2017 CRO MARKET SIZE PROJECTIONS - 2016-2021 PREVIEW OF MARCH, 2017

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P R E V I E W     O F

2017 CRO MARKET
SIZE PROJECTIONS
2016-2021
M A R C H ,     2 0 1 7
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
had biopharma mergers and
we’ve had biopharma mega-
                                    for clinical development services
                                    segmented by phase, geography,
                                                                                25
                                                                               PAGES
mergers. We’ve had public           and service line.
offerings and we’ve had
privatizations. Overall, the CRO    ISR utilizes both publicly available
market has been one of the
best performing sectors in the
                                    information and data obtained
                                    through our syndicated primary
                                                                                24
                                                                               CHARTS
financial circles.                  market research efforts.
                                                                              & GRAPHS

Publication Date: March, 2017

What you will learn
•     Estimated R&D expenditures through 2021
•     Projected spending on development, Phase I-IV development,
      and outsourced Phase I-IV development through 2021,
      segmented by sponsor type:
                                                                           WHY ISR?
       • Large pharma – large molecule                                     1. ISR has leveraged
       • Large pharma – small molecule                                     data from our primary
                                                                           market research. These
       • Non-large pharma – large molecule                                 data, coupled with the
       • Non-large pharma – small molecule                                 “facts and figures” from
                                                                           secondary sources, allow
       • Generic/Specialty
                                                                           for intelligent projections
       • Government                                                        into the CRO market size.
       • Private
                                                                           2. The use of primary
       • Association/Non-profit                                            research data gives ISR
       • Academic                                                          the unique ability to break
                                                                           down the outsourced
•     Spending on CRO services segmented by:
                                                                           market further than
       • Geography                                                         ever before, by offering
       • Service-line                                                      geographic, service
                                                                           line, and Phase I-IV
       • Phase I-IV                                                        assessments.
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 (2016-2021)
                   Model adjustments – From R&D to CRO market size
                   Development spending
                   Table 2: Development as a percent of R&D by segment (2017)
                   Table 3: Development expenditures by segment (2016-2021)
                   Phase I-IV development spending
                   Table 4: Ph I-IV development as a percent of development by segment (2017)
                   Table 5: Ph I-IV development expenditures by segment (2016-2021)
                   Outsourced Phase I-IV development spending
                   Table 6: Outsourced Ph I-IV development as a percent of development
                   by segment (2016-2021)
                   Table 7: Outsourced Ph I-IV development expenditures by segment (2016-2021)
                   2017 full model analysis
                2017 GEOGRAPHIC ASSESSMENT
                   Table 8: 2017 geographic distribution (%) of the CRO market size
                   Table 9: 2017 geographic distribution ($B) of the CRO market size
                2017 SERVICE-LINE ASSESSMENT
                   Table 10: 2017 service-line distribution (%) of the CRO market size
                   Table 11: 2017 service-line distribution ($B) of the CRO market size
                2017 DEVELOPMENT PHASE I-IV ASSESSMENT
                   Table 12: 2017 development phase distribution (%) of the CRO market size
                   Table 13: 2017 development phase distribution ($B) of the CRO market size
                2016-2021 CRO MARKET MODEL
                   2016-2021 CRO market model – growth rates
                2016 PUBLIC CRO MARKET SHARE
                   Table 14: 2016 Public CRO market shares
                ABOUT INDUSTRY STANDARD RESEARCH

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Introduction

2016 CRO MARKET SIZE PROJECTIONS 2015-2020

          S A M P L E                    P A G E :

          INTRODUCTION

                       SMARTER QUESTONS                                          SMARTER ANSWERS

                               INTRODUCTION
                              2016 was probably the year “CRO” finally became a household name on Wall Street and in the halls
                              of private equity firms� That said, those of us who have been in the industry for a while witnessed
                              just another year of solid growth and exchanges of ownership� Make no mistake, more and more
                              people are watching the CRO space� Let’s recap:

                                     •      Bioclinica was busy buying Clinverse, Cinven, and Compass Research

                                     •      Covance names industry veteran, John Ratliff, as its CEO

                                     •      ICON purchases Clinical Research Management

                                     •      INC Research focuses new service offerings on sites and patients

                                     •      inVentiv Health Clinical files their S-1, opening the door to going public

                                     •      Medpace goes public (market capitalization of ~$1�5B)

                                     •      PAREXEL closes on several bolt-on acquisitions (e�g� Health Advances, ExecuPharm, and
                                            The Medical Affairs Company in early 2017)

                                     •      PPD buys Evidera and Synexus and is rumored to be a potential take-over candidate for
                                            LabCorp/Covance

                                     •      PRA Health Sciences stock was up ~22% in 2016

                                     •      Premier Research receives a growth investment from Metalmark Capital

                                     •      Quintiles and IMS merge (market capitalization north of $18B) and buys TKL Research

                                     •      SynteractHCR was acquired by Amulet Capital Partners

                              We think there are several reasons why it might not be too late to jump on the CRO bandwagon�
                              Let’s start with first principals, demand� In the United States and Western Europe, the two largest
                              pharmaceutical markets, the population is aging and the demand for pharmaceutical products is
                              increasing� Therefore it is not surprising that, according to various estimates, underlying global R&D
                              expense (read: potential CRO revenue) continues to grow� This helps form a solid foundation from
                              which to build a growing business� If your demand has a relatively consistent 2-4% annual growth
                              rate, then just keeping your market share constant will result in increased revenue� Pharmapro-
                              jects also has some good news for the CRO industry� According to its projections, the preclinical
                              pipeline increased from ~6,000 candidates in 2015 to ~6,800 candidates in 2016 (a healthy 13% in-
                              crease in one year)� This increasing preclinical pipeline should provide a solid base for clinical stud-
                              ies over the coming years� ISR projects that outsourcing rates will continue to increase at a modest
                              rate for the next few years� With these fundamentals in place, CROs should see solid topline growth
                              over the next few years� That said, this is far from certain�

                        www.ISRreports.com ©2017                                     2017 Edition of the CRO Market Size Projections: 2016-2021                                                    5
                 This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR (info@ISRreports.com).

                                                             Questions about this report? Contact us
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 its 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
                                                                 PRO J ECT E D 2017 TOTAL R& D B RE AK DOWN ( $B )
 the major sources of R&D activity.
                                                                 Academic $44.8
 This page shows the projected                                   15%                                                                                                  Small molecule $98.7
                                                                                                                                                                      34%
 total R&D breakdown for 2017.                                   Association $6.1
                                                                 2%

                                                                 Private $4.3
                                                                 1%                                                © Industry Standard Research

                                                                 Government $72.6
                                                                 25%
                                                                                                                                                                      Large molecule $51.5
                                                                                                                                                                      18%
                                                                 Generic/Specialty $15.5
                                                                 5%

                                                               Table 1: R&D expenditures by segment (2016-2021)

                                                                         $B USD                                    2016                  2017                  2018                   2019                  2020                   2021
                                                                 Large company,
                                                                                                                  $69�5                 $68�6                  $68�3                  $66�5                  $64�9                 $64�3
                                                                 small molecule
                                                                 Non-large company,
                                                                                                                  $30�4                  $30�1                 $30�0                  $29�3                  $28�7                 $28�5
                                                                 small molecule
     SMARTER QUESTONS                    SMARTERLarge
                                                  ANSWERS
                                                      company,
                                                                                                                  $31�8                 $35�8                  $38�8                  $42�9                  $47�3                 $50�8
                                                                 large molecule
                                                                 Non-large company,
                                                                                                                  $13�9                  $15�7                  $17�1                 $18�9                  $20�9                 $22�5
                                                                 large molecule
                                                                 Generic/Specialty                                $15�0                  $15�5                 $16�0                  $16�4                  $16�8                  $17�1
                                                                 Government                                       $68�8                  $72�6                 $76�7                  $78�9                  $81�0                  $81�7
                                                                 Private                                           $4�3                  $4�3                   $4�3                   $4�3                   $4�3                  $4�3
                                                                                                                                                                                                                     © Industry Standard Research
                                                                 Association/Non-profit                            $5�8                   $6�1                  $6�3                   $6�4                   $6�6                   $6�7
                                                                 Academic                                         $43�1                 $44�8                  $46�3                  $47�4                  $48�7                 $49�9
                                                                 Total                                           $282�7                $293�4                 $303�7                 $311�1                 $319�1                 $325�6

      R&D sources and distribution                             www.ISRreports.com ©2017                                     2017 Edition of the CRO Market Size Projections: 2016-2021                                                    9
      As previously stated, ISR starts its market model by gathering the R&D spending from the major
                                                        This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR (info@ISRreports.com).

      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
       PR OJEC T ED 2 01 7 TOTA L R& D BREAK D OWN ( $ B)
                                                                                                                                                                                             >>This chart shows
       Academic $44.8                                                                                                                                                                        the sources of R&D
       15%                                                                                                 Small molecule $98.7
                                                                                                           34%                                                                               spending for 2017. Small
       Association $6.1                                                                                                                                                                      molecule and Large
       2%
                                                                                                                                                                                             molecule account for
       Private $4.3                                                                                                                                                                          52% of R&D spending.
       1%                            © Industry Standard Research

       Government $72.6                                                                                                                                                                      Data available in the
       25%
                                                                                                           Large molecule $51.5                                                              full report. Click here
                                                                                                           18%
       Generic/Specialty $15.5                                                                                                                                                               to purchase from
       5%
                                                                                                                                                                                             ISRreports.com

      Table 1: R&D expenditures by segment    (2016-2021)
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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 2017 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 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�

                                                                                                    2017 R&D:
                                                                                                     $293.4B

                                                                                         2017 Development:
                                                                                              $120.7B

                                                                                                   2017 Phase I-IV
                                                                                                   Development:
                                                                                                       $85.9B

                                                                                                  © Industry Standard Research

                                                                          2017 Outsourcing Phase I-IV
                                                                             Development Market:
                                                                                   $34.3B

                         www.ISRreports.com ©2017                                     2017 Edition of the CRO Market Size Projections: 2016-2021                                                  10
                  This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR (info@ISRreports.com).

                                                                   Questions about this report? Contact us
Introduction

2016 CRO MARKET SIZE PROJECTIONS 2015-2020

          S A M P L E                       P A G E :

          2017 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

                         2017 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: 2017 service-line distribution (%) of the CRO market size

                                                                                      2017
                           Clinical Monitoring                                       21�1%
                                                                                                                      2017
                             ClinicalPayments
                           Investigator Monitoring                                   13�2%                              XX%
                           Data Management                                           10�9%
                            Investigator
                           Laboratory                    Payments                    10�7%                              XX%
                            DataManagement
                           Project Management                                         9�0%                              XX%
                           Patient and Site Recruitment                               8�7%
                            Laboratory
                           Technology                                                 7�3%                              XX%
                           Biostatistics
                            Project            Management                             6�4%                              XX%
                           Medical Writing                                            3�1%
                            Patient
                           Imaging            and Site Recruitment
                                                               3�1%                                                     XX%
                           Regulatory                                                 2�8%
                             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 ©2017                                     2017 Edition of the CRO Market Size Projections: 2016-2021                                                  19
                  This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR (info@ISRreports.com).

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Introduction

2016 CRO MARKET SIZE PROJECTIONS 2015-2020

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                                                                                           ISR’S HEALTH PANEL
                                               THE                                         The industry’s fastest growing panel
         ISR’S                              COMMON                                          of health care and pharmaceutical
                                                                                             professionals, with nearly 1,500
                                     VS.   SYNDICATED
       REPORTS                                                                                    members worldwide.
                                             REPORT
                                                                                                        Other 6%
                                                                                             CRO 6%
                                                                                     Research
                                                                                     Site 10%
RESEARCH METHODS                                                                                            BY
           Mostly primary                     One size                                                   COMPANY
           research; always                   fits all; usually                                            TYPE
           appropriate for                    publically
           the topic                          available data

                                                                                                                            Sponsor 78%
DATA COLLECTION
           ISR’s proprietary data             Struggle to                                                           C-level 13%
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                                                                                                               BY
RESPONDENTS                                                                                                   JOB
                                                                                                             LEVEL
           Sophisticated screening            Undisclosed
           ensures genuine                    methodologies
           decision-makers                    and respondent
           make up respondents                demographics
                                                                                                            Director 46%

SAMPLE SIZE                                                                                                  3-5 years 5%
           Robust                             Often insufficient                                                        6-10 years 11%
           sample sizes                       industry representation                     20+
           that instill                       that leaves you                             years
           confidence                         defending results                            37%              BY
                                                                                                        EXPERIENCE                   11-15
ANALYSTS                                                                                                 IN YEARS                    years
                                                                                                                                      24%
           Decades of experience              Junior analysts
           means more                         capable of
           insights that are                  reporting
           immediately usable                 numbers                                                 16-20 years 23%
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