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 drug product manufacturing projects. In this Consumer Reports-style analysis, ISR presents data on 423 service encounters from 217 respondents who have been involved in outsourced fill finish projects in the past 18 months.
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 drug product
manufacturing projects. In this Consumer Reports-style
analysis, ISR presents data on 423 service encounters from
217 respondents who have been involved in outsourced fill
finish 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
2 1 7 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
156
PAGES
70
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 fill
finish / drug product manufacturing
• 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
fill finish and related services by accessing performance evaluation
information across 26 key attributes
• Gain insight into sponsor best practices for outsourced drug product
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
3M Drug
Delivery Systems
AAI/Cambridge
Major
AbbVie Contract
Manufacturing
Aenova
Aeras CMO
Aesica
Albany
Molecular
Research Inc.
(AMRI)
Albemarle
Almac
Althea
Aptuit
Avid Bioservices
Baxter
BioPharma
Solutions
BioReliance
(SAFC)
Boehringer
Ingelheim
Cambrex
Capsugel
Catalent
Celltrion
Chartwell
Pharmaceuticals
Cobra Biologics
Cook Pharmica
Corden Pharma
CoreRx
CPL
Cytovance
Biologics
Dalton Pharma
Services
DPT
Dr. Reddy’s CPS
Ei
Emergent
Biosolutions
Evonik
Fareva
Glatt
Pharmaceutical
Services
GSK Contract
Manufacturing
Halo Pharma
Helsinn
Hetero
Hospira One 2
One
Hovione
IDT Biologika
Jubilant
HollisterStier
Kemwell
Metrics
NextPharma
Norwich
Novasep
Paragon
Patheon
Pfizer
CentreSource
Pharmatek
Pii
Piramal Pharma
Solutions
Recipharm
Rentschler
Richter-Helm
Rottendorf
Pharma
SAFC
Samsung
BioLogics
Sanofi CEPiA
Siegfried
Symbiosis
Therapure
BioPharma
Unither
Pharmaceuticals
UPM
Pharmaceuticals
Vetter
WellSpring
Wockhardt
Wuxi AppTec
Xcelience
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
Full range of manufacturing for the dosage
forms we require
Has capacity to meet our demands
Low cost
Metrics for meeting overall project timelines
Offers innovative solutions
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 70
CMOs; 8 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/fill-finish-contract-manufacturer-quality-benchmarking-2016/
8. Introduction
SMARTER QUESTIONS SMARTER ANSWERS
ORDERING INFORMATION
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.
ABOUT INDUSTRY STANDARD RESEARCH
>> R E G I S T E R N O W
>>Receive $250 instant credit towards any ISR report
>>Earn 10% credit towards all future purchases
>>Receive advanced notifications on ISR’s latest reports and
free resources
SAVE ON THIS,
OR ANY ISR REPORT, BY
CREATING A
FREE ACCOUNT
For pricing and ordering information, visit ISR’s website:
www.isrreports.com/reports/fill-finish-contract-manufacturer-quality-benchmarking-2016/