Primary Immunodeficiency Disorders Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Primary Immunodeficiency Disorders Market is projected to expand from USD 7.12 Billion in 2025 to USD 10.62 Billion by 2031, registering a CAGR of 6.89%. Primary Immunodeficiency Disorders (PIDs) encompass a diverse array of hereditary genetic anomalies that compromise the immune system, leaving patients acutely vulnerable to serious infections and autoimmune conditions. Management of these disorders primarily depends on immunoglobulin replacement therapies, prophylactic antibiotic regimens, and hematopoietic stem cell transplantation. The sector's growth is fundamentally underpinned by the widespread adoption of newborn screening initiatives and the enhanced availability of genetic testing, which collectively boost diagnostic rates and facilitate the early identification of patients requiring lifelong therapeutic intervention.

Nevertheless, the market faces a substantial scalability hurdle due to the intricate and costly nature of manufacturing plasma-derived treatments, a factor that often results in global supply deficits. This strain is exacerbated by the rapid discovery of unique disease variants necessitating care. As noted by the International Patient Organisation for Primary Immunodeficiencies in 2024, the International Union of Immunological Societies classification has identified over 559 distinct types of primary immunodeficiency. This ongoing fragmentation of the disease landscape adds complexity to the standardization of treatment protocols and places further pressure on the already finite supply of essential plasma resources.

Market Drivers

The broadening of government-mandated newborn screening programs serves as a pivotal catalyst for market expansion by enabling the early identification of life-threatening defects prior to the onset of severe infections. Implementing universal screening protocols drastically minimizes diagnostic delays for conditions such as severe combined immunodeficiency (SCID), ensuring infants promptly receive curative treatments like hematopoietic stem cell transplantation. This public health evolution is effectively narrowing the disparity between disease prevalence and actual diagnosis in major regions. For instance, the Immunodeficiency Foundation Australia announced in May 2024 that every Australian state and territory has successfully incorporated SCID testing into their standard newborn bloodspot screening panels, systematically enlarging the diagnostic net and, consequently, the patient population requiring lifelong care.

Simultaneously, the rising utilization of immunoglobulin replacement therapies is driving market revenue, supported by vigorous global demand for both intravenous and subcutaneous administration methods. As diagnostic rates rise, the dependence on plasma-derived therapies for managing immune deficiencies grows, necessitating that manufacturers expand their plasma collection and fractionation capacities. According to Grifols' 'Full Year Results 2024' report released in February 2025, the company's immunoglobulin division saw accelerated growth with a 15.3% increase in revenue, highlighting strong underlying demand. This positive trend is mirrored across major industry players; CSL Limited reported in 2024 that sales of their immunoglobulin portfolio rose by 20% to $5.66 billion, underscoring the significant financial magnitude of this therapeutic sector.

Market Challenges

The immense complexity and significant capital investment required for manufacturing plasma-derived therapies represent a critical bottleneck that directly constrains the expansion of the Global Primary Immunodeficiency Disorders Market. Unlike traditional pharmaceuticals, immunoglobulin replacement therapies depend on human plasma as a finite biological raw material, necessitating strict and expensive collection and fractionation procedures. This inherent rigidity in manufacturing results in a supply chain that struggles to adapt quickly to sudden spikes in global demand, leading to recurring product shortages. Such limitations hinder manufacturers from effectively scaling production volumes, thereby stalling revenue growth and market development despite increasing patient diagnosis rates.

This market vulnerability is further compounded by a heavy reliance on specific geographic regions for raw material sourcing. Data from the Plasma Protein Therapeutics Association in 2024 indicates that North American donors contributed over 63% of the global plasma supply utilized for manufacturing, revealing a severe regional imbalance. Because of this dependence on a single region for the majority of critical resources, any logistical disruptions, regulatory shifts, or labor challenges in North America disproportionately affect the global availability of therapies. Consequently, this insufficient diversification in the supply chain impairs the industry's capacity to ensure consistent treatment access, directly inhibiting the market's long-term sustainability.

Market Trends

The growing transition toward subcutaneous immunoglobulin (SCIG) for home-based care is fundamentally altering treatment paradigms by emphasizing patient autonomy and decreasing reliance on clinical settings. In contrast to traditional intravenous methods that require frequent hospital visits, advanced facilitated subcutaneous systems permit self-administration at home, greatly improving the quality of life for those with chronic conditions. This shift is especially significant for pediatric patients, for whom reducing the burden of medical appointments is essential for long-term adherence. For example, Takeda announced in June 2024 that Health Canada had expanded HyQvia's authorization to include children aged two to sixteen, making it the sole subcutaneous immune globulin infusion for this age group that supports home administration every three to four weeks.

In parallel, the industry is moving beyond broad-spectrum immune support toward personalized medicine designed for specific genetic mutations. Clinicians are increasingly utilizing targeted therapies that address unique molecular pathways - such as the PI3K delta signaling pathway involved in activated phosphoinositide 3-kinase delta syndrome (APDS) - instead of relying exclusively on non-specific replacement therapies. This precision approach directly modulates the dysregulated immune responses linked to distinct genetic defects, thereby enhancing clinical outcomes for patients with rare variants. According to Pharming Group N.V.'s 'First Quarter 2024 Financial Results' from May 2024, revenue for the targeted therapy Joenja reached $9.6 million, a 21% sequential increase attributed to the ongoing identification of patients with confirmed genetic markers for APDS.

Key Players Profiled in the Primary Immunodeficiency Disorders Market

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

Report Scope

In this report, the Global Primary Immunodeficiency Disorders Market has been segmented into the following categories:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Primary Immunodeficiency Disorders Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

This product will be delivered within 1-3 business days.