Pregnancy Point of Care Testing Market

In Brief

• The pregnancy point of care testing market grew at a steady value CAGR of 3.7% during 2013-2017, as low availability and product penetration of pregnancy point of care testing products in emerging economies impacted the market growth.
• In 2018, the pregnancy point of care testing market reached US$ 1.2 billion and, with growing awareness about infertility disorders and increasing healthcare spending across the world, the market is expected to witness 5.0% y-o-y in 2019.
• The global pregnancy point of care testing market is likely to envisage incremental growth at a healthy 4.5% CAGR during the forecast period 2018-2028. Technological advancements and awareness about the accuracy and efficiency of pregnancy point of care testing products will contribute to increasing growth of the market during the assessment period.

• Backed by strong presence of leading market players in the U.S., North America will continue to remain the leading market for pregnancy point of care testing products throughout the forecast period.
• South Asia is expected to emerge as a high-growth market for pregnancy point of care testing with lucrative opportunities for product penetration and increasing preference for home monitoring devices for ovulation tracker among end-users in South Asian countries.

What are the Key Growth Drivers of Pregnancy Point of Care Testing Market?

• Growing prevalence of gynecological issues and fertility disorders, coupled with high preference for fast and self-contained tests is primarily boosting sales of pregnancy point of care testing products.
• Increasing awareness about the availability of technologically advanced and high-precision pregnancy point of care testing products is providing an impetus to market growth.
• Manufacturers are adopting next-generation technologies to introduce advanced features, such as accuracy and ease of use, and improve the reliability of pregnancy point of care testing products.
• Leading players in the pregnancy point of care testing market are launching products with smartphone connectivity to attract modern customers and boost adoption of smart pregnancy point of care testing products.

What are the Key Challenges in the Pregnancy Point of Care Testing Market?

• An increasing number of new entrants in the pregnancy point of care testing market are introducing innovative products at competitive prices. A huge price gap between new market players’ and leading players’ products will impact growth of the global pregnancy point of care testing products.
• Questions raised on the accuracy of pregnancy point of care testing products and the possibility of getting inaccurate results is restricting consumers to rely on these products, consequently hampering growth of the market.
• Stringent regulations and standards along with lengthy certification processes, developed by governing bodies influence salient business strategies. Strict product approval rules also make a significant impact on the manufacturing cost of pregnancy point of care testing products, creating challenges for manufacturers at introducing products at competitive prices in the market.

Pregnancy Point of Care Testing Market – Notable Developments

• In December 2018, Quidel Corporation – an American manufacturer of point of care testing and diagnostics healthcare products – announced that it is resuming the manufacturing of Quidel Triage® Placental Growth Factor (PLGF) Test, a biomarker for placental dysfunction, which will be available in the U.S. markets in 2019. It claims that the Quidel Triage PLGF Test can help healthcare professionals to accurately risk-stratify pregnant women with the help of an accurate as well as early diagnosis of preterm pre-eclampsia. The company also announced that the ownership of the Triage PLGF Test product transferred to Quidel after the company acquired Alere Inc.’s Triage® business. By reintroducing the Triage PLGF test product, the company aims to expand its presence in the pregnancy point of care testing market in the coming years.
• In July 2018, NOW Diagnostics Inc. – a U.S.-based player active in the point of care testing market – announced that it has acquired Cellmic LLC – a U.S.-based manufacturer of mobile-phone-based holographic imaging and diagnostics – to strengthen its position in the rapid diagnostics and mobile health space. By integrating Cellamic’s advanced reader technology with its point of care testing platform, NOW Diagnostics aims to improve accuracy, ease of use, convenience, and cost-efficiency of its point of care testing products, with this acquisition.
• In October 2017, Swiss Precision Diagnostics (SPD) GmbH – a Swiss medical diagnostic company owned by Procter & Gamble – announced that it has introduced a new pregnancy point of care test, which is an ovulation testing system that can be synced with a smartphone application, under its ovulation brand Clearblue®. The company also announced that the new Clearblue® Connected Ovulation Test System is a urine test, which adapts and tracks the levels of LH and estrogen, and accurately compares to an ultrasound.
• In March 2019, Group K Diagnostics Inc. – a biotechnology company in the point of care testing market – announced that it is designing and developing a point of care Zika assay in collaboration with the Centers for Disease Control and Prevention (CDC). The company also announced that it is one of the important goals of the collaboration with CDC is to offer a rapid point of care testing tool that can also be used by women living in areas at risk of ZIKV transmission throughout pregnancy for prenatal care.
• In September 2018, Sugentech, Inc. – a South Korean manufacturer of pregnancy point of care testing products – announced that it has expanded its distributors’ network in North America. The company announced that it established a collaboration with CGETC, Inc. in 2017 to distribute its products in the U.S., and now its products are available in the country through Amazon.com. The company aims to capitalize on the increasing growth of the pregnancy point of care testing market in the U.S. by strengthening its distribution capacities in the North American region.

Abbott Laboratories

Abbott Laboratories was established in 1888 and is headquartered in Tokyo, Japan. Abbott Laboratories is one of the leading healthcare company in the world that offers a wide range of in vitro diagnostic products. The company acquired Alere, Inc. and St. Jude’s Medical, Inc. in 2017, and aims to continue expanding in emerging economies through acquisition strategies in the upcoming years.

Quidel Corporation

Established in 1987, Quidel Corporation is headquartered in California, U.S., and the company manufactures and markets rapid diagnostic test products. Quidel Corporation’s products mainly cover women’s health and gastrointestinal diseases, and therapeutic areas of infectious diseases. Its products are distributed and marketed under various brands, such as Quidel, QuickVue, Micro Vue, Fresh Cells, and Sofia.

Swiss Precision Diagnostics (SPD) GmbH

Founded in 2007, Swiss Precision Diagnostics (SPD) GmbH is headquartered in Geneva, Switzerland and is a leading provider of consumer diagnostic products. The company was established as a joint venture between Alere Inc. (Abbott Laboratories) and Procter & Gamble (P&G), which are two leading manufacturers of consumer diagnostics products. The company supplies its diagnostic products through its brands including Clearblue, Persona, Fact Plus, Crystal Clear, and Accu-Clear.

NOW Diagnostics Inc.

Founded in 1939 and headquartered in Bentonville, AR, U.S., NOW Diagnostics Inc. is a leader in innovative diagnostic health testing market. The company offers an hCG (human chorionic gonadotropin) test— ADEXUSDx® hCG Test—in Europe and the United States, and two cardiac tests and three toxicology tests in Europe.

Church & Dwight Co. Inc.

Church & Dwight Co. Inc. was founded in 1846 and it is headquartered in New Jersey, U.S. The company offers its personal care products under the range of over 80 of its flagship brands, including FIRST RESPONSE™. The company operates through its three business divisions – specialty products, consumer domestic, and consumer international. The company launched its first Bluetooth-enabled digital pregnancy PRO test in 2016, and it aims to expand its presence in countries outside the U.S. with a major focus on mergers and acquisition.

Abbott Laboratories, Quidel Corporation, Prestige Brands Holdings, Swiss Precision Diagnostics (SPD) GmbH, Church & Dwight Co., Inc., BIOSYNEX SA, EKF Diagnostics Holdings plc, NOW Diagnostics Inc, NG BIOTECH SAS, ulti med Products (Deutschland) GmbH, Procter & Gamble Co., Piramal Enterprises, bioMérieux SA, Atlas Medical UK, and Home Health (UK) Ltd are among the key companies in the pregnancy point of care testing market.

Pregnancy Test Kits Selling Higher than Fertility Test Kits

The preliminary 2016 data released by the Centers for Disease Control and Prevention shows that more women are delaying their first pregnancy, as the birth rate among women in their 30s surpassed that among women in their 20s, in 2015. 

Social norms vis-à-vis the age of motherhood have changed in developed countries with remarkable speed, especially among highly-educated women. Increasing concerns about women’s health and pregnancy are triggering the adoption of pregnancy test kits among women.

Moreover, low levels of awareness about fertility issues and reproductive health, especially in developing nations, is restricting the sales of fertility test kits. In addition, concerns about the accuracy of at-home fertility test kits limits the adoption of fertility test kits.

On the contrary, the ease of use and technological advancements in pregnancy test kits has been boosting its demand, marking an emerging trend in the pregnancy point of care testing market.

Research Methodology

The Fact.MR research study on pregnancy point of care testing market offers industry-best intelligence and insights into the global pregnancy point of care testing market forecast.

The research study on pregnancy point of care testing market is a result of extensive research methodology, comprising of a primary phase and a secondary phase. The report on pregnancy point of care testing market gives a comprehensive analysis of its growth prospects and opportunities over the forecast period, including a detailed segmentation.

Pregnancy Point of Care Testing Market: Segmentation

• Product Type

  • Strips/ Dip Sticks and Cards
  • Mid Stream Devices
  • Cassettes
  • Digital Devices
  • Line-Indicator Devices

• Test Type

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

• Sample Type

  • Blood
  • Urine

• Distribution Channel

  • Pharmacy
  • Drug Stores
  • Hypermarkets & Supermarkets
  • Online Sales
  • Obstetrics and Gynecology Clinics