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The intravenous immunoglobulin (IVIG) market is a fast-growing industry, where different classes of immunoglobulin such as IgG, IgA, and IgM are used for the treatment of various immunological and neurological diseases. Immunoglobulins are glycoproteins that are produced in the blood plasma in response to antigens. For therapeutic use, these glycoproteins are obtained through combination of plasma from multiple healthy donors. Intravenous immunoglobulin / IVIg is concentrate of comprising more than 90% IgG. This concentrate is then administered into the patients intravenously. In addition to the intravenous route of administration subcutaneous and intramuscular immunoglobulin products are also available. Historically, immunoglobulins were primarily administered via intramuscular and subcutaneous routes. However, in response to the limitations associated with these methods, developers created intravenous gamma globulin preparations, which have since been employed to address a wide array of clinical conditions.
FDA has till now approved at least 12 human IVIg for treatment of several disorders. It is worth highlighting that Yimmugo, developed by Biotest, is the most recent intravenous immunoglobulin to receive approval in the United Kingdom for the treatment of patients with congenital and acquired immunodeficiencies and for immunomodulation. This approval was announced in September 2023, and it enables future sales growth and provides an important therapeutic option for pediatric and adult patients with these conditions.
The global intravenous immunoglobulin market is highly fragmented, with the presence of several international as well as regional players.
The key market drivers for the intravenous immunoglobulin industry include the growing geriatric population, rising prevalence of immunodeficiency diseases, increasing adoption of IVIG treatments, rising use of off-label indications, robust pipeline, government initiatives, enhanced purification techniques, and approval of novel IVIG therapies.
The World Health Organization reports that there are currently over 50 distinct Primary Immune Deficiency (PID) conditions such as specific antibody deficiency, X-lined hypo-gamma-globulinemia, and others. PID encompass 176 different types of rare hereditary disorders. The U.S. National Library of Medicine and National Institute of Health estimates that approximately 6 million patients are affected by PID worldwide. Growing incidences of these diseases are expected to boost the demand for immunoglobulin therapies over the forecast period.
The key market restraints for the intravenous immunoglobulin market include stringent government regulations, high risk of side effects, and high cost of IVIG therapy.
Immunoglobulin infusions are typically administered every 3 to 4 weeks, with around 12-16 sessions per year. The estimated cost of IVIG is approximately USD 73.89 per gram, with a total cost of up to USD 10,000 depending on the severity of the illness. Immunoglobulin replacement treatments are long-term therapies that typically last for 6 months. According to the ABIM Foundation, the expense of IgG treatment therapy exceeds USD 30,000 per year. The cost of IVIG treatment varies depending on several factors, such as the indication, duration of treatment, and the patient's body weight. On average, the reported cost for IVIG treatment in the US is approximately USD 9,720, and if patients undergo 4 to 5 infusions per month, then it would cost them around USD 41,796 per month.
The key market opportunities for the intravenous immunoglobulin market include high adoption of IVIG treatments, emerging revenue pockets, growing aging population, surge in prevalence of diseases, global expansion strategies, and advancements in IVIG production.
There is a notable high adoption of IVIG treatments, indicating a growing market size and revenue potential. Additionally, the increasing aging population, coupled with a surge in the prevalence of diseases, is driving the demand for IVIG therapies. Furthermore, global expansion strategies and advancements in IVIG production techniques are creating avenues for market expansion and innovation. These factors collectively underscore the promising opportunities within the IVIG market, reflecting a landscape ripe for growth and development.
The intravenous immunoglobulin market forecast on the basis of distribution by therapeutic area, dosage form, type of immunoglobulin, end user, and key geographical regions. On the basis of distribution by therapeutic area, the market is divided into primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy (CIDP), guillain-barré syndrome (GBS), immune thrombocytopenic purpura (ITP) and multifocal motor neuropathy (MMN). On the basis dosage form, the market is segregated into liquid and lyophilized. On the basis of end user market is categorized into hospitals, clinics, homecare and other end users. By geographical regions, the market is analyzed across North America, Europe, Asia-Pacific, Middle East and North Africa and Latin America.
Based on therapeutic area, the intravenous immunoglobulin market is analyzed across Primary Immunodeficiency, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Guillain-Barré Syndrome (GBS), Immune Thrombocytopenic Purpura (ITP), Multifocal Motor Neuropathy (MMN). Majority of the market is significantly influenced by the increasing prevalence of primary and acquired immunodeficiency diseases (PID & AID), followed by Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Moreover, the segment associated with Hypogammaglobulinemia accounted for the third-largest share, attributed to the increasing incidence of primary immunodeficiency diseases (PID) globally, particularly prevalent in patients with lymphoproliferative disorders (LPDs). Furthermore, the segment related to Kawasaki disease is expected to exhibit substantial growth during the forecast period.
Based on region, the intravenous immunoglobulin market is analyzed across North America, Europe, Asia-Pacific, and LAMEA. North America is the largest contributor toward the global market, followed by Asia-Pacific. These regions collectively occupy almost 75% of the global market revenue. Presence of the largest plasma production facilities and high adoption rate in the developed countries majorly boost the market growth. However, LAMEA is projected to register the highest growth rate during the forecast period.
Key market players that are engaged in intravenous immunoglobulin market are (in alphabetical order) Bio Products Laboratory, Biotest, China biologics Products Holdings, CSL Behring, Grifols, Kedrion, LFB, Octapharma, Shanghai RAAS Blood products and Shire. This market report includes an easily searchable excel database of all the intravenous immunoglobulin companies worldwide.
|by Therapeutic Area
|Type of Immunoglobulin
|Key Geographical Regions
|Key Market Players
There has been recent activity in the intravenous immunoglobulin industry and some of the key developments have been mentioned below: