North America Intravenous Immunoglobulin Market
The report highlights trends prevailing in the market and factors driving and hindering the North America intravenous immunoglobulin market growth. increase in use of immunoglobulins and rising immunodeficiency disease prevalence drive the market growth. However, the high cost of intravenous immunoglobulin (IVIG) therapy hamper the North America intravenous immunoglobulin market growth.
Rising Immunodeficiency Disease Prevalence Fuel North America Intravenous Immunoglobulin Market Growth
Patients with autoimmune diseases are treated with intravenous immunoglobulins. Autoimmune diseases are conditions wherein the immune system accidentally attacks its own tissues or cells. Chronic inflammation, and organ and system damage result from this aberrant immune reaction against healthy cells. Fatigue, joint pain, muscle weakness, skin rashes, and neurological disturbances are a few of the typical signs and symptoms of autoimmune diseases. Symptoms of autoimmune diseases such as Guillain-Barré syndrome (GBS), myasthenia gravis (MS), rheumatoid arthritis (RA), systemic lupus erythematosus (LE), and immune thrombocytopenia (ITP) can be alleviated with the IVIG therapy. Benefits of this therapy include the rapid relief of symptoms and long-lasting effects, leading to improved quality of life among patients.
According to the Intermountain Healthcare, autoimmune and immune-mediated diseases and conditions affect 23.5–50 million Americans. Rheumatoid arthritis (RA) is the most prevalent type of autoimmune arthritis, and 1 in 4 adults in the US have arthritis, according to the Centers for Disease Control and Prevention. As per the Myasthenia Gravis Foundation of America, Inc., the prevalence of myasthenia gravis (MG) is estimated at 14–20 per 100,000 of the US population. In Canada, the incidence of MG is estimated to be 23 per 1 million person-years, with a prevalence of 263 per 1 million people, and the numbers have been stable over the past few decades.
With a decrease in the body’s capacity to produce T- or B-cells, aging impairs a person’s ability to fight off infections and cancerous cells. Immunosenescence, i.e., a weakening of the immune system, is the term used to describe the aging-related changes to the immune system. The elderly population is more prone to immunodeficiency diseases because of immunosenescence. Elderly patients with these diseases are prescribed IVIG therapies. Thus, an upsurge in the geriatric population and the rising prevalence of immunodeficiency disorders propel the growth of the North America intravenous immunoglobulin market.
North America Intravenous Immunoglobulin Market: Segmental Overview
Based on type, the North America intravenous immunoglobulin market is segmented into IgG, IgA, IgM, and others. In 2022, the IgG segment held the largest market share and is expected to grow at the fastest rate during 2022–2030. IgG is expanded as immunoglobulin G and is a type of antibody. It is the most abundant antibody found in blood, lymph fluid, cerebrospinal fluid, and peritoneal fluid and plays a vital role in the humoral immune response. IgG constitutes approximately 75% of total serum antibodies and is equally distributed between intravascular and extravascular serum pools. IgG is the only class of immunoglobulins that can cross the placenta and reach fetal circulation. Human IgG can be divided into four subclasses (IgG1, IgG2, IgG3, IgG4) based on unique antigenic determinants on their heavy chain constant-region domains and associated biologic functions.
Moreover, intravenous immunoglobulin (IVIg) is a replacement therapy and treatment of choice for patients with antibody deficiencies or suffering from immunodeficiency disorders. For instance, in primary or secondary hypogammaglobulinemia, IVIg replacement therapy protects against infections by providing an adequate amount of IgG in the blood. Additionally, IVIg is a blood product prepared from the serum of between 1000-15000 donors per batch where only the IgG is purified from plasma in the production of IVIg products. So IVIg used for treatment contains 95- 98% pure IgG with only small amounts of other plasma proteins, including some IgA and IgM.
Thus, the wide application of IgG in treating several categories of disorders is likely to complement the growth of the IgG segment during the forecast period.
IgA is the body’s most synthesized immunoglobulin, but due to its unstable nature, it is present in lower amounts at any given time. Therefore, it is the second most abundant immunoglobulin type found in the body and, consequently, has a crucial role in protection against antigens. IgA, one of the five primary immunoglobulins, plays a pivotal role in mucosal homeostasis in the gastrointestinal, respiratory, and genitourinary tracts, functioning as the dominant antibody of immunity.
As IgA is a primary immunoglobulin, its deficiency leads to a condition called as Selective IgA Deficiency. Selective IgA Deficiency is defined as a primary immunodeficiency characterized by an undetectable level of IgA in the blood and secretions but no other immunoglobulin deficiencies. Selective IgA deficiency leads to many other conditions such as recurrent ear infections, sinusitis, bronchitis, pneumonia, and autoimmune diseases including arthritis, lupus, endocrinopathies, chronic active hepatitis, and hematologic disorders. Additionally, IgA-deficient patients are at risk for the development of anti-IgA antibodies on receipt of blood products. Thus, to treat such conditions intravenous IgA is administered along with other immunoglobulins as a preparation.
North America Intravenous Immunoglobulin Market: Competitive Landscape
Takeda Pharmaceutical Co Ltd; Grifols SA; Pfizer Inc.; ADMA Biologics, Inc.; Bio Products Laboratory Ltd; Octapharma AG; Kedrion SpA.; CSL Ltd.; LFB Group; and Prothya Biosolutions B.V are among the leading companies operating in the North America intravenous immunoglobulin market. These players focus on expanding and diversifying their market presence and acquiring a novel customer base, tapping prevailing business opportunities in the North America intravenous immunoglobulin market.
A few of the recent developments in the North America intravenous immunoglobulin market are mentioned below:
- In August 2021, Octapharma USA announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has awarded seven years of marketing exclusivity for Octagam 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis (DM). This approval will exclusively drive the growth of Octagam sales.
- In April 2021, ADMA Biologics, Inc. announced that the U.S. Food and Drug Administration (“FDA”) has granted approval for the Company’s expanded manufacturing process, enabling fractionation and purification of a 4,400-liter plasma pool for the manufacture of Intravenous Immune Globulin (“IVIG”).
