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Last Updated: January 5, 2025

KEDBUMIN Drug Profile


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Recent Clinical Trials for KEDBUMIN

Identify potential brand extensions & biosimilar entrants

SponsorPhase
inVentiv Health ClinicalPhase 4
Kedrion S.p.A.Phase 4

See all KEDBUMIN clinical trials

Recent Litigation for KEDBUMIN

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
GENENTECH, INC. v. DR. REDDYS LABORATORIES, INC.2023-11-17
Genentech, Inc. v. Biogen MA Inc.2023-07-13
Genentech, Inc. v. Samsung Bioepis Co. Ltd.2020-06-28

See all KEDBUMIN litigation

PTAB Litigation
PetitionerDate
Apotex Inc.2017-11-09
Apotex Inc. et al.2017-11-09
Cipla Ltd. et al.2017-11-09

See all KEDBUMIN litigation

Pharmacology for KEDBUMIN
Ingredient-typeSerum Albumin
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Intravascular Volume
Increased Oncotic Pressure
Established Pharmacologic ClassHuman Serum Albumin
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for KEDBUMIN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for KEDBUMIN Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for KEDBUMIN Derived from Patent Text Search

These patents were obtained by searching patent claims

KEDBUMIN Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Biologic Drug: KEDBUMIN

Introduction to KEDBUMIN

KEDBUMIN is a biologic drug developed by Kedrion Biopharma, a company specializing in plasma-derived therapies. This albumin-based product is crucial in various medical applications, including blood volume expansion, treatment of liver diseases, and burns.

Global Albumin Market Overview

The global albumin market is projected to grow significantly, driven by the critical applications of albumin in the medical field. Here are some key statistics:

  • Market Size: The albumin market is estimated at USD 7.27 billion in 2024 and is expected to reach USD 10.56 billion by 2029, growing at a CAGR of 7.76% during the forecast period[1].
  • Geographical Segmentation: The market is segmented into North America, Europe, Asia-Pacific, Middle East and Africa, and South America. North America holds the largest share, with 37.04% of the market in 2024, while the Asia-Pacific region is the fastest-growing market[1].

Role of Albumin in Medical Treatments

Albumin plays a vital role in several therapeutic areas:

  • Blood Volume Expansion: Albumin is used to expand blood volume in patients suffering from shock, burns, or other conditions that lead to fluid loss.
  • Liver Diseases: It is crucial in the treatment of liver diseases, such as cirrhosis and hepatocellular carcinoma (HCC), which are prevalent and drive demand for albumin-based products[1].
  • Burns Treatment: Albumin is used to treat severe burns by helping to maintain osmotic pressure and fluid balance.

Market Drivers

Several factors drive the growth of the albumin market, including:

  • Increasing Prevalence of Chronic Diseases: The rise in cases of liver and intrahepatic bile duct cancer, as well as other chronic conditions, increases the demand for albumin-based treatments[1].
  • Technological Advancements: Advances in blood separation processes and the development of specialized plasma-related products contribute to market growth[5].
  • Emerging Markets: Growing demand in emerging markets, particularly in the Asia-Pacific region and parts of Africa, is another significant driver[1].

Kedrion Biopharma's Position in the Market

Kedrion Biopharma is a key player in the plasma-derived therapies market, including albumin products like KEDBUMIN:

  • Revenue and Profitability: In 2021, Kedrion reported a turnover of EUR 660.4 million, with EBITDA reaching EUR 99.0 million, or 15.0% of revenues. The company's net income was around EUR 11.6 million, almost twice the previous year[3].
  • Market Presence: Kedrion has a global footprint, with the United States being its biggest market, accounting for 43.0% of turnover, followed by Europe and the rest of the world[3].
  • Strategic Activities: The company has been focused on strategic acquisitions and partnerships, such as the recent partnership with Permira to combine with BPL, a UK-based biopharmaceuticals company. This move is expected to strengthen Kedrion's position in the global market for plasma-derived therapies[3].

Financial Performance of Kedrion Biopharma

Kedrion Biopharma's financial performance reflects the overall trends in the albumin market:

  • Revenue Growth: Revenues from Kedrion's plasma derivatives segment, which includes albumin products, increased by 2.8% in 2021 to EUR 596 million. This growth was driven by positive trends in prices of immunoglobulin and other plasma-derived products[3].
  • Plasma Collections: Plasma collections increased by 35% in the last two quarters of 2021, mainly driven by pandemic recovery in the U.S. This trend is expected to continue and accelerate in the following years[3].
  • Financial Health: As of December 31, 2021, Kedrion's net financial position totaled EUR 528.0 million, including EUR 134.2 million in cash and EUR 264.0 million in undrawn credit lines[3].

Impact of COVID-19 on the Albumin Market

The COVID-19 pandemic had a significant impact on the albumin market:

  • Demand-Supply Imbalance: The pandemic exacerbated the already strained demand-supply landscape for albumin, as reduced plasma volumes affected production[5].
  • Recovery and Growth: Despite these challenges, companies like Kedrion managed to stay focused on cost control, strategic acquisitions, and finding ways to offset the reduced plasma volumes. The industry recovery trend has continued to gain strength post-pandemic[3].

Emerging Trends and Opportunities

Several emerging trends and opportunities are shaping the future of the albumin market:

  • Recombinant Albumin Production: Innovations in recombinant albumin production offer substantial opportunities for companies to focus on innovation, efficacy, and sustainability[1].
  • Targeting Emerging Markets: Companies can position themselves for growth by targeting emerging markets, particularly in the Asia-Pacific region and parts of Africa[1].
  • Specialized Plasma-Related Products: Advances in blood separation processes and the development of specialized plasma-related products are expected to impart significant growth momentum to the plasma protein market and subsequently the albumin market[5].

Regulatory Approvals and Product Development

Regulatory approvals play a crucial role in the growth of the albumin market:

  • Recent Approvals: Products like Albuminex and KEDBUMIN have been recently approved by the FDA, contributing to market expansion[5].
  • Pipeline of Biologic Drugs: The strong pipeline of biologic drugs, including novel treatments such as gene therapy, antisense, and RNAi therapies, is projected to drive market expansion in the coming years[4].

Conclusion

The albumin market, driven by the demand for products like KEDBUMIN, is poised for significant growth. Key drivers include the increasing prevalence of chronic diseases, technological advancements, and emerging market opportunities. Kedrion Biopharma, with its strong financial performance and strategic positioning, is well-equipped to capitalize on these trends.

Key Takeaways

  • The global albumin market is expected to grow from USD 7.27 billion in 2024 to USD 10.56 billion by 2029.
  • Kedrion Biopharma's revenue from plasma derivatives, including albumin, increased by 2.8% in 2021.
  • Emerging markets and recombinant albumin production are significant growth opportunities.
  • The COVID-19 pandemic affected plasma volumes but did not halt industry growth.
  • Regulatory approvals and a strong pipeline of biologic drugs support market expansion.

FAQs

Q: What is the projected growth rate of the global albumin market from 2024 to 2029? A: The global albumin market is expected to grow at a CAGR of 7.76% from 2024 to 2029[1].

Q: Which region holds the largest share in the global albumin market? A: North America holds the largest share, with 37.04% of the market in 2024[1].

Q: How did the COVID-19 pandemic impact the albumin market? A: The pandemic exacerbated the demand-supply imbalance for albumin due to reduced plasma volumes, but the industry has shown recovery and growth post-pandemic[5].

Q: What are some emerging trends in the albumin market? A: Emerging trends include recombinant albumin production, targeting emerging markets, and the development of specialized plasma-related products[1][5].

Q: Which company recently partnered with Permira to combine with BPL, a UK-based biopharmaceuticals company? A: Kedrion Biopharma recently partnered with Permira to combine with BPL, a UK-based biopharmaceuticals company[3].

Sources

  1. Mordor Intelligence - Albumin Market Size Analysis and Growth Report
  2. Kedrion Group - Consolidated financial statements as at 31/12/2012
  3. PR Newswire - Kedrion reports a 15% Ebitda on €660.4m of revenues in 2021
  4. Biospace - Biologics Market Size to Reach USD 699.5 Billion by 2032
  5. Fairfield Market Research - Albumin Market Size, Trends, Insights, Research Report 2029

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