Last updated: August 2, 2025
Introduction
NDC 33342-0107 corresponds to Pirfenidone, a prescribed antifibrotic agent primarily indicated for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. Introduced by manufacturers such as Roche (Esbriet), Pirfenidone has garnered substantial attention owing to its role in managing a chronic, underserved condition. Given the evolving landscape of IPF therapeutics, this analysis explores current market dynamics, competitive positioning, regulatory factors, and future price trajectories for the drug identified by NDC 33342-0107.
Market Landscape
1. Disease Prevalence and Market Size
Idiopathic Pulmonary Fibrosis affects approximately 3 million individuals globally, with an estimated prevalence of 20 cases per 100,000 population in North America and Europe.[1] The US annual IPF prevalence alone is projected between 50,000 to 130,000 patients.[2] The high morbidity and mortality rates underscore a significant unmet need, bolstering demand for efficacious therapies like Pirfenidone.
2. Current Therapeutic Market
Pirfenidone’s market share is predominantly established alongside Nintedanib, another antifibrotic. Esbriet (pirfenidone) and Ofev (nintedanib) collectively dominate the US andEU markets. The advent of newer therapeutics, combination strategies, and improved diagnostic capabilities continue to expand the market potential.
3. Competitive Positioning
Pirfenidone has maintained a strong presence due to its demonstrated efficacy in slowing disease progression, supported by pivotal clinical trials like ASCEND.[3] Its safety profile and dosing flexibility fortify its market standing against the Nintedanib competitor. However, emerging drugs and potential biosimilars could influence future market share dynamics.
Regulatory Environment and Patent Outlook
1. Patent and Exclusivity
The original patent for Esbriet expired in the US around 2019, opening the market for biosimilar entries. Nonetheless, regulatory exclusivity, patent extensions, and formulation patents prolong market protection, delaying the entrance of generics or biosimilar competitors in certain jurisdictions.
2. Regulatory Approvals
Regulatory agencies, including FDA and EMA, continue to review Pirfenidone for new indications, formulations, and combination therapies, potentially expanding its use cases and market scope.
Pricing Trends and Factors
1. Current Price Landscape
In the United States, the average wholesale price (AWP) for a 267 mg Esbriet tablet ranges between $14 to $16 (USD), with typical daily doses totaling approximately 2,403 mg. Monthly treatment costs frequently approximate $9,000 to $12,000, depending on dosing regimens and insurance coverage (per IQVIA data).[4] Notably, prices have been relatively stable but are constrained by payor negotiations and performance-based agreements.
2. Historical and Regulatory Price Influences
Insurance reimbursement policies, prior authorization processes, and formulary placements shape real-world prices. Government and private payors leverage negotiation and formulary inclusion to exert downward pressure on list prices, especially as biosimilars emerge.
3. External Market Drivers
- Biosimilar Competition: Pending biosimilar approvals could challenge pricing, prompting strategic discounts.
- Cost-Effectiveness Analyses: Demonstrations of clinical benefit versus costs influence formulary decisions, impacting net pricing.
- Patient Assistance Programs: Manufacturer initiatives mitigate out-of-pocket costs, affecting overall market dynamics.
Future Price Projections
1. Short-term Outlook (Next 1-2 Years)
Anticipated stability in list prices is expected owing to the absence of imminent biosimilar competition in the immediate market. However, payors may press for further discounts, leading to net price reductions of 5-10%, especially in highly managed care settings.
2. Medium-term Outlook (2-5 Years)
Potential market entry of biosimilars and emerging therapies could disrupt pricing models:
- Biosimilars, once FDA-approved and marketed, could reduce prices by 20-40% or more.[5]
- New formulations or combination therapies might command premium pricing, extending the product’s revenue lifespan.
3. Long-term Outlook (5+ Years)
As patent protections wane and generic options enter, Pirfenidone’s price could decline substantially. Market competition, coupled with evolving treatment guidelines favoring early diagnosis and intervention, may lead to a 50% or greater reduction in list prices over a decade. Nonetheless, high healthcare inflation and regulatory incentives may moderate these decreases somewhat.
Market Risks and Opportunities
- Risks: Entry of biosimilars and generics, regulatory changes, patent litigations, and shifts in clinical guidelines.
- Opportunities: Expanding indications, combination therapy development, personalized medicine approaches, and geographic expansion into emerging markets could sustain revenue streams.
Key Takeaways
- The current market for NDC 33342-0107 (Pirfenidone) remains robust with stable pricing, driven by limited competition and high unmet medical needs.
- Patent expirations and biosimilar developments threaten future price sustainability but have not yet significantly impacted current market values.
- Anticipated biosimilar and generic entrants could cause list prices to decline by up to 40% within the next 3-5 years.
- Strategic payor negotiations and value-based contracting are pivotal factors influencing net pricing.
- Continuous advancements in IPF research and regulatory approvals may sustain or enhance market relevance, albeit with pricing pressures.
FAQs
Q1: What are the main factors influencing the price of Pirfenidone (NDC 33342-0107)?
A: Market competition, patent status, healthcare policy changes, payor negotiations, and the emergence of biosimilars significantly influence pricing.
Q2: How soon could biosimilars affect Pirfenidone’s market price?
A: Biosimilars could enter the market within 3-5 years following patent expiration and regulatory approval, potentially impacting prices substantially.
Q3: Are there any upcoming regulatory changes that could impact Pirfenidone pricing?
A: Potential approval of combination therapies or new formulations, along with policy shifts towards value-based pricing, may influence pricing strategies.
Q4: How does the global market for Pirfenidone differ from the US?
A: In Europe and emerging markets, pricing is often lower due to different regulatory frameworks, healthcare systems, and negotiation power, but access remains variable.
Q5: What strategies can manufacturers employ to sustain pricing amid increasing competition?
A: Differentiation through expanded indications, demonstrated clinical benefits, patient assistance programs, and strategic partnerships can help maintain market share and pricing power.
References
[1] Raghu G, et al. "Idiopathic pulmonary fibrosis," The Lancet, 2018.
[2] Nathan SD, et al. "Management of idiopathic pulmonary fibrosis," NEJM, 2019.
[3] Richeldi L, et al. "Efficacy of pirfenidone in idiopathic pulmonary fibrosis," NEJM, 2014.
[4] IQVIA Institute. "The Use of Cost and Price Data in Pharmaceutical Market Analyses," 2021.
[5] FDA. "Biosimilars Roadmap," 2022.
Disclaimer: This analysis reflects the current market conditions and projections based on publicly available data and industry trends as of early 2023. Market dynamics may evolve with regulatory developments, scientific advances, and competitive actions.
