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Medical Device Labels Manufacturing Market, 2019-2030
NEW YORK, Nov. 7, 2019 /PRNewswire/ --
As of August, over 30 medical devices were approved by the US FDA alone, in 2019. Given recent technological advances and the increasing complexity of such products, the need for proper medical device labels has become a concern that is being addressed by both label manufacturers and regulators. In this context, it is worth highlighting that more than 10% of product recalls observed in this market are attributed to medical device labeling related issues. Labels ensure that a product is used according to the manufacturer's instructions and also serve to protect the developer from litigation pertaining to off-label use / abuse of a marketed device. Over the years, medical device packaging and labeling operations have evolved significantly. Presently, a variety of novel label designs, equipped with advanced features (such as traceability, tamper-evident sealing provisions and environmental resistance), are available. In addition, there have been significant upgrades pertaining to medical device label materials and label printer technologies.
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As the demand for innovative medical devices continues to grow, we believe that innovator companies are more likely to outsource certain aspects of their business operations, such as label manufacturing. Owing to the expertise and infrastructure required to develop and produce certain advanced types of pharmaceutical labels, the demand for contract service providers has increased substantially in this domain. Moreover, in order to cope up with the innovation in this domain, service providers are actively engaged in improving their core capabilities, procuring necessary certifications (such as ISO 13485), and optimizing business strategy. As a result, the industry has witnessed notable consolidation in the last five years, with many of the smaller players being acquired by more established businesses in efforts to augment the latter companies' offerings.
SCOPE OF THE REPORT
The "Medical Device Labels Manufacturing Market, 2019-2030" report features an extensive study of the current market landscape of companies offering manufacturing services for medical device labels. The study also features detailed analysis and an elaborate discussion on the future potential of this evolving market. Amongst other elements, the report includes:
• A detailed review of the overall landscape of companies offering manufacturing services for medical device labels, along with information on location of headquarters, year of establishment, company size, details related to regulatory certification / accreditation, types of label printing technologies used (digital, flexographic, screen, foil stamping, embossing, thermal, offset and others), types of labels manufactured (glue-applied, pressure sensitive, shrink-sleeve, in mold, custom die-cut, cut and stack and others), additional label-related features (extended content, external conditions proof, traceability and tamper-evident), type of material used (paper, plastic and film) and the manner in which the labels are folded (map fold, fan fold, mini fold, booklets, folding cartons and roll fed).
• An analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the key value drivers of such deals inked between 2014 and 2019 (till June).
• A detailed acquisition target analysis, which takes into consideration the historical trend of activity of top acquirers, providing a means for industry stakeholders to identify potential acquisition targets.
• An industry-wide benchmark analysis, highlighting the key focus areas of small, mid-sized and large companies, comparing their existing capabilities within and beyond their respective (geography-based) peer groups.
• A detailed business portfolio analysis based on the 9-box attractiveness and competitiveness (AC) matrix framework, highlighting the current market attractiveness and competitive strength of different printing technologies used by label manufacturers.
• An elaborate discussion on the various guidelines established by major regulatory bodies, governing medical device labeling-related practices and product approval, across different countries.
• Elaborate profiles of key players that claim to have a diverse range of capabilities for the manufacturing of different types of labels for medical devices; each profile includes an overview of the company, its financial performance (wherever available), information on its label manufacturing capabilities and an informed future outlook.
• A discussion on important industry-specific trends, key market drivers and challenges, under a SWOT framework, featuring a qualitative Harvey ball analysis that highlights the relative impact of each SWOT parameter on the overall medical device labels market.
• A review of the various upcoming opportunities and anticipated future trends related to medical device label manufacturing that are expected to influence the evolution of this industry over the coming years.
One of the key objectives of this report was to evaluate the current opportunity and the future growth potential within the medical device labels manufacturing market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. In addition, we have provided the likely distribution of the opportunity across different [A] types of labels (glue applied, pressure sensitive, in mold, sleeve and others), [B] type of material (paper, plastic and film), [C] application areas(therapeutic devices, diagnostic devices, drug delivery devices and other devices), [D] device classes (class I devices, class II devices and class III devices), and [E] geographical regions (North America, Europe, Asia-Pacific and rest of the world). To account for the uncertainties associated with the growth of medical device labels market and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.
All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified
The data presented in this report has been gathered via secondary research. For most of our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include:
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts' views
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the medical device label manufacturing market and its likely evolution in the short-mid-term and long term.
Chapter 3 provides an introduction to medical devices packaging and labeling, highlighting the different types of labels, components of labels and their purpose. It lays some emphasis on the general principles that have been laid down by product developers / regulators for medical device labels, and a review of the GMP requirements for companies that claim to offer label manufacturing services. Further, it features information on the different types of label printing techniques available, types of folding and various special features that are gradually being introduced into pharmaceutical labels. The chapter also includes a detailed discussion on the various challenges associated with the production of labels.
Chapter 4 features a detailed discussion on the guidelines established by major regulatory bodies, governing medical device labeling practices and product approval, across various geographies, namely North America (the US and Canada), Europe (specifically the UK scenario) and Asia-Pacific (Japan, China and India).
Chapter 5 provides a comprehensive overview of the overall landscape of companies offering manufacturing services for medical device labels. It includes information related to over 80 companies that are actively involved in the manufacturing of medical device labels. It features an in-depth analysis of the market, based on parameters such as location of headquarters, year of establishment, company size, details related to regulatory certification / accreditation, types of label printing techniques used, type of labels manufactured, additional label-related features, type of material used, and the manner in which labels are folded.
Chapter 6 features elaborate profiles of key players that claim to have a diverse range of capabilities dedicated to the manufacturing of medical device labels. Each profile includes an overview of the company, its financial performance (wherever available), its service and product portfolio and an informed future outlook.
Chapter 7 features a detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2014-2019 (till July), based on parameters such as key value drivers, year of acquisition, type of acquisition, geographical location of the acquirer and the acquired company, and financial details of the deal (if available). The analysis also features an ownership change matrix, providing insights on the involvement of private and public sector entities in this domain. Moreover, it presents a schematic world map representation of the geographical distribution of this activity, highlighting inter and intracontinental deals.
Chapter 8 features a detailed discussion on the future potential acquisition targets of the more established label manufacturing companies. Moreover, based on the historical trend of acquisition activity reported by the aforementioned players, the chapter provides a means for industry stakeholders to identify potential acquisition targets.
Chapter 9 presents an industry-wide benchmark analysis, highlighting the capabilities of small, mid-sized and large companies in terms of their expertise in medical device label-related services. Further, the analysis allows companies to compare their existing capabilities within and beyond their respective (geography-based) peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.
Chapter 10 features a detailed analysis of label printing technologies based on the 9-box AC matrix framework. It further includes a discussion on the relative market attractiveness and competitive strength of the aforementioned technologies. The purpose of the analysis is to enable companies to analyze their respective technical expertise, develop informed growth strategies (with regard to technical strength), and also make decisions related to acquiring new technology or divesting outdated printing platforms.
Chapter 11 presents a likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. In addition, we have provided the likely distribution of the opportunity across different [A] types of labels (glue applied, pressure sensitive, in mold, sleeve and others), [B] label material (plastic, paper and others), [C] application (monitoring and diagnostic equipment, disposable consumables and therapeutic equipment), [D] type of device class (class I devices, class II devices and class III devices), and [E] geographical regions (North America, Europe, Asia-Pacific and rest of the world).
Chapter 12 provides a discussion on important industry-specific trends, key market drivers and challenges, under a SWOT framework, featuring a qualitative Harvey ball analysis, that highlights the relative impact of each SWOT parameter on the overall medical device label manufacturing industry.
Chapter 13 features a review of the future opportunities and anticipated trends related to medical device label manufacturing market that are likely to influence the evolution of this industry over the coming years.
Chapter 14 is an appendix that contains a list on companies that offer label manufacturing services as a part of medical device manufacturing (not included in the database).
Chapter 15 is an appendix that contains tabulated data and numbers for all the figures provided in the report.
Chapter 16 is an appendix that contains a list of companies and organizations included in the database / mentioned in this report.
Chapter 26 is an appendix, which contains the list of companies and organizations mentioned in the report.
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