Regulatory affairs outsourcing market to reach US$5.7bn by 2023, forecasts report


Spending on clinical trial applications and product registration expected to rise substantially over the forecast period

The global regulatory affairs outsourcing market was valued at US$1.9bn in 2014 and is expected to rise to $5.7bn by 2023, at a CAGR of 11.5%, according to a new market report from Transparency Market Research.

According to the report, 'Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015-2023', contract research organisations (CROs) manage various drug development activities for pharmaceutical firms, including conducting pre-clinical studies, clinical trial data management, medical writing and regulatory submission.

In recent years, small and large biopharmaceutical companies are increasingly relying on CROs for their clinical trial and other drug development activities. Biopharmaceutical companies are outsourcing their regulatory affairs to access the new capabilities of CROs, so that they can focus on their core competencies, reduce fixed costs and expand their geographical presence.

Some of the benefits provided by regulatory affairs outsourcing activities include the reduction of fixed costs and internal resource utilisation, risk mitigation, efficient execution of services, and speeding up the commercialisation of new drugs, the report says.

CROs provide several regulatory support services to large pharmaceutical companies such as regulatory intelligence, regulatory document submissions, product labelling, liaison with regulatory authorities, setting up of regulatory strategies and others.

Small and large biopharmaceutical companies are increasingly relying on CROs for their clinical trial and other drug development activities

Currently, the majority of pharmaceutical companies are outsourcing content authoring, component coordination and assembly, dispatch and archiving and internal review.

The stability of CROs, use of technological advances, flexibility, staffing, reputation and their location are some of the factors scrutinised by pharmaceutical companies when selecting their outsourcing partner. Factors such as the increasing importance of the documentation mandated during the drug approval process and high costs of research and development and clinical trial activities might favour market growth, the report says. On the other hand, the high risk associated with data security along with hidden costs and huge price fluctuations offered by various CROs might hamper this growth.

Regulatory writing and the publishing segment accounted for the largest share of the regulatory affairs outsourcing market, followed by clinical trial applications and product registration.

Clinical study protocols, standard operating procedures, ethics submission, regulatory submission, patient informed consent forms, and other pharmacology details are some of the regulatory writing and publishing services.

Increasing use of technological platforms for clinical data management activities along with the rising number of clinical trials worldwide could mean that the clinical trial application and product registration segment will see the highest growth during the forecast period, the report says.

It is expected that the regulatory consulting and legal representation service segment will record the second-highest growth rate of more than 12% during the forecast period owing to the need for consistent client interactions with regulatory agencies, increasing demand for consultation with respect to countrywide filing strategies and gap analysis.

Regulatory submissions services include pre-approval submissions and post-approval regulatory activities and this segment accounted for the third-largest share of the total regulatory affairs outsourcing market.

The regulatory affairs outsourcing market is a consolidated area where a few companies account for a major share. Several large CROs are looking to acquire smaller CROs to scale up their operations and offer diverse specialised regulatory services with high efficiency.

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The global regulatory affairs outsourcing market is influenced by the presence of large regional players and is predominant in developed economies. However, these players are focusing on expansion in emerging economies, especially in India, China and Australia.