Intravenous Immunoglobulin Market Outlook 2024-2034:
The intravenous immunoglobulin market size reached a value of USD 12.7 Billion in 2023. Looking forward, the market is expected to reach USD 23.5 Billion by 2034, exhibiting a growth rate (CAGR) of 5.76% during 2024-2034.
The market is driven by an increase in autoimmune and inflammatory diseases, advancements in production technologies, and heightened awareness about IVIG therapies. Moreover, technological advancements in plasma fractionation and purification processes are ensuring a more consistent and high-quality product, addressing previous supply constraints. Additionally, efforts are being made to enhance supply chain logistics, ensuring better accessibility and affordability of IVIG treatments worldwide.
Advancements in Production Technologies: Driving the Intravenous Immunoglobulin Market
The intravenous immunoglobulin (IVIG) market is seeing substantial advances in production technology, which are changing the landscape of IVIG medicines. These innovations seek to improve the efficiency, safety, and scalability of IVIG manufacturing, meeting both present and future demand. Plasma fractionation techniques have improved significantly, making them one of the biggest technical advances. Plasma fractionation is the separation of plasma into its constituent components, which include immunoglobulins. Traditional fractionation procedures, like as the Cohn process, have been improved to boost the production and purity of immunoglobulin. Newer techniques, like chromatography and precipitation, offer more precise separation, resulting in higher-quality IVIG products with fewer impurities and contaminants. Another significant development is the implementation of advanced purification processes. These processes are designed to remove potential pathogens and contaminants more effectively. For example, virus inactivation and removal steps have become more sophisticated, employing methods such as solvent/detergent treatment, nanofiltration, and pasteurization. These steps ensure that IVIG products are safe for patient use, minimizing the risk of transfusion-transmitted infections.
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Furthermore, automation and digitization in manufacturing processes are vital to the progress of IVIG production. IVIG production is more efficient and consistent because of automated plasma collection, processing, and quality control technologies. Digital technologies and data analytics are being used to monitor and improve production parameters, assuring excellent product quality and compliance with regulatory requirements. These features minimize human error and promote traceability across the production chain. Additionally, advancements in genetic engineering and recombinant DNA technology hold promise for the future of IVIG production. Researchers are exploring the potential of producing immunoglobulins through recombinant methods, which involve genetically modifying cell lines to produce large quantities of specific antibodies. This approach could offer a more sustainable and scalable alternative to plasma-derived IVIG, reducing reliance on human donors and addressing supply constraints. Early-stage research and clinical trials are underway to evaluate the feasibility and efficacy of recombinant IVIG products.
Expanding Therapeutic Applications: Contributing to Market Expansion
The intravenous immunoglobulin (IVIG) market is witnessing an expansion in therapeutic applications, broadening the scope of conditions that can be effectively treated with IVIG therapies. This trend is driven by ongoing research and clinical trials that explore the potential of IVIG in treating a wide range of diseases beyond its traditional uses. Historically, IVIG has been primarily used to treat primary immunodeficiency disorders, where patients lack sufficient antibodies to fight infections. However, the therapeutic potential of IVIG extends far beyond these initial indications. One of the most significant expansions is in the treatment of autoimmune and inflammatory diseases. IVIG is now commonly used to manage conditions such as chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain-Barré syndrome, and multifocal motor neuropathy (MMN). These conditions involve the immune system attacking the body’s own tissues, and IVIG helps by modulating immune responses and reducing inflammation.
Another burgeoning area of application is in the field of neurology. IVIG is increasingly being utilized to treat various neurological disorders, including myasthenia gravis, multiple sclerosis, and certain forms of epilepsy. These conditions often have an autoimmune component, where the immune system disrupts normal neurological function. IVIG has shown promise in stabilizing symptoms and improving the quality of life for patients with these debilitating disorders. Moreover, the role of IVIG in treating infectious diseases is also expanding. During the COVID-19 pandemic, IVIG was explored as a potential treatment option for severe cases, leveraging its broad-spectrum antiviral and immunomodulatory properties. Although its efficacy for COVID-19 treatment is still under investigation, this application highlights the versatility of IVIG in managing emerging infectious diseases and supporting immune responses in critically ill patients. In addition to these therapeutic areas, IVIG is being studied for its potential in treating dermatological conditions, such as autoimmune blistering diseases and severe psoriasis. These skin conditions often involve complex immune dysregulation, and IVIG’s ability to modulate immune activity makes it a valuable treatment option. Clinical trials are ongoing to determine the optimal dosing and long-term efficacy of IVIG in these dermatological applications.
Increased Adoption in Neurological Disorders:
The intravenous immunoglobulin (IVIG) market is experiencing increased adoption in the treatment of neurological disorders, a trend driven by growing evidence of its efficacy in managing various neurological conditions. This expanding use of IVIG in neurology is reshaping the therapeutic landscape and offering new hope for patients with challenging and often debilitating neurological diseases. One of the primary neurological disorders where IVIG has gained prominence is chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rare autoimmune condition characterized by progressive weakness and impaired sensory function in the limbs. IVIG is considered a first-line treatment for CIDP, as it helps to reduce inflammation and halt disease progression. Clinical studies have demonstrated that IVIG can improve motor strength and functional abilities in CIDP patients, making it a cornerstone of therapy.
IVIG is also widely used in the management of Guillain-Barré syndrome (GBS), an acute autoimmune disorder that affects the peripheral nervous system. GBS often leads to rapid-onset muscle weakness and paralysis, and early treatment with IVIG can significantly improve recovery outcomes. By modulating the immune response and preventing further nerve damage, IVIG helps to accelerate recovery and reduce the severity of symptoms in GBS patients. Another key area of increased IVIG adoption is in the treatment of myasthenia gravis (MG), a chronic autoimmune neuromuscular disorder that causes muscle weakness and fatigue. IVIG is used as a therapeutic option during myasthenic crises, where patients experience severe muscle weakness that can affect breathing and swallowing. IVIG provides rapid immunomodulation, stabilizing symptoms and preventing life-threatening complications. Additionally, it is used as a maintenance therapy for patients who do not respond adequately to conventional treatments. Apart from this, multiple sclerosis (MS) is another neurological condition where IVIG is being explored as a potential treatment. MS is an autoimmune disorder that affects the central nervous system, leading to a range of neurological symptoms such as muscle weakness, vision problems, and cognitive impairment. While IVIG is not a first-line treatment for MS, it is considered for patients with relapsing-remitting MS who do not respond to standard therapies. IVIG’s immunomodulatory properties can help reduce the frequency and severity of relapses, improving overall disease management.
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Leading Companies in the Intravenous Immunoglobulin Market:
The market research report by IMARC encompasses a comprehensive analysis of the competitive landscape in the market. Across the global intravenous immunoglobulin market, several leading companies are at the forefront of developing and commercializing treatments for intravenous immunoglobulin. Some of the major players include CSL Behring, Grifols, and Takeda Pharmaceuticals Company. These companies are driving innovation in the intravenous immunoglobulin market through continuous research, strategic collaborations, and expanding their product offerings to meet the growing demand for effective treatments.
CSL Behring has made notable advancements in the intravenous immunoglobulin (IVIG) market. One significant update is the FDA approval for their new 50mL/10g prefilled syringe for Hizentra®, a subcutaneous immunoglobulin (SCIg) product. This innovation is designed to improve convenience for patients with Primary Immunodeficiency (PI) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), allowing them to self-administer treatments at home, thus enhancing their quality of life and adherence to therapy. The 50mL prefilled syringe will be available in early 2024, expanding the options for patients requiring higher volumes of medication .
In June 2024, Grifols announced that its subsidiary, Biotest, received FDA approval for Yimmugo, a new intravenous immunoglobulin (IVIG) therapeutic. Yimmugo is designed to treat primary immunodeficiencies (PID) and represents the first Biotest medicine approved in the U.S. This innovative IVIG is produced at Biotest’s FDA-certified “Next Level” production facility in Dreieich, Germany, which underscores its high production standards and responsible use of resources. The product was previously introduced in Europe at the end of 2022 and will be commercially launched in the U.S. in early 2025.
In January 2024, Takeda Pharmaceutical Company Limited received FDA approval for Gammagard Liquid (immune globulin infusion 10%) for treating adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This approval marks a significant milestone as Gammagard Liquid is now the only intravenous immunoglobulin (IVIG) approved for multiple neuromuscular disorder indications in the U.S., enhancing Takeda’s extensive portfolio of plasma-derived therapies.
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Regional Analysis:
The major markets for intravenous immunoglobulin include the United States, Germany, France, the United Kingdom, Italy, Spain, and Japan. According to projections by IMARC, the United States has the largest patient pool for intravenous immunoglobulin while also representing the biggest market for its treatment. This can be attributed to the prevalence of autoimmune and chronic diseases, the aging population in the United States, technological advancements in plasma fractionation, and the introduction of new formulations.
Moreover, in January 2024, the FDA also approved Hyqvia, a combination of immune globulin infusion 10% with recombinant human hyaluronidase, as maintenance therapy for CIDP. Hyqvia showed superiority over placebo in preventing relapse and improving patient outcomes in clinical studies.
Besides this, the FDA approved Octapharma’s IVIG product, Octagam 10%, for the treatment of adults with dermatomyositis, a chronic autoimmune disease characterized by skin rashes and muscle weakness. The approval was based on a phase 3 clinical trial demonstrating significant improvement in patients treated with IVIG compared to placebo.
Key information covered in the report.
Base Year: 2023
Historical Period: 2018-2023
Market Forecast: 2024-2034
Countries Covered
· United States
· Germany
· France
· United Kingdom
· Italy
· Spain
· Japan
Analysis Covered Across Each Country
· Historical, current, and future epidemiology scenario
· Historical, current, and future performance of the intravenous immunoglobulin market
· Historical, current, and future performance of various therapeutic categories in the market
· Sales of various drugs across the intravenous immunoglobulin market
· Reimbursement scenario in the market
· In-market and pipeline drugs
Competitive Landscape:
This report offers a comprehensive analysis of current intravenous immunoglobulin marketed drugs and late-stage pipeline drugs.
In-Market Drugs
· Drug Overview
· Mechanism of Action
· Regulatory Status
· Clinical Trial Results
· Drug Uptake and Market Performance
Late-Stage Pipeline Drugs
· Drug Overview
· Mechanism of Action
· Regulatory Status
· Clinical Trial Results
· Drug Uptake and Market Performance
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