原発性免疫不全症治療薬の市場規模、シェア、成長分析、適応症別、薬剤クラス別、投与経路別、年齢層別、流通チャネル別、地域別 - 産業予測 2025年～2032年

原発性免疫不全症治療薬の世界市場規模は2023年に28億米ドルと評価され、2024年の29億6,000万米ドルから2032年には46億1,000万米ドルに成長し、予測期間（2025-2032年）のCAGRは5.7％で成長する見通しです。

世界の原発性免疫不全症（PI）治療薬市場は、認知度の向上、診断法の改善、オーダーメイド治療へのアクセス強化などを背景に、緩やかな拡大を見せています。免疫反応に影響を及ぼす遺伝的欠陥に起因する原発性免疫不全症として分類される長期的な希少疾患は約450種類あり、免疫グロブリンの補充、標的生物製剤、幹細胞移植などの長期的な治療に対するニーズが高まっています。遺伝子技術やスクリーニング法の進歩により早期診断が容易になり、この需要がさらに高まっています。北米と欧州の規制機関は希少疾病用医薬品の開発を優先しており、その結果、新薬への投資が高まっています。さらに、PI疾患が国家希少疾患イニシアチブに指定されたことで、資金が集まり、治療の障壁が軽減される一方、患者アドボカシーと官民パートナーシップは、特に発展途上地域におけるアクセスの改善に不可欠です。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次と一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析

原発性免疫不全症治療薬市場規模：適応症別& CAGR（2025-2032）

• 市場概要
• 分類不能型免疫不全症（CVID）
• X連鎖無ガンマグロブリン血症（XLA）
• 重症複合免疫不全症（SCID）
• ウィスコット・アルドリッチ症候群（WAS）
• 高IgM症候群（HIGM）

原発性免疫不全症治療薬市場規模：薬剤クラス別& CAGR（2025-2032）

• 市場概要
• 免疫グロブリン補充療法
• 免疫調節剤
• 幹細胞療法
• 遺伝子治療
• 抗生物質

原発性免疫不全症治療薬市場規模：投与経路別& CAGR（2025-2032）

• 市場概要
• 静脈内（IV）
• 皮下（SC）
• 筋肉内（IM）

原発性免疫不全症治療薬市場規模：年齢層別& CAGR（2025-2032）

• 市場概要
• 小児
• 成人

原発性免疫不全症治療薬市場規模：流通チャネル別& CAGR（2025-2032）

• 市場概要
• 病院
• 専門薬局
• オンライン薬局

原発性免疫不全症治療薬市場規模& CAGR（2025-2032）

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情報

• 上位5社の比較
• 主要企業の市場ポジショニング（2024年）
• 主な市場企業が採用した戦略
• 最近の市場動向
• 企業の市場シェア分析（2024年）
• 主要企業の企業プロファイル
  • 企業の詳細
  • 製品ポートフォリオ分析
  • 企業のセグメント別シェア分析
  • 収益の前年比比較（2022-2024年）

主要企業プロファイル

• 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 S.p.A.（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 S.A.（France）
• Bristol Myers Squibb（USA）

結論と提言

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