Immune globulin subcutaneous (human) - Biologic Drug Details

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Summary for immune globulin subcutaneous (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	4
BLAs:	4
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for immune globulin subcutaneous (human)

Recent Clinical Trials for immune globulin subcutaneous (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Baxalta now part of Shire	Phase 1
Baxalta Innovations GmbH, now part of Shire	Phase 1
CSL Behring	Phase 4

See all immune globulin subcutaneous (human) clinical trials

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:

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.

General brand-side disclosures

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.

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) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Subcutaneous Immunoglobulin (Human)

Market Overview

The subcutaneous immunoglobulin (SCIG) market is experiencing significant growth, driven by several key factors. Here are the main dynamics and financial projections for this market.

Market Size and Growth

The global subcutaneous immunoglobulin market is estimated to be valued at USD 11.19 billion in 2023 and is projected to reach USD 12.72 billion in 2024, growing at a compound annual growth rate (CAGR) of 13.7%[4].

By 2029, the market is expected to expand to USD 19.70 billion, with a CAGR of 11% during the forecast period (2024-2029)[1].

Key Drivers of Growth

Increasing Prevalence of Immunodeficiency Disorders

The rising incidence of primary and secondary immunodeficiency disorders, such as HIV and common variable immunodeficiency (CVID), is a major driver of market growth. For instance, India reported around 2.4 million HIV cases in 2022, and CVID affects up to 1 in 25,000 people worldwide[1].

Patient Preference for Home-Based Care

Patients increasingly prefer subcutaneous immunoglobulin due to its convenience and the ability to self-administer at home. This shift from intravenous immunoglobulin (IVIG) to SCIG is driven by patient preferences, improved treatment adherence, and reduced healthcare burden[2][3].

Expanding Therapeutic Applications

Immunoglobulin is no longer limited to treating primary immunodeficiency disorders. Its applications now extend to neurology, hematology, autoimmune diseases, and other areas. This expansion in therapeutic uses is driving increased demand and attracting a broader range of healthcare professionals and patients[3].

Favorable Reimbursement Policies

Growth in the market is also attributed to favorable reimbursement policies, which make immunoglobulin therapies more accessible to patients. This support from regulatory bodies ensures the safety and efficacy of these products, further boosting market growth[4].

Geographic Market Analysis

North America Dominance

North America is expected to dominate the subcutaneous immunoglobulin market during the forecast period. This dominance is due to the presence of key players, high prevalence of immunodeficiency diseases, an increasing geriatric population, and an established healthcare infrastructure in the region[1].

Global Market Distribution

Other regions, such as Europe and Asia-Pacific, are also expected to contribute significantly to the market growth, driven by increasing awareness, diagnosis rates, and the expansion of healthcare facilities[4].

Economic Burden and Cost Analysis

Cost of Treatment

The cost of immunoglobulin therapy is substantial but varies based on the delivery method and site of care. Shifting from IVIG to SCIG and from hospital-based to home-based care has been shown to reduce costs. For example, a German cost-minimization analysis found that switching to home-based SCIG resulted in total savings of $7,592 per patient over three years[2].

Impact on Healthcare Utilization

Undiagnosed or misdiagnosed primary immunodeficiencies lead to higher healthcare costs due to increased hospitalizations, outpatient visits, and drug utilization. Early diagnosis and treatment with immunoglobulin can significantly reduce these costs. A study found that annual treatment costs for patients with primary immunodeficiencies declined from $111,053 per patient before diagnosis to $25,271 per patient after diagnosis[2].

Product and Application Segments

Product Types

The market is segmented by product types, including Immunoglobulin A (IgA), Immunoglobulin G (IgG), and Immunoglobulin M (IgM). IgG was the highest revenue-grossing segment in 2023, while IgA is predicted to grow at the fastest CAGR during the forecast period[5].

Applications

The primary applications include primary immunodeficiency disorders, autoimmune diseases, neurological disorders, and other conditions. Secondary immunodeficiency diseases were the highest revenue-grossing segment in 2023, but primary immunodeficiency diseases are expected to grow at the fastest CAGR in the coming years[5].

Innovations and Trends

Advancements in Drug Delivery Systems

Innovations in drug delivery systems, such as the development of more convenient and patient-friendly SCIG formulations, are driving market growth. These advancements enhance treatment accessibility and adherence[4].

Personalized Medicine

The trend towards personalized medicine is significant, with SCIG offering a tailored approach to immunoglobulin therapy. This personalized care aligns with patient preferences and improves treatment outcomes[3].

Home Infusion Therapies

The increasing demand for home infusion therapies is another major trend. Patients prefer the convenience and comfort of receiving treatments at home, which also reduces the burden on healthcare facilities[4].

Financial Projections

Revenue Growth

The global subcutaneous immunoglobulin market is expected to reach USD 27.33 billion by 2034, growing from USD 10.35 billion in 2023. This represents a significant increase in revenue over the forecast period[5].

Cost Savings

The shift to SCIG and home-based care is expected to continue generating cost savings for both patients and healthcare systems. Studies have shown that these shifts can result in substantial reductions in annual medical costs[2].

Key Takeaways

The subcutaneous immunoglobulin market is projected to grow significantly, driven by increasing prevalence of immunodeficiency disorders, patient preference for home-based care, and expanding therapeutic applications.
North America is expected to dominate the market due to its established healthcare infrastructure and high prevalence of immunodeficiency diseases.
Innovations in drug delivery systems and the trend towards personalized medicine are key drivers of market growth.
Cost savings from shifting to SCIG and home-based care are substantial, reducing the economic burden on healthcare systems.

FAQs

What is the projected market size of the subcutaneous immunoglobulin market by 2029?

The subcutaneous immunoglobulin market is expected to reach USD 19.70 billion by 2029, growing at a CAGR of 11% during the forecast period (2024-2029)[1].

Why is there a preference for subcutaneous immunoglobulin over intravenous immunoglobulin?

Patients prefer SCIG due to its convenience, the ability to self-administer at home, and improved treatment adherence. This shift also reduces the healthcare burden and costs associated with IVIG[2][3].

What are the main applications of subcutaneous immunoglobulin?

How does the geographic distribution of the market look?

North America is expected to dominate the market, followed by other regions such as Europe and Asia-Pacific, which are also expected to contribute significantly to market growth[1][4].

What are the key innovations driving the market growth?

Key innovations include advancements in drug delivery systems, the trend towards personalized medicine, and the increasing demand for home infusion therapies[3][4].

Sources

Mordor Intelligence: Subcutaneous Immunoglobulin Market Size & Share Analysis
AJMC: Managing Cost of Care and Healthcare Utilization in Patients Using Immunoglobulin Agents
Precedence Research: Immunoglobulin Market Size To Reach USD 28.70 Billion By 2034
The Business Research Company: Subcutaneous Immunoglobulin (SCIG) Global Market Report 2024
PR Newswire: Global Subcutaneous Immunoglobulin Market Analysis & Forecast 2024-2034 by Product, Application, End-User, and Region

Last updated: 2024-12-22

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