Emerging Market for Clinical Trials in Brazil - Improved Guidelines from ANVISA and CONEP are Shortening the Regulatory Approval Process and Advancing the Market by GBIResearch

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									       Emerging Market for Clinical Trials in Brazil - Improved
       Guidelines from ANVISA and CONEP are Shortening the
       Regulatory Approval Process and Advancing the Market
 Reference Code: GBIHC109MR                                                                                                                 Publication Date: July 2011


  Brazil has recorded the             GBI Research‟s analysis finds that the presence of a large treatment-naïve population and their
  highest number of clinical          highly active participation in clinical trials has attracted many pharmaceutical companies to conduct
  trials in all other countries       clinical trials in Brazil. Increasing operations of multinational and local contract research
  of Latin America from               organizations have made Brazil the largest clinical trial market in Latin America. Brazil has
  2005 to 2010.                       recorded the highest number of clinical trials in all other countries of Latin America from 2005 to
                                      2010. Moreover, improvements in the country‟s regulatory approval process are expected to fuel
                                      the market growth in the future. Therefore, Brazil is considered very attractive for conducting
                                      clinical trials.
                                      Rising Cost of Drug Development and Decrease in R&D Output has Resulted in Outsourcing
                                      of Clinical Trials to Brazil

                                        Clinical Trials in Brazil, Global BLA and NME Approvals vs. R&D Spending (bn),
                                        1995-2009

                                                                         60                                                                                        70



                                                                                                                                                                   60
                                                                         50




                                                                                                                                                                        Research &Development Spending ($bn)
                                                                                                                                                                   50
                                           Number of NME/BLA Approvals




                                                                         40


                                                                                                                                                                   40

                                                                         30

                                                                                                                                                                   30

                                                                         20
                                                                                                                                                                   20


                                                                         10
                                                                                                                                                                   10



                                                                          0                                                                                        0
                                                                              1995 1996 1997 1998 1999 2000 2001 20 02 2003 2004 2005 2006 2007 2008 2009

                                                                                                NME Approvals    BLA A pprovals   R&D Spending


                                        Source: GBI Research, University of Hong Kong, Clinical Trial Magnifier



                                      GBI Research‟s analysis suggests that pharmaceutical R&D (Research & Development)
                                      expenditure over the years has been increasing relative to the number of drug approvals. The
                                      decreasing number of New Molecular Entities (NME) approvals against ever-increasing R&D
                                      expenditure has made it difficult for pharmaceutical companies to extract better Return on
                                      Investment (ROI) from their drugs as the cost of developing a single drug has increased
                                      exponentially.




Emerging Market for Clinical Trials in Brazil - Improved                                                                                GBIHC109MR / Published JUL 2011
Guidelines from ANVISA and CONEP are Shortening the
Regulatory Approval Process and Advancing the Market                                                                                                                   Page 1
                                                                                                     © GBI Research. This is a licensed product and is not to be photocopied
                                      Brazil is an Attractive Market for Contract Research Organizations due to Rapid Patient
                                      Enrollment
    Brazil has a large                Patient recruitment causes delays for clinical trials in Western countries as people have access to
    treatment-naïve                   good medical care from government hospitals and also they have medical insurance by which they
    population concentrated in        can afford treatment even in private hospitals. But in Brazil many people are devoid of medical care
    urban areas, compared to          as there are limited facilities concentrated to a few cities/provinces and thus these patients can be
    the US, the UK, Western           easily availed for conducting clinical research and it‟s also easier to find patients who are currently
    Europe and other                  not on any therapy. Brazil has a large treatment-naïve population concentrated in urban areas,
    countries of Latin                compared to the US, the UK, Western Europe and other countries of Latin America.
    America.
                                      Patients in Brazil are rational and they emphasize on the country‟s scientific progress on par with
                                      personal health benefits and monetary reimbursements. These factors result in a high participation
                                      rate in clinical trials. Therefore the large urban population in Brazil and their close proximity to the
                                      principal regulatory body National Health Surveillance Agency (ANVISA) and other major health
                                      care institutions; the large treatment-naïve patient population, high participation rate and large
                                      number of qualified patients for clinical trials are the main drivers for faster enrollment of patient
                                      population.
                                      The Availability of Qualified and Experienced Talent Pool Presents a Big Advantage
                                      One of the most important factors for the successful conduction of clinical trials is the presence of
                                      qualified and experienced principal investigators and clinical research teams. Brazil has recorded
                                      the highest growth rate in the number of US FDA (Food and Drug Administration) regulated
                                      principal investigators from 2001 to 2010, compared to the US, the UK and other Latin American
                                      countries. Emphasis on early Good Clinical Practice (GCP) training for health professionals has
                                      resulted the significant number of US-trained investigators compliant with ICH-GCP regulations
                                      over the years. Therefore these factors have contributed effectively to this growth in the number of
                                      principal investigators.
                                      Changes in the Regulatory Approval Process Could Drive the Market in Future
                                      Until recently, Brazilian regulatory approval followed a sequential process, making the entire
                                      regulatory approval process lengthier than in the US and other Latin American countries. It resulted
                                      in a slight decline in the clinical trials market between 2008 and 2010. However, major changes in
                                      regulation occurred in Brazil with Resolution 39 by ANVISA, which came into effect on 5 July 2008,
                                      making National Ethics Committee (CONEP) and ANVISA review and approval a parallel process.
                                      This development has resulted in potential time savings of six to eight weeks for a clinical study to
                                      receive approval.
                                      Therefore the parallel regulatory process has become successful in picking up the clinical trials
                                      market in Brazil from that decline during 2008-2010 and the market is expected to grow at a
                                      considerable rate in the future. Representatives from the industry, ANVISA, CONEP, and certain
                                      professional associations, such as the non-profit Brazilian Society of Pharmaceutical Medicine, are
                                      working together as a team to make further positive changes in the Brazilian regulatory process.




Emerging Market for Clinical Trials in Brazil - Improved                                                     GBIHC109MR / Published JUL 2011
Guidelines from ANVISA and CONEP are Shortening the
Regulatory Approval Process and Advancing the Market                                                                                     Page 2
                                                                          © GBI Research. This is a licensed product and is not to be photocopied
                                      1      Table of Contents
                                      1   Table of Contents ........................................................................................................................ 3
                                          1.1    List of Tables..................................................................................................................... 5
                                          1.2    List of Figures ................................................................................................................... 7
                                      2   Emerging Market for Clinical Trials in Brazil – Introduction ......................................................... 9
                                          2.1    GBI Research Report Guidance ..................................................................................... 10
                                      3   Emerging Market for Clinical Trials, Brazil - Market Overview ................................................... 11
                                          3.1    The Clinical Research Process- Overview ...................................................................... 11
                                             3.1.1    Drug Discovery ........................................................................................................ 11
                                             3.1.2    Pre-clinical Study/Development ............................................................................... 12
                                             3.1.3    Clinical Trials ........................................................................................................... 12
                                          3.2    Clinical TrialDesign and Types........................................................................................ 13
                                             3.2.1    Types of Design....................................................................................................... 13
                                          3.3    Role of CROs .................................................................................................................. 18
                                          3.4    Sponsors of Clinical Trials............................................................................................... 20
                                          3.5    The Need for Outsourcing Clinical Trials ........................................................................ 21
                                             3.5.1    High Risks and Costs Associated With Drug Development ..................................... 21
                                             3.5.2    Escalating Costs of Clinical Trials ............................................................................ 22
                                             3.5.3    Global Increase in the Number of Clinical Trials Conducted ................................... 23
                                             3.5.4    Restructuring the R&D ............................................................................................. 24
                                             3.5.5    Increased Screening Rates during R&D .................................................................. 25
                                             3.5.6    Expiring Patents Pressurize Pharmaceutical Companies to Reduce Costs ............ 25
                                      4   Emerging Market for Clinical Trials, Brazil - Clinical Trial Trends .............................................. 26
                                          4.1    Analysis of Clinical Trials Registered in Brazil ................................................................ 26
                                             4.1.1    Clinical Trials Registered in 2010 ............................................................................ 26
                                             4.1.2    Registration of Phase I Clinical Trials ...................................................................... 27
                                             4.1.3    Registration of Phase II Clinical Trials ..................................................................... 28
                                             4.1.4    Registration of Phase III Clinical Trials .................................................................... 29
                                             4.1.5    Registration of Phase IV Clinical Trials .................................................................... 30
                                          4.2    Comparative Analysis of Registered Clinical Trials in Brazil, Russia, Brazil and China
                                                 (BRIC) Countries ............................................................................................................. 31
                                          4.3    Comparative Analysis of Registered Clinical Trials in Six Major Countries of Latin
                                                 America ........................................................................................................................... 32
                                          4.4    Comparative Analysis of Population Statistics ................................................................ 33
                                             4.4.1    Distribution of Population among Six Major Countries of Latin America .................. 33
                                             4.4.2    Population Forecast of Brazil ................................................................................... 34
                                          4.5    Comparative Analysis of Industry-sponsored Clinical Trials Registered in US Trials
                                                 Registry ........................................................................................................................... 35
                                             4.5.1    Industry-sponsored Clinical Trials Registered in BRIC Countries ............................ 35
                                             4.5.2    Industry-sponsored Clinical Trials Registered in Six Major Countries of Latin
                                                      America ................................................................................................................... 36
                                          4.6    Analysis of Clinical Trials Registered by MNCs in Brazil ................................................. 37
                                          4.7    Comparative Analysis of Sites for Industry-sponsored Clinical Trials Registered in Six
                                                 Major Countries of Latin America .................................................................................... 38
                                             4.7.1    Number of Registered Sites for Industry-sponsored Clinical Trials.......................... 38
                                             4.7.2    Number of Multinational Sites Registered for Industry-sponsored Trials (Phase II /
                                                      III) ............................................................................................................................ 39
                                             4.7.3    Number of Local Sites Registered for Industry-sponsored Trials (Phase II/III) ........ 42
                                          4.8    Number of Recruiting Sites by Multinational Companies (MNCs) in Brazil ..................... 45
                                          4.9    Number of Recruiting Sites for Major Therapeutic Areas in Brazil .................................. 46
                                      5   Emerging Market for Clinical Trials, Brazil - Market Characterization ....................................... 48
                                          5.1    Increase in Growth of Global CRO Market will Foster the Growth of the Clinical Trial
                                                 Market in Brazil ............................................................................................................... 48
                                             5.1.1    Increase in Multinational Sites to Conduct Clinical Trials will Drive the Clinical Trial
                                                      Market in Brazil ........................................................................................................ 49


Emerging Market for Clinical Trials in Brazil - Improved                                                                                 GBIHC109MR / Published JUL 2011
Guidelines from ANVISA and CONEP are Shortening the
Regulatory Approval Process and Advancing the Market                                                                                                                            Page 3
                                                                                         © GBI Research. This is a licensed product and is not to be photocopied
                                           5.1.2    Access to a Large Patient Pool................................................................................ 50
                                           5.1.3    Patient Availability for Major Diseases ..................................................................... 51
                                           5.1.4    Subject Recruitment, Retention and Speed of Trials ............................................... 55
                                           5.1.5    Cost Advantage in Brazil ......................................................................................... 60
                                           5.1.6    Favorable Clinical Infrastructure Improve the Clinical Trial Environment ................. 60
                                           5.1.7    Qualified and Experienced Talent Pool ................................................................... 62
                                           5.1.8    Good Quality of Clinical Trial Data........................................................................... 64
                                        5.2    Market Restraints ............................................................................................................ 64
                                           5.2.1    Issues Related to Intellectual Property and New Medicine Approval ....................... 64
                                           5.2.2    Cultural and Socioeconomic Factors Could Cause Problems in Conducting Clinical
                                                    Research ................................................................................................................. 64
                                        5.3    Clinical Trial Market Size in Brazil ................................................................................... 65
                                      6 Emerging Market for Clinical Trials, Brazil - Regulatory Landscape .......................................... 66
                                        6.1    Introduction ..................................................................................................................... 66
                                        6.2    Regulatory Provisions in Brazil Related to Clinical Trials ................................................ 66
                                        6.3    Major Regulatory Authorities/Institutions in Brazil ........................................................... 67
                                           6.3.1    Ministry of Health (MOH) ......................................................................................... 67
                                           6.3.2    Agência Nacional de Vigilância Sanitária (ANVISA) ................................................ 67
                                           6.3.3    Ethics Committees ................................................................................................... 68
                                        6.4    Key Documents For Conducting Clinical Trials in Brazil ................................................. 68
                                           6.4.1    Additional Country Specific Documents to be Submitted in Brazil ........................... 70
                                        6.5    Clinical Trial Regulation in Brazil ..................................................................................... 71
                                           6.5.1    Approval Process for Clinical Trials in Brazil ........................................................... 71
                                           6.5.2    Documents Required With the Investigator and Sponsor of Clinical Trials .............. 72
                                        6.6    Recent Regulatory Changes in Clinical Trials ................................................................. 75
                                           6.6.1    Parallel Approval Process by CONEP and ANVISA ................................................ 75
                                      7 Emerging Market for Clinical Trials, Brazil - CRO Landscape ................................................... 76
                                        7.1    CRO Profiles ................................................................................................................... 76
                                           7.1.1    Quintiles .................................................................................................................. 76
                                           7.1.2    Covance .................................................................................................................. 78
                                           7.1.3    Kendle ..................................................................................................................... 80
                                           7.1.4    PPD ......................................................................................................................... 82
                                           7.1.5    PRA International .................................................................................................... 84
                                           7.1.6    Chiltern .................................................................................................................... 86
                                           7.1.7    ICON plc. ................................................................................................................. 88
                                           7.1.8    Omnicare ................................................................................................................. 90
                                           7.1.9    INC Research .......................................................................................................... 92
                                           7.1.10 PAREXEL ................................................................................................................ 94
                                           7.1.11 Intrials ...................................................................................................................... 96
                                           7.1.12 Eurotrials ................................................................................................................. 97
                                           7.1.13 PGS Medical/Statistics ............................................................................................ 98
                                        7.2    Major Deals in the Brazilian CRO Market........................................................................ 99
                                           7.2.1    Deal Summary ......................................................................................................... 99
                                      8 Emerging Market for Clinical Trials – Brazil - Appendix ........................................................... 100
                                        8.1    Market Definitions ......................................................................................................... 100
                                        8.2    Abbreviations ................................................................................................................ 100
                                        8.3    Research Methodology ................................................................................................. 101
                                           8.3.1    Coverage ............................................................................................................... 101
                                           8.3.2    Secondary Research ............................................................................................. 101
                                           8.3.3    Primary Research .................................................................................................. 101
                                           8.3.4    Expert Panel Validation ......................................................................................... 102
                                        8.4    Contact Us .................................................................................................................... 102
                                        8.5    Disclaimer ..................................................................................................................... 102
                                        8.6    Sources ......................................................................................................................... 103



Emerging Market for Clinical Trials in Brazil - Improved                                                                             GBIHC109MR / Published JUL 2011
Guidelines from ANVISA and CONEP are Shortening the
Regulatory Approval Process and Advancing the Market                                                                                                                      Page 4
                                                                                       © GBI Research. This is a licensed product and is not to be photocopied
                                      1.1     List of Tables
                                      Table 1:    Clinical Trials in Brazil, Global BLA and NME Approvals vs. R&D Spending (bn), 1995-
                                                  2009 ............................................................................................................................... 21
                                      Table 2:    Clinical Trials in Brazil, Global BLA and NME Approvals vs. R&D Spending (bn), 1995-
                                                  2009 ............................................................................................................................... 21
                                      Table 3:    Clinical Trials in Brazil, Global, Drug Patent Expiry ($m), 2010-2017 ............................ 25
                                      Table 4:    Clinical Trials in Brazil, Number of Phase l Clinical Trials Registered, 2005-2010 ......... 27
                                      Table 5:    Clinical Trials in Brazil, Number of Phase lI Clinical Trials Registered, 2005-2010 ....... 28
                                      Table 6:    Clinical Trials in Brazil, Number of Phase III Clinical Trials Registered, 2005-2010 ...... 29
                                      Table 7:    Clinical Trials in Brazil, Number of Phase IV Clinical Trials Registered, 2005-2010 ..... 30
                                      Table 8:    Clinical Trials in Brazil, Number of Clinical Trials Registered, BRIC, 2010 .................... 31
                                      Table 9:    Clinical Trials in Brazil, Number of Clinical Trials in Six Major Countries of Latin America,
                                                  2010 ............................................................................................................................... 32
                                      Table 10:   Clinical Trials in Brazil, Distribution of Population among Six Major Countries of Latin
                                                  America (%), 2010 ......................................................................................................... 33
                                      Table 11:   Clinical Trials in Brazil, Population Forecast of Brazil (Million), 2005 – 2050 ................. 34
                                      Table 12:   Clinical Trials in Brazil, Comparative Analysis of Industry-sponsored Clinical Trials
                                                  Registered, BRIC, 2005 - 2010 ...................................................................................... 35
                                      Table 13:   Clinical Trials in Brazil, Comparative Analysis of Industry-sponsored Clinical Trials
                                                  Registered, Six Major Countries of Latin America, 2005 - 2010 ..................................... 36
                                      Table 14:   Clinical Trials in Brazil, Number of Clinical Trials Registered by MNCs in Brazil, 2005 -
                                                  2010 ............................................................................................................................... 37
                                      Table 15:   Clinical Trials in Brazil, Number of Registered Sites for Industry-sponsored Clinical
                                                  Trials, Six Major Countries of Latin America, 2005 - 2010 ............................................. 38
                                      Table 16:   Clinical Trials in Brazil, Number of Multinational Sites for Industry-sponsored Trials
                                                  (Phase II / III), Six Major Countries of Latin America, 2005 - 2010................................. 39
                                      Table 17:   Clinical Trials in Brazil, Number of Multinational Sites for Industry-sponsored Phase II
                                                  Trials, Six Major Countries of Latin America, 2008-2010 ............................................... 40
                                      Table 18:   Clinical Trials in Brazil, Number of Multinational Sites for Industry-sponsored Phase III
                                                  Trials, Six Major Countries of Latin America, 2008-2010 ............................................... 41
                                      Table 19:   Clinical Trials in Brazil, Number of Local Sites for Industry-sponsored Trials (Phase II/III),
                                                  Six Major Countries of Latin America, 2005-2010 .......................................................... 42
                                      Table 20:   Clinical Trials in Brazil, Number of Local Sites for Industry-sponsored Phase II Trials, Six
                                                  Major Countries of Latin America, 2008 - 2010 .............................................................. 43
                                      Table 21:   Clinical Trials in Brazil, Number of Local Sites for Industry-sponsored Phase III Trials,
                                                  Six Major Countries of Latin America, 2008 - 2010 ........................................................ 44
                                      Table 22:   Clinical Trials in Brazil, Number of Recruiting Sites by MNCs (%), 2005-2009 .............. 45
                                      Table 23:   Clinical Trials in Brazil, Number of Recruiting Sites for Major Therapeutic Areas, Brazil,
                                                  2005-2009 ...................................................................................................................... 47
                                      Table 24:   Clinical Trials in Brazil, Global, CRO Market ($bn), 2006-2015...................................... 48
                                      Table 25:   Clinical Trials in Brazil, Number of Local and Multinational Sites in Major Cities, Brazil,
                                                  2005-2009 ...................................................................................................................... 49
                                      Table 26:   Clinical Trials in Brazil, Patient Population (Million), 2010 .............................................. 50
                                      Table 27:   Clinical Trials in Brazil, Number of Deaths by Major Diseases (%), 2008 ...................... 51
                                      Table 28:   Clinical Trials in Brazil, Population Forecast for HIV/AIDS („000), 2010-2015 ................ 52
                                      Table 29:   Clinical Trials in Brazil, Population Forecast for CVD (Million), 2010-2015 .................... 53
                                      Table 30:   Clinical Trials in Brazil, Population Forecast for Diabetes (Million), 2010-2015 ............. 54
                                      Table 31:   Clinical Trials in Brazil, Population Forecast for Cancer („000), 2010-2015 ................... 55
                                      Table 32:   Clinical Trials in Brazil, Average Number of Patients per Trial, BRIC, 2005- 2009......... 56
                                      Table 33:   Clinical Trials in Brazil, Average Number of Patients per Trial, Six Major Countries of
                                                  Latin America, 2005- 2009 ............................................................................................. 57
                                      Table 34:   Clinical Trials in Brazil, Average Number of Patients per Site, BRIC, 2005-2009 .......... 58
                                      Table 35:   Clinical Trials in Brazil, Average Number of Patients per Site, Six Major Countries of
                         
								
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