PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1933335
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1933335
The global therapeutic albumin market is witnessing steady growth due to the increasing prevalence of chronic diseases, trauma, and burn injuries. Therapeutic albumin, a purified protein derived primarily from human blood plasma, plays a crucial role in maintaining oncotic pressure, transporting hormones, enzymes, and drugs, and treating hypovolemia, burns, hypoalbuminemia, acute liver failure, and shock. The market's expansion is further supported by advancements in recombinant albumin production and increasing applications in regenerative medicine and cell therapy.
In 2025, the market was valued at USD 7.23 billion, growing to USD 7.70 billion in 2026, and projected to reach USD 13.33 billion by 2034, registering a CAGR of 7.10% from 2026-2034. Asia Pacific dominated in 2025 with a 55.49% share, driven by a high incidence of chronic diseases and burn cases.
Market Drivers and Trends
Increasing Chronic Disease Burden and Burn Incidents
The rising prevalence of liver disorders, kidney diseases, and cancer, along with increasing burn injuries, is driving market growth. For instance, the U.S. had 6.0 million kidney disease cases and 4.5 million chronic liver disease cases in 2024, while 32,540 severe burn cases required hospitalization in 2023, highlighting the significant demand for therapeutic albumin in fluid resuscitation and critical care settings.
Advancements in Albumin Production
Due to limitations of human-derived albumin, such as supply shortages, pathogen transmission risk, and batch variability, companies are investing in recombinant albumin and advanced albumin formulations. Innovations like Shilpa Medicare's sRbumin, a yeast-derived recombinant albumin, address supply gaps and improve safety and consistency.
Emerging Applications in Regenerative Medicine
Therapeutic albumin's biocompatibility and protein stabilization properties make it ideal for cell therapy and tissue engineering, presenting new opportunities for market growth. Collaborations, such as Albumedix and Heartseed, are exploring recombinant albumin in cardiac cell therapy, indicating expanding clinical applications.
Market Challenges
Regulatory hurdles, high production costs, and limited availability of human plasma remain key challenges. Approval processes from the FDA, EMA, and NMPA slow product launches, while developing economies struggle with accessibility and affordability. Supply chain disruptions, such as the 2024 U.S. blood shortage reported by the American Red Cross, further constrain market growth.
Market Segmentation
By Source
By Indication
By Distribution Channel
Asia Pacific dominated in 2025 with USD 4.01 billion, projected to lead with Japan at USD 0.85 billion, China at USD 1.86 billion, and India at USD 0.46 billion in 2026, driven by chronic disease prevalence and burn cases.
North America is growing steadily, with the U.S. market projected at USD 1.52 billion in 2026, benefiting from strong plasma donation networks and advanced manufacturing facilities.
Europe holds the second-largest market, with the UK at USD 0.18 billion and Germany at USD 0.28 billion in 2026, supported by clinical trials and research activities.
Latin America and the Middle East & Africa hold smaller shares but are expected to grow due to rising chronic disease prevalence and increasing plasma collection initiatives.
Competitive Landscape
Key players like Grifols, S.A., Octapharma AG, Kedrion S.p.A., Takeda Pharmaceutical, CSL, and China Biologic dominate the market through strategic acquisitions, collaborations, and new product launches. Notable developments include Grifols inaugurating a new purification plant in Dublin (2022) and Shilpa Medicare completing FDA inspection of its facility in India (2025), highlighting the focus on production capacity expansion and regulatory compliance.
Conclusion
The therapeutic albumin market is projected to grow from USD 7.23 billion in 2025 to USD 13.33 billion by 2034, driven by chronic disease prevalence, burn injuries, technological advancements in recombinant albumin, and expanding clinical applications in regenerative medicine. Asia Pacific remains the leading region, while North America and Europe continue steady growth. Challenges like supply constraints, regulatory barriers, and high production costs persist, but innovations in recombinant albumin and advanced formulations are expected to sustain market growth and improve global patient access to this vital therapeutic protein.
Segmentation By Source
By Indication
By Distribution Channel
By Region