血漿分画の市場規模、シェア、成長分析：製品別、用途別、エンドユーザー別、地域別 - 産業予測、2024-2031年

世界の血漿分画市場規模は、2022年に約308億7,000万米ドルと評価され、2023年の334億3,000万米ドルから2031年には632億7,000万米ドルに達し、予測期間（2024-2031年）のCAGR で8.3%の成長が予測されています。

COVID-19パンデミックの際、回復期血漿は当初ウイルス感染患者の治療に使用されたため、需要が急増しました。2021年6月のFrontiers論文によると、回復期血漿はCOVID-19症例を管理し、疾患の進行を緩和するために国際的に広く投与されました。回復期の血漿輸血が症状の改善とウイルスクリアランスに寄与したことが研究で示され、血漿分画の必要性が高まりました。しかし、パンデミックが沈静化し、感染率が低下していることから、回復期血漿市場は予測期間を通じて安定した成長が見込まれています。血漿分画市場の拡大にはいくつかの要因が寄与しています。これには、さまざまな治療領域での免疫グロブリン使用の増加、高齢者人口の増加、世界の血漿収集施設の増加などが含まれます。2022年10月のWHOのデータによると、世界の60歳以上の高齢者人口は2050年までにほぼ3倍になると予測されており、低・中所得国に大きく集中しています。この人口動態の変化により、希少疾患の有病率が増加し、その結果、血漿製品の需要も増加すると予想されます。さらに、世界人口の約1％が罹患しているフォン・ヴィレブランド病の流行は、血漿由来の治療に対するニーズをさらに高めます。Bio Products Laboratory LtdやFreedom Plasmaが開設したような血漿採取センターの拡大は、血漿ベースの製品生産を後押しすることで市場の成長をサポートすると期待されています。さらに、製品の革新や戦略的提携など、大手企業の取り組みが業界の成長を後押ししています。しかし、厳しい規制要件、高コスト、償還の問題などの課題は、市場力学に影響を与える可能性があります。

目次

イントロダクション

• 調査の目的
• 定義
• 市場範囲

調査手法

• 情報調達
• 二次データソースと一次データソース
• 市場規模予測
• 市場の想定と制限

エグゼクティブサマリー

• 市場概要見通し
• 供給需要動向分析
• セグメント別機会分析

市場力学と見通し

• 市場力学
  • 促進要因
  • 機会
  • 抑制要因
  • 課題
• ポーターの分析

主な市場の考察

• 市場の成功要因
• 競合の程度
• 主な投資機会
• 市場魅力度指数
• エコシステムマッピング
• 技術分析
• コスト分析
• 市場動向分析
• 競合分析
• サプライチェーン分析
• 投資分析
• 特許分析
• バリューチェーン分析
• 管轄分析
• 貿易分析
• ケーススタディ分析
• ポーターのファイブフォース分析

血漿分画市場：製品別

• 免疫グロブリン
  • 静脈内免疫グロブリン
  • 皮下免疫グロブリン
  • その他
• 凝固因子濃縮物
  • 第VIII因子
  • 第IX因子
  • フォン・ヴィレブランド因子
  • プロトロンビン複合体濃縮物
  • フィブリノゲン濃縮物
  • 第XIII因子
  • その他
    • アルブミン
    • プロテアーゼ阻害剤
    • その他

血漿分画市場：用途別

• 神経学
• 免疫学
• 血液学
• 救命救急
• 呼吸器科
• 血液腫瘍学
• リウマチ学
• その他

血漿分画市場：エンドユーザー別

• 病院・診療所
• 臨床研究ラボ
• 学術機関

血漿分画市場規模：地域別

• 市場概要
• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • 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（MEA）
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ地域

競合情勢

• 上位5社の比較
• 主要企業の市場ポジショニング（2023年）
• 主な市場企業が採用した戦略
• 市場における最近の活動
• 主要企業の市場シェア（2023年）

主要企業プロファイル

• CSL Behring（Australia）
• Grifols（Spain）
• Octapharma（Switzerland）
• Kedrion（Italy）
• China Biologic Products Holdings（China）
• Sanquin（Netherlands）
• Bio Products Laboratory（UK）
• Japan Blood Products Organization（Japan）
• LFB Group（France）
• Shanghai RAAS Blood Products（China）
• Green Cross Corporation（South Korea）
• Baxter International Inc.（US）
• Takeda Pharmaceutical Company Limited（Japan）
• Beijing Tiantan Biological Products（China）
• Biotest AG（Germany）
• China National Pharmaceutical Group Co.（Sinopharm）（China）
• GC Pharma（South Korea）
• ADMA Biologics（US）
• Emergent BioSolutions（US）
• Renishaw plc（UK）
• HP Inc.（USA）

Global Plasma Fractionation Market size was valued at around USD 30.87 billion in 2022 and is expected to rise from USD 33.43 billion in 2023 to reach a value of USD 63.27 billion by 2031, at a CAGR of 8.3% over the forecast period (2024-2031).

During the COVID-19 pandemic, the demand for convalescent plasma surged as it was initially used to treat patients infected with the virus. According to a June 2021 Frontiers paper, convalescent plasma was widely administered internationally to manage COVID-19 cases and mitigate disease progression. Studies have shown that convalescent plasma transfusions contributed to improved symptoms and virus clearance, leading to a heightened need for plasma fractions. However, as the pandemic has waned and infection rates have decreased, the market for convalescent plasma is expected to experience steady growth throughout the forecast period. Several factors are contributing to the expansion of the plasma fractionation market. These include the increasing use of immunoglobulins in various therapeutic areas, a growing elderly population, and a rise in plasma collection facilities worldwide. According to WHO data from October 2022, the global population aged over 60 is projected to nearly triple by 2050, with a significant concentration in low- and middle-income countries. This demographic shift is anticipated to increase the prevalence of rare diseases and, consequently, the demand for plasma products. Additionally, the prevalence of Von Willebrand's disease, affecting approximately 1% of the global population, further drives the need for plasma-derived treatments. The expansion of plasma collection centers, such as those opened by Bio Products Laboratory Ltd and Freedom Plasma, is expected to support market growth by boosting plasma-based product production. Furthermore, industry growth is bolstered by major players' initiatives, including product innovations and strategic partnerships. However, challenges such as stringent regulatory requirements, high costs, and reimbursement issues may impact market dynamics.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Plasma Fractionation 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 Plasma Fractionation Market Segmental Analysis

The global plasma fractionation market is segmented based on product, method, application, end use, and region. Based on product, the market is segmented into Albumin, Immunoglobulins (Intravenous, Subcutaneous, Others), Coagulation Factors (Factor VIII, Factor XI, Von Willebrand, Prothrombin complex, Fibrinogin, factor XIII, others), Protease Inhibitors, Others. By application, the market is segmented into Neurology, Hematology, Oncology, Immunology, Critical care, Hemato-Oncology, rheumatology, Pulmonology and others. By end use, the market is segmented into hospitals & clinics, clinical research, and others. Based on region, the market is segmented into North America, Europe, Asia-Pacific, South America, and MEA.

Drivers of the Global Plasma Fractionation Market

In recent years, protease inhibitors such as alpha-1-antitrypsin (AAT) have gained prominence in treating hepatic and lung conditions like cirrhosis, fibrosis, and liver inflammation. Alpha-1-antitrypsin deficiency (AATD) is a hereditary metabolic disorder that often goes undiagnosed and can lead to severe health issues. In the US, AATD accounts for 2-3% of emphysema cases. This condition leads to early-onset pan-lobular emphysema in both smokers and non-smokers, while the abnormal accumulation of alpha-1-antitrypsin in the liver causes various liver diseases. Although AATD occurs globally, its prevalence differs by region. Chronic obstructive pulmonary disease (COPD), which includes emphysema and chronic bronchitis, is frequently associated with severe AATD. According to a study published by Elsevier B.V. in July 2023, the prevalence of the PI*ZZ Alpha-1 Antitrypsin genotype among COPD patients varies significantly by region: approximately 50% in Europe, 37% in America, 9% in Asia, 3% in Australasia, and 1% in Africa. The estimated prevalence of COPD among individuals over 40 years old is 13.51% in the US, 12.45% in Europe, 13.22% in Africa, 11.70% in Asia, and 11.86% in Australasia. This data highlights a markedly higher prevalence in Europe, the US, Canada, New Zealand, and Australia compared to lower rates observed in parts of Asia and Africa.

Restraints in the Global Plasma Fractionation Market

Recent approvals for recombinant factors such as AFSTYLA (CSL), VONVENDI (Takeda/Shire), and Kovaltry (Bayer) are expected to boost financial performance for companies in this market segment. Recombinant factor products are categorized into two types: standard half-life and extended half-life products. Standard half-life products remain in the body for the same duration as natural factor VIII or IX, while extended half-life products are engineered to last longer in the body compared to conventional versions. According to the World Federation of Hemophilia's 2020 Annual Global Survey, recombinant factors VIII and IX are increasingly preferred in developed countries over plasma-derived alternatives for treating bleeding disorders. Meanwhile, their adoption is also rising in emerging markets such as Brazil, India, and Russia. This growing preference for recombinant factors is likely to restrict the development of plasma-derived coagulation factors, potentially affecting overall market growth.

Market Trends of the Global Plasma Fractionation Market

Immunoglobulins are the primary treatment for various immunologic, hematologic, and neurologic disorders. Advances in technology over the past decade have led to an increase in the diagnosis of immunological conditions, driving up the clinical need for immunoglobulins as more patients are identified with immunodeficiency. The growing body of genetic research aimed at defining and diagnosing these conditions further contributes to the demand for immunoglobulins. According to IG Living, a publication for the immunoglobulin (IG) community, about 20-60% of immunoglobulin use is for off-label indications, with these uses having recently surpassed those for on-label indications. The rise in rare and autoimmune disorders, coupled with an increase in global immunology research, is accelerating market growth. The National Center for Advancing Translational Sciences reported in February 2022 that only a fraction of the 7,000 to 10,000 rare diseases have available treatments. As the number of rare disorders rises, so does the demand for immunoglobulins, further fueling market expansion.

Table of Contents

Introduction

• Objectives of the Study
• Definitions
• Market Scope

Research Methodology

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

Executive Summary

• Market Overview Outlook
• Supply Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Dynamics
  • Drivers
  • Opportunities
  • Restraints
  • Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of Substitute Products
  • Bargaining Power of Buyers
  • Threat of New Entrants
  • Bargaining Power of Suppliers

Key Market Insights

• Key Success Factors of The Market
• Degree Of Competition
• Top Investment Pockets
• Market Attractive Index
• Ecosystem Mapping
• Technology Analysis
• Cost Analysis
• Market Trend Analysis
• Competition Analysis
• Supply chain analysis
• Investment Analysis
• Patent analysis
• Value chain analysis
• Jurisdiction analysis
• Trade analysis
• Case study analysis
• Porter's five forces analysis

Plasma Fractionation Market by product

• Immunoglobulins
  • Intravenous Immunoglobulins
  • Subcutaneous Immunoglobulins
  • Other Immunoglobulins
• Coagulation Factor Concentrates
  • Factor VIII
  • Factor IX
  • Von Willebrand Factor
  • Prothrombin Complex Concentrate
  • Fibrinogen Concentrates
  • Factor XIII
  • Other Coagulation Factor Concentrates
    • Albumin
    • Protease Inhibitors
    • Other Plasma Products

Plasma Fractionation Market by application

• Neurology
• Immunology
• Hematology
• Critical care
• Pulmonology
• Hemato-Oncology
• Rheumatology
• Other Applications

Plasma Fractionation Market by end-user

• Hospitals and Clinics
• Clinical Research Laboratories
• Academic institutes

Plasma Fractionation Market Size by Region

• Market Overview
• North America
  • USA
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East & Africa (MEA)
  • GCC Countries
  • South Africa
  • Rest of MEA

Competitive Landscape

• Top 5 Player Comparison
• Market Positioning of Key Players, 2023
• Strategies Adopted by Key Market Players
• Recent Activities in the Market
• Key Companies Market Share (%), 2023

Key Company Profiles

• CSL Behring (Australia)
  • 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
• Kedrion (Italy)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• China Biologic Products Holdings (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sanquin (Netherlands)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bio Products Laboratory (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Japan Blood Products Organization (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• LFB Group (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Shanghai RAAS Blood Products (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Green Cross Corporation (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Baxter International Inc. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Takeda Pharmaceutical Company Limited (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Beijing Tiantan Biological Products (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biotest AG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• China National Pharmaceutical Group Co. (Sinopharm)(China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• GC Pharma (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ADMA Biologics (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Emergent BioSolutions (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Renishaw plc (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• HP Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments