Towards Healthcare
Standard Pen Needles Market
Updated Date: 02 January 2026   |   Report Code: 6561

Standard Pen Needles Market Amid Smart Devices Adoption

According to market projections, the standard pen needle sector is expected to grow from USD 1.71 billion in 2025 to USD 3.31 billion by 2035, reflecting a CAGR of 6.84%. The increasing prevalence of type 1 diabetes and advances in medical technologies drive the global market. North America dominated the global market due to a robust healthcare infrastructure and favorable regulatory support. 

Last Updated : 02 January 2026 Category: Medical Devices Insight Code: 6561 Format: PDF / PPT / Excel
Revenue, 2025
USD 1.71 Billion
Forecast, 2035
USD 3.31 Billion
CAGR, 2026-2035
6.84%
Report Coverage
Global

Standard Pen Needles Market Size, Key Players with Dynamics and Insights

The global standard pen needles market size is expected to be worth around USD 3.31 Billion by 2035, from USD 1.71 billion in 2025, growing at a CAGR of 6.84% during the forecast period from 2026 to 2035.

Standard Pen Needles Market Trends and Growth (2026)

The standard pen needles market is experiencing robust growth, driven by the increasing use of insulin pens and the growing demand for self-administration. Standard pen needles are available in various sizes, tailored to individual insulin injections and patient needs. Government bodies launch initiatives and provide funding to support early diagnosis and treatment of diabetes. Novel insulin pens are developed to help reduce injection pain, enhancing patient comfort.

Key Takeaways

  • Standard pen needles sector pushed the market to USD 1.83 billion by 2026.
  • Long-term projections show USD 1.71 billion valuation by 2035.
  • Growth is expected at a steady CAGR of 6.84% in between 2026 to 2035.
  • North America held a major revenue share of the market in 2025.
  • Asia-Pacific is expected to grow at the fastest CAGR in the upcoming years.
  • By drug type, the insulin segment dominated the standard pen needles market in 2025.
  • By drug type, the GLP-1 segment is expected to witness the fastest growth in the market over the forecast period.
  • By disease indication, the diabetes segment contributed the biggest revenue share of the market in 2025.
  • By disease indication, the obesity segment is expected to grow at the fastest CAGR in the market during the forecast period.
  • By needle size, the 4 mm segment led the market in 2025.
  • By needle size, the 6 mm segment is expected to expand significantly in the market in the coming years.
  • By distribution channel, the retail pharmacy segment accounted for the highest revenue share of the standard pen needles market in 2025.
  • By distribution channel, the online pharmacy segment is expected to grow with the highest CAGR in the market during the studied years.

Executive Summary Table

Key Elements Scope
Market Size in 2026 USD 1.83 Billion
Projected Market Size in 2035 USD 1.71 Billion
CAGR (2026 - 2035) 6.84%
Leading Region North America
Market Segmentation By Drug Type, By Disease Indication, By Needle Size, By Distribution Channel, By Region
Top Key Players Becton, Dickinson and Company, Allison Medical, Terumo Corporation, Hindustan Syringes & Medical Devices Ltd., Klinion, Cardinal Health, Inc., Sol-Millennium Medical, Oven Mumford, AdvaCare Pharma, McKesson Medical-Surgical, Inc.

Precision at the Point: Standard Pen Needles

The standard pen needles market refers to the development and distribution of needles used in different insulin pens for insulin delivery. Pen needles are single-use, small, disposable needles that contain an insulin cartridge and are used to inject the insulin into the subcutaneous fat layer beneath the skin. They can be as thin as a couple of human hairs and are frequently designed for less pain and improved insulin flow into the body. They range from 4 mm to 12 mm, with a diameter of 29 to 32 gauge.

AI at the Tip: Redefining Standard Pen Needle Design

Artificial intelligence (AI) is embedded in insulin pens to support patient-directed interventions, improving diabetes management decisions for patients in real-time. Smart insulin pens and connected software can be enabled with real-time dosing alerts and reminders. AI and machine learning (ML) algorithms can analyze vast amounts of data and suggest the desired size and type of pen needles. They also assist manufacturers in the bulk production of pen needles, enhancing efficiency, accuracy, and reproducibility.

  • Increasing Diabetes Prevalence: The growing geriatric population and a family history of diabetes increase the risk of diabetes among people of all age groups.
  • Improved Patient Compliance: Standard pen needles lower pain, discomfort, and anxiety during injection to improve patient compliance with their treatment plan.
  • Needlestick Injuries: As pen needles are disposable, they possess a lower chance of contamination at the injection site, minimizing the risk of infection.

Mapping Worldwide Insulin Use: A Country-Wise Perspective

Insulin Usage (In Millions)

Countries Insulin Usage (in millions)
United States 4
India 5.1
Germany 2.2

Strategic Alliances Powering the Standard Pen Needles Market

  • In November 2025, Embecta Corp. announced an expansion of its partnership with Direct Relief to provide pen needles and insulin syringes to those in most need across the globe. This collaboration represents Embecta’s largest humanitarian partnership and supports Direct Relief’s comprehensive diabetes programs serving vulnerable populations.
  • In August 2024, Medical Technology and Devices (MTD) announced the acquisition of Ypsomed’s Pen Needles and Blood Glucose Monitoring Systems (BGM) businesses. This acquisition enables MTD to provide superior diabetes and obesity care solutions on a global scale.

Segmental Insights

Drug Type Insights

Which Drug Type Segment Dominated the Standard Pen Needles Market?

The insulin segment held a dominant position in the market in 2025, due to the rising prevalence of type 1 diabetes and the need for subcutaneous drug delivery. Insulin is unstable for oral administration; hence, it is administered through the subcutaneous route only, necessitating the use of pen needles. It is estimated that over 100 million diabetes patients need insulin globally. Standard pen needles contribute to the comfort and efficacy of the insulin injection.

GLP-1

The GLP-1 segment is expected to grow at the fastest CAGR in the market during the forecast period. Standard pen needles are essential for delivering GLP-1 analogs, treating patients with diabetes or obesity. Most patients are aware of weight loss medications, such as Wegovy or Ozempic. According to a new Circana report, GLP-1 medications for weight loss are set to account for 35% of U.S. food and beverage sales by 2030.

Disease Indication Insights

Why Did the Diabetes Segment Dominate the Standard Pen Needles Market?

The diabetes segment held the largest revenue share of the market in 2025, due to the growing pediatric and geriatric population and the increasing diabetes prevalence. The International Diabetes Federation (IDF) reported that approximately 589 million individuals were living with diabetes globally. Standard pen needles are widely used among diabetics to deliver the precise dose of insulin. They have proven to reduce injection anxiety among young children and older adults.

Obesity

The obesity segment is expected to grow with the highest CAGR in the market during the studied years. Obesity is a major public health concern among people of all age groups and is a serious issue, particularly in wealthy countries. It is mainly caused by sedentary lifestyles and the increasing consumption of fast foods. The World Obesity Federation predicts that obesity will increase by more than 115% from 524 million in 2010 to 1.13 billion by 2030.

Needle Size Insights

How the 4 mm Segment Dominated the Standard Pen Needles Market?

The 4 mm segment contributed the biggest revenue share of the market in 2025, due to its relatively small size, causing the least pain. 4 mm needles are the shortest, most comfortable, and effective for all body types. They are mostly used for children and adults, especially those with sensitive skin. They are compatible with multiple insulin pens. Shorter needles reduce the risk of injecting into muscle while providing the same insulin delivery results.

6 mm

The 6 mm segment is expected to witness significant growth in the market over the forecast period. 6 mm needles are used by people who prefer a bit more depth and have thicker skin. They enhance the administration of insulin through pen injectors, ensuring minimal discomfort and efficient delivery. They offer widespread compatibility and a user-friendly design. They are integral for healthcare professionals and pharmacies to offer versatile and patient-centered solutions.

Distribution Channel Insights

Which Distribution Channel Segment Led the Standard Pen Needles Market?

The retail pharmacy segment led the market in 2025, due to the availability of a favorable infrastructure and suitable capital investments. This enables retail pharmacies to adopt a wide range of pen needles of different sizes, serving a larger patient population. Retail pharmacies possess skilled professionals who provide tailored services to patients. They offer numerous benefits, such as specialized discounts, 24/7 facilities, and same-day delivery.

Online Pharmacy

The online pharmacy segment is expected to expand rapidly in the market in the coming years. Online pharmacies offer patients multiple options and allow them to compare prices, allowing them to choose products at affordable prices. They enable free home delivery and special discounts. Patients can purchase pen needles from manufacturers and suppliers of various countries, irrespective of geographical barriers.

Regional Distribution

Standard Pen Needles Market Share, By Region, 2025 (%)

  • North America registered dominance in the standard pen needles market in 2025.
  • The U.S. led the market by capturing the largest revenue share in 2025.
  • Asia Pacific is expected to be the fastest-growing region in the studied years.
  • India is anticipated to grow at a rapid CAGR during the forecast period.
  • Europe is expected to grow at a significant CAGR during the forecast period.
  • The UK is anticipated to grow at a rapid CAGR over the upcoming years.

Which Factors Govern the Standard Pen Needles Market in North America?

North America dominated the global market in 2025. The availability of a robust healthcare infrastructure, state-of-the-art research and development facilities, and the presence of key players are the factors that govern market growth in North America. Government organizations provide funding to support the development of advanced insulin pens and pen needles to cater to a larger patient population. Moreover, technological innovations and favorable regulatory support bolster market growth.

U.S. Market Trends

Key players, such as Cardinal Health, McKesson Medical-Surgical, and Sol-Millennium Medical, are major contributors to the market in the U.S. Out-of-pocket costs of insulin in the U.S. are capped at $35 million per monthly prescription among Medicare Part D enrollees. The Centers for Medicare and Medicaid Services releases programs to reduce the cost of insulin for Medicare beneficiaries, increasing affordability.

How is Asia-Pacific Growing in the Standard Pen Needles Market?

Asia-Pacific is expected to host the fastest-growing market in the coming years. Countries like China, India, and Japan have the highest number of people with diabetes and obesity globally. This necessitates the demand for insulin administration, thereby requiring pen needles. People are becoming aware of advanced drug delivery devices for insulin, enhancing patient comfort. Government initiatives encourage the general public to screen for and diagnose metabolic diseases, such as diabetes and obesity, enabling healthcare professionals to provide early intervention.

India Market Trends

India records the highest diabetes and obesity prevalence across the world. More than 101 million people are estimated to have diabetes, while approximately 80 million Indians are obese. The Indian government’s Ayushman Bharat Pradhan Mantri Jan Aarogya Yojana improves healthcare access, enabling citizens to seek treatment for various illnesses, including diabetes and obesity.

Will Europe Grow in the Standard Pen Needles Market?

Europe is expected to grow at a considerable CAGR in the upcoming period. The rising adoption of advanced technologies, such as ultra-thin wall designs and safety-engineered needles, and the burgeoning healthcare sector propel the market. European nations make constant efforts to reduce the burden of chronic diseases among Europeans by raising awareness of the diagnosis and treatment of such disorders. The increasing investments and collaborations among key players also augment market growth.

Insulin pens and pen needles are strictly regulated by regulatory agencies and are available on prescription. Approximately 4 million single-use insulin pens are prescribed in England annually, accounting for about half of all prescriptions. The NHS West Yorkshire ICB recommends prescribing diabetes pen needles costing less than £3 per 100 needles, enhancing affordability.

Top Global Exporters of Pen Needles

Top Global Exporters of Pen Needles

Export Countries Number of Shipments (May 2024 to April 2025) Import Countries
China 471 U.S., Turkey, and Malaysia
South Korea 138 U.S., India, and Peru
Ireland 92 India, Russia, and Vietnam

Value Chain Analysis: Standard Pen Needles Market

R&D

  • Standard pen needle R&D involves design optimization, material selection, rigorous testing (biocompatibility, functionality), and regulatory approval to ensure patient safety and comfort.
  • Companies involved: Embecta Corp., Novo Nordisk, B. Braun, and Terumo

Clinical Trials & Regulatory Approvals

  • Standard pen needles are classified as low to intermediate risk medical devices and generally do not require full-scale clinical trials for regulatory approval in major markets like the U.S. (FDA) and the E.U. (MDR). Instead, manufacturers demonstrate safety and efficacy through compliance with recognized consensus standards (like ISO 11608-2), extensive bench testing, and comparison to existing, legally marketed predicate devices.
  • Companies involved: Embecta Corp., Novo Nordisk A/S, B. Braun SE, Terumo Corporation, and Ypsomed AG

Patient Support & Services

  • The standard steps for patient support and services when using a standard pen needle involve preparation, injection, and post-injection care. These steps ensure correct dosing, minimize infection risk, and prevent complications. 

Top Companies & Their Offerings in the Standard Pen Needles Market

Standard Pen Needles Market Key Players

Companies Headquarters Offerings
Becton, Dickinson and Company New Jersey, United States It offers Ultra-Fine Pen Needles and Nano 4mm Pen Needles that feature ultra-thin wall technology, ensuring the highest inner diameter.
Allison Medical Colorado, United States SureComfort pen needles are ISO compliant with all major diabetes pens & dosers, with new sizes, lubricated for superior injection comfort.
Terumo Corporation Tokyo, Japan Terumo Fineglide Pen Needles 4mm 32G are compatible with most standard insulin pens, providing versatility and ease of use.
Hindustan Syringes & Medical Devices Ltd. Haryana, India It manufactures sterile, single-use Dispovan insulin pen needles that are the least painful and patient-friendly.
Klinion Oud Beijerland, Netherlands It offers pen needles in various combinations with a length of 4, 5, 6, 8, or 12mm, and a thickness of 32G, 31G, or 29G.
Cardinal Health, Inc. Ohio, United States Monoject Standard Pen Needles features shorter needle lengths and 32G options to help make injections less painful.
Sol-Millennium Medical Chicago, United States Sol-M Pen Needles support accurate and reliable insulin delivery and are engineered for comfortable medication delivery with silicone oil lubrication.
Oven Mumford Oxfordshire, United Kingdom It offers Unifine Pentips Standard Insulin Pen Needle 31G 8mm for optimal performance.
AdvaCare Pharma Wyoming, United States Its Insulin Pen Needles come in various sizes, ranging from 29G to 32G.
McKesson Medical-Surgical, Inc. Virginia, United States It offers Standard Insulin Pen Needle Comfort EZ 32G that is silicone-coated with special lubrication for a more comfortable injection.

SWOT Analysis in the Standard Pen Needles Market

Strengths

  • The increasing use of insulin pens across the globe potentiates the need for standard pen needles.
  • Single-use pen needles reduce the risk of needlestick injuries, enhancing patient comfort and care.
  • Manufacturers develop universal pen needles of optimum size that are compatible with numerous injection devices.

Weaknesses

  • Standard pen needles have a tiny protective casing cover over the needles, which may not be noticeable and may pose safety issues.
  • Pen needles can hit muscle tissue and can cause pain or bleeding at the injection site.

Opportunities

  • Continuous innovations are made in pen needles to enhance compatibility, safety, and drug delivery accuracy.
  • Smart & traceable syringes are developed that are embedded with laser-marked traceability codes, sterilization tracking, and anti-counterfeit identifiers.
  • The growing awareness of environmental sustainability encourages manufacturers to use biodegradable polymers for syringes and pen needles.

Threats

  • Several studies have found that patients who have not been educated about the proper use of disposable standard pen needles have experienced severe harm and died.
  • Supply chain disruption is another major threat for manufacturers and suppliers, impacting the timely delivery of pen needles.
  • The development of reusable insulin pens and needle-free injections for insulin delivery restricts market growth.

Recent Developments in the Standard Pen Needles Market

  • In August 2025, Trividia Health UK Limited launched the TRUEplus 5-Bevel Pen Needles in the UK to provide various needle gauges and sizes at a low cost to diabetes patients. These needles are developed for maximum comfort, delivering high-quality, safety, and ease of use in multiple different needle sizes.
  • In May 2025, Stevanato Group developed a scalable, customizable pen injector, Alina injector, for various applications, including diabetes care, weight management, and cardiovascular and neurological disorders. The injector is compatible with standard pen needles and features a pre-injection dose to avoid underdosing.

Segments Covered in the Report

By Drug Type

  • Insulin
  • GLP-1
  • Growth Hormone
  • Others

By Disease Indication

  • Diabetes
  • Obesity
  • Hormone Deficiency
  • Others

By Needle Size

  • 4 mm
  • 5 mm
  • 6 mm
  • 8 mm
  • 12 mm

By Distribution Channel

  • Hospital Pharmacy
  • Retail Pharmacy
  • Online Pharmacy

By Region

  • North America
    • U.S.
    • Canada 
    • Mexico 
    • Rest of North America
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Europe 
    • Western Europe 
      • Germany 
      • Italy
      • France
      • Netherlands
      • Spain
      • Portugal 
      • Belgium
      • Ireland
      • UK 
      • Iceland 
      • Switzerland
      • Poland
      • Rest of Western Europe
    • Eastern Europe 
      • Austria
      • Russia & Belarus 
      • Türkiye
      • Albania 
      • Rest of Eastern Europe 
  • Asia Pacific
    • China 
    • Taiwan
    • India 
    • Japan 
    • Australia and New Zealand
    • ASEAN Countries (Singapore, Malaysia)
    • South Korea 
    • Rest of APAC 
  • MEA 
    • GCC Countries
      • Saudi Arabia 
      • United Arab Emirates (UAE)
      • Qatar 
      • Kuwait 
      • Oman 
      • Bahrain 
    • South Africa
    • Egypt 
    • Rest of MEA

FAQ's

Answer : The standard pen needles market holds a valuation of USD 1.83 billion as of 2026, and will expand to USD 3.31 billion by 2035, achieving a CAGR of 6.84% between 2026 and 2035.

Answer : North America is leading the standard pen needles market due to favorable regulatory support and a robust healthcare infrastructure.

Answer : The standard pen needles market includes 5 segments by drug type, by disease indication, by needle size, by distribution channel, and by region.

Answer : Some key players include Cardinal Health, Inc., Allison Medical, and Terumo Corporation.

Answer : Sharp bins are the safest way to get rid of needles and other sharp objects that have been used. They are designed with a lid to ensure sharp objects are not exposed to anyone.

Tags

Meet the Team

Shivani Zoting is a dedicated research analyst specializing in the healthcare industry. With a strong academic foundation, a B.Sc. in Biotechnology and an MBA in Pharmabiotechnology, she brings a unique blend of scientific understanding and strategy.

Learn more about Shivani Zoting

Aditi Shivarkar is a seasoned professional with over 14 years of experience in healthcare market research. As a content reviewer, Aditi ensures the quality and accuracy of all market insights and data presented by the research team.

Learn more about Aditi Shivarkar

Related Reports