OUTSOURCED

RICAL MA
ME N

UF
M
ELOPMENT VS CO

ACU
RING PRACTICE
DEV

P R E V I E W O F

DEVELOPMENT
VS COMMERCIAL
OUTSOURCED
MANUFACTURING
PRACTICES:
BIOLOGICS
J U N E , 2 0 1 7
 Introduction

SMARTER QUESTIONS SMARTER ANSWERS

REPORT OVERVIEW President 3%

Vice President 10%

Smal
than $1

Each year, more CMOs expand their service offerings to

include specialized development capabilities, particularly Director 30%
contract manufacturers focused on biologic drugs. Cell line Associate 14%

development, process, analytical and formulation development, JOB

clinical trial manufacturing and commercial manufacturing for TITLE
drug substance and drug product may be obtained from a single
provider with end-to-end services. Knowing whether this is the
best approach for your organization is challenging. This report
dives into how the decision-making process differs among
drug innovators outsourcing development activities from those C-Level 14% Manager 29% $1
outsourcing commercial manufacturing when it comes to
CMO/CDMO selection criteria, use patterns, preferences and
perceived leadership. Readers will gain insight into four different
outsourcing scenarios President
for biologic
3%
drugs enabling them to Small (R&D less RESPONDENT LOCATION
make more educated purchases of CMO services based on than $100M), 20%
their unique needs. CMOs will gain
Vice President 10% a better understanding of
customers requirements and how they change as a compound Director 30%
moves through the development
Associate 14% to commercialization process.
JOB Large
COMPANY EUROPE
(R&D $1B or22%
TITLE NORTH
TYPE more), 44%
AMERICA
73%

DATA 30-MINUTE, 176 Mid-size (R&D

COLLECTION IN C-Level
W E B -14%
BASED R E S P O N DManager
E N T S 29% $100M-$999M), 36%
Q4, 2016 QUANTITATIVE SURVEY

What you will learn: RESPONDENT LOCATION

DRUG DEVELOPERS *by office location

EUROPE
Differences in CMO engagement and usage patterns based on
MAJOR
22% ASIA AND
outsourcing stage and internal capabilities and/or capacity
NORTH OTHER
AMERICA 5%
Key differences in CMO selection
73% drivers based on four different

outsourcing scenarios: development-stage API manufacturing,

commercial API manufacturing, development-stage drug product
TOPICS:
manufacturing and commercial drug product manufacturing 1. Outsourcing Philosophies
Learn which CMO attributes are becoming more important to and Practices
different types of outsourcing peers in order to gain advantages
from their experiences 2. CMO Perceptions and
Interactions

CONTRACT MANUFACTURERS 3. CMO Selection Drivers

Ways to improve your companys sales and marketing strategies 4. Study Data
to specifically address thelocation
*by office needs of different customer bases,
as identified in CMO selection criteria, during specific decision-
making scenarios Full Table of Contents on
next page.
Outsourcing propensity of the different buyers of outsourced
services for both drug substance and drug product manufacturing
How CMO awareness, familiarity, leadership, proposal volume, use
and preference vary between outsourcers of development-stage
or commercial-scale manufacturing in order to target specific
audiences with the precise information they need

2
To learn more: contact us at info@isrreports.com or +1(919)301-0106
 Introduction

SMARTER QUESTIONS SMARTER ANSWERS

TABLE OF CONTENTS
COPYRIGHT AND USAGE GUIDELINES
INTRODUCTION
METHODOLOGY
Respondent Demographics and Qualifications
4 Major Sections
OUTSOURCING PHILOSOPHIES AND PRACTICES
Primary Section Takeaways
Outsourcing DriversBiologic API
Outsourcing DriversBiologic Drug Product
Use of Preferred ProvidersBiologic API
Number of Preferred ProvidersBiologic API
Use of Preferred ProvidersBiologic Drug Product
Number of Preferred ProvidersBiologic Drug
Product
Outsourcing ModelsBiologic API
Outsourcing ModelsBiologic Drug Product
Outsourced Manufacturing ActivitiesBiologic API
Outsourced Manufacturing ActivitiesBiologic
Drug Product
CMO PERCEPTIONS AND INTERACTIONS
Outsourcing DriversBiologic Drug Product
Outsourced Manufacturing ActivitiesBiologic API
Outsourced Manufacturing ActivitiesBiologic
Drug Product
Outsourcing ModelsBiologic API
Outsourcing ModelsBiologic Drug Product
Use of Preferred ProvidersBiologic API
Number of Preferred ProvidersBiologic API
Use of Preferred ProvidersBiologic Drug Product
Number of Preferred ProvidersBiologic
Drug Product
Top 5 CMO Selection AttributesBiologic API
#1 CMO Selection AttributesBiologic API
Top 5 CMO Selection AttributesBiologic
Drug Product
#1 CMO Selection AttributesBiologic
Drug Product
CMO Selection Attributes Gaining Importance
Biologic API
CMO Selection Attributes Gaining Importance
Biologic Drug Product

Primary Section Takeaways CMO Familiarity Among Development

OutsourcersBiologic API
CMO FamiliarityBiologic API
CMO Familiarity Among Commercial
CMO FamiliarityDrug Product OutsourcersBiologic API
CMO LeadersBiologic API CMO Familiarity Among Development
CMO LeadersBiologic Drug Product OutsourcersBiologic Drug Product
Received ProposalsBiologic API CMO Familiarity Among Commercial
OutsourcersBiologic Drug Product
Received ProposalsBiologic Drug Product
CMO LeadersBiologic API
CMO UseBiologic API
CMO LeadersBiologic Drug Product
CMO UseBiologic Drug Product
Received ProposalsBiologic API
CMO PreferenceBiologic API
Received ProposalsBiologic Drug Product
CMO PreferenceBiologic Drug Product
CMO Use Among Development Outsourcers
Summary TableBiologic API
Biologic API
Summary TableBiologic Drug Product
CMO Use Among Commercial Outsourcers
CMO SELECTION DRIVERS Biologic API
Primary Section Takeaways CMO Use Among Development Outsourcers
CMO Selection Attributes Biologic Drug Product

CMO Selection Attributes Gaining Importance CMO Use Among Commercial Outsourcers
Biologic Drug Product
STUDY DATA
CMO PreferenceBiologic API
Outsourcing DriversBiologic API
CMO PreferenceBiologic Drug Product

3
To learn more: contact us at info@isrreports.com or +1(919)301-0106
 Introduction

SMARTER QUESTIONS SMARTER ANSWERS

TABLE OF CONTENTS continued

DEMOGRAPHICS
Company Type
Headquarters Location
Office Location
Job Title
Decision-making Responsibility
Contract Manufacturing Responsibilities
Involvement in Outsourced Manufacturing
Years of Industry Experience
ABOUT INDUSTRY STANDARD RESEARCH

83
PAGES

84
CHARTS
AND GRAPHS

SAMPLE PAGES

4
To learn more: contact us at info@isrreports.com or +1(919)301-0106
 Introduction

SMARTER QUESTIONS SMARTER ANSWERS

S A M P L E P A G E :
CMO PERCEPTIONS AND INTERACTIONS

CMO
CMO FamiliarityDrug Product
FAMILIARITY The table below only includes CMOs that >10% of respondents (combined across development and

DRUG
commercial outsourcers) have used. For full data on CMO familiarity, see the Study Data section.

PRODUCT
Please indicate your level of familiarity with each of the following providers of drug product manufac-
Familiarity and use data combined turing services?

with CMO preference statistics

can support drug innovators Development (n=27) I have used
I am very familiar
with this compa-
I am somewhat
familiar with
I am aware of
this company
I have never
this company's ny's manufactur- this company's but know noth-
CMO selection decision, by Commercial (n=20)
manufacturing
services
ing services but
have not used
manufacturing
services but have
ing about its
manufacturing
heard of this
company

knowing which companies 3M Drug Delivery

them not used them services

their peers have used for AbbVie CMO

different types of projects and AMRI

Baxter BioPharma
how pleased they are with the Boehringer Ingelheim

relationship. CMOs can benefit by Catalent

understanding which audiences Cook Pharmica

Dalton Pharma Services

may have awareness gaps and Famar

develop marketing strategies to GSK CMO

close those gaps. Jubilant HollisterStier

Patheon 11% 35%

Pfizer CentreOne 19% 0%
Piramal

Rentschler

SAFC

Samsung BioLogics

Vetter

Wuxi AppTec

DATA IN FULL REPORT

www.ISRreports.com 2017 Development vs Commercial Outsourced Manufacturing Practices: Biologics 24

C L O S E R L O O K :
<< As the table shows,
Patheon has stronger
awareness among
Development (n=27) development-stage
I have never
heard of this respondents while Pfizer
Commercial (n=20) company CentreOne has stronger
awareness among
Patheon 11% 35%
commercial respondents.
Pfizer CentreOne 19% 0%

The full data is available in the

report, click here to purchase
from ISRreports.com.

5
To learn more: contact us at info@isrreports.com or +1(919)301-0106
 Introduction

SMARTER QUESTIONS SMARTER ANSWERS

S A M P L E P A G E :

SUMMARY TABLEBIOLOGIC API

Based on the outsourcing scenario, the same company may have a very different
perception among its buying audiences. Lonza takes the #1 rank for perceived leadership
among development-stage API respondents, but four other CMOs outrank the company
among commercial-scale API respondents.

The full data is available in the report, click here to purchase from ISRreports.com.

CMO PERCEPTIONS AND INTERACTIONS

Summary TableBiologic API

Development (n=72) Commercial (n=57)

Rank Leadership Proposal Volume Use Preference

1 Lonza

5 Lonza

10

DATA IN FULL REPORT

There are similarities and differences in the highest ranking CMOs for Leadership, Proposal Volume,
Use and Preference between development-stage biologic API respondents and commercial-scale
respondents.

www.ISRreports.com 2017 Development vs Commercial Outsourced Manufacturing Practices: Biologics 33

6
To learn more: contact us at info@isrreports.com or +1(919)301-0106
 Introduction

SMARTER QUESTIONS SMARTER ANSWERS

S A M P L E P A G E :

CMO SELECTION ATTRIBUTES

As the table below shows, a CMO attribute very important to one outsourcing scenario
may not be among the top 10 attributes for other outsourcing scenarios. For example,
Right-first-time measurements ranks 3rd among respondents outsourcing development-
stage drug product, but does not make the top 10 among other respondent groups.
Attributes below have been alphabetized.

The full data is available in the report, click here to purchase from ISRreports.com.

CMO SELECTION DRIVERS

CMO Selection Attributes

To understand how the selection of a large molecule contract manufacturer can vary based on the
outsourcing scenario, ISR asks respondents about the key service provider selection drivers used in
each scenario in which they participate. Those outsourcing development-stage API manufacturing
tell us what is important when choosing a provider, as do respondents outsourcing commercial-scale
API manufacturing. These selection criteria differ in some degree from the attributes desired in a drug
product manufacturer, and as such, ISR compares what drivers are important when choosing a drug
product manufacturer for clinical versus commercial supply for biologic API and drug product.

The table below contains the top six selection attributes for each outsourcing scenario, with rankings
based off respondents five most important criteria when selecting a provider. For comparison and
completeness, ranks for attributes that are in the top six attributes for one scenario but not for others
are shown in parentheses. Ties are given the average of the ranks they would have received if no
scores had tied. Full results for attribute importance can be found in the Study Data section.

Top Six Selection Attributes by Outsourcing Scenario

Development- Commercial- Development- Commercial-

stage biologic scale biologic stage biologic scale biologic
API API drug product drug product
Ability to smoothly scale up manufacturing
and transfer technology

Accessible senior management

Cultural fit

Experience level of staff

Has capacity to meet our demands

Low cost

Proven ability to manufacture biologic API /

Full range of the dosage forms we require

Reliable on-time delivery

Right-first-time measurements (22.5) (11.5) 3 (23)

Scientific knowledge

Strong regulatory track record

Track record of meeting quality performance

metrics
Up-front contingency planning, risk manage-
ment

Well-regarded within the industry

DATA IN FULL REPORT

www.ISRreports.com 2017 Development vs Commercial Outsourced Manufacturing Practices: Biologics 37

7
To learn more: contact us at info@isrreports.com or +1(919)301-0106
 Introduction

SMARTER QUESTIONS SMARTER ANSWERS

ORDERING INFORMATION
To obtain full access to this report, please select one of the following licenses:

SINGLE-USER LICENSE A single-user license allows access to a single individual user. $4,960 USD

SITE-WIDE LICENSE A site-wide license allows access to organization $7,440 USD

employees within a particular geographic site/location (i.e.
NYC or London office).

ENTERPRISE-WIDE An enterprise-wide license allows access to ALL employees $9,920 USD

LICENSE in an organization this is the recommended license
if a report has widespread relevance throughout an
organization.

To purchase the report with a credit card or invoice, simply click the button below to be taken to the
report page. If youd like to inquire about a different payment method or have questions, contact us at
Sales@ISRreports.com or +1.919.301.0106.

To schedule a call to discuss this report with one of our analysts, please e-mail us at info@ISRreports.com.

PURCHASE REPORT

>> R E G I S T E R N O W
SAVE ON THIS, >>Receive $250 instant credit towards any ISR report
OR ANY ISR REPORT, BY >>Earn 10% credit towards all future purchases
CREATING A >>Receive advanced notifications on ISRs latest reports and
free resources
FREE ACCOUNT

ABOUT INDUSTRY STANDARD RESEARCH

Industry Standard Research (ISR) is the premier, full service market research provider to the pharma and pharma services
industries. With over a decade of experience in the industry, ISR delivers an unmatched level of domain expertise.

For more information about our off-the-shelf intelligence and custom research offerings, please visit our Web site at
www.ISRreports.com, email info@ISRreports.com, or follow us on twitter @ISRreports.

8
To learn more: contact us at info@isrreports.com or +1(919)301-0106
 Introduction

SMARTER QUESTIONS SMARTER ANSWERS

SOMETHING TO CONSIDER

LIBRARY ACCESS CUSTOM RESEARCH

SUBSCRIPTION UNDERSTAND YOUR MARKETS
ISRs library access subscription provides your entire Leverage ISRs experience and institutional
organization access to our full library of syndicated knowledge to create a fit-for-purpose market
market research reports (100+ titles) plus access research project that addresses the business
to all reports (~25 per year) released during your decisions you need to make.
subscription period.
Are you:
Our research categories include: Developing a new product or service?
Evaluating a new market?
Targeting a new customer segment?
Entering a new geography?
Needing a deeper understanding of your
customer or potential customer base?

Biosimilars & Clinical Trial Commercialization Department

Biologics Recruitment & Models &
Retention Structures
UNDERSTAND YOUR CUSTOMERS
Who makes the decisions and in what contexts?
ISR can help you gain a deeper understanding of
your customers decision-making units (DMUs) and
decision-making processes (DMPs).

Trends & Manufacturing Service Key Questions Addressed:

Technologies Provider Quality
Benchmarking What motivates the purchase decision?
How are companies, products, solutions, and/or
brands evaluated?
DISTINCTIVE Receive novel insights What factors drive the final buying decision?
from industry decision-makers on topics Where are your customers won or lost in the
including: service provider quality, patient purchasing process?
Why were specific opportunities won or lost?
recruitment, biosimilars, clinical technology,
How do you keep customers engaged and
manufacturing, clinical operations, and
manage their loyalty over time?
commercial activities.

UNRESTRICTED ISR doesnt sell seats.

Instantly obtain access for all employees within CUSTOM RESEARCH SERVICES
your organization Investigator Forum
Brand, Advertising, and Message Testing
AFFORDABLE Receive access to Loyalty Management
ALL reports in ISRs library, as well as those New Product and Service Development
released during your subscription period. ISRs Competitive Intelligence
competitive library pricing equates to the cost of Strategy War Games
a few individual report purchases. MORE

9
TO LEARN MORE: CONTACT US AT INFO@ISRREPORTS.COM OR +1(919)301-0106
 Introduction

THE ISR DIFFERENCE

SMARTER QUESTIONS SMARTER ANSWERS

act with confidence

ISRS HEALTH PANEL

THE The industrys fastest growing panel
ISRS 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
ISRs proprietary data Struggle to C-level 13%
tools and channels recruit the right
support fast, high targets and Manager
quality data collection enough of them 29%
VP 10%
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%
www.ISRreports.com 2013 | Preview of: Benchmarking the Pharma Industrys HEOR Functions 10
10
To learn more, visit www.ISRreports.com