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The immunoglobulin products market size is forecast to increase by USD 9.7 billion at a CAGR of 10.11% between 2023 and 2028. The market is experiencing significant growth, driven by recent developments in immunoglobulin products and advancements in biotechnology and manufacturing processes. These innovations have led to the production of more effective and efficient therapies, catering to a wider range of indications. However, the high cost of immunoglobulin therapies remains a major challenge, limiting accessibility and affordability for many patients. Despite this, the market is expected to continue growing, fueled by increasing prevalence of immunodeficiency disorders and an aging population. Additionally, regulatory approvals for new indications and product launches are expected to further drive market growth. Overall, the market is poised for continued expansion, with a focus on improving patient outcomes while addressing affordability concerns.
The market encompasses the production and sale of immunoglobulin-based therapies for various medical conditions. These conditions include Guillain-Barre syndrome, Primary immunodeficiency disease, Immune thrombocytopenic purpura, and Plasma-related disorders such as Severe Combined Immunodeficiency (SCID), Agammaglobulinemia, and Hypogammaglobulinemia. Immunoglobulin therapy is administered through multiple channels, including Hospitals, Clinics, Homecare settings, and Plasma collection centers. Immunoglobulin products are derived from Plasma and undergo fractionation to isolate specific immunoglobulins. These include Intravenous Immunoglobulin (IVIG) and Subcutaneous Immunoglobulin (SCIG), which possess both Anti-inflammatory and Immunomodulatory properties. IVIG is used to treat conditions like Myasthenia Gravis (MG), Guillain-Barre Syndrome, and Primary Immunodeficiency Disease (PID).
SCIG is used for the treatment of Primary Immunodeficiency Disease and Immune thrombocytopenic purpura. IVIG is also used in the treatment of HIV. The market for Immunoglobulin Products is expected to grow due to the increasing prevalence of these medical conditions and the rising demand for effective treatment options. The market is driven by factors such as the increasing number of plasma collection centers and advancements in Plasma fractionation technology. Additionally, the growing awareness of these conditions and the availability of reimbursement policies are also contributing to the growth of the market.
The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD billion" for the period 2024-2028, as well as historical data from 2018 - 2022 for the following segments.
The igG segment is estimated to witness significant growth during the forecast period. The global market encompasses a substantial segment of IgG products, given their extensive application in addressing various immune-related disorders. IgG, the most prevalent antibody isotype in the human body, plays a pivotal role in the immune system's response and defense against pathogens. IgG products are sourced from donated plasma and are accessible in diverse formulations, including intravenous (IV), subcutaneous (SC), and intramuscular (IM) preparations. These therapies find extensive usage in managing primary immunodeficiencies, autoimmune diseases, neurological disorders, and specific infectious diseases, among other indications.
Notable players in the IgG product segment include prominent pharmaceutical companies, such as CSL Ltd., who contribute significantly to the market. Indications for IgG products include Guillain-Barre syndrome, primary immunodeficiency diseases, immune thrombocytopenic purpura, Myasthenia Gravis (MG), Common Variable Immunodeficiency, and HIV, among others. IgG products exhibit both anti-inflammatory and immunomodulatory properties, making them indispensable in the treatment of these conditions. Plasma collection and fractionation processes are crucial in the production of IgG products. Agammaglobulinemia and hypogammaglobulinemia are additional indications for IgG therapy.
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The IgG segment accounted for USD 9 billion in 2018 and showed a gradual increase during the forecast period.
North America is estimated to contribute 35% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.
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The market in North America is experiencing significant growth due to the increasing prevalence of various diseases, including Guillain-Barre syndrome, primary immunodeficiency diseases, immune thrombocytopenic purpura, and conditions like Myasthenia Gravis (MG), Common Variable Immunodeficiency, HIV, and others. These diseases necessitate the use of immunoglobulin therapy, which includes Intravenous Immunoglobulin (IVIG) and Subcutaneous Immunoglobulin (SCIG). Plasma collection and fractionation processes are essential for the production of these immunoglobulin products. The rising prevalence of diseases such as cancer, autoimmune diseases, metabolic diseases, musculoskeletal disorders, and central nervous system disorders, along with blood disorders, is driving the demand for immunoglobulin products.
Moreover, the increasing awareness and availability of homecare services for immunoglobulin therapy are expanding the market's reach beyond hospitals and clinics. The healthcare reforms in the US have led to an increase in the number of insured individuals, thereby driving the demand for immunoglobulin products in hospitals and clinics. The aging population in the region, with its associated health issues, is another significant factor contributing to the market's growth. The anti-inflammatory and immunomodulatory properties of immunoglobulin products make them effective treatments for various diseases, further boosting market growth. Plasma collection and fractionation processes are crucial for the production of immunoglobulin products.
Agammaglobulinemia and hypogammaglobulinemia are conditions that require regular immunoglobulin replacement therapy. The global rise in the prevalence of these conditions, particularly in North America, is expected to offer excellent opportunities for the growth of the regional market.
Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
Recent immunoglobulin product developments is the key driver of the market. The global market is experiencing significant growth due to the increasing number of new product launches by pharmaceutical companies. These new formulations, delivery methods, and indications for immunoglobulin therapies expand treatment options and address unmet medical needs for various patient populations. For instance, in January 2024, Takeda Pharmaceutical Co. Ltd. Received US FDA approval for its intravenous immunoglobulin therapy, GAMMAGARD Liquid, for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in adults. Similarly, CSL Ltd. Launched a subcutaneous immunoglobulin, a prefilled syringe of Hizentra, for the treatment of Common Variable Immunodeficiency (CVID) and primary immunodeficiency. Immunoglobulin therapies, such as intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin, play a crucial role in treating various conditions, including Guillain-Barre syndrome, Primary Immunodeficiency Disease (PIDD), Immune thrombocytopenic purpura (ITP), Myasthenia Gravis (MG), and Human Immunodeficiency Virus (HIV).
These therapies possess anti-inflammatory and immunomodulatory properties, making them essential for managing these conditions. Plasma collection and fractionation processes are crucial in the production of immunoglobulin products. Agammaglobulinemia and Hypogammaglobulinemia are common indications for immunoglobulin therapy.
Advancements in biotechnology and manufacturing processes is the upcoming trend in the market. The global market is experiencing significant growth due to advancements in biotechnology and manufacturing processes. These innovations have led to the production of safer, more effective, and higher-quality therapies, such as intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG), for various indications including Guillain-Barre syndrome, primary immunodeficiency diseases like Common Variable Immunodeficiency and Agammaglobulinemia, Hypogammaglobulinemia, Immune thrombocytopenic purpura, Myasthenia Gravis (MG), and HIV. Biotechnological advancements, such as recombinant DNA technology and protein engineering, have revolutionized the production of immunoglobulin products by enabling the creation of recombinant monoclonal antibodies and engineered antibody fragments with enhanced therapeutic properties. These next-generation immunoglobulin products offer greater therapeutic benefits to patients, including improved potency, specificity, and reduced immunogenicity.
Leading biopharmaceutical companies, such as CSL Ltd., Takeda Pharmaceutical Co. Ltd., Grifols SA, and Octapharma AG, are at the forefront of leveraging these advancements to advance the field of immunoglobulin therapy. Plasma collection and plasma fractionation processes have also evolved to ensure the production of high-quality plasma, ensuring the efficacy and safety of immunoglobulin products. Immunoglobulin therapy is administered in various settings, including hospitals, clinics, and homecare, to meet the diverse needs of patients.
High cost of immunoglobulin therapies is a key challenge affecting the market growth. The global market is significantly influenced by the high cost of immunoglobulin therapies, which poses a challenge for both patients and healthcare systems. For instance, the average price of intravenous immunoglobulin (IVIG) products ranges from USD 50 to USD 100 per gram, with patients often requiring multiple grams per infusion session. A typical IVIG infusion for a patient with a primary immunodeficiency disorder may require doses of 400-800 milligrams per kilogram of body weight every 3-4 weeks, leading to substantial treatment expenses over time. Similarly, subcutaneous immunoglobulin (SCIG) therapies, while generally less expensive than IVIG, still come with significant costs. Immunoglobulin therapies are used to treat various conditions, including Guillain-Barre syndrome, primary immunodeficiency diseases such as agammaglobulinemia and hypogammaglobulinemia, immune thrombocytopenic purpura, Myasthenia Gravis (MG), and HIV.
These therapies offer anti-inflammatory and immunomodulatory properties, making them essential for the treatment of these conditions. Plasma collection and fractionation are crucial processes in the production of immunoglobulin products. However, the high production costs contribute to the overall expense of these therapies. The use of immunoglobulin therapies is not limited to hospitals and clinics but also extends to homecare settings, highlighting the need for affordable and accessible treatment options.
The market forecasting report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.
Customer Landscape
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.
ADMA Biologics Inc. - The company provides a range of immunoglobulin products, including Bivigam, which is a 10% Immune Globulin Intravenous (Human) solution. This product is indicated for the treatment of patients diagnosed with primary humoral immunodeficiency (PI). Bivigam undergoes rigorous manufacturing processes to ensure the highest quality and efficacy.
The market research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
Immunoglobulin products play a crucial role in managing various immune disorders such as Guillain-Barre syndrome, Primary immunodeficiency disease, Immune thrombocytopurpura, and Myasthenia Gravis (MG). These disorders are characterized by weakened immune responses, leading to increased susceptibility to infections and other complications. Immunoglobulin therapy, including Intravenous Immunoglobulin (IVIG) and Subcutaneous Immunoglobulin (SCIG), is an essential treatment for these conditions. Plasma, the source of immunoglobulins, is collected from hospitals, clinics, and homecare settings through plasma fractionation and plasma collection processes. Immunoglobulin products exhibit both anti-inflammatory and immunomodulatory properties, making them effective in managing conditions like Common Variable Immunodeficiency, HIV, and other immune disorders.
Key disorders like Myasthenia Gravis (MG) and Guillain-Barre Syndrome significantly benefit from immunoglobulin therapy. Agammaglobulinemia and Hypogammaglobulinemia are primary immunodeficiency diseases that result in decreased production of immunoglobulins. Immunoglobulin therapy is an essential treatment for these conditions, providing the necessary immunoglobulins to help patients maintain a healthy immune system. In conclusion, the market plays a vital role in addressing the medical needs of patients with various immune disorders. The growing prevalence of these disorders and the increasing awareness of the benefits of immunoglobulin therapy are expected to drive market growth.
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Market Scope |
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Report Coverage |
Details |
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Page number |
169 |
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Base year |
2023 |
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Historic period |
2018-2022 |
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Forecast period |
2024-2028 |
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Growth momentum & CAGR |
Accelerate at a CAGR of 10.11% |
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Market growth 2024-2028 |
USD 9.7 billion |
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Market structure |
Concentrated |
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YoY growth 2023-2024(%) |
8.65 |
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Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
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Performing market contribution |
North America at 35% |
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Key countries |
US, Germany, UK, China, and Japan |
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Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
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Key companies profiled |
ADMA Biologics Inc., Bio Products Laboratory Ltd., Biocon Ltd., CSL Ltd., GC Biopharma corp. , Grifols SA, Kedrion S.p.A, LFB SA, Novartis AG, Octapharma AG, Pfizer Inc., Serum Institute of India Pvt. Ltd., Shanghai RAAS Blood Products Co. Ltd., Taibang Biological Group Co. Ltd., Taj Pharmaceuticals Ltd., and Takeda Pharmaceutical Co. Ltd. |
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Market dynamics |
Parent market analysis, market growth inducers and obstacles, market forecast, fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, market condition analysis for the forecast period |
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Customization purview |
If our market report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Product
7 Market Segmentation by Route of Administration
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
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