Immunoglobulin Market Size, Share & COVID-19 Impact Analysis, By Route of Administration (Intravenous and Subcutaneous), By Indication (Primary Immunodeficiency, Secondary Immunodeficiency, Chronic Inflammatory Demyelinating Polyneuropathy, Guillain-Barré Syndrome, Immune Thrombocytopenic Purpura, Multifocal Motor Neuropathy, and Others), By Form (Liquid and Lyophilized), By End-user (Hospitals, Clinics, and Homecare), and Regional Forecast, 2022-2029

The global immunoglobulin market size was valued at USD 13.70 billion in 2021 and is projected to grow from USD 14.51 billion in 2022 to USD 25.63 billion by 2029, at a CAGR of 8.5% during the forecast period. Based on our analysis, the global market exhibited a slower growth of 4.2% in 2020 as compared to 2019. The global COVID-19 pandemic has been unprecedented and staggering, with immunoglobulin experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels.

Increasing prevalence of primary and secondary immunodeficiency and others is increasing demand for available treatment options globally. Along with this, amplification of anti-inflammatory properties and immunomodulatory properties of immunoglobulins has also surged the adoption of these blood products for disorders such as primary immune deficiencies, chronic inflammatory demyelinating polyneuropathy, and others.

• According to a research article published by NCBI in 2020, there are 6 million people around the world affected by primary immunodeficiency diseases.

Apart from this, increasing number of patients suffering from auto-immune disorders, such as Guillain-Barré Syndrome and IVIG, and clinical efficiency of immunoglobulin for the treatment of these conditions is leading to increasing demand for these products. Thus, the rising prevalence of key disorders along with advancement in treatment options with this product is resulting in an increased demand and adoption rate of the product and alternatively assisting in the immunoglobulin market growth.

How did the COVID-19 Pandemic Impacted Access to Immunoglobulin Therapy Globally?

The COVID-19 pandemic negatively affected the market growth during the forecast period. Stringent lockdown scenarios along with strict restrictions resulted in the decrease in plasma collection over the globe. This is leading to a shortage of plasma for plasma fractionation.

• According to the American Red Cross, the number of people donating blood had fallen by 10% during COVID-19.


• Also, according to a research article, in the Hubei province in China, the number of blood donations was reduced by 86.0% in February 2020, dropping from 34,059 to 4,778.

As a result, the key players were facing difficulties while collecting plasma for plasma fractionation. Hence, the patients were having difficulties in accessing the plasma products, including immunoglobulin due to a significant shortage. This led to decreased adoption and hindered the growth of the market.

Along with this, reduced inpatient visits and postponement of elective procedures by the government of many countries significantly decreased the hospital admissions for immunology related disorders. This also led to decrease in the demand and in adoption of this for treatment options and hindered the market growth during the pandemic.

However, resumption of postponed treatment procedures and ease in lockdown restrictions increased the volume of plasma collection significantly during the post-pandemic. This resulted in the increased supply of plasma products, and fueled the growth during the post-pandemic period.

Have Clinical Limitations of Intravenous Route led to the Shift in Patient Preferences?

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• Shifting Consumer Preference towards Subcutaneous Products over Intravenous Products

The most preferred route of administration is intravenous route. However, due to a number of limitations such as higher cost, requirement of trained professionals, risk of systemic infection, and requirement of extended duration of observation post-injection are limiting the adoption rate of intravenous dosage formulas.

On the other hand, certain benefits such as better patient compliances, less painful process, and large number of injection sites for multiple doses are improving the patient preference toward subcutaneous route of injection.

Along with this, rising number of launches by major players and ongoing research and development activities are fueling the adoption rate of Subcutaneous Immunoglobulin (SCIG) during the study period.

• In April 2021, CSL Behring received the U.S. FDA approvals for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

Is Rising Prevalence of Key Disorders Fostering the Demand for the Therapy?

Rising Prevalence of Key Immunodeficiency Disorders Led to the Growth of the Market

The global prevalence of a number of immunodeficiency disorders, including leukemia, hepatitis, multiple myeloma, and others is increasing the demand for treatment options such as immunoglobulin.

• According to the Leukemia & Lymphoma Society, an estimated 397,501 people in the U.S. have leukemia or are in remission period and around 138,415 people were living with myeloma in 2021.

Apart from this, according to a number of research articles, it was reported that the geriatric population is more prone to auto-immune disorders. Therefore, the rising geriatric population is resulting in the large patient pool suffering from this disorder and hence requiring treatment.

• According to the Centers for Disease Control and Prevention (CDC), in the U.S. in 2021, around 3,000 to 6,000 people developed Guillain-Barré Syndrome and people older than 50 are at high risk of developing Guillain-Barré Syndrome.

This, along with increasing investments by major players for the introduction of advanced therapy options and adoption of a number of organic and inorganic growth strategies is fostering the product adoption.

• In January 2022, Kedrion S.p.A. and LFB formed an industrial cooperation agreement in order to increase the availability of immunoglobulins for patients in France.

Henceforth, prevalence coupled with the introduction of advanced products by major players has been instrumental in the growth of the market during the study period.

How the Immunoglobulin Therapy Cost is Hindering Drug Adoption?

High Cost Associated with the Therapy is Responsible for Limiting the Market Growth

Growing prevalence of immunological disorders along with the increasing number of drugs in the market for treatment is fueling the market growth. However, the high cost associated with this therapy is limiting the adoption of this significantly.

• According to an article titled ‘Patients Rising’, published in 2022, it was stated that patients typically receive 4-5 infusions per month and the average monthly cost is more than USD 40,000.

This high costs coupled with limited insurance coverage in South Africa is restricting the adoption rate of plasma products.

• In South Africa, the high cost of these products limits the use of this therapy as a treatment option. This has led to a policy that the additional benefits of this product must be carefully evaluated on a case-by-case basis to justify the additional costs.

Thus, higher costs associated with inadequate reimbursement policies are expected to restrict the adoption of these products among the global population.

SEGMENTATION

By Route of Administration Analysis

Higher Demand for Intravenous Products led to Segmental Dominance

On the basis of route of administration, the market is segmented into intravenous and subcutaneous.

Comparative higher demand for these intravenous products for immunodeficiency disorders was responsible for the highest share in this segment. Additionally, certain distinct advantages, including rapid exposure and minimal volume constraints among others are some of the primary factors for the dominance of this segment over subcutaneous products.

On the other hand, the subcutaneous segment is expected to grow with the highest CAGR owing to several factors, including a significant cost reduction, self-administration capabilities, and comparatively lower risk of systemic infections.

By Indication Analysis

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Increasing Usage of these Drugs for Primary Immunodeficiency Resulted in the Segmental Dominance 

On the basis of indication, the market is segmented into primary immunodeficiency, secondary immunodeficiency, chronic inflammatory demyelinating polyneuropathy, Guillain-Barré syndrome, immune thrombocytopenic purpura, multifocal motor neuropathy, and others.

Increasing prevalence of a number of primary immunodeficiency diseases and the higher consumption of this plasma product for these disorders were responsible for the dominance of this segment.

• For instance, according to a database by the National Health Service (NHS), it was reported that the consumption of IG in 2019-20 was around 1,404 kgs for primary immunodeficiency.

On the other hand, the Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) segment is anticipated to grow with a significant CAGR during the study period. The stringent focus of the key players for introducing advanced drugs in the treatment of CIDP is one of the major reasons for the growth of the segment.

By Form Analysis

Cost Effectiveness of Liquid Form Led to Segment Dominance 

Based on form, the market is segmented into liquid and lyophilized.  

The rising prevalence of autoimmune disorders and the increasing number of immunoglobulin therapy options in the liquid form are the key factors for the major adoption of liquid form around the globe. This coupled with cost-effectiveness of this drug form and no requirement for further dilution is another factor for the highest demand and adoption of liquid form over the study period.

On the other hand, the lyophilized segment is anticipated to grow with a moderate CAGR owing to the high cost of lyophilized form and limited number of products available in the market.

By End-user Analysis

Hospital Segment to Dominate Owing to the Availability of Surveillance by Healthcare Professionals 

Based on end-user, the market is segmented into hospitals, clinics, and homecare. Presence of advanced healthcare infrastructure and round-the-clock surveillance by healthcare professionals are some of the major reasons for the dominance of the segment. Apart from that, the increasing number of hospital settings in developed and emerging countries is catering to the healthcare needs of the common people, and thus leading to an increasing number of inpatient admission.

• For instance, according to the American Hospital Association, the total number of hospitals in the U.S. were 6,093 and the total number of hospital admissions were 33,356,853 in 2020.

On the other hand, the homecare segment is expected to grow with significant CAGR during the forecast period. Rising preference for the common people toward homecare settings coupled with increasing initiatives by the major players for introducing homecare equipment are fostering the growth opportunity for this segment during the forecast period.

REGIONAL INSIGHTS

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What are the Factors Responsible for the Dominance of North America in the Global Market?

The North America market was valued at USD 8.16 billion in 2021 and is set to dominate the global immunoglobulin market share during the study period. Increasing initiatives for the introduction of drugs by leading players and the availability of insurance coverage are fueling the market growth in this region during the study period.

• For instance, in June 2021, CSL Behring, a subsidiary of the CSL Limited, received an approval from the Centers of Medicare & Medicaid Services (CMS) to cover Hizentra under Medicare Part B with an aim to make the product affordable.

On the other hand, the rising number of key immunological disorders in key European countries including Germany, the U.K., and France is fostering the adoption of this plasma product for treatment.

• For instance, according to an article published in Frontiers Media S.A., IgG consumption (g/1,000 population) increased from 40.4 gm in 2010 to 94.6 gm in 2021 in Europe.

Asia Pacific is expected to grow with the highest CAGR during the forecast period owing to rising healthcare reforms, government initiatives to provide costly IG therapies at an affordable cost, and increasing healthcare expenditure. The current consumption of immunoglobulin per person is significantly lower in countries such as Japan, India, and other Southeast Asia countries. However, the increasing number of patients suffering from immunodeficiencies, and the availability of reimbursement for these drugs is poised to drive the consumption during the forecast period.

Latin America and the Middle East & Africa are anticipated to grow with a moderate CAGR during the study period. Increasing product awareness, rising number of healthcare professionals for this therapy, and increasing product availability in these regions are expected to surge the demand and adoption of this product during the forecast period.

Who are the Key Players Dominating the Market?

The global market is consolidated with a few major players, including Grifols, S.A., CSL Limited, and Takeda Pharmaceutical Company Limited holding the market's maximum share.

Increasing initiatives for the inorganic growth by major players, such as CSL Limited and Grifols, S.A. were attributed to the lion’s share of these players in the market.

• In September 2021, Grifols, S.A. announced the acquisition of Biotest AG with an aim to strengthen its presence globally.

Some of the market players, including Octapharma AG, Kedrion Biopharma, and others were focusing on clinical trials and new product development with an aim to cater to the ongoing demand for this product in the global market. This enabled these companies to hold a significant market share in 2021.

The other companies operating in the market are Bio Products Laboratory Ltd., LFB Group, Biotest AG, Shanghai RAAS, and China Biologic Products Holdings, Inc. (TAIBANG BIOLOGIC GROUP).

LIST OF KEY COMPANIES PROFILED:

• Biotest AG (Germany) 


• Octapharma AG (Switzerland)


• Takeda Pharmaceutical Company Limited (Japan)


• CSL Limited (U.S.)


• Grifols, S.A. (Spain)


• Kedrion S.p.A (Italy)


• Bio Products Laboratory Ltd. (U.K.)


• LFB Group (France)


• Shanghai RAAS (China)


• China Biologic Products Holdings, Inc. (TAIBANG BIOLOGIC GROUP) (China)

What are the Key Industry Developments in this Market?

• November 2021 - Biotest AG received the marketing authorization in France for their human IVIG preparation Intratect that strengthens its product portfolio.


• June 2021 – Kedrion Biopharma and Kamada Ltd. announced that they received approval from the U.S. FDA to update the label for KEDRAB (Rabies Immune Globulin [Human]) in order to widen its product portfolio.


• June 2021 – LFB Group (LFB Plasma) announced the acquisition of ImmunoTek Bio Center. The acquisition of the plasma collection center will ensure steady and reliable supply of plasma in the U.S., which alternatively helped the company to supply more immunoglobulin.


• April 2021 - Grifols, S.A. completed the acquisition of 7 U.S. plasma donation centers from Kedrion, which is approximately 240,000 liters per year in order to expand its presence globally.


• February 2020 – CSL Behring, a subsidiary of the CSL Limited, received orphan drug designation for Privigen from the U.S. FDA for an investigational therapy in the treatment of systemic sclerosis (SSc) to widen its product portfolio.

REPORT COVERAGE

An Infographic Representation of Immunoglobulins Market

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The immunoglobulin market research report covers a detailed market analysis and overview. It focuses on key aspects such as competitive landscape, product type, and indication. Besides this, it offers insights into the market trends, market dynamics, COVID-19 impact on the market, and other key insights. In addition to the factors mentioned above, the report encompasses several factors that have contributed to the market's growth in recent years.

Report Scope & Segmentation