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Market Analysis and Price Projections for NDC 70000-0309
Last updated: March 21, 2026
What is NDC 70000-0309?
The National Drug Code (NDC) 70000-0309 corresponds to Pirfenidone (Esbriet), used for idiopathic pulmonary fibrosis (IPF). It is marketed by Roche/Genentech.
Market Overview
The global IPF treatment market is driven by increasing diagnosis rates[1], aging populations, and lack of alternative therapies. Pirfenidone accounts for a significant share due to its approval and inclusion in treatment guidelines.
Market Size
Estimated global market value in 2022: $1.3 billion
Compound annual growth rate (CAGR) 2022–2028: 10%
Key Factors
Growing IPF Incidence: IPF incidence ranges from 6.8 to 19.3 cases per 100,000 persons annually[2].
Unmet Medical Need: Limited options restrict therapy to antifibrotic drugs like pirfenidone and nintedanib.
Geographic Expansion: Approval in emerging markets increases potential patient pool.
Competitive Landscape
Product
Market Share (2022)
Price (per 270 mg capsule)
Manufacturer
Pirfenidone (Esbriet)
65%
$70-$80
Roche/Genentech
Nintedanib (Ofev)
35%
$75-$85
Boehringer Ingelheim
Price Trends and Projections
Current Pricing
U.S.: Approximate wholesale price for a 270 mg capsule: $75
Estimated U.S. patient population: 20,000–25,000 treated annually[3].
Average annual dosing: 2.4 g/day, equating to approximately 2 capsules/day.
Projected revenue (2023):$120 million–$160 million in the U.S. alone, based on current pricing and distribution.
Regulatory and Patent Outlook
Patent expiry in the U.S.: 2027.
Patent expiry in Europe: 2025–2026.
Regulatory approvals in key markets: US (2014), EU (2016), Japan (2014).
Key Market Takeaways
The market for pirfenidone is growing steadily, driven by increasing IPF prevalence.
Pricing is expected to decline gradually with patent expirations and entry of generics.
Roche maintains market dominance through pricing strategies and ongoing clinical development.
Competitive pressures, especially from nintedanib, influence pricing and market share.
Future growth hinges on expanding indications and geographic penetration.
FAQs
What are the main factors affecting pirfenidone pricing?
Patent status, generic entry, competition from nintedanib, and reimbursement policies impact price levels.
How does patent expiry influence future pricing?
Patent expiry allows generics, which typically sell at 30-50% lower prices, to enter the market, causing significant price erosions.
What markets are most lucrative for pirfenidone?
The U.S., due to its large patient population and high willingness-to-pay, and Europe, with high prevalence and established reimbursement pathways.
Are there ongoing clinical trials that could affect the market?
Yes, trials exploring new indications or combination therapies may impact future demand.
What is the expected timeframe for generic competition?
In the U.S., patent expiration is projected for 2027, with generics potentially entering the market in 2028–2029.
References
[1] GlobalData. (2022). Pulmonary fibrosis market analysis.
[2] American Thoracic Society. (2017). IPF incidence and prevalence.
[3] IQVIA. (2023). U.S. pulmonary fibrosis drug utilization data.
[4] FDA. (2014). Drug approval history for pirfenidone.
[5] European Medicines Agency. (2016). Regulatory status of Esbriet.
Key Takeaways:
The global market is set to grow at a 10% CAGR, reaching over $2 billion by 2028.
Pricing will face downward pressure post-patent expiry, with generics expected from 2027 onward.
Roche’s dominant market position depends on patent protection and strategic pricing.
The market remains sensitive to legislative and reimbursement shifts.
Future growth opportunities include expanding indications and geographic penetration.
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