Dear members of the press
[Report Ocean Press Release] We have conducted a survey to understand the state of the medical device regulatory services market in 2022.
Increasing demand for advanced medical devices for oncology and hematology has also increased the demand for necessary regulatory services, driving the growth of the market.
Survey period: September 1st to November 30th, 2022
Research agency :
Survey contractor: Report Ocean Co., Ltd.
Survey target: The survey was conducted with 890 leaders from organizations of all sizes around the world.
Number of valid responses: (890 people)
Survey method: Telephone survey of 300 people, Internet survey of 590 people Survey Respondents: The survey was conducted across companies based on revenue. [Image 1
Survey results :
Q: Which services are popular in the medical device regulatory affairs market? Based on services, the market is segmented into regulatory
consulting/strategy services, regulatory writing and publishing, legal representation, product registration and clinical trials, and others. The legal representative segment was the largest revenue contributor to the market in 2021. This is due to increased demand for
conventional and specialty 510(k)s, premarket approval (PMA) preparation and submission, design dossier preparation and FDA notified bodies. The accessibility of ISO 13485 registrar audit preparation and participation is expected to drive market growth. [Image 2
Q: Which service provider has the highest market share in the medical device regulatory affairs market?
By service provider, it is classified into in-house and outsourcing. By service provider, outsourcing has the highest revenue contribution. The increasing number of clinical trials being conducted and the provision of regulatory guidance for medical device approval to smaller industries are acting as factors that will boost the growth of the market.
Q: How is the market segmented by type?
By type, it includes diagnostics and therapeutics.
By type, the Therapeutics segment is in the regulatory business of medical devices due to the increasing prevalence of various chronic diseases such as cancer, diabetes, cardiovascular disease, and respiratory disease, and increasing demand for advanced therapeutic products. Contribution to the industry.
Q: How is the medical device regulatory services market distributed by indication?
By indication, the market is segmented into infectious diseases, oncology/hematology, gynecology/obstetrics, musculoskeletal disorders, respiratory, cardiovascular, and others.
By indication, the musculoskeletal disorders segment is the most profitable. Increasing demand for advanced medical devices for oncology and hematology has also increased demand for necessary regulatory services, fueling market growth.
Q: What are the key factors driving the medical device regulatory services market?
This market will grow during the forecast period due to the increasing introduction and development of advanced medical devices for the treatment of various diseases such as cardiovascular, cancer and other infectious diseases, as well as various technological advancements and their applications in the healthcare field. is expected to grow slowly. In addition, the rapid growth of the geriatric population and the advancement of various technologies to meet unmet patient needs presents great opportunities for existing players and new entrants. Growing geriatric population, investment in research and development, and government support for the use of advanced medical devices for chronic diseases are the major factors driving the growth of the medical device regulatory services market.
From a CXO perspective, the global market for medical device regulatory services is expected to grow steadily over the next few years. The global market for medical device regulatory affairs is doing well with increasing demand for faster approval processes. The rise of developing industries such as clinical research laboratories and pharmaceuticals has increased the need for medical device regulatory services worldwide.
Developing a new medical device can cost millions of dollars, and errors can have a huge impact on a company’s reputation. As medical devices play a very important role in people’s lives, they help in diagnosing, preventing and treating various diseases, so it is important to check the quality of products/medical devices and for this purpose Pharmaceutical affairs professionals take full
responsibility for this. Match products and track all paperwork. One of the regulatory professionals’ most important responsibilities is to ensure that all information about the device is accurately
communicated to the patient. Even a small misstep in regulatory action can result in millions of dollars lost as well as product recalls. It focuses on increasing number of product approvals, increasing number of clinical trial procedures, surge in demand for regulatory services, strong presence of prominent players in Asia Pacific and high demand for advanced medical devices.
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Dear members of the press