Medical Devices Contract Research Organizations Market (3rd Edition), 2022-2035

Medical Devices Contract Research Organizations Market (3rd Edition), 2022-2035

According to the World Health Organization (WHO), presently, around two million medical devices are available across the globe. Further, just over 35 medical devices received approval by the USFDA, every year. It is worth highlighting that, since 2020, the USFDA has approved around 105 medical devices. Moreover, the medical devices are expected to capture more than 40% of the global medtech industry and this value is projected to grow at a steady pace over the coming years. In this context, the number of medical device focused clinical trials have increased at a considerable rate, over the past few years. However, only a few players engaged in this domain claim to have the technical expertise to carry out in-house clinical research. This can be attributed to the high costs associated with acquiring the required infrastructure and capabilities to carry out research in this domain. In addition, various regulatory guidelines render medical devices subject to rigorous quality assessments, thereby, making it difficult for firms with limited finances to undertake research initiatives. Specifically, post the onset of the COVID-19 pandemic, there has been a substantial increase in the demand for medical devices as they have the ability to enable early diagnosis, as well as provide non-invasive and effective treatments.

Given the surge in demand for medical devices in the recent past, coupled to the aforementioned constraints faced by developers, a large number of small, as well as well-established, players prefer to outsource a significant share of their respective clinical operations and regulatory affairs management to contract research organizations (CROs). Since 2010, over 75 CROs have been established in this domain. Further, in order to support the growing demand, medical device CROs have been re-evaluating and bolstering their existing capabilities to offer a wide range of services to their clients. Integration of novel technologies and tools, such as cloud computing, risk monitoring tools, real-world evidence and advanced data analytics, is another key initiative being undertaken by several CROs to distinguish themselves from their competitors. To enable expansion of their existing capabilities, more than 55 acquisitions and / or strategic alliances have been established by service providers in this market, since 2015. Considering the prevalent trends and projected opportunity associated with the overall medical devices market, we believe that the medical devices CROs market is likely to witness consistent grow, till 2035.

The ‘Medical Devices Contract Research Organizations Market (3rd Edition) by Target Therapeutic Area (Cardiovascular Disorders, CNS Disorders, Metabolic Disorders, Oncological Disorders, Ophthalmological Disorders, Orthopedic Disorders, Pain Disorders, Psychological Disorders, Respiratory Disorders, and Others), Scale of Operation (Clinical / Preclinical), Device Class (Class I, Class II, Class III), Type of Clinical Service Offered (Clinical Trial Management, Data Management, Regulatory Affairs Management, Consulting), Type of Preclinical Service Offered (Biocompatibility Testing, Sterility, Microbiology Testing, Material Characterization, Analytical Services), and Key Geographies
(North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2022-2035’ report features an extensive study of the current market landscape and future opportunities associated with the medical device contract research organizations market. The study also includes an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. Amongst other elements, the report features:
A detailed overview of the overall landscape of medical devices CROs, along with information on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters (North America, Europe, Asia-Pacific, Middle East and North Africa, and Rest of the World), area of specialization (medical device and in vitro diagnostics), device class (class I, class II, and class III), types of services offered by [A] clinical service providers (biostatistics, consulting, clinical operations, post marketing surveillance / studies, quality assurance, regulatory affairs management, reimbursement and training), [B] preclinical service providers (consulting, biocompatibility testing, materials characterization and analytical testing, preclinical trials support, sterility testing and microbiology testing, and training) and [C] stand-alone service providers.
An elaborate discussion on the various guidelines established and issued by major regulatory bodies for medical device approval, across North America (the US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe), and Asia-Pacific and Rest of the World (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). It also features an insightful multi-dimensional, heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe.
Elaborate profiles of key players (shortlisted on the basis of the company competitiveness analysis) that specialize in offering services for both clinical and preclinical stage development of medical devices.. Each profile features a brief overview of the company, along with information on their year of establishment, number of employees, location of headquarters, key executives, medical device focused service portfolio, recent developments, and an informed future outlook.
An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers engaged in this domain, based on information gathered via secondary research (for top-ten medical device players) and primary research.
A competitive benchmarking, highlighting the key focus areas of small, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups (small, mid-sized and large players based in North America, Europe, Asia-Pacific, and Rest of the World), and providing a means for stakeholders to identify ways to gain a competitive advantage in the industry.
A detailed brand positioning analysis of leading industry players (shortlisted on the basis of revenues generated in 2021), highlighting the current perceptions regarding their proprietary brands by taking into consideration several relevant aspects, such as number of service(s) offered and device class.
An in-depth analysis of completed, ongoing, and planned clinical studies focused on medical devices, based on several relevant parameters, such as trial registration year, trial phase, current trial status, enrolled patient population, study design, leading industry players (in terms of number of trials conducted), target therapeutic area(s) and key geographical regions.
A detailed analysis of the various mergers and acquisitions that have taken place in this domain, during the period 2015-2022, based on several relevant parameters, such as year, type of agreements and geographical location of the companies.
A detailed analysis of the total cost of ownership for a medical device contract research service provider. It features an informed estimate of direct and indirect expenses taking into consideration 19 relevant parameters, over a span of 20 years.
A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing contract research services to medical device developers.
A discussion on industry affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the evolution of this field; it includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on industry dynamics.

One of the key objectives of the report was to estimate the existing market size and the future growth potential within the medical devices contract research market over the coming years. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2022-2035. Additionally, the report features the likely distribution of the current and forecasted opportunity across [A] target therapeutic area (Cardiovascular disorders, CNS disorders, Metabolic disorders, Oncological disorders, Ophthalmological disorders, Orthopedic disorders, Pain disorders, Psychological disorders, Respiratory disorders, and Others), [B] scale of operation (clinical and preclinical), [C] device class (class I, class II and class III), [D] types of clinical services offered (clinical trial management, consulting, data management, regulatory affairs management and others) [E] types of preclinical services offered (material characterization and analytical services, biocompatibility testing, sterility and microbiology testing and others), and [F] key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic tracks of the industry’s evolution.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following stakeholders:
Lajos Sarosi (Chief Executive Officer and Co-founder, HungaroTrial)
Lee King (Senior Vice President, Business Development and Marketing)
Christopher Rupp (Vice President of Global Marketing and Commercial Operations, NAMSA)
Claus Hemiker (Head, Business Development)
Christian Wolflehner (General Manager, CW Research & Management)
Troy W. Mccall (Chief Commercial Officer, CROMSOURCE)
Nazish Urooj (Senior manager, Medical & Clinical Operations, Metrics Research)
C. Omprakash (Technical Director and Partner, Vyomus Consulting)
Tania Persson (Director of Business Development, A+ Science)
Alexa Foltin-Mertgen (Business Development Manager, AtoZ-CRO)

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.

MARKET SEGMENTATION

Medical Devices Contract Research Organizations Market: Market Segmentations
S. No. Market Segments Details
1 Forecast Period 2022 - 2035
2 Scale of Operation Clinical
Preclinical
3 Device Class Class I
Class II
Class III
4 Target Therapeutic Area Cardiovascular Disorders
CNS Disorders
Metabolic Disorders
Oncological Disorders
Ophthalmological Disorders
Orthopedic Disorders
Pain Disorders
Psychological Disorders
Respiratory Disorders
Others
5 Key Geographical Region North America
Europe
Asia-Pacific
Rest of the World
\Source: Roots Analysis

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. Wherever 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 over the coming decade, the report also provides our independent view on various emerging trends 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.

KEY QUESTIONS ANSWERED

Who are the key players engaged in offering contract research services for medical devices?
Which regions represent the key contract research hubs for medical devices?
What are the key regulatory guidelines, related to medical devices that have been established across various geographies?
What are the key value drivers of the merger and acquisition activity observed within this domain?
What percentage of the medical devices research operations are presently outsourced?
What are the likely future trends in contract research services market for medical devices?
How is the current and future opportunity likely to be distributed across key market segments?
What is the total cost of ownership required to set up a medical device contract research organization?

CHAPTER OUTLINE
Chapter 2 is an executive summary of key insights captured during our research. It offers a high-level view on the current state of the medical devices contract research market and its likely evolution in the short to mid-term and long term.

Chapter 3 provides a brief introduction to medical devices, highlighting the key historical and development milestones, and classification of such devices. It also provides a general overview of the concept of CROs, featuring a discussion on the historical evolution of contract research services market in the medical device domain. Further, it presents details related to the various types of CROs that operate within the medical device market and the different types of services offered. It further lists the advantages as well as challenges associated with outsourcing medical device research and clinical operations to contract service providers, along with the key parameters that need to be considered while selecting a CRO partner.

Chapter 4 features a detailed overview of the current market landscape of medical devices CROs, along with information on several relevant parameters, such as their year of establishment, company size (in terms of company size), location of headquarters (North America, Europe, Asia-Pacific, Middle East and North Africa, and Rest of the World), area of specialization (medical device and in vitro diagnostics), device class (class I, class II, and class III), types of services offered by [A] clinical service providers (biostatistics, consulting, clinical operations, post marketing surveillance / studies, quality assurance, regulatory affairs management, reimbursement and training), [B] preclinical service providers (consulting, biocompatibility testing, materials characterization and analytical testing, preclinical trials support, sterility testing and microbiology testing, and training) and [C] stand-alone service providers.
Chapter 5 features a discussion on the various guidelines established by major regulatory bodies for medical device approvals across North America (the US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe), and Asia-Pacific and Rest of the World (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). The report also features an insightful multi-dimensional heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe.

Chapter 6 features detailed profiles of key players (shortlisted on the basis of the company competitiveness analysis) engaged in this domain. Each profile features a brief overview of the company, along with information on year of establishment, number of employees, location of headquarters, key executives, details related to contract research services offered, recent developments, and an informed future outlook.

Chapter 7 features an analysis on the key value drivers and performance indicators used by sponsor companies to evaluate service providers engaged in this domain, based on information gathered via secondary research (for top-ten medical device players), as well as credible inputs from primary research.

Chapter 8 presents a competitive benchmarking 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 services. The analysis allows companies to compare their existing capabilities within and beyond their respective peer groups (small, mid-sized and large players based in North America, Europe, Asia-Pacific, and Rest of the World) and providing a means for stakeholders to identify ways to gain a competitive advantage in the industry.

Chapter 9 provides an elaborative brand positioning analysis of leading industry players (shortlisted on the basis of revenues generated in 2021), highlighting the current perceptions regarding their proprietary brands by taking into consideration several relevant aspects, such as number of services offered and device class.

Chapter 10 presents a detailed analysis of completed, ongoing, and planned clinical studies focused on medical devices, based on several relevant parameters, such as trial registration year, trial phase, current trial status, enrolled patient population, study design, leading industry players (in terms of number of trials conducted), target therapeutic area(s) and key geographical regions.

Chapter 11 features a detailed analysis of the various mergers and acquisitions that have taken place in this domain, during the period 2015-2022 (till March). It is worth mentioning that the data captured during our research was analysed based on multiple parameters, such as year, type of agreements and geographical location of the companies.

Chapter 12 detailed analysis of the total cost of ownership for a medical device contract research service provider. It features an informed estimate of direct and indirect expenses taking into consideration 19 relevant parameters, over a span of 20 years.

Chapter 13 presents insights from the survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing contract research services to medical device developers.

Chapter 14 presents an insightful market forecast analysis, highlighting the likely growth of the medical devices contract research market till the year 2035. In order to provide details on the future opportunity, our projections have been segmented on the basis of [A] target therapeutic area (Cardiovascular disorders, CNS disorders, Metabolic disorders, Oncological disorders, Ophthalmological disorders, Orthopedic disorders, Pain disorders, Psychological disorders, Respiratory disorders, and Others), [B] scale of operation (clinical and preclinical), [C] device class (class I, class II and class III), [D] types of clinical services offered (clinical trial management, consulting, data management, regulatory affairs management and others) [E] types of preclinical services offered (material characterization and analytical services, biocompatibility testing, sterility and microbiology testing and others), and [F] key geographical regions (North America, Europe, Asia-Pacific and Rest of the World).

Chapter 15 provides a discussion on industry affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the evolution of this field; it includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on industry dynamics.

Chapter 16 presents a discussion on the upcoming opportunities / trends of medical device contract services market that are likely to impact the future evolution of this domain over the coming years. These include (but not limited to) growth in number of connected devices, adoption of data analytics and real-time monitoring solutions, growing need for cloud-based computing and storage solutions and growing demands for real-world evidence to obtain regulatory approval.

Chapter 17 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of interview held with Lajos Sarosi (Chief Executive Officer and Co-founder, HungaroTrial), Lee King (Senior Vice President, Business Development and Marketing), Christopher Rupp (Vice President of Global Marketing and Commercial Operations, NAMSA), Claus Hemiker (Head, Business Development), Christian Wolflehner (General Manager, CW Research & Management), Troy Mccall (Chief Operating Officer, CROMSOURCE), Nazish Urooj (Senior Manager, Medical & Clinical Operations, Metrics Research), C. Omprakash (Technical Director and Partner, Vyomus Consulting), Tania Persson (Director of Business Development, A+ Science) and Alexa Foltin-Mertgen (Business Development Manager, AtoZ-CRO).

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 provides the list of companies and organizations mentioned in the report.