DEVELOPMENT VS COMMERCIAL OUTSOURCED MANUFACTURING PRACTICES: SMALL MOLECULEJ U N E , 2 0 1 7

P R E V I E W O F

DEVE

LOPM

ENT V

S COM

MERICAL OUTSOURCED MANUFACURING PRACTICES

Introduction

SMARTER QUESTIONS SMARTER ANSWERS

2

Associate 16%

Director 31%

Vice President 8%

C-level 14%

Manager 27%

President 4%

Large (R&D $1B or more), 22%

Small (R&D less than $100M), 45%

Mid-size (R&D $100M-$999M), 34%

RESPONDENT LOCATION

NORTHAMERICA

71%

EUROPE25% ASIA AND

OTHER4%

JOBTITLE

COMPANYTYPE

*by o�ce location

Associate 16%

Director 31%

Vice President 8%

C-level 14%

Manager 27%

President 4%

Large (R&D $1B or more), 22%

Small (R&D less than $100M), 45%

Mid-size (R&D $100M-$999M), 34%

RESPONDENT LOCATION

NORTHAMERICA

71%

EUROPE25% ASIA AND

OTHER4%

JOBTITLE

COMPANYTYPE

*by o�ce location

CMOs continue to expand their service offerings to include spe-cialized development capabilities, especially contract manufac-turers with strengths in formulating poorly soluble compounds. Formulation development, analytical development and character-ization, clinical trial manufacturing and commercial manufactur-ing for 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 re-port dives into how the decision-making process differs among drug innovators outsourcing development activities from those outsourcing commercial manufacturing when it comes to CMO/CDMO selection criteria, use patterns, preferences and perceived leadership. Readers will gain insight into four different outsourc-ing scenarios for small molecule drugs enabling them to make more educated purchases of CMO services based on their unique needs. CMOs will gain a better understanding of customers’ re-quirements and how they change as a compound moves through the development to commercialization process.

D A T A C O L L E C T I O N I N Q 4 , 2 0 1 6

3 0 - M I N U T E , W E B - B A S E D

Q U A N T I T A T I V E S U R V E Y

REPORT OVERVIEW

1 9 4 R E S P O N D E N T S

MAJOR TOPICS:1. Outsourcing Philosophies

and Practices

2. CMO Perceptions and Interactions

3. CMO Selection Drivers

4. Study Data

Full Table of Contents on next page.

What you will learn:

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

DRUG DEVELOPERS

CONTRACT MANUFACTURERS

• Differences in CMO engagement and usage patterns based on outsourcing stage and internal capabilities and/or capacity

• Key differences in CMO selection drivers based on four different outsourcing scenarios: development-stage API manufacturing, commercial API manufacturing, development-stage drug product manufacturing and commercial drug product manufacturing

• Learn which CMO attributes are becoming more important to different types of outsourcing peers in order to gain advantages from their experiences

• Ways to improve your company’s sales and marketing strategies to specifically address the needs of different customer bases, as identified in CMO selection criteria, during specific decision-making scenarios

• 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

Introduction

SMARTER QUESTIONS SMARTER ANSWERS

3

COPYRIGHT AND USAGE GUIDE

INTRODUCTION

METHODOLOGY

Participant Criteria

Respondent Demographics

4 Major Sections

OUTSOURCING PHILOSOPHIES AND PRACTICES

Primary Section Takeaways

Outsourcing Drivers—Small Molecule API

Outsourcing Drivers—Small Molecule Drug Product

Use of Preferred Providers—Small Molecule API

Number of Preferred Providers—Small Molecule API

Use of Preferred Providers—Small Molecule Drug Product

Number of Preferred Providers—Small Molecule Drug Product

Outsourcing Models—Small Molecule API

Outsourcing Models—Small Molecule Drug Product

Outsourced Manufacturing Activities—Small Molecule API

Outsourced Manufacturing Activities—Small Molecule Drug Product

CMO PERCEPTIONS AND INTERACTIONS

Primary Section Takeaways

CMO Familiarity—Small Molecule API

CMO Familiarity—Small Molecule Drug Product

CMO Leaders—Small Molecule API

CMO Leaders—Small Molecule Drug Product

Received Proposals—Small Molecule API

Received Proposals—Small Molecule Drug Product

CMO Use—Small Molecule API

CMO Use—Small Molecule Drug Product

CMO Preference—Small Molecule API

CMO Preference—Small Molecule Drug Product

Summary Table—Small Molecule API

Summary Table—Small Molecule Drug Product

CMO SELECTION DRIVERS

Primary Section Takeaways

CMO Selection Attributes

CMO Selection Attributes Gaining Importance

STUDY DATA

Outsourcing Drivers—Small Molecule API

Outsourcing Drivers—Small Molecule Drug Product

Outsourced Manufacturing Activities—Small Molecule API

Outsourced Manufacturing Activities—Small Molecule Drug Product

Outsourcing Models—Small Molecule API

Outsourcing Models—Small Molecule Drug Product

Use of Preferred Providers—Small Molecule API

Number of Preferred Providers—Small Molecule API

Use of Preferred Providers—Small Molecule Drug Product

Number of Preferred Providers—Small Molecule Drug Product

Top 5 CMO Selection Attributes—Small Molecule API

#1 CMO Selection Attributes—Small Molecule API

Top 5 CMO Selection Attributes—Small Molecule Drug Product

#1 CMO Selection Attributes—Small Molecule Drug Product

CMO Selection Attributes Gaining Importance—Small Molecule API

CMO Selection Attributes Gaining Importance—Small Molecule Drug Product

CMO Familiarity Among Development Outsourcers—Small Molecule API

CMO Familiarity Among Commercial Outsourcers—Small Molecule API

CMO Familiarity Among Development Outsourcers—Small Molecule Drug Product

CMO Familiarity Among Commercial Outsourcers—Small Molecule Drug Product

CMO Leaders—Small Molecule API

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TABLE OF CONTENTS

Introduction

SMARTER QUESTIONS SMARTER ANSWERS

4

CMO Leaders—Small Molecule Drug Product

Received Proposals—Small Molecule API

Received Proposals—Small Molecule Drug Product

CMO Use Among Development Outsourcers—Small Molecule API

CMO Use Among Commercial Outsourcers— Small Molecule API

CMO Use Among Development Outsourcers—Small Molecule Drug Product

CMO Use Among Commercial Outsourcers— Small Molecule Drug Product

CMO Preference—Small Molecule API

CMO Preference—Small Molecule Drug Product

DEMOGRAPHICS

Company Type

Headquarters Location

Office Location

Job Title

Decision-making Responsibility

Contract Manufacturing Responsibilities

Involvement in Outsourced Manufacturing

Years of Industry Experience

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TABLE OF CONTENTS continued

SAMPLE PAGES

84PAGES

84CHARTS

AND GRAPHS

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Development vs Commercial Outsourced Manufacturing Practices: Small Molecule 23www.ISRreports.com ©2017

CMO PERCEPTIONS AND INTERACTIONS

CMO Familiarity—Small Molecule APIThe table below only includes CMOs that >10% of respondents (combined across development and commercial outsourcers) have used. For full data on CMO familiarity, see the Study Data section.

CMO familiarity varies somewhat by outsourcing stage. When it comes to a complete lack of aware-ness, or respondents who indicated they had “never heard of” the company, most CMOs showed parity across the audiences, indicating a broad marketing strategy to increase awareness would benefi t many companies (i.e. those with >30% unaware).

“Please indicate your level of familiarity with each of the following providers of small molecule API manufacturing services?”

Development (n=67) I have used this company's manufacturing

services

I am very familiar with this compa-ny's manufactur-ing services but have not used

them

I am somewhat familiar with

this company's manufacturing

services but have not used them

I am aware of this company

but know noth-ing about its

manufacturing services

I have never heard of this

company Commercial (n=42)

AbbVie Contract Manufacturing

AMRI

Alcami

Almac

Aptuit

Ash Stevens

Cambrex

Dr. Reddy's CPS

Evonik

GSK CMO

Halo Pharma

Lonza

Novasep

Patheon

Pfi zer CentreOne

PharmaCore

Piramal Pharma Solutions 30% 50%

Sanofi CEPiA

Siegfried 46% 26%

Wuxi AppTec

S A M P L E P A G E :

CMO FAMILIARITY—SMALL MOLECULE APIFamiliarity and use data combined with CMO preference statistics can support drug innovators’ CMO selection decision, by knowing which companies their peers have used for different types of projects and how pleased they are with the relationship. CMOs can benefit by understanding which audiences may have awareness gaps and develop marketing strategies to close those gaps.

C L O S E R L O O K :

<< As the table shows, Piramal Pharma Solutions has stronger awareness among development-stage respondents while Siegfried has stronger awareness among commercial respondents.

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

D A T A I N F U L L R E P O R T

Development (n=67) I have never heard of this

company Commercial (n=42)

Piramal Pharma Solutions 30% 50%

Siegfried 46% 26%

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6

34www.ISRreports.com ©2017

CMO PERCEPTIONS AND INTERACTIONS

Development vs Commercial Outsourced Manufacturing Practices: Small Molecule

Summary Table—Small Molecule Drug Product

There is a fair amount of crossover between development-stage and commercial-scale outsourcing re-spondents when it comes to perceived Leadership, Proposal Volume, Use and Preference for small mol-ecule drug product manufacturing.

Development (n=48) Commercial (n=37)

Rank Leadership Proposal Volume Use Preference

1 Company ASanofi CEPiA

2 Company B Company J

3 Company C Company C

4 Company D Company H

5 Company E Company D

6 Company F Company B

7 Company G Company A

8 Company H Company K

9 Company I Company G

10 Company JCompany

L/M/N

S A M P L E P A G E :

SUMMARY TABLE—SMALL MOLECULE DRUG PRODUCTBased on the outsourcing scenario, the same company may have a very different percep-tion among its buying audiences. Sanofi CEPiA takes the #1 rank for perceived leadership among among commercial-scale drug product respondents, but does not appear in the top 10 among respondents outsourcing development-stage drug product manufacturing.

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

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D A T A I N F U L L R E P O R T

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CMO SELECTION DRIVERS

Development vs Commercial Outsourced Manufacturing Practices: Small Molecule

CMO Selection Attributes Gaining ImportanceThe table below contains the top three selection attributes for each outsourcing scenario that respondents have indicated are becoming more important when it comes to CMO selection. Again, for comparison and completeness, ranks for attributes that are in the top three 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 selection attributes gaining in importance can be found in the Study Data section.

Top Three Selection Attributes Gaining Importance by Outsourcing Scenario

Develop-ment-stage

small molecule API

Commer-cial-scale small molecule API

Develop-ment-stage

small molecule drug product

Commer-cial-scale small molecule drug

product

Low cost

Reliable on-time delivery

Strong regulatory track record

Scientifi c knowledge

Up-front contingency planning,risk management

(14) (22) (17) 2.5

• Up-front contingency planning tied for second-third ranks among commercial-scale drug product respondents, but did not make the top 10 among any other respondent group.

• ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

• ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

• -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

• ----------------------------------------------------------------------------------------------------------------------------

S A M P L E P A G E :

SUMMARY TABLE—CMO SELECTION ATTRIBUTES GAINING IMPORTANCEAs 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.

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

D A T A I N F U L L R E P O R T

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ISR’S HEALTH PANELThe industry’s fastest growing panel of health care and pharmaceutical

professionals, with nearly 1,500 members worldwide.

BYJOB

LEVEL

Director 46%

Manager 29%

C-level 13%

VP 10%

BYEXPERIENCE

IN YEARS

16-20 years 23%

11-15 years 24%

6-10 years 11%

3-5 years 5%

20+ years 37%

BYCOMPANY

TYPE

Other 6%

Sponsor 78%

CRO 6%

ResearchSite 10%