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Last Updated: December 26, 2024

PRIVIGEN Drug Profile


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

Identify potential brand extensions & biosimilar entrants

SponsorPhase
University Hospital of Saint-EtiennePhase 4
University Hospital of North NorwayPhase 4
Sorlandet Hospital HFPhase 4

See all PRIVIGEN clinical trials

Pharmacology for PRIVIGEN
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 PRIVIGEN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

PRIVIGEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: PRIVIGEN

Introduction

PRIVIGEN, a key product in the immunoglobulin market, is a biologic drug used primarily for the treatment of primary immunodeficiency diseases (PIDD) and other immune system disorders. This article delves into the market dynamics and financial trajectory of PRIVIGEN, highlighting its current status, growth drivers, and future projections.

Market Overview of Immunoglobulins

The global immunoglobulin market has been experiencing significant growth, driven by increasing demand for immunoglobulin replacement therapies. In 2023, the global immunoglobulin market size was valued at USD 16.24 billion and is projected to grow to USD 35.85 billion by 2032, with a CAGR of 9.3% during the forecast period[5].

PRIVIGEN and CSL Behring

PRIVIGEN is a product of CSL Behring, a major player in the biologics market. CSL Behring's immunoglobulin product sales, including PRIVIGEN, have shown robust growth. In the first half of the 2024 financial year, CSL Behring reported immunoglobulin product sales of $2,757 million, an increase of 23% compared to the prior period, driven by global plasma supply and patient demand[2].

Key Drivers of Market Growth

Several factors are driving the growth of the immunoglobulin market, including PRIVIGEN:

Increasing Incidence of Immunodeficiency Disorders

The rising prevalence of primary and secondary immunodeficiency disorders is a significant driver. As more patients are diagnosed with these conditions, the demand for immunoglobulin replacement therapies increases[5].

Robust Pipeline and New Product Approvals

The approval of new immunoglobulin therapies and a robust pipeline of biologic drugs are enhancing treatment options for patients. This expansion in product offerings is expected to continue driving market growth[1].

Government Initiatives and Reimbursement Policies

Government initiatives and reimbursement policies are making immunoglobulin therapies more accessible. In regions like Asia Pacific, Latin America, and the Middle East & Africa, increasing healthcare reforms and reimbursement for these drugs are poised to drive consumption[5].

Home Infusion Therapy

The adoption of home infusion therapy has accelerated, particularly due to the COVID-19 pandemic. This trend is expected to continue, as it offers safer administration of treatments at home, especially for immunocompromised patients[1].

Financial Performance of CSL Behring

CSL Behring's financial performance is a strong indicator of the market's health. Here are some key financial highlights:

Revenue Growth

In the first half of the 2024 financial year, CSL Behring's total revenue was $5,238 million, up 14% compared to the prior period. This growth is largely attributed to the strong performance of its immunoglobulin products, including PRIVIGEN[2].

Profitability

CSL Limited reported a net profit after tax of $1.90 billion for the six months ended December 2023, up 20% on a constant currency basis. This profitability is a testament to the strong demand for immunoglobulins and other biologic products[2].

Cash Flow and Financial Position

CSL Limited's cash flow from operations increased by 9% to $1,069 million, driven by higher profitability and overall growth in sales. The company's balance sheet remains strong, with net assets of $19,162 million[2].

Market Projections

The U.S. intravenous immunoglobulin market, which includes PRIVIGEN, is projected to grow at a CAGR of 7.7% from 2023 to 2030, reaching a value of USD 6.17 billion in 2023 and further expanding in the coming years[1].

Regional Growth

While the U.S. market is significant, other regions such as Asia Pacific are expected to grow with the highest CAGR during the forecast period. This growth is driven by rising healthcare reforms, government initiatives, and increasing healthcare expenditure[5].

Competitive Landscape

The global immunoglobulin market is consolidated with a few major players, including Grifols, S.A., CSL Limited, and Takeda Pharmaceutical Company Limited. These companies hold the maximum share of the market and are continuously investing in R&D to introduce advanced products[5].

Challenges and Opportunities

Despite the growth, the market faces challenges such as the high cost of immunoglobulin therapies and the need for continuous plasma supply. However, these challenges also present opportunities for innovation, such as the development of more efficient and cost-effective IVIG therapies[1].

Conclusion

The market dynamics for PRIVIGEN and other immunoglobulins are highly favorable, driven by increasing demand for immunoglobulin replacement therapies, robust pipeline growth, and supportive government initiatives. CSL Behring's strong financial performance underscores the market's potential.

Key Takeaways

  • The global immunoglobulin market is projected to grow significantly, driven by increasing prevalence of immunodeficiency disorders.
  • PRIVIGEN, as part of CSL Behring's portfolio, has shown strong growth driven by global plasma supply and patient demand.
  • Government initiatives and reimbursement policies are making immunoglobulin therapies more accessible.
  • Home infusion therapy adoption is on the rise, contributing to market growth.
  • CSL Behring's financial performance indicates a strong market position.

FAQs

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

The global immunoglobulin market size was valued at USD 16.24 billion in 2023[5].

What is the projected growth rate of the U.S. intravenous immunoglobulin market?

The U.S. intravenous immunoglobulin market is projected to grow at a CAGR of 7.7% from 2023 to 2030[1].

Which regions are expected to see the highest growth in the immunoglobulin market?

Asia Pacific is expected to grow with the highest CAGR during the forecast period, driven by rising healthcare reforms and increasing healthcare expenditure[5].

What are the key drivers of the immunoglobulin market growth?

Key drivers include increasing incidence of immunodeficiency disorders, robust pipeline and new product approvals, government initiatives, and the adoption of home infusion therapy[1][5].

Who are the major players in the global immunoglobulin market?

The major players include Grifols, S.A., CSL Limited, and Takeda Pharmaceutical Company Limited[5].

Sources

  1. Grand View Research - U.S. Intravenous Immunoglobulin Market Size Report, 2030
  2. BioSpace - Half year reported NPATA US$2 billion, up 13% at constant currency
  3. BioSpace - Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems
  4. Federal Trade Commission - Biologics Market Dynamics: Setting the Stage for Biosimilars
  5. Fortune Business Insights - Immunoglobulin Market Size, Share & Global Report [2032]

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