시장보고서
상품코드
2016157

혈장 분획 시장 보고서 : 제품별, 부문별, 용도별, 최종사용자별, 지역별(2026-2034년)

Plasma Fractionation Market Report by Product, Sector, Application, End User, and Region 2026-2034

발행일: | 리서치사: 구분자 IMARC | 페이지 정보: 영문 135 Pages | 배송안내 : 2-3일 (영업일 기준)

    
    
    




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※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.

세계의 혈장 분획 시장 규모는 2025년에 277억 달러에 이르렀습니다. 향후, 이 시장은 2034년까지 423억 달러에 이르고, 2026-2034년 CAGR 4.67%로 성장할 전망입니다. 만성질환 유병률 증가, 기술 발전, 헬스케어 분야 투자 확대 등이 시장 성장을 견인하는 주요 요인으로 꼽힙니다.

혈장 분획 시장 동향 :

고령화 진행

고령화에 따라 면역력 저하, 신경질환, 만성질환 등 다양한 건강 문제가 발생하기 쉬워지면서 혈장제제에 대한 수요가 증가하고 있습니다. 예를 들어, 세계보건기구(WHO)의 발표에 따르면 2030년까지 전 세계 인구 6명 중 1명이 60세 이상이 될 것으로 예측했습니다. 또한, 2050년까지 전 세계 60세 이상 인구는 약 21억 명에 달할 것으로 예측되고 있습니다. 또한, 미국 국립의학도서관(NLM)의 보고에 따르면, 인도 노인의 약 21%가 적어도 한 가지 이상의 만성질환을 앓고 있다고 합니다. 고혈압과 당뇨병은 전체 만성질환의 약 68%를 차지합니다. 이러한 질병을 효과적으로 치료하기 위해서는 혈장 분획에서 얻은 혈장 제제가 필수적입니다. 이러한 치료법은 증상 관리와 삶의 질 향상에 매우 중요한 역할을 하고 있습니다. 이러한 요인들이 혈장분획 시장 점유율 확대에 기여하고 있습니다.

희귀 만성질환 유병률

희귀 만성질환의 유병률 증가가 시장 성장을 크게 견인하고 있습니다. 예를 들어, 2022년 12월 미국 식품의약국(FDA)이 발표한 기사에 따르면, 미국에서는 3,000만 명 이상이 7,000여 종의 희귀질환을 앓고 있다고 합니다. 또한, 많은 희귀 만성질환은 혈장 분획 유래 치료법을 포함한 전문적인 치료가 필요합니다. 이러한 치료법은 증상 관리, 삶의 질 향상 및 생명을 구하는 중재에 필수적입니다. 예를 들어, Invest India가 발표한 기사에 따르면, 혈장 분획은 선천성 또는 면역 결핍 질환의 치료, 외상 시 혈액량 회복, HIV 및 간염 바이러스와 같은 바이러스성 오염 물질의 매우 효율적인 비활성화 등 많은 치료 용도를 가지고 있습니다. 또한, 새로운 혈장 유래 제품에 대한 규제 당국의 승인과 적응증 확대로 인해 더 많은 환자들이 혈장 유래 제품을 사용할 수 있게 됨에 따라 시장 성장이 촉진되고 있습니다. 예를 들어, 2024년 6월 다케다제약은 일본 후생노동성이 무감마글로불린혈증 또는 저감마글로불린혈증을 앓고 있는 2세 이상의 무감마글로불린혈증 또는 저감마글로불린혈증 환자에서 원발성 면역 결핍(PID) 또는 이차성 면역 결핍(SID)으로 인한 심각한 재발성 감염의 위험을 증가시키는 보충요법으로 '큐비트루'를 승인했다고 발표했습니다. 이상의 환자에 대한 보충요법으로 '큐비트루'의 사용을 승인했다고 발표했습니다.

정제 기술의 발전

정제 기술의 발전으로 혈장 유래 제품의 품질, 안전성 및 효율성이 크게 향상되었습니다. 가장 중요한 발전 중 하나는 바이러스의 비활성화 및 제거 방법에 있습니다. 용매-계면활성제 처리, 저온살균, 나노 여과 등의 기술이 정교해져 혈장 제품 내 치료용 단백질을 유지하면서 바이러스를 효과적으로 제거할 수 있게 되었습니다. 이를 통해 더 높은 안전 기준을 보장하고 바이러스 감염의 위험을 줄일 수 있습니다. 예를 들어, 미국 국립의학도서관이 발표한 논문에 따르면, 인간 알부민, 응고인자, 면역글로불린, 효소 억제제 등 치료용 혈장 단백질은 우려되는 혈액 매개 바이러스를 비활성화하기 위해 60°C에서 10시간 동안 가열 처리됩니다. 또한, 친 화성 크로마토그래피 및 이온교환 크로마토그래피와 같은 최신 크로마토그래피 기술을 통해 혈장 단백질의 특성에 따라 보다 정밀한 분리가 가능하여 정제 공정이 개선되었습니다. 이를 통해 면역글로불린, 알부민, 응고인자 등 치료용 단백질의 순도와 수율이 향상되었습니다. 예를 들어, 2023년 11월 미국에 본사를 둔 생명과학 기업 중 하나인 Cytiva사는 재조합 단백질의 정제를 효율화 및 가속화하는 'Cytiva Protein Select' 기술을 발표했습니다. 자가 절단형 미량 미량 태그와 상보적 친화력 크로마토그래피 수지는 모든 단백질 정제 과정을 표준화하여 단백질 고유의 친화력 결합 파트너가 필요 없게 합니다.

목차

제1장 서문

제2장 조사 범위와 조사 방법

제3장 주요 요약

제4장 서론

제5장 세계의 혈장 분획 시장

제6장 시장 분석 : 제품별

제7장 시장 분석 : 부문별

제8장 시장 분석 : 용도별

제9장 시장 분석 : 최종사용자별

제10장 시장 분석 : 지역별

제11장 SWOT 분석

제12장 밸류체인 분석

제13장 Porter의 Five Forces 분석

제14장 가격 분석

제15장 경쟁 구도

LSH

The global plasma fractionation market size reached USD 27.7 Billion in 2025. Looking forward, the market is expected to reach USD 42.3 Billion by 2034, exhibiting a growth rate (CAGR) of 4.67% during 2026-2034. The rising prevalence of chronic diseases, technological advancements, and the increasing investment in healthcare are some of the major factors driving the market growth.

PLASMA FRACTIONATION MARKET ANALYSIS:

  • Major Market Drivers: The rising need for preventing, managing, and treating infections, congenital deficiencies, rare blood disorders, immunologic disorders, and autoimmune diseases is driving the market growth.
  • Key Market Trends: Key players across countries are investing in R&D activities to enhance plasma production technology for product efficacy and recovery of immunoglobulin G (IgG) to isolate new plasma proteins, which is one of the emerging trends bolstering the market.
  • Competitive Landscape: Some of the prominent companies in the market include ADMA Biologics Inc., Boccard, CSL, Grifols, S.A., Intas Pharmaceuticals Ltd., Kedrion, LFB, Octapharma AG, PlasmaGen BioSciences Pvt. Ltd., and Sartorius AG, among many others.
  • Geographical Trends: North America currently dominates the global market due to the region's advanced healthcare infrastructures, high demand for plasma-derived products, and the development of affordable viral inactivation and processing technologies.
  • Challenges and Opportunities: One of the primary challenges hindering the market is the growing concerns over ensuring a stable and sufficient supply of plasma. However, the increasing donor recruitment efforts are expected to fuel the market in the coming years.

PLASMA FRACTIONATION MARKET TRENDS:

Rising Geriatric Population

As people age, they are more prone to various health conditions, such as immune deficiencies, neurological disorders, and chronic diseases, thereby propelling the need for plasma products. For instance, according to an article published by the World Health Organization (WHO), by 2030, one in every six persons in the world will be 60 or older. Moreover, the global population of individuals aged 60 and above will be approximately 2.1 billion by 2050. Besides this, as per the National Library of Medicine, about 21% of the elderly in India suffer from at least one chronic condition. Hypertension and diabetes are responsible for approximately 68% of all chronic illnesses. Plasma products derived from fractionation are essential for treating many of these conditions effectively. These therapies play a crucial role in managing symptoms and improving the quality of life in these cases. These factors are contributing to the plasma fractionation market share.

Prevalence of Rare Chronic Diseases

The rising prevalence of rare chronic diseases is significantly driving the growth of the market. For instance, according to an article published by the Food & Drug Administration (FDA) in December 2022, more than 30 million people suffer from more than 7,000 rare diseases in the U.S. Moreover, many rare chronic diseases require specialized treatments, including therapies derived from plasma fractionation. These treatments are essential for managing symptoms, improving quality of life and providing life-saving interventions. For instance, according to an article published by Invest India, there are many therapeutic applications for plasma fractionation, such as the treatment of congenital or immunological deficiency diseases, trauma blood volume restoration, and the very efficient inactivation of viral contaminants like HIV and hepatitis viruses. Besides this, regulatory approvals for new plasma-derived products and expanding indications also stimulate market growth, allowing more patients access to these treatments. For example, in June 2024, Takeda announced that the Ministry of Health, Labour, and Welfare in Japan approved the use of CUVITRU as replacement therapy for patients aged two years and older with agammaglobulinemia or hypogammaglobulinemia disorders characterized by extremely low or absent antibody levels and an increased risk of serious recurring infection caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID).

Advancements in Purification Techniques

Advancements in purification techniques have significantly enhanced the quality, safety, and efficiency of plasma-derived products. One of the most critical advancements is in the methods of viral inactivation and removal. Techniques, such as solvent/detergent treatment, pasteurization, and nanofiltration, have been refined to effectively eliminate viruses while preserving therapeutic proteins in plasma products. This ensures higher safety standards and reduces the risk of viral transmission. For instance, according to an article published by the National Library of Medicine, therapeutic plasma proteins, including human albumin, coagulation factors, immunoglobulins, and enzyme inhibitors, are pasteurized at 60°C for 10 hours to kill blood-borne viruses of concern. Moreover, modern chromatographic techniques, including affinity chromatography and ion exchange chromatography, have improved the purification process by allowing for more precise separation of plasma proteins based on their specific characteristics. This results in higher purity and yield of therapeutic proteins like immunoglobulins, albumin, and clotting factors. For instance, in November 2023, Cytiva, one of the life science companies headquartered in the United States, launched the Cytiva Protein Select technology, which streamlines and accelerates recombinant protein purification. The self-cleaving traceless tag and complementary affinity chromatography resin standardize purification for any protein, thereby eliminating the need for protein-specific affinity binding partners.

GLOBAL PLASMA FRACTIONATION INDUSTRY SEGMENTATION:

Breakup by Product:

  • Immunoglobulins
  • Albumin
  • Coagulation factor VIII
  • Coagulation factor IX

Immunoglobulins currently exhibit a clear dominance in the market

Immunoglobulins, also known as antibodies, play a dominant role in plasma fractionation due to their widespread therapeutic applications and high demand. Immunoglobulins are used to treat various medical conditions, including primary and secondary immunodeficiencies, autoimmune diseases, inflammatory disorders, and neurological diseases. They are essential for boosting immune function and managing symptoms in patients with these conditions. For instance, in September 2022, Grifols, one of the plasma medicines providers, signed a long-term agreement with Canada's national blood authority to increase the country's self-sufficiency in immunoglobulin significantly (Ig) medicines that are used to treat a variety of immunodeficiencies and other medical conditions.

Breakup by Sector:

  • Private Sector
  • Public Sector

Private sector accounts for the majority of the total market share

In the private sector, plasma fractionation plays a crucial role in producing essential plasma-derived therapies, which are vital for treating various medical conditions, such as immunodeficiencies, hemophilia, and autoimmune disorders. Private companies are pivotal in advancing the fractionation process through investment in cutting-edge technologies and infrastructure, ensuring high-quality and efficient production. They also drive innovation by developing new therapeutic products and improving existing ones, thereby expanding treatment options for patients. Additionally, the private sector contributes significantly to the global plasma supply chain, enhancing the availability of these life-saving therapies. Through strategic partnerships and robust distribution networks, private companies facilitate the timely delivery of plasma-derived products to healthcare providers and patients worldwide, underscoring their indispensable role in the healthcare ecosystem.

Breakup by Application:

  • Neurology
  • Immunology
  • Hematology
  • Other Applications

Neurology currently holds the largest market share

Neurology represented the largest segment in the market due to the high demand for plasma-derived therapies in treating neurological disorders. Conditions, including chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain-Barre syndrome, and multifocal motor neuropathy, require immunoglobulins derived from plasma for effective management. For example, intravenous immunoglobulin (IVIG) therapy, which is critical in treating CIDP, helps reduce inflammation and improve muscle strength and function in patients. The prevalence of such neurological conditions and the effectiveness of plasma-derived therapies in their treatment drive significant demand in this segment, highlighting the critical role of plasma fractionation in neurology.

Breakup by End User:

  • Hospitals and Clinics
  • Clinical Research Laboratories
  • Academic Institutes

Hospitals and clinics exhibit a clear dominance in the market

Hospitals and clinics accounted for the largest market share, as they are the primary end-users of plasma-derived therapies, which are essential for treating a wide range of medical conditions. These healthcare facilities frequently administer treatments like intravenous immunoglobulins (IVIG) for immune deficiencies, albumin for hypovolemia, and clotting factors for hemophilia patients. For instance, in cases of severe trauma or surgery, hospitals rely on albumin to restore blood volume and stabilize patients. The constant need for such critical therapies in acute care settings underscores the substantial demand from hospitals and clinics, making them the largest consumers in the plasma fractionation market. Their pivotal role in delivering comprehensive patient care drives the growth and prominence of this segment.

Breakup by Region:

  • North America
    • United States
    • Canada
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Indonesia
    • Others
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Russia
    • Others
  • Latin America
    • Brazil
    • Mexico
    • Others
  • Middle East and Africa

North America exhibits a clear dominance

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.

North America, particularly the United States, boasts advanced healthcare infrastructure with a well-established network of hospitals, clinics, and specialized treatment centers. This infrastructure supports the extensive use and distribution of plasma-derived therapies. Moreover, the region has a high demand for plasma-derived products due to a large patient population requiring treatments for various medical conditions, such as immunodeficiencies, hemophilia, autoimmune diseases, and neurological disorders. For instance, in March 2021, BPL sold 25 Grifols plasma facilities in the United States, resulting in an additional one million liters for plasma fractionation. Thus, such activities by leading industry players are expected to fuel market growth over the forecasted period.

COMPETITIVE LANDSCAPE:

The market research report has provided a comprehensive analysis of the competitive landscape. Detailed profiles of all major plasma fractionation companies have also been provided. Some of the key players in the market include:

  • ADMA Biologics Inc.
  • Boccard
  • CSL
  • Grifols, S.A.
  • Intas Pharmaceuticals Ltd.
  • Kedrion
  • LFB
  • Octapharma AG
  • PlasmaGen BioSciences Pvt. Ltd.
  • Sartorius AG

KEY QUESTIONS ANSWERED IN THIS REPORT

1. What was the size of the global plasma fractionation market in 2025?

2. What is the expected growth rate of the global plasma fractionation market during 2026-2034?

3. What has been the impact of COVID-19 on the global plasma fractionation market?

4. What are the key factors driving the global plasma fractionation market?

5. What is the breakup of the global plasma fractionation market based on the product?

6. What is the breakup of the global plasma fractionation market based on the sector?

7. What is the breakup of the global plasma fractionation market based on the application?

8. What is the breakup of the global plasma fractionation market based on the end user?

9. What are the key regions in the global plasma fractionation market?

10. Who are the key players/companies in the global plasma fractionation market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Plasma Fractionation Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Product

  • 6.1 Immunoglobulins
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Albumin
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast
  • 6.3 Coagulation factor VIII
    • 6.3.1 Market Trends
    • 6.3.2 Market Forecast
  • 6.4 Coagulation factor IX
    • 6.4.1 Market Trends
    • 6.4.2 Market Forecast

7 Market Breakup by Sector

  • 7.1 Private Sector
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Public Sector
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast

8 Market Breakup by Application

  • 8.1 Neurology
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Immunology
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Hematology
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast
  • 8.4 Other Applications
    • 8.4.1 Market Trends
    • 8.4.2 Market Forecast

9 Market Breakup by End User

  • 9.1 Hospitals and Clinics
    • 9.1.1 Market Trends
    • 9.1.2 Market Forecast
  • 9.2 Clinical Research Laboratories
    • 9.2.1 Market Trends
    • 9.2.2 Market Forecast
  • 9.3 Academic Institutes
    • 9.3.1 Market Trends
    • 9.3.2 Market Forecast

10 Market Breakup by Region

  • 10.1 North America
    • 10.1.1 United States
      • 10.1.1.1 Market Trends
      • 10.1.1.2 Market Forecast
    • 10.1.2 Canada
      • 10.1.2.1 Market Trends
      • 10.1.2.2 Market Forecast
  • 10.2 Asia-Pacific
    • 10.2.1 China
      • 10.2.1.1 Market Trends
      • 10.2.1.2 Market Forecast
    • 10.2.2 Japan
      • 10.2.2.1 Market Trends
      • 10.2.2.2 Market Forecast
    • 10.2.3 India
      • 10.2.3.1 Market Trends
      • 10.2.3.2 Market Forecast
    • 10.2.4 South Korea
      • 10.2.4.1 Market Trends
      • 10.2.4.2 Market Forecast
    • 10.2.5 Australia
      • 10.2.5.1 Market Trends
      • 10.2.5.2 Market Forecast
    • 10.2.6 Indonesia
      • 10.2.6.1 Market Trends
      • 10.2.6.2 Market Forecast
    • 10.2.7 Others
      • 10.2.7.1 Market Trends
      • 10.2.7.2 Market Forecast
  • 10.3 Europe
    • 10.3.1 Germany
      • 10.3.1.1 Market Trends
      • 10.3.1.2 Market Forecast
    • 10.3.2 France
      • 10.3.2.1 Market Trends
      • 10.3.2.2 Market Forecast
    • 10.3.3 United Kingdom
      • 10.3.3.1 Market Trends
      • 10.3.3.2 Market Forecast
    • 10.3.4 Italy
      • 10.3.4.1 Market Trends
      • 10.3.4.2 Market Forecast
    • 10.3.5 Spain
      • 10.3.5.1 Market Trends
      • 10.3.5.2 Market Forecast
    • 10.3.6 Russia
      • 10.3.6.1 Market Trends
      • 10.3.6.2 Market Forecast
    • 10.3.7 Others
      • 10.3.7.1 Market Trends
      • 10.3.7.2 Market Forecast
  • 10.4 Latin America
    • 10.4.1 Brazil
      • 10.4.1.1 Market Trends
      • 10.4.1.2 Market Forecast
    • 10.4.2 Mexico
      • 10.4.2.1 Market Trends
      • 10.4.2.2 Market Forecast
    • 10.4.3 Others
      • 10.4.3.1 Market Trends
      • 10.4.3.2 Market Forecast
  • 10.5 Middle East and Africa
    • 10.5.1 Market Trends
    • 10.5.2 Market Breakup by Country
    • 10.5.3 Market Forecast

11 SWOT Analysis

  • 11.1 Overview
  • 11.2 Strengths
  • 11.3 Weaknesses
  • 11.4 Opportunities
  • 11.5 Threats

12 Value Chain Analysis

13 Porters Five Forces Analysis

  • 13.1 Overview
  • 13.2 Bargaining Power of Buyers
  • 13.3 Bargaining Power of Suppliers
  • 13.4 Degree of Competition
  • 13.5 Threat of New Entrants
  • 13.6 Threat of Substitutes

14 Price Analysis

15 Competitive Landscape

  • 15.1 Market Structure
  • 15.2 Key Players
  • 15.3 Profiles of Key Players
    • 15.3.1 ADMA Biologics Inc.
      • 15.3.1.1 Company Overview
      • 15.3.1.2 Product Portfolio
      • 15.3.1.3 Financials
    • 15.3.2 Boccard
      • 15.3.2.1 Company Overview
      • 15.3.2.2 Product Portfolio
    • 15.3.3 CSL
      • 15.3.3.1 Company Overview
      • 15.3.3.2 Product Portfolio
      • 15.3.3.3 Financials
      • 15.3.3.4 SWOT Analysis
    • 15.3.4 Grifols, S.A.
      • 15.3.4.1 Company Overview
      • 15.3.4.2 Product Portfolio
      • 15.3.4.3 Financials
      • 15.3.4.4 SWOT Analysis
    • 15.3.5 Intas Pharmaceuticals Ltd.
      • 15.3.5.1 Company Overview
      • 15.3.5.2 Product Portfolio
    • 15.3.6 Kedrion
      • 15.3.6.1 Company Overview
      • 15.3.6.2 Product Portfolio
      • 15.3.6.3 Financials
      • 15.3.6.4 SWOT Analysis
    • 15.3.7 LFB
      • 15.3.7.1 Company Overview
      • 15.3.7.2 Product Portfolio
    • 15.3.8 Octapharma AG
      • 15.3.8.1 Company Overview
      • 15.3.8.2 Product Portfolio
      • 15.3.8.3 SWOT Analysis
    • 15.3.9 PlasmaGen BioSciences Pvt. Ltd.
      • 15.3.9.1 Company Overview
      • 15.3.9.2 Product Portfolio
    • 15.3.10 Sartorius AG
      • 15.3.10.1 Company Overview
      • 15.3.10.2 Product Portfolio
      • 15.3.10.3 Financials
      • 15.3.10.4 SWOT Analysis
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