United States Primary Immunodeficiency Diseases Market 2025 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

The Primary Immunodeficiency Diseases Market reached US$ 7.3 billion in 2023 and is expected to reach US$ 13.0 billion by 2031, growing at a CAGR of 7.6% during the forecast period 2024-2031.

Key Development:

United States: Recent Industry Developments

✅ In June 2025, Takeda announced the U.S. FDA approval of GAMMAGARD LIQUID ERC, a ready-to-use liquid immunoglobulin therapy with low IgA content, for patients aged two and older with primary immunodeficiency. Commercialization is expected to begin in 2026.

✅ In May 2025, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and Japan's Agency for Medical Research and Development (AMED) announced joint funding for early-stage research in immunology and infectious diseases, including primary immunodeficiency, under the U.S.-Japan Cooperative Medical Sciences Program.

✅ In April 2025, X4 Pharmaceuticals received U.S. FDA approval for Xolremdi (mavorixafor), the first therapy specifically for WHIM syndrome, a rare genetic immunodeficiency disorder. The treatment demonstrated a 60% reduction in infection rates in clinical trials.

Japan: Recent Industry Developments

✅ In August 2025, Japan's Ministry of Health, Labour and Welfare committed an additional USD 1 million to support the Global Antibiotic Research & Development Partnership (GARDP), aiming to develop new treatments for drug-resistant infections, which may benefit patients with primary immunodeficiency disorders.

✅ In June 2025, Takeda's GAMMAGARD LIQUID ERC received approval from the European Medicines Agency (EMA) as DEQSIGA®, marking a significant step in expanding treatment options for primary immunodeficiency in Europe.

✅ In May 2025, Japan's Agency for Medical Research and Development (AMED) and the U.S. National Institute of Allergy and Infectious Diseases (NIAID) announced joint funding for early-stage research in immunology and infectious diseases, including primary immunodeficiency, under the U.S.-Japan Cooperative Medical Sciences Program.

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Primary Immunodeficiency Diseases (PIDs) are a group of genetic disorders in which parts of the immune system are absent or dysfunctional, leading to increased susceptibility to infections, autoimmune conditions, and certain cancers. Management includes immunoglobulin therapy, bone marrow transplantation, gene therapy, and supportive care to improve immune function and patient quality of life.

Recent Mergers and Acquisitions:

United States: Recent M&A Activity

✅ In April 2025, Norgine acquired Theravia, a company specializing in rare disease treatments, including mavorixafor for WHIM syndrome. This acquisition strengthens Norgine's rare disease portfolio, aligning with its growth strategy in immunology.

✅ In May 2024, Biogen announced plans to acquire Human Immunology Biosciences (HI-Bio) for up to $1.8 billion. HI-Bio's leading drug, felzartamab, is being tested for IgA nephropathy, a condition related to primary immunodeficiency.

✅ In June 2024, Vertex Pharmaceuticals acquired Alpine Immune Sciences for $4.9 billion. Alpine's lead candidate, povetacicept, is a potential treatment for IgA nephropathy, expanding Vertex's immunology pipeline.

Japan: Recent M&A Activity

✅ In March 2025, Norgine entered a definitive agreement to acquire Theravia from Mérieux Equity Partners. This acquisition adds key rare disease treatments, including SIKLOS® for sickle cell disease and ORPHACOL® for genetic bile disorders, to Norgine's portfolio.

Key Players:

=> Abbott Laboratories, AstraZeneca, Pfizer, Baxter International, Inc., Bayer, Bristol Myers Squibb, Eli Lilly, Biotest AG, Grifols, CSL Behring among others.

Growth Forecast Projected:

The Global Primary Immunodeficiency Diseases Market is anticipated to rise at a considerable rate during the forecast period, between 2024 and 2031. In 2023, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Primary Immunodeficiency Diseases Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

➥ By Disease Type: Antibody Deficiency (Agammaglobulinaemia, IgG Subclass Deficiency, Selective IgA Deficiency, Others), Cellular Immunodeficiency (Hyper IgM Syndromes, Ataxia Telangiectasia, Wiskott-Aldrich Syndrome, Others), Innate Immune Disorders (TLR 3 Deficiencies, Natural Killer Cell Deficiency, NF Kappa B Essential Modulator Deficiency, Others)

➥ By Treatment: Immunoglobulin (Ig) Replacement Therapy, Haemopoietic Stem Cell Transplantation, Gene Therapy, Others

➥ By End-User: Hospitals, Specialty Clinics, Academic and Research Centers, Others

Regional Analysis for Primary Immunodeficiency Diseases Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Primary Immunodeficiency Diseases producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Primary Immunodeficiency Diseases revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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FAQ

What is the current size of the Primary Immunodeficiency Diseases Market?

A: In 2023, the Primary Immunodeficiency Diseases Market was valued at US$ 7.3 billion, reflecting its strong industry presence.

Q2: How large is the Primary Immunodeficiency Diseases Market expected to be by 2031?

A: By 2031, industry forecasts suggest the Primary Immunodeficiency Diseases Market will grow to around US$ 13.0 billion, demonstrating significant expansion.

Q3: What is the growth rate of the Primary Immunodeficiency Diseases Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 7.6% during the forecast period from 2024 to 2031.

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