Immunoglobulin Market Snapshot
|Fastest Growing Market:||Asia Pacific|
|Largest Market:||North America|
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The immunoglobulin market is expected to record a CAGR of 6.5% over the forecast period (2022-2027).
COVID-19 had a significant impact on the growth of the market. With the increased number of cases and high mortality due to it, there was 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. The market players have focused on research and development of the products. For instance, in May 2020, the United States 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. Thus, COVID-19 had a significant impact on the growth of the market.
The immunoglobulin market is expected to show rapid growth due to factors such as the rise in immunodeficiency disease prevalence, increased immunoglobulin adoption, and growing research and development activities.
According to the World Health Organization (WHO) July 2022 report, 38.4 million people were living with HIV globally in 2021. It also reported that of these, two-thirds, which equates to around 25.6 million, live in the WHO African Region. Such a high burden of immunodeficiency conditions creates the need for effective treatment, and since immunoglobulins are widely employed in the treatment, it is expected to drive the growth of the market.
The approval from different regulatory authorities around the globe is expected to contribute to the growth of the market. For instance, in August 2022, Argenx received the European Commission's (EC) marketing authorization grant for VYVGART (efgartigimod alfa-fcab) as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
The market players are involved in the development of innovative drugs and discovering new therapeutic areas for existing drugs. For instance, 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. The positive results from such studies may lead to the introduction of new products in the market and thus are expected to have a positive impact on the growth of the market.
Thus, owing to the abovementioned factors, the market is expected to project growth over the forecast period. However, stringent government regulations and the high cost of therapy are expected to impede market growth over the forecast period.
Scope of the Report
As per the scope of the report, immunoglobulin also referred to as an antibody, is a protein produced by plasma cells and other lymphocytes. It is a complex entity that exerts its immunomodulatory effect on different immune system components. It is obtained from the blood through the process of fractionation and is purified for therapeutic and non-therapeutic applications. The 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, and 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 also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD million) for the abovementioned segments.
|By Mode of Delivery|
|Intravenous Mode of Delivery|
|Subcutaneous Mode of Delivery|
|Chronic Inflammatory demyelinating polyneuropathy (CIDP)|
Key Market Trends
Intravenous Mode of Delivery Segment is Expected to Hold Major Share Over the Forecast Period
An intravenous mode of delivery is referred to as an injection or infusion method of drug administration into the vein through a needle or tube. Intravenous immunoglobulin is a product made of antibodies that can be given intravenously. The major factors fueling the segment's growth are the increasing number of strategic initiatives regarding intravenous immunoglobulin and the growing number of research and development coupled with approval from the regulatory authorities.
The increasing number of drug approvals is contributing to segment growth. For instance, in January 2022, Argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, revealed that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYVGART (efgartigimod alfa) intravenous infusion for the treatment of adult patients with generalized myasthenia gravis (gMG) who do not have a sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs).
Additionally, in February 2021, Pfizer Inc. received United States Food and Drug Administration (FDA) approval for the supplemental Biologics License Application (sBLA) for PANZYGA (Immune Globulin Intravenous [Human] – ifas 10% liquid preparation) to treat adult patients with a rare neurological disease of the peripheral nerves called chronic inflammatory demyelinating polyneuropathy (CIDP). Panzyga is the only intravenous immunoglobulin (IVIg) with two FDA-approved maintenance dosing options for CIDP, helping to meet the clinical needs of patients.
Thus, the aforementioned factors are likely to drive the growth of the segment during 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 an 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 immunoglobulin as an effective therapy in the treatment of COVID-19. For instance, according to the National Clinical Trial (NCT) Registry, as of March 9th, 2021, in the United States, there were around 50 immunoglobulin-based ongoing clinical trials across different phases of development, which shows a positive impact on the market as this could lead to the development of new effective therapy for COVID-19 in the near future.
The approval from the regulatory authorities is also propelling the growth of the market. For instance, in July 2021, the United States Food and Drug Administration (FDA) approved Octapharma USA for Octogam 10% [Immune Globulin Intravenous (Human)]. It is one of the first and only intravenous immunoglobulins (IVIg) to be indicated for the treatment of adult dermatomyositis, a rare immune-mediated inflammatory disease.
Additionally, the approval by the regulatory authorities for the expansion of the manufacturing process for immunoglobulins in the region is also expected to drive the growth of the market. For instance, in April 2021, ADMA Biologics, Inc., an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, received United States Food and Drug Administration ("FDA") approval for the company’s expanded manufacturing process, enabling fractionation and purification of a 4,400-liter plasma pool for the manufacture of Intravenous Immune Globulin ("IVIG"). Such approvals are expected to boost the growth of the market in the region.
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 March 2022, Grifols received approval by several European Union member state health authorities as well as by the United Kingdom for XEMBIFY. It is an innovative 20% subcutaneous immunoglobulin (SCIG) that has been approved to treat primary and selected secondary immunodeficiencies.
- In January 2022, the European Union expanded the indication for cutaquig by Octapharma. It is a human immunoglobulin for subcutaneous administration. The expanded indication covers patients with any type of secondary immunodeficiency who need immunoglobulin replacement therapy.
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 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 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 (Market Value by Size - USD million)
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
184.108.40.206 United States
220.127.116.11 United Kingdom
18.104.22.168 Rest of Europe
22.214.171.124 South Korea
126.96.36.199 Rest of Asia-Pacific
5.4.4 Middle East and Africa
188.8.131.52 South Africa
184.108.40.206 Rest of Middle East and Africa
5.4.5 South America
220.127.116.11 Rest of South America
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 Sichuan Yuanda Shuyang Pharmaceutical Co. Ltd
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 Pfizer 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 2019 - 2027.
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.
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 2021.
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.