As pharmaceutical and biopharmaceutical companies increase their levels of external development and manufacturing, the need for unbiased information to support strategic business decisions continues to grow. In this report, ISR provides pharmaceutical companies and contract manufacturers a comprehensive analysis of current outsourcing trends and practices, in addition to a quantitative analysis of CMO service quality across a series of 26 performance attributes specific to large molecule projects. In this Consumer Reports-style analysis, ISR presents data on 312 service encounters from 158 respondents who have been involved in outsourced biologic API projects in the past 18 months. http://www.isrreports.com/reports/biologic-api-contract-manufacturer-quality-benchmarking-2016/

1. BIOLOGIC API
CONTRACT
MANUFACTURER
QUALITY
BENCHMARKING
(2016)
J A N U A R Y , 2 0 1 6
P R E V I E W O F

2. REPORT OVERVIEW
WHAT YOU WILL LEARN
How you can use this report
As pharmaceutical and biopharmaceutical companies
increase their levels of external development and
manufacturing, the need for unbiased information to
support strategic business decisions continues to grow.
In this report, ISR provides pharmaceutical companies
and contract manufacturers a comprehensive analysis
of current outsourcing trends and practices, in addition
to a quantitative analysis of CMO service quality across
a series of 26 performance attributes specific to large
molecule projects. In this Consumer Reports-style analysis,
ISR presents data on 312 service encounters from 158
respondents who have been involved in outsourced
biologic API projects in the past 18 months.
D A T A
C O L L E C T I O N I N
Q 3 - Q 4 , 2 0 1 5
3 0 - M I N U T E
W E B - B A S E D
S U R V E Y
1 5 8 R E S P O N D E N T S
F R O M N O R T H A M E R I C A ,
E U R O P E , A N D A S I A
123
PAGES
32
CMOs
VALUABLE FOR
MAJOR
SECTIONS:
1. OUTSOURCING
PHILOSOPHIES AND
PRACTICES
2. CMO PERCEPTIONS AND
INTERACTIONS
3. CMO SELECTION DRIVERS
4. CMO PERFORMANCE AND
SCORECARDS ACROSS
ATTRIBUTES
5. CMO LOYALTY
6. COMPANY SERVICE
QUALITY PROFILES
7. STUDY DATA
• Which outsourcing models are drug innovators currently using and
whether the outsourcing approach will evolve over the next five years
• Learn which supplier attributes are driving CMO selection and which
attributes are gaining in importance when it comes to outsourced
primary manufacturing services for biologic projects
• Which contract manufacturers have exceeded expectations on CMO
performance metrics and which have fell short of sponsor expectations
• Compare contract manufacturers on their performance specific to
biologic API and related services by accessing performance evaluation
information across 26 key attributes
• Gain insight into sponsor best practices for outsourced biologic
manufacturing projects
• Benchmark your company’s RFP and supplier selection processes
FOR PHARMA FOR CMOs
Make a more educated
purchase of CMO services by
understanding which CMOs best
fit your company’s needs as well
as how individual CMOs have
measured up to sponsor-peer
expectations on similar projects.
Uncover your own—and competitor—
delivery strengths and weaknesses and
use the information to develop targeted
messaging that effectively portrays your
company’s strengths and differentiates its
service offerings based on areas of high
performance.
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
Full Table of Contents on
next page.
COMMERCIAL MANUFACTURING CLINICAL TRIAL
MANUFACTURING SUPPLY CHAIN OUTSOURCING/
PURCHASING R&D MANAGEMENT CMO SENIOR
MANAGEMENT BUSINESS DEVELOPMENT SALES AND
MARKETING MARKET RESEARCH

3. COMPANIES INCLUDED
ATTRIBUTES MEASURED
AbbVie Contract Manufacturing
Aeras CMO
Althea
Avid Bioservices
Boehringer Ingelheim
Catalent
Celltrion
CMC Biologics
Cobra Biologics
Cook Pharmica
Cytovance Biologics
Dalton Pharma Services
FujiFilm Diosynth Biotechnologies
GSK Contract Manufacturing
Hetero
IDT Biologika
KBI Biopharma
Kemwell
Lonza
Novasep
Paragon
Patheon
Pfizer CentreSource
Piramal Pharma Solutions
Rentschler
Richter-Helm
SAFC
Samsung BioLogics
Sandoz
Sanofi CEPiA
Therapure Biopharma
Wuxi AppTec
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
Ability to smoothly scale up manufacturing
and transfer technology
Access to desired markets
Accessible senior management
All facilities fully owned (i.e., not
subcontracted)
Complementary core competencies to in-
house or other manufacturing contractors
Cultural fit
Experience level of staff
Facility has most up-to-date manufacturing
technologies
Financial strength/ stability
Flexibility to adjust schedule for special
requests
Has capacity to meet our demands
Low cost
Metrics for meeting overall project timelines
Offers innovative solutions
Proven ability to manufacture large molecule
API
Provides regulatory support for filing
Reliable on-time delivery
Right first time measurements
Scientific knowledge
Stability testing capabilities
Storage capabilities
Strong regulatory track record
Timely project communications
Track record for meeting quality performance
metrics
Up-front contingency planning, risk
management
Well-regarded within the industry
Each
company is
evaluated on
26 CRITICAL
ATTRIBUTES
Data is included
for all 32 CMOs;
12 CMOs
received 10+
responses and
are featured
in a one-page
profile in
the report

4. Introduction
SMARTER QUESTIONS SMARTER ANSWERS
TABLE OF CONTENTS
To view the Table of Contents, download the full preview from:
www.isrreports.com/reports/biologic-api-contract-manufacturer-quality-benchmarking-2016/

5. Introduction
SMARTER QUESTIONS SMARTER ANSWERS
OUTSOURCING PHILOSOPHIES AND PRACTICES
Biologic API Contract Manufacturer Quality Benchmarking (2016) 14www.ISRreports.com ©2016
Outsourcing Models
Currently, an average of 35% of biologic API manufacturing projects are outsourced in a tactical manner, meaning
the CMO is engaged on a one-off or project-by-project basis� At present, respondents engage CMOs through
tactical outsourcing and by outsourcing to preferred providers at similar rates, however respondents anticipate
that three years from now a greater proportion of biologic manufacturing projects will be outsourced to preferred
providers and fewer projects will be outsourced on a tactical basis�
Respondents do not anticipate much change in strategic outsourcing over the next three years� Strategic
outsourcing was defined as “a relationship that allows both parties to predict the flow of work, leverage
knowledge and expertise around its pipeline, and optimize efficiencies offered by repeat business�”
“Please indicate the percentage of outsourced biologic / large molecule API manufacturing projects that are con-
tracted through each outsourcing model.” (Base=158)
“Three years from now, what percentage of outsourced biologic / large molecule API manufacturing projects will
be contracted through each outsourcing model.” (Base=158)
BIOLOGIC API CONTRACT MANUFACTURER QUALITY BENCHMARKING (2016) 1
7
32%
38%
30%
31%
34%
35%
0% 10% 20% 30% 40%
Strategic Outsourcing
Preferred Providers
Tactical Outsourcing
% of Manufacturing Projects
Current
3 Years from Now
Outsourcing Models
Currently, an average of 35% of biologic API manufacturing projects are outsourced in a tactical manner,
meaning the CMO is engaged on a one-off or project-by-project basis. At present, respondents engage
CMOs through tactical outsourcing and by outsourcing to preferred providers at similar rates, however
respondents anticipate that three years from now a greater proportion of biologic manufacturing
projects will be outsourced to preferred providers and fewer projects will be outsourced on a tactical
basis.
Respondents do not anticipate much change in strategic outsourcing over the next three years. Strategic
outsourcing was defined as “a relationship that allows both parties to predict the flow of work, leverage
knowledge and expertise around its pipeline, and optimize efficiencies offered by repeat business.”
“Please indicate the percentage of outsourced biologic / large molecule API manufacturing projects that
are contracted through each outsourcing model.” (Base=158)
“Three years from now, what percentage of outsourced biologic / large molecule API manufacturing
projects will be contracted through each outsourcing model.” (Base=158)
© Industry Standard Research
S A M P L E P A G E :
OUTSOURCING
MODELS
C L O S E R L O O K
D A T A I N F U L L R E P O R T
OUTSOURCING PHILOSOPHIES AND PRACTICES
Outsourcing Models
Currently, an average of 35% of biologic API manufacturing projects are outsourced in a tactical manner, meaning
the CMO is engaged on a one-off or project-by-project basis� At present, respondents engage CMOs through
tactical outsourcing and by outsourcing to preferred providers at similar rates, however respondents anticipate
that three years from now a greater proportion of biologic manufacturing projects will be outsourced to preferred
providers and fewer projects will be outsourced on a tactical basis�
Respondents do not anticipate much change in strategic outsourcing over the next three years� Strategic
outsourcing was defined as “a relationship that allows both parties to predict the flow of work, leverage
knowledge and expertise around its pipeline, and optimize efficiencies offered by repeat business�”
“Please indicate the percentage of outsourced biologic / large molecule API manufacturing projects that are con-
tracted through each outsourcing model.” (Base=158)
“Three years from now, what percentage of outsourced biologic / large molecule API manufacturing projects will
be contracted through each outsourcing model.” (Base=158)
32%
38%
30%
31%
34%
35%
0% 10% 20% 30% 40%
Strategic Outsourcing
Preferred Providers
Tactical Outsourcing
% of Manufacturing Projects
Current
3 Years from Now
Outsourcing Models
Currently, an average of 35% of biologic API manufacturing projects are outsourced in a tactical manner,
meaning the CMO is engaged on a one-off or project-by-project basis. At present, respondents engage
CMOs through tactical outsourcing and by outsourcing to preferred providers at similar rates, however
respondents anticipate that three years from now a greater proportion of biologic manufacturing
projects will be outsourced to preferred providers and fewer projects will be outsourced on a tactical
basis.
Respondents do not anticipate much change in strategic outsourcing over the next three years. Strategic
outsourcing was defined as “a relationship that allows both parties to predict the flow of work, leverage
knowledge and expertise around its pipeline, and optimize efficiencies offered by repeat business.”
“Please indicate the percentage of outsourced biologic / large molecule API manufacturing projects that
are contracted through each outsourcing model.” (Base=158)
“Three years from now, what percentage of outsourced biologic / large molecule API manufacturing
projects will be contracted through each outsourcing model.” (Base=158)
© Industry Standard Research
D A T A I N F U L L R E P O R T
This report offers an in-
depth look at how buyers of
outsourced services engage
contract manufacturers. On this
page, taken from the report, ISR
asked respondents about their
engagement structure. As shown in
the chart, sponsors indicated they
will be decreasing the percentage
of projects that are outsourced in a
tactical manner.
<< The data shows a
5% decrease three
years from now in the
percentage of projects
that will be outsourced
tactically.
The data has been
blinded in this sample
page, but is available in
the full report, which can
be found at:
www.ISRreports.com
(Categories after sample are in alphabetical order)

6. Introduction
SMARTER QUESTIONS SMARTER ANSWERS
S A M P L E P A G E :
DELIVERY FACTORS
Introduction
CMO PERFORMANCE AND SCORECARDS
34Small Molecule API Contract Manufacturer Quality Benchmarking (2016)www.ISRreports.com ©2016
Figure 1 – CMO Performance: Delivery Factors
Ratings Key: Clear leadership Better than most About average Falling a bit short Likely deficiency
AAI/Cambridge Major
Almac
AMPAC Fine Chemicals
AMRI
Aptuit
Cambrex
Corden Pharma
Dr. Reddy’s CPS
Evonik
GSK CMO
Halo Pharma
Hetero
Lonza
Novasep
Patheon
PCI Synthesis
Pfizer Centresource
PharmaCore
SAFC
SAI Life Sciences
Sanofi CEPiA
Siegfried
Wuxi AppTec
Flexibility
to adjust
schedule
for special
requests
Meeting
overall
project
timelines
Meeting
quality
performance
metrics
Provides
regulatory
support
for filing
Up-front
contingency
planning, risk
management
Reliable
on-time
delivery
Right
first time
measurements
S A M P L E P A G E :
DELIVERY FACTORS
C O M P A N Y A
C O M P A N Y K
C O M P A N Y B
C O M P A N Y L
C O M P A N Y C
C O M P A N Y D
C O M P A N Y E
C O M P A N Y F
C O M P A N Y G
C O M P A N Y H
C O M P A N Y I
C O M P A N Y J
This sample page comes from the CMO Performance and Scorecards Across Attributes
section of the report and is an example of how the CMO performance data is summarized for
easy analysis.
The full data is available in the report, which can be downloaded from www.ISRreports.com.
Biologic API Contract Manufacturer Quality Benchmarking (2016)

7. Introduction
SMARTER QUESTIONS SMARTER ANSWERS
S A M P L E P A G E : COMPANY PROFILE
The average customer experience chart displays how
the CMO performed relative to customer expectations
for each of the ten most important attributes as selected
by respondents. A full list of attributes can be found on
page 3 of this preview.
The highlights section
shows each company’s
highest and lowest
attributes, ranked by
actual users.
The customer
loyalty chart
displays an
aggregate
score
comprised
of overall
satisfaction,
likelihood to
recommend
and likelihood
to use the
provider again.
The loyalty
metric is
compared to
the industry
average.
The brand
snapshot chart
displays CMO
awareness,
familiarity,
leadership
and use
rates among
respondents.
Companies
with over 10
respondents
are profiled.
Introduction
AD AGENCY PERFORMANCE
Healthcare Advertising Agency Quality Benchmarking (2015) 50www.ISRreports.com ©2015
PUBLICIS LIFE BRANDS MEDICUS BRAND SNAPSHOT
PUBLICIS LIFE BRANDS MEDICUS CUSTOMER LOYALTY
PUBLICIS LIFE BRANDS MEDICUS AVERAGE CUSTOMER EXPERIENCE
TOP3
ATTRIBUTES:
Global
footprint
Quality of
media team
Quality of
strategy team
BOTTOM3
ATTRIBUTES:
100%
dedicated
creative team
Expertise in
marketing to
payers
Low cost
HIGHLIGHTS
INDUSTRY AVERAGE
PUBLICIS LIFE BRANDS MEDICUS
6.3
6.1
LEADERSHIP - 13%
PREFERENCE- 9%
PROPOSAL VOLUME - 8%
USE - 19%
Publicis Life Brands Medicus
Somewhat
Exceeds
Expectations
Somewhat
Misses
Expectations
© Industry Standard Research
PUBLICIS LIFE
BRANDS MEDICUS (N=11)
SAMPLE COMPANY CUSTOMER LOYALTY
SAMPLE COMPANY AVERAGE CUSTOMER EXPERIENCE
SAMPLE COMPANY
HIGHLIGHTS
COMPANY PERFORMANCE
INDUSTRY AVERAGE
SAMPLE AGENCY
6.3
6.8
AWARENESS 90%
FAMILIARITY 66%
USE 7%
LEADERSHIP 22%
COMPANY SERVICE QUALITY PROFILES
44www.ISRreports.com ©2016 Small Molecule API Contract Manufacturer Quality Benchmarking (2016)
AAI/CAMBRIDGE MAJOR BRAND SNAPSHOT
AAI/CAMBRIDGE MAJOR CUSTOMER LOYALTY
AAI/CAMBRIDGE MAJOR AVERAGE CUSTOMER EXPERIENCE
AAI/CAMBRIDGE
MAJOR
HIGHLIGHTS
INDUSTRY AVERAGE
AAI/CAMBRIDGE MAJOR
7.3
6.9
AWARENESS 76%
FAMILIARITY 56%
USE 11%
LEADERSHIP 12%
Strong regulatory track
record
Meeting quality
performance
metrics
Low cost Has capacity to
meet our
demands
Scientific knowledge Reliable on-time
delivery
Ability to smoothly scale
up manufacturing and
transfer technology
Experience level of
staff
Offers innovative
solutions
Ratings Key: Clear leadership Better than most About average Falling a bit short Likely deficiency
Proven ability to
manufacture small
molecule API
(N=21)
© Industry Standard Research
TOP3
ATTRIBUTES:
Timely project
communications
Proven abilitiy
to manufacture
small molecule
API
Cultural fit
BOTTOM3
ATTRIBUTES:
Complementary
core
competencies
to in-house
or other
manufacturing
contractors
Facility has most
up-to-date
manufacturing
technologies
Meeting overall
project timelines
(N=12)
© Industry Standard Research
SAMPLE COMPANY
TOP3
ATTRIBUTES:
Reliable
on-time
delivery
Scientific
knowledge
Has capacity
to meet our
demands
BOTTOM3
ATTRIBUTES:
Low cost
Meeting
quality
performance
metrics
Ability to
smoothly
scale up
manufacturing
and transfer
technology
Biologic API Contract Manufacturer Quality Benchmarking (2016)www.ISRreports.com ©2016
SAMPLE COMPANY BRAND SNAPSHOT
large

8. Introduction
SMARTER QUESTIONS SMARTER ANSWERS
ORDERING INFORMATION
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