What this market covers
Laboratory and home tests that measure the number and quality of sperm in a semen sample. Used to assess male fertility.
Typical segments
- Home sperm test kits
- Laboratory semen analysis
- Computer assisted semen analysis
- Sperm DNA fragmentation tests
Why this market is moving now
- Clinical research is active, with studies recruiting now.
Key figures
Global figures for this market, with the year each one describes. Use Cite to copy a reference to this page.
| Figure | Value | Year | Cite |
|---|---|---|---|
| Makers worldwide hold 7 FDA 510(k) clearances for sperm count test devices. | 7 510(k) clearances | 2026 | |
| 1 of those clearances were issued from 2021 to 2025. | 1 510(k) clearances | 2025 | |
| Bioshaf holds 1 FDA 510(k) clearances for sperm count test devices. | 1 510(k) clearances | 2026 | |
| Bonraybio Co. holds 1 FDA 510(k) clearances for sperm count test devices. | 1 510(k) clearances | 2026 | |
| Dyn-Bioshaf (2006) holds 1 FDA 510(k) clearances for sperm count test devices. | 1 510(k) clearances | 2026 | |
| Fertility Solutions holds 1 FDA 510(k) clearances for sperm count test devices. | 1 510(k) clearances | 2026 | |
| Humagen Fertility Diagnostics holds 1 FDA 510(k) clearances for sperm count test devices. | 1 510(k) clearances | 2026 | |
| Medical Electronic Systems holds 1 FDA 510(k) clearances for sperm count test devices. | 1 510(k) clearances | 2026 | |
| 480 clinical studies of male infertility are registered worldwide. | 480 registered studies | 2026 | |
| 65 of the registered studies of male infertility are sponsored by companies. | 65 industry-sponsored studies | 2026 | |
| 31 registered studies of male infertility are phase 3 trials. | 31 phase 3 studies | 2026 | |
| 27 studies of male infertility started worldwide in 2025. | 27 studies started in 2025 | 2025 | |
| 56 of those studies were recruiting participants in November 2026. | 56 recruiting studies | 2026 |
Calculated figures (shares, changes and prices per kilogram) are plain arithmetic on the reported values. Read how we work.
Buyers and suppliers
Who buys
- Fertility clinics
- Diagnostic laboratories
- Consumers
Companies to watch
Bioshaf
1 FDA 510(k) clearances for sperm count test devices.
Bonraybio Co.
1 FDA 510(k) clearances for sperm count test devices.
Dyn-Bioshaf (2006)
1 FDA 510(k) clearances for sperm count test devices.
Fertility Solutions
1 FDA 510(k) clearances for sperm count test devices.
Humagen Fertility Diagnostics
1 FDA 510(k) clearances for sperm count test devices.
Medical Electronic Systems
1 FDA 510(k) clearances for sperm count test devices.
What the full report covers
- 01Executive summary
The answer in one page: size, direction and what moves it - 02Market definition and scope
What is in and out of the global market - 03Global market size, 2021 to 2025
Historical series and growth rates - 04Countries and regions
Demand, supply and trade by country and region - 05Outlook to 2031
Base, low and high scenarios with stated assumptions - 06Rules, policy and deadlines
Regulation and programmes that change demand - 07Drivers and barriers
What accelerates or slows adoption, by customer segment - 08Prices, costs and margins
Unit economics where public data allows - 09Competitive landscape
8 to 12 company profiles with recent moves - 10Opportunities and risks
For new entrants, suppliers and investors - 11Method and assumptions
How every figure was built
Included with the full report
- PDF report, 40 to 60 pages
- Excel data pack
- Ready-to-use charts
- Method note and assumptions
- Written to order in 5 working days
Frequently asked questions
How many sperm count test devices are cleared by the FDA?
Makers worldwide hold 7 FDA 510(k) clearances for sperm count test devices.
How many clinical trials study male infertility?
480 studies are registered worldwide.
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