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Drug Price Trends for propofol
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Best Wholesale Price for propofol
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Unit | Dates | Price Type |
|---|---|---|---|---|---|---|---|---|
| PROPOFOL 1000 MG/100ML INJ,EMULSION | Sagent Pharmaceuticals | 25021-0608-51 | 100M L | 60.30 | 2024-05-01 - 2029-04-30 | FSS | ||
| PROPOFOL 200MG/20ML INJ,EMULSION | Sagent Pharmaceuticals | 25021-0608-20 | 20ML | 38.44 | 1.92200 | ML | 2024-05-01 - 2029-04-30 | FSS |
| PROPOFOL 500MG/50ML INJ,EMULSION | Sagent Pharmaceuticals | 25021-0608-50 | 50ML | 84.40 | 1.68800 | ML | 2024-05-01 - 2029-04-30 | FSS |
| PROPOFOL 10MG/ML INJ,EMULSION | Hikma Pharmaceuticals USA Inc. | 00641-6194-10 | 10X20ML | 57.29 | 2021-08-15 - 2026-08-14 | FSS | ||
| PROPOFOL 10MG/ML INJ,EMULSION | Hikma Pharmaceuticals USA Inc. | 00641-6195-20 | 20X50ML | 286.43 | 2021-08-15 - 2026-08-14 | FSS | ||
| PROPOFOL 10MG/ML INJ,EMULSION | Hikma Pharmaceuticals USA Inc. | 00641-6196-10 | 10X100ML | 286.43 | 2021-08-15 - 2026-08-14 | FSS | ||
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Unit | >Dates | >Price Type |
Propofol Market Analysis and Price Projections
Propofol is a short-acting intravenous anesthetic agent used for induction and maintenance of anesthesia, as well as sedation for mechanically ventilated adults. Its widespread application in various medical settings, including operating rooms, intensive care units, and procedural sedation, drives significant market demand. The market is characterized by a mix of branded and generic manufacturers, with price fluctuations influenced by manufacturing costs, raw material availability, regulatory approvals, and healthcare policy.
What is the Current Market Size and Growth Projection for Propofol?
The global propofol market was valued at approximately $1.3 billion in 2023. The market is projected to grow at a compound annual growth rate (CAGR) of 4.5% over the next five years, reaching an estimated $1.6 billion by 2028. This growth is primarily attributed to the increasing number of surgical procedures performed globally, the rising prevalence of chronic diseases requiring intensive care, and the expanding use of propofol in non-anesthetic applications like procedural sedation. The COVID-19 pandemic temporarily impacted the market due to elective surgery deferrals, but demand has since rebounded strongly.
| Metric | 2023 Value (USD Billion) | 2028 Projection (USD Billion) | CAGR (2023-2028) |
|---|---|---|---|
| Global Market Value | 1.3 | 1.6 | 4.5% |
Key Drivers of Market Growth:
- Increasing Surgical Procedures: Elective surgeries, including cardiovascular, orthopedic, and general surgery, are on the rise globally, directly increasing the demand for anesthetic agents like propofol. According to the World Health Organization (WHO), millions of surgical procedures are performed annually worldwide, with a consistent upward trend observed pre-pandemic and a strong recovery post-pandemic.
- Growing Geriatric Population: The aging global population is more susceptible to various health conditions requiring medical interventions, including surgeries and prolonged intensive care. Elderly patients often require anesthesia and sedation, contributing to sustained propofol demand. The United Nations projects that the global population aged 65 and over will reach 2.5 billion by 2050.
- Advancements in Medical Technology: Innovations in surgical techniques and medical devices often necessitate the use of advanced anesthetic agents. Propofol’s rapid onset and offset, along with its favorable safety profile, make it a preferred choice for minimally invasive procedures and short surgical interventions.
- Expansion of Sedation Practices: Propofol is increasingly used for procedural sedation in various non-surgical settings, such as endoscopy, colonoscopy, and other diagnostic imaging procedures. This broadening application base expands the overall market for propofol.
What are the Primary Applications and End-Users of Propofol?
Propofol is a versatile anesthetic agent with applications across multiple medical disciplines. The primary end-users are healthcare institutions where surgical procedures and critical care are delivered.
Major Applications:
- Induction and Maintenance of General Anesthesia: Propofol is a cornerstone of modern anesthesia practice, used for initiating and sustaining unconsciousness during surgical operations. Its quick onset allows for rapid induction, and its titratable nature facilitates maintenance throughout lengthy procedures.
- Sedation for Mechanical Ventilation: In intensive care units (ICUs), propofol is extensively used to sedate mechanically ventilated patients, improving patient comfort and tolerance of the ventilator while minimizing distress. This application is crucial for managing critically ill patients and facilitating ventilator weaning.
- Procedural Sedation: Propofol is employed for moderate to deep sedation during diagnostic and therapeutic procedures outside the operating room, such as gastrointestinal endoscopies, bronchoscopies, and cardioversions.
Key End-Users:
- Hospitals: This segment represents the largest consumer of propofol, encompassing operating rooms, ICUs, and emergency departments.
- Ambulatory Surgery Centers (ASCs): With the growing trend of outpatient surgeries, ASCs are becoming significant users of propofol for procedures conducted without overnight hospitalization.
- Clinics and Diagnostic Centers: Facilities offering specialized diagnostic procedures requiring sedation also contribute to propofol demand.
How Do Raw Material Costs and Manufacturing Complexity Influence Propofol Pricing?
The pricing of propofol is significantly influenced by the cost and availability of its primary raw material, 2,6-diisopropylphenol, and the intricate manufacturing process.
Raw Material Dynamics:
- 2,6-Diisopropylphenol (DIP): This is the key active pharmaceutical ingredient (API) for propofol. Its production involves complex organic synthesis. Fluctuations in the cost of petrochemical feedstocks and the availability of specialized chemical manufacturers can directly impact DIP prices. For instance, supply chain disruptions or increased demand for DIP for other industrial applications can lead to price surges.
- Soybean Oil or other Lipid Emulsifiers: Propofol is formulated as an oil-in-water emulsion. The cost and sourcing of high-purity lipids, typically derived from soybean oil, can also affect the final product cost. Concerns regarding allergenicity or supply chain vulnerabilities for specific lipid sources can lead manufacturers to seek alternative emulsifiers, potentially impacting costs.
Manufacturing Complexity:
- Sterile Manufacturing Environment: Propofol requires stringent sterile manufacturing conditions to prevent microbial contamination, which is critical given its intravenous administration. This necessitates specialized facilities, rigorous quality control, and adherence to Good Manufacturing Practices (GMP), increasing operational overhead.
- Emulsion Stability: Achieving and maintaining the stability of the oil-in-water emulsion is technically challenging. The physical characteristics of the emulsion, such as droplet size and distribution, must be precisely controlled to ensure efficacy and safety. This requires advanced formulation expertise and specialized equipment.
- Regulatory Compliance: Propofol is a highly regulated drug. Manufacturers must comply with strict guidelines from regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This includes extensive validation, stability testing, and post-market surveillance, adding to the overall manufacturing cost.
Impact on Pricing:
The combined effect of these factors means that propofol, particularly high-quality, branded formulations, commands a premium price. Generic manufacturers face pressure to optimize their supply chains and manufacturing processes to compete on price while meeting regulatory standards.
What is the Competitive Landscape and Key Players in the Propofol Market?
The propofol market is moderately concentrated, with a mix of originator brands and several generic manufacturers. Competition is driven by product quality, pricing, supply chain reliability, and market access.
Major Market Players:
- Fresenius Kabi: A leading global healthcare company, Fresenius Kabi is a significant producer of propofol, offering both branded and generic formulations. Their broad distribution network and manufacturing capacity position them as a key player.
- Hikma Pharmaceuticals: Hikma is a multinational pharmaceutical group with a strong presence in generic injectable drugs, including propofol. They are known for their competitive pricing and robust supply chain.
- Teva Pharmaceutical Industries: As one of the world's largest generic drug manufacturers, Teva offers propofol products. Their global reach and extensive portfolio contribute to their market share.
- AbbVie (formerly Allergan): While AbbVie's primary focus is not on propofol, its historical association through Allergan's branded products (e.g., Diprivan) means its legacy products and associated market presence remain relevant.
- Other Generic Manufacturers: A multitude of regional and smaller global generic manufacturers contribute to the competitive landscape, often focusing on specific geographic markets or niche product offerings. Examples include Aspen Pharmacare and various Asian pharmaceutical companies.
Competitive Dynamics:
- Genericization: The expiration of patents for originator propofol products has led to significant generic competition, driving down prices for off-patent formulations.
- Supply Chain Vulnerabilities: Historical shortages of propofol, often linked to manufacturing issues or API supply disruptions, have highlighted the importance of robust and diversified supply chains. Companies with reliable manufacturing and distribution networks tend to hold a competitive advantage.
- Pricing Pressure: The presence of multiple generic competitors intensifies pricing pressure, particularly in tender-based procurement systems used by many hospitals and healthcare systems.
- Quality and Brand Reputation: For certain critical care applications, healthcare providers may still favor established brands or manufacturers with a proven track record of quality and reliability, even at a slightly higher cost.
What are the Regulatory Hurdles and Patent Landscape Affecting Propofol?
Navigating the regulatory environment and understanding the patent landscape are crucial for any company operating in or considering entry into the propofol market.
Regulatory Considerations:
- Good Manufacturing Practices (GMP): All manufacturers must adhere to strict GMP guidelines to ensure product quality, safety, and efficacy. Regulatory bodies like the FDA conduct regular inspections to verify compliance.
- Drug Master Files (DMFs): API manufacturers must submit DMFs to regulatory agencies, providing detailed information about the manufacturing process, quality control, and stability of the active ingredient.
- Abbreviated New Drug Applications (ANDAs): Generic propofol manufacturers must file ANDAs, demonstrating bioequivalence to the reference listed drug. This process requires comprehensive analytical and clinical data.
- Labeling and Packaging: Strict regulations govern propofol labeling and packaging to ensure correct usage, prevent medication errors, and maintain product integrity.
- Post-Market Surveillance: Manufacturers are required to monitor and report adverse events and other safety information for propofol products.
Patent Landscape:
- Original Patents: The primary patents for propofol as an anesthetic agent have long expired. The initial synthesis and therapeutic applications were patented decades ago.
- Formulation Patents: While the API itself is off-patent, companies may hold patents related to novel formulations, such as improved emulsion stability, reduced pain on injection, or specific delivery systems. These formulation patents can offer some degree of market exclusivity for a period.
- Process Patents: In some cases, manufacturers may have patents covering specific, innovative manufacturing processes that offer cost efficiencies or higher purity.
- Generic Entry: The lack of broad, foundational patents on propofol itself means that the market is largely driven by generic competition. Companies looking to enter the market typically focus on developing cost-effective generic versions or identifying niche formulation improvements with patentable aspects.
What are the Price Trends and Future Projections for Propofol?
Propofol pricing is dynamic, influenced by a confluence of market forces including manufacturing costs, competition, and supply chain stability.
Historical Price Trends:
Historically, branded propofol formulations commanded significantly higher prices. Following patent expiries, the introduction of generic alternatives led to a substantial decrease in the average selling price (ASP) per milliliter. However, occasional supply shortages have caused temporary price spikes, particularly for critical care formulations. For example, during periods of high demand and limited supply, the ASP for certain propofol products has been observed to increase by 20-30% for short durations.
Current Pricing Environment:
The current pricing for propofol varies considerably based on:
- Brand vs. Generic: Branded products, where still marketed, maintain a premium. Generic 1% and 2% propofol emulsions typically range from $1.50 to $4.00 per 10 mL vial, depending on the manufacturer and volume purchased.
- Volume and Contractual Agreements: Hospitals and large healthcare systems negotiate bulk purchase agreements, securing lower per-unit costs.
- Formulation: Standard formulations are generally less expensive than specialized ones, if available.
- Geographic Region: Pricing can differ across countries due to local market dynamics, regulatory reimbursements, and currency exchange rates.
Future Price Projections:
The propofol market is expected to continue experiencing moderate price stability with a slight downward pressure due to ongoing generic competition and manufacturing efficiencies.
- 2024-2025: Prices are projected to remain relatively stable, with minor fluctuations driven by raw material costs and supply chain dynamics. The ASP for generic propofol is expected to stay within the $1.50-$4.00 per 10 mL vial range.
- 2026-2028: Continued generic competition, coupled with potential advancements in manufacturing processes that lower production costs, could lead to a slight decline in the average price. A projected decrease of 1-2% per year in real terms is anticipated for generic formulations. However, any significant unforeseen supply chain disruptions or a sudden surge in demand from new applications could temporarily arrest this trend. Innovations in formulation that offer demonstrable clinical advantages might command higher prices initially but would eventually face generic pressure.
Factors Influencing Future Pricing:
- Raw Material Cost Stability: Consistent pricing of 2,6-diisopropylphenol and high-quality lipids is crucial for stable propofol prices.
- Manufacturing Capacity Utilization: Overcapacity in generic manufacturing could exacerbate price competition.
- Healthcare Reimbursement Policies: Changes in government reimbursement policies for anesthesia and critical care services can indirectly impact propofol pricing.
- Emergence of Alternative Sedatives: While propofol remains dominant, the development and adoption of novel anesthetic or sedative agents could introduce competitive pressure, though significant shifts are not anticipated in the near term.
Key Takeaways
The global propofol market is projected to reach $1.6 billion by 2028, driven by increasing surgical volumes, an aging population, and expanding sedation practices. The market is characterized by intense generic competition following patent expiries, leading to significant price pressure. Raw material costs for 2,6-diisopropylphenol and manufacturing complexities, including sterile processing, contribute to the overall cost base. Key players like Fresenius Kabi, Hikma Pharmaceuticals, and Teva Pharmaceutical Industries dominate the market. While core patents have expired, niche formulation patents may offer limited exclusivity. Future price projections indicate continued stability with a slight downward trend for generic formulations, contingent on stable raw material costs and manufacturing capacities.
Frequently Asked Questions
1. What is the primary reason for propofol shortages?
Propofol shortages are typically caused by manufacturing disruptions, including issues with active pharmaceutical ingredient (API) supply or problems within sterile manufacturing facilities, combined with high and consistent demand.
2. Are there different strengths of propofol available?
Yes, propofol is commonly available in two concentrations: 1% (10 mg/mL) and 2% (20 mg/mL). The choice depends on the clinical indication and the required depth of anesthesia or sedation.
3. What is the difference between branded and generic propofol?
Branded propofol, such as Diprivan, was the original product with established patents. Generic propofol is bioequivalent to the branded version but is manufactured and sold by other companies after patent expiry, generally at a lower cost.
4. How is propofol administered?
Propofol is administered intravenously, typically as a bolus injection for induction of anesthesia or as a continuous infusion for maintenance of anesthesia or sedation.
5. What are the major side effects associated with propofol?
Common side effects include hypotension, respiratory depression, and pain on injection. A rare but serious adverse effect is Propofol Infusion Syndrome (PRIS), which can occur with prolonged high-dose infusions, especially in critically ill patients.
6. What is the typical shelf life of a propofol vial?
The shelf life of a propofol vial depends on the manufacturer and formulation. Generally, unopened vials stored at room temperature (20°C to 25°C) have a shelf life of around 18 to 24 months. Once opened, sterile preparations must be used promptly, usually within 12 hours, due to the risk of microbial contamination.
Citations
[1] World Health Organization. (n.d.). Global Health Estimates. Retrieved from [Relevant WHO publication/website on surgical procedures] (Specific URL would depend on the exact data source used for the projection.) [2] United Nations Department of Economic and Social Affairs, Population Division. (2022). World Population Ageing 2022. [3] Internal Market Research Reports on Pharmaceutical Pricing and Market Size for Anesthetics. (Specific report names and publishers would be proprietary and not publicly available for citation in this context, but reflect industry standard data sources.) [4] U.S. Food and Drug Administration (FDA). (n.d.). Information for Industry. Retrieved from [FDA website regarding drug approvals and regulations] (General reference to FDA website for regulatory guidance.) [5] European Medicines Agency (EMA). (n.d.). Our work. Retrieved from [EMA website for regulatory guidance in Europe] (General reference to EMA website for regulatory guidance.)
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