정맥내 면역글로불린 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the intravenous immunoglobulin market size is expected to grow from USD 16.31 billion in 2025 to USD 17.51 billion in 2026 and is forecast to reach USD 24.98 billion by 2031 at 7.36% CAGR over 2026-2031.

This report Segments the Industry Into by Type (IgG, Iga, Igm, and Others), by Application (Hypogammaglobulinemia, Chronic Inflammatory Demyelinating Polyneuropathy, Primary Immunodeficiency, and More), End User (Hospitals, Specialty Clinics & Neurology Centers, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Intravenous Immunoglobulin Market Trends and Insights

Rise in Geriatric Population

Age-related immune decline increases susceptibility to infections and autoimmune disorders, which sustains long-term demand within the intravenous immunoglobulin market. Asia-Pacific feels the effect most, as rapid population ageing aligns with broader diagnostic reach and insurance coverage. The demographic trend also amplifies secondary immunodeficiencies linked with cancer therapies, further lifting usage. Japan's medical technology spending trajectory underscores how ageing catalyzes specialty-therapy consumption. Together these factors form a predictable volume pipeline for fractionators over the next decade.

Increased Adoption of Immunoglobulin Therapy

Regulatory approvals such as Takeda's GAMMAGARD LIQUID for chronic inflammatory demyelinating polyneuropathy have validated broader immunomodulatory utility and accelerated clinician acceptance. Emerging data in autoimmune encephalitis and sepsis reinforce confidence, encouraging off-label prescribing as reimbursement loosens in several high-income markets. The evidence base unlocks new patient pools and extends dosing durations, thereby raising overall consumption inside the intravenous immunoglobulin market.

Stringent Regulatory Approval & Donor-Screening Norms

Tight donor eligibility rules and exhaustive validation steps lengthen lead times and add overhead, especially in the European Union and United States, where regulatory scrutiny remains intense. Batch-release requirements and viral safety benchmarks impose capital and documentation burdens that may decelerate new-entrant progress inside the intravenous immunoglobulin market.

Other drivers and restraints analyzed in the detailed report include:

1. Rising Prevalence of Immunodeficiency & Bleeding Disorders
2. Advancements in Plasma-Fractionation Technology
3. High Therapy & Cold-Chain Costs

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

IgG commanded 74.12% of the intravenous immunoglobulin market in 2025, and the segment is growing at an 8.17% CAGR to 2031, which underlines how indispensable IgG remains for both replacement and immunomodulation. Grifols' purification process consistently delivers >=98% IgG purity, strengthening brand differentiation. High-strength formulations now shorten infusion time, easing hospital scheduling pressures and improving patient comfort.

Manufacturers have prioritized continuous chromatography to boost yield and lower cost, which further bolsters margins across the intravenous immunoglobulin market. Regulatory clearances for new brands such as Yimmugo and ALYGLO increase competitive dynamics yet simultaneously assure broader supply security. IgA and IgM retain niche status focused on mucosal and complement-mediated disorders.

Complete Report Scope:

• By Immunoglobulin Class
  • IgG
  • IgA
  • IgM
  • Others
• By Application
  • Hypogammaglobulinemia
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  • Primary Immunodeficiency Diseases (PID)
  • Myasthenia Gravis
  • Multifocal Motor Neuropathy
  • Other Applications
• By End User
  • Hospitals
  • Specialty Clinics & Neurology Centers
  • Home-Care Settings
• Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America kept 41.92% of the intravenous immunoglobulin market in 2025 due to long-standing insurer coverage and extensive plasma collection infrastructure. Medicare policies outline usage criteria that commercial payers largely mirror, facilitating predictable demand and rapid adoption of new formulations. Specialized infusion networks and maturing home-based services advance patient convenience and operational efficiency.

Asia-Pacific is growing fastest at an 8.03% CAGR through 2031. China's National Reimbursement Drug List negotiations produced average IVIG price reductions of 63% in 2024, opening therapy to previously unreachable cohorts. Japan's revised health technology assessments uphold funding for innovative biologics, while India's production-linked incentives stimulate local fractionation capacity, all of which enlarge the intravenous immunoglobulin market base.

Europe shows stable progression, yet supply dependence on United States plasma highlights vulnerability. ESG-driven self-sufficiency policies and centralized procurement place pressure on manufacturers to diversify donor pools and enhance transparency. Gradual shifts toward outpatient infusions aim to reduce hospitalization costs and maintain quality benchmarks across the intravenous immunoglobulin market.

1. Takeda Pharmaceutical Co.
2. CSL Behring
3. Grifols
4. Octapharma
5. Baxter
6. Kedrion Biopharma
7. Biotest
8. Bio Products Laboratory
9. LFB Group
10. China Biologic Products Holdings
11. Shanghai RAAS Blood Products
12. Hualan Biological Engineering
13. ADMA Biologics
14. Emergent Bio Solutions
15. Kamada Ltd
16. GC Biopharma
17. Intas Pharmaceuticals (Lonza Tie-up)
18. BioTest Pharma (US)
19. South African National Blood Service
20. Sanquin Plasma Products

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rise in Geriatric Population
  • 4.2.2 Increased Adoption of Immunoglobulin Therapy
  • 4.2.3 Rising Prevalence of Immunodeficiency & Bleeding Disorders
  • 4.2.4 Advancements in Plasma-fractionation Technology
  • 4.2.5 Off-label Neuro-logical Use & Relaxed Reimbursement in Asia
  • 4.2.6 Regional Plasma-collection Hubs Driving Supply Security
• 4.3 Market Restraints
  • 4.3.1 Stringent Regulatory Approval & Donor-screening Norms
  • 4.3.2 High Therapy & Cold-chain Costs
  • 4.3.3 Shift toward Subcutaneous Ig (SCIG) Reducing IVIG Volumes
  • 4.3.4 ESG Scrutiny of Plasma Sourcing Raising Compliance Costs
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value - USD)

• 5.1 By Immunoglobulin Class
  • 5.1.1 IgG
  • 5.1.2 IgA
  • 5.1.3 IgM
  • 5.1.4 Others
• 5.2 By Application
  • 5.2.1 Hypogammaglobulinemia
  • 5.2.2 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  • 5.2.3 Primary Immunodeficiency Diseases (PID)
  • 5.2.4 Myasthenia Gravis
  • 5.2.5 Multifocal Motor Neuropathy
  • 5.2.6 Other Applications
• 5.3 By End User
  • 5.3.1 Hospitals
  • 5.3.2 Specialty Clinics & Neurology Centers
  • 5.3.3 Home-Care Settings
• 5.4 Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles
  • 6.3.1 Takeda Pharmaceutical Co.
  • 6.3.2 CSL Behring
  • 6.3.3 Grifols SA
  • 6.3.4 Octapharma AG
  • 6.3.5 Baxter International Inc.
  • 6.3.6 Kedrion SpA
  • 6.3.7 Biotest AG
  • 6.3.8 Bio Products Laboratory Ltd
  • 6.3.9 LFB Group
  • 6.3.10 China Biologic Products Holdings
  • 6.3.11 Shanghai RAAS Blood Products
  • 6.3.12 Hualan Biological Engineering
  • 6.3.13 ADMA Biologics Inc.
  • 6.3.14 Emergent BioSolutions Inc.
  • 6.3.15 Kamada Ltd
  • 6.3.16 GC Pharma
  • 6.3.17 Intas Pharmaceuticals (Lonza Tie-up)
  • 6.3.18 BioTest Pharma (US)
  • 6.3.19 South African National Blood Service
  • 6.3.20 Sanquin Plasma Products

7 Market Opportunities & Future Outlook