原发性免疫力缺乏药物市场规模、份额、成长分析（按适应症、药物类别、给药途径、年龄层、分销管道和地区）—2025 年至 2032 年产业预测

2023 年全球原发性免疫力缺乏药物市场规模为 28 亿美元，预计将从 2024 年的 29.6 亿美元成长到 2032 年的 46.1 亿美元，预测期内（2025-2032 年）的复合年增长率为 5.7%。

全球原发性免疫力缺乏(PI) 药物市场正呈现温和扩张态势，这得益于人们认识度的提高、诊断技术的改进以及个性化治疗机会的增加。约有 450 种长期罕见疾病被归类为原发性免疫力缺乏缺陷，这些疾病是由影响免疫反应的基因缺陷引起的，因此对免疫球蛋白替代疗法、靶向生技药品和干细胞移植等长期治疗的需求日益增长。基因技术和筛检方法的进步促进了早期诊断，进一步增加了这种需求。北美和欧洲的监管机构已将罕见药物的开发列为优先事项，增加了对新药的投资。此外，根据国家罕见疾病倡议指定 PI 疾病将获得资金并减少治疗障碍，而病患权益倡导和官民合作关係对于改善药物可近性至关重要，尤其是在发展中地区。

目录

介绍

• 调查目的
• 研究范围
• 定义

调查方法

• 资讯采购
• 二次资料和一次资料方法
• 市场规模预测
• 市场假设与限制

执行摘要

• 全球市场展望
• 供需趋势分析
• 细分机会分析

市场动态与展望

• 市场概览
• 市场规模
• 市场动态
  • 驱动因素和机会
  • 限制与挑战
• 波特的分析

关键市场考察

• 关键成功因素
• 竞争程度
• 主要投资机会
• 市场生态系统
• 市场吸引力指数（2024年）
• PESTEL分析
• 总体经济指标
• 价值链分析
• 定价分析

原发性免疫力缺乏缺陷症药物市场规模（按适应症和复合年增长率） (2025-2032)

• 市场概览
• 无法分类的免疫力缺乏（CVID）
• X连锁无丙种球蛋白血症（XLA）
• 严重复合型免疫力缺乏症（SCID）
• 威斯科特-奥尔德里奇症候群（WAS）
• 高IgM症候群（HIGM）

原发性免疫力缺乏缺陷症药物市场规模（依药物类别和复合年增长率） (2025-2032)

• 市场概览
• 免疫球蛋白替代疗法
• 免疫调节剂
• 干细胞疗法
• 基因治疗
• 抗生素

原发性免疫力缺乏药物市场规模（依给药途径及复合年增长率）（2025-2032）

• 市场概览
• 静脉注射（IV）
• 皮下（SC）
• 肌肉注射（IM）

原发性免疫力缺乏缺陷症药物市场规模（按年龄层划分）及复合年增长率（2025-2032 年）

• 市场概览
• 孩子们
• 成人

原发性免疫力缺乏药物市场规模（依分销管道划分）及复合年增长率（2025-2032）

• 市场概览
• 医院
• 专业药房
• 网路药局

原发性免疫力缺乏缺陷症治疗市场规模及复合年增长率（2025-2032）

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 义大利
  • 其他欧洲国家
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 其他亚太地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲
• 中东和非洲
  • 海湾合作委员会国家
  • 南非
  • 其他中东和非洲地区

竞争资讯

• 前五大公司对比
• 主要企业市场定位（2024年）
• 主要市场参与者所采取的策略
• 近期市场趋势
• 公司市场占有率分析（2024年）
• 主要企业简介
  • 公司详情
  • 产品系列分析
  • 公司分部份额分析
  • 收益与前一年同期比较对比（2022-2024 年）

主要企业简介

• CSL Behring（USA）
• Grifols（Spain）
• Octapharma（Switzerland）
• Takeda Pharmaceutical Company Limited（Japan）
• Biotest AG（Germany）
• ADMA Biologics（USA）
• Bio Products Laboratory（BPL）（USA）
• LFB SA（France）
• Kedrion Biopharma SpA（Italy）
• Pfizer Inc.（USA）
• Orchard Therapeutics（UK）
• Rocket Pharmaceuticals（USA）
• Bluebird Bio（USA）
• China Biologic Products Holdings（China）
• GC Pharma（South Korea）
• Baxter International Inc.（USA）
• X4 Pharmaceuticals（USA）
• Novartis AG（Switzerland）
• Sanofi SA（France）
• Bristol Myers Squibb（USA）

结论和建议

Global Primary Immunodeficiency Therapeutics Market size was valued at USD 2.8 billion in 2023 and is poised to grow from USD 2.96 billion in 2024 to USD 4.61 billion by 2032, growing at a CAGR of 5.7% during the forecast period (2025-2032).

The global primary immunodeficiency (PI) therapeutics market is witnessing a gradual expansion, driven by increased awareness, improved diagnostics, and enhanced access to tailored treatments. With around 450 rare long-term disorders classified as primary immunodeficiencies resulting from genetic defects affecting immune responses, there is a rising need for long-term therapies like immunoglobulin replacement, targeted biologics, and stem cell transplants. Advances in genetic technologies and screening methods have facilitated earlier diagnoses, further fueling this demand. Regulatory bodies in North America and Europe are prioritizing orphan drug development, resulting in heightened investment in new medications. Additionally, the designation of PI diseases as national rare disease initiatives is attracting funding and reducing treatment barriers, while patient advocacy and public-private partnerships are essential in improving access, especially in developing regions.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Primary Immunodeficiency Therapeutics market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Primary Immunodeficiency Therapeutics Market Segments Analysis

Global Primary Immunodeficiency Therapeutics Market is segmented by Indication, Drug Class, Route of Administration, Age Group, Distribution Channel and region. Based on Indication, the market is segmented into Common Variable Immunodeficiency (CVID), X-linked Agammaglobulinemia (XLA), Severe Combined Immunodeficiency Disorders (SCID), Wiskott-Aldrich Syndrome (WAS) and Hyper-IgM Syndrome (HIGM). Based on Drug Class, the market is segmented into Immunoglobulin Replacement Therapy, Immune-modulating Agents, Stem Cell Therapy, Gene Therapy and Antibiotics. Based on Route of Administration, the market is segmented into Intravenous (IV), Subcutaneous (SC) and Intramuscular (IM). Based on Age Group, the market is segmented into Pediatric and Adult. Based on Distribution Channel, the market is segmented into Hospitals, Specialty Pharmacies and Online Pharmacies. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Primary Immunodeficiency Therapeutics Market

Recent advancements in diagnostic technologies, particularly next-generation sequencing (NGS) and genetic screening, have substantially reduced the time needed to diagnose primary immunodeficiency (PI) diseases. Early diagnosis enables prompt initiation of treatment, leading to improved therapeutic outcomes by minimizing infection burdens. This heightened diagnostic accuracy enhances the management of PI, fosters greater patient compliance, and ultimately boosts quality of life. As a result, there is a growing demand for PI therapeutics in the market. The positive correlation between early diagnosis and effective treatment underscores the critical role of advanced diagnostics in driving growth within the global primary immunodeficiency therapeutics market.

Restraints in the Global Primary Immunodeficiency Therapeutics Market

A significant challenge facing the global primary immunodeficiency therapeutics market is the high cost associated with immunoglobulin therapies, gene treatments, and stem cell therapies. This financial burden is particularly acute in low-income countries, where patients struggle to afford crucial, potentially life-saving treatments. Additionally, rising expenses related to plasma collection have further inflated the costs of immunoglobulin therapies, a trend observed even in developed nations. These financial obstacles contribute to increasing reimbursement difficulties, ultimately restricting patient access to these therapies and making it challenging for healthcare systems to establish and sustain long-term treatment regimens effectively.

Market Trends of the Global Primary Immunodeficiency Therapeutics Market

The Global Primary Immunodeficiency (PI) Therapeutics market is witnessing a transformative trend driven by the integration of artificial intelligence (AI) into individualized immunoglobulin dosing. This cutting-edge approach tailors treatment based on specific patient parameters, such as weight, infection frequency, and metabolic rate, thereby optimizing therapeutic regimens and mitigating side effects. By enhancing treatment adherence and maximizing resource efficiency, AI is poised to redefine patient care in the PI sector. Ongoing clinical trials aim to validate these innovative dosing algorithms across diverse populations, signaling a pivotal shift towards more personalized medicine that could significantly improve patient outcomes, driving market growth in this segment.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis

Global Primary Immunodeficiency Therapeutics Market Size by Indication & CAGR (2025-2032)

• Market Overview
• Common Variable Immunodeficiency (CVID)
• X-linked Agammaglobulinemia (XLA)
• Severe Combined Immunodeficiency Disorders (SCID)
• Wiskott-Aldrich Syndrome (WAS)
• Hyper-IgM Syndrome (HIGM)

Global Primary Immunodeficiency Therapeutics Market Size by Drug Class & CAGR (2025-2032)

• Market Overview
• Immunoglobulin Replacement Therapy
• Immune-modulating Agents
• Stem Cell Therapy
• Gene Therapy
• Antibiotics

Global Primary Immunodeficiency Therapeutics Market Size by Route of Administration & CAGR (2025-2032)

• Market Overview
• Intravenous (IV)
• Subcutaneous (SC)
• Intramuscular (IM)

Global Primary Immunodeficiency Therapeutics Market Size by Age Group & CAGR (2025-2032)

• Market Overview
• Pediatric
• Adult

Global Primary Immunodeficiency Therapeutics Market Size by Distribution Channel & CAGR (2025-2032)

• Market Overview
• Hospitals
• Specialty Pharmacies
• Online Pharmacies

Global Primary Immunodeficiency Therapeutics Market Size & CAGR (2025-2032)

• North America (ndication, Drug Class, Route of Administration, Age Group, Distribution Channel)
  • US
  • Canada
• Europe (ndication, Drug Class, Route of Administration, Age Group, Distribution Channel)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (ndication, Drug Class, Route of Administration, Age Group, Distribution Channel)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (ndication, Drug Class, Route of Administration, Age Group, Distribution Channel)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (ndication, Drug Class, Route of Administration, Age Group, Distribution Channel)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• CSL Behring (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Grifols (Spain)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Octapharma (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Takeda Pharmaceutical Company Limited (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biotest AG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ADMA Biologics (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bio Products Laboratory (BPL) (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• LFB SA (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Kedrion Biopharma S.p.A. (Italy)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pfizer Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Orchard Therapeutics (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Rocket Pharmaceuticals (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bluebird Bio (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• China Biologic Products Holdings (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• GC Pharma (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Baxter International Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• X4 Pharmaceuticals (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Novartis AG (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sanofi S.A. (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bristol Myers Squibb (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations