Track and Trace Solutions Market Trends, Analysis, Size by 2030

Track and Trace Solutions Market Size and Forecast (2020 - 2030), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Component (Hardware and Software), Enterprise Size (SMEs and Large Enterprises), Application (Serialization and Aggregation), and Industry (Pharmaceutical, Medical Devices, Consumer Goods, Food & Beverages, and Others)

Publication Month : Mar 2024

  • Report Code : TIPHE100000989
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 210
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[Research Report] The track and trace solutions market size was valued at US$ 6.85 billion in 2022 and is projected to reach US$ 22.70 billion by 2030; the market is expected to register a CAGR of 16.2% from 2022 to 2030.

Market Insights and Analyst View:

Track & trace solution aims to support compliance regulations across geographies. Once adopted, it provides a comprehensive knowledge-rich environment that enables pharmaceutical companies to easily steer through track and trace compliance mandates, manage recalls better, and increase the overall efficiency of the manufacturing process. Stringent regulations and criteria for implementation of serialization and an increasing number of packaging-related product recalls are the factors responsible for the influential growth of the market. Additionally, growth in offshore pharmaceutical manufacturing offers lucrative market opportunities for the overall market growth during the forecast period. Implementation of serialization to combat counterfeit drugs, as well as the increasing number of packaging-related product recalls, fuels the track and trace solutions market growth. Further, continuous technological advancement is expected to bring new track and trace solutions market trends in the coming years.

Track and Trace Solutions Market Drivers:

Globally, pharmaceutical companies are adhering to regulatory compliance for serialization to ensure anti-counterfeiting and traceability of drugs. Most developed and developing economies have either already laid out the regulatory roadmap for serialization or plan to implement it. The regulatory push to secure the pharmaceutical supply chain is due to the rising drug-related illegal activities and supply chain inefficiencies. Efforts are aimed at addressing drug counterfeits and unauthorized parallel supply chains, improving supply chain visibility, tracking returns or recalls, and the scarcity of data-driven tools for predicting patient behavior. A few examples of government regulations mandating the serialization of medical products include:

In the US, the Drug Supply Chain Security Act (DSCSA) started in 2013. The DSCSA defines the requirements for an interoperable electronic system to identify and trace pharmaceutical products throughout their distribution in the country. As part of the requirements, pharmaceutical products must be marked with a National Drug Code (NDC), serial number, lot number, and expiration date. The Food and Drug Administration (FDA) mandates manufacturers to track specific devices through the entire distribution chain when and if they receive an order from the FDA to implement a tracking system. These devices could belong to Class I, II, or III.

In addition, the European Union (EU) has followed suit with a compliance requirement by enacting the Falsified Medicines Directive (FMD). Unit-level serialization and dispenser authentication have been mandated. Further, in Turkey, the first step for implementing serialization is the in-line printing of the relevant code and information on each unit pack. The Turkish and French Pharma plants’ early requirements revealed the risks and difficulties linked to in-line printing of a 2D code, and it took three years to deal with them. The European Union Medical Device Regulation (EU MDR) of May 2021 intends to improve the safety and performance of medical devices throughout their entire lifecycle. The rule plans to enhance the coordination of information on medical devices with better transparency and information access in the EU member states.

In 2012, India’s Directorate General of Foreign Trade (DGFT) also mandated the serialization of secondary and tertiary levels and set guidelines for reporting export shipments. Several other countries have imposed similar regulations for manufacturing and imports.  In Brazil, serializing the unit and case (transport packing container) of all pharmaceutical products is mandatory. Cases will have to include information about the units they contain. Tracking of the supply chain will be required at each level, including manufacturer/importer, wholesaler, distributor, and pharmacy levels.

Governments of various countries believe that counterfeiting is an organized crime that can be tackled by implementing product serialization, and many countries are taking steps in this regard. Serialization enables running advanced analytics programs to gather deep insights into consumption patterns, geographical penetration, sales, marketing spend effectiveness, etc. According to the 2013 Drug Supply Chain Security Act, starting from November 2017, all pharmaceutical companies selling prescription drug products in the US must serialize each salable drug unit to aid tracking from manufacturer to pharmacy or doctor’s office.

According to the EU Falsified Medicines Directive (EU FMD) mandates, by February 2019, drug manufacturers conducting business in the EU market must implement serialization. Drug manufacturers are at risk for noncompliance if they fail to follow these mandates, which can lead to huge penalties ranging from paying fines for every occurrence to being barred from product launches. If companies fails to serialize, no wholesalers in the US will purchase their products. Apart from furnishing quality, visibility, and complete traceability within the supply chain, successful serialization programs will be a key differentiator and a clear competitive reward for the companies. Thus, the serialization of pharmaceutical products to avoid counterfeiting drugs in developing countries fuels the track and trace solutions market growth.

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Track and Trace Solutions Market: Strategic Insights

track-and-trace-solutions-market
Market Size Value inUS$ 6,855.2 million in 2022
Market Size Value byUS$ 16,553.8 million by 2028
Growth rateCAGR of 15.9% from 2023 to 2028
Forecast Period2023-2028
Base Year2022
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Report Segmentation and Scope:

The track and trace solutions market analysis has been carried out by considering the following segments: component, enterprise size, application, industry, and geography. By component, the market is bifurcated into hardware and software. Hardware component is further segmented into barcode scanner, radiofrequency identification reader, and others. Software component is further divided into plant manager, line controller and others.  Based on enterprise size, the market is segmented into SMEs and large enterprise. Based on application, the market is divided into serialization and aggregation. Based on industry, the market is segmented into pharmaceutical, medical devices, consumer goods, food and beverages, and others. The scope of the track and trace solutions market report covers North America (the US, Canada, and Mexico), Europe (Spain, the UK, Germany, France, Italy, and the Rest of Europe), Asia Pacific (South Korea, China, Japan, India, Australia, and the Rest of Asia Pacific), Middle East & Africa (South Africa, Saudi Arabia, the UAE, and the Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and the Rest of South & Central America).

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Segmental Analysis:

The track and trace solutions market, by type, is bifurcated into hardware and software. The hardware component is further segmented into barcode scanner, radiofrequency identification reader, and others. The software component is further categorized into plant manager, line controller, and others. In 2022, the software segment held a larger share of the market and is expected to record a higher CAGR during 2022–2030. Track and trace software is used for various purposes and offers complete management of the entire serialization and aggregation process. The solutions provide flexibility, whether they have a single line with limited connectivity or require software for monitoring all processes across multiple production lines. The software delivers all necessary documentation and information to meet compliance. The track and trace software is used for pharmaceuticals, production, food & beverage, and seafood. Rfxcel Corp.; METTLER TOLEDO; and JDA Software Group, Inc are among the companies that offer track and trace software. The software provides unique benefits such as reduced administration and increased confidence for quality events, faster containment of quality events with a broader purview of exposed products, and protection of customers and brand image.

The track and trace solutions market, by application, is divided into serialization solutions and aggregation solutions. In 2022, the serialization solutions segment held a larger track and trace solutions market share. Moreover, the same segment is expected to record the highest CAGR during 2022–2030. Serialization refers to the assigning of a predetermined type of coding to all product items, tagging it with a unique identity in order to track the product at virtually any moment, and can be traced to its location at any stage of the production, supply chain and/or marketing chain it is presently involved in, or any point during the product life cycle. Nowadays, the supply chain for all industries is becoming longer and more complex than ever. Hence, incidences such as counterfeiting, gray marketing, and product mix-ups are rising rapidly. Most of the countries with a series of regulatory requirements for global compliance for industries such as pharmaceutical, medical devices, and life science are in need of a standardized method in order to ensure and prove end-to-end product integrity. Serialization solutions for track and trace systems have increased accountability in the pharmaceutical and medical devices supply chain by directly addressing these issues. In the global pharmaceutical industry, the ability to track and trace pharmaceutical drugs in the supply chain has been regulatory vital and evolving in order to improve drug safety and avoid counterfeits. With the help of a serialization solution, one can encode the products with an expiration date, lot code, serial number, GTIN, a 2D matrix code, and a GSI-DataMatrix symbol in order to track products for anti-counterfeiting efforts. Serialization also allows for tracking and tracing the product throughout the supply chain and provides brand and consumer protection, along with regulatory compliance.

Based on enterprise size, the global track and trace solutions market is divided into SMEs and large enterprises. In 2022, the large enterprise segment held a larger market share. The SMEs segment is expected to record a higher CAGR during 2022–2030.

The track and trace solutions market, by industry, is segmented into pharmaceutical, medical devices, consumer goods, food & beverages, and others. In 2022, the pharmaceutical segment held the largest share of the market and is expected to record the highest CAGR during 2022–2030.

Track and Trace Solutions Market, by Component – 2022 and 2030

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Regional Analysis:

Geographically, the market is categorized into North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. North America is the largest contributor to the global market. Asia Pacific is predicted to register the highest CAGR in the market during 2022–2030. North America held the largest share of the global track and trace solutions market in 2022 owing to the presence of large players launching innovative product launches and technological advancements in track and trace solutions. In North America, the US held the largest share of the track and trace solutions market share in 2022.

Industry Developments and Future Opportunities:

The track and trace solutions market forecast is estimated on the basis of various secondary and primary research findings, such as key company publications, association data, and databases. Strategies by key players operating in the track and trace solutions market are listed below:

  • In November 2023, Sys-Tech Solutions Inc. announced the launch of the UniSecure platform into the market. The platform is a comprehensive product security solution that detects diversion and counterfeiting. It offers unique product identification, traceability, and product verification through smartphones throughout the supply chain process. The newly launched platform caters to pharmaceutical, nutraceutical, medical products, skincare, and other markets.
  • In October 2022, Zebra Technologies Corporation announced the new PartnerConnect Location and Tracking Specialization for partners focused on selling RFID and real-time location systems (RTLS). Developed as a strategic component of Zebra’s award-winning PartnerConnect program, the new Location and Tracking Specialization provides resellers with the tools they need to drive RFID and RTLS sales and help businesses successfully deploy these solutions for transformational business benefits.

Competitive Landscape and Key Companies:

ACG, Axway Software SA, Antares Vision SPA, Markem-Imaje AG, Mettler-Toledo International Inc, Optel Group, SEA Vision Grp, Siemens AG, TraceLink Inc, and Zebra Technologies Corp are among the prominent players profiled in the track and trace solutions market report. In addition, several other players have been studied and analyzed during the study to get a holistic view of the market and its ecosystem. These companies focus on geographic expansions and product launches to meet the growing demand from consumers worldwide and increase their product range in specialty portfolios. Their global presence allows them to serve a large customer base, subsequently facilitating market expansion.

Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Component, Enterprise Size, Application, and Industry

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States

Frequently Asked Questions


What are the driving and restraining factors for the track & trace solutions market?

Implementation of serialization to combat counterfeit drugs and increasing number of packaging-related product recalls propel the market growth. However, the high cost of products and implementation are hampering the growth of the market.

Who are the major players in market the track & trace solutions market?

The track & trace solutions market majorly consists of the players such ACG, Axway Software SA, Antares Vision SPA, Markem-Imaje AG, Mettler-Toledo International Inc, Optel Group, SEA Vision Grp, Siemens AG, TraceLink Inc, and Zebra Technologies Corp.

What is track & trace solutions?

Track and trace solution aims to support compliance regulations across geographies. Once adopted, it provides a comprehensive knowledge-rich environment that enables pharmaceutical companies to easily steer through track and trace compliance mandates, manages recalls better, and increases the overall efficiency of the manufacturing process. Further, a track and trace solution offer numerous benefits involving purchase order numbers, container numbers, bill of lading numbers, customer information, item counts, weight, status and delivery date, freight charges, and many more.

Which segment is dominating the track & trace solutions market?

The track & trace solutions market, by type, is bifurcated into hardware and software. In 2022, the software segment held a larger share of the market and is expected to record a higher CAGR during 2022–2030.
The market, by application, is segmented into serialization solutions and aggregation solutions. In 2022, the serialization solutions segment held the largest track & trace solutions market share. Moreover, the same segment is expected to record the highest CAGR during 2022–2030.
Based on enterprise size, the global track & trace solutions market is divided into SMEs and large enterprise. In 2022, the large enterprise segment held the largest market share. The SMEs segment is expected to record the highest CAGR during 2022–2030. The track & trace solutions market, by industry, is segmented into pharmaceuticals, medical devices, consumer goods, food & beverages, and others. In 2022, the pharmaceuticals segment held a larger share of the market and is expected to record a higher CAGR during 2022–2030.
Based on geography, the track & trace solutions market is segmented into North America (the US, Canada, and Mexico), Europe (the UK, Germany, France, Italy, Spain, and the Rest of Europe), Asia Pacific (China, Japan, India, South Korea, Australia, and the Rest of Asia Pacific), the Middle East & Africa (the UAE, Saudi Arabia, South Africa, and Rest of the Middle East & Africa), and South & Central America (Brazil, Argentina, and the Rest of South & Central America). North America is the largest contributor to the growth of the global track & trace solutions market. Asia Pacific is expected to register the highest CAGR in the track & trace solutions market during 2022–2030.

The List of Companies - Track & Trace Solution Market

  1. ACG
  2. Axway Software SA
  3. Antares Vision SPA
  4. Markem-Imaje AG
  5. Mettler-Toledo International Inc
  6. Optel Group
  7. SEA Vision Grp
  8. Siemens AG
  9. TraceLink Inc
  10. Zebra Technologies Corp

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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