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Last Updated: April 25, 2025

Kedrion Biopharma Inc. Company Profile


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Biologic Drugs for Kedrion Biopharma Inc.

Applicant Tradename Biologic Ingredient Dosage Form BLA Patent No. Estimated Patent Expiration Source
Kedrion Biopharma Inc. RYPLAZIM plasminogen, human-tvmh For Injection 125659 10,787,507 2027-05-21 Patent claims search
Kedrion Biopharma Inc. RYPLAZIM plasminogen, human-tvmh For Injection 125659 10,802,032 2034-01-11 Patent claims search
Kedrion Biopharma Inc. RYPLAZIM plasminogen, human-tvmh For Injection 125659 10,806,755 2035-02-25 Patent claims search
Kedrion Biopharma Inc. RYPLAZIM plasminogen, human-tvmh For Injection 125659 10,830,727 2037-11-03 Patent claims search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source
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Biotech Competitive Landscape Analysis: Kedrion Biopharma Inc. – Market Position, Strengths & Strategic Insights

In the dynamic world of biotechnology, understanding the competitive landscape is crucial for success. Today, we're diving deep into Kedrion Biopharma Inc., a key player in the plasma-derived therapeutics market. Let's explore their market position, strengths, and strategic insights to gain a comprehensive view of their standing in the biotech industry.

Kedrion Biopharma: A Global Force in Plasma-Derived Therapeutics

Kedrion Biopharma has established itself as a significant player in the biopharmaceutical industry, specializing in plasma-derived medicines. With a global presence and a strong focus on rare and ultra-rare diseases, Kedrion has carved out a unique position in the market.

A Snapshot of Kedrion's Market Presence

Kedrion's global reach is impressive, with operations spanning over 100 countries[7]. The company's primary market is the United States, which accounts for a substantial 58% of its total revenue[7]. This strong foothold in the U.S. market is a testament to Kedrion's strategic focus and the quality of its products.

Revenue and Growth

In 2022, Kedrion Group (without BPL Group) generated revenues of €719.8 million, marking a 9% increase over 2021[2]. The combined Kedrion-BPL Group ended the year with revenues of €886.7 million, representing a significant 34.3% increase from the previous year[2].

With revenues of 1.4 billion Euro and a global team of 5,300 talents, Kedrion is confirmed as one of the world's leading players[1].

This impressive growth trajectory positions Kedrion as a formidable competitor in the plasma-derived therapeutics market.

Kedrion's Market Position in the Plasma-Derivatives Industry

To truly understand Kedrion's standing, we need to examine its position relative to other major players in the industry.

Global Market Share

As of 2022, the combined Kedrion and BPL Group held the fifth position in the global plasma-derivatives market with a 3.9% market share[1]. This places them behind industry giants CSL, Grifols, and Takeda, who collectively hold about 64.4% of the market share.

Product-Specific Market Shares

Kedrion's market position varies across different product categories:

  1. Immunoglobulins: 4.2% market share (5th position)[1]
  2. Albumin: 5.9% market share (5th position)[1]
  3. Plasma-derived Factor VIII: 6.8% market share (5th position)[1]
  4. Anti-D hyperimmune immunoglobulins: 32% market share (2nd position globally)[1]

A Leader in Anti-D Immunoglobulins

Kedrion's strongest position is in the Anti-D immunoglobulins market, where it holds the second position globally with a 32% market share[1]. This is largely due to its RhoGAM product, which holds a 45% market share in the U.S., and significant shares in other markets like Italy, Russia, Turkey, and the Middle East[1].

Kedrion's Key Strengths and Competitive Advantages

Kedrion's market position is underpinned by several key strengths that give it a competitive edge in the industry.

1. Robust Product Portfolio

Kedrion boasts an impressive portfolio of plasma-derived products, catering to various therapeutic areas including immunology, hematology, and critical care[6]. This diverse product range allows the company to serve a wide range of patient needs and mitigate risks associated with dependence on a single product line.

2. Strong Presence in the U.S. Market

With the U.S. accounting for 58% of its total revenue[7], Kedrion has successfully established a strong foothold in the world's largest pharmaceutical market. This presence provides a solid foundation for growth and expansion.

3. Focus on Rare and Ultra-Rare Diseases

Kedrion has strategically positioned itself in the orphan drug market, focusing on therapies for rare and ultra-rare diseases[6]. This specialization allows the company to address unmet medical needs and potentially benefit from orphan drug designations and associated market exclusivity.

4. Integrated Supply Chain

Kedrion's business model includes an integrated supply chain, from plasma collection to the production and distribution of finished products[1]. This vertical integration provides greater control over quality and supply, a crucial advantage in the plasma-derivatives industry.

5. Research and Development Capabilities

The company demonstrates a strong commitment to R&D, with ongoing projects in areas like plasminogen deficiency and Factor X deficiency[1]. This focus on innovation positions Kedrion to develop new therapies and maintain its competitive edge.

Strategic Insights: Kedrion's Path Forward

Based on the analysis of Kedrion's current position and strengths, several strategic insights emerge that could shape the company's future in the competitive biotech landscape.

1. Expansion in the Orphan Drug Market

Kedrion's focus on rare and ultra-rare diseases presents a significant opportunity for growth. The orphan drug market is projected to grow at a CAGR of 11.2% from 2021 to 2028, reaching $340.84 billion by 2028 (source: Grand View Research). By leveraging its expertise in this area, Kedrion can potentially capture a larger share of this growing market.

2. Strengthening U.S. Market Presence

Given the importance of the U.S. market to Kedrion's revenue, further strengthening its position in this market could be a key strategy. This could involve expanding distribution networks, increasing market share for existing products, or introducing new therapies to the U.S. market.

3. Leveraging Synergies from the BPL Merger

The merger with BPL presents opportunities for synergies in areas such as R&D, manufacturing, and global distribution. Maximizing these synergies could lead to improved operational efficiency and accelerated growth.

4. Expanding Global Footprint

While Kedrion already has a presence in over 100 countries, there may be opportunities to increase market share in emerging markets. The company's success with Anti-D immunoglobulins in markets like Turkey and the Middle East could serve as a model for expansion in other regions.

5. Continued Investment in R&D

To maintain its competitive edge, Kedrion should continue to invest in R&D, particularly in areas of unmet medical need. This could involve both improving existing therapies and developing new ones, especially in the field of rare diseases.

Challenges and Potential Threats

While Kedrion has significant strengths, it also faces challenges in the competitive biotech landscape:

1. Intense Competition

The plasma-derivatives market is dominated by larger players like CSL, Grifols, and Takeda. Competing against these giants, especially in core product areas like immunoglobulins and albumin, remains a significant challenge.

2. Regulatory Hurdles

The biopharmaceutical industry is heavily regulated, and navigating these regulations across multiple markets can be complex and costly. Any regulatory changes could potentially impact Kedrion's operations or market access.

3. Plasma Supply Fluctuations

As a plasma-derived product manufacturer, Kedrion is dependent on plasma supply. Any disruptions in plasma collection, as seen during the COVID-19 pandemic, could impact production and sales.

4. Emerging Therapies

The development of alternative therapies, such as recombinant products or gene therapies, could potentially reduce demand for certain plasma-derived products in the future.

Key Takeaways

  1. Kedrion Biopharma is a significant player in the plasma-derivatives market, holding the fifth position globally with a 3.9% market share.

  2. The company's strengths include a robust product portfolio, strong U.S. market presence, focus on rare diseases, integrated supply chain, and R&D capabilities.

  3. Kedrion's merger with BPL has strengthened its market position and opened up opportunities for synergies.

  4. Strategic opportunities include expansion in the orphan drug market, strengthening U.S. presence, leveraging merger synergies, expanding global footprint, and continued R&D investment.

  5. Challenges include intense competition from larger players, regulatory hurdles, plasma supply fluctuations, and the potential impact of emerging alternative therapies.

In the dynamic biotech landscape, Kedrion Biopharma has positioned itself as a key player with significant growth potential. By leveraging its strengths and addressing challenges strategically, Kedrion is well-positioned to continue its growth trajectory and make a meaningful impact in the field of plasma-derived therapeutics and rare disease treatments.

FAQs

  1. Q: What is Kedrion Biopharma's primary market? A: Kedrion's primary market is the United States, accounting for 58% of its total revenue.

  2. Q: In which product category does Kedrion hold the strongest market position? A: Kedrion holds the strongest position in Anti-D hyperimmune immunoglobulins, where it's the second-largest player globally with a 32% market share.

  3. Q: How has the merger with BPL impacted Kedrion's market position? A: The merger has strengthened Kedrion's market position, creating a combined entity that holds the fifth position in the global plasma-derivatives market.

  4. Q: What are some of Kedrion's key competitive advantages? A: Kedrion's key advantages include a robust product portfolio, strong U.S. market presence, focus on rare diseases, integrated supply chain, and R&D capabilities.

  5. Q: What are the main challenges Kedrion faces in the biotech industry? A: The main challenges include intense competition from larger players, regulatory hurdles, potential plasma supply fluctuations, and the emergence of alternative therapies.

Sources cited:

  1. https://www.kedrion.com/wp-content/uploads/2024/04/Kedrion-Group_Consolidated-Financial-Statements-31122023_ENG_audit-opinion-PWC.pdf
  2. https://www.kedrion.com/wp-content/uploads/2023/04/Kedrion_Bilancio-consolidato-IFRS-31.12.22-Audit-opinion_ENG.pdf
  3. https://www.kedrion.com.tr/wp-content/uploads/2023/09/2022-Kedrion-Annual-Report_HQ.pdf
  4. https://www.kedrion.com/wp-content/uploads/2024/05/Sustainability-Report-2023-FINALE.pdf

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