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ENFIT SYRINGES MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2025 - 2032)
ENFit Syringes Market, By Capacity (Enteral/Oral (1mL - 10mL), Catheter Tip (10mL - 60mL), and (Large Volume (60mL))), By Tip Type (ENFit Connectors (Standard, SafeLock) and ENFit Transition Sets/Adaptors), By Material (Polypropylene (PP), Polyethylene (PE), Polycarbonate (PC), Silicone (plunger gasket/seals), and Latex-free elastomers), By Patient Group (Neonatal, Pediatric, Adult, and Geriatric/Long-term care dependent), By End User (Hospitals, Specialty Clinics, Long Term Care Facilities, Home Care Settings, and Ambulatory Surgical Centers), By Distribution Channel (Online and Offline), By Geography (North America, Europe, Asia Pacific, Latin America, Middle East, and Africa)
- Published In : 16 Dec, 2025
- Code : CMI9083
- Pages :168
- Formats :
Excel and PDF
- Industry : Medical Devices
- Historical Range: 2020 - 2024
- Forecast Period: 2025 - 2032
Global ENFit Syringes Market Size and Forecast – 2025 to 2032
The Global ENFit Syringes Market is estimated to be valued at USD 298.9 Mn in 2025 and is expected to reach USD 458.4 Mn by 2032, reflecting a compound annual growth rate (CAGR) of 6.3% from 2025 to 2032. This steady growth is driven by increasing demand for safe and standardized enteral feeding systems across healthcare settings worldwide, supported by regulatory mandates and rising awareness about preventing feeding tube misconnections.
Key Takeaways of the Global ENFit Syringes Market
- By capacity, enteral/oral (1 mL - 10 mL) segment is expected to holds the largest market share at 59.8% in 2025.
- By tip type, ENFit connectors (Standard, SafeLock) segment is projected to capture 62.4% of the market share in 2025.
- By material, Polypropylene (PP) remains the dominant segment, representing 32.4% of the global ENFit syringes market share in 2025.
- North America is expected to lead the market, holding a share of 41.2% in 2025. Asia Pacific is anticipated to be the fastest-growing region, with 24.3% share in 2025.
Market Overview
- A notable market trend is the shift towards enhanced patient safety and infection control through the adoption of ENFit-compatible devices.
- Healthcare providers are increasingly prioritizing these syringes due to their compliance with international standards, which reduces medical errors and improves clinical outcomes.
- Additionally, technological advancements in syringe design and materials are fueling product innovation, while growing applications in home healthcare settings are further expanding market reach.
Current Events and Its Impact
|
Current Events |
Description and its Impact |
|
Hospital systems tighten enteral safety protocols |
|
|
Accelerated Adoption of Smart & Connected Medical Devices |
|
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Why Are 1–10 mL ENFit Syringes Leading the Market for Safe and Precise Enteral Medication Delivery?
The Enteral/Oral (1mL - 10mL) segment is the highest share of the global market of ENFit syringes that reaches the figure of 59.8% share in 2025. It is the great need for accurate measurements in enteral nutrition and oral drug administration that makes this segment so attractive, as usually small volumes are required in these cases.
Syringes that enable precise dosing are the ones that patients receiving enteral feeding, particularly neonates and elderly, demand. The consequence of dosing errors can be serious complications and thus the exact measurement of 1mL to 10mL syringe capacity is the one that provides the needed flexibility and control for safe and effective treatment.
For example, this trend is evident in manufacturer portfolios focused on low-volume accuracy. Baxter International and ICU Medical offer ENFit syringes in the 1 mL–10 mL range designed for neonatal and pediatric dosing protocols. BD (Becton, Dickinson and Company) has strengthened this segment with clear graduations and smooth plunger control to reduce dosing variability.
(Source: https://enteralenfitsyringes.com/ProductOverview.html)
Why Are ENFit Connectors (Standard & SafeLock) Rapidly Becoming the Preferred Tip Type for Safer, Regulation-Compliant Enteral Delivery?
By tip type, the ENFit connectors (Standard, SafeLock) segment is projected to capture 62.4% share in 2025. The primary reason behind this shift is the global healthcare industry's ever-increasing focus on patient safety and error-free drug administration through various systems.
These connectors have been specially designed to provide a high level of safety by preventing the wrong connections between feeding tubes and intravenous or respiratory devices, which have been a major cause of delivering unintended medication and severe adverse events in the past. The Standard and SafeLock connectors are compatible and provide an easy-to-use interface that is universally accepted in enteral feeding systems, thus giving the assurance that different healthcare settings can easily integrate with each other and share patients worldwide.
For example, Qosina and Vygon have expanded ENFit Standard and SafeLock connector portfolios to support hospital-wide enteral safety transitions, particularly in NICUs and intensive care units. Vesco Medical has focused on ENFit connectors with secure locking mechanisms and universal compatibility, addressing misconnection risks in high-acuity care environments.
(Source: https://www.vygon.com/en/products/enteral/enfit-nutrifit-feeding-systems)
ENFit Syringes Market Insights, By Material
Polypropylene (PP) is expected to command 32.4% of the market share in 2025, due to its cost and wide range of physical properties that it can offer. The carte blanche of PP, which is its wide acceptability, is largely attributed to its splendid chemical resistance, durability, and the ability to withstand sterilization processes which are common for medical devices. This way, the polypropylene syringes not only conform to the high standards set by the healthcare industry but also are produced and used at a lower cost due to large-scale manufacturing and use.
Polypropylene's built-in transparency and toughness allow for proper visual monitoring of drug amounts during the dispensing process, which is a critical factor in hospitals. Furthermore, the material's lightness has a positive impact on the efficiency of operations and patient care as it leads to less fatigue for the healthcare workers during the dosing that is done repeatedly.
Regulatory Compliance and Adoption Timeline for ENFit Syringes
- Regulatory compliance has been the primary catalyst shaping ENFit syringe adoption, driven by ISO 80369-3 standards aimed at eliminating enteral misconnections. Mandates and strong recommendations from bodies such as ISO, U.S. FDA, EMA, NHS, and patient safety organizations pushed manufacturers to redesign connectors, update labeling, and validate system-wide compatibility. Large healthcare providers and group purchasing organizations accelerated compliance by embedding ENFit requirements into procurement contracts, making regulatory alignment a commercial necessity rather than a choice.
- The adoption timeline shows early uptake in Europe between 2016–2018, followed by structured implementation across North America from 2019–2022 as hospitals phased out legacy connectors. Asia-Pacific markets entered a transition phase post-2022, led by Japan, Australia, and advanced urban hospitals in China and India. Full global normalization is expected by 2026–2028, with remaining growth driven by replacement cycles, neonatal and pediatric low-dose syringes, and tighter enforcement through hospital accreditation and safety audits.
Regional Insights
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North America ENFit Syringes Market Analysis and Trends
The North American region with its well-developed healthcare system, strict regulations, and patient safety advocacy is expected to command 41.2% of the global ENFit syringes market share in 2025. The USFDA has been taking an active role in promoting the use of ENFit connectors to prevent misconnection errors occurring in the enteral feeding systems.
Moreover, the presence of such prominent medical device companies and distributors as Becton Dickinson (BD), ICU Medical, and Medline Industries has not only supported innovation but also enhanced the availability of ENFit syringes. The region is characterized by comprehensive hospital networks and the rising adoption of standard enteral feeding protocols that are conducive to rapid market penetration.
Asia Pacific ENFit Syringes Market Analysis and Trends
The Asia Pacific region is predicted to have the fastest growing market for ENFit Syringes due to the increasing awareness about the safety in enteral feeding with 24.3% share in 2025, due to healthcare infrastructure expansion, and adoption of international safety standards.
Local companies like Terumo Corporation (Japan) and Shanghai Kindly Medical Instruments (China) are working with international companies to make their products available at lower prices through better competition. In addition, trade and healthcare developments are main factors contributing to the growth of the market in the Asia Pacific region.
ENFit Syringes Market Outlook for Key Countries
What’s Driving the Shift Toward ENFit Syringes in the U.S. Healthcare System?
The market for ENFit syringes in the U.S. remains at the forefront due to active regulatory requirements that push the substitution of the old enteral feeding connectors with ENFit-compliant devices. The leading brands BD and ICU Medical have come up with an extensive range of ENFit syringes to cater to hospitals and outpatient clinics.
The vast healthcare system in the country is an assurance of fast adoption of the products, which is further supported by the advocacy groups that stress the prevention of enteral misconnections. Healthcare providers are encouraged by reimbursement policies and compliance standards, thus increasing demand and at the same time fueling the continuous innovation in the design and safety features of syringes.
Why Is Germany Accelerating the Adoption of ENFit Syringes Across Hospitals and Homecare Settings?
Germany’s ENFit syringes market is marked by extraordinary medical safety levels and strong regulatory oversight from agencies such as BfArM (Federal Institute for Drugs and Medical Devices). The European company B. Braun Melsungen AG, known for its top-notch medical technology, is one of the leading developers and manufacturers of ENFit syringes, combining high-tech materials and ergonomic innovations.
Germany has a solid industrial base and a favorable trade scenario, which makes it possible for Europe to have access to the latest ENFit products. Europe trusts Germany's standardized protocols for patient safety, thus it is regarded as the main location that determines the ENFit-type syringe adoption in the entire continent.
Japan ENFit Syringes Market Trends
Japan's ENFit syringes market is an amalgamation of advanced technological skills and governmental imposed safety regulations in the medical device sector. Local manufacturers, Terumo Corporation being one, have taken part in the fabrication of ENFit syringe solutions that apply to both local and international standards.
Kenya's dependence on an elderly population and growing home treatment service provisions is a sign that there is a high demand for safe systems for enteral feeding. The avant-garde policies and reimbursement schemes of the Japanese government in health care virtually ensure the transition to feeding device connectivity that is safer, thus making Japan a leading market in the Asia pacific area.
India ENFit Syringes Market Trends
With the India ENFit syringes market, it is a different story because the healthcare investment and awareness of enteral feeding safety in both clinical and homecare environments are not only growing but also very much so the healthcare sector is being driven by the government’s initiatives to improve the country’s medical infrastructure and bring it to the level of international safety standards.
Moreover, Indian firms are getting more and more involved in partnerships with foreign firms for the manufacturing of ENFit syringes that are inexpensive, which makes these devices available to the populations of tier-2 and tier-3 cities. The patient safety innovations together with the India healthcare reforms and growing insurance coverage present the country as a vast user base, which is energized by its demographic profile and increasing demand.
Reusable vs Single-Use ENFit Syringes: Economic Comparison
|
Parameter |
Single-Use ENFit Syringes |
Reusable ENFit Syringes |
|
Upfront Cost |
Higher per-unit cost, offset by volume procurement contracts |
Lower initial purchase cost per unit |
|
Infection Control |
Strong compliance with hospital infection prevention protocols |
Higher contamination risk without validated reprocessing |
|
Regulatory Acceptance |
Widely accepted and preferred by regulators and accreditation bodies |
Increasing regulatory scrutiny on cleaning and reuse validation |
|
Operational Costs |
No reprocessing, minimal labor and documentation burden |
Added costs for cleaning, sterilization, and compliance records |
|
Clinical Adoption |
Dominant in hospitals, ICUs, NICUs, and long-term care |
Limited use in homecare and cost-sensitive settings |
|
Liability & Risk |
Lower legal and patient safety risk |
Higher liability exposure if reprocessing fails |
|
Lifecycle Economics |
Predictable, scalable, and favorable at high volumes |
Economic advantage narrows due to material wear and compliance costs |
|
Market Outlook |
Growing demand driven by safety mandates and standardization |
Gradual decline as standards tighten and reimbursement improves |
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Market Players, Key Developments, and Competitive Intelligence
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Key Developments
- In September 2024, Azurity Pharmaceuticals is a specialty drug company focused on patient friendly formulations announced FDA approval for Nymalize oral solution in prefilled ENFit syringes. The U.S. Food and Drug Administration is the national drug regulator approved the 30 mg per 5 mL ENFit syringe format. Azurity stated ENFit syringes improve dosing safety and support standardized enteral drug administration.
- In 2023, Fortune Medical produced ENFit-compatible silicone feeding tubes for both gastrostomy and nasogastric use, strengthening enteral feeding systems designed around ENFit connectors and improving seamless compatibility with ENFit-compatible syringes.
Top Strategies Followed by Global ENFit Syringes Market Players
|
Player Type |
Strategic Focus |
Example |
|
Established Market Leaders |
High R&D investment for safety-driven design, ENFit system compatibility, ergonomic improvements, regulatory-compliant materials, strategic OEM alliances, and global distribution expansion |
Companies such as BD, Baxter, B. Braun, and Fresenius Kabi invest in advanced ENFit syringe designs, collaborate with pump and enteral system OEMs, and expand across Asia-Pacific and Latin America |
|
Mid-Level Players |
Cost-effective ENFit syringes balancing quality and affordability, manufacturing optimization, technology collaborations, regional focus, and supply chain partnerships |
Players including Vygon, Amsino International, GBUK Group, and Vesco Medical emphasize efficient production, partner with technology providers, and strengthen presence in price-sensitive healthcare markets |
|
Small-Scale Players |
Niche-focused innovation, specialized ENFit syringes for neonatal, pediatric, and homecare use, novel materials, and local partnerships for market entry |
Emerging manufacturers such as NeoMed, Medela, and Hoist Medical target specialized clinical applications and collaborate with local distributors and healthcare providers to build regional traction |
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Market Report Scope
Report Coverage
| Report Coverage | Details | ||
|---|---|---|---|
| Base Year: | 2024 | Market Size in 2025: | USD 298.9 Mn |
| Historical Data for: | 2020 To 2024 | Forecast Period: | 2025 To 2032 |
| Forecast Period 2025 to 2032 CAGR: | 6.3% | 2032 Value Projection: | USD 458.4 Mn |
| Geographies covered: |
|
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| Segments covered: |
|
||
| Companies covered: |
Becton Dickinson and Company, Baxter International, B. Braun Melsungen, Cardinal Health, Medline Industries, Avanos Medical, Fresenius Kabi, Vygon, HMC Group, Medicina, GBUK Group, Vesco Medical, Amsino International, Kentec Medical, and KB Medical Group |
||
| Growth Drivers: |
|
||
| Restraints & Challenges: |
|
||
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ENFit Syringes Market Dynamics
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ENFit Syringes Market Driver - Patient Safety Focus to Prevent Misconnections with IV Luer Systems
A major factor that has been driving the ENFit syringes adoption all over the world is the heightened focus on patient safety, the most pressing concern being the prevention of erroneous connections between enteral feeding systems and IV luer devices. The use of conventional luer connectors, which are typical in IV lines, is a major contributor to mixing of enteral connectors that are often similar in both appearance and functionality, thus posing a risk of human error that could eventually lead to serious patient injury or even death. To tackle such issues, the healthcare industry along with the regulators are pushing for the ENFit syringes to be used widely, as they come with a luer lockless connector that is not only different but also designed in such a way that can physically stop the connection with IV devices in one-go. This design based on safety not only cuts down the chances of human errors in medicine but also goes hand in hand with the tough hospital safety practices and the standards required for being accredited.
In November 2021, Global Enteral Device Supplier Association is a nonprofit enteral safety body supported U.S. FDA guidance on ENFit syringes, confirming safe use when instructions are followed. The U.S. Food and Drug Administration reaffirmed ENFit low dose tip syringes reduce misconnection risks despite potential dosing errors from misuse. U.S. FDA asked manufacturers to strengthen labeling and training materials to ensure accurate ENFit syringe dosing. GEDSA reported over 120 million ENFit syringes sold and rising hospital adoption across North America.
(Source:https://www.vygon.com/en/news/risk-drug-overdose-enfit-low-dose-tip-syringe-fda-safety-communication)
ENFit Syringes Market Opportunity - Expansion of Neonatal and Pediatric Low-Dose ENFit Syringes
More and more people are becoming aware of patient safety issues, particularly in the case of vulnerable groups such as newborns and infants, which could be a major factor in the global market for low-dose ENFit syringes being expanded. ENFit syringes are purposely made so that the risk of mistakes in enteral feeding is almost entirely eliminated by the fact that they can only be connected to enteral feeding tubes, thus no accidental intravenous or other non-enteral delivery can take place. This is a very important matter in neonatal and pediatric care which has to do with the increasing number of premature births and chronic pediatric conditions that require enteral nutrition. So the healthcare providers are giving more importance to the specialized equipment that guarantees precision and safety. Thus the low-dose ENFit syringes, which offer the precise administration of small volumes of fluid, are perfect for this specific patient group, as they minimize the need for dosage accuracy in vulnerable patients.
For example, Avanos Medical targets NICU micro-dosing, Vygon emphasizes high-accuracy pediatric syringes, while Fresenius Kabi and B. Braun integrate ENFit solutions into pediatric enteral care systems. GBUK Group and Amsino International support both hospital and home-care pediatric use, reinforcing growth in this segment.
(Source:https://avanos.com/enteral-feeding/enteral-feeding-neonates-neonatologists-nicu-nurses-dietitians/)
Analyst Opinion (Expert Opinion)
- The ENFit syringes market is moving from being enforced by regulations to being used in fresh routine clinics. The main factor pushing the market forward is the demand for compliance with ISO 80369-3 which is a legal requirement for the healthcare sector to get rid of obsolete connectors. The increase in demand is coming from units dealing with newborns, children, and patients in long-term care facilities where it is very important that the right amount of medicine is given and, at the same time, no connection errors happen. Besides, manufacturers are putting their efforts into small dose syringes, ergonomics and materials. The main opportunity lies in home nutrition for the enteral, and in the emerging markets, while high device prices and conversion problems are the main issues that slow down the process of adoption.
- The industry has been gaining momentum strong through such events as MEDICA, Arab Health, MD&M West and CMEF, where the issue of connector standardization and enteral safety was discussed for over the last two or three years and made a great impact on this process. These discussions quickened up the process of clinicians' awareness and technology acceptance. On the other side of implementation, the U.S. and European hospitals-driven enteral safety programs are urging NICUs to use ENFit only, thus creating a high demand in these units. It is no longer a transitional product; ENFit syringes are becoming a standard of care as indicated by the manufacturers' portfolio expansions and healthcare providers' stricter purchasing policies.
Market Segmentation
- Capacity Insights (Revenue, USD Mn, 2020 - 2032)
- Enteral/Oral (1mL - 10mL)
- Catheter Tip (10mL - 60mL)
- Large Volume (60mL)
- Tip Type Insights (Revenue, USD Mn, 2020 - 2032)
- ENFit Connectors (Standard, SafeLock)
- ENFit Transition Sets/Adaptors
- Material Insights (Revenue, USD Mn, 2020 - 2032)
- Polypropylene (PP)
- Polyethylene (PE)
- Polycarbonate (PC)
- Silicone (plunger gasket/seals)
- Latex-free elastomers
- Patient Group Insights (Revenue, USD Mn, 2020 - 2032)
- Neonatal
- Pediatric
- Adult
- Geriatric/Long-term care dependent
- End User Insights (Revenue, USD Mn, 2020 - 2032)
- Hospitals
- Specialty Clinics
- Long Term Care Facilities
- Home Care Settings
- Ambulatory Surgical Centers
- Distribution Channel Insights (Revenue, USD Mn, 2020 - 2032)
- Online
- Offline
- Regional Insights (Revenue, USD Mn, 2020 - 2032)
- North America
- U.S.
- Canada
- Latin America
- Brazil
- Argentina
- Mexico
- Rest of Latin America
- Europe
- Germany
- U.K.
- Spain
- France
- Italy
- Russia
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- Australia
- South Korea
- ASEAN
- Rest of Asia Pacific
- Middle East
- GCC Countries
- Israel
- Rest of Middle East
- Africa
- South Africa
- North Africa
- Central Africa
- North America
- Key Players Insights
- Becton Dickinson and Company
- Baxter International
- Braun Melsungen
- Cardinal Health
- Medline Industries
- Avanos Medical
- Fresenius Kabi
- Vygon
- HMC Group
- Medicina
- GBUK Group
- Vesco Medical
- Amsino International
- Kentec Medical
- KB Medical Group
Sources
Primary Research Interviews
- Industry Stakeholders List
- Hospital procurement heads
- Clinical engineering and biomedical managers
- End users List
- NICU nursing leads
- Home enteral nutrition caregivers
Government and International Databases
- U.S. Food and Drug Administration
- European Medicines Agency
- World Health Organization
- International Organization for Standardization
- OECD Health Statistics
- National Institutes of Health
Trade Publications
- Medical Device and Diagnostic Industry
- Healthcare Packaging
- Infection Control Today
- Medical Plastics News
- DeviceTalks
- Clinical Innovations
Academic Journals
- BMJ Open
- Journal of Patient Safety
- Pediatric Critical Care Medicine
- Journal of Clinical Nursing
- Nutrition in Clinical Practice
- International Journal for Quality in Health Care
Reputable Newspapers
- The New York Times
- The Guardian
- The Wall Street Journal
- Financial Times
- The Washington Post
- BBC News
Industry Associations
- Association for the Advancement of Medical Instrumentation
- American Society for Parenteral and Enteral Nutrition
- European Society for Clinical Nutrition and Metabolism
- International Society for Quality in Health Care
- International Pediatric Safety Network
- Healthcare Supply Chain Association
Public Domain Resources
- ISO 80369 Standards Library
- FDA MAUDE Database
- ClinicalTrials Registry
- EU Medical Device Regulation Repository
- National Health Service Safety Alerts
- Public Health Agency Safety Bulletins
Proprietary Elements
- CMI Data Analytics Tool: Proprietary analytics tool to analyze real-time market trends, consumer behavior, and technology adoption in market
- Proprietary CMI Existing Repository of Information for Last 8 Years
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About Author
Komal Dighe is a Management Consultant with over 8 years of experience in market research and consulting. She excels in managing and delivering high-quality insights and solutions in Health-tech Consulting reports. Her expertise encompasses conducting both primary and secondary research, effectively addressing client requirements, and excelling in market estimation and forecast. Her comprehensive approach ensures that clients receive thorough and accurate analyses, enabling them to make informed decisions and capitalize on market opportunities.
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