The intravenous immunoglobulin market is segmented to register a CAGR of 7.13% over the forecast period, 2022-2027.
The outbreak of the COVID-19 pandemic, in its latter phase, is likely to positively impact the intravenous immunoglobulin market's global growth. According to a December 2020 published article titled "COVID-19 in patients with primary and secondary immunodeficiency: The United Kingdom experience", the study revealed that out of 100 individuals with primary immunodeficiency (PID), symptomatic secondary immunodeficiency (SID), autoinflammatory diseases, and C1 inhibitor deficiency, 70% of the individuals were infected with the SARS-CoV-2 virus, and 59% were admitted to hospitals, with 8% being admitted to intensive care units. Thus, immune-deficient individuals are at a higher risk of being infected with COVID-19, so the market for intravenous immunoglobulin therapies is expected to grow during the pandemic. Additionally, as per an October 2020 published article titled, "The use of Intravenous Immunoglobulin Gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial," the administration of intravenous immunoglobulin in patients with severe COVID-19 infection was expected to improve the clinical outcome and aid in a significant reduction of the mortality rate due to SARS-CoV2 viral infection. Thus, the studied market is expected to witness healthy growth during the pandemic due to the above factors.
Further, the significant factors fueling the market's growth are the rise in the geriatric population, the increase in the adoption of immunoglobulin treatment, and the change in the prevalence of immunodeficiency diseases and bleeding disorders.
Increasing adoption of immunoglobulin with product launches and approvals is likely to boost the market's growth in the future. The growing number of research and development activities about intravenous immunoglobulin is paving market growth. For instance, as per an October 2020 update by the National Institutes of Health, a clinical trial to test the safety, tolerability, and efficacy of a combination treatment regimen for coronavirus disease 2019 (COVID-19) consisting of the antiviral remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19, was initiated in 2020. The study was performed on hospitalized adults with COVID-19 in the United States, Mexico, and 16 other countries on five continents. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, sponsored and funded the Phase 3 trial, called Inpatient Treatment with Anti-Coronavirus Immunoglobulin, or ITAC. The antibody solution tested in the ITAC trial is anti-coronavirus hyperimmune intravenous immunoglobulin or hIVIG. Furthermore, the increasing number of government initiatives supporting the use of the intravenous mode of delivery for some medications is fuelling the market's growth. For instance, in June 2021, the Health and Family Welfare state in Karnataka, India, decided to procure an intravenous immunoglobulin (IVIG) drug worth more than INR 10 crores for emergency use among children.
Thus, the market is expected to witness significant growth over the forecast period due to the abovementioned factors.
By application, primary immunodeficiency disease (PIDs) segment is expected to hold a significant market share.
Intravenous immunoglobulin (IVIG) therapy has been majorly used in treating primary immunodeficiency diseases (PIDs) and other immune deficiency disorders over the past few years. There are several specific medical therapies available for people with PIDs with antibody deficiency, which account for more than half of the primary immunodeficiencies. These illnesses, such as common variable immune deficiency (CVID), X-linked agammaglobulinemia (XLA), and other disorders, are characterized by a lack of and/or impaired antibody function. The high burden of primary immunodeficiency is a major factor fueling the segment's growth. For instance, as per the research article titled "Systematic Review of Primary Immunodeficiency Diseases in Malaysia: 1979-2020", published in Frontiers in Immunology in 2020, approximately six million people are predicted to be living with PIDs globally, among which only 27,000-60,000 cases have been diagnosed. As per the above-mentioned source, the incidence of PIDs in Singapore was observed to be 2.65 per 100,000 live births, with an estimated occurrence rate of one in 37,000 live births. Also, as per an April 2020 update by the Centers for Disease Control and Prevention (CDC), there are more than 400 types of primary immunodeficiencies that vary in severity. Also, as per a September 2019 update by the National Institute of Allergy and Infectious Diseases, there are more than 200 different forms of primary immune deficiency disease. Thus, these statistics reflect the rising need for immunoglobulins for the treatment of immunodeficiency disorders. Hence, the growing burden of PIDs globally is expected to drive the studied segment’s growth over the forecast period.
Furthermore, several pharmaceutical companies are engaged in developing immunoglobulin products for the treatment of primary immunodeficiency. For instance, in May 2021, GC Pharma reported that the United States Food and Drug Administration (FDA) accepted the company’s Biologics License Application (BLA) for "GC5107 (Immune Globulin Intravenous (Human), 10% Liquid)" intended for the treatment of Primary Humoral Immunodeficiency, a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system.
Hence, with the availability of IVIG therapies and the advancements in intravenous immunoglobulin products to treat the highly prevalent primary immunodeficiency diseases, the studied segment is expected to grow significantly over the coming years.
The United States is expected to hold a major share of the marsignificantn North America. The major factors propelling the market growth in the country are a developed and well-structured healthcare system, a growing focus on research and development, and the strong presence of market players.
Additionally, the growing burden of target diseases such as primary immunodeficiency diseases in the region is expected to boost the market's growth. For instance, according to the National Institute of Allergy and Infectious Diseases, in 2020, more than 400 types of varied PIDs were diagnosed in the United States, accounting for more than 500,000 American populations affected by PIDs. Additionally, per the USIDNET Registry, 2020, the frequency of severe combined immunodeficiency (SCID) in the American population was 355. Further, the increasing research and development activities and the rapid product approvals are predicted to drive the intravenous immunoglobulin market growth in the region.
Furthermore, in August 2021, Emergent BioSolutions Inc., a multinational specialty biopharmaceutical company based in the United States, reported the start of a Phase III clinical trial to evaluate its investigational SARS-CoV-2 Immune Globulin Intravenous (COVID-HIG) plasma-derived therapy as a potential outpatient treatment for patients with coronavirus (COVID-19) who are at high risk of progression to severe disease. Thus, the market is expected to witness significant growth during the forecast period due to the abovementioned factors.
The intravenous immunoglobulin market is moderately competitive, and vital global players manufacture most of the intravenous immunoglobulin therapies. Market leaders with more funds for research and a better distribution system have established their positions in the market. The key players in the studied market are Grifols SA, Takeda Pharmaceutical Company Limited, Biotest AG, Bio Products Laboratory Limited, and Kedrion SpA, among others. The major players are involved in strategies such as acquisitions, collaborations, and new product launches to secure their positions in the global market.
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The outbreak of the COVID-19 pandemic, in its latter phase, is likely to positively impact the intravenous immunoglobulin market's global growth. According to a December 2020 published article titled "COVID-19 in patients with primary and secondary immunodeficiency: The United Kingdom experience", the study revealed that out of 100 individuals with primary immunodeficiency (PID), symptomatic secondary immunodeficiency (SID), autoinflammatory diseases, and C1 inhibitor deficiency, 70% of the individuals were infected with the SARS-CoV-2 virus, and 59% were admitted to hospitals, with 8% being admitted to intensive care units. Thus, immune-deficient individuals are at a higher risk of being infected with COVID-19, so the market for intravenous immunoglobulin therapies is expected to grow during the pandemic. Additionally, as per an October 2020 published article titled, "The use of Intravenous Immunoglobulin Gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial," the administration of intravenous immunoglobulin in patients with severe COVID-19 infection was expected to improve the clinical outcome and aid in a significant reduction of the mortality rate due to SARS-CoV2 viral infection. Thus, the studied market is expected to witness healthy growth during the pandemic due to the above factors.
Further, the significant factors fueling the market's growth are the rise in the geriatric population, the increase in the adoption of immunoglobulin treatment, and the change in the prevalence of immunodeficiency diseases and bleeding disorders.
Increasing adoption of immunoglobulin with product launches and approvals is likely to boost the market's growth in the future. The growing number of research and development activities about intravenous immunoglobulin is paving market growth. For instance, as per an October 2020 update by the National Institutes of Health, a clinical trial to test the safety, tolerability, and efficacy of a combination treatment regimen for coronavirus disease 2019 (COVID-19) consisting of the antiviral remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19, was initiated in 2020. The study was performed on hospitalized adults with COVID-19 in the United States, Mexico, and 16 other countries on five continents. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, sponsored and funded the Phase 3 trial, called Inpatient Treatment with Anti-Coronavirus Immunoglobulin, or ITAC. The antibody solution tested in the ITAC trial is anti-coronavirus hyperimmune intravenous immunoglobulin or hIVIG. Furthermore, the increasing number of government initiatives supporting the use of the intravenous mode of delivery for some medications is fuelling the market's growth. For instance, in June 2021, the Health and Family Welfare state in Karnataka, India, decided to procure an intravenous immunoglobulin (IVIG) drug worth more than INR 10 crores for emergency use among children.
Thus, the market is expected to witness significant growth over the forecast period due to the abovementioned factors.
Key Market Trends
The Primary Immunodeficiency Diseases Segment is Expected to Register a High CAGR Over the Forecast Period
By application, primary immunodeficiency disease (PIDs) segment is expected to hold a significant market share.
Intravenous immunoglobulin (IVIG) therapy has been majorly used in treating primary immunodeficiency diseases (PIDs) and other immune deficiency disorders over the past few years. There are several specific medical therapies available for people with PIDs with antibody deficiency, which account for more than half of the primary immunodeficiencies. These illnesses, such as common variable immune deficiency (CVID), X-linked agammaglobulinemia (XLA), and other disorders, are characterized by a lack of and/or impaired antibody function. The high burden of primary immunodeficiency is a major factor fueling the segment's growth. For instance, as per the research article titled "Systematic Review of Primary Immunodeficiency Diseases in Malaysia: 1979-2020", published in Frontiers in Immunology in 2020, approximately six million people are predicted to be living with PIDs globally, among which only 27,000-60,000 cases have been diagnosed. As per the above-mentioned source, the incidence of PIDs in Singapore was observed to be 2.65 per 100,000 live births, with an estimated occurrence rate of one in 37,000 live births. Also, as per an April 2020 update by the Centers for Disease Control and Prevention (CDC), there are more than 400 types of primary immunodeficiencies that vary in severity. Also, as per a September 2019 update by the National Institute of Allergy and Infectious Diseases, there are more than 200 different forms of primary immune deficiency disease. Thus, these statistics reflect the rising need for immunoglobulins for the treatment of immunodeficiency disorders. Hence, the growing burden of PIDs globally is expected to drive the studied segment’s growth over the forecast period.
Furthermore, several pharmaceutical companies are engaged in developing immunoglobulin products for the treatment of primary immunodeficiency. For instance, in May 2021, GC Pharma reported that the United States Food and Drug Administration (FDA) accepted the company’s Biologics License Application (BLA) for "GC5107 (Immune Globulin Intravenous (Human), 10% Liquid)" intended for the treatment of Primary Humoral Immunodeficiency, a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system.
Hence, with the availability of IVIG therapies and the advancements in intravenous immunoglobulin products to treat the highly prevalent primary immunodeficiency diseases, the studied segment is expected to grow significantly over the coming years.
North America is Expected to Dominate the Market
The United States is expected to hold a major share of the marsignificantn North America. The major factors propelling the market growth in the country are a developed and well-structured healthcare system, a growing focus on research and development, and the strong presence of market players.
Additionally, the growing burden of target diseases such as primary immunodeficiency diseases in the region is expected to boost the market's growth. For instance, according to the National Institute of Allergy and Infectious Diseases, in 2020, more than 400 types of varied PIDs were diagnosed in the United States, accounting for more than 500,000 American populations affected by PIDs. Additionally, per the USIDNET Registry, 2020, the frequency of severe combined immunodeficiency (SCID) in the American population was 355. Further, the increasing research and development activities and the rapid product approvals are predicted to drive the intravenous immunoglobulin market growth in the region.
Furthermore, in August 2021, Emergent BioSolutions Inc., a multinational specialty biopharmaceutical company based in the United States, reported the start of a Phase III clinical trial to evaluate its investigational SARS-CoV-2 Immune Globulin Intravenous (COVID-HIG) plasma-derived therapy as a potential outpatient treatment for patients with coronavirus (COVID-19) who are at high risk of progression to severe disease. Thus, the market is expected to witness significant growth during the forecast period due to the abovementioned factors.
Competitive Landscape
The intravenous immunoglobulin market is moderately competitive, and vital global players manufacture most of the intravenous immunoglobulin therapies. Market leaders with more funds for research and a better distribution system have established their positions in the market. The key players in the studied market are Grifols SA, Takeda Pharmaceutical Company Limited, Biotest AG, Bio Products Laboratory Limited, and Kedrion SpA, among others. The major players are involved in strategies such as acquisitions, collaborations, and new product launches to secure their positions in the global market.
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Table of Contents
1 INTRODUCTION
4 MARKET DYNAMICS
5 MARKET SEGMENTATION (Market Size by Value - USD million)
6 COMPETITIVE LANDSCAPE
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Bio Products Laboratory Ltd
- Biotest AG
- China Biologic Products Holdings Inc.
- CSL Behring
- Grifols SA
- Kedrion SpA
- Shanghai RAAS Blood Products Co. Ltd
- Octapharma AG
- Takeda Pharmaceutical Company Limited
- Baxter International Inc.
- Bayer AG
- LFB Biotechnologies SAS
- BDI Pharma Inc.
- Hualan Biological Engineering Inc.
- ADMA Biologics Inc.
Methodology
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