静注用凍結乾燥ヒト免疫グロブリン（pH4）の世界市場（2024年～2031年）

世界の静注用凍結乾燥ヒト免疫グロブリン（pH4）の市場規模は、2023年に557億米ドルに達し、2031年には1,409億米ドルに達すると予測され、予測期間2024年～2031年にはCAGR12.3％で成長する見込みです。

静注用凍結乾燥ヒト免疫グロブリン（pH4）は、即時および長期の免疫サポートを提供する精製血液由来製品です。感染症対策、免疫不全の管理、自己免疫疾患や炎症性疾患の治療に重要な抗体成分である免疫グロブリンGの濃縮溶液が含まれています。酸性のpHに調整され、安定性を高め、凝集を減少させることで、病院、診療所、在宅医療における免疫療法の要となっています。

市場力学：

促進要因と抑制要因

免疫不全と自己免疫疾患の有病率の上昇

免疫不全および自己免疫疾患の有病率の増加が、凍結乾燥ヒト免疫グロブリン市場を押し上げています。前述の疾患は、遺伝的または環境的に誘発されるものでもあります。医療技術の進歩や啓蒙活動により、より早い段階で病気を診断できるようになり、免疫グロブリン療法の対象となる患者層が拡大しています。世界の高齢化社会では、高齢期に免疫不全を示す傾向があり、慢性疾患を管理するためにより多くの治療が必要となります。さらに、効果的な免疫調節療法には技術革新と生産能力の向上が必要です。研究開発投資は、製剤、送達経路、適応症を改善するためにも不可欠であり、このため凍結乾燥ヒト免疫グロブリンは、この分野における最も重要な成長手段の一つとなっています。

例えば、NCBIによると、疫学調査では、ほとんどの自己免疫疾患の頻度が同様に増加しており、それぞれ世界中で年間19.1％および12.5％増加していると推定されており、医師の認知度の向上だけが明らかな増加を引き起こしているという考えとは矛盾しています。

血漿由来製品の高コストと限られた入手可能性

静注用ヒト免疫グロブリン（pH4）を法外に高価なものにしている主な要因はいくつかあります。その中には、血漿の採取、分画、精製に関わるプロセスに必要な専門施設や訓練を受けた人材、製造や規制管理の難しさ、需給力の不足、ヘルスケアシステムによる要因、市場原理による集中、副作用や合併症などが含まれます。

最も大きな要因としては、プロセス処理と血漿採取があり、これにもまた専門的な設備と人材が必要です。殺細胞精製や殺ウイルス療法の方法論のような製造工程は複雑で、専門的な施設や人的資源を必要とし、さらに、それらの操作における規制遵守のためにさらにコストがかかります。特に資源の乏しい環境や医療保険が十分に適用されない地域では、需要と供給の力学が制限されるため、価格コストがさらにかかります。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • 免疫不全症および自己免疫疾患の罹患率の上昇
• 抑制要因
  • 血漿由来製品の高コストと入手の制限
• 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析

第6章 タイプ別

• IgG
• 免疫グロブリンA
• IgM

第7章 適応症別

• 原発性免疫不全症
• 二次性免疫グロブリン欠乏症
• 免疫介在性血小板減少症
• その他

第8章 流通チャネル別

• 院内薬局
• 小売薬局
• オンライン薬局

第9章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • スペイン
  • イタリア
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋
• 中東・アフリカ

第10章 競合情勢

• 競合シナリオ
• 市況・シェア分析
• M&A分析

第11章 企業プロファイル

• Takeda Pharmaceutical Company Limited
  • 会社概要
  • 製品ポートフォリオと概要
  • 財務概要
  • 主な発展
• CSL Behring
• Grifols, S.A
• Kedrion Biopharma
• Octapharma AG
• Biotest AG
• Hualan Biological Engineering Inc
• Shanghai RAAS Blood Products Co., Ltd
• Beijing Tiantan Biological Products Co., Ltd
• Sinopharm Group Co., Ltd

第12章 付録

The global lyophilized human immunoglobulin (ph4) for intravenous injection market reached US$ 55.7 billion in 2023 and is expected to reach US$ 140.9 billion by 2031, growing at a CAGR of 12.3% during the forecast period 2024-2031.

Lyophilized Human Immunoglobulin (pH 4) for Intravenous Injection is a purified blood-derived product that provides immediate and long-term immune support. It contains a concentrated solution of immunoglobulin G, a key antibody component for combating infections, managing immune deficiencies, and treating autoimmune and inflammatory conditions. Formulated at an acidic pH, it enhances stability and reduces aggregation, making it a cornerstone in immunotherapy across hospitals, clinics, and homecare settings.

Market Dynamics: Drivers & Restraints

Rising Prevalence of Immunodeficiency and Autoimmune Disorders

The increasing prevalence of immunodeficiency and autoimmune diseases has pushed the lyophilized human immunoglobulin market forward. The aforementioned disorders are also genetically or environmentally induced. Advancements in medical technology and awareness campaigning allow the disease to be diagnosed at a much earlier stage, expanding the patient pool that is eligible for immunoglobulin therapy. The global aging population, who tends to display immune deficiencies during old age, will need more therapy to manage chronic illnesses. Additionally, effective immune modulation therapies need innovation and increased production capacity. Research and development investment is also critical for improving formulations, delivery routes, and therapeutic indications, thus making lyophilized human immunoglobulin one of the most significant avenues of growth in this field.

For instance, according to NCBI, Epidemiologic studies show similar increases in the frequency of most autoimmune diseases, with estimates of yearly increases of 19.1% and 12.5% worldwide, respectively, contradicting the idea that increased physician recognition alone may cause their apparent rises.

High Cost and Limited Availability of Plasma-Derived Products

The market is hindered by several factors mainly contribute to making human immunoglobulin (pH4) for intravenous injection prohibitively expensive. Some of these include specialized facilities and trained personnel required for the processes involved in the plasma collection, fractionation, or purification, difficulty in manufacturing and regulatory controls, deficiency in supply and demand forces, factors from the healthcare system, market-based concentration, and adverse effects and complications.

The most significant contributors include process processing and plasma collection, which again demands specialized facilities as well as personnel. Manufacturing processes such as methodologies for cytolethal purification and virucidal therapy would be complex, need specialized facilities, human resources, and even more cost upon regulatory compliance in operations given those. Price costs involved even more from restricted dynamics of supply and demand, particularly in resource-poor settings or geographical areas with insufficient health insurance coverage.

Segment Analysis

The global lyophilized human immunoglobulin (ph4) for intravenous injection market is segmented based on type, indication, distribution channel and region.

Type:

IgG segment is expected to dominate the lyophilized human immunoglobulin (PH4) for intravenous injection market share

The IgG segment holds a major portion of the lyophilized human immunoglobulin (PH4) for intravenous injection market share and is expected to continue to hold a significant portion of the lyophilized human immunoglobulin (PH4) for intravenous injection market share during the forecast period.

Immunoglobulin G (IgG) plays a crucial role in the Global Lyophilized Human Immunoglobulin (pH4) for Intravenous Injection market, as it is a therapeutic agent for treating immunodeficiencies, autoimmune disorders, and infectious diseases.

IgG's plays an crucial role in global lyophilized human immunoglobulin (PH 4) for intravenous injection market which help the market to grow further during the forecast period due to

• IgG is the most abundant antibody in the human immune system, recognized and neutralized by bacteria, viruses, and toxins.
• Lyophilized intravenous immunoglobulin (IVIg) formulations purify and concentrate IgG for good passive immunity.
• IgG is crucial in conditions like immune deficiencies, autoimmune disorders, and infectious diseases when the immune system is weak or overactive.
• IgG's stability and long-term storage make it available for immediate reconstitution by healthcare providers.

Indication:

Primary immunodeficieny diseases segment is the fastest-growing segment in lyophilized human immunoglobulin (PH4) for intravenous injection market share

The primary immunodeficieny diseases segment is the fastest-growing segment in the lyophilized human immunoglobulin (PH4) for Intravenous Injection market share and is expected to hold the market share over the forecast period.

• PIDs are rare, genetically inherited disorders causing recurrent infections, autoimmune complications, and increased cancer risk.
• IVIg is crucial for lifelong treatment, with advantages like enhanced stability, ease of storage, and extended shelf life.
• Global awareness and improved diagnostic capabilities have increased PID cases, leading to reliance on effective treatments like pH 4 IVIg.

Moreover, in December 2023, GC Biopharma Corp has received FDA approval for ALYGLO 10% Liquid, formerly known as "GC5107," for treating adult patients with primary humoral immunodeficiency (PI) aged 17 and older. The FDA-approved clinical trial, NCT02783482, was a prospective, open-label, single-arm, historically controlled, multicenter phase 3 study to assess the efficacy and safety of GC5107B in patients with a confirmed PI diagnosis.

Geographical Analysis

North America is expected to hold a significant position in the lyophilized human immunoglobulin (PH4) for intravenous injection market share

North America holds a substantial position in the lyophilized human immunoglobulin (PH4) for intravenous injection market and is expected to hold most of the market share due to

Key Driving Factors:

• Increased Incidence of Autoimmune Disorders and Immunodeficiencies, New diagnostic tests have enabled the identification of several cases of primary immunodeficiency diseases. Such diseases cause an increased demand for lyophilized human immunoglobulin among patients.
• Advances in Manufacturing Technology, Advances in production technology enhance significantly the product's safety and efficacy. Enhanced quality and treatment options will in turn improve their sales.
• Strong Regulatory Environment, for example, the U.S. Federal Drug Administration is essential in providing new therapies approval for entering the potential market from this aspect.
• Health-care System- and Reimbursement-Related Issues, a strong healthcare system and permissive reimbursement policies help improve access to immunoglobulin therapies.

Europe is growing at the fastest pace in the lyophilized human immunoglobulin (PH4) for intravenous injection market

Europe holds the fastest pace in the lyophilized human immunoglobulin (PH4) for intravenous injection market due to:

• Rapid growth driven by technological advancements and evolving consumer preferences.
• Key trends include increased adoption of innovative solutions, focus on efficiency, and integration of specialized applications.
• Supported by substantial investments and a favorable business environment.
• Diverse range of players, from established companies to emerging startups.
• Competition driven by need for innovation and specialized solutions.
• Leading manufacturers use cutting-edge technologies and innovative solutions.
• Invest in research and development, extensive product portfolios, and strategic global partnerships.

Competitive Landscape

The major global players in the lyophilized human immunoglobulin (PH4) for intravenous injection market include Takeda Pharmaceutical Company Limited, CSL Behring, Grifols, S.A, Kedrion Biopharma, Octapharma AG, Biotest AG, Hualan Biological Engineering Inc, Shanghai RAAS Blood Products Co., Ltd, Beijing Tiantan Biological Products Co., Ltd, Sinopharm Group Co., Ltd among others.

Emerging Players

The emerging players in the lyophilized human immunoglobulin (PH4) for intravenous injection market include sanquin blood supply foundation, lfb group and among others.

Key Developments

• In January 2024, The FDA has approved GAMMAGARD LIQUID as an intravenous immunoglobulin therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The therapy can be used as an induction dose followed by maintenance doses. However, GAMMAGARD LIQUID has not been studied in immunoglobulin-naive patients or as maintenance therapy for longer periods.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global lyophilized human immunoglobulin (PH4) for intravenous injection market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2023

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Component & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Type
• 3.2. Snippet by Indication
• 3.3. Snippet by Distribution Channel
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Rising Prevalence of Immunodeficiency and Autoimmune Disorders
• 4.2. Restraints
  • 4.2.1.1. High Cost and Limited Availability of Plasma-Derived Products
• 4.3. Opportunity
  • 4.3.1. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis

6. By Type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 6.1.2. Market Attractiveness Index, By Type
• 6.2. IgG*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. IgA
• 6.4. IgM

7. By Indication

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 7.1.2. Market Attractiveness Index, By Indication
• 7.2. Primary Immunodeficiency Diseases*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Secondary Immunoglobulin Deficiency Diseases
• 7.4. Immune Mediated Thrombocytopenia
• 7.5. Others

8. By Distribution Channel

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 8.1.2. Market Attractiveness Index, By Distribution Channel
• 8.2. Hospital Pharmacies*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Retail Pharmacies
• 8.4. Online Pharmacies

9. By Region

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 9.1.2. Market Attractiveness Index, By Region
• 9.2. North America
  • 9.2.1. Introduction
  • 9.2.2. Key Region-Specific Dynamics
  • 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.2.6.1. U.S.
    • 9.2.6.2. Canada
    • 9.2.6.3. Mexico
• 9.3. Europe
  • 9.3.1. Introduction
  • 9.3.2. Key Region-Specific Dynamics
  • 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.3.6.1. Germany
    • 9.3.6.2. U.K.
    • 9.3.6.3. France
    • 9.3.6.4. Spain
    • 9.3.6.5. Italy
    • 9.3.6.6. Rest of Europe
• 9.4. South America
  • 9.4.1. Introduction
  • 9.4.2. Key Region-Specific Dynamics
  • 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.4.6.1. Brazil
    • 9.4.6.2. Argentina
    • 9.4.6.3. Rest of South America
• 9.5. Asia-Pacific
  • 9.5.1. Introduction
  • 9.5.2. Key Region-Specific Dynamics
  • 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.5.6.1. China
    • 9.5.6.2. India
    • 9.5.6.3. Japan
    • 9.5.6.4. South Korea
    • 9.5.6.5. Rest of Asia-Pacific
• 9.6. Middle East and Africa
  • 9.6.1. Introduction
  • 9.6.2. Key Region-Specific Dynamics
  • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

10. Competitive Landscape

• 10.1. Competitive Scenario
• 10.2. Market Positioning/Share Analysis
• 10.3. Mergers and Acquisitions Analysis

11. Company Profiles

• 11.1. Takeda Pharmaceutical Company Limited*
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio and Description
  • 11.1.3. Financial Overview
  • 11.1.4. Key Developments
• 11.2. CSL Behring
• 11.3. Grifols, S.A
• 11.4. Kedrion Biopharma
• 11.5. Octapharma AG
• 11.6. Biotest AG
• 11.7. Hualan Biological Engineering Inc
• 11.8. Shanghai RAAS Blood Products Co., Ltd
• 11.9. Beijing Tiantan Biological Products Co., Ltd
• 11.10. Sinopharm Group Co., Ltd

LIST NOT EXHAUSTIVE

12. Appendix

• 12.1 About Us and Services
• 12.2 Contact Us