1. Market Research
  2. > Pharmaceutical Market Trends
Healthcare Regulatory Affairs Outsourcing Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2017 - 2025

Healthcare Regulatory Affairs Outsourcing Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2017 - 2025

  • February 2018
  • 140 pages
  • ID: 5392478
  • Format: PDF
  • Future Market Insight Global & Consulting Pvt Ltd
Up to $2000 off Until Feb 28th 2021

Summary

Table of Contents

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.

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.

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 150+ Million searchable statistics with tables, figures & datasets
  • More than 25,000 trusted sources
20% Off

$5000

  • Single User License — provides access to the report by one individual.
  • Department License — allows you to share the report with up to 5 users
  • Site License — allows the report to be shared amongst all employees in a defined country
  • Corporate License — allows for complete access, globally.

ReportLinker may already be registered as a supplier with your company. If you want to Order by PO, check with us first and we'll let you know if we are a registered supplier and what the vendor number is. Otherwise, we'll provide you with the necessary information to register ReportLinker as a vendor.

Ahmad helps you find the right report:
Testimonials

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

We were impressed with the support that ReportLinker’s research specialists’ team provided. The report we purchased was useful and provided exactly what we want.

Category Manager at
Ikea

ReportLinker gave access to reliable and useful data while avoiding dispersing resources and spending too much time on unnecessary research.

Executive Director at
PwC Advisory

The customer service was fast, responsive, and 100% professional in all my dealings (...) If we have more research needs, I'll certainly prioritize working with ReportLinker!

Scott Griffith

Vice President Marketing at
Maurice Sporting Goods

The research specialist provided prompt, helpful instructions for accessing ReportLinker's product. He also followed up to make sure everything went smoothly and to ensure an easy transition to the next stage of my research

Jessica P Huffman

Research Associate at
American Transportation Research Institute

Excellent customer service. Very responsive and fast.

Director, Corporate Strategy at
Ingredion

I reached out to ReportLinker for a detailed market study on the Air Treatment industry. The quality of the report, the research specialist’s willingness to solve my queries exceeded my expectations. I would definitely recommend ReportLinker for in-depth industry information.

Mariana Mendoza

Global Platform Senior Manager at
Whirlpool Corporation

Thanks! I like what you've provided and will certainly come back if I need to do further research works.

Bee Hin Png

CEO at
LDR Pte Ltd

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

FAQ
  • How we can help
    • I am not sure if the report I am interested in will fulfill my needs. Can you help me?
    • Yes, of course. You can call us at +33(0) 4 37 65 17 03 or drop us an email at researchadvisor@reportlinker.com to let us know more about your requirements.
    • We buy reports often - can ReportLinker get me any benefits?
    • Yes. Set up a call with a Senior Research Advisor to learn more - researchadvisor@reportlinker.com or +33(0) 4 37 65 17 03.
    • I have had negative experiences with market research reports before. How can you avoid this from happening again?
    • We advise all clients to read the TOC and Summary and list your questions so that we can get more insight for you before you make any purchase decision. A research advisor will accompany you so that you can compare samples and reports from different sources, and choose the study that is right for you.

  • Report Delivery
    • How and when I will receive my Report?
    • Most reports are delivered right away in a pdf format, while others are accessed via a secure link and access codes. Do note that sometimes reports are sent within a 12 hour period, depending on the time zones. However, you can contact us to escalate this. Should you need a hard copy, you can check if this option is offered for the particular report, and pay the related fees.
  • Payment conditions
    • What payment methods do you accept?
      1. Credit card : VISA, American Express, Mastercard, or
      2. You can download an invoice to pay by wire transfer, check, or via a Purchase Order from your company, or
      3. You can pay via a Check made out in US Dollars, Euros, or British Pounds for the full amount made payable to ReportLinker
    • What are ReportLinker’s Payment Terms?
    • All payments must normally be submitted within 30 days. However, you can let us know if you need extended time.
    • Are Taxes and duties included?
    • All companies based in France must pay a 20% tax per report. The same applies to all individuals based in the EU. All EU companies must supply their VAT number when purchasing to avoid this charge.
    • I’m not satisfied. Can I be refunded?
    • No. Once your order has been processed and the publisher has received a notification to send you the report, we cannot issue any refund or cancel any order. As these are not ‘traditional’ products that can be returned, reports that are dispatched are considered to be ‘consumed’.
  • User license
    • The license that you should acquire depends on the number of persons that need to access the report. This can range from Single User (only one person will have the right to read or access the report), or Department License (up to 5 persons), to Site License (a group of persons based in the same company location), or Corporate License (the entire company personnel based worldwide). However, as publishers have different terms and conditions, we can look into this for you.

ref:plp2018

Reportlinker.com © Copyright 2021. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.

Make sure you don’t miss any news and follow us on