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Last Updated: December 26, 2024

HIZENTRA Drug Profile


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Summary for Tradename: HIZENTRA
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for HIZENTRA
Recent Clinical Trials for HIZENTRA

Identify potential brand extensions & biosimilar entrants

SponsorPhase
University of Alabama at BirminghamPhase 4
Rochester General HospitalPhase 2/Phase 3
University Health Network, TorontoN/A

See all HIZENTRA clinical trials

Pharmacology for HIZENTRA
Mechanism of ActionAntigen Neutralization
Physiological EffectPassively Acquired Immunity
Established Pharmacologic ClassHuman Immunoglobulin G
Chemical StructureImmunoglobulins
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 HIZENTRA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

HIZENTRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for HIZENTRA

Introduction

HIZENTRA, a subcutaneous immunoglobulin product developed by CSL Behring, is a significant player in the biologic drug market, particularly for the treatment of primary and secondary immunodeficiencies, as well as chronic inflammatory demyelinating polyneuropathy (CIDP). Here, we delve into the market dynamics and financial trajectory of HIZENTRA.

Market Size and Growth

The global immunoglobulin market, which includes HIZENTRA, is experiencing robust growth. As of 2023, the global immunoglobulin market size was valued at USD 16.24 billion and is projected to reach USD 35.85 billion by 2032, growing at a CAGR of 9.3% during the forecast period[1].

Segmental Performance

HIZENTRA falls under the subcutaneous immunoglobulin segment, which is anticipated to grow with the highest CAGR. This segment's growth is driven by factors such as significant cost reduction, self-administration capabilities, and a lower risk of systemic infections compared to intravenous products[1][4].

Sales Performance

HIZENTRA has shown strong sales performance. In the first half of the 2024 financial year, HIZENTRA sales were up 18% driven by increasing patient diagnosis rates. It continues to be the clear market leader for subcutaneous immunoglobulin products[2].

Clinical Benefits and Patient Preferences

The preference for subcutaneous administration, such as HIZENTRA, is increasing due to its convenience and the ability for self-administration at home. This reduces the need for frequent hospital visits, aligning with patient-centered care and promoting wider adoption[4].

Competitive Landscape

CSL Behring, the manufacturer of HIZENTRA, faces competition from other immunoglobulin products and upcoming therapies. For instance, argenx is expected to gain FDA approval for Vyvgart Hytrulo, a subcutaneous product with a different mechanism of action, which will compete with HIZENTRA in the CIDP market[5].

Market Research and Patient Insights

To stay ahead in the market, CSL Behring has conducted surveys to understand patient preferences and needs. A Harris Poll commissioned by CSL revealed that patients with CIDP are looking for more convenient treatment options, which supports the continued demand for HIZENTRA and similar products[5].

Geographic Performance

The North American market, particularly the U.S., holds a significant share of the subcutaneous immunoglobulin market, including HIZENTRA. This is due to advances in technology, increased awareness among patients and healthcare providers, and growing healthcare spending[4].

Financial Impact

The strong growth in immunoglobulin sales, including HIZENTRA, has significantly contributed to CSL Behring's financial performance. In the first half of the 2024 financial year, CSL Behring's total revenue was $5,238 million, up 14% from the prior comparable period, with immunoglobulin product sales increasing by 23%[2].

Future Outlook

CSL Behring is well-positioned to continue delivering strong growth in its immunoglobulins franchise, driven by strong patient demand and ongoing initiatives to improve plasma collections and processing efficiencies. This is expected to support continued expansion in CSL Behring’s gross margin and overall financial performance[2].

Regulatory and Market Dynamics

The biologics market, including immunoglobulins like HIZENTRA, is subject to changing market dynamics such as the emergence of biosimilars. However, the unique properties and clinical benefits of HIZENTRA are expected to maintain its market position despite these challenges[3].

Key Drivers

  • Increasing Prevalence of Immunodeficiencies: The rising prevalence of primary and secondary immunodeficiencies and other autoimmune disorders drives the demand for immunoglobulin products like HIZENTRA[1].
  • Advancements in Treatment Options: The clinical benefits and immunomodulatory properties of immunoglobulins, along with advancements in subcutaneous administration, are key drivers of the market[1].
  • Patient-Centered Care: The convenience and self-administration capabilities of subcutaneous products like HIZENTRA align with patient-centered care, promoting wider adoption[4].

Challenges

  • COVID-19 Pandemic: The pandemic negatively affected the global immunoglobulin market due to a decline in plasma collection and shortages, which impacted the availability of plasma products, including HIZENTRA[1].
  • Competition: The upcoming approval of rival products, such as Vyvgart Hytrulo from argenx, poses competitive challenges to HIZENTRA in the CIDP market[5].

Regional Growth

The Asia Pacific region is expected to grow with the highest CAGR during the forecast period, driven by rising healthcare reforms, government initiatives, and increasing healthcare expenditure. This growth is poised to drive consumption of immunoglobulin products, including HIZENTRA, in countries like Japan and India[1].

Conclusion

HIZENTRA is a leading subcutaneous immunoglobulin product with a strong market presence and financial performance. Driven by increasing patient needs, advancements in treatment options, and patient preferences for self-administration, HIZENTRA is expected to continue its growth trajectory. Despite competitive and regulatory challenges, CSL Behring's strategic initiatives and market research efforts position HIZENTRA for sustained success.

Key Takeaways

  • Strong Sales Growth: HIZENTRA sales have been robust, with an 18% increase in the first half of 2024.
  • Market Leadership: HIZENTRA remains the market leader in subcutaneous immunoglobulin products.
  • Patient-Centered Care: Self-administration capabilities and convenience drive patient preference for HIZENTRA.
  • Competitive Landscape: Upcoming rival products pose competitive challenges but do not diminish HIZENTRA's market position.
  • Geographic Expansion: The Asia Pacific region is expected to drive future growth.

FAQs

Q: What is the current market size of the global immunoglobulin market?

  • The global immunoglobulin market size was USD 16.24 billion in 2023[1].

Q: What is the projected growth rate of the subcutaneous immunoglobulin market?

  • The subcutaneous immunoglobulin market is expected to grow at a CAGR of 7.73% from 2024 to 2033[4].

Q: Why is HIZENTRA preferred by patients?

  • HIZENTRA is preferred due to its self-administration capabilities, convenience, and lower risk of systemic infections compared to intravenous products[4].

Q: What are the key drivers of the immunoglobulin market?

  • The key drivers include the increasing prevalence of immunodeficiencies, advancements in treatment options, and patient-centered care[1].

Q: How has the COVID-19 pandemic affected the immunoglobulin market?

  • The pandemic negatively affected the market due to a decline in plasma collection and shortages, impacting the availability of plasma products[1].

More… ↓

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