022 to 2023, birth rates rose by less than 1% for females 20 to 24, and birth rates fell for females 25 to 44 by 1% to 3%. Most cases of advanced maternal age require closer monitoring of the mother and fetus, thus making use of continuous, non-invasive wearable technology. This trend offers manufacturers the chance to increase their addressable patient population.
- Sustained demand from national birth rates: The market is supported by a strong national birth rate, ensuring long-term product relevance. According to a report published by the CDC in April 2023, the cesarean delivery rate in 2024 went up to 32.4%, since the low-risk cesarean delivery rates remained 26.6%. Hence, stable or slightly uplifted birth rates serve as a steady user base for maternal health-monitoring tools. This very steadiness benefits the B2B procurement planning workings of hospitals, insurers, and providers of remote health care. It also strengthens scaling constructions by suppliers of devices in the market domain.
- Government-supported innovation and R&D funding: Government health authorities are supporting new product development in the wearable pregnancy devices market with focused R&D incentives. In a report published by the NIH in September 2023, the National Institutes of Health will award up to a total of USD 2 million in cash prizes to encourage innovation in diagnosis and monitoring technologies to enhance fetal health outcomes for low-resource environments. The project promotes the development of wearable, low-cost, and scalable fetal monitoring technologies. Such public investments de-risk early-stage innovation and trigger commercial partnerships. Hence, the device developers are encouraged to expedite go-to-market strategies under sponsored pilot plans.
Export and Import Values of Medical Instruments (2023)
|
Country |
Exports (USD billion) |
Imports (USD billion) |
|
U.S. |
34.8 |
37.7 |
|
Germany |
18.4 |
13.1 |
|
China |
12.3 |
10.6 |
|
Japan |
7.2 |
6.4 |
|
Netherlands |
9.3 |
14.1 |
|
Mexico |
17.6 |
4.6 |
Source: OEC, August 2025
Challenge
-
Navigating complex regulatory landscapes: The global markets face various barriers to growth, among which regulatory fragmentation across international markets is the most significant. The manufacturers must negotiate among various standards regarding device safety, data privacy, and clinical validation. It delays the time to market and skyrockets the costs of compliance. An instance would be that a device would be approved according to FDA regulations, but needs to be completely reevaluated for CE marking in Europe, or may even have to undergo approval procedures under the SFDA in Asia. Coordinating all the different expectations based on these regulations is hampering the smooth development.
Wearable Pregnancy Devices Market Size and Forecast:
|
Base Year |
2025 |
|
Forecast Year |
2026-2035 |
|
CAGR |
16.6% |
|
Base Year Market Size (2025) |
USD 10.9 billion |
|
Forecast Year Market Size (2035) |
USD 43.4 billion |
|
Regional Scope |
|