아페레시스 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the apheresis market size is expected to increase from USD 3.92 billion in 2025 to USD 4.16 billion in 2026 and reach USD 5.48 billion by 2031, growing at a CAGR of 5.67% over 2026-2031.

This report Segments the Industry Into by Product (Devices, Disposables & Consumables), Procedure (Plasmapheresis, Plateletpheresis, and More), Application (Hematological Disorders, and More), End User (Blood Banks & Component Providers, and More), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Apheresis Market Trends and Insights

Rising Prevalence of Hematologic & Autoimmune Disorders

Registry data from the American Society of Hematology and the European Hematology Association revealed an 18% increase in apheresis-eligible cases between 2024 and 2025, primarily driven by multiple myeloma and plasma cell dyscrasias. Myasthenia gravis and chronic inflammatory demyelinating polyneuropathy diagnoses rose 22%, reinforcing guideline upgrades that position therapeutic plasma exchange as first-line care. Japan added 14,000 reimbursable systemic lupus erythematosus patients after approving immunoadsorption apheresis in April 2025. An aging OECD population continues to raise baseline monoclonal-gammopathy rates, ensuring that procedure volumes remain resilient even when per-patient intensity plateaus. These epidemiologic shifts support stable device utilization and recurrent consumable revenue streams for vendors.

Technological Advances in Automation & Membrane Filtration

Fresenius Kabi's Lovo system introduced optical hematocrit sensors, which reduced hypocalcemia events by 34%, thereby reducing operator oversight requirements and broadening adoption in community hospitals. The FDA-cleared Aurora Xi separator utilizes 0.2-micron hollow-fiber membranes to minimize platelet damage associated with centrifugation, thereby increasing single-donor platelet yields by up to 22%. Terumo BCT integrated EHR connectivity into Spectra Optia in mid-2025, automatically populating patient parameters and reducing setup errors by 41% across six validation sites. Continuous-flow leukapheresis modules now process 15 liters of whole blood in under three hours, a 12-percentage-point yield gain over batch centrifugal systems. Collectively, these upgrades reduce training time, improve safety profiles, and shorten facility turnover, amplifying installed-base refresh cycles.

High Capital & Consumable Costs

Automated apheresis devices list between USD 85,000 and USD 140,000, while a 200-procedure facility spends USD 180,000-260,000 annually on disposables. Following an 18% CMS rate cut for hospital outpatient plasma exchange in 2025, profit margins narrowed to as little as USD 67 per session before overhead, which dampened new-equipment orders. Vendor-financed leasing and reagent-rental models have emerged, but adoption has been tepid because hospitals worry about being locked into consumables during supply disruptions. Until pricing models evolve, capital constraints will slow penetration in cost-sensitive regions.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Cell & Gene Therapies Needing Leukapheresis
2. Growing Demand for Plasma-Derived Therapeutics & Blood Components
3. Shortage of Trained Specialists

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

The devices segment retained a 67.43% value share in 2025; however, disposables are set to outpace the apheresis market at a 7.24% CAGR through 2031, driven by single-use kits that eliminate sterilization steps and align with ESG mandates. Hospitals adopting Amicus closed-loop sets shortened setup by nine minutes and reduced contamination risk by 62%, cementing locked-in consumable streams with 40% gross margins. Concurrently, device average selling prices slipped 4.3% as Chinese entrants priced their products 22-28% below those of incumbents, underscoring a shift in margin toward proprietary disposables.

Capital refresh cycles still matter because CAR-T collection centers need EHR-integrated automation to meet chain-of-identity audit demands. Terumo BCT disclosed that 58% of 2025 Spectra Optia shipments supported leukapheresis capacity expansions. Even so, disposables command defensible moats; FDA-cleared connector geometries prevent third-party substitutes, thereby anchoring revenue despite hardware price erosion. This pivot toward recurring consumables underpins long-run profitability for leading vendors in the apheresis market.

Plasmapheresis accounted for 41.62% of the procedures in 2025, reflecting chronic immunoglobulin replacement and neurological plasma-exchange indications. Photopheresis, however, is expanding at an 8.35% CAGR, driven by FDA-approved CELLEX systems that reduce procedure time to three hours and secure broad CMS coverage for pediatric GVHD. Plateletpheresis remains indispensable to blood-bank logistics, while leukapheresis volumes climb in lock-step with CAR-T therapy rollouts.

Erythrocytapheresis is growing modestly at 4.1% because manual exchange still accounts for 54% of sickle-cell procedures in sub-Saharan Africa, where automated devices remain scarce. The American Society for Apheresis has upgraded automated red-cell exchange to Category I for the treatment of acute chest syndrome; however, uptake hinges on device affordability and technician training. Overall, a shifting procedure mix favors platforms that handle multiple modalities without hardware swaps, a capability that entrenches premium systems in the apheresis market.

Complete Report Scope:

• By Product
  • Devices
  • Disposables & Consumables
• By Procedure
  • Plasmapheresis
  • Plateletpheresis
  • Leukapheresis
  • Erythrocytapheresis
  • Photopheresis
• By Application
  • Hematological Disorders
  • Neurological Disorders
  • Renal Disorders
  • Autoimmune Disorders
  • Other Applications
• By End User
  • Blood Banks & Component Providers
  • Hospitals & Transfusion Centers
  • Ambulatory & Specialty Clinics
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America led with a 43.35% market share in 2025, servicing the therapeutic, blood-bank, and CAR-T collection needs of 4,200 devices. CMS outpatient rate cuts redirected plasma-exchange volumes to ambulatory clinics, reducing overhead by 32% and driving demand for compact, technician-friendly systems. Canada's nine new plasma centers reduced import reliance by 14%, driving PCS2 device sales up 19%. Mexico expanded coverage to 12 hospitals, yet device penetration remains under 40% because of budgetary limits.

EMA clearance of the CliniMACS Prodigy enabled decentralized CAR-T processing at 18 sites, resulting in a savings of EUR 12,000 per patient in logistics. Germany reimbursed photopheresis for steroid-refractory GVHD, adding 1,600 patients and driving CELLEX installs. The United Kingdom increased plateletpheresis by 6.8% after rolling out Trima Accel in 14 regions. Southern Europe lags amid lower reimbursement rates.

Asia-Pacific is forecast to expand at an 8.08% CAGR through 2031, the fastest pace globally. China approved 14 device models and raised plasma fractionation capacity by 18% in 2024 to hedge against import constraints. India aims to double the number of collection centers by 2027 and has ordered 80 devices from Fresenius Kabi and Haemonetics, although the rupee's weakness challenges affordability. Japan's aging cohort increased plasmapheresis for autoimmune diseases by 12%, but a shortage of 420 trained staff curbs rural expansion. Australia and South Korea are widening coverage for LDL-apheresis and portable collection devices, respectively, supporting steady growth.

The Middle East and Africa capture 6.2% of revenue, with GCC states investing in plasma self-sufficiency and South Africa expanding plateletpheresis by 22%. Manual red-cell exchange dominates sickle-cell care in sub-Saharan Africa because automated devices remain scarce.

1. Asahi Kasei
2. B. Braun
3. Baxter
4. Bioelettronica
5. Cerus
6. Fresenius
7. Grifols
8. Haemonetics
9. HemaCare Corporation
10. Infomed
11. Kaneka
12. Kawasumi Laboratories
13. MacoPharma
14. Mallinckrodt plc
15. Medica S.p.A.
16. Miltenyi Biotec
17. Nikkiso Co., Ltd.
18. Sumitomo Bakelite Co. Ltd.
19. Terumo
20. Therakos (Mallinckrodt)

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Prevalence of Hematologic & Autoimmune Disorders
  • 4.2.2 Growing Demand for Plasma-Derived Therapeutics & Blood Components
  • 4.2.3 Technological Advances in Automation & Membrane Filtration
  • 4.2.4 Expansion Of Cell & Gene Therapies Needing Leukapheresis
  • 4.2.5 Emergence Of Portable Point-of-Care Apheresis Systems
  • 4.2.6 ESG-Driven Investment in Low-Waste Single-Use Kits
• 4.3 Market Restraints
  • 4.3.1 High Capital & Consumable Costs
  • 4.3.2 Shortage of Trained Specialists
  • 4.3.3 Supply-Chain Risks for Critical Disposables
  • 4.3.4 Competition From Pathogen-Reduced Whole-Blood Tech
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts

• 5.1 By Product
  • 5.1.1 Devices
  • 5.1.2 Disposables & Consumables
• 5.2 By Procedure
  • 5.2.1 Plasmapheresis
  • 5.2.2 Plateletpheresis
  • 5.2.3 Leukapheresis
  • 5.2.4 Erythrocytapheresis
  • 5.2.5 Photopheresis
• 5.3 By Application
  • 5.3.1 Hematological Disorders
  • 5.3.2 Neurological Disorders
  • 5.3.3 Renal Disorders
  • 5.3.4 Autoimmune Disorders
  • 5.3.5 Other Applications
• 5.4 By End User
  • 5.4.1 Blood Banks & Component Providers
  • 5.4.2 Hospitals & Transfusion Centers
  • 5.4.3 Ambulatory & Specialty Clinics
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market-level Overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Asahi Kasei Corporation
  • 6.3.2 B. Braun SE
  • 6.3.3 Baxter International Inc.
  • 6.3.4 Bioelettronica
  • 6.3.5 Cerus Corporation
  • 6.3.6 Fresenius SE & Co. KGaA
  • 6.3.7 Grifols S.A.
  • 6.3.8 Haemonetics Corporation
  • 6.3.9 HemaCare Corporation
  • 6.3.10 Infomed SA
  • 6.3.11 Kaneka Corporation
  • 6.3.12 Kawasumi Laboratories Inc.
  • 6.3.13 Macopharma SA
  • 6.3.14 Mallinckrodt plc
  • 6.3.15 Medica S.p.A.
  • 6.3.16 Miltenyi Biotec GmbH
  • 6.3.17 Nikkiso Co., Ltd.
  • 6.3.18 Sumitomo Bakelite Co. Ltd.
  • 6.3.19 Terumo Corporation
  • 6.3.20 Therakos (Mallinckrodt)

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment