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Last Updated: January 5, 2025

ALBUMINAR, ALBUMINAR-20, ALBUMINAR-25, ALBUMINAR-5 Drug Profile


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Summary for Tradename: ALBUMINAR, ALBUMINAR-20, ALBUMINAR-25, ALBUMINAR-5
High Confidence Patents:0
Applicants:1
BLAs:1
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 ALBUMINAR, ALBUMINAR-20, ALBUMINAR-25, ALBUMINAR-5 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ALBUMINAR, ALBUMINAR-20, ALBUMINAR-25, ALBUMINAR-5 Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ALBUMINAR, ALBUMINAR-20, ALBUMINAR-25, ALBUMINAR-5 Derived from Patent Text Search

These patents were obtained by searching patent claims

ALBUMINAR, ALBUMINAR-20, ALBUMINAR-25, ALBUMINAR-5 Market Analysis and Financial Projection

The Albumin Market: Dynamics and Financial Trajectory

Introduction to Albumin

Albumin, particularly human serum albumin, is a crucial protein in human blood plasma, playing a vital role in maintaining oncotic pressure, facilitating the transport of essential substances, and alleviating protein deficiencies. The market for albumin products, including ALBUMINAR and its various concentrations (ALBUMINAR-20, ALBUMINAR-25, ALBUMINAR-5), is experiencing significant growth driven by several key factors.

Market Size and Growth Projections

The global albumin market is substantial and growing rapidly. As of 2022, the market size was valued at $5.4 billion and is projected to reach $9.9 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 6.2% from 2023 to 2032[1].

Key Drivers of Market Growth

Increasing Prevalence of Chronic Diseases

The rise in chronic diseases such as hypoalbuminemia, burns, trauma, liver cirrhosis, and cardiac surgeries significantly propels the demand for albumin. For instance, approximately 11 million individuals endure burn wounds annually, highlighting the critical role albumin plays in addressing these medical conditions[1].

Therapeutic Applications

Albumin is indispensable in therapeutic interventions, particularly in scenarios involving trauma, burns, and shock. Its therapeutic advantages in managing acute liver failure, acute nephrosis, and hemolytic disease of the newborn further underscore its significance[2].

Advancements in Plasma Fractionation Technologies

Improvements in plasma fractionation technologies have enhanced the efficiency and yield of albumin production. Companies like Kedrion Biopharma are expanding their offerings in emerging markets, addressing the needs for rare disease treatments[4].

Rise of Recombinant Albumin

The shift towards recombinant albumin, produced through genetic engineering, is gaining traction due to its superior safety profile and consistency compared to traditional human serum albumin. Products like Grifols' Albutein are increasingly used in clinical research and pharmaceutical applications[4].

Growing Investment in R&D

Increased investment in research and development, particularly in North America, is accelerating innovation and improving production processes. This has led to the development of new albumin products and applications, contributing to the robust growth of the market[4].

Market Segmentation

By Type

The human serum albumin segment dominated the market in terms of revenue in 2022 and is anticipated to grow at the fastest CAGR during the forecast period. This dominance is attributed to its widespread use in therapeutic applications[1].

By Application

The therapeutics segment dominated the market in terms of revenue in 2022 and is expected to register the fastest CAGR during the forecast period. Albumin's pivotal role in addressing critical health issues such as liver diseases, trauma, and surgical procedures drives this growth[1].

By Sales Channel

The business-to-business (B2B) segment dominated the market in 2022, driven by increased collaborations and partnerships among pharmaceutical and biotech companies. However, the business-to-consumer (B2C) segment is expected to grow at the fastest CAGR, enhancing market accessibility and customer engagement[1].

Regional Dynamics

North America

North America generated the largest revenue in 2022 and is expected to maintain its lead during the forecast period, due to the availability of improved facilities and the rise in adoption of albumin by healthcare professionals[1].

Asia-Pacific

The Asia-Pacific region is anticipated to grow at the highest CAGR during the forecast period, driven by a high population base, an increase in the prevalence of diseases, and a surge in healthcare expenditure[1].

Financial Trajectory

The financial trajectory of the albumin market is promising, with significant growth projected over the next decade. Here are some key financial highlights:

  • Market Size: The global albumin market was valued at $5.4 billion in 2022 and is projected to reach $9.9 billion by 2032[1].
  • CAGR: The market is expected to grow at a CAGR of 6.2% from 2023 to 2032[1].
  • Revenue Segmentation: The therapeutics segment and human serum albumin type are expected to dominate the market in terms of revenue and growth rate[1].

Pricing and Cost Considerations

The pricing of albumin products varies based on concentration and application. For example:

  • ALBUMINAR-25%: This high-concentration solution is typically more expensive due to its specific use in critical care situations.
  • ALBUMINAR-5%: This lower-concentration solution is generally less expensive and used in a broader range of therapeutic applications[2].

Example Pricing

  • Albumin 25% IV solution: Approximately $1.97 per mL[2].
  • Albumin 5% IV solution: Approximately $0.44 per mL[2].

Industry Players and Competition

The albumin market is characterized by the presence of several major industry players, including Kedrion Biopharma, Grifols, CSL Behring, and Baxter International. These companies are involved in advancing technology, conducting R&D, and expanding their product offerings to meet the growing demand for albumin[1][4].

Challenges and Opportunities

Biosimilars and Competition

While the albumin market is growing, it faces competition from biosimilars, which could lead to downward pricing pressure. However, this also opens up opportunities for wider access to biologics and potentially increased volume growth[3].

Regulatory Framework

The regulatory environment plays a crucial role in the albumin market. Strict regulations ensure the safety and efficacy of albumin products, but they also present challenges for new entrants and innovative products[4].

Key Takeaways

  • The global albumin market is projected to grow significantly, driven by increasing applications in therapeutics and advancements in production technologies.
  • Human serum albumin and the therapeutics segment are expected to dominate the market.
  • North America leads in market share, but the Asia-Pacific region is expected to grow at the highest CAGR.
  • The rise of recombinant albumin and growing investment in R&D are key drivers of market growth.
  • Major industry players are expanding their offerings and advancing technology to meet the growing demand.

FAQs

What are the primary applications of albumin in the medical field?

Albumin is primarily used in therapeutics to manage conditions such as hypoalbuminemia, burns, trauma, liver cirrhosis, and cardiac surgeries. It is also used in drug formulation and as a component of culture media[1][2].

How does the use of recombinant albumin impact the market?

Recombinant albumin, produced through genetic engineering, offers a superior safety profile and consistency compared to traditional human serum albumin. This shift is gaining traction and contributing to market growth[4].

Which region is expected to grow at the highest CAGR in the albumin market?

The Asia-Pacific region is anticipated to grow at the highest CAGR during the forecast period, driven by a high population base, an increase in the prevalence of diseases, and a surge in healthcare expenditure[1].

What are the key drivers of the albumin market's financial growth?

The market is driven by the increasing prevalence of chronic diseases, advancements in plasma fractionation technologies, the rise of recombinant albumin, and growing investment in R&D[1][4].

How does the pricing of albumin products vary?

The pricing of albumin products varies based on concentration and application, with higher-concentration solutions generally being more expensive due to their specific use in critical care situations[2].

Sources

  1. Allied Market Research: Albumin Market Size, Share | Growth Drivers | Forecast- 2032.
  2. DrugBank: Albumin human: Uses, Interactions, Mechanism of Action.
  3. IQVIA: Disruption and maturity: The next phase of biologics.
  4. Data Bridge Market Research: Albumin Market Size, Growth Drivers, Trends & Applications By 2031.

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