Pregnancy Testing Market is expected to reach US$ 2.88 billion by 2033 | Top key players - Abbott, BIOMÉRIEUX, EKF Diagnostics Holdings plc

Market Size and Growth:

The Global Pregnancy Testing Market Size reached US$ 1.63 billion in 2023, with a rise to US$ 1.72 billion in 2024, and is expected to reach US$ 2.88 billion by 2033, growing at a CAGR of 6.0% during the forecast period 2025-2033. The Market is growing due to rising global pregnancy rates, increasing demand for early and convenient at-home detection, and greater awareness of reproductive health. According to DataM Intelligence Report.

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The Pregnancy Testing Market refers to the industry focused on products and technologies used to detect pregnancy by identifying hormones such as hCG in urine or blood. It includes home pregnancy test kits, digital tests, rapid diagnostic devices, and laboratory-based testing solutions. The market is driven by increasing awareness, improved accuracy, early detection needs, and rising access to point-of-care diagnostics.

United States: Recent Developments of Pregnancy Testing Market

✅ September 2025: Roche Diagnostics introduced a digital platform integrating pregnancy test kits with mobile applications, enhancing early detection through app-based tracking and personalized health insights.​

✅ October 2025: Quidel Corporation invested USD 5 million to expand manufacturing operations, improving production capacity and accessibility for digital pregnancy test kits amid rising home-testing demand.​

✅ November 2025: The U.S. digital pregnancy test kits market saw branded kits capture 64.20% revenue share, driven by consumer trust in accuracy and expanded retail availability.

Europe: Recent Developments of Pregnancy Testing Market

✅ September 2025: Roche Diagnostics launched a digital pregnancy testing platform with mobile app integration, boosting self-care diagnostics and aligning with EU4Health programs for reduced healthcare strain.​

✅ October 2025: Procter & Gamble collaborated with a healthcare provider on localized pregnancy test kits, tailoring offerings to improve affordability and distribution in key European markets.​

✅ November 2025: Europe maintained a 26.5% global market share in pregnancy test kits, fueled by post-COVID surge in home testing and annual sales nearing 65 million units.

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Recent FDA / Regulatory Approvals in 2025:

✅ In September 2025, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for MissLan® Early Detection Digital Pregnancy Test (and a variant "Early Result Digital Pregnancy Test"), for over‐the‐counter (OTC) use via urine hCG detection.

✅ The test is intended for home use, with sensitivity down to 10 mIU/mL hCG - allowing early detection, reportedly up to ~6 days before a missed period.

✅ This adds to the portfolio of at‐home pregnancy tests available for consumers, potentially increasing market competition, especially in value or private‐label segments.

✅ In July 2025, documentation shows that the Shinetell PlusTM Digital Early Pregnancy Test demonstrated required performance (sensitivity 10 mIU/mL, no "hook effect" at high hCG concentrations, acceptable stability/interference profile) and was cleared under FDA's hCG test system regulations.

✅ This suggests growing adoption of digital readout home‐use pregnancy tests (rather than simple line‐based ones), which may drive user convenience and accuracy.

Major Players:

Key companies in the Pregnancy Testing market include:

Abbott
BIOMÉRIEUX
EKF Diagnostics Holdings plc
Atlas Medical GmbH
QuidelOrtho Corporation
Biosynex SA
NG Biotech
Cardinal Health
Thermo Fisher Scientific Inc.
Procter & Gamble.

Segments Covered in the Pregnancy Testing Market:

By Product Type: Line Indicator Kits, Digital Devices, Others.

By Test Type: hCG Urine Test, hCG Blood Test, FSH Urine Test, LH Urine Test.

By Distribution Channel: Pharmacies/Drugstores, Online Sales, Gynecology/ Fertility Clinics, Supermarkets, Hypermarkets.

By End-User: Home Care, Hospitals, Others.

Regional Analysis for Pregnancy Testing Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline:

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Pregnancy Testing market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Pregnancy Testing Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global Pregnancy Testing market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Pregnancy Testing Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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Frequently asked questions:

➠ What is the global sales value, production value, consumption value, import and export of Pregnancy Testing market?

➠ Who are the global key manufacturers of the Pregnancy Testing Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the Pregnancy Testing market opportunities and threats faced by the vendors in the global Pregnancy Testing Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the Pregnancy Testing market?

➠ What are the different sales, marketing, and distribution channels in the global industry?

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