Перспективні напрямки розвитку ринку клінічних випробувань в світі

1. Перспективні напрямки розвитку ринку клінічних випробувань в світі 4 жовтня 2012 С.В. Громов «КвінтайлсУкраїна», м. Київ

2. Global data • Global Pharmaceutical market in 2008 = $830 bn • expected in 2012 = $1040 bn (+8% vs. 2011) • Global R&D spending expected in 2012 = $147 bn ( ? 2.2% vs. 2011) • 96,346 studies registered on ClinicalTrials.gov from 27 Sep2010 • 133,220 studies registered on ClinicalTrials.gov from 26 Sep2012 (+38.3% vs. 2010) • 28,942 recruiting studies on ClinicalTrials.gov from 26 Sep2012 • Non-U.S. =49% • U.S. Only =45% • Both U.S. & Non-U.S.=7%

3. ClinicalTrials.gov from 2Oct 2012 • World=133,338 CTs (+138 CT from 26 Sep2012) • North America =70,341 CTs • Canada =10,111 • U.S. =64,268 • Europe =35,540 CTs • Germany =9,364 • France =8,164 • UK =7,024 • Italy =5,318 • Poland =2,876 • Russia =2,130 • Czech Rep. =1,977 • Hungary =1,779 • Ukraine =891 • Japan =2,477 CTs Population =127.4 m

4. ClinicalTrials.gov from 2Oct 2012 • Central America =1,774 CTs • South America =4,471 CTs • Australia =3,776 CTs Population = 22.7 m • Africa =2,971 CTs • South Africa =1534 Population =50.6 m • Egypt =363 Population =82.6 m • Asia: • S. Korea =3,729 Population =50 m • China =3,261   Population =1.35 bn (>450 sites) • India =2,060 Population =1.2 bn • Thailand =1,164 Population =69.9 m • Singapore =1,017 Population =5.3 m

5. Emerging CTs Location, Latin America • Brazil: population =198 m • Oct,08 =1039; Oct,12 =3,027 (+1,988 CT or 191% growth ) • Argentina: population = 41 m • Oct,08 =738; Oct,12 =1,426 • Mexico: population =112.3 m • Oct,08 =845; Oct,12 =1711 • Chile: population - 16.6 m • Oct,08 =377; Oct,12 =767 • Peru: population =30.1 m • Oct,08 =366; Oct,12 =627

6. CTs in EU (27 countries, 501 m population) • Annual investment accounts for > €20 bn annually • n of applied CTs decreased by 24 %: from 5,000 CTs in 2007 to 3,800 CTs in 2011 • Insurance fees increased by 800% for industry sponsors • The average delay for launching CTs increased by 90% to 152 days • For non-commercial sponsors administrative costs increased by 98%

7. European Commission (EC) • On the 17th Jul, 12 the European Commission adopted a “Proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use and repealing the European Clinical Trials Directive (2001/20/EC) • …reforms outlined by the European Union (EU) health commissioner, John Dalli, are a centralized application procedure for trials run in more than one country, and plans for Europe to inspect the regulation of trials in other countries, such as India and China. • The new regulation can save €800 m annually in Regulatory costs

8. The largest Clinical costs • Patient recruitment =32% • Vendor fees =25% • Site recruitment =14% • CTMS and other technology =12% • Site retention =8% • Data management and validation =7% • Patient retention =2%

9. CTs costs • According to Tufts CSDD, the cost of developing a new drug is about $1.3 bn • Per patient CT costs increased by 70% during 3 years (2008-2011) • Phase I: 46% • Phase II: 72% • Phase III: 87% ($40,000 per patient in Phase IIIb) • Phase IV: 31%

11. $?bnwasted in CTs annually? • 25% of procedures administered to patients are not only necessary • 20% of average protocol budget is paid to perform non-core procedures • 18% of protocol amendments avoidable • 69% of trial had at least 1 amendment • Protocol amendment costs $450,000 and adds 61 days • Non-core procedures estimated $3bn-$5bn annually • (Tufts Centre for the study and drug development)

12. Off shoring attractive locations • Criteria: • Patients pool • Cost effectiveness • Regulatory conditions • Relevant expertise • Infrastructure and environment

13. BRIC (Brazil, Russia, India, China) • In BRIC countries registered =10,478 CTs by 2 Oct2012 • The average cost to conduct a clinical study in BRIC countries ranges: • 61% of U.S. in Brazil • 40% of U.S. in Russia • Average annual growth rates from 2008: • 47% – China • 33% – Russia • 26.9% – Argentina • 24.6% – Czech Republic • 19.6% – India

14. Global eClinicalSolutions market • Global e-Clinical Solutions products: CTMS; CDMS; EDC; IVRS; ePRO, etc • Global e-Clinical Solutions market estimated growth =13,4% in 2012-2017 • CTMS market was valued at $576.22 m in 2010 • Pharmaceutical market =49% • CRO market =46% • Healthcare providers (Hospitals, Academic Medical Centers) =5% eClinical solutions can be defined as a combination of technology, products, and services that work together as solutions to automate the management or conduct of clinical trials with the aim of replacing manual, ad hoc or paper-driven methods. eClinical solutions refer to a number of different technologies, such as EDC solutions (Electronic Data Capture), CTMS (Clinical Trials Management System), Randomization and Trial Supply Management systems, IVRS (Interactive Voice Response Systems), electronic patient diaries and other common types of electronic solutions widely used in clinical trials

15. Global CRO market (I) • CRO market growth =12% in 2009-2010 (CRO market revenue $21.4 bn in 2010) • Clinical Outsourcing in 2011 (vs. 2008) • Phase I -58% (35%) • Phase II -63% (36%) • Phase III -55% (46%) • Phase IV -51% (43%) • Estimated CRO market growth =5% annually in 2012-2015 • Outsourcing market of Pharm. R&D expenditure =25% • Expected Outsourcing of Pharm. R&D expenditure =37% by 2018

16. Global CRO market (II) • CROs serving in more collaborative roles with sponsors in consultative positions, • sharing risk and helping drug developing (Capital, Consulting, Commercial) • Multinational pharm. companies forming strategic partnerships with CROs in Asia • Top 10 CROs account for 56% of R&D outsourcing, more than 1,000 other CROs=44% • 100 Indian CROs tend to be larger and more focused on clinical trials • 300 Chinese CROs (most small) are building strong pre-clinical capabilities • Privatization of big CROs trend

17. New molecular entities (NMEs) • FDA approved “new molecular entities” (NMEs): • during 6-month period in 2012 =14; 2011=30; 2010=21; 2009=26, 2008=24 • NMEs in 2011, 10-11% from all approvals (new brand name and generic • drug products) • Time to bring NME to market (from start of clinical to FDA approval): • in CNS =8,5 years; in oncology =9,3 years • Clinical success rate is 21,5% (from start of clinical to FDA approval) (Tufts Centre for the study and drug development)

18. Generics and Biosimilars(I) • During 2005 to 2006, EMA developed guidelines for the approval of Biosimilars • Mar 2010, FDA approved generic versions of biologic drugs and grant biologics • manufactories 12 years of exclusive us before generics can be develop • In Feb 2012 FDA has released guidance for the development and approval of • ‘Biosimilars’ - generic biological drugs • FDA requested 17% increase in its budget in 2013 for the additional approvals of • generic drugs (+ $364 m fees paid by industry) • .

19. Generics and Biosimilars (II) • Developmental time of: Generic = 3 years (Bioequivalence) • Biosimilar =6-9 years (Phase I, Phase III) • Price reduction to NME: Generic =80%; Biosimilar =30% • Global Biosimilars market =$311m in 2010 • expected =$2.5 bn in 2015 • In the US more than 100 drugs went off- patent between 2007 and 2010 • To date, Biosimilars approved by EMA =14; approved by FDA=0? • .

20. Global data • Global Pharmaceutical market in 2008 = $830 bn • expected in 2012 = $1040 bn (+8% vs. 2011) • Global R&D spending expected in 2012 = $147 bn(- 2.2% vs. 2011) • 96,346 studies registered on ClinicalTrials.gov from 27 Sep2010 • 133,220 studies registered on ClinicalTrials.gov from 26 Sep2012 (+38.3% vs. 2010) • 28,942 recruiting studies on ClinicalTrials.gov from 26 Sep2012 • Non-U.S. =49% • U.S. Only =45% • Both U.S. & Non-U.S.=7%