Global human albumin market: extra revenues to come through non-therapeutic applications
Manufacturers plan to implement premium pricing strategies for commercial use of albumin as an excipient.
Human albumin is widely considered as a plasma replacement or expander for therapeutic purposes. However, for over a decade, the healthcare industry has been exploring the use of human albumin as a non-therapeutic substance/excipient for commercial settings. Across these application areas, emerging opportunities for human albumin as a drug formulation agent, vaccine ingredient, sealant in surgeries, and coating for medical devices and equipment are expected to drive production.
New analysis from Frost & Sullivan, Analysis of the Global Human Albumin Market and Product Pipeline, finds that the non-therapeutic use of human albumin as an excipient has generated plenty of interest from the industry and will create a potential customer base comprising academics, research institutes, and pharmaceutical and biopharmaceutical companies. Despite this, very few manufacturers, which include large, medium and small enterprises, currently supply human albumin for non-therapeutic applications as an excipient.
Highly consolidated, the market is dominated by a few top participants. There are about 10 key human albumin products from blood plasma manufacturers that meet the therapeutic use of human albumin in fluid replacement therapy. However, the share of albumin in the blood plasma market has decreased from almost 40% in the 1980s to 10% in 2015. As human albumin volume growth is expected to slow down during the forecast period, manufacturers will adopt premium pricing in the non-therapeutic application segment to meet their profit margins.
“When it comes to albumin for replacement therapy, a premium pricing strategy could go in vain,” said Frost & Sullivan Healthcare Senior Research Analyst Aish Vivekanandan. “This is because pricing pressures, along with limited return on investment and competition from substitute products, pose a challenge to the use of human albumin in replacement therapy.”
On the other hand, global increase in the fractionation of blood and rise in demand for human albumin in Asia-Pacific countries, especially India and China, will sustain production rates. In India, regulatory pressures and pricing control of albumin are being eased to meet the therapeutic needs of the population. With shortages in albumin products in the country, global manufacturers are likely to foray into the market, while China’s albumin market grows steadily.
The evolving need of albumin use as an excipient will also widen existing market opportunities for blood plasma product manufacturers. Going forward, a large number of biotech and biopharmaceutical firms are expected to develop recombinant versions of albumin to explore its potential in extending the half-life and stability to biologics and bio-similars. There are at least 15 products under clinical trial that involve the use of human albumin as an excipient (stabiliser, drug formulation).
“Some of the key products in which albumin is being used as a drug formulation agent, stabiliser or fusion protein for half-life extension are ABI-009 and rIX-FP,” noted Vivekanandan. “rIX-FP and Albutein for Alzheimer’s disease are expected to be launched in late 2015 and 2020, respectively.”
Developed by CSL Behring, rIX-FP is a recombinant fusion protein linking coagulation factor IX with albumin. It is indicated for the treatment of hemophilia B, with dosing intervals of up to 14 days. ABI-009 is a nanoparticle albumin-bound version of the mTOR inhibitor sirolimus or rapamycin developed by Celgene, which licensed it out to AADi LLC, a clinical-stage biopharmaceutical company.
Related News
-
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Pharma Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain. -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement. -
News BIOSECURE Act continues to loom over Chinese pharma manufacturers
With the US BIOSECURE Act on its way to passing into legislation, Chinese companies are facing declining revenues within the first half of 2024 as US pharmaceutical and healthcare companies pull their businesses from the country. -
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance