Albumin is the most abundant blood plasma protein in the human circulatory system, produced in the liver. It helps maintain blood volume and acts as a transport protein for molecules like hormones, fatty acids and pharmaceuticals. Albumin has a short half-life of around 20 days and its levels in the body need to be maintained.
Production and therapeutic uses of human albumin
Recombinant human albumin is albumin that is produced through recombinant DNA technology, without using any human blood or plasma. It is manufactured by genetically engineering mammalian cells like hamster ovary cells to synthesize albumin. rHu Albumin has the same primary amino acid sequence and biological functions as natural human albumin. Its therapeutic uses include volume expansion in surgery, burn cases, and conditions involving blood loss. It is also used for stabilizing medications and enhancing drug delivery due to its capacity to bind and transport pharmaceuticals.
Potential and size
rHu Albumin accounts for around 30% of this market currently. The increasing volume of surgeries and trauma/burn cases, rising plasma collection costs, and safety concerns associated with plasma-derived albumin are boosting adoption and demand for rHu Albumin. Developed countries utilize human albumin more commonly given stricter regulations around blood-derived products in these markets. Overall, the recombinant albumin space holds enormous commercial potential in the coming years.
Leading global manufacturers
There are only a handful of companies that have the capability and license to produce rHu Albumin at commercial scale. CSL Behring and Takeda Pharmaceuticals are globally leading players in this arena with their flagship human albumin brands Albumex and Alburx respectively. Other notable manufacturers include Albumedix (part of CSL), LFB SA, Merck and Boehringer Ingelheim. Collectively, these companies account for over 85% of the current recombinant albumin production worldwide. Given projected market expansion, each company is undertaking strategic capacity expansions and facility investments running into hundreds of millions of dollars.
Regulatory pathway and approval processes
Regulatory approval for any new drug or biologic for human therapeutic use involves rigorous clinical testing protocols along with complex review procedures by agencies like the FDA and EMA. For human albumin, companies need to prove pharmacokinetic equivalence to human plasma-derived albumin first through animal and early human trials, followed by late stage clinical evaluation establishing safety, efficacy and comparability. Additional requirements are associated with manufacturing site approvals and consistent large-scale commercial production under cGMP standards.Â
Key business strategies employed
Leading manufacturers deploy a variety of smart business strategies to gain competitive advantage and maximize profits in the crowded recombinant albumin space. Persistent focus on R&D is enabling continuous improvements in production methods for higher yields, lower costs and novel drug delivery applications. Companies also form strategic alliances for technology transfers and co-development of niche indications. Aggressive marketing campaigns highlight the safety and reliability attributes to hospitals and physicians, the key end-users. Contract manufacturing represents a significant revenue stream by leveraging excess bioreactor capacities. Lastly, geographical expansion into emerging pharma hotspots like China, India and Brazil holds promise for sustaining long-term growth.
Challenges and opportunities looking ahead
While the long-term growth drivers are overwhelming, human albumin companies must manoeuver industry-specific challenges. Production facilities remain capital-intensive limiting new entrants. Plant-related operational issues can severely impact supply continuity. Stringent intellectual property enforcement is crucial to recoup investments in novel products. Manufacturing innovation is vital to combat threat from biosimilars over time. However, potential opportunities are boundless in related areas like gene-therapy, vaccine stabilization and metabolic disorders. Further diversification into non-blood volume applications will only enlarge the commercial attractiveness of human albumin. Overall, this niche biomanufacturing industry remains primed for profitable times ahead with smart resource allocation and R&D strides.
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