Pregnancy Testing Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type (Urine based, Blood based), By Technology (Line Indicator, Digital Test), By Distribution Channel (Retail Pharmacies, Online Pharmacies, Hospital Pharmacies), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.69 Billion
CAGR (2026-2031)	5.42%
Fastest Growing Segment	Urine based
Largest Market	North America
Market Size (2031)	USD 2.32 Billion

Market Overview

The Global Pregnancy Testing Devices Market will grow from USD 1.69 Billion in 2025 to USD 2.32 Billion by 2031 at a 5.42% CAGR. Pregnancy testing devices are diagnostic instruments utilized to detect human chorionic gonadotropin in urine or serum, serving as the primary method for confirming conception. The market is fundamentally driven by the global prevalence of unintended pregnancies, which necessitates accessible and immediate confirmation methods, alongside a growing emphasis on proactive fertility management among women delaying childbirth. According to the United Nations Population Fund, in 2024, their reproductive health programs prevented approximately 18 million unintended pregnancies, a figure that highlights the extensive scope of reproductive activity necessitating reliable diagnostic solutions and monitoring.

Despite robust demand, the market faces a significant challenge regarding the accuracy and interpretation of home-based results. User procedural errors or physiological limitations can lead to false readings, resulting in consumer distrust and unnecessary medical consultations. This reliability concern is frequently exacerbated by stringent regulatory frameworks in emerging economies, which often slow the approval of improved testing formats and restrict the availability of reliable devices to the general population.

Key Market Drivers

Technological advancements in digital and connected diagnostic devices are revolutionizing the Global Pregnancy Testing Devices Market by addressing consumer demand for hygiene and ease of use. Innovations such as saliva-based testing have gained rapid traction, offering a non-invasive alternative to traditional urine-based strips that effectively eliminates the "ick factor" often associated with home diagnostics. According to Forbes, December 2024, in the 'This Startup Is On A Mission To Redefine Accessible Pregnancy Testing' article, the manufacturer Salignostics sold more than 500,000 units of its novel saliva-based test shortly after its initial commercial rollout. This strong adoption rate highlights a decisive shift toward user-centric product designs that simplify the testing procedure. Furthermore, the financial scale of this segment is expanding; according to Femtech Insider, November 2025, in the 'Salignostics Launches Saliva-Based Pregnancy Test in Germany' report, Germany's self-testing market alone generated approximately $508 million in 2024, reflecting the robust economic potential of private health monitoring tools.

The increasing prevalence of infertility and delayed parenthood trends also serves as a critical driver, fundamentally shifting the market from reactive confirmation to proactive fertility management. As women increasingly postpone childbirth, the biological window for conception narrows, necessitating frequent and precise testing to monitor reproductive cycles and confirm pregnancy at the earliest possible stage. According to the Centers for Disease Control and Prevention, July 2025, in the 'Births: Provisional Data for 2024' report, the United States general fertility rate declined to 53.8 births per 1,000 females in 2024. This downward trajectory in fertility rates paradoxically stimulates market growth, as the difficulty in conceiving drives couples to utilize diagnostic devices more intensively as part of assisted reproduction protocols and rigorous family planning strategies.

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Key Market Challenges

The issue of accuracy and the interpretation of home-based results stands as a critical challenge hampering the Global Pregnancy Testing Devices Market. User procedural errors, such as improper timing or sample collection, often yield false readings that erode consumer confidence. When individuals cannot trust the reliability of a home test, they are less likely to rely on these devices for immediate confirmation, opting instead for professional medical intervention. This consumer distrust creates a significant barrier to market penetration, particularly for new product adoption, as the fear of misdiagnosis outweighs the convenience of at-home testing.

This challenge is intensified by stringent regulatory frameworks that, while intended to ensure safety, create substantial bottlenecks for market growth. Regulatory bodies in emerging and developed economies are enforcing stricter clinical evidence requirements, which slows the approval process for improved, more user-friendly testing formats. According to MedTech Europe, in 2024, 30% of In Vitro Diagnostic manufacturers reported that at least one device certificate was significantly delayed or closed negatively due to rigorous performance and clinical evaluation challenges. These delays prevent manufacturers from swiftly introducing advanced solutions that could mitigate user errors, thereby stalling the market's ability to evolve and meet consumer demand for reliability.

Key Market Trends

The adoption of biodegradable and flushable sustainable materials is emerging as a critical trend, driven by escalating consumer demand for environmentally responsible diagnostic solutions. Manufacturers are increasingly prioritizing plastic-neutral designs to mitigate the substantial waste generated by single-use diagnostic kits, moving away from traditional non-recyclable casings. This shift is reshaping product development pipelines as companies seek to align with global sustainability goals without compromising diagnostic accuracy. According to Abingdon Health, March 2025, in the 'Interim Results' report, the company recorded H1 2025 revenues of £3.1 million while confirming the strategic development and upcoming launch of its sustainable pregnancy tests in the United States, underscoring the commercial viability and prioritization of eco-friendly innovations.

Simultaneously, the expansion of direct-to-consumer (DTC) and online subscription models is revolutionizing market access by addressing the consumer need for privacy and logistical convenience. Unlike traditional retail purchasing, these digital-first channels offer discreet, recurring deliveries that allow individuals to manage reproductive health monitoring from home, bypassing the potential discomfort of pharmacy visits. This distribution shift is supported by robust digital engagement; according to Church & Dwight Co., Inc., January 2025, in the 'Q4 2024 Earnings Call' transcript, the company reported that its online sales accounted for 21.4% of its total global sales, reflecting a significant migration of consumer purchasing behavior toward digital platforms for personal care and diagnostic products.

Segmental Insights

The urine-based segment is currently the fastest-growing category within the global pregnancy testing devices market, driven by the rising demand for convenient and non-invasive self-diagnostic solutions. This growth is underpinned by the accessibility of over-the-counter home test kits that offer privacy and rapid results. Furthermore, technological improvements such as digital displays have minimized interpretation errors, significantly enhancing consumer reliability. Approvals from regulatory bodies like the U.S. FDA for direct-to-consumer sales have strengthened market trust, making these cost-effective devices the preferred choice over clinical blood-based testing methods.

Regional Insights

North America maintains a leading share in the global pregnancy testing devices market, primarily attributed to high awareness regarding early detection and significant per capita healthcare spending. The region benefits from the widespread availability of over-the-counter diagnostic kits and a robust distribution network. Additionally, the U.S. Food and Drug Administration plays a critical role in ensuring product safety and efficacy, which fosters consumer confidence and market stability. The presence of major manufacturers further supports the expansion of the market through continuous product availability and established retail channels across the United States and Canada.

Recent Developments

• In March 2025, Cadence OTC introduced the EarlyPT Pregnancy Test to convenience stores nationwide across the United States, aiming to increase access to reproductive healthcare products. The new test was marketed as a highly sensitive over-the-counter option capable of detecting pregnancy up to six days before a missed period. By targeting the convenience store channel, the company sought to fill a critical gap in product availability, particularly in areas where pharmacies may be less accessible. The launch highlighted a shift towards making high-accuracy diagnostic tools more readily available to consumers through non-traditional retail outlets, supporting broader health equity initiatives.
• In December 2024, Salignostics secured regulatory approval from the Therapeutic Goods Administration (TGA) in Australia for its Salistick saliva-based pregnancy test. This certification cleared the path for the company to introduce its non-invasive diagnostic product to consumers in Australia and New Zealand, expanding its global market presence beyond Europe and Israel. The approval followed a rigorous review process validating the safety and efficacy of the technology, which detects the beta-hCG hormone in saliva. The company announced that this regulatory milestone would enable distribution through local partners, offering a user-friendly alternative to traditional urine-based kits in the Oceania region.
• In October 2024, Church & Dwight Co., Inc. launched the First Response Multi Check Pregnancy Test Kit in the United States, addressing consumer demand for more convenient testing methods. This new product offering combined an all-in-one "EasyCup" with two additional rapid result tests, providing users with multiple confirmatory options in a single package. The company developed the EasyCup to integrate a test strip directly into a sample collection cup, catering to the nearly 50% of users who prefer using a cup over midstream testing for cleanliness and control. This launch represented a significant innovation in the traditional urine-based testing segment by streamlining the sample collection process.
• In May 2024, Abingdon Health plc collaborated with Salignostics and Crest Medical to launch the first-ever own-brand saliva pregnancy test for Boots, a leading health and beauty retailer in the United Kingdom. The test, which utilizes Salignostics’ proprietary Salistick technology, allows users to detect pregnancy by placing a handheld applicator in their mouth for a short period, eliminating the need for urine samples. This strategic partnership facilitated the widespread retail availability of non-invasive diagnostics across Boots stores and its online platform. The launch marked a major milestone in the commercialization of saliva-based hormone detection technology within the mainstream consumer healthcare market.

Key Market Players

• Abbott
• Roche
• BD
• Siemens Healthineers
• Beckman Coulter
• Acon Laboratories
• SD Biosensor
• Hologic
• AmniSure
• Quest Diagnostics

By Product Type	By Technology	By Distribution Channel	By Region
Urine based Blood based	Line Indicator Digital Test	Retail Pharmacies Online Pharmacies Hospital Pharmacies	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Pregnancy Testing Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Pregnancy Testing Devices Market, By Product Type:

• Urine based
• Blood based

• Pregnancy Testing Devices Market, By Technology:

• Line Indicator
• Digital Test

• Pregnancy Testing Devices Market, By Distribution Channel:

• Retail Pharmacies
• Online Pharmacies
• Hospital Pharmacies

• Pregnancy Testing Devices Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE