Global Regulatory Affairs Outsourcing Market, By Services Outlook (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration, Clinical Trial Applications and Other Services), Size (Small, Medium and Large), Category (Drugs, Generics, Innovators, Biologics, Biotech, ATMPs, Medical devices, Therapeutic and Diagnostic), Indication (Oncology, Neurology, Cardiology, Immunology and Others), Stage (Preclinical, Clinical and PMA (Post Market Authorization), End User (Medical Device Companies, Pharmaceutical Companies and Biotechnology Companies), Country (U.S., Canada, Mexico, Germany, Italy, U.K., France, Spain, Netherlands, Belgium, Switzerland, Turkey, Russia, Rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia- Pacific, Brazil, Argentina, Rest of South America, South Africa, Saudi Arabia, UAE, Egypt, Israel, Rest of Middle East and Africa) Industry Trends and Forecast to 2028
Market Analysis and Insights of Regulatory Affairs Outsourcing Market
Regulatory affairs outsourcing market is expected to gain market growth in the forecast period of 2021 to 2028. Data Bridge Market Research analyses the market to account to USD 10917.15 million by 2028 growing at a CAGR of 10.66% in the above-mentioned forecast period. The entry of life sciences companies in global markets and the evolution of new areas such as orphan drugs, biosimilar, and personalized medicine are propelling the market growth has been directly impacting the growth of regulatory affairs outsourcing market.
Regulatory affairs outsourcing is the services utilized by the pharmaceutical, biotech, and medical devices manufacturing companies for gaining fast regulatory approvals from various organizations. Regulatory mainly involves extensive testing of a particular product to ensure public health protection, marketing authorization, import and distribution and meeting product safety and performance, the market player ensures that the product meets all regulatory requirements. Companies that provide remittances are obliged to keep track of regional specific regulatory requirements to ensure that the company successfully introduces and sells a pharmaceutical product, medical devices, biologics and functional food. If a product does not meet the regulatory requirements, the product may be remembered leading to a significant loss of revenue.
A significant increase in the fixed costs of in-house resources for regulatory affairs and operation activities like training, technology, specialized knowledge, and facilities is the main driving factor for the regulatory affairs outsourcing market. The rising number of clinical trials is also a driving factor for the regulatory affairs outsourcing market. The improvement in the process focusing on pre-marketing and post-marketing activities, and reduced regulatory service cost is an opportunity for the regulatory affairs outsourcing market.
Risk associated with data security and system access is a big challenge for the regulatory affairs outsourcing market. However, loss of control and technological advances leading to pricing fluctuations is the main restraint in the growth of regulatory affairs outsourcing market during the forecast period of 2021-2028.
This regulatory affairs outsourcing market report provides details of new recent developments, trade regulations, import export analysis, production analysis, value chain optimization, market share, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on Data Bridge Market Research regulatory affairs outsourcing market contact us for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.
In April 2019, Citoxlab, a non-clinical contract research organization, was acquired by Charles River Laboratories International Inc. This acquisition was made to expand the product portfolio and strengthen its market position.
Regulatory Affairs Outsourcing Market Scope and Market Size
Regulatory affairs outsourcing market is segmented on the basis of service outlook, size, category, indication, stage and end user. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.
- Based on service outlook, the regulatory affairs outsourcing market is segmented into regulatory consulting, legal representation, regulatory writing & publishing, product registration, clinical trial applications and other services.
- Based on size, the regulatory affairs outsourcing market is segmented into small, medium and large.
- Based on category, the regulatory affairs outsourcing market is segmented into drugs, generics, innovators, biologics, biotech, ATMPs, medical devices, therapeutic and diagnostic.
- Based on indication, the regulatory affairs outsourcing market is segmented into oncology, neurology, cardiology, immunology and others.
- Based on stage, the regulatory affairs outsourcing market is segmented into preclinical, clinical and PMA (Post Market Authorization).
- Based on end user, the regulatory affairs outsourcing market is segmented into medical device companies, pharmaceutical companies and biotechnology companies.
Regulatory Affairs Outsourcing Market Country Level Analysis
Regulatory affairs outsourcing market is analysed and market size insights and trends are provided by country, service outlook, size, category, indication, stage and end user as referenced above.
The countries covered in the regulatory affairs outsourcing market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.
North America is likely to lead the regulatory affairs outsourcing market. The regional market has been driven by the low costs of labour and increased availability of a skilled workforce and increasing number of clinical trials and a rising number of companies trying to enter markets. However, growing market with new players is the main factor propelling the growth of the regional market. The market in Asia-Pacific is expected to exhibit a substantial growth rate during the forecast period 2021-2028 due to growing number of regulatory affairs out-sourcing companies and availability of skilled workforce.
The country section of the regulatory affairs outsourcing market 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 consumption volumes, production sites and volumes, import export analysis, price trend analysis, cost of raw materials, down-stream and upstream value chain analysis 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 domestic tariffs and trade routes are considered while providing forecast analysis of the country data.
Healthcare Infrastructure Growth Installed Base and New Technology Penetration
Regulatory affairs outsourcing market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment’s, installed base of different kind of products for regulatory affairs outsourcing market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the regulatory affairs outsourcing market. The data is available for historic period 2010 to 2019.
Competitive Landscape and Regulatory Affairs Outsourcing Market Share Analysis
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, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to regulatory affairs outsourcing market.
The major players covered in the regulatory affairs outsourcing market report are Accell Clinical Research, LLC, Genpact, CRITERIUM, INC., PRA Health Sciences, Promedica International, WuXiAppTec, Medpace, PPD Inc., Charles River Laboratories, ICON plc, Covance, Parexel International Corporation., Freyr, Navitas Clinical Research, Inc., Medelis, Inc., Sciformix., Tech Tammina, Acorn Regulatory Consultancy Services Ltd., BIOMAPAS, REGULATORY PROFESSIONALS, CompareNetworks, Inc among other domestic and global players. Market share data is available for Global, North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.
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