The rise of FSP outsourcing in drug development

The rise of FSP (Functional Service Provider) outsourcing in drug development is revolutionising the pharmaceutical and biotechnology industries. This has occurred largely due the need to be more agile than ever in launching new medicines at speed, without sacrificing quality.

This growing development reflects the industry’s changing approach to optimising resources and expertise. Biopharma companies are increasingly turning to specialised service providers to help them minimise any difficulties in drug development, so this trend is predicted to go from strength to strength. Because of FSP outsourcing, there are now unique opportunities in the pharmaceutical industry to bring innovative therapies to market more efficiently and cost-effectively.

As the FSP market size is expected to reach a compound annual growth rate (CAGR) of 8.7% by the end of the decade, we explore what this means for the business of drug development.

What is FSP?

FSPs are companies that are contracted by other organisations for specific functions. The FSP model sees organisations partnering with specialised service providers to manage certain areas of the drug development process. Previously, the full-service model would involve outsourcing the entire project to a single contract research organisation (CRO) or contract manufacturing organisation (CMO).

This new approach allows pharmaceutical companies to tap into specialised expertise and resources, while maintaining greater control and flexibility in the development of new drugs.

Why is FSP on the rise?

Here are some key factors contributing to the rise of FSP outsourcing in drug development.

Cost efficiency

FSP outsourcing can be a cost-effective option for pharmaceutical companies, as the companies can choose to outsource only the particular functions or tasks that require specialised knowledge. This flexibility can help in reducing spend, as they don’t have to commit to a comprehensive outsourcing arrangement.

It also gives biotechnology and biopharma companies access to technologies they don’t have within their organisation. This avoids having to make a long-term investment in tech products they wouldn’t otherwise make use of or get enough value from.

Specialised expertise

Drug development is a complex and highly regulated process involving various specialised tasks, such as clinical trials, regulatory affairs, data management, and pharmacovigilance. FSP providers often have a high level of ability in these areas, leading to an excellent quality of work and better results.

If these particular skills aren’t present within the permanent workforce, companies have the benefit of being able to utilise them without needing to allocate any budget to hiring permanent internal specialists.

Resource scalability

FSPs allow pharmaceutical companies to be flexible and scale their resources up or down, as needed. During pressured times of work fluctuation or in response to bottlenecks, they can hire FSP providers for specific projects or phases of drug development. They can adjust their outsourcing strategy based on each project’s requirements and pipeline changes.

Focus on core competencies

By outsourcing non-core functions to FSP providers, pharmaceutical companies can focus their in-house resources and skillsets on core research and development activities. This can help to accelerate project timelines and bring new drugs to market more quickly.

It also means there are fewer vendor relationships to manage, as they are consolidated within the FSP. This relationship maintenance in itself can take away valuable time over the course of developing a new product. FSPs can additionally support relationships with sites by minimising disruption if there is a high turnover of clinical research associates (CRAs).

Global reach

FSP providers often have a global presence, enabling pharmaceutical companies to tap into a broader network of resources, expertise, and patient populations for clinical trials and regulatory approvals. This helps to maximise opportunities for profitable growth across new markets and territories.

Risk mitigation

Sharing responsibilities with specialised FSP providers can help to limit the risks associated with drug development. This is because these providers often have an in-depth understanding of regulatory requirements and compliance issues, which can significantly slow down the launch of new drugs.

Technological advances

Increasingly sophisticated technology and data analytics have made it easier for pharmaceutical companies to collaborate with FSP providers for data management, real-world evidence generation, and other critical functions.

Regulatory support

FSP providers can assist pharmaceutical companies in navigating complex regulatory landscapes. FSPs should know everything about regulatory affairs, so they can help with each stage of submissions and ensure compliance with evolving government requirements.

Strategic partnerships

Many pharmaceutical companies establish long-term strategic partnerships with FSP providers, going on to collaborate over multiple projects. When they find FSPs they can trust, this further streamlines the entire process, as companies can be more reactive and quickly call upon high-quality providers as soon as the need arises.

COVID-19 impact

The COVID-19 pandemic undoubtedly accelerated the adoption of FSP outsourcing with the new challenges it posed, as organisations had to balance new ways of working. This occurred for a number of reasons:

• Companies began to seek flexible and remote work options for certain functions, such as clinical trial monitoring and data analysis, in order to have access to a global talent pool
• As organisations ran trials for new diagnostics, vaccines and treatments, they were able to place the required focus on these projects while keeping ongoing studies running separately
• The use of remote monitoring, such as Electronic Clinical Outcome Assessment (eCOA), quickly became commonplace as the collection of patient information went digital-first

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