Global Intravenous Immunoglobulin (IVIG) market size was USD 11.23 Billion in 2021 and is expected to register revenue CAGR of 6.9% during the forecast period. Increase in prevalence of immunodeficiency diseases, increasing technological advancements and investments, rise in adoption of immunoglobulin therapies, and growing geriatric population are factors expected to drive market revenue growth during the forecast period. IVIG is a sterile set of concentrated antibodies extracted from healthy people administered directly into the vein. It is used to treat the disorder of immune systems or to boost immune response.
According to the World Health Organisation, by 2030, one in six people in the world will be aged 60 years or over. The share of population aged 60 years and over will increase from 1 billion in 2020 to 1.40 billion. This aging population is vulnerable and faces impact due to accumulation of molecular and cellular damage with time, often by emergence of several complex health conditions, namely geriatric syndromes. Growing geriatric population and immunodeficiency disorders and diseases are a severe cause of concern for healthcare ecosystem. Therefore, rise of geriatric population coupled with increasing immunodeficiency disorders will drive growth of market during the forecast period.
Increase in cases related to autoimmune diseases and disorders such as primary humoral immunodeficiency, rheumatoid arthritis, systematic sclerosis, Idiopathic Thrombocytopenic Purpura (ITP), lupus, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and others creates a need for immunoglobulin to cater to these indications. With increasing healthcare Research and Development (R&D) and awareness, demand for different IVIG increases substantially, which encourages market players to launch novel immunoglobulin products in market. For instance, in February 2020, CSL Behring announced that Food and Drugs Association (FDA) granted orphan drug status to Privigen (Immune Globulin Intravenous (Human), 10% liquid) as an investigational therapy in treatment for Systematic Sclerosis. Hence, with increase in adoption rate of immunoglobulin therapies and research and development, IVIG industry is expected to grow significantly.
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COVID-19 pandemic changed entire scenario with rise in healthcare spending across the globe. The goal to have proper and state of art healthcare facilities has become need of the time. COVID-19 creates a positive impact and creates new opportunities for intravenous immunoglobulin industry. Studies reflect those immune deficient individuals are at a higher risk of being infected with COVID-19. With increase in donations of plasma from volunteers, development of immunoglobulin products increased. Key players collaborated, and strategic partnerships were announced to aid in developing new novel immunoglobulin products for COVID-19 based on recovered COVID -19 patients’ plasma.
For instance, in April 2020, Kedrion Biopharma Inc. and Kamada Ltd. announced a strategic partnership for developing, manufacturing, and distributing plasma-derived Anti-SARs-COV-2 (COVID-19) polyclonal immunoglobulin products. Thus, IVIG industry registered steady growth during COVID-19 pandemic. Effectiveness and systematic route of administration of intravenous immunoglobulin, an investment made and infrastructure development in collection and storage of plasma, and overall approval by statuary bodies and FDA recently bears better which will drive growth of IVIG market.
Market Dynamics:
Drivers: Increase in prevalence of immunodeficiency diseases and rise in adoption of immunoglobulin therapies are key factors driving market revenue growth
Rising geriatric population and increased prevalence of immunodeficiency and neurological disorders is a high cause of concern for healthcare system across the globe. According to National Institute of Allergy and Infectious Diseases, more than 200 different forms of primary immune deficiency diseases exist in the U.S., affecting approximately five lac persons. Hence, with increasing awareness and desire for ensuring proper treatment, there is a significant increase in demand for novel intravenous immunoglobulin therapies which is expected to propel industry revenue growth.
With rising cases of primary and acquired immunodeficiency diseases, adoption of novel immunoglobulin therapies is rising among medical experts. IVIG therapies are generally safe to administer and bare minimum side effects. Owing to effectiveness, in cases of patients diagnosed with chronic inflammatory demyelinating polyneuropathy, it is considered first line of treatment. Clinical studies reflect effectiveness of IVIG treatment in proliferation of regulatory T-cells by acting directly on conventional T-cells to surpass T-cells receptor signaling. In cases of diseases such as Kawasaki disease, polymyositis, juvenile dermatomyositis, neurological disorders, peripheral neuropathies, application of IVIG has increased considerably. This is expected to boost market revenue growth over the forecast period.
Robust pipeline and increasing launches of novel products are expected to support market growth. For instance, in February 2021, Evolve Biologics Inc., declared successful completion of adult and pediatric Phase III clinical trial of PlasmaCap IG. The clinical trials have been conducted at 12 centers in the U.S. and Canada. PlasmaCap IG is an investigational IVIG replacement therapy for adult and pediatric patients with primary immunodeficiency. Thus, rising technological advancement in healthcare sectors, rise in investments supports development of innovation of novel immunoglobulin therapies which are expected to drive market revenue growth during the forecast period.
Restraints: Expensive treatment procedures is a key factor restraining revenue growth of market
High cost of intravenous immunoglobulin therapies will limit its adoption, which in turn will hamper market revenue growth to a certain extent over the forecast period. The supply chain may be a matter of concern due to dearth of raw materials, and stringent regulatory policies by various governments will restrain industry’s growth. Immunoglobulin therapy being one of the most technologically advanced therapy is highly cost intense. The costly nature of therapies is one of the key factors which hamper growth of IVIG market. In addition, collection of plasma, its purification, and shortage is highly costly owing to advanced technologies and development of proper healthcare infrastructure. Hence issue of supply chain of plasma is omnipresent in most regions of the world. Further, strict policy regarding approval of different immunoglobulin therapies is a timely process and is administered very strictly by various governments or statutory bodies. Therefore, all these factors are expected to restrain growth of IVIG market over the forecast period.
Key Takeaway
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Product Type Outlook:
Based on product type, IVIG market is segmented into Immunoglobulin G (IgG), Immunoglobulin A (IgA), Immunoglobulin M (IgM), Immunoglobulin E (IgE), and Immunoglobulin D (IgD). IgG segment is expected to account for largest market share over the forecast period. IgG is the most common antibody (75% to 80%) of all antibodies in the body, essential for fighting bacterial and viral infections. This is expected to increase adoption of IgG products, which in turn will drive growth of this segment.
IgA segment is expected to register a steady revenue growth rate over the forecast period. IgA is a set of antibodies that protect body surfaces exposed to outside foreign substances, which is expected to increase its adoption rate of IgA to protect body surfaces. This will boost revenue growth of this segment.
Application Outlook:
Based on application, global IVIG market has been segmented into hypogammaglobulinemia, immunodeficiency diseases, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), congenital AIDS, myasthenia gravis, multifocal motor neuropathy, Guillain-Barre syndrome, Kawasaki disease, and others.
Hypogammaglobulinemia segment is expected to lead in terms of revenue contribution to global market. Human immunoglobulin is one of the essential elements used to treat severe antibody deficiencies. Hypogammaglobulinemia is a disorder caused by low serum Immunoglobulin or antibody levels. It is the most common primary immunodeficiency and encompasses a majority of immune-compromised patients. The standard treatment for hypogammaglobulinemia is IgG replacement to minimize potentially fatal infection and reduce complications, thus improving patients’ survival and quality of life.
Kawasaki disease segment is expected to register a significantly rapid revenue growth rate during the forecast period. Kawasaki disease is a systemic vasculitis of unknown cause that occurs mainly during childhood, major complications represented by coronary aneurysms. Gamma globulin has generally used immunoglobulin for treatment. Increasing usage of IVIG therapies to treat Kawasaki disease will drive revenue growth of this segment.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) segment is expected to expand at a steady CAGR during the forecast period due to an increase in geriatric population globally. CIDP is a neurological disorder where progressive weakness and impaired sensory function in legs and arms is noticed. IVIG therapy is most prominent and influential therapy in such cases. It is now used as a first-line treatment in most patients due to ease of application and is generally considered safe, having minimal side effects.
Form Outlook:
The global IVIG market is segmented into liquid and lyophilized based on form. Liquid segment is expected to lead in terms of revenue contribution to market over the forecast period. The liquid form is more convenient for patient and health care providers due to shorter infusion times and easier preparation and administration. Mixing process of powder either with water or saline is a hectic process that is not convenient for healthcare workers in urgent situations, making liquid form most preferred. Liquid form is ready-to-use solution that is more convenient for patients and healthcare workers owing to ease of administration. In addition, shorter infusion time makes it more acceptable for patients and easy to monitor during clinical procedure which further fuels market growth.
End-Use Outlook:
The global IVIG market is segmented into hospitals, clinics, homecare, and others based on end-use. Hospital segment is expected to account for larger market share over the forecast period, owing to increased adoption of intravenous immunoglobulin products in hospitals. Proper channel of administration of immunoglobulin for treating diseases, and ease of time-to-time monitoring of patients is leading to increased adoption rate.
Regional Outlook:
North America is expected to account for largest market share over the forecast period. Rising incidence of autoimmune neurological diseases and steady rise in geriatric population in countries in the region are factors driving market growth. Increasing number of plasmas biocentres plasma collection facilities and dedicated infusion centers is expected to boost market growth. Well-established advanced healthcare facilities and increasing investment by private players and governments in countries such as the U.S. and Canada will augment market growth.
Asia Pacific is expected to register a steady revenue growth rate during the forecast period due to rise in geriatric population and growing awareness towards adopting immunoglobulin therapies. Rapid advancement in healthcare infrastructure and an increase in spending on research and development will boost market growth. With rise in diagnostics of primary immunodeficiency and growing awareness, there is increasing demand for immunoglobulin therapies. Developments of plasma fractionation centers in countries in the region will support market revenue growth. An increase in initiatives from the government will boost intravenous immunoglobulin market growth. In March 2019, CSL Behring LLC announced that Japan’s Ministry of Health, Labour, and Welfare approved Privigen to treat patients with chronic inflammatory demyelinating polyradiculoneuropathy.
The market in Europe is expected to register a steady revenue growth rate due to rise in adoption of immunoglobulin therapies among median age of population. Governments of countries such as Germany and the U.K investing highly in modern healthcare therapies which will drive market growth during the forecast period.
Competitive Landscape:
The intravenous immunoglobulin market is moderately fragmented with key players operating on global levels, as sizeable investments in research and development and a robust distributional channel are required to operate in this market. Some key players in the global market report include Hualan Biological Engineering Inc., Omrix Biopharmaceuticals Ltd, Shanghai RAAS Blood Products Co., Ltd, CSL Behring LLC, ADMA Biologics, Inc., Baxalta Inc., Biotest AG, Kedrion Biopharma, Inc., China Biologic Products Holdings, Inc., Octapharma AG, Grifols S.A., Pfizer Inc., and LFB Biomedicaments SA.
- In January 2022, ADMA Biologics Inc. received the U.S. FDA approval for its fourth ADMA Biocenters Plasma collection facility in Goose Creek, South California. This approval helps ADMA Biologics Inc. to be tracked towards growing its plasma supply capacity and maintain a strong foothold in regards to plasma supply position in supply-constrained U.S. plasma market.
- In January 2022, LFB Biomedicaments SA and Kedrion Biopharma Inc. declared to sign a mutual industrial cooperation agreement for supplying immunoglobulin to France. This agreement helps to meet growing need for immunoglobulin in the French market.
- In February 2021, Pfizer Inc. announced that the U.S. FDA approved supplemental Biologic License Application for PANZYGA (immune globulin intravenous 10%) to treat adult patients with chronic inflammatory demyelinating polyneuropathy. PANZYGA is the only IVIG with two FDA-approved maintenance dosing options for CIDP.
- In June 2020, Grifols S.A. announced that it had implemented acquisition arrangements worth USD 460.0 million, with South Korean company GC Pharma to acquire a ‘Plasma Fractionation’ facility in Canada. The strategic acquisition is a part of Grifols S.A’s global plan to expand plasma collection and fractionation capacity ensuring plasma-derived medicine for patients worldwide. It helps to build a legacy of partnership in Canada blood system.
- In August 2019, BioScrip Inc. and Option Care Enterprises Inc. announced successful completion of merger. The newly formed company Option Health Care Inc. emerges as the largest independent home and alternate site infusion service provider in the U.S.
Segments covered in this report:
This report offers historical data and forecasts revenue growth at a global, regional, and country-level and analyses market trends in each sub-segment from 2022 to 2030. For this report, Reports and Data have segmented intravenous immunoglobulin market based on product type, application, form, end-use, and region.
Intravenous Immunoglobulin (IVIG) Market Report Scope
Segments covered By Product Type Outlook, Application Outlook, Form Outlook, End-Use Outlook,Regional Outlook
By Product Type Outlook
Immunoglobulin G (IgG)
Immunoglobulin A (IgA)
Immunoglobulin M (IgM)
Immunoglobulin E (IgE)
Immunoglobulin D(IgD)
By Application Outlook
Hypogammaglobulinemia
Immunodeficiency Diseases
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Congenital AIDS
Myasthenia Gravis
Multifocal Motor Neuropathy
Guillain-Barre syndrome
Kawasaki Diseases
Others
By Form Outlook
Liquid
Lyophilized
By End-Use Outlook
Hospitals
Clinics
Homecare
Others
Regional scope
North America
Europe
Asia Pacific
Latin America
Middle East & Africa
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