Small Molecule API Contract Manufacturer Quality Benchmarking (2016)

SMALL MOLECULE 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 small molecule projects. In this Consumer Reports-style analysis, ISR presents data on 541 service encounters from 199 respondents who have been involved in outsourced small molecule 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 9 9 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

147 PAGES

37 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 three years

• Learn which supplier attributes are driving CMO selection and which attributes are gaining in importance when it comes to outsourced small molecule primary manufacturing services

• 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 small molecule API related services by accessing performance evaluation information across 26 key attributes

• Gain insight into sponsor best practices for outsourced small molecule manufacturing projects

• Benchmark your company’s RFP and supplier selection process

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

AAI/Cambridge Major

AbbVie Contract Manufacturing

Aesica

Albany Molecular Research Inc. (AMRI)

Almac

AMPAC Fine Chemicals

Aptuit

Ash Stevens

Cambrex

Corden Pharma

Dalton Pharma Services

Dr. Reddy’s CPS

Ei

Evonik

Fareva

Flamma

GSK Contract Manufacturing

Halo Pharma

Helsinn

Hetero

Kemwell

Lonza

Neuland

Novasep

Patheon

PCI Synthesis

Pfizer CentreSource

PharmaCore

PharmaZell

Piramal Pharma Solutions

SAFC

SAI Life Sciences

Sanofi CEPiA

Siegfried

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-houseCultural 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 small 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 37 CMOs;

24 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/small-molecule-api-contract-manufacturer-quality-benchmarking-2016/


Introduction


Introduction

OUTSOURCING PHILOSOPHIES AND PRACTICES

14 Small Molecule API Contract Manufacturer Quality Benchmarking (2016) www.ISRreports.com ©2016

Outsourcing Models

SMALL MOLECULE API CONTRACT MANUFACTURER QUALITY BENCHMARKING 2016

17

32%

41%

28%

30%

36%

33%

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

Strategic Outsourcing

Preferred Providers

Tactical Outsourcing

% of Manufacturing Projects

Current

3 Years from Now

Outsourcing Models Respondents anticipated little change in how they outsource small molecule API projects over the next three years. There was a modest decrease anticipated in the percentage of projects that would be outsourced tactically, meaning use of a CMO on a one-off basis. This was mirrored by a modest increase in the anticipated percentage of projects that would be outsourced to preferred providers. Despite the industry buzz around strategic partnerships, respondents did not predict 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 small molecule API manufacturing projects that are contracted through each outsourcing model.” (Base=199) “Three years from now, what percentage of outsourced small molecule API manufacturing projects will be contracted through each outsourcing model.” (Base=199)

Respondents anticipated little change in how they outsource small molecule API projects over the next three years. There was a modest decrease anticipated in the percentage of projects that would be outsourced tactically, meaning use of a CMO on a one-off basis. This was mirrored by a modest increase in the anticipated percentage of projects that would be outsourced to preferred providers.

Despite the industry buzz around strategic partnerships, respondents did not predict 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 small molecule API manufacturing projects that are contracted through each outsourcing model.” (Base=199)

“Three years from now, what percentage of outsourced small molecule API manufacturing projects will be contracted through each outsourcing model.” (Base=199)

© 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

Introduction

OUTSOURCING PHILOSOPHIES AND PRACTICES


Outsourcing Models

SMALL MOLECULE API CONTRACT MANUFACTURER QUALITY BENCHMARKING 2016

17

32%

41%

28%

30%

36%

33%

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

Strategic Outsourcing

Preferred Providers

Tactical Outsourcing

% of Manufacturing Projects

Current

3 Years from Now

Outsourcing Models Respondents anticipated little change in how they outsource small molecule API projects over the next three years. There was a modest decrease anticipated in the percentage of projects that would be outsourced tactically, meaning use of a CMO on a one-off basis. This was mirrored by a modest increase in the anticipated percentage of projects that would be outsourced to preferred providers. Despite the industry buzz around strategic partnerships, respondents did not predict 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 small molecule API manufacturing projects that are contracted through each outsourcing model.” (Base=199) “Three years from now, what percentage of outsourced small molecule API manufacturing projects will be contracted through each outsourcing model.” (Base=199)

Respondents anticipated little change in how they outsource small molecule API projects over the next three years. There was a modest decrease anticipated in the percentage of projects that would be outsourced tactically, meaning use of a CMO on a one-off basis. This was mirrored by a modest increase in the anticipated percentage of projects that would be outsourced to preferred providers.

Despite the industry buzz around strategic partnerships, respondents did not predict 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 small molecule API manufacturing projects that are contracted through each outsourcing model.” (Base=199)

“Three years from now, what percentage of outsourced small molecule API manufacturing projects will be contracted through each outsourcing model.” (Base=199)


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

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 show 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


Introduction

CMO PERFORMANCE AND SCORECARDS


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 FACTORSThis 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.

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 M

C O M P A N Y D

C O M P A N Y N

C O M P A N Y E

C O M P A N Y O

C O M P A N Y F

C O M P A N Y P

C O M P A N Y G

C O M P A N Y Q

C O M P A N Y H

C O M P A N Y R

C O M P A N Y U

C O M P A N Y I

C O M P A N Y S

C O M P A N Y V

C O M P A N Y J

C O M P A N Y T

C O M P A N Y W


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

Small Molecule API Contract Manufacturer Quality Benchmarking (2016)www.ISRreports.com ©2016

SAMPLE COMPANY BRAND SNAPSHOT


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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Small Molecule API Contract Manufacturer Quality Benchmarking (2016)

Healthcare

Transcript of Small Molecule API Contract Manufacturer Quality Benchmarking (2016)