Immunoglobulin Market Snapshot
|Study Period:||2018 - 2026|
|Fastest Growing Market:||Asia Pacific|
|Largest Market:||North America|
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The global immunoglobulin market was valued at approximately USD 11,575 million in 2020, and it is expected to reach USD 16,890 million in 2026 with a CAGR of 6.5% over the forecast period.
Globally, the outbreak of COVID-19 in 2020 was one of the greatest infectious challenges in recent times. Currently, few treatment options exist, and the availability of vaccines in some countries. There is an urgent need for effective therapies in the treatment of patients with COVID-19 infection. The use of immunoglobulin in the treatment of COVID-19 infection can be effective in managing the disease. For instance, according to a research study by Alan A. Nguyen et al. published in Clinical Immunology Journal 2020, the use of immunoglobulins in the treatment of COVID-19 is effective but not without potential adverse consequences.
The immunoglobulin market is expected to show rapid growth due to the rise in prevalence of immunodeficiency diseases, increased adoption of immunoglobulin, and growing research and development activities.
The spatial patterns of the genome have been identified for treating several medical conditions, which has resulted in the implementation of spatial information as a diagnostic biomarker for various diseases. There is a growing demand for biomarkers, which enables differentiation of benign tumors from the malignant tumor with higher accuracy and therefore boosts the demand for spatial genomic analysis as a cancer diagnostic tool. Therefore the cumulative demand for robust cancer diagnostic solutions helps in the growth of the overall market.
Increasing research and development activities in the development of new products in the management of diseases is expected to drive market growth. For instance, in January 2019, Kedrion Biopharma received United States Food and Drug Administration approval for conducting a clinical trial to assess the efficacy and safety of a 10% intravenous immunoglobulin in the treatment of patients with primary immunodeficiency diseases (PID).
The market players are involved in the development of innovative drugs and discovering new therapeutic areas for the existing drugs. For instance, as per the National Clinical Trial (NCT) Registry, in February 2020, in China, Peking Union Medical College Hospital, in collaboration with Tongji Hospital of Tongji Medical College and Huazhong University of Science and Technology, initiated a phase II/Phase III clinical trial to assess the efficacy and safety of intravenous immunoglobulin (IVIG) for severe 2019 novel coronavirus (2019-nCoV) pneumonia. However, the stringent government regulations and the high cost of therapy are expected to impede the market growth over the forecast period.
Scope of the Report
As per the scope of the report, immunoglobulin, also referred to as antibody, is a protein produced by plasma cells and other lymphocytes. It is a complex entity that exerts its immunomodulatory effect on different components of the immune system. It is obtained from the blood through the process of fractionation and is purified for therapeutic and non-therapeutic applications. The global immunoglobulin market is segmented by product (IgG, IgA, IgM, IgE, and IgD), mode of delivery (intravenous mode of delivery, and subcutaneous mode of delivery), application (hypogammaglobulinemia, chronic inflammatory demyelinating polyneuropathy (CIDP), immunodeficiency disease, myasthenia gravis, and other applications), and geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above-mentioned segments.
|By Mode of Delivery|
|Intravenous Mode of Delivery|
|Subcutaneous Mode of Delivery|
|Chronic Inflammatory demyelinating polyneuropathy (CIDP)|
Key Market Trends
By Application, the Hypogammaglobulinemia Segment is Expected to Hold Significant Market Share During the Forecast Period
Hypogammaglobulinemia is a condition in which enough gamma globulins are not produced in the blood. The major factor driving the hypogammaglobulinemia segment growth includes a significant increase in the prevalence of hypogammaglobulinemia disorders across the globe.
Globally, COVID-19 has become a great health challenge. Patients with cancer, especially hematologic malignancies, are at high risk for COVID-19 infection. For instance, according to a research article by Sukru Cekic et al., published in Journal of Clinical Immunology 2021, protective measures against COVID-19 infection were high in primary immunodeficiencies (PIDs) patients with hypogammaglobulinemia receiving Ig replacement therapy. Moreover, female patients with primary immunodeficiencies and hypogammaglobulinemia increased concerns about COVID-19 infection.
Hypogammaglobulinemia is the most common chronic immune defect in patients with lymphoproliferative disorders (LPDs) and invasive pneumococcal disease (IPD). According to a research study by Juthaporn Cowan et al., published in Clinical Infectious Diseases Journal 2017, as per study results, the high and low estimates of the prevalence of hypogammaglobulinemia were 31.6% and 13.5%, respectively. In Canada, hypogammaglobulinemia was present in at least 13.5% of invasive pneumococcal disease (IPD) cases. Secondary hypogammaglobulinemia is especially common in cases with hematological malignancy and invasive pneumococcal disease (IPD).
According to a research study by Namrata Singh et al., published in British Society for Haematology Journal 2020, a high prevalence of hypogammaglobulinemia was found in newly diagnosed, treatment naïve chronic lymphocytic lymphoma (CLL) patients. Patients with a low IgA or IgE were associated with higher stage chronic lymphocytic lymphoma (CLL).
Furthermore, hypogammaglobulinemia can be observed at extremes of age, which were reported in the elderly population. In adults, hypogammaglobulinemia may be seen in hematological malignancies, particularly chronic lymphocytic leukemia (CLL) and multiple myeloma (MM). Thus, the increasing prevalence of the elderly population, along with hematological malignancies, particularly chronic lymphocytic leukemia (CLL) and multiple myeloma (MM), is expected to drive the segment growth over the forecast period.
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North America is Expected to Dominate the Immunoglobulin Market Over the Forecast Period
The major factors driving the market growth in North America include rising healthcare expenditure, a growing level of consciousness for the products involved in the treatment of immunodeficiency disorders, and increasing inclination of clinicians toward immunodeficiency therapies.
In the United States, the impact of COVID-19 on the immunoglobulin market is positive as there have been increasing research studies on immunoglobulins as an effective therapy in the treatment of COVID-19. For instance, according to the National Clinical Trial (NCT) Registry, as of 9th March 2021, in the United States, there was around 50 immunoglobulin based ongoing clinical trials across different phases of development which shows a positive impact on the market as this can lead to the development of new effective therapy for COVID-19 in the near future.
The market players in the United States adopted various strategies such as product launches, developments, collaborations, mergers, and acquisitions in order to increase market share. For instance, in July 2019, ADMA Biologics Inc. received approval from the United States Food and Drug Administration (FDA) for license transfer of BIVIGAM from Biotest Pharmaceuticals Corporation, which began the commercial sales of the product.
Furthermore, in April 2019, ADMA Biologics Inc. received approval from the United States Food and Drug Administration (FDA) for ASCENIV, a novel intravenous immunoglobulin in the treatment of primary humoral immunodeficiency disease. Thus, the above-mentioned factors are expected to drive market growth over the forecast period.
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The immunoglobulin market is moderately competitive. The key manufacturers are found to offer technologically advanced techniques and platforms for a better understanding of disease biology and the introduction of novel therapeutics. Some of the global immunoglobulin market players are Baxter International Inc., CSL Ltd, Octapharma AG, Kedrion Biopharma Inc., Grifols SA, and Biotest AG.
- In September 2020, Green Cross Corporation started a phase II clinical trial to assess the efficacy and safety of Hyper-Ig (Hyper-immunoglobulin) GC5131 in patients with COVID-19.
- In May 2020, the US. Food and Drug Administration (FDA) approved the investigational new drug (IND) application by Octapharma USA for a phase three clinical trial on the efficacy and safety of Octagam 10% [Immune Globulin Intravenous (Human)] therapy in COVID-19 patients with severe disease progression.
Table of Contents
1.1 Study Assumptions
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 Prevalence of Immunodeficiency Diseases
4.2.2 Increase in Adoption of Immunoglobulin
4.2.3 Growing Research and Development Activities
4.3 Market Restraints
4.3.1 Stringent Government Regulations
4.3.2 High Cost of Therapy
4.4 Porter's Five Force 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 Product
5.2 By Mode of Delivery
5.2.1 Intravenous Mode of Delivery
5.2.2 Subcutaneous Mode of Delivery
5.3 By Application
5.3.2 Chronic Inflammatory demyelinating polyneuropathy (CIDP)
5.3.3 Immunodeficiency Disease
5.3.4 Myasthenia Gravis
5.3.5 Other Applications
5.4.1 North America
188.8.131.52 United States (by Product, Mode of Delivery, and Application)
184.108.40.206 Canada (by Product, Mode of Delivery, and Application)
220.127.116.11 Mexico (by Product, Mode of Delivery, and Application)
18.104.22.168 Germany (by Product, Mode of Delivery, and Application)
22.214.171.124 United Kingdom (by Product, Mode of Delivery, and Application)
126.96.36.199 France (by Product, Mode of Delivery, and Application)
188.8.131.52 Italy (by Product, Mode of Delivery, and Application)
184.108.40.206 Spain (by Product, Mode of Delivery, and Application)
220.127.116.11 Rest of Europe (by Product, Mode of Delivery, and Application)
18.104.22.168 China (by Product, Mode of Delivery, and Application)
22.214.171.124 Japan (by Product, Mode of Delivery, and Application)
126.96.36.199 India (by Product, Mode of Delivery, and Application)
188.8.131.52 Australia (by Product, Mode of Delivery, and Application)
184.108.40.206 South Korea (by Product, Mode of Delivery, and Application)
220.127.116.11 Rest of Asia-Pacific (by Product, Mode of Delivery, and Application)
5.4.4 Middle-East and Africa
18.104.22.168 GCC (by Product, Mode of Delivery, and Application)
22.214.171.124 South Africa (by Product, Mode of Delivery, and Application)
126.96.36.199 Rest of Middle-East and Africa (by Product, Mode of Delivery, and Application)
5.4.5 South America
188.8.131.52 Brazil (by Product, Mode of Delivery, and Application)
184.108.40.206 Argentina (by Product, Mode of Delivery, and Application)
220.127.116.11 Rest of South America (by Product, Mode of Delivery, and Application)
6. COMPETITIVE LANDSCAPE
*List Not Exhaustive
6.1 Company Profiles
6.1.1 Baxter international Inc.
6.1.2 CSL Ltd
6.1.3 Grifols SA
6.1.4 Octapharma AG
6.1.5 Kedrion Biopharma Inc.
6.1.6 LFB group
6.1.7 Biotest AG
6.1.8 China Biologics Products Inc.
6.1.9 Shire (Baxalta)
6.1.10 Bayer Healthcare
6.1.11 Takeda Pharmaceutical Company Limited
6.1.12 Bio Products Laboratory
6.1.13 Sanquin Plasma Products BV
6.1.14 Evolve Biologics Inc.
6.1.15 GigaGen Inc.
6.1.16 Shanghai RAAS Blood Products Co. Ltd
6.1.17 ADMA Biologics Inc.
6.1.18 Johnson & Johnson (Omrix Biopharmaceuticals Inc.)
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
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Frequently Asked Questions
What is the study period of this market?
The Global Immunoglobulin Market market is studied from 2018 - 2026.
What is the growth rate of Global Immunoglobulin Market?
The Global Immunoglobulin Market is growing at a CAGR of 6.5% over the next 5 years.
What is Global Immunoglobulin Market size in 2018?
The Global Immunoglobulin Market is valued at 11575 Million USD in 2018.
What is Global Immunoglobulin Market size in 2026?
The Global Immunoglobulin Market is valued at 16890 Million USD in 2026.
Which region has highest growth rate in Global Immunoglobulin Market?
Asia Pacific is growing at the highest CAGR over 2021- 2026.
Which region has largest share in Global Immunoglobulin Market?
North America holds highest share in 2020.
Who are the key players in Global Immunoglobulin Market?
Baxter international Inc., CSL Ltd., Octapharma AG, Kedrion Biopharma Inc., Grifols S.A are the major companies operating in Global Immunoglobulin Market.