Regulatory Affairs Outsourcing Market, by Service Type (Regulatory Submission, Regulatory Writing and Publication, Clinical Trail Application and Product Registration, and Regulatory Consulting and Legal Presentation) and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook and Opportunity Analysis, 2019-2026

  • To Be Published : Jul 2019 |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

The regulatory affair outsourcing companies are responsible for keeping track about the regulatory requirements specific to regions, in order to ensure that the company have successfully launches and commercializes pharmaceutical products, medical devices, biologics, and functional foods. If the product does not meet the regulatory guidelines, it can be recalled resulting in huge loss. Regulatory affairs outsourcing activities to the contract research organization (CROs) offers cost efficiency, reduced regulatory submission time, and quality control in all over manufacturing process.

 Regulatory Affairs Outsourcing Market - Drivers

Increasing research and development expenditure is a major factor driving the regulatory affairs outsourcing market growth during the forecast period. For instance, according to Pharmaceutical Research and Manufacturers of America, in 2016, the biopharmaceutical industry invested an estimated $90 billion in research and development in the U.S.

Increase in demand for various services offered by contract research organization (CRO) to pharmaceutical industry is expected to drive the regulatory affairs outsourcing market growth during the forecast period. CRO offers a variety of drug development services including clinical trial management, medical and safety monitoring, data management, and medical writing.

Regulatory Affairs Outsourcing Market-Restraints

Price fluctuation and hidden cost of regulatory affairs outsourcing services are major factors restraining the regulatory affairs outsourcing market growth. The prices of the services are not stated clearly in the healthcare regulatory affairs outsourcing sources and the fluctuations differs with the extra costs are involved in the services with the increasing use of technological platforms such as software for the clinical data management, content management, data base and document management.

Regulatory Affairs Outsourcing Market-Regional Analysis

North America is expected to hold dominant position in the regulatory affairs outsourcing market during the forecast period, owing to increased stringent government regulations and automation in regulatory affairs. For instance, according to the U.S. department of health and human service (HHS), implement the drug price ceiling and civil monetary penalties for manufactures under the 340B Drug Pricing Program in 2018. Moreover, in January 2019, Health Resource and Service Administration (HRSA) enforced the rule for creating an environment of uncertainty for life science industry in the U.S.

Asia pacific is expected to witness significant growth over the forecast period, owing to increasing number of biopharmaceutical companies and healthcare expenditure in India.

Regulatory Affairs Outsourcing Market-Competitive Landscape

Key players operating in the regulatory affairs outsourcing market include Criterium, Inc., Covance, Inc., Clinilabs, Inc., Charles River Laboratories International, Inc., and Accell Clinical Research, LLC.

Regulatory Affairs Outsourcing Market- Taxonomy

The Regulatory Affairs Outsourcing Market is segmented on the basis of Service type and region.

By Service Type

  • Regulatory Submission
  • Regulatory Writing and Publication
  • Clinical Trial Application and Product Registration
  • Regulatory Consulting and Legal Presentation

 By Region

  • North America
  • Latin America
  • Europe
  • Asia pacific
  • Middle East
  • Africa

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


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Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.
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Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization:

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

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