Outsourcing is an important part of every pharmaceutical and biotechnology companies’ value chain during research and development (R&D). The regulatory affairs outsourcing services entail medical writing and publication of regulatory documentation by professional medical authors, quality control (QC) auditors and publishers who contribute to high-quality clinical research projects. The demand for regulatory services outsourcing has been fueled by a substantial increase in clinical studies conducted in emerging economies, providing a healthy platform for this industry's growth.
The increasing number of patent expirations acts as driver for its growth in the medical device regulatory affairs outsourcing market. The fluctuation in the prices of various medical devices regulatory affairs services acts as restraint for its growth in the medical device regulatory affairs outsourcing market. The awards and recognition provides excellent opportunity for the medical device regulatory affairs outsourcing market growth. The pandemic outbreak of COVID-19 acts as challenge for the growth of the medical device regulatory affairs outsourcing market.
Medical Device Regulatory Affairs Outsourcing Market Country Level Analysis
Medical device regulatory affairs outsourcing market is analyzed and market size information is provided by the country, services, product, device type, application and end user as referenced above.
The countries covered in the medical device regulatory affairs outsourcing market report are the Japan, China, Australia, India, South Korea, Singapore, Indonesia, Thailand, Malaysia, Philippines, Rest of Asia-Pacific.
China is the leading country in the growth of the Asia-Pacific medical device regulatory affairs outsourcing market due to growing R&D activities for the regulatory affairs services segment.
The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.
Competitive Landscape and Medical Device Regulatory Affairs Outsourcing Market Share Analysis
The medical device regulatory affairs outsourcing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the company’s focus related to the Asia-Pacific medical device regulatory affairs outsourcing market.
The major companies covered in the Asia-Pacific medical device regulatory affairs outsourcing market report are Parexel International Corporation, North American Science Associates, Inc., SGS SA, Creganna (a subsidiary of TE Connectivity), Intertek Group plc, WuXi AppTec, Charles River Laboratories, Celestica Inc., Freyr, Cactus Communications, Cekindo Business International, Eurofins Scientific, TÜV SÜD, Sterigenics U.S., LLC – A Sotera Health company, TE Connectivity, FLEX LTD., Heraeus Holding, Integer Holdings Corporation, Nortech Systems, Inc., IQVIA, Covance, Plexus Corp., Sanmina Corporation, OMICS International, East West Manufacturing, Jabil Inc., Omron Corporation among other global and domestic players. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.