The world has changed in Life Sciences and innovation and efficiency have become key to survival. Pharma manufacturers and marketing authorisation holders in the Life Sciences sector are under relentless pressure to adapt to changing strategic priorities against a backdrop of globalisation and increasing regulatory complexity across the whole value chain. Xavier Duburcq, Chairman & CEO of ProductLife Group, and Denis Gross, CSO, highlight the impact this is having on regulatory service companies as they, too, race to reinvent themselves to help their pharma and medtech clients navigate increasing regulatory complexity.
In Life Sciences, the world order has changed forever now, as the golden years of traditional small-molecule drugs draw to a close and the expiry of associated patents renews the call for innovation. All of the momentum now, even among regulators and pricing and reimbursement authorities, is towards promoting new technologies and therapies that address unmet needs; biologics; health-tech and medical technology (medtech). Traditional pharma companies, which up to now have led on their legacy products, must now focus their strategies and resources on high-expertise, high-value activities, and infuse their more routine operational activities with new economies and efficiencies.
From the surge in global drug consumption and increased research and development (R&D) activity, with greater clinical trial complexity, to continuously evolving regulatory requirements globally, and a growing need for global transparency and standardisation, the Life Sciences industry is under enormous pressure to reinvent itself. This is not least as pharmaceutical companies start to develop more complex products and deliver in more countries, in an era that is seeing growing regulatory complexity across the whole value chain – from pre-clinical to commercialisation stages.
Shift to Global Partners
All of this is having an impact on the Life Sciences service provider market, which must now support pharma, biotech and medical device companies with a different blend of services and delivery models. Large pharma companies, under new price and profit pressure, must find new ways to source the support they need at lower cost, while innovative startups need specific expertise without necessarily having the budget for tailored solutions. That required support could extend from an early development phase right through to post-launch lifecycle maintenance, with differing priorities across that spectrum.
Where large pharma companies once favoured local boutique services to fulfil specific requirements, these companies are now looking for global partners that can combine the right blend of specialist expertise with international capability and right-shoring options to keep pricing competitive, where the kind of support required is more routine and/or more readily industrialised/ automated. Realising they cannot fulfil that spectrum of needs, many boutique service providers are joining forces with or being subsumed into international consultancies and regulatory/ compliance providers, to become a vital part of a wider offering that can be managed end to end for the client.