The World of Drug Development Trends

THE WORLD OF A s many blockbuster drugs reach their DRUG DEVELOPMENT patent cliffs, pharmaceutical companies TRENDS and their service providers are searching to make drug development a more efficient process. Here are just a few of the trends to look for in the coming years. TRENDING TOPICS ECLINICAL? Technology According to ISR Reports, respondents show an increasing preference for EDC over paper data capture. eClinical Risk-based monitoring Preferred providers 17 Expansion into China Use of multiple countries 77% 91% 2013 2015 Integration Use of eClinical technology continues to grow, according to ISR's EDC and eCOA/EPRO Complex trials Adaptive trials Orphan/Rare Disease Market Dynamics and Service Provider Performance (2015) and IRT Market Dynamics and Service Provider Benchmarking reports. NUMBER OF 93% 2010 |101,187 2011 119,412 REGISTERED STUDIES 2012 139,046 continues to rise each year. 2013 159,445 of respondents will use EDC systems on Phase I-IV trials in two years' time. 2014 182,426 ADAPTIVE TRIALS 80% of trials will use an off-the-shelf IRT application in 2016 Pfizer and Roche have 82% joined ICON's consortium of drugmakers working on a new technology for adaptive clinical trials which would allow study 73% sponsors to improve decision-making by reacting of respondents reported that their company's perception of adaptive trial designs is at least "slowly gaining of patient data will be collected primarily through electronic solutions in two years data in real time. momentum" OUTSOURCING $251 BILLION From 2015 to 2019, ISR is projecting the CRO market will grow at a 7.4% annual growth rate. ISR expects the CRO market will reach the $34B mark in 2019. Size of the total R&D Market. CRO Revenue is 10.2% of that. CONSOLI- ORPHAN DRUGS DATION: As many blockbuster drugs reach their patent cliffs, drug makers are turning toward rare diseases (those affecting fewer than 200,000 people in the U.S.) for new products. m&a Merger and Acquisition activity in the Pharmaceutical and Life Science Industry continues to GROWTH RATE OF ORPHAN VS. NON-ORPHAN DRUG SALES (2001-10) CAGR: 20.1% $180,000 be a trend. NON ORPHAN DRUGS (CAGR: 20.1%) $160,000 ORPHAN DRUGS (CAGR: 25.8%) Total deal value (Q1-Q3): $140,000 $121B $120,000 Q3 Q2 $106B $100,000 Q1 $18B $79B $618 $80,000 $11B CAGR: 25.8% $60,000 $218 $158 $40,000 $378 $77B $20,000 $45B $0 $21B 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2012 2013 2014 66 The cost and competition faced when conducting trials in the US and EU has become RISK-BASED MONITORING overwhelming, and many biopharmaceutical companies are seeking new destinations for trial studies that offer ISR surveyed biotech and pharma professionals about their current and future use of risk-based monitoring in clinical trials. opportunities to shorten clinical trial duration and reduce the cost of respondents said their companies are at least somewhat interested in using 97% per clinical trial subject." %3D RBM to run clinical trials. - VLADIMIR MISIK 15% VICE PRESIDENT, MIDDLE EAST, SITE MANAGEMENT, QUINTILES said RBM is quickly gaining momentum within their organizations. 72% said their companies save money with a risk-based monitoring approach. LEARN MORE AT ISRREPORTS.COM Sources: clinicaltrials.gov, ISR Reports, Quintiles, Nature.com INFOMISRREPORTS.COM | AISRREPORTS ISR reports GLOBALIZATION SALES (ŞM)