Fertility Testing Devices Market - Global Industry Size, Share, Trends, Opportunity and Forecast, Segmented By Product Type (Ovulation Prediction Kits, Fertility Monitors (Urine-based Ovulation Test, Saliva-based Ovulation Test), Male Fertility Testing Products)), By Application (Female Fertility Testing, Male Fertility Testing), By End User (Hospitals, Fertility Clinics, Home Care Settings), By Region, and Competition, 2020-2030F

Market Overview

The Global Fertility Testing Devices Market, valued at USD 690.46 Million in 2024, is projected to experience a CAGR of 7.77% to reach USD 1069.81 Million by 2030. Fertility testing devices are diagnostic instruments utilized by individuals and healthcare professionals to assess reproductive health, identifying optimal conception windows or underlying fertility concerns. Market expansion is driven by the increasing global prevalence of infertility and a societal trend towards delayed pregnancies, which necessitates reproductive health monitoring. Heightened awareness of fertility issues and continuous advancements in diagnostic technologies further propel demand.

According to the World Health Organization's 2023 report, approximately 17.5% of the adult population globally experiences infertility, demonstrating significant demand for diagnostic solutions. The Society for Assisted Reproductive Technology also reported that US IVF cycles rose from 389,993 in 2022 to 432,641 in 2023, indicating increased engagement with treatments reliant on these tools. A notable challenge impeding market growth remains the substantial cost of advanced fertility testing devices and associated procedures, limiting accessibility.

Key Market Drivers

Two primary factors significantly influencing the Global Fertility Testing Devices Market are the rising global infertility rates and the increasing average age of first-time pregnancy. The growing prevalence of infertility worldwide directly drives demand for diagnostic solutions as individuals and couples seek to understand and address their reproductive challenges. This widespread issue necessitates accurate and accessible testing to identify underlying causes and facilitate timely intervention. According to SingleCare, January 2025, 'Infertility statistics 2025: How many couples are affected by infertility? ', approximately 1 in 6 people globally have experienced infertility at some point in their lives. This substantial demographic indicates a consistent and expanding user base for various fertility testing devices, from ovulation prediction kits to more advanced diagnostic tools.

Concurrently, the trend of increasing average age of first-time pregnancy profoundly impacts the market by extending the period during which individuals may experience fertility difficulties. As career pursuits and societal shifts lead many to delay parenthood, the likelihood of encountering age- related fertility decline rises, prompting greater reliance on testing to optimize conception chances. According to Statistics Netherlands and Eurostat, May 2024, 'Women in the EU having first child ever later in life', the average age for women having their first child in the European Union rose from 28.8 years in 2013 to 29.7 years by 2022. This demographic shift creates a prolonged demand for fertility monitoring and assessment. Furthermore, the reproductive health sector continues to attract considerable investment, as evidenced by biotechnology company Gameto completing a $44 million Series C financing round, according to FirstWord Pharma, August 12, 2025, 'Gameto's $44M Series C to Help Redefine Reproductive Care, as First Patients Recruited for Pivotal Stem Cell Phase 3 Trial'. This funding underscores the ongoing innovation and confidence in the broader fertility market, including its diagnostic components.

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Key Market Challenges

The substantial cost of advanced fertility testing devices and associated procedures significantly impedes the growth of the Global Fertility Testing Devices Market by restricting access for a considerable segment of the population. When the financial burden of initial diagnostics and subsequent treatments is high, many individuals and couples are deterred from seeking necessary reproductive healthcare. This issue is particularly pronounced in regions lacking comprehensive insurance coverage or robust public funding for fertility services.

For instance, according to the American Society for Reproductive Medicine in 2023, the average cost for a single in vitro fertilization cycle in the United States was reported at $12,400, a figure that often excludes crucial medications and additional tests. This considerable expense limits patient engagement with the entire fertility treatment pathway, thereby diminishing the demand for diagnostic instruments that are integral to these procedures. The inability to afford these critical initial steps ultimately translates into a smaller user base and slower market expansion for manufacturers of fertility testing devices globally.

Key Market Trends

Advancements in at-home fertility testing technologies are significantly reshaping the market by offering individuals convenient and private diagnostic options outside traditional clinical settings. The increasing availability of user-friendly kits for hormone level assessment, ovulation prediction, and male fertility screening empowers consumers with greater control over their reproductive health journey. This trend reduces barriers to initial fertility assessment, encouraging proactive engagement with reproductive health monitoring, especially for those who value discretion. Clearblue, for example, launched a next-generation digital ovulation test kit in March 2024, which integrated mobile application support for enhanced cycle tracking and result interpretation, demonstrating the continuous innovation in this segment and directly influencing consumer adoption. This expansion provides early insights for couples, potentially streamlining the path to conception or prompting earlier consultation with specialists.

The emergence of AI-powered fertility assessment tools marks a pivotal development in the market, enhancing the precision and personalization of reproductive diagnostics. These tools leverage machine learning algorithms to analyze vast datasets, from embryo characteristics to patient histories, enabling more informed decision-making in fertility treatments. According to a comparative analysis of global surveys published in *Journal of IVF-Worldwide* in July 2025, AI usage among IVF specialists and embryologists increased from 24.8% in 2022 to 53.22% by 2025 for regular or occasional use, with embryo selection consistently identified as a primary application. For instance, AIVF introduced its AI-driven solutions to the Australian market in July 2024, aiming to improve success rates and optimize outcomes by analyzing tens of thousands of embryos to identify the most viable for transfer. This integration of AI supports clinicians in developing tailored treatment plans, thereby improving efficacy and patient outcomes.

Segmental Insights

The Ovulation Prediction Kits (OPKs) segment is experiencing rapid growth within the Global Fertility Testing Devices Market, emerging as a leading contributor to market expansion. This swift growth is primarily driven by increasing consumer awareness regarding reproductive health and family planning, alongside the rising prevalence of fertility challenges and hormonal disorders such as Polycystic Ovary Syndrome (PCOS) among women. Furthermore, a notable societal trend towards delayed pregnancies necessitates more reliable and convenient at-home fertility monitoring solutions. Technological advancements have also significantly contributed, offering user-friendly and accurate digital kits, often with smartphone integration, which enhances accessibility and consumer engagement for proactive fertility management.

Regional Insights

North America leads the global fertility testing devices market due to several interconnected factors. A significant prevalence of infertility and related conditions, such as Polycystic Ovary Syndrome, contributes substantially to the demand for testing solutions in the region. Consumers exhibit high awareness regarding reproductive health and increasingly delay childbearing, prompting greater adoption of fertility monitoring. Furthermore, North America benefits from robust healthcare infrastructure and the readily available adoption of technologically advanced testing products. The regulatory framework, including oversight by bodies such as the U. S. Food and Drug Administration, ensures product quality and safety, fostering market confidence and growth.

Recent Developments

• In May 2025, ARC Fertility was honored with the 2025 MedTech Breakthrough Award for "Best Reproductive Health Technology Solution." This recognition acknowledged ARC's innovative approach, which integrates digital tools, evidence-based treatments, and national clinical access to improve fertility outcomes. A key component cited was its FertilityNow app, providing education, emotional support, and personalized navigation for individuals undergoing family-forming journeys, thereby contributing to advancements in the global fertility technology landscape.

• In February 2025, Sasmar, Inc., the company behind the Conceive Plus fertility brand, announced a strategic partnership with iHerb, an international online health and wellness retailer. This collaboration aimed to significantly enhance the global accessibility of Conceive Plus fertility products, including supplements and sperm-friendly lubricants. The partnership leverages iHerb's extensive distribution network, reaching consumers in over 185 countries, especially in regions where local retail availability for these fertility aids was previously limited.

• In January 2025, Hera Women's Health highlighted advancements in Preimplantation Genetic Testing (PGT) technology, which significantly enhance the accuracy and comprehensiveness of identifying chromosomal abnormalities in embryos. These improvements allow for more informed embryo selection decisions, reducing the risk of miscarriage and genetic disorders. This breakthrough research in genetic profiling contributes to personalized medicine approaches within fertility treatments, aiming to provide tailored care plans based on an individual's unique genetic makeup and optimizing the environment for early embryo development.

• In October 2024, Oura, a smart ring technology company, introduced a new "Fertile Window" feature to its Cycle Insights. This enhancement allows users to view their estimated peak fertility, predicted ovulation day, and detected ovulation based on physiological data such as heart rate, temperature trends, and respiratory rate. This product development expands the Oura Ring's functionality within the Global Fertility Testing Devices Market by offering more precise and personalized ovulation predictions, building upon its existing biometric tracking capabilities.

Key Market Players

• Church & Dwight Co., Inc.
• Fairhaven Health LLC
• Geratherm Medical AG
• Abbott Laboratories, Inc.
• Quidel Corporation
• Procter & Gamble
• Swiss Precision Diagnostics GmbH
• Clearblue
• HiLin Life Products Inc.
• Fertility Focus Limited.

Report Scope:

In this report, the Global Fertility Testing Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Fertility Testing Devices Market, By Product Type:

o   Ovulation Prediction Kits

o   Fertility Monitors

o   Male Fertility Testing Product

• Fertility Testing Devices Market, By Application:

o   Female Fertility Testing

o   Male Fertility Testing

• Fertility Testing Devices Market, By End User:

o   Hospitals

o   Fertility Clinics

o   Home Care Settings

• Fertility Testing Devices Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Fertility Testing Devices Market.

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Company Information

• Detailed analysis and profiling of additional market players (up to five).

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