The global intravenous immunoglobulin market size was valued at US$ 16.03 billion in 2024 and is expected to attain around US$ 34.92 billion by 2034, growing at a CAGR of 8.1% from 2024 to 2034. The intravenous immunoglobulin market is growing rapidly due to rapid innovations in medical biotechnology. The intravenous immunoglobulin market is growing due to the rising instances of immune and autoimmune diseases, such as Kawasaki disease, dermatomyositis, and polymyositis, among the global population. Intravenous immunoglobulin is a pooled antibody, and a biological agent used to treat various immunodeficiencies, autoimmune diseases, infections, and inflammatory conditions. The goal of this treatment is to normalize a compromised immune system.
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Depending on the manufacturer, intravenous immune globulin can be pooled immune globulin collected from 1,000 to 100,000 healthy donors. Intravenous immunoglobulin inhibits the proliferation of autoreactive B cells, thereby controlling the production of autoantibodies by inducing B cell G1 phase arrest and apoptosis.
North America dominated the global intravenous immunoglobulin market in 2023
- North America dominated the global intravenous immunoglobulin market in 2023 and is expected to remain a notable region, accounting for approximately 25% to 30% of replacement therapy for primary immunodeficiency disease in the United States.
- Organizations such as the National Institute for Health and Care Research and other large pharmaceutical companies are increasingly funding studies into intravenous immunoglobulin for treating diseases such as encephalitis in children aged six months to 16 years. According to the Foundation for Research on Equal Opportunity, the United States was the world leader in scientific and technological advancement in healthcare.
Asia Pacific is anticipated to see the fastest growth during the forecast period
- The region accounts for approximately two-thirds of the world’s population. Rising disposable incomes, an aging population, and lifestyle changes in the region contribute to higher healthcare spending. A rise in medical tourism and the rising popularity of alternative therapies are also driving growth in the region.
Key Takeaways
· North America has captured revenue share of 47.14% in 2023.
· By product, IgG dominates the intravenous immunoglobulin market.
· By route of administration, intravenous is preferably used more in the intravenous immunoglobulin market.
· By application, the immunodeficiency diseases segment captured more than 21% of the revenue share in 2023.
· By end-user, the hospital segment shares the maximum CAGR during the projection period.
· By distribution channel, the hospital pharmacy segment contributed more than 58% of revenue share in 2023.
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Top Growth Factors of Intravenous Immunoglobulin Market
- A global spike in immunodeficiencies and autoimmune diseases such as immune thrombocytopenic purpura, Guillain–Barré syndrome, and optic neuritis is leading to growing demand in the market.
- Prophylactic polyclonal human intravenous immunoglobulin is widely being adopted to prevent infectious diseases in patients of all ages with primary or secondary agammaglobulinemia.
- Research and development spending in intravenous immunoglobulin research is also driving growth in the market.
Expanding Applications in Autoimmune and Immune-Mediated Disorders
The intravenous immunoglobulin market is experiencing growth due to its widespread occurrence of various autoimmune and immunological diseases. The treatment is approved for specific indications and off-label uses and is increasingly used as an alternative therapy. New insights into the pathophysiology of immune-mediated diseases have increased the need for immunomodulatory therapy. Intravenous immunoglobulin is particularly effective in treating autoimmune bullous diseases such as infectious epidermolysis bullosa and mucosal membrane pemphigoid, and the market continues to expand by expanding its clinical uses and improving medical management.
Rising Demand and Manufacturing Enhancements
The intravenous immunoglobulin market has seen robust growth in the past decade, seeing a 128% increase in demand. Medical advances in treating patients with primary prevention, along with significant industry innovations such as immune system clearance and enhancement, have improved the performance and safety of immunoglobulin therapies. These improvements reduce adverse events and improve patient outcomes. Manufacturers have responded to demand by expanding existing operations and constructing new facilities. Together, these factors create a vast opportunity for growth in the market.
High Costs and Complex Production Processes
The intravenous immunoglobulin market faces challenges due to its high investment and operational costs. The creation of intravenous immunoglobulin involves the collection of vast quantities of donor plasmas and then undertaking an extensive manufacturing and testing process to ensure patient safety and efficacy. The necessity of such stringent management and manufacturing processes results in high operational costs, which are then passed on to patients. These factors limit the accessibility and affordability of the treatment, thus restricting the overall growth in the market.
Recent Breakthroughs in Intravenous Immunoglobulin Market
- In June 2024, Biotest AG announced that its intravenous antibiotic Yimmugo was approved in the United States for treating patients with primary immunodeficiency virus. Yimmugo is the first drug approved in the U.S. to be manufactured using an innovative process in the firm’s new Biotest production facility.
- In November 2023, AbbVie Inc. announced the acquisition of ImmunoGen and its flagship cancer therapy mirvetuximab soravtansine-gynx. The drug is a first-in-class antibody combination approved for platinum-resistant ovarian cancer. The acquisition was set to accelerate AbbVie’s entry into the commercial market for ovarian cancer.
Report Highlights
Product Insights
By product, the IGG segment registered its dominance over the global market in 2023. IGG antibodies play a crucial role in protecting their host from microbial infections. IGG autoantibodies can suppress various autoimmune and chronic inflammatory diseases by neutralizing pathogenic autoantibodies through the anti-idiotypic network and modulating the expression of Fc receptors. Glycosylation of the IgG Fc fragment has also proved instrumental in promoting anti-inflammatory activity in several mouse models.
Route of Administration Insights
The Intravenous segment dominated the intravenous immunoglobulin market in 2023. Due to the characteristics of the medications used in these therapies, intravenous administration is the most prescribed method. The half-life of an immunoglobulin injection is approximately 3 to 4 weeks.
The subcutaneous mode of administration is set to show notable growth in the forecast period. Subcutaneous immunoglobulin infusion is a slow injection of purified immunoglobulin into the subcutaneous fatty tissue. These infusions are slow to absorb and are usually administered through the outer area of the upper arm, abdomen, front of the thigh, and upper back.
Application Insights
The immunodeficiency diseases segment held a dominant presence in the market in 2023. Intravenous immunoglobulin therapy is now standard for most immunodeficiencies. The treatment is commonly used in patients with X-linked agammaglobulinemia, common variable immunodeficiency, and X-linked hyper-immunoglobulin. It also has wider applications in severe combined immunodeficiency and Wiskott–Aldrich syndrome.
The Chronic inflammatory demyelinating polyneuropathy segment is set to be the fastest-growing in the intravenous immunoglobulin market during the forecast period. Recent research has shown that this therapy is superior to placebo in reducing disability and impairment in chronic inflammatory demyelinating polyneuropathy patients. The efficacy of the treatment is similar to that of plasma exchange and oral prednisolone replacement strategies.
End User Insights
The hospitals segment is set to be the fastest-growing intravenous immunoglobulin market during the forecast period. Healthcare providers are increasingly adopting intravenous immunoglobulin therapies due to their proven efficacy and safety record. Hospitals are the primary point of contact for most patients with immune system-related diseases.
Distribution Channel Insights
The hospital pharmacy segment dominated the market in 2023, as the use of these therapies, both licensed and off-label, continues to grow steadily. Many patients are receiving advanced treatments such as intravenous immunoglobulin therapies at hospitals, prompting hospital pharmacies to maintain a steady inventory.
The retail pharmacy segment is projected to expand rapidly in the market in the coming years. As ambulatory care centers increasingly administer these therapies, retail pharmacies are beginning to stock up on serums and injections used in intravenous immunoglobulin treatments.
Recent Developments
Amgen - Recent Development
- In June 2024, Amgen announced positive results from a randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical study evaluating inebilizumab-cdon for treating immunoglobulin G4-related disease.
Takeda - Recent Development
- In January 2024, Takeda announced that the U.S. Food and Drug Administration approved GAMMAGARD LIQUID [immunoglobulin infusion (human) 10% solution] as an intravenous therapy to treat neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy.
GC Biopharmaceuticals – Recent Development
- In December 2023, GC Biopharmaceuticals announced that the U.S. Food and Drug Administration had approved ALYGLO (immune globulin intravenous, human-stwk) for treating patients aged 17 years and older with primary humoral immunodeficiency. The therapy met the primary endpoints for safety and efficacy established by the FDA-recommended guidelines in Phase 3 clinical trials.
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Key Players Intravenous Immunoglobulin Market
Market Segmentation
By Product
By Route of Administration
By Application
By End-Users
By Distribution Channel
By Region
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