The COVID-19 pandemic has left its mark on the clinical research and trials sector, but disruptions have only served to temper the steel of long-timers. Clinical research organisations (CROs) are helping pharma companies roll out the COVID-19 trials and while this is a huge business opportunity, it is also fraught with risk. Besides the usual risks associated with testing new products, is the fact that the trials had to be run under severe logistical constraints.
In September, an analysis by Frost & Sullivan informed that with the increased threat of COVID-19 and worldwide lockdowns in effect, the CRO market is experiencing interruptions in ongoing clinical trials and delays in new trials. Recovery is expected to commence from 2023; although it will be staggered, it will take revenue to the original growth trajectory by 2024–2025. As per the revised forecast after the impact of the COVID-19 pandemic, the CRO market is estimated to garner revenue of $63.83 billion by 2024 from $43.03 billion in 2019, at a compound annual growth rate (CAGR) of 8.2 per cent.
The report titled, Hybridisation of Clinical Trial Designs Reviving Global CRO Market Post-pandemic; 2019-2024, reveals that hybrid clinical trials and remote patient monitoring are key trends driving the global CRO market. Hybrid clinical trials leveraging safety-focused, direct-to-consumer logistical solutions are taking centre stage, ensuring research continuity.
Surviving testing times
But disruption is not new to the global CRO sector. India’s CRO sector went through one such upheaval when new clinical trial guidelines were released in 2013-14 but the revised regulations of 2019 have steadied the sector. One of the CROs which seem to have survived this testing time is SIRO Clinpharm (SIRO).
Founded in 1996 by Dr Gautam Daftary, initially as a subsidiary of Bharat Serums and Vaccines, a company set by his father, SIRO is one of India’s earliest CROs.
The company enjoyed a good run, growing as the sector matured in the country, notching up 250+ clinical trials spanning the pharma, medical devices and FMCG sectors.
Regulatory speed breaker
The company took on private equity investors (PEs) in 2007 to scale up but a fresh set of guidelines for clinical trials in 2013-2014 halted not just SIRO but the entire sector.
Meanwhile, the second generation was ready to join SIRO. Post an undergraduate degree from Emory University in Economics and Mathematics, Dr Daftary’s elder son, Akshay started his career at Bharat Serums and Vaccines in 2014, moving to SIRO in 2018. He now serves as a Director, in charge of global business development activities and client management.
Post an undergraduate degree from Babson College with a focus on finance and entrepreneurship, his younger sibling Karan worked at the Puma Group for a while before joining SIRO in 2018. He is now Global VP, SIRO Clinpharm and is in charge of ancillary services including finance, human resources, quality assurance, IT, legal and corporate marketing.
As the second generation at the helm, Karan and Akshay witnessed how the stringent clinical trial regulations of 2013-2014 caused many large global companies to leave India, resulting in a large reduction in clinical trials in India. They narrate this had a sizeable impact on SIRO’s operations as well, which was dependent on winning complex studies from global pharma companies.
According to them, SIRO was slightly better placed to weather the turbulence as before this regulatory downturn, the company grew its medical writing vertical extensively to ensure stability and holistic growth of the organisation. This service offering brought “great stability” to SIRO’s operations with standalone and annuity clients in alternative geographies.
Survival, not revival
Both siblings agree that the new Drugs and Clinical Trial Rules launched in 2019 created a very positive shift in sponsor sentiment and a willingness to return to India for their global clinical trials. This has revived an industry that was undergoing a significant downturn.
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