Global Immunoglobulins Market Grows Steadily at a CAGR of 7.81%

Introduction

Immunoglobulins are antibodies produced by plasma cells, which are immune system cells. Immunoglobulins are glycoprotein molecules that are secreted in response to an incoming antigen. IgA, IgE, IgM, IgG, and IgD are the various types of immunoglobulins based on their structure. Each immunoglobulin serves a distinct purpose in the body. IgG is the most prevalent immunoglobulin class found in nearly all body tissues. In various autoimmune diseases, such as primary and secondary immunodeficiency, immunoglobulins are used as replacement therapy to strengthen the immune system by restoring normal antibodies or immunoglobulins. Donor plasma contains numerous plasma proteins, including immunoglobulins, albumin, fibrinogen, clotting factors, anti-clotting factors, and complementary proteins.

Market Dynamics

Recent Regulatory Approvals for Immunoglobulin Drive the Global Market

The expansion of immunoglobulin products in treating numerous rare and autoimmune diseases has fueled the growth of the immunoglobulins market. In the plasma-derived therapy market, vendors focus on introducing novel products. Regulatory approvals for new products fuel this expansion. In 2018, the FDA approved CSL Behring's Hizentra for treating CIDP or chronic inflammatory demyelinating polyneuropathy. Hizentra is a 20% subcutaneous immunoglobulin solution. It was the first subcutaneous immunoglobulin treatment for CIDP. Similarly, in 2021, Pfizer Inc. announced the approval of Panzyga, an intravenous immunoglobulin solution containing 10% immunoglobulins. Panzyga has been approved for the treatment of CIDP in adults. The treatment became the first intravenous immunoglobulin formulation with two FDA-approved dosing options for CIDP patients receiving maintenance therapy.

Immunoglobulins in Homecare Creates Tremendous Opportunities

Due to the increased production of biologics and complex active pharmaceutical ingredients, the number of recently approved new and parenteral drugs awaiting approval has increased. The Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration approves parenteral drugs as new molecular entities (NMEs). The number of these NMEs has increased over the years. From 2015 to 2019, 40% to 50% of NME approvals involved parenteral drugs. In 2019, the FDA approved 48 NMEs, of which 20 (or 42%) were parenteral drugs. Parenteral drugs allow for gradual or instantaneous controlled release, which is impossible with oral medications. A clinician must administer these medications, reducing the likelihood of errors and the resulting costly and dangerous consequences. Consequently, the increase in approval of novel parenteral products administered intravenously contributes to the growth opportunities for PIVCs.

Regional Analysis

North America is the most significant global immunoglobulins market shareholder and is anticipated to grow at a CAGR of 6.62% during the forecast period. The market for immunoglobulins in North America is mature. Therefore, the region is expected to experience slower steady growth than other regions over the forecast period. The introduction of self-sufficiency programs in other regions is anticipated to reduce the amount of plasma imported by these countries from the United States. Additionally, many nations opt for locally produced plasma-derived pharmaceuticals due to their greater acceptability and availability. The United States and Canada have the highest IVIG product consumption. This is attributable to several factors, including increased awareness of personal health, a patient-centric healthcare system, advancements in healthcare, a higher throughput of plasma collection centers, and the presence of market-leading global vendors.

Europe is estimated to exhibit a CAGR of 7.34% over the forecast period. The expansion of the plasma-derived therapy market is attributable to increased blood and plasma donation awareness, high acceptance of plasma-derived medicinal products, a well-regulated market, and several key vendors. The European immunoglobulins market has benefited from the proactive efforts of vendors to increase blood and plasma donation awareness. The European Plasma Alliance, or EPA, is formed by sellers of plasma-derived medicinal products on the European market. Biotest, CSL Plasma, Europlasma, Grifols, Haema, KEDPLASMA, Octapharma, Plasmavita, Ruhrplasma, Takeda Pharmaceuticals, and Unicaplasma are included in this list. The EPA intends to increase regional awareness of safe blood collection procedures. Moreover, as the prevalence of autoimmune diseases increases in the region, so does the demand for immunoglobulin products, driving market expansion.

Key Highlights

• The global immunoglobulins market was valued at USD 15.79 billion in 2022. It is estimated to reach USD 31.06 billion by 2031, growing at a CAGR of 7.81% during the forecast period (2023–2031).
• Based on the product, the global immunoglobulins market is bifurcated into intravenous immunoglobulin, subcutaneous immunoglobulin, and intramuscular immunoglobulin. The intravenous immunoglobulin segment dominates the global market and is predicted to grow at a CAGR of 7.10% over the forecast period.
• Based on application, the global immunoglobulins market is divided into primary immunodeficiency, chronic immune deficiency polyradiculoneuropathy, secondary immunodeficiency, immune thrombocytopenic purpura, myasthenia gravis, and others. The primary immunodeficiency segment is responsible for the largest market share and is anticipated to exhibit a CAGR of 7.06% over the forecast period.
• Based on end-user, the global immunoglobulins market is segmented into hospitals and clinics and homecare. The hospitals and clinics segment owns the largest market share and is estimated to exhibit a CAGR of 7.27% during the forecast period.
• North America is the most significant global immunoglobulins market shareholder and is anticipated to grow at a CAGR of 6.62% during the forecast period.

Competitive Players

Competitive Players

The key players in the global immunoglobulins market are CSL Limited, Takeda Pharmaceutical Company Limited, Octapharma AG, Kendrion Biopharma, China Biologic Products Holdings, Inc., Reliance Life Sciences, Biotest AG, LFB S.A., ADMA Biologics, Inc., Omrix Biopharmaceuticals LTD, Zydus Cadila, Bharat Serums and Vaccines Limited, Grifols S.A., and many others.

Recent Developments

Market News

• In March 2023, Celltrion and Genuv Inc., a clinical-stage biotechnology company based in Seoul focusing on drug discovery, partnered to develop novel therapeutic antibodies using Genuv's SHINE MOUSE platform.
• In March 2023, Talem Therapeutics, a division of Immunoprecise Antibodies, collaborated with Libera Bio on multi-target artificial intelligence (AI)-driven antibody discovery. The partnership will employ nanotechnology, demonstrated in vivo, to deliver antibodies inside tumor cells, potentially solving the medical problem.

Segmentation

Global Immunoglobulins Market: Segmentation

By Product

• Intravenous Immunoglobulin
• Subcutaneous Immunoglobulin
• Intramuscular Immunoglobulin

By Applications

• Primary Immunodeficiency
• Chronic Immune Deficiency Polyradiculoneuropathy
• Secondary Immunodeficiency
• Immune Thrombocytopenic Purpura
• Myasthenia Gravis
• Others

By End-User

• Hospital and Clinic
• Homecare

By Regions

• North America
• Europe
• Asia-Pacific
• Latin America
• The Middle East and Africa