The global medical device labeling market size is expected to be valued at USD 1.34 billion in 2025. It is poised to reach a USD 1.95 billion valuation by 2032, displaying a CAGR of 5.5% during the forecast period (2025-2032).  

The transparency required in labeling for medical devices to prevent unauthorized use and purchase is the primary driver of the market. Regulatory authorities are enforcing new laws to ensure the safety of patients through clear and readable language on medical devices. Personalized medical labeling solutions are expected to open new growth opportunities for the market in the coming years.

However, rising production costs while adhering to the latest regulatory requirements can act as a setback for the market growth.

Key Market Insights

The global medical device labeling market growth is likely driven by the launch of new medical devices and drugs requiring clean labels. The publishing of guides on the use of medical devices for ethnicity-conscious care can bolster its growth during the forecast period.

• By device type, the in vitro diagnostic devices segment is projected to garner a huge market share over the forecast period owing to stringent labeling requirements by federal agencies in the European Union and the U.S. Food & Drug Administration (FDA). The addition of symbols to simplify usage in self and near-patient settings can prevent miscommunication among its users and preserve their usage in specific settings.
• By labeling format, the informative labeling segment is bound to capture a significant share of the medical device labeling market over the forecast period. Proper labeling standards made mandatory by pharmaceutical, medical device, and drug safety agencies can drive the segment growth. For instance, the Central Drugs Standard Control Organization (CDSCO), a government agency in India akin to the U.S. FDA, has mandated proper labeling rules that make the information clear to healthcare professionals and their patients. This brings transparency to its use and protects the user from unintended use.
• By end user, the home healthcare segment is expected to exhibit a strong growth rate in the global market. Usage of medical devices in at-home settings can drive the demand within the segment. In April 2024, the U.S. Food and Drug Administration allocated over USD 1 million toward the establishment of a virtual reality (VR) hub designed to support and advance the development of at-home medical devices. The program intended to expand the application of medical devices at homes and hospital-at-home programs. The agency agreed to clear labeling requirements to ensure the safety of these devices and of their users.
• By region, North America is reported to capture the largest share of the medical device labeling market in 2024. The launch of new medical devices for hospitals and at-home settings can drive the market demand significantly. Additionally, the presence of regulatory bodies like the FDA to protect patients from negligent use can augur favorably for the market. The compliance by prominent market leaders in the healthcare sector, as well as investments in research and development of new products, can bolster the regional market growth.

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Medical Device Labeling Market Report Coverage

Report Coverage	Details
Market Revenue in 2025	USD 1.34 billion
Estimated Value by 2032	USD 1.95 billion
Growth Rate	5.5%
Historical Data	2020–2024
Forecast Period	2025–2032
Forecast Units	Value (USD billion)
Report Coverage	Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered	By Device Type, Labeling Format, and End User
Geographies Covered	North America (U.S. and Canada), Latin America (Brazil, Argentina, Mexico, and Rest of Latin America), Europe (Italy, Spain, U.K., Germany, France, Russia, and Rest of Europe), Asia Pacific (China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific), The Middle East (GCC Countries, Israel, and Rest of Middle East), and Africa (South Africa, North Africa, and Central Africa)
Growth Drivers	Increasing Demand for Medical Devices Due to a Growing Aging Population Regulatory Requirements Mandating Clear and Durable Labeling for Medical Devices
Opportunities	Expansion into Emerging Markets with Increasing Health Investments Technological Advancements in Smart Labeling Solutions
Trends	Labeling Providing Branding Opportunities Use of AI for Medical Device Labeling
Restraints & Challenges	High Cost Associated with Advanced Labeling Technologies

Market Dynamics

The worldwide market is embracing the use of artificial intelligence for device labeling in the manufacturing plants. Generative AI models trained on huge datasets can increase efficiency in the labeling development process. Its ability to identify label gaps, proofread content, and verify data complete with translation can drive the market growth. The speed in the production process and its capacity to adhere to new regulations without stakeholder review can provide a huge impetus to the demand for medical device labeling.

Circular packaging or the packaging circularity process entails the use of eco-friendly materials as well as instruction for use (IFU) for its disposal or recovery. This approach can conserve resources and contribute to a sustainable healthcare ecosystem. For instance, UPM Raflatac attained the APR Design for Recyclability Recognition for their pressure-sensitive labels to be used on medical device packaging in March 2024.

Market Opportunity: Labeling for Ethnicity-conscious Care

Ethnicity-conscious care by medical device manufacturers to increase patient health outcomes through transparent labeling can bode well for the medical device labeling market. The initiative promotes inclusivity and eliminates race-based assumptions from clinical practice. For instance, Medtronic promoted race-conscious care by updating the labels on its pulse oximeters on the flawed readings on people with darker skin tones in November 2024. Additionally, the U.S. FDA, in January 2025, was open to recommendations on the testing of new pulse oximeters for clinical and non-clinical performance.

Market Challenge: Labor Costs to Remain a Hurdle

Labor costs remain a challenge for the medical device sector owing to increasing operational overheads and the pressure of inflation. Manufacturers are embracing automation to reduce their dependence on manual labor.

Analyst’s View

• The medical device labeling market is set to gain from self-branding opportunities using innovative methods to display product information on packages.
• Smart labeling solutions will take precedence, adhering to ongoing regulatory considerations and enhancing product safety.
• The market is headed for consolidation due to a spate of mergers and acquisitions.

Recent Developments

Iwata Label USA, an entity of IL Group, showcased its containment and light protection solutions at INTERPHEX NYC, a global biotechnology and pharmaceutical event, from April 1-3, 2025. The Vial Protect Pack and Light Protect Pack were aimed at protecting vials.

Competitor Insights

• UPM Raflatac
• Resource Label Group
• WS Packaging Group
• Syndicate Label
• Faubel
• Schreiner Group
• Iwata Label
• LINTEC Corporation
• Labeltape
• Topflight Corporation
• Multi-Color Corporation
• Tapp Label
• CCL Industries, Inc.

Market Segmentation

• Device Type
• Implantable Devices
• Non-Implantable Devices
• In Vitro Diagnostic (IVD) Devices
• Labeling Format
• Regulatory Labeling
• Informative Labeling
• Promotional Labeling
• End User
• Hospitals
• Clinics/Ambulatory Surgical Centers
• Diagnostic Laboratories
• Home Healthcare

Regional Insights

• North America
  • U.S.
  • Canada
• Latin America
  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America
• Europe
  • Italy
  • Germany
  • U.K.
  • Spain
  • Russia
  • France
  • Rest of Europe
• Asia Pacific
  • South Korea
  • India
  • China
  • Japan
  • Australia
  • ASEAN
  • Rest of Asia Pacific
• Middle East
  • GCC Countries
  • Israel
  • Rest of Middle East
• Africa
  • South Africa
  • North Africa
  • Central Africa