Pregnancy rapid test kits are used to confirm pregnancy. Fertility rapid test kits can help to find the exact day of ovulation or to confirm the presence of menopause in women, while in men, they are used to detect the sperm count.

Statistics:

The global fertility and pregnancy rapid test kits market is estimated to account for US$ 1,217.5 Mn in terms of value in 2019 and is expected to reach US$ 1,653.5 Mn by the end of 2027.

Global Fertility and Pregnancy Rapid Test Kits Market: Drivers

Increasing first-time pregnancy age is expected to propel growth of the global fertility and pregnancy rapid test kits market over the forecast period. For instance, according to the National Health Statistics Reports, published in July 2018, in 2011–2015, the mean age at first birth among women who had ever had a child was 23.1 and 20% of married women have had a first birth at age 30 and over compared to those who were not married, in the U.S.

Global Fertility and Pregnancy Rapid Test Kits Market: Opportunities

The first rapid pregnancy test, the e.p.t Pregnancy Test was launched in the U.S. market over four decades ago, when researchers discovered the radioimmunoassay that could detect hCG in urine. In 2003, next generation rapid tests devices based onlateral flow immuno assay were launched in the market. However, the same technology is being used in current pregnancy and fertility rapid tests, which needs to be improved to avoid false positive and false negative results of the test.

Global Fertility and Pregnancy Rapid Test Kits Market: Restraints

Device related issues and controversies are expected to hinder growth of the global fertility and pregnancy rapid test kits market. Physicians often rely on laboratory tests instead of home testing and recommend the same to patients. Moreover, unreliability of results such as false positive and false negative results dissuade consumers to a certain extent from opting for home pregnancy tests. Non-adherence to user instructions, obscure time window for test and device complications such as insensitivity or hook effect are some of the reasons of obtaining false or unreliable results.

Key Takeaways:

Pregnancy rapid tests segment in the global fertility and pregnancy rapid test market was valued at US$ 678.1 in 2018 and is expected to reach US$ 951.4 Mn by 2027 at a CAGR of 4.3% during the forecast period. /Increasing number of Adolscent pregnancies is expected to support growth of the segment over the forecast period. For instance, according to the World Health Organization (WHO), 2019, an estimated 21 million girls aged between 15 – 19 years in developing regions become pregnant annually.

The hCG Urine segment held dominant position in the global fertility and pregnancy rapid test kits market in 2018, accounting for 43.3% share in terms of value, followed by LH Urine, and FSH Urine, respectively.

Pregnancy testing using hCG Urine is easy compared to other tests, and women can easily check for pregnancy themselves using test kits and urine sample. hCG level are high in the urine in pregnant women which can be easily checked using pregnancy tests. These factors are expected to support growth of the market over the forecast period.          

The North America region held dominant position in the global fertility and pregnancy rapid test kits market in 2018, accounting for 50.7% share in terms of value, followed by Asia Pacific and Europe, respectively.

North America region has presence of key manufacturers, who offer their products to the potential customer base present in the region. Factors such as product launches are expected to support growth of the region over the forecast period.

Market Trends

The market is witnessing preference to mid-stream devices over strips and cassettes. Women are opting to use mid-stream devices over strips and cassettes due to ease and convenience of use. Cassettes are least preferred by most of users due to trouble in using droppers to add accurate quantity of sample to the sample well.

Physicians often recommend women on fertility treatment or contraception therapy to check levels of reproductive hormones such as luteinizing hormone and estrogen levels using the home fertility and pregnancy testing kits. Women tend to use the tests multiple times to confirm the test results.

Conventional line indicator devices and strips for fertility of pregnancy testing are rapidly being replaced by digital devices, owing to difficulty in interpretation of test results in case of line indicator devices.

Regulations

Europe

  • According to the European Union, pregnancy and fertility self-testing devices are required to be registered under EU Directive 98/79/EC
  • These devices are classified as Non Annex II (self-test) devices and are subject to performance evaluation by the respective country’s regulatory authority
  • Pregnancy and ovulation self-tests are covered under IVD 0405 and are subject to EC type examination by notified body as directed under Annex VII of EU Directive 98/79/EC
  • EC type certification involves the examination of technical designing of product and verification/attestation that the designing meets the legislative requirement applicable to the device as per device classification
  • Manufacturers of these devices need to give self-declaration of conformity, which is needed to be reviewed by the notified body
  • The notified body reviews the declaration for device design and labeling information for its appropriateness for non-professional users
  • Manufacturers outside the EU need to appoint authorized representatives for conformity assessment prior to launch of the device in the European market

Global Fertility and Pregnancy Rapid Test Kits Market: Competitive Landscape

Major players operating in the global fertility and pregnancy rapid test kits market include, SPD Swiss Precision Diagnostic GmbH, DCC Plc., Procter & Gamble, Abbott Laboratories, Alere Inc., Quidel Corporation, bioMérieux SA, Church & Dwight Co., Inc., Prestige Brands Holdings, Inc., and Geratherm Medical AG.

Global Fertility and Pregnancy Rapid Test Kits Market: Key Developments

October 2019: Natalist, a startup that offers products such as fertility tests and prenatal vitamins, raised US$5 million in a seed round

March 2019: Thorne launched five at-home health tests for vitamin D, heart health, weight management, testosterone, and menopause

Segmentation

  • By Product Type
    • Pregnancy Rapid Tests
      • Line-Indicator Devices
        • Strips/Dip Sticks
        • Mid-Stream
        • Cassettes
      • Digital
    • Fertility Rapid Tests
      • Line-Indicator
      • Digital
    • By Test Type
      • LH Urine
      • FSH Urine
      • hCG Blood
      • hCG Urine
    • By Distribution Channel
      • Hospital Channel
      • Retail Channel
      • Online Channel
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