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Last Updated: December 24, 2024

ALBUTEIN Drug Profile


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Recent Clinical Trials for ALBUTEIN

Identify potential brand extensions & biosimilar entrants

SponsorPhase
The University of Texas Health Science Center, HoustonPhase 4
Grifols Biologicals, LLCPhase 2
Hunter Holmes Mcguire Veteran Affairs Medical CenterPhase 2

See all ALBUTEIN clinical trials

Recent Litigation for ALBUTEIN

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
GENENTECH, INC. v. DR. REDDYS LABORATORIES, INC.2023-11-17
Genentech, Inc. v. Biogen MA Inc.2023-07-13
Genentech, Inc. v. Samsung Bioepis Co. Ltd.2020-06-28

See all ALBUTEIN litigation

PTAB Litigation
PetitionerDate
Apotex Inc.2017-11-09
Apotex Inc. et al.2017-11-09
Cipla Ltd. et al.2017-11-09

See all ALBUTEIN litigation

Pharmacology for ALBUTEIN
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 ALBUTEIN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ALBUTEIN Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ALBUTEIN Derived from Patent Text Search

These patents were obtained by searching patent claims

ALBUTEIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: Albutein

Introduction

Albutein, a human albumin solution, is a crucial biologic drug used in various medical treatments, including the management of hypoalbuminemia, burns, trauma, and liver cirrhosis. The market for albumin, including Albutein, is experiencing significant growth driven by several key factors.

Global Albumin Market Size and Growth

The global albumin market is substantial and growing rapidly. As of 2024, the market size is estimated to be around USD 6.74 billion, with projections to reach USD 11.64 billion by 2034, growing at a Compound Annual Growth Rate (CAGR) of 5.62% from 2024 to 2034[1].

Key Drivers of Market Growth

Several factors are driving the growth of the albumin market:

Increasing Demand in Emerging Economies

Emerging economies, particularly in the Asia-Pacific region, are witnessing a surge in demand for albumin due to increasing healthcare spending and the need for advanced medical treatments. Countries like China, India, and South Korea are becoming key players in the production and consumption of recombinant albumin[1].

Advancements in Biotechnology

Advancements in biotechnology have improved the production of albumin, making it more accessible and efficient. This includes the development of recombinant albumin, which is gaining traction in the market[1].

Rising Prevalence of Chronic Diseases

The increasing prevalence of chronic diseases such as liver cirrhosis, hepatitis B, and other conditions that require albumin-based therapies is a significant driver. For instance, China has the world’s highest chronic hepatitis B virus (HBV) infection burden, with an estimated 90 million people living with chronic HBV, many of whom require albumin treatment[1].

Expansion of Plasma Fractionation Facilities

The growth in plasma fractionation facilities is also contributing to the increased availability of albumin products. This expansion is driven by robust underlying demand for key proteins and favorable product mix[3].

Regional Market Dynamics

North America

North America currently holds the largest share of the albumin market due to advanced medical technologies, a well-developed healthcare network, and a high incidence of diseases requiring albumin treatments. The region is home to several leading pharmaceutical manufacturers, driving innovation and product availability[5].

Asia-Pacific

The Asia-Pacific region is expected to exhibit the highest CAGR during the forecast period. This growth is attributed to the rising geriatric population, increased prevalence of disorders, and ongoing enhancements in healthcare infrastructure. The region also sees a rise in research activities and the presence of domestic companies, which are expected to provide notable opportunities for market growth[5].

Clinical Trials and Innovations

Grifols, a leading producer of plasma-derived medicines, has been at the forefront of innovations in albumin therapy. The company recently completed enrollment in a phase 3 clinical trial (PRECIOSA) to evaluate the efficacy and safety of long-term Albutein® treatment for patients with decompensated cirrhosis and ascites. This study aims to determine if albumin can increase survival time in these patients until a liver transplant is available[2].

Financial Performance of Key Players

Grifols, the manufacturer of Albutein, has delivered strong financial performance in recent years. In 2022, Grifols reported total revenue of EUR 6,064 million, with a significant portion coming from its Biopharma segment, which includes albumin products. The company's adjusted EBITDA stood at EUR 1,247 million, reflecting a 20.6% margin. Grifols continues to focus on improving its financial performance and executing operational improvement plans to drive future growth[3].

Market Segmentation

By Product

The albumin market is segmented by product, with human albumin solutions like Albutein being a major category. Recombinant albumin is also gaining traction due to its efficiency and cost-effectiveness[1].

By Application

Albumin is used in various applications, including the treatment of hypoalbuminemia, burns, trauma, and liver cirrhosis. Its use as a volume expander in burn shock resuscitation and in correcting hypoalbuminemia is particularly significant[5].

By End-User

The market is segmented by end-users, including hospitals, research institutions, and pharmaceutical companies. The business-to-business (B2B) segment dominates the market due to bulk purchases for research, manufacturing, and development activities[5].

Competition Analysis

The albumin market is competitive, with several key players including Grifols, CSL Behring, and Takeda. Grifols, with its strong portfolio of plasma-derived medicines, is a leading player. The company's commitment to innovation and its extensive clinical trials, such as the PRECIOSA study, position it well in the market[2].

Future Outlook

Growing Demand for Therapeutic Interventions

The market's growth is closely tied to its indispensability in therapeutic interventions, especially in scenarios involving trauma, burns, and shock. The surge in shock and burn cases, with approximately 11 million individuals enduring burn wounds annually, underscores the critical role albumin plays in modern healthcare[5].

Expanding Healthcare Infrastructure

Ongoing enhancements in healthcare infrastructure, particularly in the Asia-Pacific region, are expected to drive market expansion. Initiatives aimed at raising awareness and facilitating the use of albumin products will further contribute to market growth[5].

Direct-to-Consumer Sales

The business-to-consumer (B2C) segment is expected to register the fastest CAGR in the forecast period. Direct sales from businesses to individual consumers enhance market accessibility, foster customer engagement, and potentially lead to increased sales[5].

Key Takeaways

  • The global albumin market is projected to grow significantly, reaching USD 11.64 billion by 2034.
  • Emerging economies and advancements in biotechnology are key drivers of market growth.
  • The Asia-Pacific region is expected to exhibit the highest CAGR due to rising healthcare spending and increasing demand for advanced medical treatments.
  • Grifols' innovations, such as the PRECIOSA clinical trial, highlight the potential of albumin in treating decompensated cirrhosis.
  • The market is segmented by product, application, and end-user, with B2B transactions dominating due to bulk purchases.

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 albumin market from 2024 to 2034?

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

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

The Asia-Pacific region is expected to exhibit the highest CAGR during the forecast period due to rising healthcare spending and increasing demand for advanced medical treatments[5].

What are the primary applications of albumin in medical treatments?

Albumin is primarily used in the treatment of hypoalbuminemia, burns, trauma, and liver cirrhosis, and as a volume expander in burn shock resuscitation[5].

Which company is conducting a phase 3 clinical trial for long-term albumin treatment in patients with decompensated cirrhosis?

Grifols is conducting the PRECIOSA phase 3 clinical trial to evaluate the efficacy and safety of long-term Albutein® treatment for patients with decompensated cirrhosis and ascites[2].

Sources

  1. Precedence Research: Albumin Market Size to Hit USD 11.64 Billion by 2034
  2. Grifols: Grifols completes enrollment in phase 3 study of long-term Albutein® (albumin-human injection) therapy for patients with decompensated cirrhosis
  3. CNMV: Grifols delivers strong 2022 performance and is positioned for sustainable future growth
  4. IQVIA: Outlook for Global Medicines through 2021
  5. Allied Market Research: Albumin Market Size, Share | Growth Drivers | Forecast- 2032

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