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Last Updated: January 20, 2025

Immune globulin intravenous (human) - Biologic Drug Details


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Summary for immune globulin intravenous (human)
Tradenames:8
High Confidence Patents:0
Applicants:8
BLAs:10
Suppliers: see list7
Recent Clinical Trials: See clinical trials for immune globulin intravenous (human)
Recent Clinical Trials for immune globulin intravenous (human)

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Longyan City First HospitalPhase 4
Fujian Medical University Union HospitalPhase 4
The First Affiliated Hospital of Xiamen UniversityPhase 4

See all immune globulin intravenous (human) clinical trials

Pharmacology for immune globulin intravenous (human)
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 immune globulin intravenous (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Intravenous Immunoglobulin (IVIG)

Market Overview

The intravenous immunoglobulin (IVIG) market is experiencing significant growth, driven by several key factors. As of 2023, the market size was valued at USD 12.7 billion, and it is projected to reach USD 23.5 billion by 2034, growing at a Compound Annual Growth Rate (CAGR) of 5.76% during the forecast period of 2024-2034[1].

Key Drivers of Market Growth

Increasing Prevalence of Autoimmune and Inflammatory Diseases

The rising incidence of autoimmune and inflammatory diseases, such as chronic inflammatory demyelinating polyneuropathy (CIDP) and hypogammaglobulinemia, is a major driver of the IVIG market. These conditions require long-term treatment, which increases the demand for IVIG therapies[3].

Technological Advancements

Advancements in plasma fractionation and purification processes have improved the quality and consistency of IVIG products. These technological improvements address previous supply constraints and enhance the overall efficacy of IVIG treatments[1].

Heightened Awareness and Early Diagnosis

Increased awareness about IVIG therapies and early diagnosis of immunodeficiency disorders have led to higher adoption rates. This heightened awareness, coupled with better diagnostic tools, contributes significantly to market growth[4].

Expanding Applications

IVIG is being used for an increasing number of medical conditions, including off-label indications. This expansion into novel immunomodulatory treatments further fuels the market's growth[4].

Regional Market Analysis

Major Markets

The United States is the largest market for IVIG, driven by the prevalence of autoimmune and chronic diseases, an aging population, and technological advancements in plasma fractionation. Other significant markets include Germany, France, the United Kingdom, Italy, Spain, and Japan[1].

North America's Dominance

North America is expected to account for a substantial portion of the market growth, with the region anticipated to contribute 49.5% of the total market growth by 2032[3].

Economic Benefits and Cost Considerations

Cost Savings of Home-Based Treatments

Studies have shown that home-based subcutaneous immunoglobulin (SCIG) treatments can be more cost-effective than hospital-based IVIG treatments. For instance, a cost-minimisation model estimated that SCIG treatment reduced costs to the healthcare system by $5736 per patient over three years, primarily due to reduced use of hospital personnel[2].

Site of Care and Delivery Method

The cost of IVIG treatment is significantly influenced by the site of care and the delivery method. Home infusion settings have been shown to reduce annual costs by $18,876 to $26,136 per patient compared to outpatient hospital settings[5].

Market Restraints

High Costs and Side Effects

Despite the growth, the IVIG market faces challenges such as high treatment costs and the risk of side effects. The therapy is expensive, with infusions typically given every 3-4 weeks, and the treatment lasts approximately 12-16 sessions per year[3].

Regulatory Constraints

Strict government regulations on IVIG products also act as a restraint, ensuring that only high-quality products are approved, but this can slow down market growth[3].

Market Opportunities

Personalized Medicine and Novel Treatments

The trend towards personalized medicine and the use of IVIG in novel immunomodulatory treatments present significant opportunities for market growth. New formulations, such as the FDA-approved Hyqvia (a combination of immune globulin infusion 10% with recombinant human hyaluronidase), are enhancing patient outcomes and expanding market potential[1][4].

Expanded Distribution Channels

The expansion of distribution channels, including hospital and specialty pharmacies, is also contributing to the market's growth. This broader accessibility makes IVIG treatments more available to a wider patient population[4].

Impact of COVID-19

The COVID-19 pandemic has highlighted the vulnerability of individuals with primary and secondary immunodeficiencies. Studies have shown that these individuals are at a higher risk of infection, which has increased the demand for IVIG therapies. This increased demand is expected to continue, driving market growth during and post-pandemic periods[4].

Financial Trajectory

Projected Growth

The IVIG market is expected to grow substantially, with an incremental growth of USD 24.4 billion by 2032 from USD 12.6 billion in 2022, at a CAGR of 7% during the forecast period[3].

Cost Savings and Efficiency

Efforts to optimize costs, such as dose optimization and shifting treatments to home settings, have resulted in significant savings. For example, a care management program led to a 17% overall reduction in total Ig spend, translating to an estimated annual savings of approximately $1.4 million[5].

Key Takeaways

  • The IVIG market is projected to reach USD 23.5 billion by 2034, driven by increasing prevalence of autoimmune diseases and technological advancements.
  • Home-based SCIG treatments offer significant cost savings compared to hospital-based IVIG.
  • The market faces restraints such as high treatment costs and regulatory constraints but presents opportunities in personalized medicine and expanded distribution channels.
  • The COVID-19 pandemic has increased the demand for IVIG therapies due to the higher risk of infection among immunodeficient individuals.

FAQs

Q: What is the projected market size of the IVIG market by 2034? A: The IVIG market is expected to reach USD 23.5 billion by 2034[1].

Q: What are the main drivers of the IVIG market growth? A: The main drivers include the increasing prevalence of autoimmune and inflammatory diseases, technological advancements in plasma fractionation, and heightened awareness about IVIG therapies[1][3].

Q: How do home-based SCIG treatments compare to hospital-based IVIG in terms of cost? A: Home-based SCIG treatments are estimated to reduce costs to the healthcare system by $5736 per patient over three years compared to hospital-based IVIG[2].

Q: What impact did the COVID-19 pandemic have on the IVIG market? A: The pandemic increased the demand for IVIG therapies due to the higher risk of infection among immunodeficient individuals, contributing to market growth[4].

Q: What are some of the restraints facing the IVIG market? A: High treatment costs, risks of side effects, and strict government regulations are some of the restraints facing the IVIG market[3].

Sources

  1. Biospace: Intravenous Immunoglobulin Market Size to Reach USD 23.5 Billion by 2034[1].
  2. PubMed: Economic benefits of subcutaneous rapid push versus intravenous immunoglobulin therapy in primary immune deficiency patients[2].
  3. GlobeNewswire: Intravenous Immunoglobulin Market size to grow by USD 24.4 Billion by 2032[3].
  4. Mordor Intelligence: Intravenous Immunoglobulin Market - IVIG - Share, Trends & Growth[4].
  5. AJMC: Managing Cost of Care and Healthcare Utilization in Patients Using Immunoglobulin Agents[5].

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