Pen Needles Market Analysis & Forecast: 2026-2033
The Pen Needles Market size is anticipated to grow at a CAGR of 10.4% with USD 3.14 Bn in 2026 and is expected to reach USD 6.28 Bn in 2033. The primary drivers are defined by the increasing prevalence of diabetes, rising adoption of insulin and other injectable therapies, expansion of home-based disease management, and growing preference for shorter and thinner needles. According to the International Diabetes Federation, approximately 589 million adults aged 20–79 years were living with diabetes in 2024, and the number is projected to reach 853 million by 2050. This expanding treatment population is strengthening demand for conventional, ultra-thin, safety-engineered, and short-length pen needles across retail pharmacies, hospitals, clinics, and homecare settings.
On the basis of type of needle, the standard pen needles segment is projected to account for the largest Pen Needles Market share of 68.1% in 2026. The segment’s growth is owing to the lower unit prices, simple product architecture, extensive availability, broad pen compatibility, and widespread use in patient-administered insulin therapy.
Embecta states that it supplies approximately 8 billion injection units annually through manufacturing facilities in the U.S., Ireland, and China. Its January 2026 investor presentation further indicated that pen needle and safety products represented approximately 85% of fiscal 2025 adjusted revenue, thereby highlighting the commercial importance of these product categories.
In November 2025, Embecta reported additional contracts and purchase orders from pharmaceutical partners seeking to co-package its pen needles with potential generic GLP-1 therapies. The company stated that its needles had been included in multiple partner-managed regulatory submissions, with selected commercial launches potentially beginning in 2026.
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On the basis of needle length, the 4 mm segment lead with a major 49.6% share in 2026. The growth is owing to their wide usage. They are designed to deliver medication into subcutaneous tissue while reducing the probability of an intramuscular injection. They are suitable for children, adults, older patients, and individuals across different body-mass categories when used according to product instructions and clinical guidance.
Novo Nordisk states that 4 mm needles are associated with a lower risk of intramuscular injection than 6 mm needles and that the 4 mm length is suitable regardless of body mass index. Its NovoFine Plus product uses a 32G cannula and SuperFlow technology intended to support medication flow. Owen Mumford supplies both 32G and 33G products at the 4 mm length, demonstrating the industry’s movement toward a combination of shorter length and smaller external diameter.
Innovation in the U.S. Pen Needles Market is centered on shorter needle lengths, higher gauges, thin-wall cannulas, improved silicone coatings, better medication flow, and mechanisms that reduce exposure to the needle before and after an injection. Manufacturers are also expanding compatibility with different insulin, human growth hormone, obesity, and metabolic-disease injection pens.
In November 2025, the U.S. Food and Drug Administration cleared Terumo Corporation’s Pen Injector Needle 32.5 through the 510(k) pathway. The device uses a thin-wall 32.5G stainless-steel cannula, is available in lengths ranging from 4 mm to 8 mm, and is intended for subcutaneous administration of medicines including insulin and human growth hormone.
Ultra-thin and safety-engineered pen needles represent a major technology breakthrough because they address two persistent challenges in injectable therapy: patient discomfort and accidental sharps exposure. Ultra-thin needles generally use higher gauge cannulas, thin-wall construction, optimized bevel geometry, and silicone lubrication to reduce insertion force while maintaining sufficient internal diameter for medication flow. Shorter needle lengths also simplify injection technique for many patients because extensive skin-fold formation may not be required.
The U.S. Occupational Safety and Health Administration reports approximately 385,000 sharps-related injuries among hospital-based healthcare workers annually, supporting institutional interest in protected needle systems.
In January 2026, the FDA cleared an HH Global Technology pen needle portfolio containing both ordinary as well as safety configurations. The devices are individually packaged, sterilized by irradiation, and designed for use by healthcare personnel, adult patients, and lay users.
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Mandatory use of four EUDAMED modules from May 2026 |
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FDA recognition of updated sharps-protection standard |
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The North America region accounts for 39.5% of the market share in 2026. The region’s growth is owing to the high diagnosed diabetes prevalence, broad access to insulin pens, strong pharmacy networks, well-developed reimbursement systems, and substantial healthcare expenditure.
North America also has a substantial injectable GLP-1 user base. The U.S. National Center for Health Statistics reported that 6.9 million adults with diagnosed diabetes used GLP-1 injectable treatments in 2024. The growing use of injectable metabolic therapies is encouraging manufacturers to evaluate retail packs and co-packaged pen needles for non-insulin applications.
In March 2026, the U.S. FDA cleared Sandstone Medical’s Easydrip Classic, Plus, Classic Pro, and Plus Pro pen needles through the 510(k) pathway. The Class II devices include new five-bevel models and broader use for subcutaneous delivery of FDA-approved drugs.
Asia Pacificis is expected to witness strong growth in market over the forecast period. The region’s growth is owing to the large diabetes population, increasing diagnosis rates, expanding retail pharmacy networks, growth in private healthcare expenditure, and gradual transition from vial-and-syringe administration to portable injection pens.
The International Diabetes Federation estimates that China had 148.0 million adults aged 20–79 years with diabetes in 2024, the highest national total worldwide. India had approximately 89.8 million adults with diabetes, while Japan had approximately 10.8 million. This is creating opportunities for premium ultra-thin needles as well as value-oriented standard products.
In August 2024, MTD Group completed the acquisition of Ypsomed’s pen needle and blood glucose monitoring businesses, increasing annual pen needle production capacity beyond 2.5 billion units. The deal expanded MTD’s presence in China and India and supported major investments in European manufacturing facilities.
In the United States, the Pen Needles Market is influenced by the large treated diabetes population, substantial use of insulin and GLP-1 medicines, and highly developed pharmacy distribution system. The Diabetes.org estimates that 29.1 million people had diagnosed diabetes in 2023, while approximately 11.0 million adults with diabetes remained undiagnosed. The large diagnosed population generates recurring demand for pen needles, test supplies, continuous-glucose-monitoring products, insulin pens, as well as related consumables.
In April 2025, Owen Mumford launched UnifineOTC pen needles, an affordable cash-pay option designed for uninsured, underinsured, and high-copayment diabetes patients. Available in 4mm and 5mm sizes, the product simplifies pharmacy dispensing while maintaining trusted Unifine quality and performance standards.
China is emerging as a major growth market for Pen Needles. The growth is owing to the large diabetes treatment population and wider use of injectable therapies. Official Shanghai government reporting cited 2024 national data showing diabetes prevalence among Chinese adults at 12%, sustaining demand for insulin pens and compatible disposable needles.
Some of the major key players in Pen Needles Market are Novo Nordisk A/S, Becton, Dickinson and Company, Ypsomed AG, UltiMed, Inc., TERUMO CORPORATION, HTL-STREFA, Owen Mumford Ltd., B. Braun Melsungen AG, Allison Medical, Inc., Hindustan Syringes and Medical Devices Ltd., and Artsana S.p.a.
| Report Coverage | Details | ||
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| Base Year: | 2025 | Market Size in 2026: | USD 3.14 Bn |
| Historical Data for: | 2020 To 2024 | Forecast Period: | 2026 To 2033 |
| Forecast Period 2026 to 2033 CAGR: | 10.4% | 2033 Value Projection: | USD 6.28 Bn |
| Geographies covered: |
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| Companies covered: |
Novo Nordisk A/S, Becton, Dickinson and Company, Ypsomed AG, UltiMed, Inc., TERUMO CORPORATION, HTL-STREFA, Owen Mumford Ltd., B. Braun Melsungen AG, Allison Medical, Inc., Hindustan Syringes and Medical Devices Ltd., and Artsana S.p.a. |
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Manisha Vibhute is a consultant with over 5 years of experience in market research and consulting. With a strong understanding of market dynamics, Manisha assists clients in developing effective market access strategies. She helps medical device companies navigate pricing, reimbursement, and regulatory pathways to ensure successful product launches.
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