Immunoglobulin Market Size, Share & Trends Analysis Report By Product (IgG, IgA, IgM, IgE, IgD), By Mode of Delivery (Intravenous Mode of Delivery, Subcutaneous Mode of Delivery), By Applications (Hypogammaglobulinemia, Chronic Inflammatory demyelinating polyneuropathy (CIDP), Immunodeficiency Disease, Myasthenia Gravis) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2022-2030

Market Overview

The immunoglobulin market size was valued at USD 13,799.45 million in 2022. It is expected to reach USD 24,446.1 million by 2030, growing at a CAGR of 6.56% during the forecast period (2023–2031).

Immunoglobulins are a group of glycoprotein molecules made by plasma or white blood cells, also called antibodies. Typically found in immune system serum and cells, they serve as antibodies by explicitly recognizing and binding antigens like bacteria or viruses and assisting in their eradication; their examinations aid in diagnosing immune deficiencies, allergies, and autoimmune diseases like celiac disease, lupus, and juvenile idiopathic arthritis. Immunoglobulins currently come in various classes based on biological characteristics, structure, target specificity, and distribution.

Market Dynamics

Global immunoglobulin market drivers:

Rise in immunoglobulin adoption

Increasing immunoglobulin adoption will likely spur future market expansionwith product launches and approvals. The market is displaying a trend toward more people using immunoglobulin. The approval of more effective pharmaceuticals in various countries is the goal of numerous businesses. According to the company's release in July 2019, the U.S. Food and Drug Administration (USFDA) has approved Grifols' novel 20% subcutaneous immunoglobulin Xembify. For the treatment of primary immunodeficiencies, use Xembify. The company introduced the product in the U.S. It will also be introduced in Canada, Europe, and other markets. As more effective medications become available to patients, the adoption rate will rise. This will accelerate the market's growth in the years to come. Therefore, the market will likely expand soon, given the above factors.

Growing research and development activities

Research and development (R&D) is crucial to the growth and success of any business. Research and development (R&D) can lead to useful new products for companies. For this reason, investing more in R&D is a surefire way to boost business growth. As of the end of 2020, the HIV Indicator Registry predicted that low and medium-income countries had access to USD 21.5 billion in domestic and international resources for the HIV response. Increased attention, resources, and the effectiveness and efficiency of HIV care, treatment, and prevention programs are needed to decrease HIV incidence and shorten life expectancy. The increasing number of people living with HIV is a significant factor in the growth of the market for HIV treatments and drugs.

The demand for immunoglobulin drugs is increasing due to the rising prevalence of chronic diseases like HIV, which is anticipated to fuel research and development activities and drug discovery initiatives. As a result, the demand for products used in detection and treatment is anticipated to rise, which will fuel the growth of the studied market for immunoglobulins over the study's forecast period.

Global immunoglobulin market restraints:

Strict governmental regulations

Therapy using intravenous immunoglobulin (IVIG) is a routinely changing procedure. Larger-scale clinical trials are necessary to assess the efficacy of treatments for illnesses that may not be possible to treat in other rare conditions. A treating doctor is responsible in such cases for disseminating individual case reports and taking part in a collaborative effort to develop IVIG therapeutic recommendations. The government's use of strict regulations to control drug development will impede the market's expansion.

Global immunoglobulin market opportunities:

Rising incidence of immunodeficiency diseases

Numerous developments and advancements have been taking place in the global immunoglobulin market, which may broaden the potential for market growth. One of the leading causes of the market's rising demand for immunoglobulins is the rising incidence of immunodeficiency diseases. Due to crucial players' mergers, acquisitions, and agreements, which will increase market innovation, the market is anticipated to grow. Another important factor driving the growth of the immunoglobulin market is market expansion. Similarly, other market participants made product development investments to spur market expansion. For instance, Janssen applied for teclistamab's approval to treat patients with relapsed or refractory (R/R) multiple myeloma in December 2021 by submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).

Regional Analysis

North america dominates the global market

By region, the global immunoglobulin market is segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa.

North America is the most significant revenue contributor and is expected to grow at a CAGR of 6.16% during the forecast period. Rising healthcare costs increased consumer awareness of the products used to treat immunodeficiency disorders. A growing propensity among clinicians for immunodeficiency therapies is the main factor propelling market growth in the United States. In a study by Namrata Singh et al., published in the British Society for Haematology Journal 2020, it was discovered that patients with newly diagnosed, untreated chronic lymphocytic lymphoma (CLL) had a high prevalence of hypogammaglobulinemia. Low IgA or IgE levels in patients were linked to more advanced stages of chronic lymphocytic lymphoma (CLL).

The U.S. Food and Drug Administration (FDA) approved ADMA Biologics Inc. for ASCENIV, a brand-new intravenous immunoglobulin for managing primary humoral immunodeficiency disease, in April 2019. As a result, throughout the forecast period, the factors above are anticipated to fuel market growth. Considering the above factors, the segment is expected to grow during the forecast period.

Europe is expected to grow at a CAGR of 6.89% during the forecast period. The immunoglobulin market in Germany is expected to expand quickly due to the increasing prevalence of immune deficiency diseases, increased immunoglobulin use, and increased research and development efforts. The immunoglobulin used to treat COVID-19 patients has been the subject of numerous clinical studies conducted in the nation. For instance, Pfizer Inc. and BioNTech S.E. published additional information on neutralizing antibodies and T-cell responses from the Phase 1/2 BNT162b2 trial conducted in Germany in December 2020. The study's findings show that BNT162b2 induces a combined adaptive humoral and cellular immune response against SARS-CoV-2 and shed light on the multifaceted nature of BNT162b2-induced T-cell immunity. Therefore, the market is expected to experience significant growth over the upcoming years due to all the above-mentioned factors.

In China, the prevalence of immunodeficiency disorders is rising, and immunoglobulins are used more frequently to treat medical conditions. Disorders that cause immunodeficiencies are becoming more common, all contributing to the growth of the Chinese immunoglobulin market. As with developing novel drugs, market participants are also involved in identifying new therapeutic applications for already available drugs.Also predicted to affect market growth positively is the growing use of immunoglobulins in determining the prevalence of SARS-CoV-2 infection.

Kingdom of Saudi Arabia, Kuwait, Bahrain, Qatar, United Arab Emirates, and Oman are the six Arab nations that comprise the GCC. Due to the rising prevalence of immunodeficiency disorders, the expansion of underlying diseases that cause immunodeficiency, and the rise in strategic alliances among the major players in the industry, the GCC immunoglobulin market is predicted to experience significant growth. For instance, according to a July 2019 article titled "The Kuwait National Primary Immunodeficiency Registry 2004-2018" in Frontiers in Immunology, Kuwaitis were found to have Primary Immunodeficiency (PIDs) at a cumulative incidence of 24.96/100,000. 314 PID patients (165 men and 149 women) were registered during the study period. Therefore, a high prevalence of PIDs in the nation is anticipated to increase patient demand for and uptake of immunoglobulin therapies, fueling market expansion.

Segmental Analysis

The global immunoglobulin market is segmented by product, mode of delivery, and application.

Based on the product, the global immunoglobulin market is bifurcated into IgG, IgA, IgM, IgE, and IgD.

The IgG segment is the highest contributor to the market and is expected to grow at a CAGR of 6.45% during the forecast period. Blood and tissue fluids contain the highest immunoglobulin G (IgG) concentration, regarded as a significant class of immunoglobulin. IgG1, IgG2, IgG3, and IgG4 are the four subclasses of immunoglobulin G (IgG). Additionally, by keeping track of the germs that people have previously been exposed to, these immunoglobulins guard against infections. Further, this class of immunoglobulins provides the primary defense against local and systemic infections of the lower respiratory tract. This examination determines the blood's immunoglobulin G concentration. This test is typically carried out on a person to see if they have a virus or bacterial infection.

IgA is a blood protein that is an antibody and a component of the immune system. IgA, which blocks bacterial and viral adhesion to epithelial cells and neutralizes bacterial toxins and viruses, is regarded as the first line of defense in the resistance against infection. It also gets rid of pathogens or antigens by binding to them and transporting immune complexes via polyimmunoglobulin receptors. Saliva, tears, breastmilk, and mucous membranes of the respiratory and digestive tract are the typical locations of IgA. The factors above suggest that the segment will proliferate over the forecast period.

Based on the mode of delivery, the global immunoglobulin market is bifurcated into the intravenous mode of delivery and subcutaneous mode of delivery.

The intravenous mode of delivery segment owns the highest market and is expected to grow at a CAGR of 6.53% during the forecast period. An injection or infusion of medication into a vein using a needle or tube is referred to as an intravenous mode of delivery. The quickest way to deliver medications is through this mode of delivery. A product made of antibodies that can be administered intravenously is called intravenous immunoglobulin. The proliferation of government-related strategic initiatives is one of the main drivers of market growth. Intravenous immunoglobulin, more and more research and development, and immunoglobulin research and development are becoming more prevalent, fostering market expansion.

The delivery of medications using a brief needle into the tissue layer between the skin and the muscle is referred to as a subcutaneous mode of delivery. In comparison to the other mode of delivery, this one is somewhat slower. Increased subcutaneous immunoglobulin-related strategic initiatives, research and development, and the prevalence of infectious diseases support the segment's expansion. The subcutaneous method of delivery is becoming more widely used.

Based on application, the global immunoglobulin market is bifurcated into hypogammaglobulinemia, chronic inflammatory demyelinating polyneuropathy (CIDP), immunodeficiency disease, and myasthenia gravis.

The immunodeficiency disease segment is the highest contributor to the market and is expected to grow at a CAGR of 6.01% during the forecast period. Immunodeficiency disease is also known as immunocompromise, a condition in which the immune system's capacity to fight cancer and infectious diseases is significantly reduced or nonexistent. The rising incidence of immune deficiency disorders and the increasing number of product approvals are the main drivers of market expansion. Additionally, the market is expanding due to the rising number of approvals for the use of immunoglobulins in the treatment of immunodeficiency disorders.

A condition known as hypogammaglobulinemia is when the blood does not produce enough gamma globulins. The development of potential treatments, such as immunoglobulin replacement therapy, as well as the significant rise in the prevalence of hypogammaglobulinemia disorders worldwide, are the main factors propelling the growth of the hypogammaglobulinemia market. As immunoglobulin replacement therapy is the preferred treatment for patients with hypogammaglobulinemia, the demand for immunoglobulins will rise with the prevalence of hypogammaglobulinemia, supporting the market's expansion. Therefore, the above factors will likely fuel the segment's growth during the forecast period.

Recent Developments

• January 2023- Eisai and Biogen received approval for their antibody Leqembi (lecanemab-irmb), 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD).
• October 2022- Leader in global biotechnology CSL announced that it had signed a Strategic Option and License Agreement for Translational Sciences' improved thrombus-dissolving drug candidate, TS23, with the company based in Arizona.