Immune globulin subcutaneous (human), 20% liquid - Biologic Drug Details

Summary for immune globulin subcutaneous (human), 20% liquid

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
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Pharmacology for immune globulin subcutaneous (human), 20% liquid

Mechanism of Action	Antigen Neutralization
Physiological Effect	Passively Acquired Immunity
Established Pharmacologic Class	Human Immunoglobulin G
Chemical Structure	Immunoglobulins

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1. Brand-side disclosures in response to biosimilar applications

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.

2. General brand-side disclosures

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3. Patents from broad patent text search

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 immune globulin subcutaneous (human), 20% liquid Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for immune globulin subcutaneous (human), 20% liquid Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for immune globulin subcutaneous (human), 20% liquid Derived from Patent Text Search

No patents found based on company disclosures

Immune globulin subcutaneous (human), 20% liquid Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Subcutaneous Immunoglobulin (Human) 20% Liquid

Market Overview

The subcutaneous immunoglobulin market, particularly for the 20% liquid formulation, is experiencing significant growth driven by several key factors. As of 2023, the global market size was valued at approximately USD 10.42 billion, and it is anticipated to grow substantially over the coming years[1][4].

Growing Demand for Immunoglobulin Therapies

The increasing prevalence of immunodeficiency disorders, including primary and secondary immunodeficiency syndromes, is a major driver of the market. Patients with compromised immune systems require regular subcutaneous immunoglobulin infusions, which has led to a surge in demand for these therapies. The convenience and flexibility of subcutaneous administration compared to traditional intravenous methods are key factors contributing to this growth[1][4].

Technological Innovations and Patient-Centric Care

Technological advancements in formulations and delivery methods, such as the use of autoinjectors and vaccination devices, have enhanced the efficacy and patient comfort of subcutaneous immunoglobulin treatments. These innovations have led to improved patient compliance and satisfaction, as they allow for self-administration at home, reducing the need for hospital visits[1][4].

Regulatory Approvals and Expanding Treatment Choices

Companies in the market are receiving approvals for new solutions, which is further fueling the growth. For instance, Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) received orphan-drug exclusivity from the US FDA for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) and primary immunodeficiency (PI) in adults and pediatric patients[3].

Economic Benefits and Cost Savings

From a healthcare system perspective, subcutaneous immunoglobulin (SCIG) is economically beneficial compared to intravenous immunoglobulin (IVIG). Studies have shown that SCIG can reduce costs significantly, primarily due to the reduced need for hospital personnel and supplies. For example, a study estimated that SCIG treatment could save up to $5736 per patient over three years, with total cost savings of $1.308 million if 50% of patients switched from IVIG to SCIG[2].

Regional Market Dynamics

North America dominated the global subcutaneous immunoglobulin market in 2023, driven by advances in technology, increased awareness among patients and healthcare providers, and growing healthcare expenditure. The region's market thrives on the recognition of the clinical value of SCIG and the expansion of treatment choices through regulatory approvals[1][4].

Product Segmentation

By product type, IgG was the highest revenue-grossing segment in 2023, due to its widespread acceptance and the increasing number of regulatory approvals for new products. However, IgA is expected to grow at the fastest CAGR during the forecast period, driven by rising product launches and research and development activities[5].

Application Segmentation

Secondary immunodeficiency diseases were the highest revenue-grossing segment by application in 2023, driven by the increasing prevalence of conditions such as AIDS, immune system-related cancers, and immune-complex diseases. Primary immunodeficiency diseases are expected to grow at the fastest CAGR, due to the rising use of interventions to boost the immune system and the emphasis on creating innovative treatment alternatives[5].

Financial Trajectory

The global subcutaneous immunoglobulin market is projected to grow significantly over the next decade. By 2033, the market size is estimated to reach around USD 32.59 billion, growing from USD 15.48 billion in 2023 at a CAGR of 7.73%[4].

Market Size Projections

• 2023: USD 10.42 billion[1]
• 2024: USD 11.83 billion[1]
• 2033: USD 32.59 billion[4]

Key Drivers

• Increasing prevalence of immunodeficiency disorders
• Technological innovations in formulations and delivery methods
• Patient-centric care and self-administration benefits
• Regulatory approvals and expanding treatment choices
• Economic benefits and cost savings compared to IVIG

Challenges and Limitations

Despite the growth, the market faces significant challenges, particularly the high cost of treatment. The expense of products and administration equipment hinders widespread adoption, especially in regions with insufficient insurance coverage. This cost factor influences healthcare providers' prescribing preferences, often favoring more traditional and cost-effective treatments[1].

Conclusion

The subcutaneous immunoglobulin market, particularly for the 20% liquid formulation, is poised for substantial growth driven by increasing demand for immunoglobulin therapies, technological innovations, and patient-centric care. While the market faces challenges related to cost, the economic benefits, regulatory approvals, and expanding treatment choices are expected to drive its financial trajectory positively.

Key Takeaways

• The subcutaneous immunoglobulin market is growing due to the increasing prevalence of immunodeficiency disorders.
• Technological innovations and patient-centric care are key drivers of market growth.
• Regulatory approvals and economic benefits are significant factors contributing to the market's expansion.
• North America dominates the global market due to advanced technology and growing healthcare expenditure.
• The market faces challenges related to the high cost of treatment but is expected to reach USD 32.59 billion by 2033.

FAQs

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

The current market size of the subcutaneous immunoglobulin market was valued at approximately USD 10.42 billion in 2023[1].

Q: What are the primary drivers of the subcutaneous immunoglobulin market growth?

The primary drivers include the increasing prevalence of immunodeficiency disorders, technological innovations, patient-centric care, and regulatory approvals[1][4].

Q: How does subcutaneous immunoglobulin compare to intravenous immunoglobulin in terms of cost?

Subcutaneous immunoglobulin is economically beneficial, reducing costs to the healthcare system by up to $5736 per patient over three years compared to intravenous immunoglobulin[2].

Q: Which region dominates the global subcutaneous immunoglobulin market?

North America dominates the global subcutaneous immunoglobulin market, driven by advances in technology and growing healthcare expenditure[1][4].

Q: What are the projected market size and growth rate for the subcutaneous immunoglobulin market by 2033?

The market is projected to reach around USD 32.59 billion by 2033, growing at a CAGR of 7.73% from 2024 to 2033[4].

Sources

1. Polaris Market Research: Subcutaneous Immunoglobulin Market Size, Global Report, 2024.
2. PubMed: Economic benefits of subcutaneous rapid push versus intravenous immunoglobulin in primary immune deficiency.
3. PR Newswire: Hizentra Immune Globulin Subcutaneous Human 20% Liquid Receives Orphan-Drug Exclusivity.
4. Precedence Research: Subcutaneous Immunoglobulin Market Size to Hit USD 32.59 Bn by 2033.
5. PR Newswire: Global Subcutaneous Immunoglobulin Market Analysis & Forecast 2024-2034.