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Regulatory affairs is a profession established from the desires governments which helps to protect public health by analysing and monitoring the safety and efficacy of products in areas including pharmaceuticals, medical devices, agrochemicals, pesticides, veterinary medicines cosmetics and complementary medicines. Regulatory affairs outsourcing are the services offered by the pharmaceutical, biotech and medical devices manufacturing industries. Regulatory affair outsourcing services help to achieve fast regulatory approvals. Regulatory affairs outsourcing industries are helping to get approval for new products, preparing protocol for conducting clinical trial, publishing report etc. Regulatory outsourcing services provide various types of services including regulatory consultant, regulatory writing & publishing, product registration & clinical trial applications, legal representation, patent application. Pharmaceutical companies play major role in contributing largest market share in global regulatory affair outsourcing market.
COVID-19 Scenario Analysis:
Coronavirus disease 2019 (COVID-19) has created an economic crisis along with a health care crisis. COVID-19 pandemic has stretched healthcare system worldwide, developed countries are expected to cause economic recession. The Covid-19 pandemic has an adverse impact on the healthcare system, resulting in 50% to 70% drop in revenue from March. Many small hospitals, clinics and nursing homes, have been forced to shut their operations. As a result of social distancing and localized curfews have resulted in delayed elective surgical procedures. In addition, visa cancellations have led to a hiatus in medical tourism and can negatively impact the healthcare services market growth. Due to the ongoing outbreak of COVID-19 It affect the regulatory affair outsourcing market. It affect the industries outsourcing practices due to the temporarily shutdown of industries. It affect on implementing clinical trial studies for developing innovative drugs.
As the COVID-19 virus outbreak in December 2019, the disease has spread to almost 100 countries across the globe with the “World Health Organization” announcing it a public health emergency. The global impacts of the COVID-19 pandemic are already starting to be felt, and will significantly affect the regulatory affair outsourcing market in 2020. COVID-19 can affect the global economy in three main ways by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on firms and financial markets.
Globally, North America dominates regulatory affairs outsourcing market due to the increasing revenue contribution than other countries. While Europe is considered as second-largest revenue share in the global regulatory affairs outsourcing market. Whereas, Asia-Pacific is expected to rise at the highest growth rate during the forecast period due to the rising development of life sciences industries, rising demand for cost effective outsourcing, skilled staff with technical expertise
Major driving factors such as rising number of clinical trials, development of life sciences industries in global markets, rising development in the areas such as biosimilar, personalized medicine orphan drugs, etc., Increasing in-house resources for healthcare regulatory affairs, rising investment in R&D activities to produce biosimilar, orphan and generic drug, rising investment in clinical research, rising focus on product development to expand product supply, Strict government regulation, growing FDA approved manufacturing plant is drive the growth of global regulatory affairs outsourcing market. Opportunities available in the global regulatory affairs outsourcing market for global and medium market players such as providing low cost of regulatory services, rising focus on improving marketing activities. The factor that restrain the market growth such as increasing cost of regulatory services, low investment in R&D activities and clinical trials.
The new product with improved capabilities have been launched by leading market Players. They have taken necessary steps to improve accuracy and functionality of devices. Leading regulatory affairs outsourcing market players have determined how improved accuracy can be influential in many applications. In 2019, “Freyer”, has launched new regulatory affair outsourcing software such as “RIM” and “Freyer rDMS” which provide end to end regulatory document management solution such as it create, capture, manage, organized, and deliver data in efficient manner.
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Questions answered in the Regulatory Affairs Outsourcing Market research report:
Key Market Segments
Key Market Players
