Immunoglobulin Market size was valued at around USD 15.3 billion in 2022 and is estimated to reach USD 32.2 billion by 2032. The market is poised for accelerated growth due to the increasing adoption of both organic and inorganic strategies by various market players.
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For instance, Takeda's recent announcement in April 2023, regarding the U.S. Food and Drug Administration's approval of a supplemental biologics license application (sBLA) to broaden the application of HYQVIA, a subcutaneous immune globulin (ScIG) used for treating primary immunodeficiency (PI) in children aged 2-16, serves as an illustrative example. This growing number of product approvals is expected to bolster market expansion. Additionally, the rising prevalence of autoimmune diseases like Guillain-Barre syndrome, primary immunodeficiency disease (PID), and immune thrombocytopenic purpura (ITP), among others, is set to further propel market progress.
Immunoglobulins, also known as antibodies, are specialized proteins produced by the immune system in response to the presence of foreign substances such as bacteria, viruses, and other pathogens. They play a critical role in the body’s defense against infection and diseases by recognizing and binding to specific antigen on the surface of this invaders, thereby making them for disruption by other immune cells or neutralizing their harmful effects. There are several types of immunoglobulins including IgA, IgD, IgE, IgG, and IgM each with unique structures and functions.
|Immunoglobulin Market Size in 2022:||USD 15.3 Billion|
|Forecast Period:||2023 to 2032|
|Forecast Period 2023 to 2032 CAGR:||7.7%|
|2032 Value Projection:||USD 32.2 Billion|
|Historical Data for:||2018 to 2022|
|No. of Pages:||210|
|Tables, Charts & Figures:||374|
|Segments covered:||Product Type, Route of Administration, Application, End-use, and Region|
|Pitfalls & Challenges:|
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The COVID-19 pandemic had a negative impact on the immunoglobulin market. Plasma collection decreased globally because of severe lockdown circumstances and constraints. This caused a storage of plasma and plasma fractionation. The largest declines in transfusion were noted in surgery department for fresh frozen plasma. As a result, it was challenging for the major players to collect plasma for plasma fractionation. Thus, because of the severe shortage, patients were having trouble getting access to plasma products, particularly immunoglobulin. Such factor hampered the market's expansion.
Furthermore, the government of many nations drastically decreased the hospital admission for immunology-related disorders by reducing inpatient visits and delaying elective procedures. This further led to the decreased adoption of market during pandemic.
The rise in the occurrence of immunodeficiency disorders can be attributed to sedentary lifestyle habits, including the consumption of saturated fats, excessive salt and sweets, reduced physical activity, and high alcohol intake. Consequently, the escalating frequency of lifestyle-related illnesses such as obesity and conditions stemming from inadequate antibody production is set to expedite market expansion. For instance, as indicated by a report from the National Institute of Health, there exist over 200 distinct types of primary immune deficiency diseases (PIDDs), impacting roughly 500,000 individuals in the United States alone. Hence, the demand for immunoglobulin therapy is expected to surge in the foreseeable future due to the growing prevalence of both primary and acquired immunodeficiency ailments.
The anticipated impediment to the growth of the market stems from the considerable expenses associated with this therapy. For instance, according to findings from the Children's Hospital of Philadelphia Research Institute, immunoglobulin replacement therapy (IRT) represents the standard of care for congenital agammaglobulinemia in the U.S. and other high-income countries. This therapy is administered either monthly through intravenous infusion or weekly/biweekly via subcutaneous infusion. While the treatment significantly reduces the occurrence of infections, it does not offer absolute prevention for all infections. Furthermore, the need for frequent infusions impacts the quality of life for patients. Moreover, the cost of IRT treatment falls within the range of USD 30,000 to USD 90,000 in the U.S. Consequently, the elevated treatment expenses are expected to act as a barrier to market demand.
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Based on product type, the immunoglobulin market is segmented as IgG, IgA, IgM, IgD, and IgE. The IgG segment accounted around 74% of the business share in 2022 and is projected to witness robust growth over the analysis timeframe. During the projected period, market growth is expected to be driven by the increasing acceptance of immunoglobulins, a growing frequency of product launches, and swift approvals from governmental regulatory bodies at various levels.
For instance, in January 2022, Argenx SE, a global immunology company, announced the approval of VYVGART by Japan's Ministry of Health, Labour and Welfare (MHLW). VYVGART, administered through intravenous infusion (efgartigimod alfa), is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who have not responded adequately to steroids or non-steroidal immunosuppressive therapies (ISTs). Thus, increasing number of product approvals is expected to nurture market expansion. Another contributing factor to the global market's growth is the progression of government initiatives that endorse the intravenous delivery of medications.
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Based on route of administration, the immunoglobulin market is segmented as intravenous (IVIG), and subcutaneous (SCIg). The intravenous (IVIG) held a dominant business share of around 71.2% in 2022 and is expected to grow at a significant pace during the analysis period. The rapid absorption rate provided by intravenous mode of delivery and the high immunoglobulin bioavailability are the factors supporting the expansion of the intravenous mode of delivery market. Furthermore, numerous immunoglobulins are receiving more financing, which is fostering the market's expansion.
For instance, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring and funding the Phase 3 trial, called Inpatient Treatment with Anti-Coronavirus Immunoglobulin, or ITAC. The antibody solution being tested in the ITAC trial is anti-coronavirus hyperimmune intravenous immunoglobulin, or hIVIG. Such factor will accelerate the market growth. Moreover, increasing application of plasma derived therapy for the treatment of rare diseases will further escalate the market expansion.
Based on application, the immunoglobulin market is segmented as chronic inflammatory demyelinating polyneuropathy (CIDP), multifocal motor neuropathy (MMN), primary immunodeficiency disease (PID), secondary immunodeficiency disease (SID), Guillain-Barre syndrome, immune thrombocytopenic purpura (ITP) and others. The chronic inflammatory demyelinating polyneuropathy (CIDP) segment is expected to grow at a steady pace of 8% between 2023 to 2032. The market is set to experience accelerated growth due to the increasing incidence of chronic inflammatory demyelinating polyneuropathy (CIDP). For instance, CIDP's overall prevalence is estimated to range from 4.8 to 8.9 cases per 100,000 individuals, with a lower estimated prevalence of 0.5 cases per 100,000 persons among children. CIDP treatment typically involves the use of immunosuppressants, steroids, and plasmapheresis.
However, intravenous immunoglobulin (IVIG) emerges as an effective long-term alternative to these methods, thereby serving as a catalyst for market expansion. Furthermore, the associated advantages, such as safety, minimally invasive procedures, and user-friendly treatment options, are expected to contribute significantly to the growth of the industry.
Based on end-use, the immunoglobulin market is segmented as hospitals, clinics, and homecare. The hospitals segment held a dominant market share in 2022 and is expected to grow at a significant pace of 8.1% between 2023 to 2032. The segment's predominance can be chiefly attributed to its advanced medical infrastructure and continuous medical supervision provided by healthcare professionals around the clock. Additionally, the expanding healthcare facilities catering to the health needs of both developed and emerging nations have led to a rise in the number of patients receiving hospital care.
For instance, data from the American Hospital Association (AHA) in 2022 reveals that the U.S. had a total of 6,129 hospitals with a cumulative 3.4 million hospital admissions. As a result, the increasing count of patients seeking hospitalization services is poised to bolster growth within this segment.
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U.S. immunoglobulin market exceeded USD 7.6 billion in 2022. The business share in this region can be attributed to several factors, including the increasing healthcare spending, growing awareness about products used in the treatment of immunodeficiency disorders, and the rising preference among physicians for immunodeficiency therapies. Moreover, the market is expected to benefit from the expanding regulatory approvals for enhancing the manufacturing processes of immunoglobulins.
For example, in April 2021, ADMA Biologics, Inc., a biopharmaceutical company specializing in the production, promotion, and development of specialized plasma-derived biologics, announced that it had received approval from the U.S. FDA for an expanded manufacturing process. This approval enables the fractionation and purification of a 4,400-liter plasma pool for the production of intravenous immune globulin ("IVIG"). Such regulatory clearance is projected to stimulate market demand.
Some of the major market players operating in the immunoglobulin market are
These players focus on strategic partnerships, new product launch & commercialization for market expansion. Furthermore, these players are heavily investing in research that allows them to introduce innovative products and garner maximum revenue in the market.
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By Product Type, 2018 - 2032 (USD Million)
By Route of Administration, 2018 - 2032 (USD Million)
By Application, 2018 - 2032 (USD Million)
By End-use, 2018 - 2032 (USD Million)
The above information is provided for the following regions and countries: