Healthcare Regulatory Affairs Outsourcing Market

Healthcare Regulatory Affairs Outsourcing Market: Increase in the Number of CROs and Regulatory Outsourcing Agencies to be Beneficial for Companies and Manufacturers: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2017 - 2025

Mid-size pharmaceutical companies and biotechnology companies may compete in the global healthcare regulatory affairs outsourcing market

The global healthcare regulatory affairs outsourcing market is at a surge with the increase in demand for various services it offers. It includes medical writing and publishing of the regulatory documentation offered by experienced medical writers, quality control (QC) auditors and publishers that plays an important role to develop high-quality documents for clinical research projects. Then there are regulatory submissions which refer to the submission of any documentation or information on a healthcare product to a regulatory agency in order to get it reviewed. There are also outsourcing services like clinical trial applications, and regulatory consulting and legal representations. All these services are in high demand from end users like mid-size pharma companies, large pharma companies, biotechnology companies, medical device manufacturers and food & beverage companies.

The analysis of global healthcare regulatory affairs outsourcing market depicts that, among various end users in the market, the mid-size pharmaceutical companies are expected to dominate with a market value of over US$ 700 Mn by the end of 2025, growing at a CAGR of 13.8% during the forecast period.  Biotechnology companies are expected to be a lucrative end user segment of the market with a significant demand expected during the forecast period of 2017-2025. The biotechnology companies segment is expected to grow at a CAGR of 13.2% during the forecast period, giving tough competition to mid-size pharmaceutical companies.

global healthcare regulatory affairs outsourcing market

Increasing R&D activities and development of new products to boost the healthcare regulatory affairs outsourcing market

Various countries are gradually increasing their investments in the R&D departments. This has triggered development of new products in the industry. With the increasing strictness by the respective regulatory authorities worldwide, a growing collaboration between the drug developers and Clinical Research Organizations (CROs) and contract manufacturing organizations (CMOs) has been observed in order to mitigate risks. As CROs and CMOs help the companies in such risks, companies are able to focus on their core businesses. Therefore, increasing research and development activities along with patent expirations have been identified as the major factors fueling the growth of the regulatory affairs outsourcing market.

The rise in demand for services offered by healthcare regulatory affairs outsourcing market is also a result of increasing documentation during drug and device manufacturing. The mid or small size pharmaceutical companies, face problems like extensive documentation. The regulatory authorities, owing to their stringent policies, demand the need for trained and skilled regulatory professionals capable of efficiently handling registration, evaluation and compilation of scientific data. Subsequently, the pharmaceutical and biotechnology companies are seeking help of regulatory service providers, thereby driving the market’s growth.

Hidden costs and pricing fluctuations may discourage many end users from using services available in the healthcare regulatory affairs outsourcing market

There’s an increase in the instances where prices of the services are not stated clearly in the healthcare regulatory affairs outsourcing market. In addition, extra costs are said to be involved in the services with the increasing use of technological platforms such as software for the clinical data management, content management, database and document management. The use of such technologies results in hyped ultimate price for the services offered and this in turn would hamper the market’s growth. The technological advances no doubt improves the overall process but adds to the total costs as well. But makes the companies hesitant of spending high extra amounts. Many companies even confine themselves by outsourcing the regulatory activities to one destination country.

Unique Research Methodology – Future Market Insights’ Most Important Tool 

The global healthcare regulatory affairs outsourcing market is researched with the help of a unique research methodology. Future Market Insights follows a robust research process which delivers high accuracy in market number crunching and statistical data analysis, thus delivering the necessary value addition from a strategic standpoint. Secondary research, along with an extensive primary research along with opinions from key players and sources are the three pillars of this value adding research process. The secondary research gives an overview of the market scenario on the basis of which a large number of primary interviews are conducted and with the insights obtained from market observers, the data is validated. This data is again re-validated as the primary interview process continues and each data point gets a realistic shape. With this the data triangulation is carried out to achieve maximum accuracy, eliminating the possible market deviations and errors thereby presenting a thought leader angle to the researched insights. This also enables the reader of the report to correlate the various segmentations and micro segmentations included in the report with the past, current and future market scenario.

Actionable Intelligence at Your Disposal

It becomes important to understand the pulse running the global healthcare regulatory affairs outsourcing market and mere numbers or data or conclusions would not help if not given the right contour. Every region has its own characteristic value which contributes to the global healthcare regulatory affairs outsourcing market scenario. An unbiased opinion is what matters and the market research report on the global healthcare regulatory affairs outsourcing market offers actionable insights which can be used to unmask the trends, develop strategies, and sketch a growth road map, enabling the reader to make informed decisions.

Competitive Analysis

A separate section of the global healthcare regulatory affairs outsourcing market research report discusses on the key market players. The competitive dashboard speaks about the strategies adopted by the key companies, their growth patterns, mergers and acquisitions, product portfolios and new innovations coming up, analysis of the technological aspects, their global presence, etc. It becomes easier to track the market once a view of the players piloting the market are studied and this is as vital as analysing the “to do” things in order to achieve growth with stability. The research report gives an exquisite contour of the strengths, weaknesses, the possible threats and the “could be grasped” opportunities.

Market Segmentation

Services

End Users

Geography

  • Regulatory Writing and Publishing

  • Regulatory Submissions

  • Clinical Trial Applications

  • and Product Registrations

  • Regulatory Consulting and Legal Representation

  • Other Regulatory Affairs

  • Mid-Size Pharmaceutical

  • Companies

  • Large Pharmaceutical Companies

  • Biotechnology Companies

  • Medical Devices Manufacturer

  • Food & Beverage Companies

  • North America

  • Latin America

  • Europe

  • Asia Pacific

  • Middle East and Africa

The market research report on healthcare regulatory affairs outsourcing market offers many reasons for investing in the report.

  • It elaborates all the macro economic factors influencing the market

  • It involves a detailed market segmentation which explores each brick of the market

  • It involves a detailed competitive analysis

  • It involves a detailed SWOT analysis, Porters five forces model, regulatory scenario, analysis of supply chain

  • It gives forecasts based on the past and the present scenario

  • Higher Accuracy of the market data

  • Unbiased view of the entire market

  • New developments and trends shaping the market

  • Weighted analysis to give justice to the segmentation involved

The exhaustive research report on global healthcare regulatory affairs outsourcing market gives all the guidelines essential to take the product from the conceptualisation to commercialisation stage and a feel of the future by presenting thoughts on the future scenario using an effective forecasting model.