Primary Immunodeficiency Disorders Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Disease (Antibody Deficiency, Cellular Immunodeficiency, Innate Immune Disorders, Others), By Treatment (Immunoglobulin Replacement Therapy, Antibiotic Therapy, Stem Cell/Bone Marrow Transplantation, Gene Therapy, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 7.12 Billion
CAGR (2026-2031)	6.89%
Fastest Growing Segment	Immunoglobulin Replacement Therapy
Largest Market	North America
Market Size (2031)	USD 10.62 Billion

Market Overview

The Global Primary Immunodeficiency Disorders Market will grow from USD 7.12 Billion in 2025 to USD 10.62 Billion by 2031 at a 6.89% CAGR. Primary Immunodeficiency Disorders (PIDs) are a heterogeneous group of hereditary genetic defects that impair the immune system, rendering individuals highly susceptible to severe infections and autoimmune diseases. The market for treating these conditions primarily relies on immunoglobulin replacement therapies, prophylactic antibiotics, and hematopoietic stem cell transplantation. The expansion of this sector is fundamentally driven by the broader implementation of newborn screening programs and the increasing accessibility of genetic testing, which collectively improve diagnosis rates and identify patients earlier in life who require long-term therapeutic management.

However, a significant challenge impeding market scalability is the complexity and high cost associated with manufacturing plasma-derived therapies, which frequently leads to global supply shortages. This pressure is intensified by the rapidly growing identification of unique disease variants requiring treatment. According to the International Patient Organisation for Primary Immunodeficiencies, in 2024, the International Union of Immunological Societies classification reported over 559 distinct forms of primary immunodeficiency. This continuous fragmentation of the disease landscape complicates the standardization of care and places additional strain on the limited supply of essential plasma resources.

Key Market Drivers

Expansion of Government-Mandated Newborn Screening Programs functions as a critical growth engine for the market by facilitating the early detection of life-threatening defects before the onset of severe infections. The implementation of universal screening protocols significantly reduces the diagnostic delay for conditions such as severe combined immunodeficiency (SCID), ensuring that infants receive curative interventions like hematopoietic stem cell transplantation immediately. This public health shift is rapidly closing the gap between prevalence and diagnosis in key regions. According to the Immunodeficiency Foundation Australia, May 2024, in the 'SCID Newborn Screening' announcement, all Australian states and territories have successfully integrated SCID testing into their standard newborn bloodspot screening panels. Systematically widening these diagnostic nets directly increases the identified patient population that requires lifelong therapeutic management, thereby expanding the addressable market for essential treatments.

Concurrently, the Increasing Adoption of Immunoglobulin Replacement Therapies is propelling market revenue, driven by robust global demand for both intravenous and subcutaneous administration routes. As diagnosis rates improve, the reliance on plasma-derived therapies to manage immune deficiencies intensifies, compelling manufacturers to scale plasma collection and fractionation capabilities to meet patient needs. According to Grifols, February 2025, in the 'Full Year Results 2024' report, the company's immunoglobulin franchise experienced accelerated expansion with a full-year revenue growth of 15.3%, underscored by strong underlying demand. This upward trajectory is consistent across the industry's leading entities, reflecting the indispensable nature of these biologic treatments. According to CSL Limited, in 2024, their immunoglobulin product portfolio sales notably increased by 20% to reach $5.66 billion, highlighting the substantial financial scale of this therapeutic segment.

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Key Market Challenges

The extensive complexity and substantial capital requirements involved in manufacturing plasma-derived therapies constitute a severe bottleneck that directly restricts the growth of the Global Primary Immunodeficiency Disorders Market. Unlike conventional pharmaceuticals, immunoglobulin replacement therapies rely on human plasma as a finite biological raw material, necessitating rigorous, high-cost collection and fractionation processes. This inherent manufacturing rigidity creates a supply chain that is slow to adapt to sudden surges in global demand, resulting in persistent product shortages. These limitations prevent manufacturers from scaling production volumes efficiently, thereby stalling revenue potential and market expansion despite the rising diagnosis rates.

The market’s vulnerability is further intensified by a heavy dependence on concentrated geographic regions for raw material collection. According to the Plasma Protein Therapeutics Association, in 2024, North American donors provided over 63% of the global plasma supply used for manufacturing, highlighting a critical regional imbalance. This reliance on a single area for the majority of essential resources means that any logistical disruption, regulatory change, or labor issue in North America disproportionately impacts the availability of therapies worldwide. Consequently, this lack of supply chain diversification hampers the industry’s ability to guarantee consistent treatment access, directly impeding the market's sustainable growth.

Key Market Trends

The increasing shift toward subcutaneous immunoglobulin (SCIG) for home-based care is fundamentally reshaping treatment paradigms by prioritizing patient autonomy and reducing clinical dependence. Unlike traditional intravenous administrations that necessitate frequent hospital visits, advanced facilitated subcutaneous systems enable self-administration in a home setting, significantly enhancing the quality of life for patients with chronic needs. This transition is particularly impactful for pediatric populations, where minimizing the burden of medical appointments is critical for long-term adherence. According to Takeda, June 2024, in the 'HyQvia Approved for Pediatric Patients' press release, Health Canada expanded the authorization for HyQvia to include children aged two to sixteen, distinguishing it as the only subcutaneous immune globulin infusion for this demographic that allows home administration every three to four weeks.

Concurrently, a focus on personalized medicine tailored to specific genetic mutations is moving the industry beyond broad-spectrum immune support toward precision therapies. Clinicians are increasingly adopting targeted treatments that address unique molecular pathways, such as the PI3K delta signaling pathway in activated phosphoinositide 3-kinase delta syndrome (APDS), rather than solely relying on non-specific replacement therapies. This tailored approach directly modulates dysregulated immune responses associated with distinct genetic defects, improving clinical outcomes for patients with rare variants. According to Pharming Group N.V., May 2024, in the 'First Quarter 2024 Financial Results', revenue for the targeted therapy Joenja reached $9.6 million, marking a 21% sequential increase driven by the continued identification of patients with confirmed genetic markers for APDS.

Segmental Insights

Immunoglobulin Replacement Therapy represents the fastest-growing segment within the Global Primary Immunodeficiency Disorders Market due to its essential role in managing antibody deficiencies. This expansion is primarily driven by the increasing preference for subcutaneous administration methods, which allow patients to administer treatment at home and significantly improve long-term adherence. Additionally, continued approvals by regulatory bodies such as the U.S. Food and Drug Administration for new plasma-derived products have expanded patient access to these critical therapies. Consequently, rising diagnosis rates combined with the convenience of modern delivery systems continue to accelerate the adoption of immunoglobulin treatments.

Regional Insights

North America maintains a dominant position in the Global Primary Immunodeficiency Disorders Market due to superior diagnostic rates and a well-established healthcare infrastructure. The region benefits significantly from widespread newborn screening programs for conditions such as Severe Combined Immunodeficiency, which ensures early identification and treatment of patients. Furthermore, the presence of major plasma-derived therapy manufacturers and streamlined approval processes by the US Food and Drug Administration facilitate the rapid commercialization of new treatments. Comprehensive reimbursement coverage for immunoglobulin therapies further supports patient access, driving sustained market expansion in this region.

Recent Developments

• In June 2025, Takeda announced that the U.S. FDA approved GAMMAGARD LIQUID ERC, a new 10% immune globulin infusion with low immunoglobulin A content, for patients aged two years and older with primary immunodeficiency. This ready-to-use liquid formulation serves as a replacement therapy for individuals with impaired antibody production. Alongside this approval, the company disclosed a strategic decision to discontinue the manufacturing of its older freeze-dried immunoglobulin product by late 2027. The transition aims to modernize the portfolio, with the new liquid therapy expected to become commercially available to patients in the United States in 2026.
• In March 2025, Pharming Group reported that it received regulatory approval in Australia for Joenja (leniolisib), a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS). This rare primary immunodeficiency is characterized by immune dysregulation, and the approval marked another step in the company's global expansion strategy following earlier success in the United States. The therapy functions as an oral, selective inhibitor of the PI3K delta enzyme, targeting the root cause of the disorder. The company highlighted that it was actively engaged in reimbursement negotiations to ensure patient access to this precision medicine in the newly approved market.
• In June 2024, Grifols announced that the U.S. FDA granted approval for Yimmugo, an intravenous immunoglobulin (IVIg) therapeutic derived from plasma, for the treatment of primary immunodeficiencies. Developed by the company’s subsidiary, this product became the first from its expanded portfolio to receive U.S. clearance. The therapy is manufactured at a newly certified facility in Germany and is indicated for substitution treatment in patients with primary antibody deficiency syndromes. The company emphasized that this launch would help address the increasing global demand for essential plasma-derived medicines and strengthen its offerings in the Global Primary Immunodeficiency Disorders Market.
• In April 2024, X4 Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved XOLREMDI (mavorixafor) capsules for the treatment of patients aged 12 years and older with WHIM syndrome. This approval represented the first therapy specifically indicated for this rare combined primary immunodeficiency and chronic neutropenic disorder, which is caused by dysfunction in the CXCR4 pathway. The oral medication serves as a selective CXCR4 antagonist intended to increase circulating mature neutrophils and lymphocytes. The company noted that this regulatory milestone provided a targeted therapeutic option to address the underlying disease mechanism rather than solely managing symptoms for the affected population.

Key Market Players

• CSL Behring
• Grifols
• Takeda
• Octapharma
• Sanofi
• Baxalta
• Kamada
• Sandoz
• Baxter
• Shire

By Disease	By Treatment	By Region
Antibody Deficiency Cellular Immunodeficiency Innate Immune Disorders Others	Immunoglobulin Replacement Therapy Antibiotic Therapy Stem Cell/Bone Marrow Transplantation Gene Therapy Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Primary Immunodeficiency Disorders Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Primary Immunodeficiency Disorders Market, By Disease:

• Antibody Deficiency
• Cellular Immunodeficiency
• Innate Immune Disorders
• Others

• Primary Immunodeficiency Disorders Market, By Treatment:

• Immunoglobulin Replacement Therapy
• Antibiotic Therapy
• Stem Cell/Bone Marrow Transplantation
• Gene Therapy
• Others

• Primary Immunodeficiency Disorders Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE