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Market Dynamics
Rising Gynecological Disorders, Infertility, and Adoption of Point-of-Care Testing Driving Global Market Growth
The increasing prevalence of gynecological disorders, rising infertility rates, and the growing adoption of point-of-care testing are key factors propelling the global market during the forecast period.
According to UCLA Health (2020), approximately 15% of couples experience difficulties conceiving. Data from Fertility Answers further reveals that infertility cases are distributed as follows: 30% attributed solely to females, 30% to males, another 30% to both partners, and 10% with unknown causes.
Gynecological disorders affect the normal functioning of female reproductive organs, including the uterus, ovaries, fallopian tubes, vagina, vulva, and breasts. Common conditions include cervical dysplasia, pelvic floor prolapse, polycystic ovarian syndrome (PCOS), and uterine fibroids.
The increasing prevalence of these conditions is significantly driving the demand for pregnancy point-of-care testing. For example, the Johns Hopkins Medicine Organization reports that cervical dysplasia affects between 250,000 and one million women in the United States annually, with the highest occurrence in women aged 25 to 35.
This rising burden of gynecological disorders underscores the need for advanced and accessible diagnostic solutions, further fueling market growth.
Market Segments
By Product Type (Pregnancy Test Kits, Fertility Test Kits, and others)
By Test Type (FSH Urine,hCG Blood,hCG Urine, LH Urine, and others)
By Distribution Channel (Gynecology/ Fertility Clinics, Online Sales, Hypermarkets and Supermarkets and others)
By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa)
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Market Regional Share
North America Leads the Global Pregnancy Point-of-Care Testing Market
North America holds the largest share in the global pregnancy point-of-care testing market, driven by rising infertility rates, increasing unplanned pregnancies, and growing awareness of pregnancy detection kits.
According to the Centers for Disease Control and Prevention (CDC), infertility rates in the United States continue to rise. The United Nations reports that the global fertility rate has declined from an average of five children per woman in 1950 to just two in 2020. In the U.S., approximately 11% of women and 9% of men of childbearing age experience infertility. Among heterosexual women aged 15 to 49 who have never given birth, about 19% face infertility, whereas only 6% of married women in this age group struggle with infertility.
The demand for pregnancy test kits and devices has surged in North America, partly due to the increasing incidence of unplanned pregnancies. The National Library of Medicine estimates that the U.S. sees approximately 3 million unwanted pregnancies and 1.5 million induced abortions annually.
Additionally, factors such as rising awareness of pregnancy self-detection methods, increased knowledge of the benefits of home pregnancy test kits, growing teenage pregnancy rates, and strong government support for pregnancy testing solutions further contribute to market expansion in North America.
Market Key Players
Key players are Abbott Laboratories, EKF Diagnostics Holdings plc, BioMérieux SA, Mylab, Atlas Medical, Quidel Corporation, BIOSYNEX SA, Prestige Brands Holdings, Swiss Precision Diagnostics (SPD) GmbH, Piramal Enterprises and NG BIOTECH SAS.