Global Regulatory Affairs Outsourcing Market was valued US$ XX Bn in 2018 and is expected to reach US$ XX Bn by 2026, at CAGR of 12.8% during forecast period of 2019 to 2026.
Drivers and Restrains:
Regulatory outsourcing has now become a norm as various companies are looking for partners to manage operational tasks containing report publishing and submission publishing. Regulatory affairs outsourcing are the services used by the pharmaceutical, medical and biotech devices manufacturing companies for gaining fast regulatory approvals from several organizations.
The report study has analyzed revenue impact of covid-19 pandemic on the sales revenue of market leaders, market followers and disrupters in the report and same is reflected in our analysis.
Increasing R&D activities especially in the life science industry across the world for the reduction in overall approval process by reducing delays in regulatory filings and rise in cost efficiency, and the development in the return on investment (ROI) are expected to drive the regulatory affairs outsourcing market growth. Moreover, Changing regulatory mandates are anticipated to drive the market growth globally. e.g., ICH E17 guidance on multi-regional clinical trials are published by the U.S Food and Drug Administration (FDA). This initiative is expected to bring global clinical trials under a single protocol, submitted by numerous authorities in different regions.
The global regulatory affairs outsourcing market is driven by economic and competitive pressures, growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs. However, the risk associated with data security, technological advancement, which is leading to rapid pricing fluctuations, monitoring issues and lack of standardization are hampering the market growth at the global level. Emerging economies are likely to create lucrative opportunities in the global regulatory affairs outsourcing market. This is evidence, as the revenue from emerging economies are estimated to reach approximately US$ XX million by 2026. An implementation of changing rules are the key challenges for the global regulatory affairs outsourcing market during the forecast period.
Global Regulatory Affairs Outsourcing Market Segmentation Analysis:
Based on the service, the regulatory writing and publishing segment held the XX% market share of the regulatory affairs outsourcing market in 2018 and is expected to continue its leading position over the forecast period. The Legal representation and Regulatory consulting segments are expected to grow at the highest CAGR of 14%, over the upcoming period, owing to regulatory reforms in the developing countries. Rising adoption of legal representatives in industrialized regions such as North America and Europe are gaining traction for the insights regarding market authorization for companies who want to set up a base in the respective country. Globalization of clinical trials particularly in regions such as the Asia Pacific and Latin America are estimated to gain demand for clinical trial application and product registration services, thereby contributing to the market growth.
Global Regulatory Affairs Outsourcing Market Regional Analysis:
Geographically, the regulatory affairs outsourcing market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America was valued US$ XX Mn in 2018 for regulatory affairs outsourcing market and is estimated to reach US$ Mn end of 2026, with a CAGR of XX%. Due to the existence of life sciences and pharmaceutical companies, implementation of well-structured regulatory policies such as FDA and the availability of talent pool will contribute to the overall market growth. But, high service cost than developing economies such as Latin America and Asia Pacific are a major challenge affecting the regional market growth.
Asia Pacific is projected to be the fastest-growing region in the near future. The region is expected to hold the XX% of market share in the upcoming period. Rising cases of regulatory filings and the availability of low-cost labor are the factors impelling the regional growth. The development of multinational pharmaceutical and life science companies are also projected to boost the regional demand.
The objective of the report is to present a comprehensive analysis of global regulatory affairs outsourcing market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all aspects of the industry with a dedicated study of key players that includes market leaders, followers and new entrants by region. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors by region on the market are presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analyzed, which will give a clear futuristic view of the industry to the decision-makers.
The report also helps in understanding global regulatory affairs outsourcing market dynamics, structure by analyzing the market segments and project the global regulatory affairs outsourcing market size. Clear representation of competitive analysis of key players By Type, Price, Financial position, Product portfolio, Growth strategies, and regional presence in the global regulatory affairs outsourcing market make the report investor’s guide.
Scope of the Global Regulatory Affairs Outsourcing Market:
Global Regulatory Affairs Outsourcing Market, by Service:
• Regulatory consulting
• Legal representation
• Regulatory writing and publishing
• Product registration and clinical trial application
• Other regulatory services
Global Regulatory Affairs Outsourcing Market, by Region:
• Asia Pacific
• North America
• Europe
• Latin America
• Middle East Africa
Global Regulatory Affairs Outsourcing Market, Major Players:
• Accell Clinical Research
• PRA International
• PAREXEL International Corporation
• Quintiles Transnational Holdings
• Charles River Laboratories International Inc.
• Clinilabs Inc.
• Criterium Inc.
• Wuxi AppTec
• Medpace Inc.
• IQVIA Holdings Inc.
• Pharmaceutical Product Development, (PPD) LLC
• Promedica International
• ICON plc.
• BlueReg Group
• Covance, Inc.,
• Dr.Regenold GmbH
• FMD K&L
• Genpact Limited
• ProductLife Group S.A.
• Intertek Group plc
• Kinapse Ltd
• Medpace, Inc.
• Navitas Life Sciences
• PharmaLex GmbH
• PRA Health Sciences, Inc.
• Syneos Health, Inc.
• Verisk 3E.
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