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
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 CMOsMake 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
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 technologyAccess to desired marketsAccessible senior managementAll facilities fully owned (i.e., not subcontracted)Complementary core competencies to in-house or other manufacturing contractorsCultural fitExperience level of staffFacility has most up-to-date manufacturing technologiesFinancial strength/ stabilityFlexibility to adjust schedule for special requestsHas capacity to meet our demandsLow costMetrics for meeting overall project timelines
Offers innovative solutionsProven ability to manufacture large molecule APIProvides regulatory support for filingReliable on-time deliveryRight first time measurementsScientific knowledgeStability testing capabilitiesStorage capabilitiesStrong regulatory track recordTimely project communicationsTrack record for meeting quality performance metricsUp-front contingency planning, risk managementWell-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
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/
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
OUTSOURCING PHILOSOPHIES AND PRACTICES
Biologic API Contract Manufacturer Quality Benchmarking (2016) 14www.ISRreports.com ©2016
Outsourcing ModelsCurrently, 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)
BIOLOGICAPICONTRACTMANUFACTURERQUALITYBENCHMARKING(2016) 17
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
Biologic API Contract Manufacturer Quality Benchmarking (2016) 14www.ISRreports.com ©2016
Outsourcing ModelsCurrently, 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)
BIOLOGICAPICONTRACTMANUFACTURERQUALITYBENCHMARKING(2016) 17
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)
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
S A M P L E P A G E :
DELIVERY FACTORS
Introduction
CMO PERFORMANCE AND SCORECARDS
34 Small 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)
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
TOP 3 ATTRIBUTES:Global footprint
Quality of media team
Quality of strategy team
BOTTOM 3 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
SomewhatExceeds
Expectations
SomewhatMisses
Expectations
© Industry Standard Research
PUBLICIS LIFE BRANDS MEDICUS
(N=11)
SAMPLE COMPANY CUSTOMER LOYALTY
SAMPLE COMPANY AVERAGE CUSTOMER EXPERIENCE
SAMPLE COMPANYHIGHLIGHTS
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
TOP 3 ATTRIBUTES:Timely project communications
Proven abilitiy to manufacture small molecule API
Cultural fit
BOTTOM 3 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
TOP 3 ATTRIBUTES:Reliable on-time delivery Scientific knowledge Has capacity to meet our demands
BOTTOM 3 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
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
ORDERING INFORMATION
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