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Primary Immunodeficiency Disorders - Global Strategic Business Report

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    Report

  • 64 Pages
  • May 2025
  • Region: Global
  • Global Industry Analysts, Inc
  • ID: 6071094
The global market for Primary Immunodeficiency Disorders was estimated at US$7.9 Billion in 2024 and is projected to reach US$10.4 Billion by 2030, growing at a CAGR of 4.8% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The report includes the most recent global tariff developments and how they impact the Primary Immunodeficiency Disorders market.

Global Primary Immunodeficiency Disorders (PID) Market - Key Trends & Drivers Summarized

Why Is There an Increasing Need for Primary Immunodeficiency Disorder Treatments?

Primary Immunodeficiency Disorders (PIDs) are a group of rare genetic conditions that impair the immune system’s ability to defend against infections, making affected individuals highly susceptible to recurrent and severe illnesses. With over 450 identified forms of PID, the demand for effective diagnostic tools and therapeutic solutions has risen significantly. Advances in genetic testing and newborn screening programs have improved early detection, enabling timely interventions that prevent severe complications. Treatment options for PIDs primarily include immunoglobulin replacement therapy (IVIG and SCIG), hematopoietic stem cell transplantation (HSCT), and gene therapy. The growing understanding of the molecular mechanisms underlying immunodeficiencies has also led to the development of targeted biologics and immunomodulatory therapies, offering more personalized treatment options. Additionally, increased patient advocacy and funding for rare disease research have accelerated efforts to enhance treatment accessibility and expand therapeutic pipelines. As healthcare providers and policymakers prioritize PID management, the market for diagnostic and therapeutic solutions is poised for significant growth.

What Challenges Are Hindering the Advancement of PID Therapies?

Despite advancements in PID diagnosis and treatment, several challenges continue to limit access and innovation in the field. One of the primary concerns is the high cost of immunoglobulin replacement therapy, which is a lifelong requirement for many PID patients. The limited availability of donor plasma for IVIG production further constrains supply, leading to periodic shortages and pricing fluctuations. Additionally, the complexity of diagnosing PIDs presents a significant hurdle, as many symptoms overlap with common infections or autoimmune diseases, resulting in delayed or missed diagnoses. Regulatory barriers also slow down the approval of emerging gene therapies and biologics, prolonging the time-to-market for new treatments. Furthermore, disparities in healthcare infrastructure and diagnostic capabilities prevent timely access to PID therapies in low-income regions, exacerbating disease burden in underserved populations. Addressing these challenges requires increased investment in alternative treatment approaches, expanded newborn screening programs, and greater collaboration between stakeholders to improve access and affordability.

How Are Innovations in Gene Therapy and Immunotherapy Transforming PID Treatment?

Technological advancements in gene therapy and immunomodulatory treatments are reshaping the landscape of PID management, offering curative and targeted therapeutic approaches. Gene therapy has shown promising results in correcting underlying genetic mutations responsible for severe PIDs, such as Severe Combined Immunodeficiency (SCID) and Chronic Granulomatous Disease (CGD), reducing the need for lifelong IVIG therapy. The development of monoclonal antibodies and cytokine-based therapies is further expanding treatment options, helping to regulate immune function in patients with specific immunodeficiency subtypes. Additionally, advancements in precision medicine are enabling better patient stratification, ensuring that individuals receive the most effective therapy based on their genetic profile. AI-driven diagnostic tools and next-generation sequencing (NGS) are improving early detection and risk assessment, facilitating proactive treatment planning. The integration of telehealth and digital patient monitoring is also enhancing disease management, allowing healthcare providers to track patient responses to treatment in real time. As these innovations continue to progress, the future of PID treatment is becoming increasingly personalized and effective.

What Is Driving the Growth of the Primary Immunodeficiency Disorders Market?

The growth in the primary immunodeficiency disorders market is driven by several factors, including increasing awareness of rare immune disorders, advancements in genetic diagnostics, and expanding treatment options. The rising prevalence of diagnosed PID cases, facilitated by improved screening programs, is contributing to higher demand for immunoglobulin therapy and targeted biologics. Government initiatives supporting rare disease research and orphan drug development are further accelerating market expansion, encouraging pharmaceutical companies to invest in novel therapies. The growing adoption of cell and gene therapy approaches is also reshaping the PID treatment landscape, offering potentially curative solutions for severe cases. Additionally, patient advocacy organizations and non-profit initiatives are playing a key role in driving research funding, enhancing access to diagnostic services, and improving disease awareness. As treatment innovations and global healthcare policies continue to evolve, the primary immunodeficiency disorders market is expected to see substantial growth, paving the way for more effective and accessible care solutions.

Report Scope

The report analyzes the Primary Immunodeficiency Disorders market, presented in terms of market value (US$ Thousand). The analysis covers the key segments and geographic regions outlined below.

Segments: Treatment Type (Immunoglobulin Replacement Therapy, Antibiotic Therapy, Stem Cell/Bone Marrow Transplantation, Gene Therapy, Other Treatment Types); Disease Type (Antibody Deficiency, Cellular Immunodeficiency, Innate Immune Disorders, Other Disease Types)

Geographic Regions/Countries: World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Key Insights:

  • Market Growth: Understand the significant growth trajectory of the Immunoglobulin Replacement Therapy segment, which is expected to reach US$4.4 Billion by 2030 with a CAGR of a 3.8%. The Antibiotic Therapy segment is also set to grow at 4.9% CAGR over the analysis period.
  • Regional Analysis: Gain insights into the U.S. market, estimated at $2.1 Billion in 2024, and China, forecasted to grow at an impressive 7.5% CAGR to reach $2.0 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Why You Should Buy This Report:

  • Detailed Market Analysis: Access a thorough analysis of the Global Primary Immunodeficiency Disorders Market, covering all major geographic regions and market segments.
  • Competitive Insights: Get an overview of the competitive landscape, including the market presence of major players across different geographies.
  • Future Trends and Drivers: Understand the key trends and drivers shaping the future of the Global Primary Immunodeficiency Disorders Market.
  • Actionable Insights: Benefit from actionable insights that can help you identify new revenue opportunities and make strategic business decisions.

Key Questions Answered:

  • How is the Global Primary Immunodeficiency Disorders Market expected to evolve by 2030?
  • What are the main drivers and restraints affecting the market?
  • Which market segments will grow the most over the forecast period?
  • How will market shares for different regions and segments change by 2030?
  • Who are the leading players in the market, and what are their prospects?

Report Features:

  • Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
  • In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
  • Company Profiles: Coverage of players such as Abbott Laboratories, ADMA Biologics, Alexion Pharmaceuticals, Inc., Amgen Inc., Astellas Pharma Inc. and more.
  • Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Select Competitors (Total 34 Featured):

  • Abbott Laboratories
  • ADMA Biologics
  • Alexion Pharmaceuticals, Inc.
  • Amgen Inc.
  • Astellas Pharma Inc.
  • Baxter International Inc.
  • Bio Products Laboratory Ltd.
  • Biotest AG
  • CSL Behring LLC
  • GC Biopharma
  • Grifols S.A.
  • Horizon Therapeutics plc
  • Kedrion Biopharma Inc.
  • LFB S.A.
  • Lupin Pharmaceuticals
  • Merck KGaA
  • Novartis International AG
  • Octapharma AG
  • Pharming Group N.V.
  • Takeda Pharmaceutical Company Limited

Tariff Impact Analysis: Key Insights for 2025

Global tariff negotiations across 180+ countries are reshaping supply chains, costs, and competitiveness. This report reflects the latest developments as of April 2025 and incorporates forward-looking insights into the market outlook.

The analysts continuously track trade developments worldwide, drawing insights from leading global economists and over 200 industry and policy institutions, including think tanks, trade organizations, and national economic advisory bodies. This intelligence is integrated into forecasting models to provide timely, data-driven analysis of emerging risks and opportunities.

What’s Included in This Edition:

  • Tariff-adjusted market forecasts by region and segment
  • Analysis of cost and supply chain implications by sourcing and trade exposure
  • Strategic insights into geographic shifts

Buyers receive a free July 2025 update with:

  • Finalized tariff impacts and new trade agreement effects
  • Updated projections reflecting global sourcing and cost shifts
  • Expanded country-specific coverage across the industry

Table of Contents

I. METHODOLOGYII. EXECUTIVE SUMMARY
1. MARKET OVERVIEW
  • Influencer Market Insights
  • Tariff Impact on Global Supply Chain Patterns
  • Primary Immunodeficiency Disorders - Global Key Competitors Percentage Market Share in 2024 (E)
  • Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2024 (E)
2. FOCUS ON SELECT PLAYERS
3. MARKET TRENDS & DRIVERS
  • Rising Global Incidence and Improved Diagnosis of Rare Immunodeficiencies Throws the Spotlight on Market Expansion Opportunities
  • Growth in Newborn Screening Programs and Early Detection Initiatives Drives Adoption of Life-Saving Therapies for PIDs
  • Advancements in Genetic Testing and Next-Generation Sequencing Expand Addressable Market Through Precise Diagnosis
  • Increased Availability of Immunoglobulin Replacement Therapies Drives Adoption of Long-Term Disease Management Strategies
  • Emergence of Subcutaneous Immunoglobulin (SCIG) Products Strengthens Business Case for Home-Based Treatment Modalities
  • Surge in Research on Monogenic Immune Disorders Spurs Growth in Targeted Therapeutic Development
  • Expansion of Orphan Drug Designation and Regulatory Incentives Propels Investment in Novel PID Treatments
  • Rising Use of Hematopoietic Stem Cell Transplantation (HSCT) in Severe PID Cases Enhances Treatment Landscape Complexity
  • Integration of Gene Therapy Platforms Generates Breakthrough Opportunities in Curative PID Interventions
  • Improved Physician Awareness and Educational Outreach Drives Early Intervention and Therapy Uptake
  • Increasing Support from Patient Advocacy Organizations Accelerates Public Policy Engagement and Access to Therapies
  • Development of Long-Acting Immunoglobulin Formulations Drives Convenience-Oriented Innovation in PID Care
  • Expansion of Specialty Pharmacies and Infusion Centers Strengthens Supply Chain for Advanced PID Treatments
  • Growing Application of Personalized Medicine Approaches Spurs Customized Immunomodulatory Therapies
  • Adoption of AI-Driven Clinical Decision Support Tools Enhances Diagnostic Accuracy and Treatment Optimization
  • Rising Government and Non-Profit Funding for Rare Disease Research Generates Pipeline Momentum
  • Emergence of Combination Immunotherapy Strategies Drives Clinical Trials in Complex Immune Dysregulation Disorders
  • Challenges in Reimbursement and Treatment Cost Justification Create Demand for Health-Economic Evidence
  • Globalization of Clinical Trials Expands Therapeutic Availability and Regional Market Penetration
  • Focus on Pediatric Patient-Centric Formulations and Administration Routes Enhances Compliance and Treatment Outcomes
  • Digital Health Integration in PID Patient Monitoring and Adherence Management Sustains Market Growth
  • Post-COVID Emphasis on Immune Health Drives Increased Vigilance and Screening for Underlying Immune Deficiencies
4. GLOBAL MARKET PERSPECTIVE
  • TABLE 1: World Primary Immunodeficiency Disorders Market Analysis of Annual Sales in US$ Million for Years 2015 through 2030
  • TABLE 2: World Recent Past, Current & Future Analysis for Primary Immunodeficiency Disorders by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 3: World Historic Review for Primary Immunodeficiency Disorders by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 4: World 15-Year Perspective for Primary Immunodeficiency Disorders by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets for Years 2015, 2025 & 2030
  • TABLE 5: World Recent Past, Current & Future Analysis for Immunoglobulin Replacement Therapy by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 6: World Historic Review for Immunoglobulin Replacement Therapy by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 7: World 15-Year Perspective for Immunoglobulin Replacement Therapy by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
  • TABLE 8: World Recent Past, Current & Future Analysis for Antibiotic Therapy by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 9: World Historic Review for Antibiotic Therapy by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 10: World 15-Year Perspective for Antibiotic Therapy by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
  • TABLE 11: World Recent Past, Current & Future Analysis for Stem Cell / Bone Marrow Transplantation by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 12: World Historic Review for Stem Cell / Bone Marrow Transplantation by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 13: World 15-Year Perspective for Stem Cell / Bone Marrow Transplantation by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
  • TABLE 14: World Recent Past, Current & Future Analysis for Gene Therapy by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 15: World Historic Review for Gene Therapy by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 16: World 15-Year Perspective for Gene Therapy by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
  • TABLE 17: World Recent Past, Current & Future Analysis for Other Treatment Types by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 18: World Historic Review for Other Treatment Types by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 19: World 15-Year Perspective for Other Treatment Types by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
  • TABLE 20: World Recent Past, Current & Future Analysis for Antibody Deficiency by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 21: World Historic Review for Antibody Deficiency by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 22: World 15-Year Perspective for Antibody Deficiency by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
  • TABLE 23: World Recent Past, Current & Future Analysis for Cellular Immunodeficiency by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 24: World Historic Review for Cellular Immunodeficiency by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 25: World 15-Year Perspective for Cellular Immunodeficiency by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
  • TABLE 26: World Recent Past, Current & Future Analysis for Innate Immune Disorders by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 27: World Historic Review for Innate Immune Disorders by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 28: World 15-Year Perspective for Innate Immune Disorders by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
  • TABLE 29: World Recent Past, Current & Future Analysis for Other Disease Types by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 30: World Historic Review for Other Disease Types by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 31: World 15-Year Perspective for Other Disease Types by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
III. MARKET ANALYSIS
  • UNITED STATES
  • Primary Immunodeficiency Disorders Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United States for 2025 (E)
  • CANADA
  • JAPAN
  • Primary Immunodeficiency Disorders Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Japan for 2025 (E)
  • CHINA
  • Primary Immunodeficiency Disorders Market Presence - Strong/Active/Niche/Trivial - Key Competitors in China for 2025 (E)
  • EUROPE
  • Primary Immunodeficiency Disorders Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Europe for 2025 (E)
  • FRANCE
  • Primary Immunodeficiency Disorders Market Presence - Strong/Active/Niche/Trivial - Key Competitors in France for 2025 (E)
  • GERMANY
  • Primary Immunodeficiency Disorders Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Germany for 2025 (E)
  • ITALY
  • UNITED KINGDOM
  • Primary Immunodeficiency Disorders Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United Kingdom for 2025 (E)
  • SPAIN
  • RUSSIA
  • REST OF EUROPE
  • ASIA-PACIFIC
  • Primary Immunodeficiency Disorders Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Asia-Pacific for 2025 (E)
  • AUSTRALIA
  • Primary Immunodeficiency Disorders Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Australia for 2025 (E)
  • INDIA
  • Primary Immunodeficiency Disorders Market Presence - Strong/Active/Niche/Trivial - Key Competitors in India for 2025 (E)
  • SOUTH KOREA
  • REST OF ASIA-PACIFIC
  • LATIN AMERICA
  • Primary Immunodeficiency Disorders Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Latin America for 2025 (E)
  • ARGENTINA
  • BRAZIL
  • MEXICO
  • REST OF LATIN AMERICA
  • MIDDLE EAST
  • Primary Immunodeficiency Disorders Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Middle East for 2025 (E)
  • IRAN
  • ISRAEL
  • SAUDI ARABIA
  • UNITED ARAB EMIRATES
  • REST OF MIDDLE EAST
  • AFRICA
  • Primary Immunodeficiency Disorders Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Africa for 2025 (E)
IV. COMPETITION

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Abbott Laboratories
  • ADMA Biologics
  • Alexion Pharmaceuticals, Inc.
  • Amgen Inc.
  • Astellas Pharma Inc.
  • Baxter International Inc.
  • Bio Products Laboratory Ltd.
  • Biotest AG
  • CSL Behring LLC
  • GC Biopharma
  • Grifols S.A.
  • Horizon Therapeutics plc
  • Kedrion Biopharma Inc.
  • LFB S.A.
  • Lupin Pharmaceuticals
  • Merck KGaA
  • Novartis International AG
  • Octapharma AG
  • Pharming Group N.V.
  • Takeda Pharmaceutical Company Limited

Table Information