Immunoglobulin Market Size, Share & Industry 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, 2024-2032

The global immunoglobulin market size was USD 16.24 billion in 2023 and is projected to grow from USD 17.58 billion in 2024 to USD 35.85 billion by 2032, exhibiting a CAGR of 9.3% during the forecast period (2024-2032). Moreover, the U.S. immunoglobulins market size is projected to grow significantly, reaching an estimated value of USD 18.98 billion by 2032, driven by the growing prevalence of autoimmune disorders. Increasing prevalence of primary and secondary immunodeficiency and others is increasing the 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.

The COVID-19 pandemic negatively affected the global market owing to a decline in plasma collection and the shortage of plasma for fractionation. 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.

• Rising Preference for Subcutaneous Ig Products Among the Population

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 September 2023, Takeda Pharmaceutical Company Limited received the approval of the Japanese Ministry of Health, Labour and Welfare for its CUVITRU, subcutaneous immunoglobulin, for patients with agammaglobulinemia or hypogammaglobulinemia in Japan.

• 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 a 2023 article published by the Immune Deficiency Foundation, common variable immune deficiency (CVID) is one of the most commonly diagnosed primary immunodeficiencies in adults, which occurs in 1 in 25,000 individuals.

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.

• 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 a 2023 article published by AmeriPharma Specialty Care, a single IVIF infusion can cost around USD 100 to more than USD 350 per gram. The patients need to undergo 4-5 infusions per month which will cost an average of around USD 42,000 per month.

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.

Immunoglobulin Market Segmentation Analysis

By Route of Administration Analysis

Higher Demand for Intravenous Products Led to Segmental Dominance

Based on of route of administration, the market is segmented into intravenous and subcutaneous.

The rising prevalence of primary immunodeficiency disorders among the population is resulting in an increasing demand for intravenous products in the market. The clinical benefits of intravenous products, 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. The rising focus of national organizations to increase the availability of the subcutaenous products is another major factor contributing to the growth of the segment.

• For instance, The National Blood Authority of Australia announced that Xembify, a 20% concentration SCIg product, will be available for order via the Australian Red Cross Lifeblood from January 2024.

By Indication Analysis

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

Based on 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.

The increasing prevalence of several primary immunodeficiency diseases and the rising adoption of plasma products for these disorders are some of the attributable factors that led to the segment's dominance.

• 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.

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.

The rising prevalence of disorders such as Guillain Barré Syndrome, Immune Thrombocytopenic Purpura (ITP), Multifocal Motor Neuropathy (MMN), and others, is a key factor driving the segment growth. Furthermore, the increasing R&D focus of market players to develop and introduce novel products for the treatment of these disorders are some of the factors supporting the growth of these segments.

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?

Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

The North America market was valued at USD 9.73 billion in 2023 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?

• Rising R&D Focus of Key Players to Expand their Product Portfolio is Supporting the Growing Market Share

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 plans 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 2023.

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 (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 Blood Products Co., Ltd. (China)


• China Biologic Products Holdings, Inc. (China)

What are the Key Industry Developments in this Market?

• January 2024 – Takeda Pharmaceutical Company Limited received the U.S. FDA approval for its GAMMAGARD Liquid, an intravenous immunoglobulin therapy, for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.


• January 2024 – CSL launched prefilled syringe of Hizentra, a subcutaneous immunoglobulin,  for the treatment of primary immunodeficiency (PI) and chronic inflammatory demyelinating polyneuropathy (CIDP).


• November 2023 – Grifols, S.A. received the U.S. FDA approval for the expansion of its immunoglobulin purification and filling capacity at its North Carolina site.


• 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.


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

REPORT COVERAGE

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

ATTRIBUTE	DETAILS
Study Period	2019-2032
Base Year	2023
Estimated Year	2024
Forecast Period	2024-2032
Historical Period	2019-2022
Growth Rate	CAGR of 9.3% from 2024-2032
Unit	Value (USD billion)
Segmentation	By Route of Administration Intravenous Subcutaneous
By Indication Primary Immunodeficiency (PI) Secondary Immunodeficiency (SID) Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Guillain Barré Syndrome Immune Thrombocytopenic Purpura (ITP) Multifocal Motor Neuropathy (MMN) Others
By Form Liquid Lyophilized
By End-user Hospitals Clinics Homecare
By Geography North America (By Route of Administration, By Indication, By Form, By End-user, and By Country) U.S. Canada Europe (By Route of Administration, By Indication, By Form, By End-user, and By Country/Sub-region) U.K. Germany France Italy Spain Scandinavia Rest of Europe Asia Pacific (By Route of Administration, Bu Indication, By Form, By End-user, and By Country/Sub-region) China Japan India Australia Southeast Asia Rest of Asia Pacific Latin America (By Route of Administration, By Indication, By Form, By End-user, and By Country/Sub-region) Brazil Mexico Rest of Latin America Middle East & Africa (By Route of Administration, Bu Indication, By Form, By End-user, and By Country/Sub-region) GCC South Africa Rest of Middle East & Africa