Infertility is defined as the failure to attain a clinical pregnancy after a minimum duration of one year of regular and timely attempts, which was later known to include physiological or psychological conditions that were inconsistent with the natural encounter of the gametes. According to a study titled, “Fertility and infertility: Definition and epidemiology,” published in Elsevier B.V., infertility is known to affect around 8–12% of couples worldwide, and this proportion is gradually increasing. Rising awareness about testing, technological advancements in ovulation monitors, and changing lifestyles with increasing trends of unhealthy diets leading to infertility and gynecological disorders in men and women are among the significant factors responsible for the infertility testing market growth.
North America accounted for a major share of the global infertility testing market in 2022 due to the high occurrence of infertility, increasing awareness of infertility testing among men and women, rising age of first pregnancy among women, and easy availability of infertility test kits through e-commerce websites. Changing lifestyles with increasing trends of unhealthy diets leading to infertility and gynecological disorders in men and women also drive the market growth. Growing demand for self-testing and remote monitoring testing among women and innovation of new products are expected to create profitable market opportunities in North America during the forecast period.
Asia Pacific is expected to register the highest CAGR in the global infertility testing market during 2022–2030. The market growth in the region is attributed to an increase in the number of women affected by lifestyle disorders, rise in funding/investments in the development of infertility testing products, and upsurge in focus by international and domestic players on the Asia Pacific infertility test market. Furthermore, increasing demand for advanced and innovative technologies, rising healthcare expenditure, and the implementation of mitigation measures are positively impacting the regional market.
In terms of test kits, the infertility testing market is segmented into human follicular stimulating hormone (FSH) test kits, human chorionic gonadotropin (HCG) hormone test kits, luteinizing hormone (LH) test kits, and others. The human follicular stimulating hormone (FSH) test kits segment held the largest market share in 2022 and is anticipated to record the highest CAGR of 9.2% during the forecast period. The follicular stimulating hormone (FSH) test kit helps in measuring the concentration of FSH hormone present in the blood. The test is often used to assess FSH levels in men and women for various reasons such as fertility problems, menopause, or problems with sexual development. FSH helps control menstrual cycle of a woman and the growth of follicles that contain eggs in the ovaries. In men, FSH regulates the production and transport of sperm. The test is used to determine the sperm count. Therefore, an FSH test kit is an important diagnostic tool for assessing reproductive problems and other conditions related to hormonal imbalances. In addition, advanced biosimilar FSH products, regulatory approvals, market access, technological advances in FSH kit production, and a growing need for effective contraceptive options are predicted to accelerate the global market growth.
Lack of Awareness and Limitations Associated with Infertility Testing Kits to Restrain Infertility Testing Market Growth
There are several at-home test kits available for evaluating anti-Müllerian hormone, follicle-stimulating hormone, estradiol, luteinizing hormone, and thyroid-stimulating hormone. However, test results from home options do not provide interpretation. In addition, they lack the seriousness and integrity of the laboratory. Many people need to be made aware of the different infertility testing options and the benefits of such tests. Ovulation prediction kits calculate the luteinizing hormone (LH) increase that occurs 24–36 hours before ovulation. Ovulation monitors can only detect LH and cannot identify other important ovulation markers, such as whether cervical mucus is fertile. This lack of awareness has resulted in relatively low demand for infertility testing services.
Anti-Müllerian hormone (AMH) may not be a good indicator of fertility due to a lack of standards for the test. While AMH is the favored method for determining ovarian reserve (the number of eggs someone has), there are no international standards for the test. The comparison of the tests is difficult due to lack of standards. Further, many insurance companies do not cover the cost of infertility testing for people under 35 unless they have been trying to conceive for a full year. For couples aged 35 and above, testing is usually covered after having unprotected and timely sex for six months. Therefore, such factors are limit the infertility testing market growth.
Infertility Testing Market: Type Overview
Based on type, the infertility testing market is bifurcated into male infertility testing and female infertility testing. The female infertility testing segment held a larger market share in 2022. The male infertility testing segment is anticipated to register a higher CAGR of 9.2% during the forecast period. Declining female fertility rates, increasing prevalence of gynecological problems in women, busier lifestyles of working women leading to less stress, and low ovarian counts are among the main factors responsible for the high market share. Additionally, the availability of many female infertility tests contributes to the market growth for the segment.
Infertility Testing Market: Competitive Landscape and Key Developments
Merck KgaA; Procter & Gamble; bioMerieux SA; Alere Inc.; Babystart Ltd.; bioZhena Corporation; Quidel Corporation; CENTOGENE N.V.; SCSA Diagnostics, Inc.; and Boditech Med Inc. are among the key companies operating in the infertility testing market. Leading players are implementing strategies such as expansions, new product launches, and acquisitions (companies or new clientele) to tap prevailing business opportunities. As per the press releases by leading players operating in the market, a few strategic developments are listed below:
- In August 2023, Trajan Scientific and Medical supplied CE-IVD registered Mitra devices to Fertilly, a German start-up that launched Europe’s first at-home fertility testing kits using dried blood micro samples with VAMS technology.
- In February 2021, Fertility Focus partnered with ExSeed Health (which deals in at-home sperm testing) to provide solutions for those planning pregnancy.
- In June 2020, Modern Fertility launched ovulation and pregnancy test kits and a mobile application to centralize fertility-related data.
- In March 2020, Proov received FDA approval for its home ovulation test kit.