Safety Needles Market Analysis & Forecast: 2025-2032

Safety Needles Market Analysis & Forecast: 2025-2032

Safety Needles Market size is estimated to be valued at USD 6.63 Bn in 2025 and is expected to reach USD 11.74 Bn in 2032, exhibiting a compound annual growth rate (CAGR) of 8.5% from 2025 to 2032.

Key Takeaways

• By Product Type, The Hypodermic Needle Segment is projected to lead with 17.0% market share in 2025, owing to its widespread use in vaccinations, drug delivery, and blood collection.
• By Region, North America is forecasted to retain dominance in the global safety needles market outlook, capturing 44.3% of the market share in 2025, primarily due to stringent safety regulations and advanced healthcare infrastructure.

Market Overview

The Safety Needles Market growth is experiencing robust growth, primarily driven by the increasing incidence of needlestick injuries (NSIs) and the consequent risk of transmitting bloodborne diseases like HIV and hepatitis. This has led to heightened awareness and the implementation of stringent regulations promoting the adoption of safety-engineered needles. For instance, the Needlestick Safety and Prevention Act in the U.S. mandates the use of safety needles in healthcare settings. Additionally, the rising prevalence of chronic diseases necessitating frequent injections, such as diabetes and cancer, further propels market demand. In India, government-led vaccination initiatives and efforts to improve injection safety are significantly contributing to market expansion.

Current Events and Its Impact

Current Events and Its Impact on the Safety Needles Market

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Global Safety Needles End User Pricing Analysis

The safety needles market features diverse pricing across product types and applications, reflecting differences in manufacturing complexity, regulatory compliance, and brand reputation.

• Hypodermic Safety Needles from leading brands range from approximately USD 0.35 to 1.20 per unit, with BD Safety-Lok syringes priced between $0.50 and $1.20, and Smiths Medical Jelco needles at $0.35 to $0.80.
• IV Catheter Safety Needles command higher prices, ranging from $1.80 to $4.50 per piece, depending on the brand and model, such as BD’s Insyte Autoguard BC priced at $2.50 to $4.50.
• Blood Collection Safety Needles typically range from $0.50 to $2.50 per piece or set, with BD Vacutainer Eclipse needles priced $0.60 to $1.30 and Sarstedt’s Safety-Multifly sets at $1.50 to $2.50.
• Specialty Safety Needles, like pen needles for insulin injection, are priced between $0.20 and $0.70 per unit, exemplified by BD AutoShield Duo pen needles at $0.30 to $0.60.
• Pricing varies by region due to factors like regulatory standards, with North America and Western Europe generally showing higher prices, while Asia-Pacific markets benefit from local manufacturing and volume-based discounts.

Overall, safety needle prices are influenced by raw material costs, device complexity, certification requirements, brand strength, purchase volume, and geographic location. The market trend shows a steady emphasis on investing in high-quality safety devices despite cost variations.

Patent Landscape

• As per May 2025, the global safety needles market demand is optimally positioned with a firm patent portfolio consisting of more than 350 live patents pertaining to safety needle mechanisms. Key patented holders are: BD (Becton, Dickinson and Company), Smiths Medical, Retractable Technologies, Nipro, and Terumo Corporation.
• Benchmark innovations revolve around improving user safety and device sustainability, including the development of auto-retractable needle systems, integrated sharps protection technologies, and the implementation of green polymer materials.
• A notable recent patent is the one by BD for a passive retractable needle with dual-locking mechanism is filed under patent no US2024/0198876A1. This underscores the firm’s commitment towards improving safety features of needle designs.
• This active patent terrain illustrates remarkable constancy; these ever-increasing technological innovations will always enhance competition among players in the market while simultaneously fueling product distinction.

Reimbursement Scenario

• Within the United States, safety needles are part of the Medicare Part B coverage and outpatient services Medicaid offers, with differing state provisions, especially concerning diabetes care. They reimburse using CPT and HCPCS coding like 96372, 96374, A4206, and A4215. Medicare pays approximately 80% of the costs after deductibles for outpatient services, while Medicaid depends on the state, paying 90-100% of the costs.
• Germany offers reimbursement through its statutory health insurance schemes for hospitals and nursing home use well within institutional settings.
• The UK’s policy allows the NHS to fully reimburse their listed primary care services safety needles for WHO essential procedures considered acute care in other medical settings.
• In contrast India and much of the Southeast Asia region face the shortage of reimbursement policies or set no boundary for reimbursement as purchasing involves paying through public tenders, making out-of-pocket costs a restriction for the broader populace.
• There is a growing trend where private insurers have emerged worldwide, who without fail stipulate the use of safety needles to process claims to lower their risks for liability and shifts client financial burden onto them.
• Overall, such gaps in frameworks for reimbursement tend to occur with a wide range generated by using policies focusing infection control regulation owing to how advanced the health care system is or coding policies and the level of development the country is at.

Government Regulations

• The adoption and compliance of safety needles across all global markets is governed by certain key regulations. In the United States, the Occupational Safety and Health Administration (OSHA) mandates the use of safety-engineered needles through the Needlestick Safety and Prevention Act to lessen occupational hazards.
• In the European Union, Medical Device Regulation (EU MDR) compels all safety-engineered sharps devices to obtain a CE marking after passing rigorous conformity assessments for safety and performance.
• Startin in 2024, China's National Medical Products Administration (NMPA) will require additional clinical data submission for safety needle approvals, thus changing the scope of post market surveillance supervision. These changes indicate heightened regulatory scrutiny.
• India’s Central Drugs Standard Control Organization (CDSCO) has also been more active as they recently published instructional notices aimed at integrating labeling and quality control standards for single use safety syringes.
• The therapeutic Goods Administration (TGA) in Australia is also enhancing their policies as they are paying more attention to human factors engineering and usability testing of the developed safety devices which concentrates on the well-being of healthcare staff and patients.
• These regulations help bolster innovation and the overall product safety as well as the compliance of various healthcare systems.

Segmental Analysis

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Global Safety Needles Market Insights, By Product Type 

The hypodermic needle segment is expected to dominate the safety needle market forecast owing to large volume of hypodermic needle market share of 17.0% that are being used in healthcare industries for diverse medical conditions.

Global Safety Needles Market Insights, By Application

The drug delivery segment is expected to hold a dominant position in the safety needles market during the forecast period and this is attributed to the increasing usage in growing clinical applications.

Global Safety Needles Market Insights, By Distribution channel

The hospital segment is expected to dominate the market over the forecast period and this is attributed to the increasing prevalence of chronic diseases such as HIV, cancer therapy and spine disorders.

Global Safety Needles Market- Regional Analysis

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North America Safety Needles Market Analysis and Trends

North America is estimated to hold a dominant position in the global safety needles market trend over the forecast period. North America is estimated to hold 44.3% of the market share in 2025. The growing prevalence of chronic diseases and spine disorders directly impacts the increased demand for the safety needles market.

For instance, in July 2022, according to an article published by StatPearls publishing, in North America, millions of healthcare workers use needles in their daily work, and hence, the risk of needlestick injuries is always a concern. While the introduction of universal precautions and safety conscious needle designs has led to a decline in needlestick injuries. However, the major concern after a needlestick injury is not HIV but hepatitis B or hepatitis C.

Market Report Scope

Global Safety Needles Market – Driver

 Product launch by the key players, and rising number of diabetic patients

To prevent the needlesticks injuries, the needs of safety needles conducting both prenatal and postnatal research, key market players are focused on launching new products to expand their product portfolio.

For instance, on January 10 2023, Sharps Technology, Inc., an medical device and drug delivery company offering patented, best-in-class syringe products, announced the advancement of the company's specialized prefillable syringe ("PFS") system product line, which will be manufactured in collaboration with Nephron Pharmaceuticals at the Inject EZ facility in West Columbia, South Carolina, U.S.

Global Safety Needles Market Cross Sectional Analysis:

Rising incidence of chronic diseases like HIV, cancer, hepatitis and spine disorders in emerging economies is also expected to boost demand for safety needles. For instance, on January 25 KORU Medical Systems, Inc., a medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use subcutaneous drug delivery device that improve quality of life for patients, announced a development agreement with a pharmaceutical manufacturer of subcutaneous immunoglobulin therapy (SCIg) to develop and seek regulatory approval of the Freedom Infusion System with an SCIg prefilled syringe.

Global Safety Needles Market: Key Trends

• Better healthcare infrastructure

Due to improved healthcare infrastructure, effective government policies, and a sizable base of multinational corporations, the safety needles market is expected to experience considerable expansion in the North American region. Products with advanced features such as self-retracting needles and needles with safety locking system are gaining traction among healthcare professionals and patients.

In October 2021, West Pharmaceutical Services, a designer and manufacturer of injectable pharmaceutical packaging and delivery systems announced its latest offering for the Indian domestic market – NovaGuard SA Pro Safety System, a single-use accessory for prefilled ISO standard 0.5mL staked needle syringes.

• Effective government policies

Effective government policy such as awareness about the proper usage of needles, running campaigns for the safety measures, and so on is expected to drive the global safety needle market. For instance, in April 2022, American Medical Association (AMA) urges states to adopt new Maine needle, syringe exchange policy to modify restrictive laws and regulations concerning the sale and possession of needles and syringes to maximize the availability of sterile syringes and needle.

Analysts’ Views on Global Safety Needles Market:

• The Safety Needles Market is expected to witness robust growth, driven by increasing emphasis on healthcare worker safety and regulatory mandates aimed at reducing needlestick injuries.
• Growing concerns about the transmission of bloodborne infections such as HIV and hepatitis have accelerated the adoption of safety-engineered needles featuring retractable or shielded mechanisms.
• Rising awareness around infection control and the implementation of stricter global healthcare guidelines are further propelling market expansion, as facilities work to ensure compliance and enhance patient and worker safety.
• Limited awareness and insufficient training on the correct usage and disposal of safety needles also hinder broader adoption in certain markets.
• Nevertheless, market opportunities remain strong, supported by the increasing global burden of chronic diseases and the growing volume of surgical and diagnostic procedures.
• Technological innovations such as needleless systems and passive safety mechanisms are enabling manufacturers to develop differentiated products and gain competitive advantage.
• North America currently leads the market, driven by strict regulatory frameworks, high healthcare expenditures, and widespread integration of advanced medical technologies.
• The Asia-Pacific region is expected to grow at the fastest rate, supported by ongoing improvements in healthcare infrastructure, increased healthcare spending, and enhanced awareness of infection prevention in major countries like China and India.

Global Safety Needles Market: Key Developments

• In May 2025, BD (Becton, Dickinson and Company) launched a new retractable passive safety needle series aimed at insulin and vaccine applications, enhancing safety and usability in these critical markets.
• In April 2025, Smiths Medical expanded its presence in the Asia-Pacific region by forming a strategic alliance with local medical device suppliers, strengthening its distribution network.
• In March 2025, Retractable Technologies Inc. secured FDA clearance for its redesigned auto-disable safety syringes, advancing device safety and compliance.
• In February 2025, Medline Industries invested in a new manufacturing facility in Mexico to lower production costs and improve supply chain flexibility.
• In January 2025, Nipro Medical Corporation introduced eco-friendly safety needle packaging, aligning with growing green healthcare initiatives worldwide.

Global Safety Needles Market - Key Players

Major players operating in the global safety needles market include Medtronic, Plc. Becton Dickinson Company, Boston Scientific Corporation, Smith Medical, Inc., Abbott Laboratories, Argon Medical Devices, Inc., Novo Nordisk A/S, Terumo Corporation, Eli Lily and Company, Nipro Medical Corporation, and B. Braun Melsungen AG.

Market Segmentation:

• Global Safety Needles Market, By Product Type:
  • Fine Aspirating Needle
  • Biopsy Needle
  • Hypodermic Needle
  • Pen Needle
  • Suture Needle
  • IV Catheter Needle
  • Huber Needle
  • Blood Collection Needle
  • Spinal Anesthesia Needle
  • Prefilled Syringe Needle
  • V. Fistula Needle
  • Cannula Needle
• Global Safety Needles Market, By Application:
  • Sample Collection
  • Drug Delivery
• Global Safety Needles Market, By Distribution:
  • Hospitals Pharmacies
  • Private Clinics
  • Retail Pharmacies
  • E-commerce
• Global Safety Needles Market, By Region:
  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East
  • Africa

Sources:

Primary Research Interviews:

• Industry Experts from Safety Needles Manufacturing Companies
• Product Managers from Healthcare Institutions
• Supply Chain Executives from Pharmaceutical Distributors
• Business Development Executives from Medical Device Distributors
• Others

Databases:

• World Health Organization (WHO) Database
• Centers for Disease Control and Prevention (CDC)
• Others

Magazines:

• Medical Device and Diagnostic Industry Magazine (MD+DI)
• Healthcare Global Magazine
• MedTech Outlook Magazine
• Others

Journals:

• International Journal of Nursing Studies
• Journal of Hospital Infection
• American Journal of Infection Control
• Others

Newspapers:

• The New York Times Health
• Healthcare Business News (DotMed)
• The Guardian Health Section
• Others

Associations:

• Association for Professionals in Infection Control (APIC)
• International Safety Center
• American Nurses Association (ANA)
• Occupational Safety and Health Administration (OSHA)
• Others

Public Domain Sources:

• U.S. Food and Drug Administration (FDA)
• United States Department of Health and Human Services (HHS)
• European Medicines Agency (EMA)
• ClinicalTrials.gov
• Others

Proprietary Elements:

• CMI Data Analytics Tool, Proprietary CMI Existing Repository of Information for Last 8 Years

*Definition: - Safety needles are created to stop needlestick wounds and lessen the chance of infection and contamination in medical environments. They exist in several varieties, such as blunt-tip, sheathed, and retractable needles. The prevalence of needlestick injuries, which can result in the spread of bloodborne infections like hepatitis B, hepatitis C, and HIV, has been demonstrated to decrease with the use of safety needles. The rise in chronic diseases such as cancer, HIV, and spine problems, as well as the rising older population, are both credited with driving the market's expansion. Additionally, the increasing awareness about the risks associated with needlestick injuries and the need for safe injection practices is also expected to contribute to the growth of the safety needle market.