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Last Updated: February 12, 2025

Immune globulin (human) - Biologic Drug Details


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Summary for immune globulin (human)
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Suppliers: see list1
Recent Clinical Trials: See clinical trials for immune globulin (human)
Recent Clinical Trials for immune globulin (human)

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaPhase 1
Assistance Publique - Hôpitaux de ParisPhase 3
National Science and Technology CouncilPhase 2

See all immune globulin (human) clinical trials

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

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Immune Globulin (Human)

Introduction

Immune globulin, also known as immunoglobulin, is a biologic drug that has been a cornerstone in the treatment of various immune-related conditions for decades. The market for immune globulin is experiencing significant growth, driven by several key factors. Here, we delve into the market dynamics and financial trajectory of this crucial therapeutic agent.

Market Size and Growth

The global immunoglobulin market has been expanding rapidly. In 2022, the market size was valued at approximately $13.5 billion and is projected to reach $25.6 billion by 2032, growing at a CAGR of 6.6% from 2023 to 2032[1][3][4].

Key Drivers

Several factors are driving the growth of the immunoglobulin market:

Prevalence of Target Diseases

The increasing prevalence of primary immunodeficiency diseases, myasthenia gravis, and idiopathic thrombocytopenic purpura (ITP) is a significant driver. For instance, around 8 million people globally are affected by primary immunodeficiency, and myasthenia gravis affects approximately 36,000 to 60,000 individuals in the U.S.[1].

Aging Population

The growing geriatric population, which is more susceptible to immune-related disorders, further fuels the market's growth. Aging populations in regions like North America and Asia-Pacific are contributing to the increased demand for immunoglobulin therapies[1][3].

Expanding Indications

Immunoglobulins are being used for an increasing number of indications, including chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain-Barré syndrome (GBS), and autoimmune diseases. This expansion in therapeutic uses is driving market growth[3][4].

Distribution Channels

The immunoglobulin market is segmented by distribution channels, with hospital pharmacies holding the largest market share in terms of revenue. However, the drug stores and retail pharmacy segment is expected to exhibit the fastest CAGR during the forecast period due to the growing preference for outpatient care and the convenience of home delivery and self-administration[1].

Regional Analysis

North America

North America accounted for the largest share in terms of revenue in 2022 and is expected to remain dominant during the forecast period. This is attributed to a well-developed healthcare infrastructure, a notable prevalence of diseases requiring immunoglobulin therapies, and proactive adoption of advanced medical treatments[1][3].

Asia-Pacific

The Asia-Pacific region is anticipated to witness significant growth due to a large population base, heightened healthcare awareness, and an increase in cases of immunodeficiency disorders and autoimmune diseases. Government initiatives and rising healthcare spending in this region are also contributing to the market's growth[1][4].

Economic Burden and Cost Management

Cost of Treatment

Immunoglobulin therapies are among the top drug categories in terms of annual spending, despite being required by less than 1% of the population. The cost of immunoglobulin can be substantial, with treatment costs ranging from $10,000 to over $30,000 annually, depending on the disease severity and delivery method[2][3].

Cost Savings

Studies have shown that shifting immunoglobulin therapies from intravenous (IVIG) to subcutaneous (SCIG) and from hospital settings to home care can result in significant cost savings. For example, a study found a 70.2% cost-saving benefit when IVIG was managed under the pharmacy benefit rather than the medical benefit[2].

Patient Preferences

Patients with primary immunodeficiencies prefer home delivery and subcutaneous administration, which not only improves their quality of life but also reduces healthcare utilization and costs[2].

Market Segmentation

By Type

The immunoglobulin market is segmented by type, including IgG, IgM, IgA, IgE, and IgD. IgG is the most commonly used type due to its broad therapeutic applications[3].

By Indication

The market is also segmented by indication, with primary immunodeficiency holding a significant share. Other indications include CIDP, GBS, ITP, and various autoimmune diseases[3].

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 a significant market share and are driving innovation and expansion in the sector[4].

Future Outlook

The immunoglobulin market is expected to continue its robust growth trajectory, driven by increasing prevalence of immune-related disorders, expanding therapeutic indications, and advancements in delivery methods. The Asia-Pacific region is poised for significant growth due to rising healthcare awareness and government initiatives[1][3][4].

Key Takeaways

  • The global immunoglobulin market is projected to grow from $13.5 billion in 2022 to $25.6 billion by 2032.
  • The market is driven by the prevalence of primary immunodeficiency diseases, an aging population, and expanding therapeutic indications.
  • Hospital pharmacies currently dominate the market, but drug stores and retail pharmacies are expected to grow rapidly.
  • North America leads the market, but the Asia-Pacific region is anticipated to experience significant growth.
  • Cost management strategies, including home care and subcutaneous administration, are crucial for reducing healthcare costs.

FAQs

What is the current market size of the immunoglobulin market?

The global immunoglobulin market size was valued at approximately $13.5 billion in 2022[1].

What is the projected growth rate of the immunoglobulin market?

The market is projected to grow at a CAGR of 6.6% from 2023 to 2032[1].

Which region dominates the immunoglobulin market?

North America currently holds the largest share in terms of revenue and is expected to remain dominant during the forecast period[1].

What are the primary drivers of the immunoglobulin market growth?

The primary drivers include the prevalence of target diseases like primary immunodeficiency, myasthenia gravis, and ITP, as well as the growing geriatric population and expanding therapeutic indications[1].

How does the cost of immunoglobulin treatment vary?

The cost of immunoglobulin treatment can range from $10,000 to over $30,000 annually, depending on the disease severity and delivery method[2][3].

What are the preferred delivery methods for immunoglobulin therapies?

Patients prefer subcutaneous administration (SCIG) and home delivery, which offer cost savings and improved quality of life[2].

Sources

  1. Allied Market Research - Immunoglobulin Market Size, Growth Analysis| Forecast- 2032
  2. AJMC - Managing Cost of Care and Healthcare Utilization in Patients Using Immunoglobulin Agents
  3. Market.US - Intravenous Immunoglobulin Market | CAGR of 7.0%
  4. Fortune Business Insights - Immunoglobulin Market Size, Share & Global Report [2032]

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