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Last Updated: December 25, 2024

BUMINATE, FLEXBUMIN Drug Profile


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Summary for Tradename: BUMINATE, FLEXBUMIN
High Confidence Patents:0
Applicants:1
BLAs:1
Pharmacology for BUMINATE, FLEXBUMIN
Ingredient-typeSerum Albumin
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Intravascular Volume
Increased Oncotic Pressure
Established Pharmacologic ClassHuman Serum Albumin
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for BUMINATE, FLEXBUMIN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for BUMINATE, FLEXBUMIN Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for BUMINATE, FLEXBUMIN Derived from Patent Text Search

These patents were obtained by searching patent claims

BUMINATE, FLEXBUMIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Biologic Drugs: BUMINATE and FLEXBUMIN

Introduction

Biologic drugs, including albumin products like BUMINATE and FLEXBUMIN, are crucial in modern medicine, particularly in treating various medical conditions such as hypoalbuminemia, burns, and cardiopulmonary bypass surgery. Here, we delve into the market dynamics and financial trajectory of these biologic drugs.

Global Albumin Market Overview

The global albumin market is experiencing significant growth, driven by several key factors. As of 2024, the market size is estimated to be around USD 6.74 billion and is projected to reach USD 11.64 billion by 2034, growing at a CAGR of 5.62% during the forecast period[1].

Market Drivers

Increasing Demand in Emerging Economies

The demand for albumin is rising rapidly in emerging economies, particularly in the Asia-Pacific region. Countries like China, India, and South Korea are becoming key players in the production and consumption of recombinant albumin. This growth is fueled by increasing healthcare spending and the rising demand for advanced medical treatments[1].

Advancements in Biotechnology

Advancements in biotechnology have improved the production of albumin, making it more accessible and affordable. Recombinant albumin, for instance, is gaining traction due to its consistency and reduced risk of viral contamination compared to human serum albumin[4].

Plasma Fractionation Facilities

The expansion of plasma fractionation facilities is another significant driver. These facilities are essential for the production of albumin and other plasma-derived products, and their growth supports the increasing demand for these therapies[1].

Rising Prevalence of Chronic Diseases

The rising prevalence of chronic diseases such as liver diseases, burns, and cardiopulmonary conditions that require albumin-based therapies is a major market driver. For example, China has the world’s highest chronic hepatitis B virus (HBV) infection burden, which significantly increases the demand for albumin treatments[1].

Product Segmentation

Human Serum Albumin

Human serum albumin is one of the primary types of albumin used in therapeutic applications. Products like BUMINATE and FLEXBUMIN fall under this category. These products are indicated for conditions such as hypoalbuminemia, hypovolemia, burns, and cardiopulmonary bypass surgery[5].

Recombinant Albumin

Recombinant albumin is gaining popularity due to its purity and consistency. This type of albumin is produced through genetic engineering and is free from the risks associated with human-derived products[4].

Bovine Albumin

Bovine albumin, though less commonly used in human therapeutics, is still a significant segment, particularly in research and development activities and as a component in culture media[4].

Application Segmentation

Therapeutic Applications

Albumin products like BUMINATE and FLEXBUMIN are primarily used in therapeutic applications. These include treating hypoalbuminemia, hypovolemia, burns, and supporting patients undergoing cardiopulmonary bypass surgery[5].

Drug Delivery

Albumin is also used as a carrier in drug delivery systems due to its biocompatibility and ability to bind and transport drugs effectively[4].

Vaccine Ingredient

Albumin can be used as an ingredient in vaccine formulations to enhance stability and efficacy[4].

Culture Media

In research and development, albumin is used as a component in culture media to support cell growth and proliferation[4].

Regional Insights

North America

North America is currently the largest market for albumin products, driven by a well-developed pharmaceutical industry and robust healthcare infrastructure. However, the market is relatively mature, and growth is expected to be steady rather than rapid[1].

Asia-Pacific

The Asia-Pacific region is anticipated to witness the fastest growth in the albumin market. Countries like China, India, and South Korea are driving this growth due to increasing healthcare spending and the rising demand for advanced medical treatments[1].

Financial Trajectory

Market Size and Growth

The global albumin market is expected to grow from USD 6.74 billion in 2024 to USD 11.64 billion by 2034, at a CAGR of 5.62%. This growth is driven by the increasing demand for albumin in emerging economies and advancements in biotechnology[1].

Revenue Streams

The revenue for albumin products is generated across various segments, including therapeutic applications, drug delivery, vaccine ingredients, and culture media. Therapeutic applications remain the largest revenue generator due to the high demand for treatments like hypoalbuminemia and burns[4].

Competitive Landscape

The albumin market is consolidated at the top with major players like Baxter International, Inc., CSL Behring LLC, and Octapharma AG. These companies are continuously innovating and expanding their product portfolios to maintain market share. For instance, Baxter's FLEXBUMIN 5% was approved by the FDA in 2014, marking a significant milestone in the company's albumin product line[5].

Key Players and Innovations

Baxter International, Inc.

Baxter International, Inc. is a key player in the albumin market. The FDA approval of FLEXBUMIN 5% in 2014 was a significant innovation, offering a flexible container solution for albumin therapy. This product is indicated for hypovolemia, hypoalbuminemia, burns, and cardiopulmonary bypass surgery[5].

CSL Behring LLC

CSL Behring LLC is another major player that has been investing heavily in research and development. The company's focus on plasma-derived products, including albumin, has helped in expanding its market presence globally[4].

Challenges and Opportunities

Regulatory Challenges

Stringent regulations and limited reimbursement are significant challenges facing the albumin market. However, these challenges also present opportunities for innovation and compliance, which can drive market growth[4].

Emerging Markets

The rapid growth in developing countries across the Asia-Pacific region offers lucrative opportunities for albumin market players. These markets are expected to drive the future growth of the albumin industry[1].

Conclusion

The market dynamics for biologic drugs like BUMINATE and FLEXBUMIN are characterized by strong growth driven by increasing demand in emerging economies, advancements in biotechnology, and the rising prevalence of chronic diseases. The financial trajectory indicates a steady and significant increase in market size, with the Asia-Pacific region expected to be a major driver of this growth.

Key Takeaways

  • The global albumin market is projected to grow from USD 6.74 billion in 2024 to USD 11.64 billion by 2034.
  • The Asia-Pacific region is expected to witness the fastest growth due to increasing healthcare spending and demand for advanced medical treatments.
  • Therapeutic applications remain the largest revenue generator for albumin products.
  • Major players like Baxter International, Inc., and CSL Behring LLC are driving innovation and market expansion.
  • Stringent regulations and limited reimbursement are significant challenges, but they also present opportunities for compliance and innovation.

FAQs

What is the current market size of the global albumin market?

The global albumin market size is estimated to be around USD 6.74 billion in 2024[1].

What is the projected growth rate of the global albumin market?

The global albumin market is expected to grow at a CAGR of 5.62% from 2024 to 2034[1].

Which region is expected to witness the fastest growth in the albumin market?

The Asia-Pacific region is anticipated to witness the fastest growth in the albumin market[1].

What are the primary therapeutic applications of albumin products like BUMINATE and FLEXBUMIN?

These products are primarily used to treat hypoalbuminemia, hypovolemia, burns, and to support patients undergoing cardiopulmonary bypass surgery[5].

Who are the major players in the global albumin market?

Major players include Baxter International, Inc., CSL Behring LLC, and Octapharma AG[4].

Sources

  1. Precedence Research, "Albumin Market Size to Hit USD 11.64 Billion by 2034," June 2024.
  2. Milliman, "Impact of H.R. 5376 Phase-in for Plasma Therapies on Part D," December 2021.
  3. Maximize Market Research, "Biological Drugs Market: Global Industry Analysis," 2023.
  4. MarketsandMarkets, "Global Albumin Market by Application, Product & Geography - 2022."
  5. Baxter International, Inc., "FDA Approves Baxter's FLEXBUMIN 5%, First and Only 5% Human Albumin Solution in a Flexible Container," August 4, 2014.

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