Overview of KEDBUMIN
KEDBUMIN, a 25% human albumin solution, is a sterile, aqueous product used for intravenous administration. It is manufactured by Kedrion SpA and has been approved by the US FDA since June 2011. The solution contains 0.25 g per mL of human albumin, derived from pooled human plasma obtained from FDA-licensed facilities in the USA[3].
Clinical Trials Associated with KEDBUMIN
Ongoing and Completed Trials
One notable clinical trial associated with KEDBUMIN is the Phase 4 study titled "A Prospective, Randomized, Multicenter, Controlled, Open-Label Study to Evaluate the Safety of Kedbumin 25% Compared to Normal Saline Solution in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients Undergoing Major Elective Surgery." This trial, sponsored by Kedrion SpA, aimed to evaluate the safety of KEDBUMIN in pediatric patients undergoing major surgeries. The study was conducted at several surgical and pediatric intensive care units in the US over a period of 19 months and involved at least 60 pediatric subjects between 0 days and 12 years of age[2].
Trial Outcomes and Implications
While the specific outcomes of this trial are not publicly available without a login, such studies are crucial for assessing the safety and efficacy of KEDBUMIN in various clinical settings. These trials help in understanding the pharmacokinetics and any potential adverse reactions, which are vital for its continued use and approval in different indications.
Indications and Usage
KEDBUMIN is indicated for several critical medical conditions, including:
- Hypovolemia: For the restoration and maintenance of circulating blood volume where volume deficiency is demonstrated and colloid use is appropriate[3].
- Hypoalbuminemia: For severe albumin deficiency caused by illness or active bleeding[3].
- Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites: To maintain cardiovascular function following the removal of large volumes of ascitic fluid due to cirrhosis[3].
- Ovarian Hyperstimulation Syndrome (OHSS): As a plasma expander in the fluid management of severe forms of OHSS[3].
- Burns: To treat hypoalbuminemia and correct lower osmotic pressure in the blood, especially after severe burns[3].
- Adult Respiratory Distress Syndrome (ARDS): To manage fluid balance and maintain blood volume[3].
- Hemodialysis: For patients undergoing long-term dialysis who cannot tolerate substantial volumes of salt solution[3].
Market Analysis and Projections
Global Albumin Market
The global albumin market, which includes products like KEDBUMIN, is experiencing significant growth. In 2022, the market size was valued at $5.4 billion and is projected to reach $9.9 billion by 2032, growing at a CAGR of 6.2% from 2023 to 2032. This growth is driven by the increasing prevalence of diseases such as hypoalbuminemia, burns, trauma, liver cirrhosis, and cardiac surgeries[2].
Market Segments
- Type: The human serum albumin segment dominated the market in terms of revenue in 2022 and is expected to grow at the fastest CAGR during the forecast period[2].
- Application: The therapeutics segment dominated the market in terms of revenue in 2022 and is anticipated to grow at the fastest CAGR during the forecast period[2].
- Sales Channel: The B2B segment dominated the market in terms of revenue in 2022, but the B2C segment is expected to grow at the fastest CAGR during the forecast period[2].
Regional Analysis
- North America: Generated the largest revenue in 2022, but the Asia-Pacific region is projected to exhibit the highest CAGR during the forecast period. This growth in the Asia-Pacific region is attributed to the rising geriatric population, increased prevalence of disorders, and enhancements in healthcare infrastructure[2].
Growth Drivers
The albumin market, including KEDBUMIN, is driven by several key factors:
- Increasing Prevalence of Diseases: Conditions such as hypoalbuminemia, burns, trauma, liver cirrhosis, and cardiac surgeries significantly propel the market growth[2].
- Surge in Burn and Shock Cases: According to the World Health Organization (WHO), approximately 11 million individuals endure burn wounds annually, highlighting the critical role of albumin in addressing these medical consequences[2].
- Advancements in Healthcare Infrastructure: Ongoing enhancements in healthcare infrastructure, particularly in the Asia-Pacific region, are expected to drive market expansion[2].
Competition Analysis
The albumin market is competitive, with several players involved in the production and distribution of human albumin products. Kedrion SpA, the originator of KEDBUMIN, faces competition from other manufacturers, but its well-established presence and ongoing research activities contribute to its market position[2].
Key Takeaways
- Clinical Trials: Ongoing and completed trials are crucial for evaluating the safety and efficacy of KEDBUMIN in various clinical settings.
- Market Growth: The global albumin market is projected to grow significantly, driven by increasing disease prevalence and advancements in healthcare infrastructure.
- Regional Expansion: The Asia-Pacific region is expected to exhibit the highest CAGR during the forecast period due to rising geriatric populations and increased healthcare infrastructure.
- Indications: KEDBUMIN is indicated for a range of critical medical conditions, including hypovolemia, hypoalbuminemia, and burns.
FAQs
What is KEDBUMIN used for?
KEDBUMIN is used to treat conditions such as hypovolemia, hypoalbuminemia, prevention of central volume depletion after paracentesis due to cirrhotic ascites, ovarian hyperstimulation syndrome (OHSS), burns, adult respiratory distress syndrome (ARDS), and in hemodialysis patients[3].
What is the current market size of the global albumin market?
The global albumin market was valued at $5.4 billion in 2022 and is projected to reach $9.9 billion by 2032[2].
What drives the growth of the albumin market?
The growth of the albumin market is driven by the increasing prevalence of diseases such as hypoalbuminemia, burns, trauma, liver cirrhosis, and cardiac surgeries, as well as advancements in healthcare infrastructure[2].
In which regions is the albumin market expected to grow the most?
The Asia-Pacific region is expected to exhibit the highest CAGR during the forecast period due to the rising geriatric population and increased healthcare infrastructure[2].
What is the significance of clinical trials for KEDBUMIN?
Clinical trials are essential for evaluating the safety and efficacy of KEDBUMIN in various clinical settings, which helps in understanding its pharmacokinetics and potential adverse reactions[2].
Sources
- Albumin (Human) (Kedrion) - Drug Targets, Indications, Patents. Synapse.
- Albumin Market Size, Share | Growth Drivers | Forecast- 2032. Allied Market Research.
- Kedbumin: Package Insert / Prescribing Information - Drugs.com. Drugs.com.
- U.S. Clinical Trials Market Size Industry Analysis Report, 2033. BioSpace.
