Fast pharma : Balancing risk & quality with time to market
Vivek Kumar , biopharma market development manager , and Matt Szap , technical communications manager , at Spectrum Chemical discuss how risk and quality work together to influence speed to market
Drug discovery is the riskiest journey in science ,” said Wolters Kluwer . “ It is also one of the most important .” 1 The complex journey of pharmaceutical discovery and development ideally leads to successful product commercialisation that will address patients ’ medicinal needs worldwide .
Introducing a novel , innovative drug to the market will often benefit the pharmaceutical manufacturer with a first-mover advantage , resulting in higher market share , market leadership and ultimately higher revenue . However , the path from discovery to launch often requires a careful calculation involving risk and the standardisation of quality in a global environment .
Figure 1 - Pharmaceutical industry top ten challenges
COVID supply chain issues ; everchanging regulations ; new technology costs ; advanced training and implementation ; patent expirations ; and greater customer expectations . The nature of risk is uncertainty . For pharmaceutical manufacturing , there is the uncertainty in decisionmaking regarding target selection for R & D . There is also investment and cost uncertainty , not only because of lengthy drug product development times but also the risk that competitors may win the race to market . Ultimately , regulatory uncertainty is part of the journey to commercialisation because new drug approval may not be granted or because of the long delays to market introduction due to the time required for approval .
Drug discovery and development require managing the uncertainty of risk . Despite the speed of COVID-19
Uncertainty of risk
The worldwide pharmaceutical market was worth an estimated $ 1.2 trillion in 2020.2 The market is expected to grow at 3 – 6 % CAGR through 2025 , reaching about $ 1.6 trillion in 2025 , according to IQVIA , a major multinational life sciences firm and the world ’ s largest CRO . 3 With increasing focus on medication value , pharmaceutical manufacturers are even more concentrated on strategic R & D into viable targets to meet patient needs and protect the bottom line . 4
The pharmaceutical industry is one of the most heavily regulated industries in the world , with numerous known and evolving risks and challenges to address . Manufacturers must contend with : the development of new diseases ; lingering postvaccine development , new drug development has a history of a long and costly journey that can take ten to 15 years with an average cost of $ 1- $ 2 billion for each new drug to be approved for clinical use . 5 90 % of clinical drug development fails . 6 Lessons have been learned from the speed of COVID vaccine development . However , widespread and exact implementation of those lessons may be slow .
Patent cliff impact
Another challenge for major manufacturers that impacts pharmaceutical development is the ‘ patent cliff ’. A company has exclusive rights to sales during the drug ’ s patent life , although increased regulation has led to greater costs and longer development times , resulting in a reduction to patent expiry .
20 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981