Last updated: February 15, 2026
Overview
NDC 42571-0132 refers to Lutropin alfa, a recombinant human luteinizing hormone (LH). It primarily treats fertility issues caused by LH deficiency, often used alongside follitropin alfa for controlled ovarian hyperstimulation or in specific hypogonadotropic hypogonadism cases. Lutropin alfa is marketed under brand names such as Luveris.
Market Landscape
- Indications: Primarily fertility treatments for women undergoing controlled ovarian stimulation; approved for LH supplementation in hypogonadotropic hypogonadism.
- Market Size: The global fertility drugs market was valued at approximately $5.3 billion in 2022 and projected to grow to $9.8 billion by 2030, with LH-related treatments representing a niche but stable segment.
- Key Competitors:
- Follitropin alfa (Gonal-F, Follistim)
- Menotropins (Humegon, Repronex)
- Human chorionic gonadotropin (hCG) formulations
- Patents and Exclusivity: Liabilities such as patent expirations can influence market entry timing for biosimilars. Luveris’s primary patents expired in 2022, opening competition from biosimilars.
Market Drivers
- Increasing infertility rates globally, driven by lifestyle factors, delayed childbearing, and rising awareness.
- Expansion into emerging markets with growing healthcare infrastructure.
- New indications or combination therapies could expand market share.
- Reimbursement policies favoring advanced fertility treatments.
Market Constraints
- High treatment costs, including multiple cycles, restrict patient accessibility.
- Strict regulatory pathways for biosimilar approval impact market entry speed.
- Limited awareness in some regions about LH supplementation benefits.
Price Trends and Projections
Current Pricing
- Brand (Luveris): Estimated at $7,500–$10,000 per vial (typically 75–150 International Units (IU) per vial).
- Biosimilars: Entering markets post-patent expiry, expected to undercut brand prices by 20–40%. Initial biosimilar prices may start at $5,000–$8,000 per vial.
Price Drivers
- Biosimilar competition will exert downward pressure.
- Larger markets and economies of scale may further reduce costs.
- Reimbursement policies and insurance coverage significantly impact net pricing.
- Manufacturing costs are relatively stable, but biosimilars' entry could prompt aggressive pricing strategies.
Future Price Projections (2023–2030)
| Year |
Estimated Brand Price (per vial) |
Estimated Biosimilar Price (per vial) |
Notes |
| 2023 |
$8,000 |
$5,500–$6,500 |
Biosimilars entering the market, initial discounting. |
| 2025 |
$7,500–$8,000 |
$4,500–$6,000 |
Market stabilization; biosimilar competition intensifies. |
| 2028 |
$7,000–$7,500 |
$3,800–$5,000 |
Continued price erosion, more biosimilars. |
| 2030 |
$6,500–$7,000 |
$3,200–$4,500 |
Market maturity, prices stabilize at reduced levels. |
Regional Variations
- North America: High reimbursement rates support higher pricing, but biosimilars are gaining traction.
- Europe: Multiple biosimilars approved, leading to more aggressive price reductions.
- Asia-Pacific: Growing markets with price sensitivity; biosimilar uptake driven by cost containment policies.
Key Takeaways
- The market for LH-based fertility treatment drugs is driven by increasing infertility cases, with existing treatments dominated by biologics like Lutropin alfa.
- Patent expirations have opened the market for biosimilars, pressuring prices downward across regions.
- Current estimated prices for brand Lutropin alfa range from $7,500 to $10,000 per vial, with biosimilars expected to enter at significantly lower prices.
- Price erosion is projected to continue through 2030, with biosimilars reducing the market price by 40% or more in mature markets.
- Market growth is contingent on regulatory approval, reimbursement policies, and healthcare infrastructure expansion.
FAQs
Q1: When did Lutropin alfa (Luveris) patents expire?
A1: Primary patents expired in 2022, paving the way for biosimilar competition.
Q2: What are the main factors influencing pricing of LH therapies?
A2: Patent status, biosimilar competition, manufacturing costs, reimbursement policies, and regional market dynamics.
Q3: How do biosimilars impact the market share of branded Luveris?
A3: Biosimilars typically capture a significant share within 1–3 years of approval, exerting downward pressure on prices.
Q4: Are there emerging indications for LH therapies beyond fertility?
A4: Currently, LH therapy use remains focused on fertility and hypogonadotropic hypogonadism; exploration for other endocrine disorders is limited.
Q5: Which regions are most active in biosimilar uptake for LH treatments?
A5: Europe and Asia-Pacific lead in biosimilar approvals and market penetration, driven by cost containment initiatives.
References
[1] Market data: Grand View Research. "Fertility Drugs Market Size, Share & Trends Analysis," 2023.
[2] Patent and regulation info: U.S. FDA, 2022; EMA approvals, 2022–2023.
[3] Pricing estimates: IQVIA, 2023.
[4] Biosimilar market analysis: EvaluatePharma, 2023.
