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 the management of 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 found to be effective, but not without potential adverse consequence.
The immunoglobulin market is expected to show rapid growth due to the rise in prevalence of immunodeficiency diseases, increase in 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 tumor 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 the diseases is expected to drive market growth. For instance, in January 2019, Kedrion Biopharma received United States Food and Drug Administration approval for conducting 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 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, factors such as stringent government regulations and high cost of therapy is expected to impede the market growth over the forecast period.
Key Market Trends
By Application, 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 the greatest 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, have increased concern 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 prevalence of hypogammaglobulinemia was found to be 31.6% and 13.5%. in Canada. In addition, 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., publsihed in British Society for Haematology Journal 2020, high prevalence of hypogammaglobulinemia was found in newly diagnosed, treatment naive 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 was reported in the elderly population. In adults, Hypogammaglobulinemia may be seen in hematological malignancies, particularly chronic lymphocytic leukemia (CLL) and multiple myeloma (MM). Thus, increasing prevalence of 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.
North America is Expected to Dominate the Immunoglobulin Market Over the Forecast Period
The major factors driving the market growth in the North America region include rising healthcare expenditure, a growing level of consciousness for the products involved in the treatment of immunodeficiency disorders, and increasing inclination of clinicians towards 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 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 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 United States Food and Drug Administration (FDA) for ASCENIV, a novel intravenous immuneglobulin in the treatment of primary humoral immunodeficiency disease. Thus, owing to above mentioned factors it is expected to drive market growth over the forcast period.
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 S.A, Biotest AG, and others.
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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
- 5.1.1 IgG
- 5.1.2 IgA
- 5.1.3 IgM
- 5.1.4 IgE
- 5.1.5 IgD
- 5.2 By Mode of Delivery
- 5.2.1 Intravenous Mode of Delivery
- 5.2.2 Subcutaneous Mode of Delivery
- 5.3 By Application
- 5.3.1 Hypogammaglobulinemia
- 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 Geography
- 5.4.1 North America
- 220.127.116.11 United States (By Product, By Mode of Delivery and By Application)
- 18.104.22.168 Canada (By Product, By Mode of Delivery and By Application)
- 22.214.171.124 Mexico (By Product, By Mode of Delivery and By Application)
- 5.4.2 Europe
- 126.96.36.199 Germany (By Product, By Mode of Delivery and By Application)
- 188.8.131.52 United Kingdom (By Product, By Mode of Delivery and By Application)
- 184.108.40.206 France (By Product, By Mode of Delivery and By Application)
- 220.127.116.11 Italy (By Product, By Mode of Delivery and By Application)
- 18.104.22.168 Spain (By Product, By Mode of Delivery and By Application)
- 22.214.171.124 Rest of Europe (By Product, By Mode of Delivery and By Application)
- 5.4.3 Asia-Pacific
- 126.96.36.199 China (By Product, By Mode of Delivery and By Application)
- 188.8.131.52 Japan (By Product, By Mode of Delivery and By Application)
- 184.108.40.206 India (By Product, By Mode of Delivery and By Application)
- 220.127.116.11 Australia (By Product, By Mode of Delivery and By Application)
- 18.104.22.168 South Korea (By Product, By Mode of Delivery and By Application)
- 22.214.171.124 Rest of Asia-Pacific (By Product, By Mode of Delivery and By Application)
- 5.4.4 Middle East and Africa
- 126.96.36.199 GCC (By Product, By Mode of Delivery and By Application)
- 188.8.131.52 South Africa (By Product, By Mode of Delivery and By Application)
- 184.108.40.206 Rest of Middle East and Africa (By Product, By Mode of Delivery and By Application)
- 5.4.5 South America
- 220.127.116.11 Brazil (By Product, By Mode of Delivery and By Application)
- 18.104.22.168 Argentina (By Product, By Mode of Delivery and By Application)
- 22.214.171.124 Rest of South America (By Product, By Mode of Delivery and By Application)
6 COMPETITIVE LANDSCAPE
- 6.1 Company Profiles
- 6.1.1 Baxter international Inc.
- 6.1.2 CSL Ltd.
- 6.1.3 Grifols S.A
- 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 B.V.
- 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