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OUTSOURCING
SURVEY
W ELCOME TO OUR 6th Annual CONTRACT PHARMA
Outsourcing Survey! More than 350 sponsor-side respon-
dents offered up their opinions on outsourcing trends for this
Signs of Improvement?
Last year, a whopping 62% of total respondents believed that
they’d spend the same or less on outsourcing spending in
year’s poll. the coming year; this year, that dipped to 55%. Happily, the 10%+
On the following pages, we’ve provided a sample of the find- less spending than previous year” respondents dropped from
ings, focusing mainly on the major outsourcing projections of our to 13%; from 23% last year, while no change increased from to
respondents, broken out by their business categories. Here’s a 29% of all correspondents, from 25% last year.
breakdown of the respondents: Along those lines, 35% of respondents said that they had
cancelled outsourcing projects in the previous year due to
Company Type Job Function
the economy; the same percentage as in our 2009 survey. We
Top 20 Pharma . . . . . . .23.4%
Small/Mid-Tier Pharma .18.0%
R&D . . . . . . . . . . . . . . . .21.5%
Corp. Mgmt. . . . . . . . . .13.0%
added “to reduce company size” to our responses for “Why The Science Of Research
does your company outsource?”; 7% of respondents chose
Generic Pharma . . . . . .10.1% QA/QC/Validation . . . .12.3%
that answer, led by Top 20 Pharma, with 41% of those responses. At DiTEBA, we are committed to your success by providing
Virtual Pharma . . . . . . . .9.8% Project Manager . . . . . . .9.5%
Emerging Biopharma . . . .8.2% Contract Manager . . . . . .6.6% analytical and bioanalytical chemistry services that accelerate
—GYR
Specialty Pharma . . . . . . .7.0% Purchasing/Sourcing . . . .5.7%
Top 10 Biopharma . . . . . .6.3% Production/Mfg./Pkg. . . . .5.7% Photo courtesy of Fisher Clinical Services R&D intensive projects.
Consumer/ . . . . . . . . . . .3.5% Business Development . .5.7%
OTC Healthcare Marketing/Sales . . . . . . . .5.4% As a pharmaceutical contract research organization, we strive
Other . . . . . . . . . . . . . . .13.6% Clinical Research . . . . . . .4.1%
Supply Chain Manager . . .3.5%
to be an innovative and cost-effective partner that delivers
Regulatory Affairs . . . . . .2.5% consistent, quality services with unmatched integrity.
Engineering . . . . . . . . . . .1.3%
Other . . . . . . . . . . . . . . . .3.2% Through the science of research, let DiTEBA expedite
the process of bringing your product to market.
Research
Turning Research Into Reality
Reality
1620 Tech Avenue, Unit 3
Analytical Testing Formulation Development Mississauga, ON Canada
Bioanalytical Testing Support Testing L4W 5P4
In Vitro Release Rate Testing Toll Free: 1•800•671•9053
Stability Storage and Testing
Physical Testing Phone: 905•625•7995
Cleaning Verification and Fax: 905•625•3767
Validation Testing www.diteba.com
info@diteba.com
2010 OUTSOURCING SURVEY 2010 OUTSOURCING SURVEY
Past Imperfect
Respondents who report that their outsourcing spending Respondents who report that their outsourcing spending
GREW in the previous year: 43.9% SHRANK in the previous year: 33.9%
WHAT DO THEY DO? WHAT DO THEY DO?
R&D ................................................................................18.5% R&D ................................................................................25.0%
Corporate Management ..................................................15.3% QA/QC/validation ............................................................14.6%
QA/QC/Validation ............................................................10.5% Corporate Management ..................................................14.6%
Project Manager..............................................................10.5% Project Manager................................................................9.4%
WHAT TYPES OF OUTSOURCING DO THEY MANAGE?* WHAT TYPES OF OUTSOURCING DO THEY MANAGE?*
Analytical & Testing Services..........................................50.0% Analytical & Testing Services ..........................................47.9%
Manufacturing: Fill/Finish .................................................37.1% Manufacturing: API..........................................................30.2%
Methods Development / Validation ..................................37.1% QA/QC ............................................................................30.2%
Process Development / Scale-Up....................................37.1% Formulation Development...............................................29.2%
Stability Studies ..............................................................36.3% CMC................................................................................25.0%
Manufacturing: Solid Dosage..........................................34.7% Methods Development / Validation .................................25.0%
Formulation Development...............................................33.1% Stability Studies ..............................................................25.0%
2 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 3
2010 OUTSOURCING SURVEY 2010 OUTSOURCING SURVEY
Future Shock
Respondents who project that their outsourcing spending Respondents who project that their outsourcing spending
will GROW in the next year: 44.9% will SHRINK in the next year: 26.1%
WHAT DO THEY DO? WHAT DO THEY DO?
R&D ................................................................................20.3% R&D ................................................................................20.3%
Corporate Management...................................................11.7% QA/QC/validation ............................................................14.9%
QA/QC Validation.............................................................11.7% Corporate Management ..................................................13.5%
Project Manager..............................................................10.2% Project Manager..............................................................10.8%
WHAT TYPES OF OUTSOURCING DO THEY MANAGE?* WHAT TYPES OF OUTSOURCING DO THEY MANAGE?*
Analytical & Testing Services..........................................49.2% Analytical & Testing Services ..........................................41.9%
Manufacturing: Fill/Finish ................................................32.0% Formulation Development...............................................28.4%
Methods Development / Validation .................................32.0% Manufacturing: API ..........................................................27.0%
Stability Studies...............................................................31.3% Process Development / Scale-Up....................................27.0%
Manufacturing: Clinical Trials Materials...........................28.9% Clinical Trials (Phase I-IV)...............................................25.7%
CMC................................................................................28.1% Manufacturing: Fill/Finish ................................................25.7%
Process Development / Scale-Up ...................................28.1% Manufacturing: Solid Dosage..........................................25.7%
4 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 5
2010 OUTSOURCING SURVEY 2010 OUTSOURCING SURVEY
Commercial Interruption
Of the respondents who say that their companies outsource at least 50% of their commercial manufacturing . . .
59.4% report that more than half of their outsourcing dollars go to preferred providers
78.1% report that their company have never received a warning letter due to an inspection at a CMO
51.6% either probably or definitely will not outsource a project to Asia in the next year
81.3% are would use the word “partnership” to describe their relations with a provider
31.7% report that they have canceled or delayed outsourcing projects in the past year, due to the economy
are most likely to work at a Virtual Pharma (32.8% of respondents), and also predominantly
outsource more than half of clinical materials (85.2% of respondents) and APIs (88.9% of respondents)
6 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 7
2010 OUTSOURCING SURVEY 2010 OUTSOURCING SURVEY
The other 50% said they would describe their outsourcing model as
Tactical (case-by-case, based on availability).
Virtual Pharma companies were most likely to call their relationship Strategic (70%),
while Small/Mid-Tier Pharma was most likely to call their relationship Tactical (63%).
The largest group to say it will do 10+% more outsourcing next year
describe their companies as Top 20 Pharma, at 28%.
That was also the demographic that said it will do 10+% less outsourcing in the next year,
with 19% of the responses to that question.
8 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 9
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CONTRACTING &
OUTSOURCING 2010
CONFERENCE & TABLETOP EXHIBITION
SEPTEMBER 23-24, 2010 • HYATT REGENCY NEW BRUNSWICK
10 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 11
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2010 OUTSOURCING SURVEY
ONLINE
WWW.CONTRACTPHARMA.COM
IN PRINT
WEEKLY E-NEWSLETTER
CPDIRECT
Outsourcing Decisions
How much did your outsourcing spending WHAT TYPES OF OUTSOURCING DECISIONS ARE YOU INVOLVED IN?*
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I Would Prefer To
46.5% of respondents said that more than half of their outsourcing dollars go to preferred providers.
26 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 27
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• Specific class of APIs • Late stage product • Delayed start of API and CTM manufac-
• Tech transfer to CMO • Delayed non-priority projects turing until toxicology or clinical results
• Analytical services • Clinical manufacturing and packaging became available. Canceled API/CTM
• Synthesis • Nutritional manufacturing if toxicology or trial
• Alternate clinical dosage forms • API Manufacturing results were not as expected.
• Analytical testing • Timelines shifted • Any project that went down in the list on
• Re-packaging and pre-clinical services • Validation support time to market or future values
• BE Studies • Clinical development programs • Tech transfers from one CMO to another
• Phase I API manufacturing • CMC to consolidate our outsourced base
• Early phase • Development • Discovery programs
• CMC devleopment • Clinical trials • Basic chemistry was normally out-
• Contract synthesis delayed • Small chemistry and pathology services sourced, but a low level of projects led to
• Phase III trial and CMO production • Preclinical and CMC doing the work in house
• Phase II clinical trials • Analytics, clinical trials • Preclinical
• Capital intensive • Tox studies • Bulk biologics manufacturing optimiza-
• Clinical and IND-enabling studies • Scale-up tion
• New product types or innovations • Lower priority candidates • Difficult synthetic projects
• Intermediate and API synthesis • Manufacture of CTM • Specialty formulation development
• Clinical trials • Clinical Trials • Phase I & II
28 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 29
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Cancellation Policy
35% of respondents said that they 65% of respondents said that they
HAVE cancelled an outsourcing project HAVE NOT cancelled an outsourcing project
in the past year due to the economy in the past year due to the economy
WHAT DO THEY DO? WHAT DO THEY DO?
R&D .................................................................................27.8% R&D ................................................................................19.0%
Corporate Management..................................................20.3% QA/QC/validation ............................................................16.3%
Purchasing/Sourcing ........................................................11.4% Project Manager..............................................................12.9%
QA/QC Validation ..............................................................7.6% Corporate Management ..................................................12.2%
WHAT TYPES OF OUTSOURCING DO THEY MANAGE?* WHAT TYPES OF OUTSOURCING DO THEY MANAGE?*
Analytical & Testing Services..........................................54.4% Analytical & Testing Services ..........................................51.0%
CMC................................................................................39.2% Manufacturing: Fill/Finish ................................................32.0%
Process Development / Scale-Up ...................................38.0% Methods Development / Validation .................................32.0%
R&D Services .................................................................36.7% Manufacturing: API..........................................................30.6%
Methods Development / Validation .................................35.4% Stability Studies ..............................................................30.6%
Stability Studies ..............................................................35.4% Formulation Development...............................................29.9%
Packaging: Clinical..........................................................34.2% Process Development / Scale-Up....................................27.9%
34 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 35
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More on Cancellations
About those 35% who said they have cancelled outsourcing projects in the past year:
HOW MUCH DID THEIR OUTSOURCING SPENDING HOW MUCH DO THEY EXPECT THEIR OUTSOURCING
CHANGE FROM THE PREVIOUS YEAR? SPENDING TO CHANGE IN THE NEXT YEAR?
10%+ less than previous year .........................................31.6% 10%+ less than last year.................................................15.2%
6-10% less than previous year .........................................8.9% 6-10% less than last year .................................................6.3%
1-5% less than previous year............................................6.3% 1-5% less than last year....................................................3.8%
Did not change................................................................13.9% Will not change ...............................................................20.3%
1-5% more than previous year ..........................................8.9% 1-5% more than last year................................................20.3%
6-10% more than previous year........................................8.9% 6-10% more than last year..............................................10.1%
10%+ more than previous year .......................................21.5% 10%+ more than last year...............................................24.1%
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0 1 2 3 4 5 0 1 2 3 4 5
0 1 2 3 4 5 0 1 2 3 4 5
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0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5
0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5
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