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ALBUMIN HUMAN - Generic Drug Details

What are the generic sources for albumin human and what is the scope of patent protection?

Albumin human is the generic ingredient in one branded drug marketed by Ge Healthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ALBUMIN HUMAN

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	1,396
Patent Applications:	5,885
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALBUMIN HUMAN
What excipients (inactive ingredients) are in ALBUMIN HUMAN?	ALBUMIN HUMAN excipients list
DailyMed Link:	ALBUMIN HUMAN at DailyMed

Recent Clinical Trials for ALBUMIN HUMAN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Glostrup University Hospital, Copenhagen	Phase 4
King's College London	Phase 4
Juvenile Diabetes Research Foundation	Phase 4

See all ALBUMIN HUMAN clinical trials

Pharmacology for ALBUMIN HUMAN

Drug Class	Contrast Agent for Ultrasound Imaging
Mechanism of Action	Ultrasound Contrast Activity

Anatomical Therapeutic Chemical (ATC) Classes for ALBUMIN HUMAN

B05AA	Blood substitutes and plasma protein fractions
B05A	BLOOD AND RELATED PRODUCTS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for ALBUMIN HUMAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997		RX	Yes	Yes

Expired US Patents for ALBUMIN HUMAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997

ALBUMIN HUMAN Market Analysis and Financial Projection Experimental

Albumin Human Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The global albumin market is experiencing significant growth, driven by various factors including the increasing prevalence of diseases, advancements in healthcare, and rising demand for albumin in pharmaceutical applications.

• As of 2022, the global albumin market 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[1].
• Another projection indicates that the human serum albumin market was valued at $6.35 billion in 2023 and is expected to reach $9.55 billion by 2031, growing at a 4.5% CAGR from 2024 to 2031[3].
• A more extended forecast suggests the market will be worth around $11.64 billion by 2034, growing at a CAGR of 5.62% from 2024 to 2034[4].

Key Drivers of Market Growth

Several factors are driving the growth of the albumin market:

• Increasing Prevalence of Diseases: The rise in conditions 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 of albumin in addressing these medical consequences[1].
• Advancements in Healthcare: The growing need for medicines generated from plasma and the increasing prevalence of chronic disorders are key drivers. Advances in healthcare and rising healthcare costs also contribute to the rising demand for albumin[3].
• Public Awareness and Research: Increasing public awareness of the benefits of albumin and ongoing research into its therapeutic applications further support market growth. The versatile properties of albumin make it a valuable component in pharmaceutical formulations, enhancing drug stability and delivery[1].

Segmental Overview

The albumin market is segmented based on several criteria:

• 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[1].
• By Application: The therapeutics segment dominated the market in terms of revenue in 2022 and is expected to continue growing at the fastest CAGR. Albumin is crucial in treating conditions such as burns, trauma, and liver illnesses[1][3].
• By Sales Channel: The B2B segment dominated the market in 2022, but the B2C segment is expected to grow at the fastest CAGR during the forecast period. The B2B model facilitates bulk purchases, while the B2C model enhances market accessibility and customer engagement[1].
• By Region: North America generated the largest revenue in 2022 due to advanced medical technologies and a well-developed healthcare network. However, the Asia-Pacific region is anticipated to grow at the highest CAGR during the forecast period, driven by increasing healthcare spending and demand for advanced medical treatments[1][4].

Regional Market Dynamics

• North America: This region accounted for the largest albumin market size in 2022, driven by growing access to advanced medical technologies and a well-developed network of healthcare facilities[1].
• Asia-Pacific: Expected to grow at the highest CAGR, this region is driven by rapid growth in the biotechnology and pharmaceutical industries, particularly in countries like China, India, and South Korea. Progressive liver disease, such as chronic hepatitis B, is a leading indication for albumin in China[1][4].

Impact of Economic Downturns

During economic downturns, the albumin market experiences both negative and positive impacts:

• Negative Impacts: Economic downturns can lead to reduced healthcare spending, affecting the demand for medical products like albumin. Budget constraints may limit the adoption of albumin in certain medical applications[1].
• Positive Impacts: The therapeutic benefits of albumin in treating critical health conditions can create opportunities. The focus on cost-effective and efficient healthcare solutions during economic downturns may drive the use of albumin in treating liver diseases, trauma, and surgical interventions. Ongoing research and development efforts may also uncover new therapeutic applications for albumin[1].

Clinical Significance and Outcomes

Studies have highlighted the critical role of albumin levels in patient outcomes:

• Serum Albumin Trajectories: Research on sepsis patients identified four distinct serum albumin trajectory groups, showing that patients with persistently low albumin levels had the worst clinical outcomes, including higher mortality rates and increased incidence of acute kidney injury and fluid accumulation[2].
• Association with Hypertension: A study found that moderate increases in serum albumin concentrations and high stable trajectories were significantly associated with a reduced risk of hypertension[5].

Illustrative Statistics

• Market Size: The global albumin market is projected to grow from $5.4 billion in 2022 to $9.9 billion by 2032[1].
• CAGR: The market is expected to grow at a CAGR of 6.2% from 2023 to 2032[1].
• Burn Incidents: Approximately 11 million individuals endure burn wounds annually, underscoring the critical role of albumin in addressing these medical consequences[1].
• Chronic Hepatitis B: China has the world’s highest chronic hepatitis B virus (HBV) infection burden, with an estimated 90 million people living with chronic HBV, of whom 28 million require treatment[4].

Quotes from Industry Experts

"The albumin market is experiencing growth propelled by increasing initiatives aimed at raising awareness about blood donation. As awareness campaigns gain momentum, there is a positive impact on the supply of human plasma, a key source of albumin."[1]

Key Takeaways

• The global albumin market is growing significantly due to the increasing prevalence of diseases and advancements in healthcare.
• The market is segmented by type, application, sales channel, and region, with the human serum albumin segment and therapeutics application dominating.
• North America currently leads in market size, but the Asia-Pacific region is expected to grow at the highest CAGR.
• Economic downturns have mixed impacts on the market, but the therapeutic benefits of albumin can create opportunities.
• Clinical studies highlight the importance of serum albumin levels in patient outcomes.

FAQs

Q1: What is the current market size of the global albumin market? The global albumin market was valued at $5.4 billion in 2022[1].

Q2: What is the projected growth rate of the albumin market? The market is projected to grow at a CAGR of 6.2% from 2023 to 2032[1].

Q3: 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[1][4].

Q4: What are the key drivers of the albumin market growth? Key drivers include the increasing prevalence of diseases, advancements in healthcare, and rising demand for albumin in pharmaceutical applications[1][3].

Q5: How does economic downturn affect the albumin market? Economic downturns can reduce healthcare spending but also create opportunities for cost-effective and efficient healthcare solutions using albumin[1].

Cited Sources

1. Allied Market Research - Albumin Market Size, Share | Growth Drivers | Forecast- 2032
2. Frontiers in Nutrition - Associations between serum albumin level trajectories and clinical outcomes in sepsis patients
3. Market Research Intellect - Human Serum Albumin Market Size and Projections
4. Precedence Research - Albumin Market Size to Hit USD 11.64 Billion by 2034
5. Frontiers in Cardiovascular Medicine - Association between serum albumin concentration change trajectory and risk of hypertension