Albumin Market Trends

Growth Drivers

• Rising prevalence of chronic diseases boosts albumin demand: The market has been expanding due to the increasing incidence of chronic diseases such as liver cirrhosis, hypoalbuminemia, and kidney disorders, as albumin is crucial for the treatment to maintain the fluid balance and plasma volume. According to the American Liver Foundation in September 2023, approximately 4.5 million U.S. adults (about 1.8%) have been diagnosed with liver disease, which indicates a growth in the market. However, it is estimated that between 80 and 100 million adults in the U.S. have fatty liver disease, many of whom are unaware of their condition. This growing population base has, in turn, increased the circulation of albumin therapies throughout the world. 
• Biotechnology advancements enable safer recombinant albumin products: Technological innovation in biotechnology and recombinant DNA techniques stood as drivers for the albumin market. According to the American Liver Foundation in September 2023, Liver disease or cirrhosis is found in different amounts among groups, such as 6.9% of the U.S. population from Japan, 6.7% of Latino people, and 4.1% of White people. Since 2022, several recombinant albumin therapies have received approval from the U.S. Food and Drug Administration (FDA), promoting their usage in drug formulation and vaccine development. While the presence of recombinant albumin therapies answers what is now a growing demand on one hand, these therapies also address safety concerns.
• Expansion of plasma fractionation infrastructure fuels albumin supply: The global growth in plasma fractionation capacity, especially in emerging markets, is paramount in satisfying the increasing demand for market. The World Health Organization (WHO) reported in October 2023 that an estimated 180,000 deaths occur annually due to burns, which require albumin for effective burn shock resuscitation. Many new plasma fractionation sites have been established in response to therapeutic needs, thereby enhancing the production capacity of albumin. Such infrastructural development shall ensure the constant supply of albumin for critical medical applications. Hence, with an improved production capacity, the demands for albumin continue to expand.

Albuminuria Categories in Chronic Kidney Disease (2022)

Source: NLM

Challenges

• Existence of black-market sales: The existence of the illicit albumin market readily endangers patients’ lives and erodes trust, thus causing a hindrance to the market growth. Besides, the gray market in India effectively thrives, owing to gaps in the supply system, with markups increasing. Therefore, all these issues deter manufacturers, resulting in incompetence. However, rigid enforcement and public awareness campaigns are probable solutions to combat these challenges.
• Limitations in clinical guidelines: The presence of strict treatment protocols tends to curb the expansion of the market internationally. Hence, the UK’s NICE has recommended albumin for use only in burns and cirrhosis, thereby excluding off-label applications. Likewise, Medicare has authorized rules in the U.S., which have caused delays of prescriptions through bureaucratic appeals. Thus, all these limitations reflect cost risks in comparison to clinical faults, as evident in studies conducted to ensure albumin’s efficacy in post-surgical and sepsis recovery.