The report of global regulatory affairs outsourcing market by Service (Regulatory consulting, Legal representation, Regulatory writing and publishing, Product registration and clinical trial application, Other regulatory service) and Region (Asia Pacific, North America, Europe, Latin America, and Middle East Africa) is expected to reach US$ XX Bn by 2026, at a CAGR of 12.8% during a forecast period.
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 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 advances 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 market. An implementation of changing rules are the key challenge for the global regulatory affairs outsourcing market during the forecast period.
Legal representation and Regulatory consulting segments are expected to grow at the highest XX% CAGR during the forecast period.
The Legal representation and Regulatory consulting segments are likely to expand at the highest CAGR of 12.8%, over the upcoming period, owing to the increasing need for the consultation specifically with respect to country wise filing strategies and for gap analysis. Rising demand for legal representatives in developed regions such as Europe and North America is gaining traction for the insights regarding market authorization for companies who want to establish a base in the respective country. Globalization of clinical trials especially in regions such as the Asia Pacific and Latin America is expected to increase demand for clinical trial application and product registration services thereby contributing to the market growth.
The North America dominated the regulatory affairs outsourcing market in 2018
In 2018, North America held the XX% share of the regulatory affairs outsourcing market owing to the existence of life sciences and pharmaceutical companies, robust regulators such as FDA and the availability of talent pool will contribute to the overall market growth in this region. In terms of both value and volume, the Asia Pacific region will record a significant CAGR of XX% during the forecasted period due to rising cases of regulatory filings and the availability of low-cost labor.
Key players operating the global regulatory affairs outsourcing market are 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. and Verisk 3E.
Maximize Market Research, a global market research firm with a dedicated team of specialists and data has carried out extensive research about the global regulatory affairs outsourcing market. The report encompasses the market by different segments and regions, providing an in-depth analysis of the overall industry ecosystem, useful for making an informed strategic decision by the key stakeholders in the industry. Importantly, the report delivers forecasts and share of the market, further giving an insight into the market dynamics and future opportunities that might exist in the global regulatory affairs outsourcing market. The driving forces, as well as considerable restraints, have been explained in depth. In addition to this, competitive landscape describing the strategic growth of the competitors has been taken into consideration for enhancing market know-how of our clients and at the same time explain global regulatory affairs outsourcing market positioning of competitors.
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