跟踪和追踪解决方案市场基于(关键地区、市场参与者、规模和份额)- 到 2030 年的预测

  • Report Code : TIPHE100000989
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 210
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【研究报告】2022年追踪解决方案市场规模为68.5亿美元,预计到2030年将达到227.0亿美元;预计从 2022 年到 2030 年,该市场的复合年增长率将达到 16.2%。

市场洞察和分析师观点:

跟踪和追踪解决方案旨在支持跨地区的合规性法规。一旦采用,它可以提供一个全面的、知识丰富的环境,使制药公司能够轻松地完成跟踪和追踪合规性要求,更好地管理召回,并提高制造过程的整体效率。实施系列化的严格法规和标准以及越来越多的包装相关产品召回是市场增长的重要因素。此外,离岸药品制造的增长为预测期内的整体市场增长提供了利润丰厚的市场机会。打击假药的系列化实施以及包装相关产品召回数量的增加,推动了追踪解决方案市场的增长。此外,持续的技术进步预计将在未来几年带来新的跟踪和追溯解决方案市场趋势。

跟踪和追溯解决方案市场驱动因素:

在全球范围内,制药公司正在遵守监管合规性系列化,确保药品防伪、可追溯。大多数发达和发展中经济体要么已经制定了系列化监管路线图,要么计划实施。由于与毒品相关的非法活动不断增加和供应链效率低下,监管机构推动确保药品供应链安全。这些努力的目的是解决药品假冒和未经授权的平行供应链问题,提高供应链的可见性,跟踪退货或召回,以及用于预测患者行为的数据驱动工具的稀缺。强制执行医疗产品序列化的政府法规的一些示例包括:

在美国,药品供应链安全法案 (DSCSA) 于 2013 年开始实施。DSCSA 定义了可互操作电子系统的要求,以识别和识别追踪药品在该国的整个分销过程。作为要求的一部分,药品必须标有国家药品代码 (NDC)、序列号、批号和有效期。美国食品和药物管理局 (FDA) 要求制造商在收到 FDA 实施跟踪系统的命令时,在整个分销链中跟踪特定设备。这些设备可能属于 I 类、II 类或 III 类。

此外,欧盟 (EU) 也遵循合规要求,颁布了伪造药品指令 (FMD)。已强制执行单元级序列化和分配器身份验证。此外,在土耳其,实施序列化的第一步是在每个单元包装上在线打印相关代码和信息。土耳其和法国制药厂的早期要求揭示了在线打印二维码的风险和困难,并花了三年时间来解决这些问题。 2021 年 5 月的欧盟医疗器械法规 (EU MDR) 旨在提高医疗器械整个生命周期的安全性和性能。该规则计划加强欧盟成员国医疗器械信息的协调,提高透明度和信息获取能力。

2012 年,印度对外贸易总局 (DGFT) 还要求对二级和三级产品进行序列化水平并制定报告出口货运的指南。其他几个国家也对制造和进口实施了类似的规定。在巴西,所有药品的单位和箱子(运输包装容器)都必须进行序列化。案例必须包含有关其所包含单位的信息。每个级别都需要对供应链进行跟踪,包括制造商/进口商、批发商、分销商和药房级别。

各国政府认为,假冒是一种有组织的犯罪,可以通过实施产品序列化来解决,许多国家正在这方面采取行动。序列化可以运行高级分析程序,以深入了解消费模式、地域渗透率、销售、营销支出有效性等。根据 2013 年《药品供应链安全法案》,从 2017 年 11 月开始,所有在美国销售处方药产品的制药公司必须对每个可销售药品单位进行序列化,以帮助从制造商到药房或医生办公室进行追踪。

根据欧盟伪造药品指令 (EU FMD) 的要求,到 2019 年 2 月,在欧盟市场开展业务的药品制造商必须实施序列化。如果药品制造商不遵守这些规定,他们将面临违规风险,这可能会导致巨额处罚,从每次发生罚款到被禁止推出产品。如果公司未能进行序列化,美国的批发商将不会购买其产品。除了在供应链内提供质量、可见性和完整的可追溯性之外,成功的序列化计划将成为公司的关键差异化因素和明显的竞争奖励。因此,发展中国家为避免假药而对药品进行系列化,推动了追踪解决方案市场的增长。

战略见解

报告细分和范围:

跟踪跟踪解决方案市场分析是通过考虑以下细分市场进行的:组件、企业规模、应用程序、行业和地理位置。按组件划分,市场分为硬件和软件。硬件组件进一步细分为条码扫描仪、射频识别读取器等。软件组件又分为工厂管理器、生产线控制器等。根据企业规模,市场分为中小企业和大型企业。根据应用,市场分为系列化和聚合化。根据行业,市场分为制药、医疗器械、消费品、食品和饮料等。追踪解决方案市场报告的范围涵盖北美(美国、加拿大和墨西哥)、欧洲(西班牙、英国、德国、法国、意大利和欧洲其他地区)、亚太地区(韩国、中国) 、日本、印度、澳大利亚和亚太其他地区)、中东和非洲(南非、沙特阿拉伯、阿联酋以及中东和非洲其他地区)以及南美洲和中美洲(巴西、阿根廷和南美洲和中美洲的其他地区)。

细分分析:

跟踪和追踪解决方案市场按类型分为硬件和软件。硬件组件进一步细分为条码扫描仪、射频识别读取器等。软件组件进一步分为工厂管理器、生产线控制器等。 2022年,软件领域占据了更大的市场份额,预计2022-2030年期间复合年增长率将更高。跟踪和追踪软件用于各种目的,并提供对整个序列化和聚合过程的完整管理。这些解决方案提供了灵活性,无论它们是具有有限连接的单条生产线,还是需要软件来监控多条生产线的所有流程。该软件提供了满足合规性所需的所有文档和信息。跟踪和追溯软件用于制药、生产、食品和饮料以及海鲜。 Rfxcel 公司;梅特勒-托利多;和 JDA Software Group, Inc 等公司提供跟踪和追踪软件。该软件具有独特的优势,例如减少管理并提高对质量事件的信心、通过更广泛的暴露产品范围更快地遏制质量事件以及保护客户和品牌形象。

跟踪和追溯解决方案市场,按应用,分为序列化解决方案和聚合解决方案。到 2022 年,序列化解决方案领域将占据更大的跟踪解决方案市场份额。此外,预计该细分市场在 2022 年至 2030 年期间将创下最高复合年增长率。序列化是指为所有产品分配预定类型的编码,为其贴上唯一的标识,以便几乎在任何时刻跟踪产品,并可以在生产、供应链和生产的任何阶段追溯到其位置。 /或其目前涉及的营销链,或产品生命周期中的任何点。如今,所有行业的供应链都比以往任何时候都变得更长、更复杂。因此,假冒伪劣、水货营销和产品混淆等现象迅速增加。大多数对制药、医疗器械和生命科学等行业的全球合规性有一系列监管要求的国家都需要标准化方法来确保和证明端到端产品的完整性。跟踪系统的序列化解决方案通过直接解决这些问题,增强了制药和医疗器械供应链的责任感。在全球制药行业,跟踪和追踪供应链中的药品的能力对于监管至关重要,并且为了提高药品安全性和避免假冒而不断发展。借助序列化解决方案,人们可以对产品进行有效期、批号、序列号、GTIN、二维矩阵码和 GSI-DataMatrix 符号的编码,以便跟踪产品以进行防伪工作。序列化还允许在整个供应链中跟踪和追踪产品,并提供品牌和消费者保护以及法规遵从性。

根据企业规模,全球跟踪和追踪解决方案市场分为中小企业和大型企业。 2022年,大型企业细分市场占有更大的市场份额。中小企业细分市场预计在 2022 年至 2030 年期间将录得更高的复合年增长率。

跟踪解决方案市场按行业细分为制药、医疗设备、消费品、食品和饮料等。 2022 年,制药领域占据最大的市场份额,预计 2022 年至 2030 年期间复合年增长率将达到最高。

按组件划分的跟踪和追溯解决方案市场 - 2022 年和 2030 年

区域分析:

从地理上看,市场分为北美、欧洲、亚太地区、中东和非洲以及南美洲和中美洲。北美是全球市场的最大贡献者。预计 2022 年至 2030 年,亚太地区的复合年增长率将达到最高。由于大型企业推出创新产品以及跟踪解决方案的技术进步,北美在 2022 年占据全球跟踪解决方案市场的最大份额。在北美,到 2022 年,美国将占据跟踪和追踪解决方案市场份额的最大份额。

行业发展和未来机遇:

跟踪和追踪解决方案市场预测是根据各种二级和一级研究成果的基础,例如主要公司出版物、协会数据和数据库。下面列出了跟踪解决方案市场主要参与者的策略:

2023 年 11 月,Sys-Tech Solutions Inc. 宣布向市场推出 UniSecure 平台。该平台是一个全面的产品安全解决方案,可检测转移和假冒行为。它通过智能手机在整个供应链流程中提供独特的产品识别、可追溯性和产品验证。新推出的平台可满足制药、营养保健品、医疗产品、护肤品和其他市场的需求。2022 年 10 月,Zebra Technologies Corporation 宣布推出新的 PartnerConnect 定位和跟踪专业化,面向专注于销售 RFID 和实时定位系统的合作伙伴(实时定位系统)。作为 Zebra 屡获殊荣的 PartnerConnect 计划的战略组成部分,新的定位和跟踪专业化为经销商提供了推动 RFID 和 RTLS 销售所需的工具,并帮助企业成功部署这些解决方案以实现转型业务收益。竞争格局和主要公司:

ACG、Axway Software SA、Antares Vision SPA、Markem-Imaje AG、Mettler-Toledo International Inc、Optel Group、SEA Vision Grp、Siemens AG、TraceLink Inc 和 Zebra Technologies Corp 等知名企业在跟踪解决方案市场报告中。此外,研究期间还对其他几家参与者进行了研究和分析,以全面了解市场及其生态系统。这些公司专注于地域扩张和产品发布,以满足全球消费者不断增长的需求,并增加其专业产品组合的产品范围。他们的全球业务使他们能够为庞大的客户群提供服务,从而促进市场扩张。
Report Coverage
Report Coverage

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

Segment Covered
Segment Covered

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to segments covered.

Regional Scope
Regional Scope

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

Country Scope
Country Scope

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to country scope.

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 and advised several client 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 organization 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 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/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.

  • 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.

  • 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.

  • 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.

  • 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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