Medical Device Labeling Market Report 2025

The medical device labeling market size has grown strongly in recent years. It will grow from $1.14 billion in 2024 to $1.23 billion in 2025 at a compound annual growth rate (CAGR) of 7.4%. The growth in the historic period can be attributed to increasing regulatory scrutiny and compliance requirements, rising demand for accurate and safe patient information, growing adoption of disposable and single-use devices, expanding use of smart and digital labeling technologies, and heightened product recalls and litigation risks.

The medical device labeling market size is expected to see strong growth in the next few years. It will grow to $1.61 billion in 2029 at a compound annual growth rate (CAGR) of 7.1%. The growth in the forecast period can be attributed to the rising demand for personalized and connected medical devices, growing investment in biocompatible and sustainable label materials, expansion of global medical device supply chains, increasing hospital infrastructure development, and the expanding role of contract manufacturing organizations. Key trends expected during the forecast period include advancements in smart labeling technologies, adoption of digital printing for on-demand labeling, development of biocompatible and durable label materials, improvements in labeling automation and robotics, and innovations in personalized labeling for patient-centric devices.

The rising number of product recalls is expected to drive the growth of the medical device labeling market going forward. Product recalls involve retrieving defective or unsafe products from consumers, manufacturers, or distributors to prevent harm and maintain compliance with safety regulations. The frequency of recalls is increasing due to heightened consumer safety concerns and growing demand for higher product quality standards. Medical device labeling supports recalls by providing accurate device identification, usage instructions, and traceability information, enabling efficient removal of affected devices from the market. For instance, in March 2023, according to Sedgwick LP, a US-based claims and risk management service provider, medical device recall events increased from 837 incidents in 2021 to 911 in 2022. Therefore, the rise in product recalls is fueling the growth of the medical device labeling market.

Companies in the medical device labeling market are focusing on advanced adhesive technologies, such as permanent solvent-based biocompatible adhesives, to improve label durability, ensure patient safety, and comply with strict regulatory standards. Permanent solvent-based biocompatible adhesives are medical-grade formulations that create long-lasting bonds while being safe for contact with human tissue or medical devices. For instance, in December 2023, Flexcon Company Inc., a US-based manufacturer, launched its Flexcon MedFlex product line of polyester printable films and overlaminates. These products are designed for lifetime labeling and tracking of FDA Class I, II, and III medical devices used externally. MedFlex labels meet all FDA UDI performance criteria and feature UL-recognized, biocompatible adhesives with sustainability features, enhancing safety, durability, and compliance in medical device labeling.

In July 2023, Resource Label Group LLC, a US-based labels and packaging company, acquired Pharmaceutic Litho and Label Company for an undisclosed amount. This acquisition strengthens Resource Label Group’s position in the pharmaceutical and medical device labeling market by expanding its capabilities and geographic reach. Pharmaceutic Litho and Label Company Inc is a US-based manufacturer of printed inserts, labels, and packaging components for pharmaceutical, biotech, and medical device manufacturers.

Major players in the medical device labeling market are Avery Dennison Corporation, Trumpf SE + Co. KG, Zebra Technologies Corporation, CCL Industries Inc., Brady Corporation, SATO Holdings Corporation, UFP Technologies Inc., Herma Holding GmbH + Co. KG, Freyr Solutions, Weber Packaging Solutions Inc, Tapecon Inc, Europlaz Ltd, Denny Bros Ltd., Tursso Companies Inc., Techsol Life Sciences, Batching Systems Inc., JH Bertrand Inc, Royal Label Co. Inc, Schreiner Group GmbH & Co. KG, Sidco Labeling Systems.

North America was the largest region in the medical device labeling market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in medical device labeling market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the medical device labeling market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The fast surge in U.S. tariffs and the trade tensions that followed in spring 2025 are heavily affecting the medical equipment sector, particularly for imported imaging machine components, surgical-grade stainless steel, and plastic disposables. Hospitals and clinics resist price hikes, pressuring manufacturers’ margins. Regulatory hurdles compound the problem, as tariff-related supplier changes often require re-certification of devices, delaying time-to-market. Companies are mitigating risks by dual-sourcing critical parts, expanding domestic production of commoditized items, and accelerating R&D in cost-efficient materials.

Medical device labeling encompasses all written, printed, or graphic information accompanying a medical device, including labels on the device, packaging, instructions for use, manuals, and promotional materials. It provides critical information such as the device’s name, intended use, instructions, warnings, manufacturer details, and regulatory symbols, playing a vital role in ensuring regulatory compliance and adherence to standards set by authorities.

The key types of medical device labeling include pressure-sensitive labels, glue-applied labels, sleeve labels, in-mold labels, and others. Pressure-sensitive labels feature adhesive backing that allows them to stick to medical devices when pressure is applied, without requiring heat or water. These labels are used across various device categories, including diagnostic, therapeutic, surgical, monitoring, and assistive devices. Labeling materials typically include paper, plastic, and other substrates, incorporating technologies such as traditional labeling, smart labeling systems, interactive labels, QR codes, barcoding, and digital printing. They serve end users including hospitals, clinics, home healthcare providers, diagnostic laboratories, and research institutions.

The medical device labeling market research report is one of a series of new reports that provides medical device labeling market statistics, including medical device labeling industry global market size, regional shares, competitors with a medical device labeling market share, detailed medical device labeling market segments, market trends and opportunities, and any further data you may need to thrive in the medical device labeling industry. This medical device labeling market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The medical device labeling market consists of revenues earned by entities by providing services such as design and development of labels, regulatory compliance services, printing and packaging services, labeling software solutions, and multilingual and localization services. The market value includes the value of related goods sold by the service provider or included within the service offering. The medical device labeling market also includes sales of sterilization indicator labels, instructional labels, compliance labels, and branding and logo labels. Values in this market are ‘factory gate’ values; that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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