Last updated: March 8, 2026
What is the drug associated with NDC 31722-0036?
NDC 31722-0036 corresponds to Risdiplam (brand name: Evrysdi), a pharmacological agent developed by Hoffmann-La Roche. It is an oral medication approved for treating spinal muscular atrophy (SMA) in pediatric and adult patients.
What is the current market landscape?
Key factors influencing Risdiplam's market
- Indication scope: Approved for SMA types one, two, and three, expanding its potential patient base.
- Market competition: Main competitors are Biogen's Spinraza (nusinersen) and Novartis' Zolgensma (gene therapy).
- Pricing models: Risdiplam's annual list price was approximately $340,000 as of 2022.
- Regulatory approvals: Approved in multiple regions, including the U.S. (FDA, August 2020), EU, and Japan, broadening access and market potential.
Market size and growth
- Prevalence of SMA: Estimated at 1 in 10,000 live births, with about 10,000 to 15,000 patients in the U.S. eligible for treatment.
- Market penetration: Despite high treatment costs, the oral administration route favorably influences adoption.
- Expected growth rate: CAGR of 15-20% from 2022 to 2027, driven by new approvals and expanding indications.
What are the price projections and revenue estimates?
Current pricing landscape
- List Price: Approximately $340,000 per year (2022 figures).
- Reimbursement dynamics: Commercial insurers and government programs negotiate discounts, reducing net prices by 30-50%.
Projected revenue estimates (2023-2027)
| Year |
Estimated U.S. Revenue |
Key Assumptions |
| 2023 |
$600 million |
Market stabilization, competition from Zolgensma's limited coverage |
| 2024 |
$900 million |
Increased patient access, expansion of indications, pricing adjustments |
| 2025 |
$1.2 billion |
Entry into additional markets, implementation of new clinical guidelines |
| 2026 |
$1.5 billion |
Continued market expansion, potential price increases for new formulations or indications |
| 2027 |
$1.8 billion |
Mature market with sustained demand and minimal price erosion |
Price projection considerations
- Demand elasticity: Sensitive to pricing adjustments, especially in price-sensitive regions.
- Market access: Flexible pricing strategies or rebates could influence net prices.
- Regulatory pressures: Cost-effectiveness assessments may lead to price caps.
- Competing therapies: Entry of biosimilars or alternative treatments could suppress prices.
What are the critical risk factors?
- Regulatory challenges: Potential restrictions in emerging markets.
- Pricing and reimbursement policies: Increased pressure to lower prices could affect revenue.
- Market acceptance: Slow adoption due to entry of competitors or physician hesitancy.
- Manufacturing scalability: Supply chain disruptions may impact availability and pricing.
Key market dynamics summary
| Factor |
Impact |
Source |
| Increased indications |
Expands patient pool |
[1] |
| Competition (Spinraza, Zolgensma) |
Limits market share |
[2] |
| Price sensitivity |
Affects revenue |
[3] |
| Geographic expansion |
Growth potential |
[4] |
Closing assessment
Risdiplam's (NDC 31722-0036) market is poised for steady expansion over the next five years. The high list price and expanding indications drive revenue growth, but market penetration depends on competitive dynamics and payer negotiations. Price projections range from $600 million in 2023 to $1.8 billion in 2027 in the U.S., with global revenues likely increasing proportionally.
Key Takeaways
- Risdiplam faces competition but benefits from oral administration and expanding approvals.
- Estimated U.S. revenues will grow from $600 million in 2023 to ~$1.8 billion in 2027.
- Price sensitivity and market access policies will influence net revenue.
- Global expansion opportunities present upside potential.
- Market risks include regulatory hurdles and new competitor entry.
FAQs
1. How does the pricing of Risdiplam compare to competitors?
Risdiplam's list price is comparable to Spinraza, with similar annual costs in the $340,000 range. Zolgensma uses a one-time gene therapy model with different pricing.
2. What regions could expand sales for Risdiplam?
Europe, Japan, and emerging markets are the primary targets for growth, benefiting from regulatory approvals and access programs.
3. How will competition affect future prices?
Entry of biosimilars, improved efficacy of competitors, or new treatment paradigms could pressure prices upward or downward.
4. Are there any anticipated label expansions?
Yes, ongoing trials for additional SMA types and age groups could broaden the market.
5. What are the main barriers to higher revenue?
Pricing negotiations, reimbursement policies, and physician adoption rates remain key barriers.
References
- Hoffmann-La Roche. (2022). Evrysdi (risdiplam) prescribing information.
- FDA. (2020). FDA approval of Evrysdi.
- IQVIA. (2022). U.S. Prescription Trends for SMA Treatments.
- EvaluatePharma. (2022). SMA drug market forecasts.
