Global Butterfly Needle Sets Market

Global Butterfly Needle Sets Market is worth USD 230 million, fueled by chronic disease prevalence and safety-engineered innovations for blood collection and IV access.

Region:Global

Author(s):Dev

Product Code:KRAD0441

Pages:90

Published On:August 2025

About the Report

Base Year 2024

Global Butterfly Needle Sets Market Overview

  • The Global Butterfly Needle Sets Market is valued at USD 230 million, based on a five-year historical analysis. This growth is primarily driven by the increasing prevalence of chronic diseases, the rising number of diagnostic and blood collection procedures, and advancements in safety-engineered winged infusion sets that enhance patient comfort and reduce needlestick injuries.
  • Key players in this market are concentrated in regions such as North America and Europe, where healthcare infrastructure is well-established and adoption of minimally invasive blood collection and IV access devices is high; North America holds a significant share, while Europe remains a major contributor. Countries like the United States and Germany maintain strong demand due to advanced healthcare systems and sustained investments in medical technology and safety compliance.
  • In 2023, the U.S. Food and Drug Administration did not issue a new regulation specifically mandating enhanced safety features uniquely for butterfly needle sets; however, safety-engineered sharps (including winged infusion sets) have long been subject to requirements under the Needlestick Safety and Prevention Act and FDA/OSHA frameworks, and manufacturers market butterfly sets with integrated safety shields and 510(k)-cleared designs to minimize needlestick injuries.
Global Butterfly Needle Sets Market Size

Global Butterfly Needle Sets Market Segmentation

By Type:The market segmentation by type includes various categories such as standard butterfly needle sets, safety-engineered butterfly needle sets, pre-attached tubing and holder sets, and different gauge sizes. Among these, safety-engineered butterfly needle sets are gaining traction due to their ability to reduce the risk of needlestick injuries, which is a significant concern in healthcare settings. The demand for these products is driven by increasing awareness of safety protocols and regulations in hospitals and clinics.

Global Butterfly Needle Sets Market segmentation by Type.

By End-User:The end-user segmentation includes hospitals, diagnostic laboratories, outpatient clinics, home healthcare services, and others. Hospitals are the dominant end-user segment, driven by the high volume of procedures requiring venipuncture and blood collection. The increasing number of outpatient procedures and the growing trend of home healthcare services are also contributing to the demand for butterfly needle sets, as they offer convenience and safety for patients.

Global Butterfly Needle Sets Market segmentation by End-User.

Global Butterfly Needle Sets Market Competitive Landscape

The Global Butterfly Needle Sets Market is characterized by a dynamic mix of regional and international players. Leading participants such as Becton, Dickinson and Company (BD), Terumo Corporation, Smiths Medical (ICU Medical, Inc.), Nipro Corporation, Medline Industries, LP, Fresenius Kabi AG, Vygon SA, Medtronic (Covidien), Amsino International, Inc., Halyard Health, Inc. (Owens & Minor, Inc.), Aesculap AG (B. Braun Group), B. Braun Melsungen AG, SOL-Millennium Medical Group, Cardinal Health, Inc., Hindustan Syringes & Medical Devices Ltd. (HMD) contribute to innovation, geographic expansion, and service delivery in this space.

Becton, Dickinson and Company (BD)

1897

Franklin Lakes, New Jersey, USA

Terumo Corporation

1921

Tokyo, Japan

Smiths Medical (ICU Medical, Inc.)

1940

San Clemente, California, USA

Nipro Corporation

1954

Osaka, Japan

Medline Industries, LP

1966

Northfield, Illinois, USA

Company

Establishment Year

Headquarters

Global presence and regulatory clearances (FDA 510(k), CE mark)

Product portfolio breadth (gauges, safety-engineered variants)

Revenue growth rate (butterfly/vascular access segment)

Average selling price (ASP) by region

Market penetration (hospital, lab, blood bank accounts)

Contract coverage via GPOs/IDNs and tenders

Global Butterfly Needle Sets Market Industry Analysis

Growth Drivers

  • Increasing Demand for Minimally Invasive Procedures:The global shift towards minimally invasive procedures is a significant growth driver for butterfly needle sets. In future, the minimally invasive surgical market is projected to reach $50 billion, reflecting a 10% increase from the previous year. This trend is fueled by patient preferences for reduced recovery times and lower complication rates. As healthcare providers adopt these techniques, the demand for specialized devices like butterfly needles is expected to rise, enhancing patient outcomes and operational efficiency.
  • Rising Prevalence of Chronic Diseases:The World Health Organization reported that chronic diseases account for 71% of global deaths, with 41 million people dying annually from conditions such as diabetes and cardiovascular diseases. This alarming statistic underscores the increasing need for effective medical interventions, including butterfly needle sets, which facilitate easier blood draws and medication administration. As the prevalence of these diseases continues to rise, healthcare systems will increasingly rely on advanced medical devices to manage patient care effectively.
  • Technological Advancements in Medical Devices:The medical device industry is witnessing rapid technological advancements, with the global market for medical devices expected to reach $600 billion in future. Innovations such as safety-engineered butterfly needles, which reduce the risk of needle-stick injuries, are gaining traction. These advancements not only improve patient safety but also enhance the efficiency of healthcare delivery, driving the adoption of butterfly needle sets in various clinical settings, including hospitals and outpatient facilities.

Market Challenges

  • High Cost of Advanced Butterfly Needle Sets:The cost of advanced butterfly needle sets can be a significant barrier to widespread adoption, particularly in resource-limited settings. For instance, premium butterfly needle sets can range from $1.50 to $3.00 per unit, which may be prohibitive for smaller clinics or hospitals operating on tight budgets. This financial constraint can limit access to these essential devices, hindering their potential market growth in certain regions.
  • Stringent Regulatory Requirements:The regulatory landscape for medical devices is becoming increasingly stringent, with agencies like the FDA and EMA enforcing rigorous approval processes. In future, the average time for device approval is projected to be around 12-18 months, which can delay market entry for new butterfly needle innovations. These regulatory hurdles can stifle innovation and limit the availability of advanced products, posing a challenge for manufacturers aiming to meet evolving healthcare needs.

Global Butterfly Needle Sets Market Future Outlook

The future of the butterfly needle sets market appears promising, driven by ongoing innovations and a growing emphasis on patient safety. As healthcare systems increasingly prioritize minimally invasive techniques, the demand for specialized devices is expected to rise. Additionally, the integration of smart technology into medical devices will likely enhance functionality and user experience. With a focus on sustainability, manufacturers are also expected to develop eco-friendly products, aligning with global environmental goals and consumer preferences.

Market Opportunities

  • Expansion in Emerging Markets:Emerging markets present significant growth opportunities for butterfly needle sets, driven by increasing healthcare investments. For example, countries like India and Brazil are projected to increase healthcare spending by 12% annually, creating demand for advanced medical devices. This expansion can lead to greater accessibility and adoption of butterfly needle sets in these regions, enhancing patient care.
  • Development of Innovative Products:The ongoing development of innovative butterfly needle designs, such as those with integrated safety features, represents a key market opportunity. As healthcare providers prioritize patient safety, products that minimize risks associated with needle-stick injuries are likely to gain traction. This innovation can drive market growth and improve overall healthcare outcomes, positioning manufacturers favorably in a competitive landscape.

Scope of the Report

SegmentSub-Segments
By Type

Standard (winged infusion) butterfly needle sets

Safety-engineered butterfly needle sets (with integrated safety shield)

Pre-attached tubing and holder sets (e.g., with luer/adapter or vacutainer)

Gauge size: 19G

Gauge size: 21G

Gauge size: 23G

Gauge size: 25G

Others (e.g., 27G, micro-infusion variants)

By End-User

Hospitals

Diagnostic laboratories and blood banks

Outpatient clinics and ambulatory surgery centers

Home healthcare and phlebotomy services

Others

By Application

Blood collection and venipuncture

IV rehydration and medication delivery

Blood transfusion and apheresis access

Pediatric and geriatric vascular access

Others

By Distribution Channel

Direct sales to hospitals and IDNs

Medical distributors and group purchasing organizations (GPOs)

Online channels and e-procurement platforms

Others

By Material

Stainless steel needle with polymer wings (PVC/PE/TPU)

Safety shield materials (polycarbonate/ABS)

Tubing materials (PVC-free/DEHP-free options)

Others

By Region

North America

Europe

Asia-Pacific

Latin America

Middle East & Africa

By Price Range

Low Price Range

Mid Price Range

High Price Range

Others

Key Target Audience

Investors and Venture Capitalist Firms

Government and Regulatory Bodies (e.g., Food and Drug Administration, European Medicines Agency)

Manufacturers and Producers

Distributors and Retailers

Healthcare Providers and Hospitals

Medical Device Wholesalers

Industry Associations

Health Insurance Companies

Players Mentioned in the Report:

Becton, Dickinson and Company (BD)

Terumo Corporation

Smiths Medical (ICU Medical, Inc.)

Nipro Corporation

Medline Industries, LP

Fresenius Kabi AG

Vygon SA

Medtronic (Covidien)

Amsino International, Inc.

Halyard Health, Inc. (Owens & Minor, Inc.)

Aesculap AG (B. Braun Group)

B. Braun Melsungen AG

SOL-Millennium Medical Group

Cardinal Health, Inc.

Hindustan Syringes & Medical Devices Ltd. (HMD)

Table of Contents

Market Assessment Phase

1. Executive Summary and Approach


2. Global Butterfly Needle Sets Market Overview

2.1 Key Insights and Strategic Recommendations

2.2 Global Butterfly Needle Sets Market Overview

2.3 Definition and Scope

2.4 Evolution of Market Ecosystem

2.5 Timeline of Key Regulatory Milestones

2.6 Value Chain & Stakeholder Mapping

2.7 Business Cycle Analysis

2.8 Policy & Incentive Landscape


3. Global Butterfly Needle Sets Market Analysis

3.1 Growth Drivers

3.1.1 Increasing demand for minimally invasive procedures
3.1.2 Rising prevalence of chronic diseases
3.1.3 Technological advancements in medical devices
3.1.4 Growing geriatric population

3.2 Market Challenges

3.2.1 High cost of advanced butterfly needle sets
3.2.2 Stringent regulatory requirements
3.2.3 Risk of needle-stick injuries
3.2.4 Limited awareness in emerging markets

3.3 Market Opportunities

3.3.1 Expansion in emerging markets
3.3.2 Development of innovative products
3.3.3 Strategic partnerships and collaborations
3.3.4 Increasing focus on patient safety

3.4 Market Trends

3.4.1 Shift towards single-use devices
3.4.2 Integration of smart technology in medical devices
3.4.3 Growing preference for home healthcare solutions
3.4.4 Emphasis on sustainability in product design

3.5 Government Regulation

3.5.1 FDA regulations on medical devices
3.5.2 CE marking requirements in Europe
3.5.3 ISO standards for quality management
3.5.4 Guidelines for safe disposal of medical waste

4. SWOT Analysis


5. Stakeholder Analysis


6. Porter's Five Forces Analysis


7. Global Butterfly Needle Sets Market Market Size, 2019-2024

7.1 By Value

7.2 By Volume

7.3 By Average Selling Price


8. Global Butterfly Needle Sets Market Segmentation

8.1 By Type

8.1.1 Standard (winged infusion) butterfly needle sets
8.1.2 Safety-engineered butterfly needle sets (with integrated safety shield)
8.1.3 Pre-attached tubing and holder sets (e.g., with luer/adapter or vacutainer)
8.1.4 Gauge size: 19G
8.1.5 Gauge size: 21G
8.1.6 Gauge size: 23G
8.1.7 Gauge size: 25G
8.1.8 Others (e.g., 27G, micro-infusion variants)

8.2 By End-User

8.2.1 Hospitals
8.2.2 Diagnostic laboratories and blood banks
8.2.3 Outpatient clinics and ambulatory surgery centers
8.2.4 Home healthcare and phlebotomy services
8.2.5 Others

8.3 By Application

8.3.1 Blood collection and venipuncture
8.3.2 IV rehydration and medication delivery
8.3.3 Blood transfusion and apheresis access
8.3.4 Pediatric and geriatric vascular access
8.3.5 Others

8.4 By Distribution Channel

8.4.1 Direct sales to hospitals and IDNs
8.4.2 Medical distributors and group purchasing organizations (GPOs)
8.4.3 Online channels and e-procurement platforms
8.4.4 Others

8.5 By Material

8.5.1 Stainless steel needle with polymer wings (PVC/PE/TPU)
8.5.2 Safety shield materials (polycarbonate/ABS)
8.5.3 Tubing materials (PVC-free/DEHP-free options)
8.5.4 Others

8.6 By Region

8.6.1 North America
8.6.2 Europe
8.6.3 Asia-Pacific
8.6.4 Latin America
8.6.5 Middle East & Africa

8.7 By Price Range

8.7.1 Low Price Range
8.7.2 Mid Price Range
8.7.3 High Price Range
8.7.4 Others

9. Global Butterfly Needle Sets Market Competitive Analysis

9.1 Market Share of Key Players

9.2 Cross Comparison of Key Players

9.2.1 Company name
9.2.2 Global presence and regulatory clearances (FDA 510(k), CE mark)
9.2.3 Product portfolio breadth (gauges, safety-engineered variants)
9.2.4 Revenue growth rate (butterfly/vascular access segment)
9.2.5 Average selling price (ASP) by region
9.2.6 Market penetration (hospital, lab, blood bank accounts)
9.2.7 Contract coverage via GPOs/IDNs and tenders
9.2.8 Innovation cadence (new SKUs, safety upgrades, PVC-free lines)
9.2.9 Manufacturing footprint and capacity utilization
9.2.10 Distribution network efficiency (fill rate, on-time delivery)
9.2.11 Quality and safety KPIs (recall incidence, complaint rate)
9.2.12 Customer satisfaction/NPS among phlebotomy users

9.3 SWOT Analysis of Top Players

9.4 Pricing Analysis

9.5 Detailed Profile of Major Companies

9.5.1 Becton, Dickinson and Company (BD)
9.5.2 Terumo Corporation
9.5.3 Smiths Medical (ICU Medical, Inc.)
9.5.4 Nipro Corporation
9.5.5 Medline Industries, LP
9.5.6 Fresenius Kabi AG
9.5.7 Vygon SA
9.5.8 Medtronic (Covidien)
9.5.9 Amsino International, Inc.
9.5.10 Halyard Health, Inc. (Owens & Minor, Inc.)
9.5.11 Aesculap AG (B. Braun Group)
9.5.12 B. Braun Melsungen AG
9.5.13 SOL-Millennium Medical Group
9.5.14 Cardinal Health, Inc.
9.5.15 Hindustan Syringes & Medical Devices Ltd. (HMD)

10. Global Butterfly Needle Sets Market End-User Analysis

10.1 Procurement Behavior of Key Ministries

10.1.1 Government healthcare procurement policies
10.1.2 Budget allocation for medical supplies
10.1.3 Evaluation criteria for suppliers

10.2 Corporate Spend on Infrastructure & Energy

10.2.1 Investment in healthcare infrastructure
10.2.2 Spending on medical equipment
10.2.3 Trends in healthcare expenditure

10.3 Pain Point Analysis by End-User Category

10.3.1 Challenges faced by hospitals
10.3.2 Issues in outpatient clinics
10.3.3 Concerns in home healthcare

10.4 User Readiness for Adoption

10.4.1 Training requirements for healthcare staff
10.4.2 Acceptance of new technologies
10.4.3 Infrastructure readiness

10.5 Post-Deployment ROI and Use Case Expansion

10.5.1 Measurement of cost savings
10.5.2 Impact on patient outcomes
10.5.3 Opportunities for product expansion

11. Global Butterfly Needle Sets Market Future Size, 2025-2030

11.1 By Value

11.2 By Volume

11.3 By Average Selling Price


Go-To-Market Strategy Phase

1. Whitespace Analysis + Business Model Canvas

1.1 Market gaps and opportunities

1.2 Value proposition development

1.3 Revenue model identification

1.4 Key partnerships and resources

1.5 Customer segments and relationships

1.6 Cost structure analysis

1.7 Channels for delivery


2. Marketing and Positioning Recommendations

2.1 Branding strategies

2.2 Product USPs

2.3 Target market identification

2.4 Communication strategies

2.5 Digital marketing initiatives


3. Distribution Plan

3.1 Urban retail strategies

3.2 Rural NGO tie-ups

3.3 Online distribution channels

3.4 Direct sales force deployment


4. Channel & Pricing Gaps

4.1 Underserved routes

4.2 Pricing bands analysis

4.3 Competitor pricing strategies

4.4 Customer willingness to pay


5. Unmet Demand & Latent Needs

5.1 Category gaps

5.2 Consumer segments analysis

5.3 Emerging trends in consumer preferences


6. Customer Relationship

6.1 Loyalty programs

6.2 After-sales service

6.3 Customer feedback mechanisms


7. Value Proposition

7.1 Sustainability initiatives

7.2 Integrated supply chains

7.3 Competitive advantages


8. Key Activities

8.1 Regulatory compliance

8.2 Branding efforts

8.3 Distribution setup


9. Entry Strategy Evaluation

9.1 Domestic Market Entry Strategy

9.1.1 Product mix considerations
9.1.2 Pricing band strategies
9.1.3 Packaging innovations

9.2 Export Entry Strategy

9.2.1 Target countries analysis
9.2.2 Compliance roadmap development

10. Entry Mode Assessment

10.1 Joint Ventures

10.2 Greenfield investments

10.3 Mergers & Acquisitions

10.4 Distributor Model


11. Capital and Timeline Estimation

11.1 Capital requirements

11.2 Timelines for market entry


12. Control vs Risk Trade-Off

12.1 Ownership considerations

12.2 Partnerships evaluation


13. Profitability Outlook

13.1 Breakeven analysis

13.2 Long-term sustainability strategies


14. Potential Partner List

14.1 Distributors

14.2 Joint Ventures

14.3 Acquisition targets


15. Execution Roadmap

15.1 Phased Plan for Market Entry

15.1.1 Market Setup
15.1.2 Market Entry
15.1.3 Growth Acceleration
15.1.4 Scale & Stabilize

15.2 Key Activities and Milestones

15.2.1 Milestone tracking
15.2.2 Activity scheduling

Research Methodology

ApproachModellingSample

Phase 1: Approach1

Desk Research

  • Analysis of industry reports from healthcare and medical device associations
  • Review of published articles in medical journals focusing on needle technology
  • Examination of market data from government health departments and regulatory bodies

Primary Research

  • Interviews with product managers at leading medical supply companies
  • Surveys with healthcare professionals using butterfly needle sets in clinical settings
  • Field interviews with procurement officers in hospitals and clinics

Validation & Triangulation

  • Cross-validation of findings through multiple data sources including sales and usage statistics
  • Triangulation of insights from primary interviews with secondary research data
  • Sanity checks conducted through expert panels comprising industry veterans

Phase 2: Market Size Estimation1

Top-down Assessment

  • Estimation of market size based on overall healthcare expenditure trends
  • Segmentation by end-user categories such as hospitals, clinics, and home care
  • Incorporation of growth rates from emerging markets and developed regions

Bottom-up Modeling

  • Volume estimates derived from sales data of butterfly needle sets from key manufacturers
  • Cost analysis based on pricing strategies of various product lines
  • Calculation of market size using unit sales multiplied by average selling price

Forecasting & Scenario Analysis

  • Multi-variable regression analysis incorporating factors like population growth and chronic disease prevalence
  • Scenario modeling based on potential regulatory changes and technological advancements
  • Development of baseline, optimistic, and pessimistic forecasts through 2030

Phase 3: CATI Sample Composition1

Scope Item/SegmentSample SizeTarget Respondent Profiles
Hospital Procurement Departments120Procurement Managers, Supply Chain Coordinators
Clinical Usage in Emergency Rooms90Emergency Room Physicians, Nursing Staff
Outpatient Clinics and Practices80Clinic Managers, Healthcare Practitioners
Home Healthcare Providers60Home Care Nurses, Patient Care Coordinators
Medical Supply Distributors70Sales Representatives, Distribution Managers

Frequently Asked Questions

What is the current value of the Global Butterfly Needle Sets Market?

The Global Butterfly Needle Sets Market is valued at approximately USD 230 million, reflecting a five-year historical analysis. This growth is driven by the increasing prevalence of chronic diseases and advancements in safety-engineered winged infusion sets.

What factors are driving the growth of the butterfly needle sets market?

Which regions are leading in the butterfly needle sets market?

What types of butterfly needle sets are available in the market?

Other Regional/Country Reports

Indonesia Global Butterfly Needle Sets Market

Malaysia Global Butterfly Needle Sets Market

KSA Global Butterfly Needle Sets Market

APAC Global Butterfly Needle Sets Market

SEA Global Butterfly Needle Sets Market

Vietnam Global Butterfly Needle Sets Market

Why Buy From Us?

Refine Robust Result (RRR) Framework
Refine Robust Result (RRR) Framework

What makes us stand out is that our consultants follow Robust, Refine and Result (RRR) methodology. Robust for clear definitions, approaches and sanity checking, Refine for differentiating respondents' facts and opinions, and Result for presenting data with story.

Our Reach Is Unmatched
Our Reach Is Unmatched

We have set a benchmark in the industry by offering our clients with syndicated and customized market research reports featuring coverage of entire market as well as meticulous research and analyst insights.

Shifting the Research Paradigm
Shifting the Research Paradigm

While we don't replace traditional research, we flip the method upside down. Our dual approach of Top Bottom & Bottom Top ensures quality deliverable by not just verifying company fundamentals but also looking at the sector and macroeconomic factors.

More Insights-Better Decisions
More Insights-Better Decisions

With one step in the future, our research team constantly tries to show you the bigger picture. We help with some of the tough questions you may encounter along the way: How is the industry positioned? Best marketing channel? KPI's of competitors? By aligning every element, we help maximize success.

Transparency and Trust
Transparency and Trust

Our report gives you instant access to the answers and sources that other companies might choose to hide. We elaborate each steps of research methodology we have used and showcase you the sample size to earn your trust.

Round the Clock Support
Round the Clock Support

If you need any support, we are here! We pride ourselves on universe strength, data quality, and quick, friendly, and professional service.

Why Clients Choose Us?

400000+
Reports in repository
150+
Consulting projects a year
100+
Analysts
8000+
Client Queries in 2022