Regulatory affairs play a crucial role in the medical device and in vitro diagnostic device (IVD) industry. These affairs are concerned with the lifecycle of different healthcare products. Regulatory affairs outsourcing provides tactical, strategic, and operational support and direction to the manufacturing companies so that they could work within the regulatory framework. By doing so, the manufacturing companies of medical devices and IVD devices expedite the development and delivery of effective and safe healthcare products to institutions and individuals around the world. Investments in the regulatory information systems have considerably increased, as they help keep pace with the need to automate many activities such as publishing and regulatory operations.
COVID-19 Impact Analysis
COVID-19 is an infectious disease that originated in the Hubei province of the Wuhan city in China in late December. The highly contagious disease, caused by a virus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is transmitted from human to human. Since the outbreak in December 2019, the disease has spread to almost 213 countries around the globe with the World Health Organization declaring it a public health emergency on March 11, 2020.
The global outbreak of COVID-19 leads to an ongoing downturn in the healthcare market. Apart from communities, COVID-19 was equally disastrous for major world economies, especially the healthcare sector. Prominent stakeholders are continuing to adapt their strategies to the rapidly changing situation. COVID-19 is projected to have significant long-term impacts on the healthcare industry. Countries and major players would have to undertake critical healthcare changes until the crisis takes a back seat.
Technological progress, cost containment, and increased access are projected to be an integral part of healthcare reforms in the near future. Digital health and telehealth have taken a front seat in the ongoing outbreak. COVID-19 re-emphasized the importance of remote diagnosis, care, and consultation. Over the past few years, regulatory and behavioral barriers have slowed telehealth growth.
The social distancing measures mandated online consultation of patients with moderate symptoms. In addition, it reduced the burden on hospitals already swamped by counts of COVID-19 patients.
Medical IoT devices that are used at home are now being used for optimizing outpatient treatment and minimizing repeat visits, and these devices can be further used in a crisis situation. The pandemic led to severe resource constraints. With many individuals focusing on personalized medicine themselves it is expected to result in the development of competitive pricing and value-based medical device and IVD regulatory affairs outsourcing software models, which boosts the growth of the medical device and IVD regulatory affairs outsourcing market.
Top Impacting Factors
Increase in expansion activities by companies in different regions of the world for speedy product approvals in the regional and local market has contributed to the growth of the medical device and IVD regulatory affairs outsourcing market.
In addition, increase in research and development activities regarding medical devices and IVDs has led to the launch of new products, which contributes to the growth of the market.
Medical device and IVD regulatory affairs outsourcing helps to augment the volume of product registrations and clinical trial approvals. This factor has boosted the growth of the market in recent years.
However, changing regulations regarding medical devices in different regions of the world are posing a challenge for the growth of the market. Therefore, this factor impedes the growth of the medical device and IVD regulatory affairs outsourcing market.
Key Market Trends
In May 2020, the European med-tech industry called for the postponement regarding the implementation of the new European Medical Devices Regulation due to the COVID-19 pandemic.
Consulting firms in various parts of the world are using quality management software to help deploy a quality-driven culture for different med-tech companies. For instance, the quality management system from Qualio is highly publicized for firms that are focused on product innovations.
Key players of the medical device and IVD regulatory affairs outsourcing market are focused on offering project-based support and solutions to different healthcare organizations. This helps them have long-term outsourcing agreements.
Apart from the North America, many medical device and IVD regulatory affairs outsourcing players are penetrating the market of Asia-Pacific. They are doing so by increasing the portfolio in regulatory audits.
Key Benefits of the Report
- This study presents the analytical depiction of the medical device and IVD regulatory affairs outsourcing industry along with the current trends and future estimations to determine the imminent investment pockets.
- The report presents information related to key drivers, restraints, and opportunities along with a detailed analysis of the medical device and IVD regulatory affairs outsourcing market share.
- The current market is quantitatively analyzed to highlight the medical device and IVD regulatory affairs outsourcing market growth scenario.
- Porter’s five forces analysis illustrates the potency of buyers & suppliers in the medical device and IVD regulatory affairs outsourcing market.
- The report provides a detailed analysis depending on competitive intensity and how the competition will take shape in the coming years.
Questions Answered in the Medical Device and IVD Regulatory Affairs Outsourcing Report
- Which are the leading players active in the medical device and IVD regulatory affairs outsourcing market?
- How is each segment of the market expected to grow during the forecast period?
- What are the adoption trends for the medical device and IVD regulatory affairs outsourcing market in emerging economies and established economies across the world?
- What are the current trends that will influence the market in the next few years?
- What are the driving factors, restraints, and opportunities of the medical device and IVD regulatory affairs outsourcing market?
- What future projections would help in taking further strategic steps in the market?
- What are the impacts of COVID-19 on the industry?
- What are medical device and IVD regulatory affairs outsourcing?
- What are the current and predicted trends of the market?
Medical Device and IVD Regulatory Affairs Outsourcing Market Report Highlights
| Aspects | Details |
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 By Software |
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 By Region |
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 Key Market Players | RegIQ Solutions, Assent Compliance, Inc, Covance, Inc, AxSource Consulting, Inc, LORENZ Life Sciences Group, Promedica International Company, MakroCare, Freyr Solutions |
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