혈액 처리용 일회용 제품 시장 : 제품 유형별, 용도별, 최종사용자별, 혈액 성분별, 재료별, 판매 채널별 - 세계 예측(2025-2032년)

The Blood Processing Disposables Market is projected to grow by USD 29.36 billion at a CAGR of 11.04% by 2032.

An authoritative framing of clinical, regulatory, and supply chain dynamics that shape blood processing disposables across care settings

The blood processing disposables landscape sits at the intersection of clinical necessity, manufacturing precision, and regulatory scrutiny. Devices such as blood bags, centrifugation kits, collection sets, filtration devices, and transfer sets are integral to a wide spectrum of clinical pathways including collection, separation, and transfusion. In turn, these products underpin services delivered by blood banks, diagnostic laboratories, and hospitals, creating an interconnected ecosystem that demands high reliability and traceability.

Technological advances, evolving clinical protocols, and materials science improvements have steadily raised performance and safety standards. Simultaneously, supply chain dynamics and regulatory expectations have imposed new layers of complexity for manufacturers and procurement teams. Given the critical nature of blood handling, even incremental gains in device safety, handling ergonomics, or sterilization assurance translate into meaningful clinical and operational improvements. This introduction frames the fundamental dynamics that the subsequent sections unpack in greater technical and commercial detail.

Converging clinical automation, materials innovation, regulatory traceability, and sustainability pressures are reshaping the disposables landscape and supplier strategies

The last several years have witnessed transformative shifts across clinical practice, supply chain architecture, and innovation models that collectively redefine the blood processing disposables market. First, clinical workflows increasingly prioritize automation and closed-system designs to reduce contamination risk and streamline labor-intensive tasks; automated centrifugation kits and automated separation techniques are gaining attention for their capacity to standardize outputs and improve throughput. Second, materials innovation - from advanced polymers to improved barrier films - has enabled devices with longer shelf stability and enhanced biocompatibility, creating new possibilities for cold chain management and extended storage of sensitive components.

Concurrently, procurement strategies have evolved toward supplier consolidation and vendor-managed inventory to mitigate disruption risk and control cost. Regulatory authorities have raised expectations for post-market surveillance and traceability, prompting manufacturers to embed serialization and data capture capabilities into disposables. Finally, sustainability considerations are nudging design choices toward recyclable or lower-impact materials and processes, while also driving interest in devices that minimize waste through multi-functionality or modularity. Together, these shifts are realigning competitive positioning, investment priorities, and adoption timelines across the ecosystem.

New 2025 tariff dynamics are forcing cost reallocation, regional manufacturing shifts, and sourcing diversification across the full disposables product and channel spectrum

The introduction of updated tariff schedules and trade policy adjustments in 2025 has introduced tangible complexity for manufacturers, distributors, and procurement teams operating in or sourcing from the United States. Tariff changes affect landed costs across the product portfolio - blood bags including primary and satellite variants, centrifugation kits both automated and manual, collection sets whether accessory or complete, filtration devices such as leukocyte reduction and pathogen reduction filters, and transfer sets that range from custom to standard configurations. These cost pressures cascade differently depending on the route to market, as direct sales operations and third-party distributors each face distinct margin sensitivities and contractual constraints.

In response, supply chain managers and commercial leaders are recalibrating sourcing strategies, exploring regionalization of production, and negotiating longer-term contracts to stabilize input cost exposure. Some manufacturers are accelerating qualification of alternate suppliers for key materials like polypropylene, PVC, and silicone to diversify risk, while others are revisiting transfer pricing, inventory buffers, and logistics routing to optimize total landed costs. The tariff environment also amplifies the value of localized manufacturing capacity in the Americas and in other strategic regions, since proximity can reduce the tariff burden and improve service levels for end users such as blood banks, diagnostic laboratories, and hospitals. Ultimately, the interplay between tariffs, product complexity, and channel structure will determine which players can preserve competitiveness and which will need to adapt commercial models to maintain access to the US market.

Segment-level insights reveal how product variants, clinical applications, end users, component-specific handling, materials, and sales channels determine commercial and regulatory priorities

A nuanced segmentation approach reveals differentiated value drivers and operational requirements across product, application, end-user, blood component, material, and sales channel dimensions. Product-level distinctions separate Blood Bags and their primary and satellite configurations from Centrifugation Kits offered in automated and manual formats, while Collection Sets span accessory and complete solutions; Filtration Devices vary between leukocyte reduction and pathogen reduction capabilities, and Transfer Sets range from custom-engineered solutions to standardized offerings. Application segmentation distinguishes Collection from Separation and Transfusion workflows, with Separation itself bifurcated into automated and manual processes that have divergent equipment, staffing, and quality control implications.

End users include Blood Banks that emphasize throughput, traceability, and long-term storage compatibility; Diagnostic Laboratories that prioritize specimen integrity, chain-of-custody, and throughput for testing workflows; and Hospitals that require reliable, on-demand disposables for both routine and emergency transfusion pathways. Blood Component segmentation highlights plasma offerings such as cryoprecipitate and fresh frozen plasma, platelets, red blood cells, and whole blood, each with unique handling, filtration, and storage demands that influence product design and validation. Material choices - polypropylene, PVC, and silicone - drive compatibility with sterilization methods, shelf life, and regulatory filing strategies, while sales channels split between Direct and Distributor routes, shaping service models, contract terms, and post-sale support obligations. When viewed collectively, this segmentation underscores that product development, regulatory strategy, and commercial execution must be aligned to the specific clinical and operational contexts of target customers.

Regional variation in clinical adoption, regulatory complexity, and manufacturing priorities requires tailored market access strategies across the Americas, EMEA, and Asia-Pacific

Regional dynamics exert strong influence on innovation adoption, regulatory timelines, and procurement behavior across the Americas, Europe, Middle East & Africa, and Asia-Pacific regions. In the Americas, centralized blood bank networks and integrated hospital systems create demand for scalable, high-throughput disposable systems and incentivize suppliers to invest in quick-response logistics and domestic qualification. Conversely, Europe, the Middle East & Africa presents a mosaic of regulatory regimes and procurement models where conformity to diverse standards, localization of labeling, and regional distributor partnerships are critical to market access and sustained uptake.

Asia-Pacific is characterized by rapid capacity expansion, heterogeneous clinical infrastructure, and an accelerating push toward automation in higher-volume centers, which together create opportunities for both global incumbents and regional manufacturers. Transitioning between these regional realities requires suppliers to balance global product platforms with configurable localization, invest in region-specific clinical validation, and cultivate distributor or hospital system relationships that can bridge regulatory and logistical barriers. Moreover, cross-border trade considerations, tariff regimes, and local manufacturing incentives will continue to shape where and how suppliers prioritize capital allocation and commercial focus.

Competitive dynamics reward integrated solution providers, technical specialists, and regionally agile manufacturers that demonstrate reliability and clinical value

Competitive dynamics in the blood processing disposables sector are defined by a mix of global incumbents with broad product portfolios, specialized niche manufacturers focused on advanced filtration or automated separation technologies, and regional players who leverage localized production and distributor networks. Leading organizations emphasize integrated solutions that combine disposables with compatible instrumentation, quality management systems, and service offerings to lock in account-level relationships. Meanwhile, specialist firms differentiate through proprietary filtration media, advanced polymer formulations, or single-use automation modules that address specific clinical pain points such as leukocyte reduction efficiency or pathogen mitigation.

Strategic partnerships and M&A remain common approaches for scaling capabilities, accelerating market entry into new geographies, or complementing product portfolios with adjacent technologies. Companies that excel at regulatory harmonization, robust post-market surveillance, and rapid field support secure preferential status with high-volume blood banks and hospital systems. Additionally, investments in manufacturing flexibility, including configurable transfer sets and customizable collection set assemblies, allow suppliers to respond quickly to clinician preferences and procurement tenders. Collectively, the competitive landscape rewards technical differentiation, supply reliability, and the ability to demonstrate measurable clinical and operational benefits to end users.

Practical strategic steps for leaders to align product modularity, sourcing resilience, automation, channel balance, and sustainability to secure competitive advantage

Industry leaders should adopt a multi-dimensional strategy that aligns product development, supply chain resilience, and commercial execution with evolving clinical needs and trade realities. First, prioritize modular and scalable product designs that allow for rapid configuration between primary and satellite blood bags, automated and manual centrifugation kits, accessory and complete collection sets, and both leukocyte reduction and pathogen reduction filtration devices. This design flexibility reduces time-to-market for localized variants and improves responsiveness to clinician feedback.

Second, diversify material sourcing for critical polymers such as polypropylene, PVC, and silicone, and qualify alternate suppliers across multiple regions to reduce exposure to tariff-driven cost volatility. Third, invest in automation and closed-system workflows that support both automated and manual separation use cases, enabling end users to standardize procedures and improve traceability. Fourth, strengthen distributor relationships in complex regulatory regions while maintaining direct sales capabilities in high-volume systems to balance margin, control, and service requirements. Finally, incorporate sustainability targets into product roadmaps and packaging strategies to meet procurement criteria and public-sector tender priorities, while documenting lifecycle impacts to support procurement decisions.

A transparent mixed-methods research process combining technical review and stakeholder interviews to validate operational and commercial insights with robust triangulation

The research approach combined a structured review of technical literature, regulatory filings, and publicly available clinical guidance with qualitative primary research to validate operational and commercial insights. Secondary analysis focused on device specifications, material property data, and standards guidance relevant to blood bags, centrifugation kits, collection sets, filtration devices, and transfer sets, as well as policies that affect collection, separation, and transfusion workflows. To complement this, the primary research program included interviews with senior procurement leaders from blood banks, laboratory managers, clinicians overseeing transfusion services, and executives from manufacturer and distributor organizations to surface first-hand perspectives on pain points and adoption drivers.

Data validation employed triangulation across sources, cross-referencing product claims with regulatory summaries and clinician feedback to ensure practical relevance. Where possible, lifecycle and materials compatibility discussions were corroborated through technical white papers and manufacturer technical dossiers. The methodology emphasized transparency in assumptions, traceability of qualitative inputs, and iterative validation of emerging themes, ensuring that the conclusions reflect grounded, actionable observations rather than speculative projections.

Concluding synthesis of how product differentiation, sourcing resilience, regulatory alignment, and regional focus convert technical advances into clinical and operational value

In conclusion, the blood processing disposables domain is at an inflection point where clinical demand for safety and efficiency intersects with supply chain pressures and evolving regulatory expectations. Product-level differentiation across blood bags, centrifugation kits, collection sets, filtration devices, and transfer sets will increasingly be interpreted through the lenses of automation capability, materials performance, and regional market access. End users from blood banks to diagnostic laboratories and hospitals will favor suppliers that can demonstrably reduce contamination risk, improve handling ergonomics, and ensure reliable availability under shifting tariff and logistics conditions.

Forward-looking organizations that integrate design modularity, diversified sourcing, and strong post-market support will find themselves better positioned to capture operational partnerships with high-volume centers. At the same time, the ability to localize production and adapt to region-specific regulatory and procurement nuances will determine market entry success across the Americas, Europe, Middle East & Africa, and Asia-Pacific. These coordinated efforts will enable stakeholders to convert technical advancements into measurable clinical and operational value.

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Integration of digital tracking systems for blood bag inventory and chain of custody management
• 5.2. Development of closed system blood collection sets to minimize contamination risks
• 5.3. Adoption of pathogen reduction disposable kits for improved blood product safety
• 5.4. Growing preference for ready-to-use disposable leukoreduction filters in transfusion centers
• 5.5. Advancements in microfluidic disposable cartridges for rapid bedside blood analysis
• 5.6. Regulatory emphasis on sterilization validation of single-use blood tubing assemblies
• 5.7. Expansion of biodegradable and ecofriendly materials in blood processing disposables manufacturing
• 5.8. Collaboration between device makers and biopharma for bespoke disposable blood separators
• 5.9. Integration of RFID-enabled disposables for real-time monitoring of blood component usage
• 5.10. Surge in demand for freeze-dried plasma bags and single-use reconstitution kits

6. Cumulative Impact of United States Tariffs 2025

7. Cumulative Impact of Artificial Intelligence 2025

8. Blood Processing Disposables Market, by Product Type

• 8.1. Blood Bags
  • 8.1.1. Primary Bags
  • 8.1.2. Satellite Bags
• 8.2. Centrifugation Kits
  • 8.2.1. Automated Kits
  • 8.2.2. Manual Kits
• 8.3. Collection Sets
  • 8.3.1. Accessory Sets
  • 8.3.2. Complete Sets
• 8.4. Filtration Devices
  • 8.4.1. Leukocyte Reduction Filter
  • 8.4.2. Pathogen Reduction Filter
• 8.5. Transfer Sets
  • 8.5.1. Custom Sets
  • 8.5.2. Standard Sets

9. Blood Processing Disposables Market, by Application

• 9.1. Collection
• 9.2. Separation
  • 9.2.1. Automated Separation
  • 9.2.2. Manual Separation
• 9.3. Transfusion

10. Blood Processing Disposables Market, by End User

• 10.1. Blood Bank
• 10.2. Diagnostic Laboratory
• 10.3. Hospital

11. Blood Processing Disposables Market, by Blood Component

• 11.1. Plasma
  • 11.1.1. Cryoprecipitate
  • 11.1.2. Fresh Frozen Plasma
• 11.2. Platelet
• 11.3. Red Blood Cell
• 11.4. Whole Blood

12. Blood Processing Disposables Market, by Material

• 12.1. Polypropylene
• 12.2. PVC
• 12.3. Silicone

13. Blood Processing Disposables Market, by Sales Channel

• 13.1. Direct
• 13.2. Distributor

14. Blood Processing Disposables Market, by Region

• 14.1. Americas
  • 14.1.1. North America
  • 14.1.2. Latin America
• 14.2. Europe, Middle East & Africa
  • 14.2.1. Europe
  • 14.2.2. Middle East
  • 14.2.3. Africa
• 14.3. Asia-Pacific

15. Blood Processing Disposables Market, by Group

• 15.1. ASEAN
• 15.2. GCC
• 15.3. European Union
• 15.4. BRICS
• 15.5. G7
• 15.6. NATO

16. Blood Processing Disposables Market, by Country

• 16.1. United States
• 16.2. Canada
• 16.3. Mexico
• 16.4. Brazil
• 16.5. United Kingdom
• 16.6. Germany
• 16.7. France
• 16.8. Russia
• 16.9. Italy
• 16.10. Spain
• 16.11. China
• 16.12. India
• 16.13. Japan
• 16.14. Australia
• 16.15. South Korea

17. Competitive Landscape

• 17.1. Market Share Analysis, 2024
• 17.2. FPNV Positioning Matrix, 2024
• 17.3. Competitive Analysis
  • 17.3.1. Terumo Corporation
  • 17.3.2. Fresenius Kabi AG
  • 17.3.3. Baxter International Inc.
  • 17.3.4. Grifols S.A.
  • 17.3.5. Haemonetics Corporation
  • 17.3.6. Becton Dickinson and Company
  • 17.3.7. Pall Corporation
  • 17.3.8. Macopharma SA
  • 17.3.9. Terumo BCT, Inc.
  • 17.3.10. Cerus Corporation