The intravenous immunoglobulin market was valued at approximately USD 10,183.35 million in 2020, and it is expected to witness a revenue of USD 15,344.93 million by 2026, with a CAGR of 7.13% over the forecast period (2021-2026).
The outbreak of the COVID-19 pandemic is expected to have a positive impact on the growth of the intravenous immunoglobulin market globally. According to the research article published in the Journal of Allergy and Clinical Immunology, 2020, the United Kingdom Primary Immunodeficiency Network had documented the impact of COVID-19 infection on primary immunodeficiency disease (PID) and symptomatic secondary immunodeficiency (SID) individuals. The study revealed that out of 100 individuals with PID, SID, autoinflammatory diseases, and C1 inhibitor deficiency, 70% of the individuals were infected with the SARS-CoV2 virus, and 59% were admitted to hospitals, with 8% being admitted to intensive care units. Thus, as immune-deficient individuals are at higher risk of being infected with COVID-19, the market for immunoglobulin therapies is expected to grow during the pandemic. Additionally, as per the research article published in BMC Infectious Diseases, 2020, 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, owing to the aforementioned factors, the studied market is expected to witness healthy growth during the pandemic era.
Intravenous immunoglobulin (IVIG) therapy is the use of a mixture of antibodies (immunoglobulins) to treat health conditions, including primary immunodeficiency, immune thrombocytopenic purpura, chronic inflammatory demyelinating polyneuropathy, Kawasaki disease, certain cases of HIV/AIDS and measles, Guillain-Barre syndrome, and certain other infections. Depending on the formulation, it can be injected into the muscle, a vein, or under the skin.
An increase in the geriatric population and the prevalence of immunodeficiency disorders and bleeding disorders have increased the demand for novel intravenous immunoglobulin therapies. This has led to an increase in the adoption rate of these therapies. Hence, these factors have helped the market growth. However, stringent regulatory approval processes and regulations and the high cost of therapy have been restraining the growth of the market.
Key Market Trends
The Primary Immunodeficiency Diseases Segment is Expected to Register a High CAGR Over the Forecast Period
The primary immunodeficiency diseases segment is expected to witness healthy growth over the forecast period. According to the research article published in Frontiers in Immunology, 2020, the incidence of primary immunodeficiency diseases (PIDs) is 1 in 10,000 population globally, and the majority of PIDs are presented in early childhood. Additionally, as per the research article titled "Systematic Review of Primary Immunodeficiency Diseases in Malaysia: 1979-2020", published in Frontiers in Immunology, 2020, approximately six million people are predicted to be living with PIDs globally, among which only 27,000-60,000 cases were diagnosed. The incidence of PIDs in Singapore was observed to be 2.65 per 100,000 live births and an estimated occurrence rate of one in 37,000 live births, as per the above-mentioned source. Hence, the growing burden of PIDs globally is expected to drive the studied segment's growth over the forecast period.
Intravenous immunoglobulin (IVIG) therapy has been used in primary immunodeficiency diseases (PI) and other immune deficiency disorders. 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. In October 2019, ADMA Biologics began the first commercial sales of ASCENIV, a plasma-derived polyclonal human immune globulin product indicated for the treatment of primary immunodeficiency diseases in adults and adolescents, which received US FDA approval in April 2019.
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
North American countries like the United States and Canada have a developed and well-structured healthcare system. These systems also encourage research and development. These initiatives allow foreign businesses to invest in the United States and Canada. As a result, these countries enjoy the presence of many global market players, which is one of the major factors for the growth of the intravenous immunoglobulin market in the region.
Additionally, the growing burden of target diseases such as primary immunodeficiency diseases in the region is expected to boost the market growth. For instance, according to the National Institute of Allergy and Infectious Diseases, 2020, more than 400 types of varied PIDs were diagnosed in the United States, accounting for more than 500,000 American populations being affected with PIDs. Additionally, as per the USIDNET Registry, 2020, the frequency of severe combined immunodeficiency (SCID) in the American population was found to be 355. Additionally, the increasing research and development activities and the rapid product approvals are predicted to drive the intravenous immunoglobulin market growth in the region.
Furthermore, these countries have a large portion of the population that is insured. This enables this population to get medicines and therapies at subsidized rates. Hence, as the increasing demand is met by the presence of global players in the region, the market is further expected to grow.
The intravenous immunoglobulin market is moderately competitive, and the majority of the intravenous immunoglobulin therapies are being manufactured by the global key players. Market leaders with more funds for research and a better distribution system have established their positions in the market. Moreover, Asia-Pacific is witnessing the emergence of some small players due to the rise of awareness. This has also helped the market grow. The key players of 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. For instance, in January 2020, Kedrion Biopharma completed the enrollment for its CARES10, which is a Phase 3, multi-center, open-label, prospective study to assess the pharmacokinetics, safety, and efficacy of a 10% intravenous immunoglobulin in adults with primary immunodeficiency disease.
- The market estimate (ME) sheet in Excel format
- 3 months of analyst support
TABLE OF CONTENTS
- 1.1 Study Assumptions and Market Definition
- 1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
- 4.1 Market Overview
- 4.2 Market Drivers
- 4.2.1 Rise in Geriatric Population
- 4.2.2 Increase in Adoption of Immunoglobulin Treatment
- 4.2.3 Growth in Prevalence of Immunodeficiency Diseases and Bleeding Disorders
- 4.3 Market Restraints
- 4.3.1 Stringent Government Regulations
- 4.3.2 High Cost of Therapy
- 4.4 Porter's Five Forces Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION
- 5.1 By Type
- 5.1.1 IgG
- 5.1.2 IgA
- 5.1.3 IgM
- 5.1.4 IgE
- 5.1.5 IgD
- 5.2 By Application
- 5.2.1 Hypogammaglobulinemia
- 5.2.2 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- 5.2.3 Primary Immunodeficiency Diseases
- 5.2.4 Myasthenia Gravis
- 5.2.5 Multifocal Motor Neuropathy
- 5.2.6 Other Applications
- 5.3 Geography
- 5.3.1 North America
- 18.104.22.168 United States
- 22.214.171.124 Canada
- 126.96.36.199 Mexico
- 5.3.2 Europe
- 188.8.131.52 Germany
- 184.108.40.206 United Kingdom
- 220.127.116.11 France
- 18.104.22.168 Italy
- 22.214.171.124 Spain
- 126.96.36.199 Rest of Europe
- 5.3.3 Asia-Pacific
- 188.8.131.52 China
- 184.108.40.206 Japan
- 220.127.116.11 India
- 18.104.22.168 Australia
- 22.214.171.124 South Korea
- 126.96.36.199 Rest of Asia-Pacific
- 5.3.4 Middle-East and Africa
- 188.8.131.52 GCC
- 184.108.40.206 South Africa
- 220.127.116.11 Rest of Middle-East and Africa
- 5.3.5 South America
- 18.104.22.168 Brazil
- 22.214.171.124 Argentina
- 126.96.36.199 Rest of South America
6 COMPETITIVE LANDSCAPE
- 6.1 Company Profiles
- 6.1.1 Bio Products Laboratory Ltd
- 6.1.2 Biotest AG
- 6.1.3 China Biologic Products Holdings Inc.
- 6.1.4 CSL Behring
- 6.1.5 Grifols SA
- 6.1.6 Kedrion SpA
- 6.1.7 Shanghai RAAS Blood Products Co. Ltd
- 6.1.8 Octapharma AG
- 6.1.9 Takeda Pharmaceutical Company Limited
- 6.1.10 Baxter International Inc.
- 6.1.11 Bayer AG
- 6.1.12 LFB Biotechnologies SAS
- 6.1.13 BDI Pharma Inc.
- 6.1.14 Hualan Biological Engineering Inc.
- 6.1.15 ADMA Biologics Inc.
7 MARKET OPPORTUNITIES AND FUTURE TRENDS
8 IMPACT OF COVID-19 ON THE MARKET