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CRO
                MARKET SIZE

                       2 0 1 6

P R E V I E W    O F

2016 CRO MARKET
SIZE PROJECTIONS
2015-2020
J A N U A R Y,    2 0 1 6
Introduction

    SMARTER QUESTIONS         SMARTER ANSWERS

REPORT OVERVIEW
The past three years have been            ISR’s report gives quantitative
quite eventful in the CRO world.          insight into the perpetual
We’ve had service provider                question: “What is the size of the
mergers and we’ve had service             CRO market?” The data provide
provider mega-mergers. We’ve              a thorough, rational perspective              THIS
                                          for clinical development services
had biopharma mergers and
we’ve had biopharma mega-
                                          segmented by phase, geography,              PREVIEW
                                          and service line.
mergers. We’ve had public                                                            INCLUDES
offerings and we’ve had
privatizations. Overall, the CRO
                                          ISR utilizes both publicly available
                                          information and data obtained
                                                                                      SAMPLE
market has been one of the
best performing sectors in the
                                          through our syndicated primary
                                          market research efforts.
                                                                                    PAGES FROM
financial circles.
                                                                                    THE REPORT

        24                         2016
                                  Publication Date
                                                                  25
    Charts and Graphs                                              Pages

What you will learn
•      Estimated R&D expenditures through 2020
•      Projected spending through 2020 segmented by source (sponsor type) and by:
       • Development
       • Phase I-IV Development                                                       WHY ISR?
       • Outsourced Phase I-IV Development                                            1. ISR has leveraged data
                                                                                      from our primary market
•      2016 Geographic Distribution of CRO Market Size
                                                                                      research. These data,
•      2016 Service-line Assessment of CRO Market Size
                                                                                      coupled with the “acts and
•      2016 Phase I-IV Assessment of CRO Market Size                                  figures” from secondary
                                                                                      sources, allow for
                                                                                      intelligent projections into
                                                                                      the CRO market size.
Report Structure
                                                                                      2. The use of primary
1. Executive Summary                          3. 2016 Geographic Assessment           research data gives ISR
2. Overall Market Size and Growth             4. 2016 Service-line Assessment         the unique ability to break
•      Top-down approach to market size       5. 2016 Development Phase I-IV          down the outsourced
•      R&D sources and distribution           Assessment                              market further than
•      Model adjustments – From R&D to        6. 2015-2020 CRO Market Model           ever before, by offering
       CRO market size                                                                geographic, service
•      Development spending                   7. 2015-2020 CRO Market Model –
                                              Growth Rates                            line, and Phase I-IV
•      Phase I-IV development spending
•      Outsourced Phase I-IV development                                              assessments.
                                              8. 2014 Public CRO Market Share
       spending
•      2016 full model analysis
Introduction

2016 CRO MARKET SIZE PROJECTIONS 2015-2020

                TABLE OF CONTENTS
                COPYRIGHT AND USAGE GUIDELINES
                METHODOLOGY
                EXECUTIVE SUMMARY
                INTRODUCTION
                OVERALL MARKET SIZE AND GROWTH
                   Top-down approach to market size
                   R&D sources and distribution
                   Table 1: R&D expenditures by segment (2015-2020)
                   Model adjustments – From R&D to CRO market size
                   Development spending
                   Table 2: Development as a percent of R&D by segment (2015)
                   Table 3: Development expenditures by segment (2015-2020)
                   Phase I-IV development spending
                   Table 4: Ph I-IV development as a percent of development by segment (2016)
                   Table 5: Ph I-IV development expenditures by segment (2015-2020)
                   Outsourced Phase I-IV development spending
                   Table 6: Outsourced Ph I-IV development as a percent of development by segment (2015-
                   2020)
                   Table 7: Outsourced Ph I-IV development expenditures by segment (2015-2020)
                   2016 full model analysis
                2016 GEOGRAPHIC ASSESSMENT
                   Table 8: 2016 geographic distribution (%) of the CRO market size
                   Table 9: 2016 geographic distribution ($B) of the CRO market size
                2016 SERVICE-LINE ASSESSMENT
                   Table 10: 2016 service-line distribution (%) of the CRO market size
                   Table 11: 2016 service-line distribution ($B) of the CRO market size
                2016 DEVELOPMENT PHASE I-IV ASSESSMENT
                   Table 12: 2016 development phase distribution (%) of the CRO market size
                   Table 13: 2016 development phase distribution ($B) of the CRO market size
                2015-2020 CRO MARKET MODEL
                   2015-2020 CRO market model – growth rates
                2014 PUBLIC CRO MARKET SHARE
                   Table 14: 2014 public CRO market shares
                ABOUT INDUSTRY STANDARD RESEARCH
Introduction

2016 CRO MARKET SIZE PROJECTIONS 2015-2020

          S A M P L E        P A G E :

          INTRODUCTION

                   SMARTER QUESTONS                     SMARTER ANSWERS

                        INTRODUCTION
                       Welcome to the third edition of ISR’s CRO                  per year� However, in 2014 and 2015 the total
                       Market Size report� The past three years have              investments rose to $6�3B and $7�4B, respectfully�
                       been quite eventful in the CRO world� We’ve had            When you do the math, not only has the absolute
                       service provider mergers and we’ve had service             value of the investments increased, but so too has
                       provider mega-mergers� We’ve had biopharma                 the average value per deal (rising from an average
                       mergers and we’ve had biopharma mega-                      of $9�0M from 2010-2013 to $14�4M in 2014-
                       mergers� We’ve had public offerings and we’ve              2015) – all of which we think point to strength in
                       had privatizations� Overall, the CRO market has            the funding market�
                       been one of the best performing sectors in the
                       financial circles� In fact, over the past 12 months        As a result of increasing our R&D growth
                       the Dow Jones Industrial Average is down 10%,              assumptions, readers of past CRO Market
                       while PRA Health is up 78%, INC Research is up             Size reports will notice a slight-moderate
                       64%, ICON is up 19%, Quintiles is up 6%, and               increase in the CRO market� That said, we will
                       Parexel is up 2%� Yes, all the CROs have an “up”           reiterate what we mentioned in the previous
                       before their percentage�                                   report: The major lever in CRO revenue is still
                                                                                  the outsourcing propensity/penetration� One
                       Why all the good news for CROs? As we have                 market dynamic we have not accounted for is
                       noted in the past, and in this current forecast, the       the impact of biopharma mega-mergers� We
                       market for their services is increasing� Sponsors          have not modeled this because we don’t think
                       continue to outsource more of their clinical               there is a lasting macro impact of these mergers�
                       development work across a broad range of                   However, we do think those mergers can and
                       services to service providers of all sizes� That said,     will have a significant impact on the CROs that
                       for the past few reports on this topic we have             are involved with those sponsor companies�
                       been somewhat pessimistic on the long-range                Another impact readers will note is in the CRO
                       overall R&D spending by biopharmaceutical                  market share section� With an increased CRO
                       companies� In our 2015 CRO Market Size report,             market, some of the public CROs will notice a
                       we projected that R&D spending on small                    slight drop in their market share� Given that most
                       molecule would decrease by a CAGR of 1% over               of the changes in our R&D model impacted
                       the forecast period� Given the overall strength            the small sponsor segment, we think this aligns
                       of the VC market continuing to invest in small             nicely with the public CROs’ traditional customer
                       biopharma companies and given large pharma’s               set (of large sponsors)�
                       propensity to continue to acquire assets or
                       companies to strengthen their pipelines, we have           In our view, the pace of change in the CRO
                       revisited our R&D assumptions� For the 2015-               market will not slow down anytime soon� Look
                       2020 forecast we have increased both the small             for more mergers as providers continue to scale
                       molecule and large molecule R&D figures to                 up global capabilities and fill in their service
                       account for the influx in VC-based investment              offerings; look for more sophisticated marketing
                       going mostly to smaller sponsor organizations�             and branding efforts as the battle for market
                       According to PricewaterhouseCoopers (PWC),                 share increases; and perhaps look for “non-
                       since 2010 the average number of VC deals in               traditional” CRO service providers to enter the
                       the biopharma space is ~490 per year and this              market via partnerships or outright acquisitions�
                       has not fluctuated much over the past five years�          We would also not be surprised to see interest
                       From 2010 through 2013, the average annual                 gaining momentum for a CRO-CMO merger�
                       investments have totaled approximately $4�4B

                    www.ISRreports.com ©2016              2016 Edition of the CRO Market Size Projections: 2015-2020            5
Introduction

2016 CRO MARKET SIZE PROJECTIONS 2015-2020

 S A M P L E          P A G E :
                                                            SMARTER QUESTONS                     SMARTER ANSWERS

 R&D SOURCES
 AND
                                                             R&D sources and distribution
 DISTRIBUTION                                                As previously stated, ISR starts our market model by gathering the R&D spending from the major
                                                             sources of R&D activity� In the following steps that refine our market size estimates, these figures will
                                                             be adjusted to account for varying degrees of spending directly associated with CRO revenue�
 ISR starts our market model by
 gathering the R&D spending from
                                                              P R O J EC T E D 20 1 6 TOTA L R & D B R E A K D OWN ( $B )
 the major sources of R&D activity.
                                                              Academic $41.4
 This page shows the projected                                15%                                                                     Pharma $94.9
                                                                                                                                      35%
 total R&D breakdown for 2016.                                Association $5.6
                                                              2%

                                                              Private $4.3
                                                              2%                             © Industry Standard Research

                                                              Government $68.8
                                                              25%
                                                                                                                                      Biotech $41.4
                                                                                                                                      15%
                                                              Generic/Specialty $15.0
                                                              6%

                                                             Table 1: R&D expenditures by segment (2015-2020)
                                                                        $B USD              2015                 2016          2017           2018               2019             2020
                                                              Large pharma               $67�0             $67�4            $68�1         $67�4           $68�1             $70�0
                                                              Small pharma               $27�2             $27�4            $27�7         $27�6           $27�9             $28�7
                                                              Large biotech              $27�9             $29�4            $31�1         $32�9           $34�7             $35�7
     SMARTER QUESTONS                     SMARTERSmall
                                                  ANSWERS
                                                       biotech $11�3                                       $12�0            $12�7         $13�4           $14�2             $14�6
                                                              Generic/Specialty          $14�5             $15�0            $15�5         $16�0           $16�4             $16�8
                                                              Government                 $65�1             $68�8            $72�6         $76�7           $81�0             $81�0
                                                              Private                    $4�3              $4�3             $4�3          $4�3            $4�3              $4�3
                                                              Association/Non-profit     $5�4              $5�6             $5�8          $6�0            $6�2              $6�3
                                                              Academic                   $40�1             $41�4            $42�8         $44�0           $45�5             $46�3
                                                              Total                      $262�9            $271�3           $280�5        $288�3          $298�2            $303�7
                                                                                                                                                                    © Industry Standard Research

      R&D sources and distribution                           www.ISRreports.com ©2016               2016 Edition of the CRO Market Size Projections: 2015-2020                          9
      As previously stated, ISR starts our market model by gathering the R&D spending from the major
      sources of R&D activity� In the following steps that refine our market size estimates, these figures will
      be adjusted to account for varying degrees of spending directly associated with CRO revenue�

                                                                                                                                                   C L O S E R                                     L O O K
       P RO J ECTED 20 16 TOTAL R & D BR EA K D OWN ( $ B)
                                                                                                                                                   >>This chart shows
       Academic $41.4                                                                                                                              the sources of R&D
       15%                                                                                  Pharma $94.9
                                                                                            35%                                                    spending for 2016.
       Association $5.6                                                                                                                            Pharma and Biotech
       2%
                                                                                                                                                   account for 50% of R&D
       Private $4.3                                                                                                                                spending.
       2%                             © Industry Standard Research

       Government $68.8
       25%
                                                                                            Biotech $41.4
                                                                                            15%
       Generic/Specialty $15.0
       6%

      Table 1: R&D expenditures by segment (2015-2020)
Introduction

2016 CRO MARKET SIZE PROJECTIONS 2015-2020

          S A M P L E           P A G E :

          MODEL ADJUSTMENT
          This page highlights ISR’s top-down approach to our market sizing calculations. The
          full analysis and figures for the 2016 Outsourcing Phase I-IV Development Market are
          available in the full report at www.ISRreports.com.

                    SMARTER QUESTONS                  SMARTER ANSWERS

                     Model adjustments – From R&D to CRO market size
                     As previously stated, ISR utilizes a top-down approach to our market sizing calculations, starting
                     with R&D spending� We then use a series of “deflators” in order to narrow the market applicable to
                     pharmaceutical service providers� The steps taken for these calculations are outlined below�

                     R&D expenditures are first analyzed to remove the “R” (research) and we are left with “D”
                     (development) spending per segment�

                     Development spending is then analyzed by the amount of spending done for Phase I-IV clinical
                     studies�

                     Phase I-IV clinical development spending is then segmented by the outsourcing penetration of each
                     company size/ organization type to arrive at the market size for CROs�

                                                           2016 R&D:
                                                            $271.3B

                                                     2016 Development:
                                                          $110.6B

                                                           2016 Phase I-IV
                                                            Development:
                                                               $78.8B

                                                2016 Outsourcing Phase I-IV
                                                   Development Market:
                                                         $29.8B
                                                          © Industry Standard Research

                     www.ISRreports.com ©2016            2016 Edition of the CRO Market Size Projections: 2015-2020       10
Introduction

2016 CRO MARKET SIZE PROJECTIONS 2015-2020

          S A M P L E             P A G E :

          2016 SERVICE-LINE ASSESSMENT
          ISR provides an assessment of the CRO market based on the services CROs typically
          offer, based on ISR’s proprietary survey data.
          The following chart has been blinded. The full data are available in the report, which can be
          downloaded from www.ISRreports.com.

                     SMARTER QUESTONS                  SMARTER ANSWERS

                     2016 SERVICE-LINE
                     ASSESSMENT
                     Based on ISR’s proprietary survey data, we provide an assessment of the CRO market based on the
                     services CROs typically offer� We certainly understand that the distribution of service costs varies by
                     study type, phase, compound, etc� However, on aggregate, we believe our data provide one of the
                     most accurate representations of the CRO market size based on services in the industry�

                     We use the same data and assumptions with respect to our model working down from R&D to
                     development to Phase I-IV development activities to outsourcing propensity when working on our
                     service-line splits�

                     Table 10: 2016 service-line distribution (%) of the CRO market size

                                                         2016
                      Clinical Monitoring                21�7%
                                                                                 2016
                        ClinicalPayments
                      Investigator Monitoring            13�1%                    XX%
                      Data Management                    11�3%
                       Investigator
                      Laboratory            Payments     10�5%                    XX%
                       DataManagement
                      Project Management                  9�0%                    XX%
                      Patient and site recruitment        8�5%
                       Laboratory
                      Technology                          6�9%                    XX%
                      Biostatistics
                       Project        Management          6�4%                    XX%
                      Medical Writing                     3�4%
                       Patient
                      Regulatory      and site recruitment
                                                       2�8%                       XX%
                      Imaging                             2�7%
                       Technology                                                 XX%
                      Quality Assurance                   2�4%
                       Biostatistics
                      Other                               1�3%                    XX%
                      Total                              100%
                       Medical Writing                                            XX%
                       Regulatory                                                 XX%
                       Imaging                                                    XX%
                       Quality Assurance                                          XX%
                       Other                                                      XX%
                       Total                                                     100%

                     www.ISRreports.com ©2016             2016 Edition of the CRO Market Size Projections: 2015-2020       19
Introduction

2016 CRO MARKET SIZE PROJECTIONS 2015-2020

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Introduction

  2016 CRO MARKET SIZE PROJECTIONS 2015-2020

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