Last updated: August 18, 2025
Introduction
The drug with NDC code 55111-0611 pertains to Bupivacaine Hydrochloride injection, a local anesthetic widely used for surgical anesthesia, labor analgesia, and post-operative pain management. Understanding its market dynamics, current pricing, and future projections is critical for stakeholders such as healthcare providers, investors, and pharmaceutical companies aiming to navigate this segment effectively.
Product Profile and Market Position
Bupivacaine Hydrochloride is a long-acting amide local anesthetic, marketed by multiple manufacturers under different brand names, such as Marcaine (by AstraZeneca) and equivalents produced by generic manufacturers. The drug's indications span intraoperative anesthesia, epidural analgesia, and nerve blocks, making it a staple in surgical and obstetric settings.
Currently, the drug is primarily supplied via institutional formularies, hospital purchase agreements, and pharmacy channels. Its role remains significant owing to its duration of action and efficacy, although emerging alternatives and evolving pain management strategies influence market trajectories.
Market Size and Demand Dynamics
Historical Market Overview
The US market for bupivacaine injections was valued at approximately USD 300–400 million in recent years, with steady growth aligned with increasing surgical procedures and anesthetic utilization [1]. The demand predominantly stems from hospitals, outpatient surgical centers, and anesthesia providers.
Factors Influencing Demand
- Surgical Volume: The rising volume of elective and emergency surgeries globally sustains demand.
- Obstetric and Post-Operative Pain Management: Increasing awareness and guidelines promoting effective pain relief augment use.
- Generics vs. Branded Considerations: Price sensitivity and reimbursement policies drive a significant shift towards generic options, influencing overall market share distribution.
Market Trends
- Shift Towards Generics: The dominance of generic bupivacaine injections has suppressed prices over the past decade.
- Alternative Analgesic Strategies: Introduction of liposomal bupivacaine (e.g., EXPAREL by Pacira Biosciences) offers extended duration, impacting traditional bupivacaine sales.
- Regulatory and Supply Factors: Supply chain integrity and regulatory approvals influence availability and pricing stability.
Pricing Analysis: Current Market Price
Pricing Overview
Based on market surveys, typical wholesale acquisition costs (WAC) for injectable bupivacaine range from USD 5 to USD 20 per mL for generic formulations, depending on concentration, volume, and purchase terms [2]. Brand-name products like Marcaine generally command higher prices, often surpassing USD 25 per mL.
Influencing Factors on Price
- Volume discounts: Hospitals often negotiate substantial discounts based on volume commitments.
- Formulation and Concentration: Higher concentration formulations or preservative-free options tend to fetch premium pricing.
- Supply Chain and Manufacturing Costs: Variability in raw material costs and manufacturing efficiencies impact pricing.
Competitive Landscape
The market is highly competitive, characterized by:
- Dominance of Generics: Multiple manufacturers, including Hikma Pharmaceuticals, Pfizer, and Teva, produce generic formulations that capture the majority market share.
- Brand-Name Market Niche: Brands like AstraZeneca's Marcaine retain a premium positioning, primarily in settings where brand trust influences choice.
- Emerging Alternatives: Liposomal formulations and multi-modal analgesia regimens influence the competitive landscape, affecting traditional bupivacaine sales.
Future Price Projections
Market Drivers Affecting Future Pricing
- Patent and Regulatory Environments: Most formulations are off patent, pressuring prices downward, although some combination products or novel formulations could sustain premium pricing.
- Introduction of Extended-Release Formulations: Liposomal bupivacaine (e.g., EXPAREL) offers longer pain control, potentially reducing demand for traditional formulations and impacting volume-based pricing strategies.
- Healthcare Cost Containment: Payor and hospital initiatives pushing towards cost-effective alternatives will enforce downward pressure on prices.
Projected Price Trends (Next 3-5 Years)
- Stable to Slight Decrease in Generic Prices: Wholesale prices are expected to decline marginally by 2–4% annually, driven by competition and cost efficiencies.
- Potential Premium Pricing for Specialized Formulations: Extended-release options may command prices 30–50% higher than standard injectables, though adoption remains limited due to cost and clinical preferences.
- Impact of Supply Chain Disruptions: Scarcity events or raw material price hikes could temporarily inflate prices, but such shocks are generally transient.
Regulatory and Market Forces Impact
Regulatory dynamics, including FDA approvals and alerts, influence supply stability and pricing structures. The growing emphasis on opioid-sparing pain management strategies also shifts market share towards non-opioid alternatives, potentially reducing demand for traditional bupivacaine formulations.
Additionally, global market expansion, particularly in emerging economies with increasing surgical volumes, presents future growth opportunities, albeit with pricing pressures stemming from local procurement policies.
Summary and Strategic Insights
- The current market for NDC 55111-0611's formulation is highly competitive, predominantly driven by generics.
- Prices are expected to trend downward modestly due to intensified competition and healthcare cost containment.
- Premium formulations, such as liposomal bupivacaine, could sustain higher prices, influencing overall market segmentation.
- Supply chain resilience and regulatory considerations remain critical to stable pricing.
Key Takeaways
- The bupivacaine injection market is mature with declining average prices, yet steady demand from surgical and anesthetic procedures sustains profitability.
- Generics dominate, exerting downward pressure on prices, though brand-name and extended-release options command higher premiums.
- Stakeholders should monitor regulatory changes, supply chain stability, and emerging analgesic alternatives to adjust procurement, investment, or development strategies accordingly.
- Innovative formulations and expanding global markets may offset domestic price declines, creating growth avenues.
- Cost optimization and supplier negotiations remain crucial for healthcare providers and distributors to maintain margins.
FAQs
1. What is the current average price of NDC 55111-0611's formulation?
The wholesale acquisition cost for generic bupivacaine injections typically ranges from USD 5 to USD 20 per mL, depending on concentration, supplier, and purchase volume.
2. How do brand-name formulations compare in price to generics?
Brand-name products like Marcaine often cost 25–50% more than generics, with prices exceeding USD 25 per mL, reflecting brand trust and market positioning.
3. What factors influence future pricing trends for bupivacaine injections?
Competition among generics, adoption of extended-release formulations, healthcare cost policies, and supply chain stability mainly influence future pricing.
4. How is the emergence of liposomal bupivacaine affecting market dynamics?
Liposomal formulations offer longer pain relief, leading to higher prices and potentially cannibalizing sales of traditional formulations, especially in settings prioritizing prolonged analgesia.
5. What opportunities exist for manufacturers seeking to penetrate this market?
Innovating with extended-release or combination formulations, entering emerging markets, and offering competitive pricing strategies can facilitate market entry or expansion.
References
[1] Market Research Future. “Bupivacaine Market Analysis & Trends.” 2022.
[2] RedBook. “Hospital Pharmacy Pricing Data.” 2023.
