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Drug Discovery Technologies, BCC Research
Date:9/6/2012

OALS AND OBJECTIVES 1

REASONS FOR DOING THIS STUDY 1

SCOPE AND FORMAT 2

METHODOLOGY AND INFORMATION SOURCES 2

INTENDED AUDIENCE 2

ANALYST CREDENTIALS 3

RELATED REPORTS 3

BCC ON-LINE SERVICES 3

DISCLAIMER 4

CHAPTER TWO: SUMMARY 5

SUMMARY 5

SUMMARY TABLE GLOBAL MARKET FOR DRUG DISCOVERY

TECHNOLOGIES AND PRODUCTS, THROUGH 2017 ($ BILLIONS) 6

SUMMARY FIGURE GLOBAL MARKET FOR DRUG DISCOVERY

TECHNOLOGIES AND PRODUCTS, 2011–2017 ($ BILLIONS) 7

CHAPTER THREE: OVERVIEW 8

INTRODUCTION 8

INTRODUCTION (CONTINUED) 9

PRECLINICAL TESTING AND SUBMISSION OF AN

INVESTIGATIONAL NEW DRUG 10

CLINICAL TRIALS 11

SUBMISSION OF NEW DRUG APPLICATION OR

BIOLOGICAL LICENSING APPLICATION 12

POST–FOOD AND DRUG ADMINISTRATION APPROVAL 13

IMPACT OF GOVERNMENT REGULATIONS AND REGULATORY

APPROVALS ON THE DRUG DISCOVERY INDUSTRY 14

NEW DRUG APPROVALS 14

TABLE 1 NEW MOLECULAR ENTITY (NME) APPLICATIONS

VERSUS APPROVAL BY THE FDA, 2006–2010 14

FIGURE 1 NEW MOLECULAR ENTITY (NME) APPLICATIONS

VERSUS APPROVAL BY THE FDA, 2006–2010 14

New Drug Approvals (Continued) 15

TIMELINE AND COSTS 16

FIGURE 2 TIMELINE FOR DRUG DEVELOPMENT PROCESS 16

TABLE 2 FACTS ABOUT DRUG DISCOVERY AND DEVELOPMENT

FOR 2010 17

TABLE 3 R&D SPENDING FOR DRUG DISCOVERY IN

BIOPHARMACEUTICAL COMPANIES, 2008–2012 ($ MILLIONS) 17

IMPORTANCE OF TECHNOLOGY IN DRUG DISCOVERY 18

MARKET LANDSCAPE IN THE DRUG DISCOVERY SECTOR 19

TABLE 4 FDA-APPROVED DRUGS FOR SALE IN THE U S 2001-2011 20

TABLE 5 GLOBAL PHARMACEUTICAL MARKET VALUE, THROUGH

2017 ($ BILLIONS) 21

MARKET PARTICIPANTS IN THE DRUG DISCOVERY

SECTOR 21

TABLE 6 TOP GLOBAL PHARMACEUTICAL CORPORATION

RANKING, 2009 22

TABLE 7 NUMBER OF
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