Fertility and Pregnancy Rapid Test Kits Market – Insights
Pregnancy and fertility rapid tests are the point of care tests used in male and female to qualitatively detect the presence of reproductive hormones such as FSH, LH and hCG either in urine or blood sample.
To perform rapid pregnancy or fertility tests, small amount of blood or urine sample is required, depending upon the type of device being used. These devices work on color changing immunoassay techniques.
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
High incidence of infertility is a major factor boosting growth of the global fertility and pregnancy rapid test kits market over the forecast period. For instance, according to the National Survey of Family Growth data published in September 2018, 15.5% of all women who intend to become pregnant are infertile and 6.7% of married women aged 15 to 44 years are infertile, in the U.S.
Moreover, increasing incidence of gynecological disorders is also expected to aid in growth of the market. For instance, according to the Centers of Disease Control and Prevention’s U.S. Cancer Statistics September 2019, around 94,000 women were diagnosed with gynecologic cancer each year, in the U.S., between 2012 and 2016.
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.
Global Fertility and Pregnancy Rapid Test Kits Market: Restraints
Lack of buyers in emerging economies is expected to hinder growth of the global fertility and pregnancy rapid test kits market. In spite of high infertility rates in countries such as South Africa, Nigeria, Bangladesh, and Morocco, lack of awareness towards fertility and pregnancy rapid test products as well as inability to buy products due to economic insufficiency can hamper growth of the global market to a certain extent.
Moreover, the market for fertility and pregnancy test products is highly competitive, with number of established and local players striving to maintain their market shares. Over 300 brands are available in market for fertility or pregnancy testing, which can lead to a problem of plenty, wherein consumers cannot choose one brand and instead opt for alternative laboratory tests. This can significantly reduce consumer base and thus, lead to decline or stagnation in market.
Global Fertility and Pregnancy Rapid Test Kits Market: Opportunities
Devices for pregnancy and fertility rapid tests are not covered in most pregnancy coverage policies or health insurance. Cost of pregnancy and fertility rapid test devices are comparatively high in the U.S. and Europe. Therefore, effective reimbursement policies and reduction in costs is expected to offer lucrative growth opportunities for players in the market.
Direct-to-consumer (DTC) medical tests can be an affordable option help low income countries. Therefore, players in the market can focus on introducing DTC medical tests.
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.
Market Trends/Key Takeaways
Manufacturers are offering pregnancy test kits with dual capability as well as combined packs of fertility and pregnancy tests, which can be used to qualitatively detect the presence of hCG hormone in both urine and serum/blood. For instance, various products such as QuickVue hCG Combo, Test & Confirm, and ICON 25 hCG are available that offer dual capability.
Major players in the market such as Alere and Swiss Precision Diagnostics GmbH are employing co-promotions and co-marketing strategies to expand their commercial presence in the global market. For instance, SPD GmbH co-market their products with Alere Inc. in India and with Boots Pharmaceuticals in the U.K.
- Pregnancy test devices are classified by FDA as hCG tests system under 21 CFR, section 1155(a)
- Pregnancy and fertility rapid test devices fall under subpart B- Clinical Chemistry Tests Systems in Class II and class III medical devices
- Pregnancy and fertility test devices are thus subject to FDA review for premarket approval (PMA) under section 510 (k) of Federal Food drug and Cosmetics Act and the submitter may market the device immediately after 510(k) clearance is obtained
- The submitter of 510 (k) for the sale of medical devices in U.S. market can be a domestic manufacturer, specification developer, re-packer or re-labeler and foreign manufacturer/exporter
- As per medical devices amendment of 1976, manufacturer of class II and class III devices need to submit PMA for all changes in device that affect safety and effectiveness under new section 515 (d)(6) of FDA Modernization act
- Fertility rapid test devices are classified under 21 CFR, section 862.1300 as Follicle Stimulating hormone test systems and section 862.1485 as Luteinizing hormone test system
- As per amendment of May 2000, these devices are exempted from premarket notification in subpart E of part 807, chapter I of FD& C Act
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
Players in the global fertility and pregnancy rapid test kits market are focused on raising funds to expand their product portfolio. For instance, in August 2019, Dadi, a health company that offers male fertility testing and sperm storage, announced the close of a US$ 5 million investment.
Players in the market are also focused on lunching new products to expand their product portfolio. For instance, in January 2019, Medical Electronic Systems announced availability of its YO Home Sperm test for PC platforms