Rapid pregnancy and fertility tests are point-of-care tests used in both men and women to detect the presence of reproductive hormones such as FSH, LH, and hCG in urine or blood samples. At-home fertility monitors are digital devices that predict ovulation based on electrolytes in the saliva, LH levels in the urine, or a woman's basal body temperature. At-home fertility monitors can record data over multiple menstrual cycles, allowing women to better predict ovulation and plan for pregnancy. Although at-home fertility tests can assist couples in planning for pregnancy, they are not a substitute for fertility testing prescribed by a doctor. Fertility testing by a doctor may yield more accurate results.

Recent Developments:

According to the IEEE report, there are currently 45 million couples worldwide dealing with infertility, with male infertility accounting for more than 40% of those cases. To assist such couples, Harvard medical researchers have developed a smart phone attachment that could allow men to perform simple and inexpensive home fertility tests. The new device, which looks like a bulky smart phone charging case or cradle, has a slot for a disposable microchip slide containing the sperm sample. This allows men to quickly load a sample and receive results from a custom smart phone app in less than five seconds. The low cost and ease of use could be game changers for many couples who would otherwise have to rely on expensive and time-consuming lab tests to get the most accurate fertility test results, an option that is often out of reach for many low-income families in both developed and developing countries. Testing 350 patient sperm samples, both fresh and cryopreserved, showed that the new smart phone device can detect abnormal sperm samples with nearly 98% accuracy.

COVID-19 impact on fertility testing kit market

Prior to the COVID-19 pandemic, most fertility care required in-person consultations, blood work, follow-up visits, exams, and procedures. During the COVID-19 pandemic, the need for at-home serologic testing and telehealth visits became apparent as our fertility clinics and phlebotomy labs were forced to close by government mandate. And apart from pandemic-related changes in care delivery, at-home serologic testing could be incorporated into standard fertility care. Patients must have a pelvic ultrasound and uterine cavity evaluation before receiving “in-cycle” treatments. These two procedures necessitate an in-person visit, but they are rarely scheduled on the same day or early in the day as fasting blood work. The prevalence of at-home fertility testing during the government-mandated clinical closure for the SARS-CoV-2 pandemic demonstrates the potential patient interest and utility of at-home testing. Despite an out-of-pocket cost of US$159.8 in a region where insurance mandated fertility coverage, 41% of patients offered at-home testing chose to use it. The ease of completing a test at home, particularly one timed to coincide with the start of a menstrual cycle, allows a patient to complete the test from wherever the patient is located, without a last-minute appointment or commute.

Market Driver

Awareness of fertility testing kit/devices upsurge the market growth worldwide

The introduction of new technologies and the democratization of fertility testing may upend the traditional approach to couples' fertility testing. With the ease of access to home screening for abnormal bulk sperm parameters, for example, the male partner may now seek formal evaluation by a reproductive specialist before the female partner. Traditional attitudes toward male factor infertility are already changing as a result of the use of high-quality home sperm testing, even if the results are only semi-quantitative, the infertile couples are beginning to initiate their own evaluations. Because of its ease of use, home sperm testing has the potential to improve public understanding of male factor infertility. Lensless on-chip microscopy, paper-based diagnosis, digital holography, and micro fluidic channels are some of the new approaches to home sperm testing that are attempting to overcome the limitations of current technology. Improved systems that automatically measure multiple parameters and possibly analyze sperm morphology and distinguish normal and abnormal spermatozoa are some potential advancement. With the ability to accurately, automatically, and quantitatively evaluate all parameters tested in traditional analysis, including morphology, but without the major drawbacks of high cost, long wait times, a lack of skilled technicians, and inconvenience, these systems have the potential to become a common alternative to, or even replacement for, current conventional sperm analysis methods.

Market Opportunity

Most pregnancy coverage policies and health insurance do not cover devices for pregnancy and fertility rapid tests. The cost of pregnancy and fertility rapid test devices is relatively high in the United States and Europe. As a result, effective reimbursement policies and cost reductions are expected to provide lucrative growth opportunities for market participants. Direct-to-consumer (DTC) medical tests may be a cost-effective option for low-income countries. As a result, market participants can concentrate on introducing DTC medical tests.

Market Segmentation

The global fertility testing kit market is segmented based on type, product, and distribution channel. By type, the market is segmented based on LH urine test, FSH urine test, hCG blood test, and hCG urine test. By product, the market is bifurcated into digital device and line indicator devices. Based on distribution channel, the market is segmented as pharmacies, drugstores, gynecology & fertility clinics, online sales, and hypermarkets & supermarkets.

Regional Overview

North America dominates the fertility testing kit market Asia Pacific records fastest growing CAGR till the forecast period

North America remains the most profitable market for fertility testing kits. The market for fertility and pregnancy rapid test kits in the United States has consistently shown year-on-year growth, and the market is expected to grow at a rate of more than 3.9% in 2020. This increase is expected as a result of the Covid-19 effect (people's abstinence from visiting hospitals due to social distancing) and an increase in first-time pregnancies.

Asia Pacific, on the other hand, is expected to have the fastest growing CAGR during the forecast period. Competitive pricing of pregnancy test kits, increasing preference for at-home monitoring of ovulation periods, and a consistently growing female population in the maternal age group are the major factors driving the Asia Pacific market's rapid growth.

Competitive Landscape

The prominent players involved in the global fertility testing kit market are Quidel Corporation, Alere Inc., Prestige Consumer Healthcare Inc., Church & Dwight Co., Inc., bioMérieux SA, Geratherm Medical AG, The Procter & Gamble Company, among others.

Market Segmentation

Market By Type

LH Urine Test
FSH Urine Test
hCG Blood Test
hCG Urine Test

Market By Product

Digital Device
Line-Indicator Devices

Market By Distribution Channel

Pharmacies
Drugstores
Gynecology & Fertility Clinics
Online Sales
Hypermarkets & Supermarkets

Market By Geography

North America
•    U.S.
•    Canada

Europe
•    U.K.
•    Germany
•    France
•    Spain
•    Rest of Europe

Asia-Pacific
•    China
•    Japan
•    India
•    Australia
•    South Korea
•    Rest of Asia-Pacific

Latin America
•    Brazil 
•    Mexico
•    Rest of Latin America

Middle East & Africa
•    GCC
•    South Africa
•    Rest of Middle East & Africa