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The primary immunodeficiency therapeutics market size is forecast to increase by USD 1.70 billion, at a CAGR of 4.5% between 2023 and 2028. The biotechnology industry is witnessing significant growth due to the increasing prevalence of immunodeficiency diseases and rising incidences of immune diseases in children. According to the World Health Organization, an estimated 350 million people worldwide live with immunodeficiencies, and approximately 170 million children under the age of five are at risk of developing immune disorders. Technological advancements in gene therapy offer promising solutions for treating these conditions. Gene therapy involves introducing new genes into a patient's cells to replace or supplement missing or defective genes. This innovative approach holds immense potential for treating various genetic disorders, including immunodeficiencies, and improving children's health and well-being. Gene therapy is a rapidly evolving field, and ongoing research and development efforts are expected to yield new treatments and therapies for immunodeficiencies and other immune disorders.
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Primary immunodeficiency diseases (PID) are a group of genetic disorders characterized by recurring infections, immune cells or proteins deficiencies, and susceptibility to tumors and genetic abnormalities. The primary immunodeficiency therapeutics market caters to the treatment of various types of PID, including antibody deficiency, cellular immunodeficiency, and innate immune disorders. Immunoglobulin replacement therapy, using immunoglobulin therapy and antibiotics, is a common approach to managing antibody deficiencies. For cellular immunodeficiencies, stem cell and bone marrow transplantation are effective treatments. Gene therapy and genetic testing are emerging therapies for PID, providing a potential cure by addressing the underlying genetic causes.
Additionally, hospitals and clinics are the major end-users of primary immunodeficiency therapeutics due to the complex nature of these diseases and the need for specialized care. Diagnostic technologies and tests play a crucial role in the early detection and diagnosis of PID, enabling timely intervention and effective treatment. The market for primary immunodeficiency therapeutics is driven by the increasing prevalence of immune deficiencies, technological advancements in diagnostic and therapeutic interventions, and growing awareness and advocacy efforts. Conditions such as rheumatoid disease, deficiency anemia, hypothyroidism, and tumors are also treated with immunomodulatory therapies, contributing to the market growth.
Increasing prevalence of immunodeficiency diseases is notably driving the market growth. The market is anticipated to expand significantly during the forecast period due to the rising prevalence of primary immunodeficiency disorders (PIDDs). For instance, Adenosine deaminase deficiency, a rare disorder responsible for approximately 15% of severe combined immunodeficiency syndrome (SCID) cases, is estimated to occur in approximately 1 in 200,000 to 1,000,000 newborns worldwide. Moreover, according to the World Health Organization (WHO), around 1.5 million new Human Immunodeficiency Virus (HIV) infections were reported globally in 2020, with 37.6 million people living with HIV, which causes Acquired Immunodeficiency Disorder Syndrome (AIDS).
In the US, the prevalence of PIDDs is estimated at 1 in 2000 individuals. Advanced diagnostic tools such as flow cytometry and next-generation sequencing are used for the diagnosis of these disorders. The market is expected to witness growth due to the development and approval of targeted therapies, gene therapies, biologics, and immunomodulatory drugs. Healthcare regulatory scenarios and healthcare expenditure are significant factors influencing the market dynamics. Life line curves indicate the potential long-term benefits of these therapeutics in managing and treating these disorders, thereby improving patient outcomes. Thus, such factors are driving the growth of the market during the forecast period.
Increasing R&D activities is the key trend in the market. The market is projected to expand significantly during the forecast period, driven by the increasing number of research and development (R&D) initiatives by market players. These efforts are aimed at enhancing the efficacy of immunodeficiency therapies, including flow cytometry, next generation sequencing, targeted therapies, gene therapies, biologics, and immunomodulatory drugs. For instance, a recent investigational study supported by the National Institutes of Health (NIH) reported that 96% of children receiving new experimental lentiviral gene therapy for immunodeficiency diseases experienced restored immune function.
In the competitive landscape, companies are focusing on the development of custom-made medicines for primary immunodeficiency diseases to gain a competitive edge. Healthcare regulatory scenarios and healthcare expenditure will also influence market growth. Life line curves indicate the potential longevity of patients with primary immunodeficiencies, making it crucial for healthcare professionals to provide effective and timely treatments. Thus, such trends will shape the growth of the market during the forecast period.
Side effects of immunotherapy is the major challenge that affects the growth of the market. Primary immunodeficiency therapeutics encompass a range of treatments, including flow cytometry, next generation sequencing, targeted therapies, gene therapies, biologics, and immunomodulatory drugs. These interventions aim to restore or enhance the immune system's function, addressing the underlying causes of immunodeficiencies. Healthcare professionals play a crucial role in administering these therapies and monitoring their effects on patients. Side effects of immunotherapies, such as biologics and immunomodulatory drugs, can pose challenges. These side effects, which include inflammation, autoimmune reactions, and infections, can impact various organs and systems. Their occurrence and severity can be influenced by factors like the patient's overall health, the location and type of cancer, and the specific treatment regimen. Understanding the potential side effects and their management is essential for healthcare professionals. They must be vigilant for signs and symptoms, such as fever, fatigue, rash, and gastrointestinal issues.
In some cases, life-line curves and healthcare regulatory scenarios may necessitate the implementation of specific protocols to minimize risks and ensure optimal patient care. Next generation sequencing and flow cytometry can aid in early detection and diagnosis of potential side effects, enabling timely intervention. Targeted therapies and gene therapies, which are increasingly being explored for primary immunodeficiencies, offer the potential for more precise and personalized treatments, reducing the risk of side effects. In conclusion, primary immunodeficiency therapeutics, including biologics, immunomodulatory drugs, targeted therapies, gene therapies, and diagnostic tools like flow cytometry and next generation sequencing, play a vital role in managing primary immunodeficiencies. Healthcare professionals must remain informed about potential side effects, their management, and the latest advancements in these therapeutic areas to provide optimal care for their patients. Hence, the above factors will impede the growth of the market during the forecast period
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.
Bayer AG - The company offers primary immunodeficiency therapeutics that enables the body to produce the required proteins itself.
The market research and growth report also 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.
The antibody deficiency segment is estimated to witness significant growth during the forecast period. The market encompasses various treatments for immune deficiencies, including antibody deficiency and cellular immunodeficiency. Antibody deficiency, a significant segment in this market, affects B cells and is the most common type of primary immunodeficiency in humans. Approximately half of all primary immunodeficiency patients have antibody deficiency disorders. These disorders can result in recurring infections, which can lead to complications such as tumors, genetic abnormalities, and neurologic disorders. Immunoglobulin replacement therapy, stem cell transplantation, bone marrow transplantation, antibiotic therapy, gene therapy, and immunodeficiency diagnostic technologies are some of the therapeutic approaches used to manage antibody deficiency. Immunoglobulin therapy involves the administration of antibodies to replace the deficient ones, while antibiotics help prevent infections.
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The antibody deficiency was the largest and was valued at USD 2.50 billion in 2018. Stem cell and bone marrow transplantation can replace faulty immune cells, and gene therapy can correct the underlying genetic abnormalities. Cellular immunodeficiency, on the other hand, affects the immune cells and their functions. It includes disorders such as X-linked SCID, Wiskott-Aldrich Syndrome, and Non-Hodgkin's lymphoma. These disorders can lead to conditions like rheumatoid arthritis, deficiency anemia, hypothyroidism, lymphoma, arrhythmias, electrolyte disorders, coagulopathies, weight loss, rhinitis, and atopic dermatitis. Immunodeficiency diseases can significantly impact patients' quality of life and require ongoing supportive care. Diagnostic tests, such as genetic testing and diagnostic technologies, play a crucial role in identifying these disorders and guiding appropriate therapies. Overall, the market is expected to continue growing due to the increasing prevalence of these disorders and the development of new therapeutic approaches.
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Europe is estimated to contribute 38% 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. Immunodeficiency diseases encompass a range of disorders, including Antibody Deficiency and Cellular Immunodeficiency, which affect the production or function of immune cells and proteins. These disorders include Innate Immune Disorders, such as deficiencies in complement components, as well as Primary Immunodeficiency diseases, such as X-linked SCID, Wiskott Aldrich Syndrome, and Non-Hodgkin's lymphoma. Treatment options for immunodeficiencies depend on the underlying cause. Immunoglobulin Replacement Therapy is commonly used for Antibody Deficiencies, while Stem Cell and Bone Marrow Transplantation are effective for Cellular Immunodeficiencies.
In addition, antibiotic Therapy is used to prevent and treat recurring infections. Gene Therapy and Genetic therapy are emerging treatments for certain genetic abnormalities. Immunodeficiency diseases can also manifest in various forms, such as Rheumatoid disease, Deficiency anemia, Hypothyroidism, Lymphoma, Neurologic disorders, Arrhythmias, Electrolyte disorders, Coagulopathies, Weight loss, Rhinitis, and Atopic dermatitis. Diagnostic tests, such as genetic testing and diagnostic technologies, are crucial for accurate diagnosis and effective treatment. Supportive care, including proper nutrition and vaccinations, is also essential for managing these conditions. Hospitals and clinics play a vital role in the diagnosis and treatment of immunodeficiencies, providing access to specialized therapies and supportive care.
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.
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Primary immunodeficiency diseases (PIDDs) are a group of genetic disorders that impair the function of the immune system, making individuals more susceptible to recurring infections, tumors, and other health complications. These disorders can be classified into antibody deficiencies, cellular immunodeficiencies, and innate immune disorders. The therapeutic landscape for primary immunodeficiencies encompasses various treatment modalities such as Immunoglobulin Replacement Therapy (IGRT), Stem Cell Transplantation (SCT), Antibiotic Therapy, Gene Therapy, and Immunomodulatory agents. IGRT involves the administration of exogenous antibodies to replace the deficient ones in the body. SCT, which includes Bone Marrow Transplantation (BMT), is used to replace defective immune cells with healthy ones. Antibiotic therapy is used to prevent and treat infections in individuals with primary immunodeficiencies. Gene therapy, a promising approach, aims to correct the underlying genetic abnormalities. Immunomodulatory agents, such as cytokines and interferons, help enhance the immune response.
Further, the market is driven by the increasing prevalence of these disorders, the availability of advanced diagnostic technologies, and the growing demand for effective and targeted therapies. Some of the key disorders addressed by these therapeutics include Rhinitis, Atopic Dermatitis, X-linked SCID, Wiskott Aldrich Syndrome, Non-Hodgkin's Lymphoma, Rheumatoid Arthritis, Hypothyroidism, Deficiency Anemia, Lymphoma, Neurologic Disorders, Arrhythmias, Electrolyte Disorders, Coagulopathies, Weight Loss, and various other disorders. The therapeutic market caters to various end-users, including hospitals, clinics, and diagnostic centers. The market is expected to grow significantly due to the increasing awareness and diagnosis of primary immunodeficiencies, the availability of advanced diagnostic tests, and the development of new and innovative therapeutic approaches. In conclusion, the market is a dynamic and evolving landscape, driven by the growing need for effective and targeted therapies for a diverse range of disorders. The market is expected to witness significant growth in the coming years, fueled by advancements in diagnostic technologies, therapeutic approaches, and an increasing focus on personalized medicine.
Market Scope |
|
Report Coverage |
Details |
Page number |
136 |
Base year |
2023 |
Historic period |
2018-2022 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 4.5% |
Market growth 2024-2028 |
USD 1.70 billion |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
4.23 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
Europe at 38% |
Key countries |
US, Germany, China, UK, and Canada |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
Key companies profiled |
ADMA Biologics Inc., Astellas Pharma Inc., Baxter International Inc., Bayer AG, Bio Products Laboratory Ltd., Biocon Ltd., Biotest AG, CSL Ltd., Grifols SA, Kedrion Spa, LFB SA, Lupin Ltd., Octapharma AG, Pfizer Inc., Sanquin, and Takeda Pharmaceutical Co. Ltd. |
Market dynamics |
Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for the market forecast period |
Customization purview |
If our the market report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Disease Type
7 Customer Landscape
8 Geographic Landscape
9 Drivers, Challenges, and Opportunity/Restraints
10 Competitive Landscape
11 Competitive Analysis
12 Appendix
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