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Global Subcutaneous Immunoglobulin Market Size study, by Product Type (Intravenous Immunoglobulin, Subcutaneous Immunoglobulin, Hyperimmune Immunoglobulin), by Application (Primary Immunodeficiency, Secondary Immunodeficiency, Inflammatory Diseases, Neuro

Publisher Bizwit Research & Consulting
Published May 25, 2025
Length 285 Pages
SKU # BIZW20048214

Description

Global Subcutaneous Immunoglobulin Market is valued approximately at USD 11.4 billion in 2023 and is anticipated to grow with a healthy growth rate of more than 4.76% over the forecast period 2024–2032. As immune-related conditions gain prominence across global healthcare systems, the subcutaneous immunoglobulin (SCIG) market is emerging as a pivotal player in immunotherapy, especially for patients requiring lifelong antibody replacement. SCIG, known for its ability to provide sustained immunoprotection with fewer systemic side effects and greater patient autonomy, has witnessed a surge in demand due to its convenience in self-administration and reduced dependency on hospital-based infusion setups. In contrast to intravenous options, SCIG has democratized immunoglobulin therapy, especially in the context of chronic immunodeficiency diseases, improving patient quality of life and healthcare cost-efficiency.

The global market has been significantly catalyzed by rising awareness regarding primary and secondary immunodeficiency disorders, as well as a marked uptick in autoimmune and inflammatory diseases. Innovations in drug formulation, infusion devices, and prefilled syringes have enhanced product efficacy and safety, empowering both patients and providers. Meanwhile, pharmaceutical leaders are reinforcing their pipelines with SCIG-focused biologics to address therapeutic gaps in neurological disorders like chronic inflammatory demyelinating polyneuropathy (CIDP). Additionally, the shift toward home-based care settings, spurred by pandemic-era healthcare reforms, has underscored SCIG’s value proposition as a patient-centric solution, especially in underserved and rural communities.

Despite these promising trajectories, the market contends with challenges like supply limitations stemming from complex plasma fractionation processes and donor-dependent raw material sourcing. Moreover, discrepancies in healthcare reimbursement frameworks and regulatory hurdles across developing economies have somewhat restrained broader uptake. Still, these challenges are paving the way for technological innovations, strategic mergers, and public-private partnerships focused on optimizing plasma collection, increasing awareness, and enhancing cross-border accessibility. The market is increasingly witnessing interest in next-generation SCIG products with extended half-life and minimal site reactions to address current unmet clinical needs.

Regionally, North America commands a dominant share in the global subcutaneous immunoglobulin market due to advanced diagnostic infrastructure, favorable reimbursement policies, and rising incidence of immunodeficiencies and autoimmune diseases. The United States, in particular, leads in innovation, supported by a mature biopharmaceutical ecosystem and strong patient advocacy groups. Europe trails closely behind, propelled by progressive healthcare models and increasing product approvals in Germany, France, and the UK. Meanwhile, the Asia Pacific region is expected to experience the fastest growth during the forecast period, underpinned by healthcare modernization, growing diagnosis rates, and increased healthcare expenditure in populous nations like India, China, and Japan.

Latin America and the Middle East & Africa are steadily evolving as promising frontier markets due to expanded immunization initiatives, improving plasma collection infrastructure, and the localization of manufacturing by key biopharma players. Brazil, Mexico, Saudi Arabia, and South Africa are investing in capacity-building measures such as specialized immunology centers and mobile infusion clinics. With a strong push toward digital health integration and regulatory harmonization, these regions are setting the stage for more inclusive and scalable SCIG therapy deployment.

Major market player included in this report are:
• Grifols, S.A.
• CSL Behring
• Kedrion S.p.A.
• Biotest AG
• Octapharma AG
• Takeda Pharmaceutical Company Limited
• ADMA Biologics, Inc.
• LFB S.A.
• BPL (Bio Products Laboratory Ltd)
• Baxter International Inc.
• Shire (now part of Takeda)
• Pfizer Inc.
• Green Cross Corporation
• GC Pharma
• Bayer AG

The detailed segments and sub-segment of the market are explained below:

By Product Type
• Intravenous Immunoglobulin
• Subcutaneous Immunoglobulin
• Hyperimmune Immunoglobulin

By Application
• Primary Immunodeficiency
• Secondary Immunodeficiency
• Inflammatory Diseases
• Neurological Disorders

By Administration Route
• Subcutaneous
• Intravenous

By End Use
• Hospitals
• Homecare
• Specialty Clinics

By Region:

North America
• U.S.
• Canada

Europe
• UK
• Germany
• France
• Spain
• Italy
• Rest of Europe

Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• Rest of Asia Pacific

Latin America
• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa
• Saudi Arabia
• South Africa
• Rest of Middle East & Africa

Years considered for the study are as follows:
• Historical year – 2022
• Base year – 2023
• Forecast period – 2024 to 2032

Key Takeaways:
• Market Estimates & Forecast for 10 years from 2022 to 2032.
• Annualized revenues and regional level analysis for each market segment.
• Detailed analysis of geographical landscape with country-level analysis of major regions.
• Competitive landscape with information on major players in the market.
• Analysis of key business strategies and recommendations on future market approach.
• Analysis of competitive structure of the market.
• Demand side and supply side analysis of the market.

Please note:The single user license is non-downloadable and non-printable. Global Site license allows these actions.

Table of Contents

285 Pages
Chapter 1. Global Subcutaneous Immunoglobulin Market Executive Summary
1.1. Global Subcutaneous Immunoglobulin Market Size & Forecast (2022–2032)
1.2. Regional Summary
1.3. Segmental Summary
1.3.1. By Product Type
1.3.2. By Application
1.3.3. By Administration Route
1.3.4. By End Use
1.4. Key Trends
1.5. Reimbursement Impact
1.6. Analyst Recommendation & Conclusion
Chapter 2. Global Subcutaneous Immunoglobulin Market Definition and Research Assumptions
2.1. Research Objective
2.2. Market Definition
2.3. Research Assumptions
2.3.1. Inclusion & Exclusion
2.3.2. Limitations
2.3.3. Supply Side Analysis
2.3.3.1. Plasma Availability
2.3.3.2. Fractionation Infrastructure
2.3.3.3. Regulatory Environment
2.3.3.4. Market Competition
2.3.3.5. Cost Structures
2.3.4. Demand Side Analysis
2.3.4.1. Healthcare Access
2.3.4.2. Patient Awareness
2.3.4.3. Technological Advances
2.3.4.4. Reimbursement Frameworks
2.4. Estimation Methodology
2.5. Years Considered for the Study
• Historical year – 2022
• Base year – 2023
• Forecast period – 2024 to 2032
2.6. Currency Conversion Rates
Chapter 3. Global Subcutaneous Immunoglobulin Market Dynamics
3.1. Market Drivers
3.1.1. Rise in Primary and Secondary Immunodeficiencies
3.1.2. Shift Toward Home-Based Self-Administration
3.1.3. Growth in Neurological and Inflammatory Indications
3.2. Market Challenges
3.2.1. Plasma Supply Constraints
3.2.2. High Therapy Costs and Reimbursement Variability
3.2.3. Regulatory Complexities Across Regions
3.3. Market Opportunities
3.3.1. Development of Next-Generation SCIG Formulations
3.3.2. Expansion in Emerging Markets
3.3.3. Integration of Digital Monitoring and Delivery Devices
Chapter 4. Global Subcutaneous Immunoglobulin Market Industry Analysis
4.1. Porter’s Five Forces Model
4.1.1. Bargaining Power of Suppliers
4.1.2. Bargaining Power of Buyers
4.1.3. Threat of New Entrants
4.1.4. Threat of Substitutes
4.1.5. Competitive Rivalry
4.1.6. Future Outlook on Porter’s Forces
4.1.7. Impact Assessment
4.2. PESTEL Analysis
4.2.1. Political Factors
4.2.2. Economic Factors
4.2.3. Social Factors
4.2.4. Technological Factors
4.2.5. Environmental Factors
4.2.6. Legal & Regulatory Factors
4.3. Top Investment Opportunities
4.4. Top Winning Strategies
4.5. Disruptive Trends
4.6. Industry Expert Perspectives
4.7. Analyst Recommendation & Conclusion
Chapter 5. Global Subcutaneous Immunoglobulin Market Size & Forecasts by Product Type 2022–2032
5.1. Segment Dashboard
5.2. Product Type Revenue Trend Analysis, 2022 & 2032 (USD Billion)
5.2.1. Intravenous Immunoglobulin
5.2.2. Subcutaneous Immunoglobulin
5.2.3. Hyperimmune Immunoglobulin
Chapter 6. Global Subcutaneous Immunoglobulin Market Size & Forecasts by Application 2022–2032
6.1. Segment Dashboard
6.2. Application Revenue Trend Analysis, 2022 & 2032 (USD Billion)
6.2.1. Primary Immunodeficiency
6.2.2. Secondary Immunodeficiency
6.2.3. Inflammatory Diseases
6.2.4. Neurological Disorders
Chapter 7. Global Subcutaneous Immunoglobulin Market Size & Forecasts by Administration Route 2022–2032
7.1. Segment Dashboard
7.2. Route of Administration Revenue Trend Analysis, 2022 & 2032 (USD Billion)
7.2.1. Subcutaneous
7.2.2. Intravenous
Chapter 8. Global Subcutaneous Immunoglobulin Market Size & Forecasts by End Use 2022–2032
8.1. Segment Dashboard
8.2. End Use Revenue Trend Analysis, 2022 & 2032 (USD Billion)
8.2.1. Hospitals
8.2.2. Homecare
8.2.3. Specialty Clinics
Chapter 9. Global Subcutaneous Immunoglobulin Market Size & Forecasts by Region 2022–2032
9.1. North America Market
9.1.1. U.S. Market
9.1.2. Canada Market
9.2. Europe Market
9.2.1. UK Market
9.2.2. Germany Market
9.2.3. France Market
9.2.4. Spain Market
9.2.5. Italy Market
9.2.6. Rest of Europe
9.3. Asia Pacific Market
9.3.1. China Market
9.3.2. India Market
9.3.3. Japan Market
9.3.4. Australia Market
9.3.5. South Korea Market
9.3.6. Rest of Asia Pacific
9.4. Latin America Market
9.4.1. Brazil Market
9.4.2. Mexico Market
9.4.3. Rest of Latin America
9.5. Middle East & Africa Market
9.5.1. Saudi Arabia Market
9.5.2. South Africa Market
9.5.3. Rest of Middle East & Africa
Chapter 10. Competitive Intelligence
10.1. Key Company SWOT Analysis
10.1.1. Grifols, S.A.
10.1.2. CSL Behring
10.1.3. Kedrion S.p.A.
10.2. Top Market Strategies
10.3. Company Profiles
10.3.1. Grifols, S.A.
10.3.1.1. Key Information
10.3.1.2. Overview
10.3.1.3. Financial (Subject to Data Availability)
10.3.1.4. Product Summary
10.3.1.5. Market Strategies
10.3.2. CSL Behring
10.3.3. Kedrion S.p.A.
10.3.4. Biotest AG
10.3.5. Octapharma AG
10.3.6. Takeda Pharmaceutical Company Limited
10.3.7. ADMA Biologics, Inc.
10.3.8. LFB S.A.
10.3.9. BPL (Bio Products Laboratory Ltd)
10.3.10. Baxter International Inc.
10.3.11. Shire (Takeda)
10.3.12. Pfizer Inc.
10.3.13. Green Cross Corporation
10.3.14. GC Pharma
10.3.15. Bayer AG
Chapter 11. Research Process
11.1. Research Process
11.1.1. Data Mining
11.1.2. Analysis
11.1.3. Market Estimation
11.1.4. Validation
11.1.5. Publishing
11.2. Research Attributes
List of Tables
TABLE 1. Global Subcutaneous Immunoglobulin market, report scope
TABLE 2. Global market estimates & forecasts by Product Type 2022–2032 (USD Billion)
TABLE 3. Global market estimates & forecasts by Application 2022–2032 (USD Billion)
TABLE 4. Global market estimates & forecasts by Administration Route 2022–2032 (USD Billion)
TABLE 5. Global market estimates & forecasts by End Use 2022–2032 (USD Billion)
TABLE 6. Global market estimates & forecasts by Region 2022–2032 (USD Billion)
TABLE 7. U.S. market estimates & forecasts, 2022–2032 (USD Billion)
TABLE 8. Europe market estimates & forecasts, 2022–2032 (USD Billion)
TABLE 9. Asia Pacific market estimates & forecasts, 2022–2032 (USD Billion)
TABLE 10. Latin America market estimates & forecasts, 2022–2032 (USD Billion)
TABLE 11. Middle East & Africa market estimates & forecasts, 2022–2032 (USD Billion)
TABLE 12. Top 15 companies’ market share analysis, 2023 (%)
TABLE 13. Pricing analysis by region
TABLE 14. Plasma supply vs. demand trends
TABLE 15. Homecare adoption rates
TABLE 16. R&D expenditure trends
TABLE 17. Regulatory approval timelines
TABLE 18. Device innovation overview
TABLE 19. Distribution channel mix
TABLE 20. Key partnership and licensing agreements
List of Figures
FIGURE 1. Global market, research methodology
FIGURE 2. Global market, estimation techniques
FIGURE 3. Global market size estimates & forecast methods
FIGURE 4. Global market, key trends 2023
FIGURE 5. Global market, growth prospects 2022–2032
FIGURE 6. Global market, Porter’s Five Forces model
FIGURE 7. Global market, PESTEL analysis
FIGURE 8. Global market, value chain analysis
FIGURE 9. Global market by segment, 2022 & 2032 (USD Billion)
FIGURE 10. Global market by region, 2022 & 2032 (USD Billion)
FIGURE 11. North America market 2022 & 2032 (USD Billion)
FIGURE 12. Europe market 2022 & 2032 (USD Billion)
FIGURE 13. Asia Pacific market 2022 & 2032 (USD Billion)
FIGURE 14. Latin America market 2022 & 2032 (USD Billion)
FIGURE 15. Middle East & Africa market 2022 & 2032 (USD Billion)
FIGURE 16. Company market share analysis (2023)
FIGURE 17. SCIG vs. IVIG adoption trends
FIGURE 18. HOME infusion vs. hospital infusion cost comparison
FIGURE 19. Plasma donor trends by region
FIGURE 20. Next-generation SCIG pipeline overview
This Table of Contents may be updated in the final report.

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