Several companies in healthcare and medical sector are focusing to restructure their operation, promote product safety and conserve municipal healthcare through regulatory affair outsourcing. The cost effective approach of regulatory affair outsourcing is gaining popularity among investors operating within healthcare sector in the recent past.
According to the Future Market Insights report, the global healthcare regulatory affairs outsourcing market is estimated to reach a value of US$ 700 Mn by the end of 2025. The market is expected to grow at an excellent CAGR of 13.8% during the forecast period 2017 – 2025. Such remarkable growth is attributed by the increasing demand for various services offered by healthcare regulatory affairs outsourcing market in a cost effective manner.
What do you think are the potential aspects of the market to fuel demand for healthcare regulatory affairs outsourcing?
The global healthcare regulatory affair outsourcing market is expected to witness rise in demand in the near future. Increasing demand for qualitative documents for clinical/medical research project has led to surge demand for regulatory affair outsourcing. This includes publication of regular documents regarding developments in healthcare sector, medical writing and quality control auditors among others. Thereby, contributes towards revenue growth of healthcare regulatory affairs outsourcing market.
As per FMI insights, which sectors are more liable to gain benefits from healthcare regulatory affair outsourcing services?
According to FMI’s demarcation based on current scenario of healthcare sector, pharmaceutical companies are likely to gain competitive advantage through regulatory affair outsourcing in near future. Companies need to submit regulatory information/ documentation on a healthcare product to get review from regulatory agency. Other services such as legal representation, regulatory consultancy and clinical trial application are practiced in order to receive authentic and confidential review for their products. Whit the continuous integration of advance development in pharmaceutical industry, increasing demand for aforementioned services, is highly likely to strengthen healthcare regulatory affairs outsourcing market.
Followed by pharmaceutical companies, manufacturers of medical devices, food & beverage companies and biotechnology companies are expected to offer noteworthy opportunities for regulatory affair outsourcing service providers.
According to you, will APEJ continue to represent the most lucrative market place for healthcare regulatory affairs outsourcing?
The Asia-pacific excluding Japan (APEJ) is expected to witness substantial growth owing to developing healthcare sector. Moreover, growing demand for skilled professionals in handling evaluation, registration and compilation of scientific documentation is highly likely to present fruitful prospect for regulatory affair outsourcing service providers in the near future. Rising number of small and medium sized biotechnology and pharmaceutical companies is expected to proliferate healthcare regulatory affair outsourcing market. Followed by APEJ, North American market players are anticipated to witness stable growth in the region and expected to account for valuable share during the forecast period.
Who, do you think, are the key stakeholders in the global healthcare regulatory affairs outsourcing market?
Several service providers of regulatory affairs outsourcing are likely to sign MoU with key stakeholders in healthcare sector in order to establish long term partnership. Companies are strongly focusing to offer their services in a cost effective manner to gain large customer based among large as well as SMEs in the near future. Several companies like Clinilabs, Inc., The Weinberg Group Inc., Covance, Inc., (LabCorp), Pharmaceutical Product Development LLC are expected to contribute towards revenue growth of healthcare regulatory affairs outsourcing market. Companies located at APEJ like Sciformix Corporation and Freyr Solutions are highly likely to account for potential opportunities in the near future. European companies like Accell Clinical Research, LLC. and ICON plc are expected to expand their service in overseas market in order to attain international recognition during the forecast period.
What do you perceive as the biggest deterrent to pursue healthcare regulatory affairs outsourcing?
One of the most restraining factor observed to hinder the market growth is the lack of clarity in prices stated for various services offered in healthcare regulatory affairs outsourcing. Moreover, high cost associated with the increasing use of advance technology like several software used for content management, clinical data management, and database/ document management is likely to be unfavorable for small and medium sized companies. Thereby companies hesitate to increase spending on regulatory affair outsourcing. As a result companies limit themselves to single destination country for regulatory outsourcing activities. Based in these factors, market players are likely to face downgrade in the market growth in the near future.
Based on services provided, where do you think market players find profitable growth in healthcare regulatory affairs outsourcing market?
Among several services provided in this market, publishing servicing and regulatory writing service are expected to witness rose in demand woth a market share of nearly US$ 800Mn by the end of forecast period. Other services such as legal presentation and regulatory consultation are expected to witness impetus growth by registering CAGR of 14.3% by the end of forecast period.
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