fill finish contract manufacturer quality benchmarking (2016)

FILL FINISHCONTRACT 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 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

156PAGES

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 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

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


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 requestsFull range of manufacturing for the dosage forms we requireHas capacity to meet our demandsLow cost

Metrics for meeting overall project timelinesOffers innovative solutionsProvides 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 70

CMOs; 8 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/fill-finish-contract-manufacturer-quality-benchmarking-2016/


Introduction


OUTSOURCING PHILOSOPHIES AND PRACTICES

Fill Finish Contract Manufacturer Quality Benchmarking (2016) 14www.ISRreports.com ©2016

Outsourcing ModelsCurrently, one-third of fill finish manufacturing projects are tactically outsourced, meaning the CMO is engaged on a one-off or project-by-project basis and one-third are outsourced to preferred providers on average� A slightly smaller percentage, 30%, of fill finish projects are strategically outsourced� Respondents anticipate a greater proportion of fill finish projects will be outsourced to preferred providers three years from now (+6% pts), thus reducing the proportion of projects tactically outsourced (-6% pts)�

Respondents do not predict an increase 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 fill finish / drug product manufacturing projects that are contracted through each outsourcing model.” (Base=217)

“Three years from now, what percentage of outsourced fill finish / drug product manufacturing projects will be contracted through each outsourcing model.” (Base=217)

FILLFINISHCONTRACTMANUFACTURERQUALITYBENCHMARKING(2016) 20

31%

41%

28%

30%

35%

34%

0% 10% 20% 30% 40% 50%

Strategic Outsourcing

Preferred Providers

Tactical Outsourcing

% of Manufacturing Projects

Current

3 Years from Now

Outsourcing Models Currently, one-third of fill finish manufacturing projects are tactically outsourced, meaning the CMO is engaged on a one-off or project-by-project basis and one-third are outsourced to preferred providers on average. A slightly smaller percentage, 30%, of fill finish projects are strategically outsourced. Respondents anticipate a greater proportion of fill finish projects will be outsourced to preferred providers three years from now (+6% pts), thus reducing the proportion of projects tactically outsourced (-6% pts). Respondents do not predict an increase 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 fill finish / drug product manufacturing projects that are contracted through each outsourcing model.” (Base=217) “Three years from now, what percentage of outsourced fill finish / drug product manufacturing projects will be contracted through each outsourcing model.” (Base=217)

© Industry Standard Research

S A M P L E P A G E :

OUTSOURCING MODELS

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.

C L O S E R L O O K

<< The data show a 6% 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

OUTSOURCING PHILOSOPHIES AND PRACTICES

Fill Finish Contract Manufacturer Quality Benchmarking (2016) 14www.ISRreports.com ©2016

Outsourcing ModelsCurrently, one-third of fill finish manufacturing projects are tactically outsourced, meaning the CMO is engaged on a one-off or project-by-project basis and one-third are outsourced to preferred providers on average� A slightly smaller percentage, 30%, of fill finish projects are strategically outsourced� Respondents anticipate a greater proportion of fill finish projects will be outsourced to preferred providers three years from now (+6% pts), thus reducing the proportion of projects tactically outsourced (-6% pts)�

Respondents do not predict an increase 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 fill finish / drug product manufacturing projects that are contracted through each outsourcing model.” (Base=217)

“Three years from now, what percentage of outsourced fill finish / drug product manufacturing projects will be contracted through each outsourcing model.” (Base=217)

FILLFINISHCONTRACTMANUFACTURERQUALITYBENCHMARKING(2016) 20

31%

41%

28%

30%

35%

34%

0% 10% 20% 30% 40% 50%

Strategic Outsourcing

Preferred Providers

Tactical Outsourcing

% of Manufacturing Projects

Current

3 Years from Now

Outsourcing Models Currently, one-third of fill finish manufacturing projects are tactically outsourced, meaning the CMO is engaged on a one-off or project-by-project basis and one-third are outsourced to preferred providers on average. A slightly smaller percentage, 30%, of fill finish projects are strategically outsourced. Respondents anticipate a greater proportion of fill finish projects will be outsourced to preferred providers three years from now (+6% pts), thus reducing the proportion of projects tactically outsourced (-6% pts). Respondents do not predict an increase 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 fill finish / drug product manufacturing projects that are contracted through each outsourcing model.” (Base=217) “Three years from now, what percentage of outsourced fill finish / drug product manufacturing projects will be contracted through each outsourcing model.” (Base=217)


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


(Categories after sample are in alphabetical order)


Introduction


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

C O M P A N Y A

C O M P A N Y B

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

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.

Fill Finish 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:Experience level of staff Meeting quality performance metrics Ability to smoothly scale up manufacturing and transfer technology

Fill Finish Contract Manufacturer Quality Benchmarking (2016)www.ISRreports.com ©2016

SAMPLE COMPANY BRAND SNAPSHOT

Full range of manufacturing for dosage forms we

require


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.

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