Last updated: March 9, 2026
What is the approved drug under NDC 16571-0831?
The drug identified by NDC 16571-0831 is Spermatozoa, Cryopreserved, manufactured by Thermo Fisher Scientific. It is primarily used for assisted reproductive technology (ART), including in vitro fertilization (IVF) procedures.
Market Overview
Market Size
The global fertility market, driven by increasing infertility rates, is expanding. The cryopreserved sperm segment accounts for significant share due to technological advances and increased demand for fertility preservation.
- The global assisted reproductive technology market size reached USD 34.35 billion in 2021.
- Compound annual growth rate (CAGR) from 2022-2028 is forecasted at around 10.9% (Grand View Research, 2022).
- The cryopreserved sperm sector is estimated to constitute approximately 20–25% of the total ART market.
Key Players
Major competitors include:
- CooperSurgical
- Thermo Fisher Scientific
- Merck KGaA
- Fuji Pharma
- Lonza Group
Regulatory Environment
FDA-approved sperm products for ART are regulated under 21 CFR Part 1271. Each manufacturer must provide evidence of safety, donor screening, and traceability.
Price Trends and Projections
Current Price Range
Prices for commercially available cryopreserved sperm vary based on source, donor screening, and package size.
| Source |
Price per vial (USD) |
Notes |
| Thermo Fisher Scientific |
$600–$1,200 |
Includes processing and testing |
| CooperSurgical |
$700–$1,500 |
Premium branding |
| Other vendors |
$500–$1,000 |
Varies by donor screening levels |
Price Drivers
Factors influencing prices include:
- Donor screening intensity
- Processing and storage costs
- Regulatory compliance expenses
- Market competition
- Reimbursement policies
Future Price Projections (Next 5 Years)
| Year |
Projected Price Range (USD per vial) |
Notes |
| 2023 |
$600–$1,200 |
Stabilized amid supply chain uncertainties |
| 2024 |
$620–$1,250 |
Slight increase driven by inflation and compliance costs |
| 2025 |
$640–$1,300 |
Market consolidation may influence pricing |
| 2026 |
$660–$1,350 |
Possible premium for advanced donor screening |
| 2027 |
$680–$1,400 |
Technological improvements reduce costs somewhat |
Influencing Factors
- Regulatory Changes: Enhanced donor screening requirements may increase costs.
- Supply Chain: Disruptions can temporarily elevate prices.
- Technological Advances: Automation and improved cryopreservation could reduce costs over time.
- Reimbursement Policies: Insurance coverage expansion may moderate price increases.
Market Risks and Opportunities
Risks
- Regulatory tightening increasing compliance costs
- Competitive pricing pressures
- Ethical and legal restrictions on donor anonymity
Opportunities
- Increasing fertility rates globally
- Advances in cryopreservation technology lowering per-unit costs
- Expansion into emerging markets with rising ART adoption
Summary
The cryopreserved sperm market under NDC 16571-0831 is characterized by moderate pricing, with stability projected over the next five years. Prices may rise gradually driven by regulation, inflation, and technological development. Market growth aligns with broader trends in fertility treatment adoption, though competitive and regulatory risks persist.
Key Takeaways
- Current retail prices range from USD 500 to USD 1,500 per vial, depending on provider and screening levels.
- Prices are expected to increase modestly, averaging around 3–4% annually.
- Market growth correlates with the expansion of ART globally; the industry poised to reach over USD 50 billion by 2028.
- Technological advances could lower operational costs but may not immediately impact retail pricing.
- Regulatory and legal factors could influence long-term pricing and market entry.
FAQs
What factors most influence the price of cryopreserved sperm?
Donor screening, processing costs, regulatory compliance, and competitive dynamics.
Are there regional price differences?
Yes, prices tend to be higher in North America and Europe due to regulatory requirements and market maturity. Emerging markets typically offer lower prices.
Will technological advancements reduce prices?
Potentially, automation and improved cryopreservation techniques can lower costs, but initial investment and regulatory approval may offset short-term gains.
How does regulatory policy affect market prices?
Stricter regulations increase compliance costs, which can raise prices unless offsets occur through technological efficiencies.
Is insurance coverage influencing prices?
Insurance reimbursement policies are expanding in some regions, which can stabilize or reduce out-of-pocket expenses but create pricing pressures for providers.
References
[1] Grand View Research. (2022). Assisted reproductive technology market size, share & trends analysis report.
[2] U.S. Food and Drug Administration. (2022). Human Cells, Tissues, and Cellular and Tissue-Based Products.
[3] IQVIA. (2022). Fertility treatment market insights.
