Pregnancy Point of Care Testing Market

Pregnancy Point of Care Testing Market Outlook (2023 to 2033)

The global pregnancy point of care testing market is valued at US$ 1.5 billion in 2023 and is forecasted to secure US$ 2.33 billion in revenue by 2033-end. Global demand for pregnancy point of care testing is predicted to rise at 4.5% CAGR over the next ten years.

Increasing prevalence of gynecological disorders and fertility issues around the world is projected to primarily influence demand for pregnancy point of care testing in the future. Surging investments in the R&D of novel pregnancy point of care testing solutions are also anticipated to bolster market development over the next ten years.

Growing awareness regarding the benefits associated with point of care testing (POCT) products and the rising reliability of the same are also slated to benefit pregnancy point of care testing demand through 2033. The rising number of adolescent pregnancies around the world is also a crucial aspect that is predicted to promote the adoption of point of care pregnancy tests over the coming years.

• As per data listed on the UNICEF (United Nations International Children’s Emergency Fund) website, around 14% of adolescent girls gave birth before the age of 18 from 2015 to 2021, which is around one in six young women.

Expanding demand for rapid diagnostics, increasing healthcare expenditure, the advent of next-generation pregnancy point of care testing devices, and a high focus on maternal care and fetal care are other prospects that could uplift sales of women’s health products in the future. On the contrary, declining birth rates around the world are expected to have a hindering effect on overall pregnancy point of care testing demand going forward.

Furthermore, strict regulatory mandates governing product standards of pregnancy POCT devices and skepticism regarding the accuracy and reliability of pregnancy point of care testing products are other factors that could further hurt market development across the forecast period.

Report Attributes	Details
Pregnancy Point of Care Testing Market Size (2023)	US$ 1.5 Billion
Projected Market Value (2033F)	US$ 2.33 Billion
Global Market Growth Rate (2023 to 2033)	4.5% CAGR
Market Share of North America (2022)	~50%
Market Share of hCG Urine Tests (2022)	~40%
Key Companies Profiled	BIOSYNEX SA Abbott Laboratories Atlas Medical UK ulti med Products (Deutschland) GmbH Church & Dwight Co. Inc. Quidel Corporation Procter & Gamble Co. Prestige Brands Holdings bioMérieux SA NOW Diagnostics Inc. Swiss Precision Diagnostics (SPD) GmbH Piramal Enterprises EKF Diagnostics Holdings plc NG BIOTECH SAS Home Health (UK) Ltd. Prestige Brands Holdings

Will New Companies Have a Shot at Making a Mark in the Pregnancy POCT Industry?

“Start-ups Developing & Launching Novel Pregnancy-related Products”

Upcoming pregnancy point of care testing providers are focusing on developing rapid diagnostic kits and other types of pregnancy-related solutions to improve pregnancy care around the world. These new companies are also integrating advanced medical technologies to improve the efficacy of their products and also improve the ease of access and use for pregnant women.

• In June 2022, Salignostics, an Israeli medical technology company, announced the launch of a new pregnancy test that allows women to check if they’re pregnant using their saliva samples. The company uses its proprietary saliva-based hormone detection technology to provide a home test for early pregnancy recognition. The company claims that its SaliStick test has 95% sensitivity when women use it after they have missed their periods.
• Lia Diagnostics, a company focusing on redesigning the way we perceive pregnancy tests, has developed a pregnancy test from biodegradable paper that is toilet-friendly and can be flushed after use. The company is bringing sustainability to pregnancy care through its offering.
• Ovry, a Canadian start-up focusing on reducing pregnancy-related stress for women, is selling extremely thin pregnancy and ovulation test strips that come in boxes of 4 or 18 strips. The company also provides the product in discreet packaging and is extremely affordable as compared to other pregnancy tests that are available in the marketplace.
• MOMM Diagnostics, a Swiss company specializing in the development of tests for early diagnosis of preeclampsia, is using its technology to bring laboratory-based tests home with self-testing kits. The company is currently focusing on developing a rapid test for preeclampsia, a condition that affects nearly 3% to 8% of all pregnancies.

A comprehensive analysis of how new developments by start-ups are altering product standards, pricing trends, local supply, and other factors affecting market potential around the world has been listed in this recently revised pregnancy point of care testing market research survey by Fact.MR, a market research and competitive intelligence provider.

Country-wise Insights

Which Country in North America is the Leading Market for Pregnancy POCT?

“United States to Account for High Pregnancy Point of Care Testing Demand”

The developed healthcare infrastructure and high healthcare spending potential in the United States create lucrative opportunities for pregnancy point of care testing providers. The high availability of novel pregnancy point of care testing solutions and services is also a prime prospect that is projected to foster market development in the country across the forecast period. Rising focus on pregnancy care and increasing spending on pregnancy point of care testing devices are estimated to benefit market development in the country.

• As per data listed on the March of Dimes website, an estimated 3,613,647 live births were recorded in the United States in the year 2020. In the same year, the fertility rate was 56 per 1,000 women of age 15 to 44.

Implementation of new regulatory mandates and safety regulations to ensure patient safety is also projected to alter pregnancy point of care testing device demand in the United States over the coming years.

• In September 2022, the American Association for Clinical Chemistry (AACC) issued new guidelines for point-of-care testing (POCT) for fertility and reproductive health and replaces guidance set out in 2007.

Will Investing in Japan Be a Smart Move for Pregnancy Point of Care Testing Product Vendors?

“Declining Birth Rates Could Obstruct Market Potential in Future”

Japan has been witnessing a continual drop in the birth rate over the past few years and this trend is anticipated to have a negative impact on demand for pregnancy point of care testing in the future. The reluctance of women to have children, the increasing costs of raising kids, and the presence of a rapidly aging population are other aspects that could hinder sales of pregnancy point of care testing products in Japan over the coming years.

• As per statistics listed on the macrotrends website, the birth rate in Japan has been declining by nearly 1.3% every year from 2019 to 2023 and stands at 7.013 per 1,000 people in 2023, which is 1.35% less than the recorded average of 2022.

Nevertheless, increasing spending on healthcare infrastructure development, supportive initiatives to promote people to have more kids, and technological advancements in pregnancy care are aspects that could create opportunities for pregnancy point of care testing companies and drive market growth across the forecast period.

Which Trends are Driving Pregnancy Point of Care Testing Demand in Europe?

“Increasing Healthcare Expenditure and Surging Availability of Novel Pregnancy POCT Kits”

European countries such as Germany, the United Kingdom, France, Ireland, etc. are anticipated to witness high demand for pregnancy point of care testing in the future owing to rising spending on healthcare and the growing availability of novel pregnancy care products.

Surging sales of point of care pregnancy tests, point of care ovulation tests, and other pregnancy testing kits are slated to create an opportune market for upcoming as well as established market players.

Category-wise Insights

Which Type of Pregnancy Tests are Popular?

“hCG Urine Tests Account for Commanding Market Share”

Based on test, the pregnancy point of care testing market is segmented into FSH urine, LH urine, hCG blood/serum, and hCG urine.

Human chorionic gonadotrophin (hCG) urine test kits are highly popular and are forecasted to maintain their demand throughout the forecast period. The high popularity of these hCG urine tests can be ascribed to the rapidly rising sales of pregnancy test kits around the world. The high accuracy and reliability of hCG urine test kits are projected to contribute to their increasing market share over the coming years.

Increasing preference of women for urine testing devices over blood devices for pregnancy tests is also a key factor that is projected to uplift sales of hCG urine test kits in the future. Simplicity and ease of use associated with at-home urine test kits are also anticipated to favor demand for hCG urine tests over the next ten years.

Competitive Landscape

Leading pregnancy point of care testing companies are collaborating and partnering to fast-track the development and launch of novel products. Mergers and acquisitions are also estimated to gain popularity among leading pregnancy point of care testing providers in the future.

• In January 2023, Atomo, a leading name in rapid diagnostics, and NG Biotech, a French biotechnology company, announced that they had a signed new commercialization agreement for the manufacturing and distribution of blood-based rapid pregnancy test kits. The new test kits are a combination of Atomo’s Pascal blood test device and NG’s hCG test assay.

Pregnancy POCT Industry Research

• By Product :

  • Pregnancy Test Kits
    • Strips/Dip Sticks & Cards
    • Mid-Stream Devices
    • Cassettes
    • Digital Devices
  • Fertility Test Kits
    • Digital Devices
    • Line-Indicator Devices

• By Test :

  • FSH Urine
  • LH Urine
  • hCG Blood/Serum
  • hCG Urine

• By Sample :

  • Blood
  • Urine

• By Distribution Channel :

  • Pharmacies
  • Drugstores
  • Hypermarkets & Supermarkets
  • Online Sales
  • Fertility/Gynaecology Clinics

• By Region :

  • North America
  • Latin America
  • Europe
  • APAC
  • MEA