Primary Immunodeficiency Disorders Market

The global Primary Immunodeficiency Disorders Market is valued at USD 7.08 Billion in 2023 and is projected to reach a value of USD 12.17 Billion by 2032 at a CAGR (Compound Annual Growth Rate) of 6.2% between 2024 and 2032. The market is driven by increasing prevalence of primary immunodeficiency with heightened awareness among both healthcare providers and the general public, is boosting the demand for effective treatments.

Key Highlights

• Based on the Disease, Antibody Deficiency category accounted for significant market share of 51.2%in 2023
• In 2023, Treatment dominated the market with largest market share of 61.6%
• North America dominated the market with 44.5% market share in 2023

Disease Overview

​The Disease segment is divided into Antibody Deficiency, Cellular Immunodeficiency, Innate Immune Disorders, Others. The Antibody Deficiency segment held the dominant share in 2023, accounting for 51.2% market share.

The antibody deficiencies segment accounted for the largest market share driven by their high prevalence and significant impact on patient health. Conditions like common variable immunodeficiency (CVID) and specific antibody deficiency (SAD) are among the most common primary immunodeficiencies, making up a large proportion of cases. These disorders are characterized by a decreased capacity to generate antibodies, which results in recurrent and serious infections. The market is expanding because to the high need for efficient treatments including intravenous and subcutaneous immunoglobulin therapy.

Treatment Overview

The Treatment segment is divided into Immunoglobulin Replacement Therapy, Antibiotic Therapy, Stem Cell/Bone Marrow Transplantation, Gene Therapy, Others. The Immunoglobulin Replacement Therapy segment dominated the market with 61.6% market share in 2023.

The immunoglobulin replacement therapy dominated the market. People with immune system deficiencies, such as congenital immunodeficiencies and common variable immunodeficiency (CVID), can receive vital antibodies through this therapy. Both the rising incidence of immunodeficiencies and its efficacy in preventing infections and improving patients' quality of life are factors contributing to its widespread use. Subcutaneous alternatives and other formulation and administration innovations have increased patient convenience and compliance. The segment's growth is further aided by a robust pipeline of immunoglobulin products and continuous research to improve their safety and efficacy.

Regional Overview

In 2023, the North America captured 44.5% of the revenue share.

North America Primary Immunodeficiency Disorders market is driven by advanced healthcare infrastructure, strong awareness, and robust research and development capabilities. The presence of top pharmaceutical and biotechnology firms promotes quick innovation and easy access to the new therapies. Significant healthcare spending and a supportive regulatory framework also help the sector.

In 2023, the U.S. held the largest share of the North American Primary Immunodeficiency Disorders market, driven by advanced healthcare infrastructure, extensive R&D efforts, and a high prevalence of immune disorders. Its position is further strengthened by the presence of significant biopharmaceutical companies, extensive insurance coverage, and established treatments.

The European market for Primary Immunodeficiency Disorders is seeing substantial growth due to increasing awareness, higher diagnosis rates, and advancements in genetic testing and innovative therapies. Improved healthcare access and favorable regulatory frameworks also contribute to the market's expansion. The UK stands out in Europe’s market due to its advanced healthcare infrastructure, high diagnostic capabilities, and significant R&D investments. Leading bio-pharmaceutical companies and a strong focus on innovative treatments also enhance the UK's prominence.

Asia Pacific region is anticipated to grow at fastest rate during the forecast period driven by increased government incentives for R&D in countries like China and India, which support the commercialization of new products. The prevalence of chronic illnesses in the region further boosts the market by increasing the target population for these therapies.

Based on the provided market data, Vantage Market Research offers customizations in the reports to meet the specific needs of clients.

Key Trends

• Growing Adoption of Subcutaneous Therapies: Treatments like subcutaneous immunoglobulin (SCIg) are gaining popularity due to their convenience, allowing patients to self-administer at home, reducing hospital visits, and improving quality of life
• Advancements in Gene Therapy: Emerging gene therapies aim to provide long-term or even curative solutions for certain PIDs, such as severe combined immunodeficiency (SCID), addressing underlying genetic defects
• Focus on Pediatric Care: The approval of therapies like Takeda’s Hyqvia for children is expanding treatment options for younger patients, addressing an important need for pediatric-friendly therapies
• Shift Toward Personalized Medicine: Precision medicine approaches, targeting specific mutations or immune dysfunctions, are becoming more prominent, allowing for tailored treatments based on a patient’s genetic profile
• Rising Demand for Immunoglobulin Replacement Therapy: The growing incidence of PID cases worldwide is driving the demand for immunoglobulin therapies, which remain the cornerstone treatment for many PIDs

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Market Dynamics

Increasing Prevalence of PID

The global rise in primary immune deficiencies (PID) is a significant market driver as more individuals are being diagnosed and seeking treatment. Primary immunodeficiencies (PIDs) impact more than 6 million people globally, with a large portion estimated between 70-90% going undiagnosed. The global prevalence of PIDs is approximately 1 in 10,000 individuals, though this is likely underestimated due to cases that are not properly identified. For instance, in France, the reported prevalence is 4.4 cases per 100,000 people. This increase is largely due to improved awareness and advancements in diagnostic techniques, such as genetic testing and enhanced screening programs. Historically, many PIDs were underdiagnosed or misdiagnosed, but with better healthcare infrastructure and knowledge, more cases are being accurately identified.

Advancements in Gene Therapy

Gene therapy is becoming a revolutionary treatment of primary immune deficiencies with the potential for long-term remedies. Gene therapy attempts to address the molecular causes of the genetic alterations that cause many PIDs, possibly establishing normal immunological function. Gene therapy provides one-time intervention that may eliminate the need for ongoing therapy, in comparison to conventional treatments that only control symptoms. The safety and effectiveness of these treatments are further enhanced by recent developed techniques like CRISPR in delivery methods making them more practical for a larger variety of PIDs.

Competitive Landscape

The Primary Immunodeficiency Disorders market is characterized by the presence of key players focused on developing innovative therapies and expanding treatment options. Major pharmaceutical companies like Takeda, CSL Behring, and Grifols dominate the market with established products such as immunoglobulin therapies (e.g., Hyqvia and Hizentra) and novel treatments targeting rare PIDs. Emerging companies like X4 Pharmaceuticals, which just received FDA approval for mavorixafor (Xolremdi) for WHIM syndrome, are likewise becoming more and more competitive in the market. These companies are investing heavily in research and development, clinical trials, and expanding their product portfolios to capture unmet needs in the PID space. Collaborations with healthcare providers, continuous educational efforts, and strategic mergers and acquisitions are key strategies employed to strengthen market positions.

The key players in the global Primary Immunodeficiency Disorders market include - Abbott Laboratories, Baxter International, CSL Behring, Takeda Pharmaceutical, Bio Products Laboratory, LFB, ADMA Biologics, Astellas Pharma, Octapharma, Biotest, Grifols, Kedrion Biopharma among others.

Recent Market Developments

FDA Approves X4 Pharmaceuticals' Mavorixafor (Xolremdi) for Treating WHIM Syndrome

• In April 2024, X4 Pharmaceuticals announced that the FDA had approved its drug mavorixafor, under the brand name Xolremdi, for the treatment of WHIM syndrome, a rare primary immunodeficiency. Mavorixafor, a CXCR4 receptor antagonist, helps increase white blood cell levels and lowers infection rates in patients. In a phase 3 clinical trial, the drug significantly raised neutrophil and lymphocyte counts, reduced infection rates by 60%, and decreased the need for antibiotics. This medication fills an unmet need in the treatment of immune disorders and will be available for patients aged 12 and older. X4 Pharmaceuticals is committed to continuing outreach to healthcare professionals and expanding diagnostic initiatives

Takeda’s Hyqvia Receives FDA Approval for Pediatric Primary Immunodeficiency Treatment

• In April 2023, Takeda’s Hyqvia gained FDA approval for use in children aged 2 to 16 with primary immunodeficiency (PI). This extended approval offers a monthly subcutaneous treatment, providing a more convenient option for pediatric patients. The approval came after successful Phase 3 trial results, which demonstrated a reduction in serious bacterial infections and a safety profile consistent with that observed in adults. This development presents families with a less frequent treatment option and is expected to contribute to the growth of the primary immunodeficiency treatment market

CSL Behring Gains FDA Approval for Hizentra Prefilled Syringes for Primary Immunodeficiency and CIDP

• In April 2023, CSL Behring received FDA approval for its 50 mL prefilled syringes of Hizentra, intended for the treatment of primary immunodeficiency in patients aged 2 and older, as well as chronic inflammatory demyelinating polyneuropathy (CIDP). This subcutaneous immune globulin (SCIg) therapy is particularly notable for its ease of use and self-administration, making it the only SCIg approved for CIDP. Already the most widely prescribed self-administered SCIg for primary immunodeficiency in the U.S., Hizentra will soon be available in prefilled syringes and vials as part of CSL Behring’s product offerings

The global Primary Immunodeficiency Disorders market can be categorized as Disease, Treatment and Region.