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, 2023-2030

The global immunoglobulin market size was valued at USD 15.05 billion in 2022 and is projected to grow from USD 16.24 billion in 2023 to USD 29.57 billion by 2030, exhibiting a CAGR of 8.9% during the forecast period.

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, myasthenia gravis, 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 lead to increased 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 around 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 fell 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 accessing 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 governments of many countries significantly decreased hospital admissions for immunology-related disorders. This also led to decreased demand and adoption of these treatment options and hindered 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 an 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 toward Subcutaneous Products to Foster the Growth

The most preferred route of administration is the 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 compliance, less painful processes, and a large number of injection sites for multiple doses are improving the patient’s preference toward the 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. Food and Drug Administration (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 a large patient pool suffering from this disorder, thus 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 introducing advanced therapy options and adopting a number of organic and inorganic growth strategies foster 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 market growth during the study period.

How 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 its adoption 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.

These 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.

Comparatively higher demand for intravenous products for immunodeficiency disorders was responsible for the highest share in the intravenous 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 significant cost reduction, self-administration capabilities, and a 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. Strong focus of 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 Segmental Dominance 

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

The rising prevalence of auto-immune disorders and the increasing number of immunoglobulin therapy options in the liquid form are the key factors for the 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 a 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 

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

The North America market was valued at USD 9.00 billion in 2022 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 Japan, India, and other Southeast Asia countries. However, the increasing number of patients suffering from immunodeficiencies and the availability of reimbursement for these drugs are poised to drive 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 inorganic growth by these major players to expand their product portfolio and brand presence is one of the major factors contributing to the growing market share of these players.

• In March 2023, Takeda Pharmaceutical Company Limited announced its plan to invest around USD 910.7 million in a new manufacturing facility for plasma-derived therapies in Japan with an aim to expand its manufacturing capacity. 

Some of the market players, including Octapharma AG, Kedrion Biopharma, and others were focusing on clinical trials and new product development to cater to the ongoing demand for this product in the global market. This enabled these companies to hold a significant market share in 2022.

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:

• Takeda Pharmaceutical Company Limited (Japan)


• CSL Limited (U.S.)


• Grifols, S.A. (Spain)


• Octapharma AG (Switzerland)


• 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?

• March 2023 – Advanced Infusion Care (AIC) entered into a distribution agreement with Kendrion S.p.A for the distribution of GAMMAKED for the treatment of ITPin adults and children and CIDP in adults.


• January 2022 – Octapharma AG expanded its indication for cutaquig, subcutaneous immunoglobulin, in the European Union for patients with secondary immunodeficiencies.


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


• July 2021 – Octapharma AG received the U.S. FDA approval for Octagam 10%, intravenous immunoglobulin, for the treatment of adult dermatomyositis, which is a rare immune-mediated inflammatory disease.


• 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.

REPORT COVERAGE

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The global 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