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Medical Device Contract Manufacturing Market, 2019-2030

NEW YORK, July 17, 2019 /PRNewswire/ --

INTRODUCTION

Recent advances in data science technology solutions, such as Internet of Things, machine learning, artificial intelligence and real world evidence-based solutions, have enabled medical device developers to digitize and automate a number of product development and manufacturing processes. In 2020, the global medical devices market is estimated to reach a net worth of approximately USD 430 billion. However, most developers lack adequate resources and the necessary expertise to manufacture medical devices and related components. Moreover, given the rapid rate of evolution, the costs associated with acquiring the necessary infrastructure and capabilities in this field are high; therefore, it is difficult for companies with limited finances to acquire such resources and carry out such operations by themselves. In addition, the evolving regulatory guidelines and complicated pathways to establishing reimbursement strategies render medical devices subject to rigorous quality assessments, especially for medium and high risk devices. The aforementioned constraints have led many of the smaller players and certain established players to outsource a significant part of their manufacturing operations to capable contract manufacturing organizations (CMOs). CMOs are known to offer significant cost-benefits, access to sophisticated / up-to-date infrastructure, large production capacities and reduction in time-to-market.



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Given the demand for medical devices, the opportunity for CMOs with expertise in medical devices is steadily rising. In fact, in 2018 alone, the USFDA approved over 100 medical devices. It is worth highlighting that, since 2000, more than 65 CMOs have been established. The demand for one-stop-shops and versatile supply chain management solutions have fuelled consolidation activity in this domain. Contemporary contract service providers have been focusing on bolstering in-house capabilities to offer a wider range of services to their clients, covering product design to distribution and marketing, along with regulatory assistance. The medical device sector is among the most highly regulated industries, and we expect the demand for core competencies, such as design and engineering, prototype development and high volume manufacturing, to continue to drive sponsor companies to outsource various parts of their product development and manufacturing operations to capable contract service providers. Amidst tough competition, the availability of advanced tools and technologies is an important differentiating factor; CMOs that invest in such upgrades are likely to gain a competitive edge.

SCOPE OF THE REPORT
The "Medical Device CMOs Market, 2019-2030" report features a comprehensive study on the current landscape of contract manufacturing service providers focused on medical devices (specifically for drug-delivery devices, diagnostic devices and therapeutic devices). The scope of the report primarily includes those manufacturers that offer finished product services for medical devices (excluding medical equipment, such as X-ray machines, ultrasound machines, operating tables and other similar products). The study features an in-depth analysis, highlighting the capabilities of the various stakeholders engaged in this domain, across different regions of the globe. Amongst other elements, the report includes:
A detailed review of the overall landscape of the medical device contract manufacturing market, featuring a list of CMOs engaged in this domain, and detailed analysis based on a number of relevant parameters, such as year of establishment, size of employee base, manufacturing facilities, geographical location, type of device manufactured (drug-delivery devices, diagnostic devices, therapeutic devices and others), scale of operation (precommercial and commercial) and types of services offered ([A] production services (such as design services, prototyping, component manufacturing, packaging, and sterilization), [B] post-production services (such as supply chain management services, labeling services, logistics, and shipping services) and [C] other services (such as regulatory services, project management services and documentation services).
An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval, across different countries. The report also features an insightful multi-dimensional bubble analysis, featuring a comparison of the contemporary regulatory scenario in key geographies across the globe.
A benchmark analysis, highlighting the key focus areas of small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.
An analysis of the medical device supply-chain, highlighting the role of CMOs engaged in this domain and analysis based on services offered, such as supply chain management services, logistics services, shipping services and warehousing services, to medical device companies.
Elaborate profiles of popular players that specialize in providing services for both precommercial and commercial scale manufacturing of medical devices. Each profile features an overview of the company, its service portfolio, details on manufacturing facilities, as well as an informed future outlook.
A geographical clinical trial analysis of ongoing and planned studies related to medical devices, featuring details related to medical devices being investigated across various geographies, based on the number of registered trials, current status of trials, phase of development, type of sponsor, therapeutic area(s) and target disease indication(s), and number of patients enrolled.
A detailed analysis of the mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2014-2019. The analysis provides information on the key value drivers for these mergers and acquisitions and the corresponding acquisition deal multiples. In addition, the analysis features an ownership change matrix, providing a summary of the involvement of private and public sector entities in this domain.
An elaborate discussion on the future opportunities / trends related to the medical device contract manufacturing market that are likely to influence the growth within this domain over the coming years.
A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall medical device CMO industry.

One of the key objectives of this report was to evaluate the current opportunity and the future market potential of the medical device CMOs 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] type of devices (drug-delivery, therapeutic and diagnostic devices), [B] device class (class I, class II and class III), [C] therapeutic areas (cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others), and [D] geographical regions (North America, Europe, Asia-Pacific and rest of the world) and [E] leading players. To account for the uncertainties associated with the growth of the medical device CMO market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all 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 technology 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

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
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 contract manufacturing market and its likely evolution in the short-mid and long terms.

Chapter 3 provides a brief introduction to medical devices, highlighting key historical milestones, their classification, and associated manufacturing requirements. It emphasizes on the contract services market for such medical products, featuring an overview of the various challenges faced by medical device manufacturers, and highlighting the role of CMOs and diverse range of benefits offered by such service provider entities. It also includes a discussion on the services offered by CMOs, along with a list of advantages and risks associated with outsourcing. Further, it describes the various factors that need to be taken into consideration by sponsor companies, while selecting a suitable CMO partner.

Chapter 4 features a detailed discussion on the various guidelines established by regulatory bodies for medical device approval, across different geographical regions, namely North America (the US and Canada), Europe (specifically the UK scenario), and Asia-Pacific (Japan, China and Australia). In addition, the chapter features an insightful, multi-dimensional bubble analysis that compares the current regulatory scenario within the overall medical device industry.

Chapter 5 provides a comprehensive overview of the overall landscape of drug-delivery device CMOs. It includes information related to over 70 companies that actively offer manufacturing services for drug-delivery devices. In addition, it features an in-depth analysis of the market, based on parameters such as year of establishment, size of employee base, location of manufacturing facility, scale of operation (precommercial and commercial) and types of services offered.

Chapter 6 provides a comprehensive overview of the overall landscape of diagnostic device CMOs. It includes information related to over 80 companies that actively offer manufacturing services for diagnostic devices. In addition, it features an in-depth analysis of the market, based on parameters such as year of establishment, size of employee base, location of manufacturing facility, scale of operation (precommercial and commercial) and types of services offered.

Chapter 7 provides a comprehensive overview of the global landscape of therapeutic device CMOs. It includes information related to over 170 companies that actively offer manufacturing services for therapeutic devices. In addition, it features an in-depth analysis of the market, based on parameters such as year of establishment, size of employee base, location of manufacturing facility, scale of operation (precommercial and commercial) and types of services offered.

Chapter 8 presents a benchmark analysis of the various players engaged in this domain. It highlights the capabilities of small-sized, mid-sized and large companies in terms of their expertise in medical device related services. Further, the analysis allows companies to compare their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.

Chapter 9 features an analysis of the medical device value-chain, highlighting the role of CMOs engaged in this domain and analysis based on services such as, such as supply chain management services, logistics services, warehouse services and shipping services.

Chapter 10 features detailed profiles of popular players that specialize in providing services for both precommercial and commercial stage medical device manufacturing. Each profile features an overview of the company, its service portfolio, details on manufacturing facilities, and an informed future outlook.

Chapter 11 presents a geographical clinical trial analysis of ongoing and planned studies related to medical devices. For the purpose of this analysis, we considered those clinical studies that have been initiated since 2013 and analysed them on the basis of various parameters, such as year of registration, regional distribution, current status of trials, phase of development, funder type, therapeutic area(s) and target disease indication(s), and number of patients enrolled across different geographies.

Chapter 12 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, 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. In addition, the chapter evaluates the deal multiples of acquisitions specifically focused on medical devices, analyzing them based on a number of parameters, namely annual revenues, number of employees and the experience of the acquired company. Moreover, it presents a schematic world map representation of the geographical distribution of this activity, highlighting inter- and intracontinental deals.

Chapter 13 features a case study highlighting the manufacturing overview of key market sectors, such as automobiles, telecommunication, banking, defense and aerospace that have experienced tremendous growth within emerging markets. It highlights the ongoing evolution in medical device manufacturing industry within developed and emerging countries, featuring a qualitative comparative analysis. Further, the chapter includes discussions regarding the business models, associated challenges and strategies to mitigate these constraints for multinational, medical device-focused companies within emerging countries.

Chapter 14 presents a likely evolution of the market in the short to mid-term and long term (2018-2030). In addition, we have provided the likely distribution of the opportunity across different A] type of device (drug-delivery, therapeutic and diagnostic devices), [B] device class (class I, class II and class III), therapeutic areas (cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others), and [D] geographical regions (North America, Europe, Asia-Pacific and rest of the world) and [E] leading players.

Chapter 15 provides a discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall medical devices CMO industry.

Chapter 16 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of the medical device CMOs market, based on the research and analysis described in the previous chapters. It also provides a recap of some of the upcoming future trends, which, we believe, are likely to influence the growth of medical device CMOs.

Chapter 17 is a collection of survey transcripts of the discussions held with key stakeholders in this market.

Chapter 18 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 19 is an appendix that contains the list of companies and organizations mentioned in this report.

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