biologic api contract manufacturer quality benchmarking (2016)

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

http://isrreports.com

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


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


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


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)


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



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


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


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


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)


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)


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


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 [email protected], 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/biologic-api-contract-manufacturer-quality-benchmarking-2016/


www.ISRreports.com

mailto:[email protected]

https://twitter.com/ISRreports

http://www.isrreports.com/register/