HUMAN ALBUMIN GRIFOLS Drug Profile

Summary for Tradename: HUMAN ALBUMIN GRIFOLS

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for HUMAN ALBUMIN GRIFOLS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HUMAN ALBUMIN GRIFOLS

Recent Clinical Trials for HUMAN ALBUMIN GRIFOLS

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Hospital Clinic of Barcelona	Phase 2

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Recent Litigation for HUMAN ALBUMIN GRIFOLS

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
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 HUMAN ALBUMIN GRIFOLS litigation

PTAB Litigation

Petitioner	Date
Apotex Inc.	2017-11-09
Apotex Inc. et al.	2017-11-09
Cipla Ltd. et al.	2017-11-09

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Pharmacology for HUMAN ALBUMIN GRIFOLS

Ingredient-type	Serum Albumin
Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Intravascular Volume Increased Oncotic Pressure
Established Pharmacologic Class	Human 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

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.

2. General brand-side disclosures

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.

3. Patents from broad patent text search

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 HUMAN ALBUMIN GRIFOLS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for HUMAN ALBUMIN GRIFOLS Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for HUMAN ALBUMIN GRIFOLS Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	10,000,553	2031-10-11	Patent claims search
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	10,016,338	2033-03-11	Patent claims search
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	10,071,139	2034-10-03	Patent claims search
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	10,072,098	2032-03-02	Patent claims search

HUMAN ALBUMIN GRIFOLS Market Analysis and Financial Projection Experimental

Human Albumin Market Dynamics and Financial Trajectory: A Comprehensive Overview

Introduction to Human Albumin

Human albumin, the most abundant protein in human plasma, is crucial for maintaining blood volume and osmotic pressure. It is synthesized by the liver and plays a vital role in various medical applications, including the treatment of hypoalbuminemia, liver diseases, and burns.

Market Size and Growth Projections

The global human albumin market is poised for significant growth over the next few years. Here are some key projections:

• The market size is estimated to grow from $6.35 billion in 2023 to $10.19 billion by 2032, exhibiting a CAGR of 5.6% during the forecast period[3].
• By 2032, the market is predicted to reach $10.56 billion, growing at a CAGR of 7.76% from 2024 to 2029[5].

Regional Analysis

Asia-Pacific

The Asia-Pacific region is a significant driver of the albumin market. In 2021, the region's albumin market size was valued at $3,145.2 million and is expected to grow with a CAGR of 6.47% during the projected period. China's growing demand, driven by its expanding healthcare infrastructure and increasing disposable income, is a key factor in this regional growth[2].

North America

North America holds a major share of the global albumin market, with the U.S. market expected to reach an estimated value of $2.00 billion by 2032. This growth is driven by strong demand for non-therapeutic applications, increased plasma collection, and rising product approvals[3][5].

Europe

Europe also contributes significantly to the albumin market, with Grifols, a leading player, experiencing solid evolution in main European countries. The gradual recovery of alpha-1 products in European countries has further boosted the market[1].

Key Drivers of Market Growth

Increasing Prevalence of Chronic Diseases

The rise in chronic diseases such as liver cirrhosis, kidney disease, and cancer is driving the demand for albumin. These conditions often lead to hypoalbuminemia, a condition where albumin levels in the blood are abnormally low[4][5].

Technological Advancements

Technological developments in drug formulation and delivery, including the use of albumin in cell culture media, present lucrative opportunities for market growth. Recombinant human albumin, with its consistent quality and lower risk of contamination, is gaining popularity[4][5].

COVID-19 Impact

The COVID-19 pandemic has positively impacted the albumin market, particularly through the increased production of vaccines that use albumin. For instance, vaccines like Covishield and Covaxin have driven up the demand for albumin[2].

Financial Performance of Grifols

Grifols, a market leader in the biopharma sector, has seen significant financial growth in its albumin segment:

• Total revenues for Grifols' Biopharma division increased by 8.9% in 2023, with albumin contributing 10-15% of the revenues. The albumin segment saw a growth of 20.1% in constant currency terms, driven by strong demand in China and solid evolution in European countries[1].

• The Bio Supplies segment, which includes albumin products, reported total revenues of €160 million, with a growth of 9.5% in constant currency terms. This growth was partly due to strong sales of hyperimmune plasma and contributions from the acquisition of Access Biologicals[1].

Market Segmentation

Human Serum Albumin

Human serum albumin (HSA) is expected to be the leading segment in the albumin market. HSA is essential for sustaining plasma colloid oncotic pressure and is widely used in cell culture procedures, drug delivery, and therapeutic applications[2][3][4].

Non-Therapeutic Applications

Non-therapeutic applications, such as in vitro cell culture and biopharmaceutical research, are also driving the demand for albumin. The increasing use of albumin in these areas is expected to contribute significantly to market growth[3][4].

Challenges and Opportunities

Regulatory Hurdles

Despite the growth potential, the albumin market faces regulatory hurdles and high production costs, particularly for recombinant human albumin. These challenges need to be addressed by market players to fully capitalize on the market opportunities[5].

Emerging Trends

Emerging trends such as recombinant albumin production and personalized medicine offer substantial opportunities for market players. Targeting emerging markets, especially in Asia-Pacific and Africa, can also drive growth[5].

Key Players

The albumin market is dominated by several key players, including:

• Grifols, S.A.
• CSL Limited
• Takeda Pharmaceutical Company Limited
• Biotest AG
• HiMedia Laboratories Pvt. Ltd.[3][4][5]

Conclusion

The human albumin market is poised for robust growth driven by increasing chronic diseases, technological advancements, and the impact of the COVID-19 pandemic. Grifols, as a market leader, has demonstrated strong financial performance in its albumin segment. However, the market also faces challenges such as regulatory hurdles and high production costs.

Key Takeaways

• The global human albumin market is projected to grow significantly, reaching $10.19 billion by 2032.
• Asia-Pacific and North America are key regions driving market growth.
• Chronic diseases and technological advancements are major drivers of the market.
• Grifols has seen strong financial growth in its albumin segment.
• Regulatory hurdles and high production costs are significant challenges.

FAQs

Q: What is the projected growth rate of the global human albumin market? A: The global human albumin market is expected to grow at a CAGR of 5.6% from 2024 to 2032[3].

Q: Which region is expected to dominate the albumin market? A: North America is expected to hold a major share of the global albumin market, but the Asia-Pacific region is also growing rapidly[3][5].

Q: What are the main drivers of the albumin market? A: The main drivers include the increasing prevalence of chronic diseases, technological advancements, and the impact of the COVID-19 pandemic[2][4][5].

Q: Who are the key players in the albumin market? A: Key players include Grifols, S.A., CSL Limited, Takeda Pharmaceutical Company Limited, Biotest AG, and HiMedia Laboratories Pvt. Ltd.[3][4][5].

Q: What are the challenges faced by the albumin market? A: The market faces challenges such as regulatory hurdles, high production costs, and market competition[5].

Sources

1. Grifols Financial Performance - Grifols.com
2. Albumin Market Size, Share, Statistics, Trends, Growth By 2032 - ResearchDive
3. Albumin Market | Key products, Applications, End-users [2032] - Fortune Business Insights
4. Global Albumin Market Size, Trends, Growth & Forecast - 2031 - Transparency Market Research
5. Albumin Market Size Analysis and Growth Report - Mordor Intelligence