USD 1.70 Billion
Report ID:
SQMIG35D2303 |
Region:
Global |
Published Date: May, 2025
Pages:
186
|Tables:
91
|Figures:
71
Global Primary Immunodeficiency Therapeutics Market size was valued at USD 1.70 Billion in 2023 and is poised to grow from USD 1.78 Billion in 2024 to USD 2.53 Billion by 2032, growing at a CAGR of 4.5% in the forecast period (2025-2032).
The global primary immunodeficiency (PI) therapeutics is experiencing modest increase everywhere in the globe. This is fueled by several factors such as heightened awareness, better diagnostic practices, and wider availability of customized therapeutic interventions. There are approximately 450 rare, long-term disorders that fall under the category of primary immunodeficiencies. These illnesses are due to inherited genetic flaws that affect the immune system's capacity to eliminate pathogens. Due to the progress in genetic technology and more sensitive screening methods, early diagnosis is now available as of 2024. This has contributed to the rising demand for long-term therapeutic treatment like immunoglobulin replacement therapy, targeted biologics, and hematopoietic stem cell transplantation.
Moreover, regulatory bodies in North America and Europe, specifically, have developed a growing interest in the production of orphan drugs and rare diseases, which has resulted in more investments in new medicines. The designation of PI diseases as national rare disease programs is increasingly being adopted by governments and health agencies. This designation leads to more funding, better access, and a decrease in treatment barriers. In addition, patient advocacy groups and public-private partnerships have contributed to consolidating the therapeutic environment globally with a strong focus on improving access in developing areas like the Asia-Pacific and Latin America.
For instance, in April 2024, CSL Behring launched a new subcutaneous immunoglobulin (SCIG) product, Hizentra 20% Liquid Plus, in Japan and Brazil. The aim of the company was to enhance the acceptability of infusions and lower the dose frequency. The drug is for use in patients with Common Variable Immunodeficiency (CVID) and X-Linked Agammaglobulinemia (XLA), and it is anticipated that it will contribute to the global primary immunodeficiency therapeutics market growth in regions that are not well served.
How Are Targeted Therapies Reshaping the Primary Immunodeficiency Treatment Landscape?
Through the provision of drugs that are highly specific and typically gene-based, targeted therapies are transforming the management of PI as a broad field. Traditional drugs can, however, affect immunity more generally, while gene therapies and monoclonal antibodies can affect the root cause of the disease or aberrant immune factors. Certain companies are endeavoring to create gene-editing and gene-transfer treatments for disorders like adenosine deaminase severe combined immunodeficiency (ADA-SCID) and chronic granulomatous disease (CGD).
Market snapshot - 2025-2032
Global Market Size
USD 1.70 Billion
Largest Segment
Homecare Settings
Fastest Growth
Specialty Clinics
Growth Rate
4.5% CAGR
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The global primary immunodeficiency (PI) therapeutics market is segmented into therapeutic class, route of administration, end-user, and region. By therapeutic class, the market is divided into immunoglobulin therapy, antibiotics, stem cell transplantation, and gene therapy. Based on route of administration, it is classified into intravenous (IVIG), subcutaneous (SCIG), and oral. Depending on end user, the market includes hospitals, specialty clinics, and homecare settings. Regionally, the market is analyzed across North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.
Why Does Immunoglobulin Therapy Dominate the Primary Immunodeficiency Therapeutics Market in 2024?
As per the 2024 global primary immunodeficiency therapeutics market analysis, the immunoglobulin therapy is the most popular treatment option since it is used in the treatment of most PI diseases and has been shown to be effective in the control of infections. Privigen by CSL Behring and Gammagard Liquid by Takeda remain to be the foremost drivers of increasing demand, significantly in Western Europe and North America, where SCIG and IVIG treatments are well known to perform strongly. To the degree that patients are opting more and more to self-administer SCIG at home, it is expected that the market for SCIG treatments would grow at a higher rate until 2025.
Gene therapy, on the other hand, is expected to be the segment that will be having the highest primary immunodeficiency therapeutics market share, even though it has a lower base. The positive results of clinical trials, the regulatory push, and the growing number of drugs coming into late-stage pipelines are all drivers that are fueling this growth. Just as Bluebird Bio, Rocket Pharma, and Orchard Therapeutics are breaking ground in the creation of curative treatments for SCID and WAS (Wiskott-Aldrich Syndrome), gene therapy can be a game-changer for certain groups of individuals with prostate cancer.
Why Is Homecare Settings Transforming the Primary Immunodeficiency Therapeutics Market?
Based on the 2024 global primary immunodeficiency therapeutics market forecast, the increasing trend of home-based treatment is significantly influencing the homecare settings segment. It makes patients continue with their treatment, enhances their quality of life, and decreases the overall cost of medical treatment. Patients can be treated with therapy without needing to take multiple visits to the hospital because SCIG products are well suited for self-administration. This trend continues to persist post-COVID, fueled by enhanced patient education and the presence of portable infusion pumps. The pandemic played a contributing role in the evolution of this key primary immunodeficiency therapeutics market trend.
Since specialty clinics possess expertise in immunological diseases and the growing use of new biologics, it is expected that these clinics would experience the strongest growth. As these specialty clinics provide individualized care, faster diagnosis, and the ability to try newer drugs, they are a better choice than general hospitals in treating primary immunodeficiency diseases that involve multiple aspects.
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High insurance coverage, early diagnosis, and strongly approved therapy pipeline in North America have resulted in the region's leadership of the primary immunodeficiency therapeutics sector. International pharmaceutical corporations with a United States headquarters are leaders in research in gene and immunoglobulin therapies. An ongoing surge in demand has been induced as a consequence of mounting identification rates, which have been induced by activist organizations like the Immune Deficiency Foundation (IDF). The efforts have led to wider registries of patients and national education campaigns.
The U.S. is the market leader in PI treatments, where over 70% of PI patients are regularly treated with IVIG or SCIG. Market leadership can be enhanced by the availability of specialist immunology clinics, pharmacies, and reimbursement policies which are beneficial. The PI treatment pipeline is strong, and there are many gene therapies currently in the later stages of investigation. Due to continuous clinical trials and improvement in immunology, the United States market keeps getting stronger as a global leader in treating PI.
Canadian Immunodeficiencies Patient Organization (CIPO) is doing its best to enhance diagnosis and SCIG uptake, which is driving Canada's increasing participation in the PI therapeutics market of the pharma industry. To make SCIG accessible to patients, Ontario and Quebec are undertaking huge spending on public reimbursement for home-based administration of SCIG. Due to Canada's increased focus on patient-focused care and advocacy for better treatment options, the nation has become a growing market for PI treatments and has emerged as a solid leader in the region of PI care within the region.
The European universal system of healthcare existing there is a key element involved in the distribution of extensive coverage of PI treatments, especially within nations like Germany, the United Kingdom, and France. ESID reviewed its guidelines in 2024 with the aim of placing greater stress on the early initiation of SCIG and integration of mental health services into long-term care. Due to enhanced public funding and patient-centered care, Europe is emerging as a hub for the development of novel treatment strategies for PI and improvement in the care that is delivered to patients.
The National Health Service (NHS) delivers comprehensive primary immunodeficiency care in the United Kingdom. This treatment is offered through specialist centers and increased availability of SCIG therapies are both encompassed. Patient advocacy groups such as PID UK have played a significant role in the promotion of early diagnosis and treatment, which has led to an increase in the use of SCIG, especially among children and adolescents. With its integrated care model offered by the National Health Service (NHS) and its continued efforts towards mental health and chronic care, the UK is a market leader in primary immunodeficiency therapy in Europe.
Primary immunodeficiency (PI) is being diagnosed at a high rate in France, and the French government is offering a great deal of funding for treatment of PI. Specifically, intravenous immunoglobulin (IVIG) is witnessing a boom in demand, and most of this demand is from academic hospitals. Increased funding for genetic screening and new PI treatments is to be introduced as part of the French Rare Disease Plan III, set to launch in 2025. Due to the initiative, patients will have greater access to new therapies, and France will be an even more significant market for further development of physical therapy services.
Germany's decentralized healthcare system allows for intravenous immunoglobulin and subcutaneous immunoglobulin therapy to be administered statewide effectively. The market is ready to develop, especially with current clinical trials and advancements in gene therapy, due to the extensive use of home-based drugs. The strong biotechnology industry of Germany offers a rich soil to establish novel therapeutic strategies. The established healthcare network of the country, combined with the increasing focus on personalized medicine, guarantees that Germany will lead the field of PI therapies in Europe.
Several factors, such as enhanced diagnostic facilities, increasing levels of awareness, and increased foreign investment, are driving the high growth of the Asia-Pacific primary immunodeficiency therapeutics market. In the diagnosis of undiagnosed cases of primary immunodeficiency, China, India, and Australia are leaders in the field. Besides the rising number of collaborations among market players and local healthcare experts, more of these nations are embracing new PI treatments, such as immunoglobulin therapy and gene therapies. Clinical trials in this sector are being invested heavily in, which is laying the foundation for driving the future expansion of the PI therapeutics market.
Sponsorship by Medicare of SCIG drugs has helped drive notable advances in the PI therapeutics market in Australia, which is experiencing strong growth.
More medication compliance is being attained, especially among patients residing in rural areas, due to the regional immunology networks and patient education initiatives. Research centers like the Murdoch Children's Research Institute are making gene therapy research progress, which is helping to create the way for creating new possible treatment options for patients with Parkinson's disease. Australia is fast emerging as an important market in the Asia-Pacific region for PI therapies. This is caused by the strong development of its healthcare infrastructure coupled with its augmented focus on the treatment of patients.
The India primary immunodeficiency therapeutics market is growing at a high rate, possibly due to the nation's efforts to make diagnosis and treatment more accessible. The Indian Council of Medical Research (ICMR) created the National PID Registry in 2024 with the goal of improving diagnosis accuracy and aiding the discovery of more efficient therapy. Due to the market, there is a need for IVIG and SCIG replacements that are cheaper. India is increasingly being a major market for PI therapies, especially those solutions that are cheaper. Major companies like Intas and Bharat Serum are increasingly involving in the market.
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Technological Breakthroughs in Diagnosis
Increased Access to Homecare and SCIG
High Price for Treatment
Lack of Awareness in Emerging Markets
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The primary immunodeficiency (PI) therapeutics industry is highly concentrated, with a few multinational drug companies controlling a large majority of the market. Multinational distribution networks and large-scale plasma collection networks are some of the assets these players use. The terrain is changing, though, due to the increased competition that is building in the area of gene therapy. Small, focused biotechnology companies are entering the later phases of clinical trials with the aim of creating therapies that are curative. This type of diversity is working to drive innovation and enhance the long-term treatment modalities available to individuals with PI worldwide.
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, the global primary immunodeficiency therapeutics market outlook is changing due to growing awareness, improved diagnostics, and patient-led innovation. Gene treatments, increased SCIG homecare schemes, and personalization through AI will be the forces that drive the industry into the future despite the reality that costs, and availability remain significant hurdles. Based on the global primary immunodeficiency therapeutics market regional forecast, Europe is emphasizing integration and access, whereas Asia-Pacific is expanding as a rapidly emerging region driven by public-private partnership and affordable innovation. North America is still leading the list in terms of innovation and infrastructure. Within the next few years, there is going to be a revolution in the treatment of chronic immunological illnesses, shifting towards therapy that could result in long-term remission or even cure.
Report Metric | Details |
---|---|
Market size value in 2023 | USD 1.70 Billion |
Market size value in 2032 | USD 2.53 Billion |
Growth Rate | 4.5% |
Base year | 2024 |
Forecast period | 2025-2032 |
Forecast Unit (Value) | USD Billion |
Segments covered |
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Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
Companies covered |
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Table Of Content
Executive Summary
Market overview
Parent Market Analysis
Market overview
Market size
KEY MARKET INSIGHTS
COVID IMPACT
MARKET DYNAMICS & OUTLOOK
Market Size by Region
KEY COMPANY PROFILES
Methodology
For the Primary Immunodeficiency Therapeutics Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Primary Immunodeficiency Therapeutics Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
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Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Primary Immunodeficiency Therapeutics Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Primary Immunodeficiency Therapeutics Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
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Global Primary Immunodeficiency Therapeutics Market size was valued at USD 1.70 Billion in 2023 and is poised to grow from USD 1.78 Billion in 2024 to USD 2.53 Billion by 2032, growing at a CAGR of 4.5% in the forecast period (2025-2032).
The primary immunodeficiency (PI) therapeutics industry is highly concentrated, with a few multinational drug companies controlling a large majority of the market. Multinational distribution networks and large-scale plasma collection networks are some of the assets these players use. The terrain is changing, though, due to the increased competition that is building in the area of gene therapy. Small, focused biotechnology companies are entering the later phases of clinical trials with the aim of creating therapies that are curative. This type of diversity is working to drive innovation and enhance the long-term treatment modalities available to individuals with PI worldwide. 'CSL Behring', 'Takeda Pharmaceutical', 'Grifols', 'Kedrion Biopharma', 'Octapharma', 'ADMA Biologics', 'Pfizer', 'Orchard Therapeutics', 'Rocket Pharmaceuticals', 'Bluebird Bio', 'LFB Group', 'Bio Products Laboratory (BPL)', 'China Biologic Products Holdings', 'Biotest AG', 'GC Pharma (Green Cross Corporation) '
Advancements in diagnostic technology, specifically over the last several years next-generation sequencing (NGS) and genetic screening, have played an important role in minimizing the period required for a diagnosis of primary immunodeficiency (PI) disease. An early diagnosis not only is it feasible to initiate treatment at an earlier date, but also therapeutic results become better because they minimize the burden of infection. This type of increased diagnostic accuracy results in enhanced PI management, greater compliance, and better patient quality of life, all resulting in a higher market demand for PI medication.
Individualized Immunoglobulin Dosing for Patients: Dose algorithms derived from artificial intelligence are helping to revolutionize PI treatment by allowing for the possibility of individualizing immunoglobulin dose recommendations. Patient weight, frequency of infections, and metabolic rate are all parameters that are considered in an effort to optimize treatment regimens and prevent side effects. This strategy enhances treatment adherence, reduces the likelihood of under- or overdosing, and optimizes use of available resources. To date, clinical trials are ongoing to confirm the efficacy of artificial intelligence (AI) in various patient populations. The early results suggest that AI needs to be employed for a more extensive duration in the clinical environment.
What Drives the North American Dominance in the Primary Immunodeficiency Therapeutics Market?
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