Infertility Testing Market

The infertility testing market is anticipated to expand from US$ 500.29 million in 2024 to US$ 890.96 million by 2031, with an estimated CAGR of 8.6% during the period of 2025-2031.

Market Insights and Analyst View:

The growth of the market is driven by the rising incidence of infertility among both men and women, along with advancements in infertility testing technologies. However, the market's expansion is hindered by a lack of awareness and the limitations of infertility testing kits.

Infertility, in the context of reproductive health, refers to a condition that does not impair physical functioning or pose a life-threatening risk, yet it can impact personal development and lead to frustration for individuals (both men and women). Approximately 50 to 80 million couples face infertility challenges at least once during their reproductive years. The prevalence of infertility varies between developing and developed nations. The World Health Organization (WHO) reports that one in six couples experiences infertility issues. Growing awareness of testing, coupled with lifestyle changes and unhealthy dietary trends contributing to infertility and gynecological disorders, is driving the expansion of the infertility testing market. Additionally, advancements in ovulation monitoring technologies are further propelling market growth. Increased tobacco and smoking consumption is expected to raise infertility rates, thereby increasing the demand for infertility testing. Furthermore, heightened awareness of fertility, the rising number of women affected by PCOS, the growing demand for self-testing and remote monitoring among both genders, and the introduction of innovative products are likely to create opportunities for the infertility testing market in the forecast period.

Growth Drivers:

Rising Incidence of Infertility in Men and Women Fuels Market Growth

Male infertility is a widespread issue globally, with varying prevalence across regions. The WHO indicates that approximately 20% of infertile couples have male-related infertility issues, while 30% of couples face infertility challenges due to both partners. Key factors contributing to male infertility include low hormone levels produced by the pituitary gland, deficiencies in semen and its quality, sexual dysfunctions affecting semen entry into the vaginal canal, and the presence of sperm antibodies. Varicocele, an enlarged vein in the testicle, is the most common cause of low sperm count, affecting about 40% of men with infertility issues, according to the US Department of Health and Human Services. The increase in male infertility cases is driving the demand for infertility testing.

Globally, fertility rates are declining due to various factors, including delayed marriages and age-related infertility. The WHO estimated that in 2020, there were around 128.5 million new chlamydia infections among adults aged 15-49 worldwide, with a prevalence of 4.0% in women and 2.5% in men. The Centers for Disease Control and Prevention (CDC) reports that about 10% of women (6.1 million) aged 15 to 44 in the US experience difficulties in conceiving or maintaining pregnancy. Consequently, the declining fertility rates are driving the demand for infertility testing to identify the causes of infertility in both men and women, thus propelling market growth.

Strategic Insights

Report Segmentation and Scope:

The infertility testing market analysis has been conducted by examining the following segments: type, test kits, sample, and end user.

Segmental Analysis:

The infertility testing market is divided into male infertility testing and female infertility testing segments. The female infertility testing segment held a larger market share in 2022, while the male infertility testing segment is expected to achieve a higher CAGR of 9.2% during the forecast period. Factors such as increased stress, obesity, smoking, and alcohol consumption contribute to male infertility. Additionally, rising awareness about infertility, increased R&D spending, initiatives by key players to launch new products, and changing lifestyles are driving growth in the male infertility testing segment.

In terms of test kits, the infertility testing market is categorized 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 projected to record the highest CAGR of 9.2% during the forecast period. FSH test kits measure the concentration of FSH hormone in the blood, which is crucial for assessing fertility issues, menopause, and sexual development problems. FSH regulates the menstrual cycle in women and sperm production in men, making it an essential diagnostic tool for reproductive health. Furthermore, advancements in biosimilar FSH products, regulatory approvals, and technological innovations in FSH kit production are expected to drive global market growth.

By sample type, the infertility testing market is segmented into blood, urine, and others. The blood segment held the largest market share in 2022 and is anticipated to achieve the highest CAGR of 9.1% during the forecast period. Infertility tests typically involve blood tests to measure key hormones, with different tests required for men and women based on their specific situations. In January 2021, health startup Yesmom launched Asia's first at-home female fertility blood test kits, enabling women to prioritize their reproductive health conveniently.

By end user, the infertility testing market is divided into hospitals & clinics, fertility centers, and homecare. The homecare segment held the largest market share in 2022 and is expected to register the highest CAGR of 9.0% during the forecast period. This growth is attributed to patients' preference for self-monitoring health conditions, easy access to fertility testing kits via e-commerce platforms, the availability of user-friendly devices, and a growing desire for confidentiality regarding test results.

Adoption of Assisted Reproductive Technologies (ART) and In Vitro Fertilization (IVF) to Boost Infertility Testing Market

Increasing awareness of infertility is likely to drive demand for IVF and ART treatments in the coming years. The introduction of advanced intra-cytoplasmic sperm injection techniques and rising awareness of medicinal and surgical IVF procedures are expected to propel the infertility testing market during the forecast period. According to UCSF Health, approximately 10% of infertility cases are attributed to unknown causes, while 30% are due to issues in male and female partners.

Common procedures for men include intracytoplasmic sperm injection (ICSI), epididymal aspirations, vasal aspiration, testicular sperm extraction, and mapping of failing testes. About 75% of men with male factor infertility have identifiable or treatable conditions. Moreover, nearly all men with male factor infertility can be treated with ARTs. Therefore, the increasing adoption of ART and IVF is likely to introduce new trends in the infertility testing market in the coming years.

Regional Analysis:

The infertility testing market report encompasses North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa.

In 2022, North America accounted for the largest share of the infertility testing market. The growth in this region is driven by the high prevalence of infertility, increased awareness of infertility testing among both genders, the rising age of first pregnancies among women, and the easy availability of infertility test kits through e-commerce platforms. Additionally, the rising rates of smoking and tobacco use are expected to contribute to increased infertility cases, further propelling market growth. Growing awareness of testing and the increasing female population affected by PCOS are also accelerating market expansion.

Europe is projected to hold the third-largest share of the global infertility testing market. The growth in the European market is fueled by heightened awareness of infertility issues, a growing diabetic population, and the presence of numerous market players along with government initiatives related to fertility. According to the European Society of Human Reproduction and Embryology, infertility was estimated to affect over 25 million people in Europe in 2021. In Europe, one child per primary school class is born through assisted reproductive technologies (ART), and in Nordic countries, between 2% and 7% of births result from ART. Spain is a preferred destination for infertility treatment due to its progressive legal framework, high number of infertility professionals, excellent facilities, and advanced medical technologies. Fertility Europe (FE) is the umbrella organization for European associations involved in infertility issues across over 20 countries, aiming to improve the rights of those affected by infertility, foster a strong cross-border network among European patients, promote social awareness about infertility, and enhance education in reproductive health protection.

The Asia Pacific infertility testing market is expected to experience the fastest growth rate of 9.1% during the forecast period. This regional growth is attributed to the increasing number of women affected by lifestyle-related disorders, rising investments in the development of infertility testing products, and a heightened focus from both international and domestic players on the Asia Pacific infertility testing market.

Infertility Testing Market Report Scope

Industry Developments and Future Opportunities:

The infertility testing market forecast can assist stakeholders in planning their growth strategies. Below are some strategic developments reported by leading players in the market:

1. In July 2023, 2San, a global leader in self-diagnostic testing, partnered with Proov to launch exclusive, user-friendly at-home fertility tests at select Hy-Vee stores across eight Midwestern states.
2. In January 2022, Kindbody, a prominent fertility and family-building care provider, launched Kind at Home, its consumer products division aimed at supporting individuals throughout their reproductive journey, starting with user-friendly home fertility hormone tests for both women and men.
3. In December 2021, Carrot Fertility introduced a new kit designed to help individuals monitor fertility hormones and related biomarkers at home, providing a comprehensive view of fertility health and enabling proactive interventions from the comfort of home.

Competitive Landscape and Key Companies:

Key companies profiled in the infertility testing market report include Merck KGaA, Procter & Gamble, bioMerieux SA, Alere Inc., Babystart Ltd., bioZhena Corporation, Quidel Corporation, CENTOGENE N.V., SCSA Diagnostics, Inc., and Boditech Med Inc. These companies are focused on developing new technologies, enhancing existing products, and expanding their geographic reach to meet the growing consumer demand worldwide.

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