Biologics Outsourcing Global Market - Forecast to 2025

 Published On: Aug, 2017 |    No of Pages: 527 |  Published By: IQ4I Research and Consultancy | Format: PDF
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The biologics outsourcing global market is expected to grow at double digit CAGR to reach $70.3 billion by 2025. Biologics are therapeutic entities composed of sugars, proteins, or nucleic acids made from natural sources such as human, animal or micro organisms. Biologics can also include live attenuated microorganisms (vaccines), allergenic extracts (allergy shots), human cells and tissues (transplantation), cell therapies and gene therapies. Like small molecule drugs, these drugs are intended for treatment of diseases and medical conditions. However, Biologics bring into picture higher range of specificity in treating a disease condition as the biologic entities like monoclonal antibodies and recombinant proteins target specific areas in the molecular mechanism of disease action.

Although biologics are much costlier than small molecule drugs, these classes of drugs prove to be highly beneficial for the patient and also bring about 40% higher profit to the manufacturers when compared to small molecule drug treatments. Due to the increasing demand for biologics drugs and increased regulatory approvals for these drugs, there is huge demand for biologics manufacture and testing at various levels of clinical studies as well as commercial supply. The Large Biopharma companies are coming up with strategies to cut down on their operational costs and concentrate more on their core competencies by outsourcing this piece of work to contract research organizations (CROs), contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs). These organizations bridge the gap between demand and supply and ensure the drug discovery process gets much faster and convenient thus bringing life saving drugs to the market to reach the needy patients.

In 2016, eight out of 10 blockbuster drugs were biologics showing a steep growth in acceptance of biologics in comparison with small molecule drugs. Some of the top selling biologics in 2016 include Humira ($16 billion), Rituxan ($7.5 billion), Herceptin ($6.7 billion), Prevnar 13 ($6.0 billion). The growth of biologics market indirectly indicates the huge demand for services spanning all stages of biologics development starting preclinical stage to commercial manufacturing. The high complexity of biologics development and manufacture requiring huge technical expertise is prompting major biopharma companies turn to outsourcing as a viable option. Various stages of biological development require different types of services as listed below.

Discovery services- Includes lead identification and validation for identifying possible drug candidates targeting specific diseases. The process further involves steps such as target validation, screening preparation, hit generation and lead selection, lead optimization and characterization and finally lead selection.

Preclinical development services- Involves in vitro and in vivo studies of the biologic drug candidates before testing them on humans to test the safety, efficacy and biological functionality against the disease target. Preclinical services include cell line engineering, process development, product analytical characterization, cGMP cell banking, cell line characterization, animal model assay development and testing services.

Clinical development- Clinical development includes testing potential drug candidates on humans in phase I, II and II trials. Services at this stage include cGMP grade clinical supply of biologics such as Mab, or recombinant protein, stability testing, fill/finish and regulatory support.

Commercialization- Once the drug has passed all the necessary approvals, the manufacture, marketing and sale of commercial quantities is performed. Outsourcing partners here manufacture the commercial supply for product launch and sale.
1 BIOLOGICS OUTSOURCING GLOBAL MARKET 19
1.1 INTRODUCTION 19
1.2 LANDSCAPE OF BIOLOGICS MARKET 20
1.3 BIOLOGICS GLOBAL MARKET 25
1.3.1 NORTH AMERICA 25
1.3.2 ASIA PACIFIC 26
1.4 CHINA BIOLOGICS OUTSOURCING MARKET 27
1.5 CHINA VS INDIA - BIOLOGICS MARKET 28
1.5.1 REGULATIONS AND GOVERNMENT INITIATIVES 31
1.5.2 CAPABILITIES AND TECHNOLOGIES 35
2 MARKET ANALYSIS 37
2.1 INTRODUCTION 37
2.2 FACTORS INFLUENCING MARKET 39
2.2.1 DRIVERS AND OPPORTUNITIES 40
2.2.1.1 Increased investment in R&D by pharmaceutical companies is increasing the outsourcing 40
2.2.1.2 Adoption of biological therapies in disease management 41
2.2.1.3 Successful collaboration and low cost for outsourcing 42
2.2.1.4 Increasing biologics approvals in the past year 43
2.2.1.5 Increasing chronic and autoimmune illnesses 43
2.2.1.6 Increasing number of branded drugs going off-patent creates a scope for biosimilars 44
2.2.1.7 Requirement of novel biologics therapeutics for certain diseases 44
2.2.1.8 Increasing demand for antibody conjugates and bispecific antibodies 45
2.2.1.9 Advanced technologies for screening, cell line engineering and bioprocessing 46
2.2.1.10 Pharma companies restricting their global presence, reducing manpower, lack of facilities for discovery and manufacturing of biologics 47
2.2.2 RESTRAINTS AND THREATS 48
2.2.2.1 Intense complexities in handling biologics 48
2.2.2.2 Requirement of highly skilled technicians 49
2.2.2.3 High cost of drug development process 50
2.2.2.4 Challenges in Oral formulations with Biologics 51
2.2.2.5 Stringent Regulatory Frameworks 52
2.2.2.6 High capital and technical requirements to obtain GMP certifications 54
2.2.2.7 Limited IP protection in developing regions 55
2.2.2.8 High chances of end stage failure of drug 55
2.2.2.9 Conflict of interest between pharmaceutical company and CRO 56
3 BIOLOGICS OUTSOURCING GLOBAL MARKET, MARKET ANALYSIS 58
3.1 INTRODUCTION 58
3.2 DISCOVERY AND PRE-CLINICAL DEVELOPMENT PROCESS 67
3.3 BIOLOGICS OUTSOURCING GLOBAL MARKET, BY PRODUCT TYPE 77
3.3.1 ANTIBODY 78
3.3.1.1 Monoclonal antibody 80
3.3.1.2 Bispecific antibody 85
3.3.1.3 Antibody drug conjugates 86
3.3.1.4 Others 88
3.3.2 RECOMBINANT PROTEIN 90
3.3.3 VACCINES 97
3.3.4 OTHERS 99
3.3.4.1 Gene therapy 101
3.3.4.2 Cell therapy 103
3.3.4.3 Others 105
3.4 MARKET SHARE ANALYSIS 108
3.5 COMPANY DEVELOPMENTS 112
3.5.1 AGREEMENTS, PARTNERSHIPS & COLLABORATIONS 112
3.5.2 ACQUISITIONS 124
3.5.3 NEW SERVICE LAUNCH 128
3.5.4 OTHER DEVELOPMENTS 131
3.6 SERVICE COST ANALYSIS 133
3.6.1 ANTIBODY PRODUCTION SERVICE COSTS 133
3.6.2 CUSTOM MONOCLONAL ANTIBODY PRODUCTION SERVICE COSTS 137
3.6.3 CUSTOM POLYCLONAL ANTIBODY PRODUCTION SERVICE COSTS 139
3.6.4 PROTEIN PRODUCTION SERVICE COSTS 140
3.6.5 ADDITIONAL ANTIBODY AND PROTEIN SERVICES 143
3.6.6 GENE EDITTING SERVICES 145
3.6.7 CAR-T/NK PLATFORM SERVICES 145
4  BIOLOGICS OUTSOURCING GLOBAL MARKET Ė ANIMAL MODEL
SERVICES 148
4.1 INTRODUCTION 148
4.1.1 COMPARISON MATRIX OF ANIMAL MODELS AND APPLICATIONS 151
4.1.2 SMALL ANIMAL MODELS 155
4.1.3 LARGE ANIMAL MODELS 157
4.2 ETHICS AND REGULATIONS 161
4.3 ALTERNATIVES TO ANIMAL MODELS 163
4.4 OVERVIEW OF APPLICATIONS OF ANIMAL MODELS 165
4.5 MARKET SHARE ANALYSIS 175
4.6 COMPETITIVE LANDSCAPE 176
4.7 COMPANY DEVELOPMENTS 187
5 BIOLOGICS OUTSOURING GLOBAL MARKET - BIOMANUFACTURING 196
5.1 INTRODUCTION 196
5.2 CONTRACT BIOMANUFACTURING, BY PROCESS 203
5.2.1 BIOMANUFACTURING BY MAMMALIAN CELL CULTURE 204
5.2.2 BIOMANUFACTURING BY MICROBIAL CELL CULTURE 206
5.2.3 BIOMANUFACTURING BY OTHER CELL CULTURE 208
5.3 CONTRACT BIOMANUFACTURING GLOBAL MARKET, BY END USERS 209
5.3.1 CONTRACT BIOMANUFACTURING OF DIAGNOSTICS 211
5.3.2 CONTRACT BIOMANUFACTURING OF RESEARCH REAGENTS 211
5.3.3 CONTRACT BIOMANUFACTURING OF THERAPEUTICS 212
5.4 CONTRACT BIOMANUFACTURING GLOBAL MARKET, BY REGION 218
5.5 COMPETITIVE LANDSCAPE 220
5.5.1 CAPACITY COMPARISON 220
5.5.2 CONTRACT MANUFACTURING GLOBAL MARKET SHARE, BY LEADING PLAYERS 224
5.6 COMPANY DEVELOPMENTS 226
5.6.1 MERGER AND ACQUISITION BY CMOS 227
5.6.2 COLLABORATIONS 230
5.6.3 CAPACITY EXPANSIONS 233
6 BIOLOGICS OUTSOURCING GLOBAL MARKET - CELL LINE DEVELOPMENT 237
6.1 INTRODUCTION 237
6.1.1 MARKET DYNAMICS 239
6.2 CELL LINE DEVELOPMENT 241
6.3 HOST CELL LINES 246
6.4 CELL LINE DEVELOPMENT SERVICES MARKET, BY EXPRESSION SYSTEM 250
6.4.1 MICROBIAL EXPRESSION SYSTEMS 252
6.4.2 MAMMALIAN EXPRESSION SYSTEM 254
6.4.3 OTHERS 255
6.5 CELL LINE DEVELOPMENT SERVICES, BY CELL TYPE 255
6.5.1 CHO 256
6.5.2 MURINE/MOUSE MYELOMA 259
6.5.3 BABY HAMSTER KIDNEY (BHK) CELLS 260
6.5.4 HYBRIDOMA 260
6.5.5 HUMAN EMBRYONIC KIDNEY (HEK) CELLS 261
6.5.6 HUMAN EMBRYONIC RETINAL CELLS (PER.C6) 261
6.5.7 OTHERS 262
6.6 CELL LINE DEVELOPMENT SERVICES, BY APPLICATIONS 264
6.6.1 RESEARCH 266
6.6.2 BIOPRODUCTION 270
6.6.3 DIAGNOSTICS 272
6.7 KEY DEVELOPMENTS 283
6.8 MARKET SHARE ANALYSIS 305
7 COMPANY PROFILES 310
7.1 ABZENA PLC 310
7.1.1 OVERVIEW 310
7.1.2 FINANCIALS 312
7.1.3 SERVICE PORTFOLIO 314
7.1.4 KEY DEVELOPMENTS 316
7.1.5 SWOT ANALYSIS 318
7.2 ADIMAB LLC. 319
7.2.1 OVERVIEW 319
7.2.2 FINANCIALS 319
7.2.3 SERVICE PORTFOLIO 319
7.2.4 KEY DEVELOPMENTS 321
7.2.5 SWOT ANALYSIS 324
7.3 ALBANY MOLECULAR RESEARCH INC 325
7.3.1 OVERVIEW 325
7.3.2 FINANCIALS 327
7.3.3 SERVICE PORTFOLIO 329
7.3.4 KEY DEVELOPMENTS 331
7.3.5 SWOT ANALYSIS 333
7.4 BEIJING VITAL STAR BIOTECHNOLOGY CO. LTD. 334
7.4.1 OVERVIEW 334
7.4.2 FINANCIALS 334
7.4.3 SERVICE PORTFOLIO 334
7.4.4 KEY DEVELOPMENTS 335
7.4.5 SWOT ANALYSIS 336
7.5 BOEHRINGER INGELHEIM 337
7.5.1 OVERVIEW 337
7.5.2 FINANCIALS 339
7.5.3 SERVICE PORTFOLIO 341
7.5.4 KEY DEVELOPMENTS 342
7.5.5 SWOT ANALYSIS 343
7.6 CATALENT INC. 344
7.6.1 OVERVIEW 344
7.6.2 FINANCIALS 346
7.6.3 SERVICE PORTFOLIO 348
7.6.4 KEY DEVELOPMENTS 349
7.6.5 SWOT ANALYSIS 353
7.7 CHARLES RIVER LABORATORIES 354
7.7.1 OVERVIEW 354
7.7.2 FINANCIALS 356
7.7.3 SERVICE PORTFOLIO 358
7.7.4 KEY DEVELOPMENTS 361
7.7.5 SWOT ANALYSIS 364
7.8 CROWN BIOSCIENCES 365
7.8.1 OVERVIEW 365
7.8.2 FINANCIALS 365
7.8.3 SERVICE PORTFOLIO 365
7.8.4 KEY DEVELOPMENTS 366
7.8.5 SWOT ANALYSIS 369
7.9 GENOWAY 370
7.9.1 OVERVIEW 370
7.9.2 FINANCIALS 371
7.9.3 SERVICE PORTFOLIO 372
7.9.4 KEY DEVELOPMENTS 373
7.9.5 SWOT ANALYSIS 373
7.10 GENSCRIPT BIOTECH CORPORATION 374
7.10.1 OVERVIEW 374
7.10.2 FINANCIALS 376
7.10.3 SERVICE PORTFOLIO 379
7.10.4 KEY DEVELOPMENTS 380
7.10.5 SWOT ANALYSIS 382
7.11 GL BIOCHEM 383
7.11.1 OVERVIEW 383
7.11.2 FINANCIALS 383
7.11.3 SERVICE PORTFOLIO 383
7.11.4 KEY DEVELOPMENTS 384
7.11.5 SWOT ANALYSIS 385
7.12 HORIZON DISCOVERY GROUP, PLC 386
7.12.1 OVERVIEW 386
7.12.2 FINANCIALS 388
7.12.3 SERVICE PORTFOLIO 390
7.12.4 KEY DEVELOPMENTS 393
7.12.5 SWOT ANALYSIS 396
7.13 JACKSON LABORATORY 397
7.13.1 OVERVIEW 397
7.13.2 FINANCIALS 397
7.13.3 SERVICE PORTFOLIO 397
7.13.4 KEY DEVELOPMENTS 399
7.13.5 SWOT ANALYSIS 400
7.14 INNOVENT BIOLOGICS 401
7.14.1 OVERVIEW 401
7.14.2 FINANCIALS 401
7.14.3 SERVICE PORTFOLIO 401
7.14.4 KEY DEVELOPMENTS 401
7.14.5 SWOT ANALYSIS 402
7.15 JHL BIOTECH INC. 403
7.15.1 OVERVIEW 403
7.15.2 FINANCIALS 403
7.15.3 SERVICE PORTFOLIO 403
7.15.4 KEY DEVELOPMENTS 404
7.15.5 SWOT ANALYSIS 406
7.16 JOINN LABORATORIES CO. LTD 407
7.16.1 OVERVIEW 407
7.16.2 FINANCIALS 407
7.16.3 SERVICE PORTFOLIO 407
7.16.4 KEY DEVELOPMENTS 409
7.16.5 SWOT ANALYSIS 409
7.17 LONZA GROUP 410
7.17.1 OVERVIEW 410
7.17.2 FINANCIALS 412
7.17.3 SERVICE PORTFOLIO 415
7.17.4 KEY DEVELOPMENTS 416
7.17.5 SWOT ANALYSIS 418
7.18 MERCK KGAA 419
7.18.1 OVERVIEW 419
7.18.2 FINANCIALS 421
7.18.3 PRODUCT PORTFOLIO 423
7.18.4 KEY DEVELOPMENTS 425
7.18.5 SWOT ANALYSIS 429
7.19 PATHEON N.V. 430
7.19.1 OVERVIEW 430
7.19.2 FINANCIALS 432
7.19.3 SERVICE PORTFOLIO 433
7.19.4 KEY DEVELOPMENTS 434
7.19.5 SWOT ANALYSIS 436
7.20 PHARMALEGACY BIOTECHNOLOGY 437
7.20.1 OVERVIEW 437
7.20.2 FINANCIALS 437
7.20.3 SERVICE PORTFOLIO 437
7.20.4 KEY DEVELOPMENTS 442
7.20.5 SWOT ANALYSIS 442
7.21 PHARMARON 443
7.21.1 OVERVIEW 443
7.21.2 FINANCIALS 443
7.21.3 SERVICE PORTFOLIO 443
7.21.4 KEY DEVELOPMENTS 445
7.21.5 SWOT ANALYSIS 446
7.22 PROSCI INC. 447
7.22.1 OVERVIEW 447
7.22.2 FINANCIALS 447
7.22.3 SERVICE PORTFOLIO 447
7.22.4 KEY DEVELOPMENTS 448
7.22.5 SWOT ANALYSIS 449
7.23 PROTEOGENIX 450
7.23.1 OVERVIEW 450
7.23.2 FINANCIALS 450
7.23.3 SERVICE PORTFOLIO 450
7.23.4 KEY DEVELOPMENTS 451
7.23.5 SWOT ANALYSIS 452
7.24 PSYCHOGENICS INC 453
7.24.1 OVERVIEW 453
7.24.2 FINANCIALS 453
7.24.3 SERVICE PORTFOLIO 453
7.24.4 KEY DEVELOPMENTS 455
7.24.5 SWOT ANALYSIS 457
7.25 SELEXIS SA 458
7.25.1 OVERVIEW 458
7.25.2 FINANCIALS 458
7.25.3 SERVICE PORTFOLIO 458
7.25.4 KEY DEVELOPMENTS 459
7.25.5 SWOT ANALYSIS 461
7.26 SHANGHAI MEDICILON 462
7.26.1 OVERVIEW 462
7.26.2 FINANCIALS 462
7.26.3 SERVICE PORTFOLIO 462
7.26.4 KEY DEVELOPMENTS 467
7.26.5 SWOT ANALYSIS 469
7.27 SHANGPHARMA CORPORATION /SHANGHAI CHEMPARTNER 470
7.27.1 OVERVIEW 470
7.27.2 FINANCIALS 471
7.27.3 SERVICE PORTFOLIO 472
7.27.4 KEY DEVELOPMENTS 475
7.27.5 SWOT ANALYSIS 477
7.28 SINO BIOLOGICAL 478
7.28.1 OVERVIEW 478
7.28.2 FINANCIALS 478
7.28.3 SERVICE PORTFOLIO 479
7.28.4 KEY DEVELOPMENTS 482
7.28.5 SWOT ANALYSIS 483
7.29 SUNDIA MEDITECH CO., LTD. 484
7.29.1 OVERVIEW 484
7.29.2 FINANCIALS 484
7.29.3 SERVICE PORTFOLIO 484
7.29.4 KEY DEVELOPMENTS 485
7.29.5 SWOT ANALYSIS 485
7.30 SYNGENE INTERNATIONAL 486
7.30.1 OVERVIEW 486
7.30.2 FINANCIALS 487
7.30.3 SERVICE PORTFOLIO 488
7.30.4 KEY DEVELOPMENTS 504
7.30.5 SWOT ANALYSIS 505
7.31 TACONIC BIOSCIENCES 506
7.31.1 OVERVIEW 506
7.31.2 FINANCIALS 506
7.31.3 SERVICE PORTFOLIO 506
7.31.4 KEY DEVELOPMENTS 508
7.31.5 SWOT ANALYSIS 509
7.32 VIVA BIOTECH LTD. 510
7.32.1 OVERVIEW 510
7.32.2 FINANCIALS 510
7.32.3 SERVICE PORTFOLIO 510
7.32.4 KEY DEVELOPMENTS 512
7.32.5 SWOT ANALYSIS 513
7.33 WUXI APPTEC 514
7.33.1 OVERVIEW 514
7.33.2 FINANCIALS 515
7.33.3 SERVICE PORTFOLIO 515
7.33.4 KEY DEVELOPMENTS 524
7.33.5 SWOT ANALYSIS 526   

LIST OF TABLES

TABLE 1 BIOSIMILAR PROJECTS IN CHINA 29
TABLE 2 HIGHLIGHTS OF THE REVISED GUIDELINES 34
TABLE 3 BIOLOGICS OUTSOURCING GLOBAL MARKET REVENUE, BY REGION (2015-2025) ($BN) 61
TABLE 4 BIOLOGICS OUTSOURCING GLOBAL MARKET REVENUE, BY PRODUCT (2015-2025) ($BN) 62
TABLE 5 LIST OF BIOLOGICS APPROVED (2012-2016) 63
TABLE 6 BIOLOGICS OUTSOURCING GLOBAL MARKET REVENUE, BY PHASE (2015-2025) ($BN) 76
TABLE 7 ANTIBODY OUTSOURCING GLOBAL MARKET REVENUE, BY PRODUCT TYPE (2015-2025) ($BN) 79
TABLE 8 OTHERS GLOBAL MARKET REVENUE, BY PRODUCT TYPE (2015-2025) ($BN) 100
TABLE 9 BIOLOGICS OUTSOURCING GLOBAL MARKET REVENUE, BY END USERS (2015-2025) ($BN) 106
TABLE 10 AGREEMENTS, PARTNERSHIP & COLLABOARTION (2016-2017) 113
TABLE 11 ACQUISITIONS (2016-2017) 125
TABLE 12 NEW SERVICE LAUNCH (2016-2017) 129
TABLE 13 OTHER DEVELOPMENTS (2016-2017) 131
TABLE 14 SERVICE COMPARISON MATRIX OF THE COMPANY BASED ON BIOLOGICS TYPE 146
TABLE 15 COMPARISON MATRIX OF ANIMAL MODELS AND APPLICATIONS 151
TABLE 16 MAJOR TYPES OF GENETICALLY ENGINEERED AND TRANSPLANTATION ANIMAL MODELS 156
TABLE 17 TYPICAL PRECLINICAL ISSUES OF BIOLOGICS 168
TABLE 18 ANIMAL MODEL SERVICE GLOBAL MARKET BY REGION ($MN) 169
TABLE 19 ANIMAL MODEL SERVICE GLOBAL MARKET BY TYPE OF ANIMAL SPECIES ($MN) 171
TABLE 20 ANIMAL MODEL SERVICE GLOBAL MARKET  BY APPLICATION ($MN) 173
TABLE 21 ANIMAL MODEL SERVICE COST (DEVELOPMENT OF TRANSGENIC MOUSE) 176
TABLE 22 ANIMAL MODEL SERVICE COST (BASED ON DISEASE MODELS) 178
TABLE 23 ANIMAL MODEL SERVICE COST (IMAGING SERVICE COST BY AN ACADEMIC INSTITUTION) 180
TABLE 24 COMPARISON MATRIX OF ANIMAL MODEL SERVICE COMPANIES  AND MODELS IN RESPECTIVE THERAPEUTIC AREAS 181
TABLE 25 COMPARISON MATRIX OF ANIMAL MODEL SERVICE COMPANIES  AND MODELS IN RESPECTIVE IMMUNOLOGY/INFLAMMATION THERAPEUTIC AREAS 184
TABLE 26 COMPARISON MATRIX OF ANIMAL MODEL SERVICE COMPANIES  AND MODELS IN RESPECTIVE FIBROSIS THERAPEUTIC AREAS 186
TABLE 27 COMPANY DEVELOPMENTS 188
TABLE 28 CAPACITY COMPARISON OF CONTRACT MANUFACTURING ORGANIZATIONS VíS IN-HOUSE CAPACITIES (L) 200
TABLE 29 CONTRACT MANUACTURING ORGANIZATIONS CAPACITY,  BY PROCESS (L) 206
TABLE 30 ANTICANCER DRUGS SYNTHESIZED IN MICROBIAL CELL CULTURE 207
TABLE 31 BIOMANUFACTURING OUTSOURCING GLOBAL MARKET  BY END USERS ($BN) 210
TABLE 32 SECOND GENERATION PROTEIN THERAPEUTICS 215
TABLE 33 THERAPEUTIC VACCINES IN PIPELINE 217
TABLE 34 BIOMANUFACTURING OUTSOURCING GLOBAL MARKET  BY REGION ($BN) 219
TABLE 35 COMPANY COMPARISON MATRIX, BY MANUFACTURING CAPABILITY 223
TABLE 36 MERGERS AND ACQUITIONS (2015-2017) 228
TABLE 37 COLLABORATIONS (2016-2017) 230
TABLE 38 CAPACITY EXPANSIONS (2016-2017) 233
TABLE 39 CELL LINE DEVELOPMENT SERVICES MARKET, BY REGION, (2015-2025) ($MN) 240
TABLE 40 APPROVED BIOLOGICS  AND CELL LINE TYPE (2012-2016) 247
TABLE 41 NUMBER OF APPROVED BIOLOGICS BY CELL LINE TYPE (2012-2016) 249
TABLE 42 CELL LINE DEVELOPMENT SERVICES MARKET, BY EXPRESSION SYSTEM, (2015-2025) ($MN) 251
TABLE 43 CELL LINE DEVELOPMENT SERVICES MARKET, BY CELL TYPE, (2015-2025) ($MN) 255
TABLE 44 CELL LINE TYPE OF SOME APPROVED BIOLOGICS MODALITIES AND CELL LINE TYPE 263
TABLE 45 CELL LINE DEVELOPMENT SERVICES MARKET, BY APPLICATION, (2015-2025) ($MN) 265
TABLE 46 CELL LINE DEVELOPMENT TECHNOLOGIES 272
TABLE 47 CELL LINE DEVELOPMENT SERVICES COST 279
TABLE 48 KEY DEVELOPMENTS (2015-2017) 285
TABLE 49 COMPARISON MATRIX OF CELL LINE DEVELOPMENT PLAYERS AND  SERVICES OFFERED 302
TABLE 50 ABZENA PLC: TOTAL REVENUE AND  R&D EXPENSES (2014-2016) ($MN) 312
TABLE 51 ABZENA PLC: TOTAL REVENUE,  BY SEGMENT, (2014-2016) ($MN) 313
TABLE 52 ALBANY MOLECULAR RESEARCH INC: TOTAL REVENUE AND R&D EXPENSES, (2014-2016) ($MN) 327
TABLE 53 ALBANY MOLECULAR RESEARCH INC: TOTAL REVENUE, BY SEGMENTS, (2014-2016) ($MN) 328
TABLE 54 ALBANY MOLECULAR RESEARCH: TOTAL REVENUE, BY GEOGRAPHY, (2014-2016) ($MN) 329
TABLE 55 BOEHRINGER INGELHEIM: TOTAL REVENUE AND  R&D EXPENSES, (2014-2016) ($MN) 339
TABLE 56 BOEHRINGER INGELHEIM: TOTAL REVENUE, BY SEGMENTS, (2014-2016) ($MN) 340
TABLE 57 BOEHRINGER INGELHEIM: TOTAL REVENUE, BY GEOGRAPHY, (2014-2016) ($MN) 341
TABLE 58 CATALENT INC: TOTAL REVENUE AND  R&D EXPENSES (2014-2016) ($MN) 346
TABLE 59 CATALENT INC: TOTAL REVENUE,  BY SEGMENT, (2014-2016) ($MN) 347
TABLE 60 CATALENT INC: TOTAL REVENUE, BY GEOGRAPHY, (2014-2016) ($MN) 348
TABLE 61 CHARLES RIVER LABORATORIES: TOTAL REVENUE AND  R&D EXPENSES, (2014-2016) ($MN) 356
TABLE 62 CHARLES RIVER LABORATORIES: TOTAL REVENUE, BY SEGMENTS, (2014-2016) ($MN) 357
TABLE 63 CHARLES RIVER LABORATORIES: TOTAL REVENUE, BY GEOGRAPHY, (2014-2016) ($MN) 358
TABLE 64 GENOWAY: TOTAL REVENUE AND  R&D EXPENSES (2014-2016) ($MN) 371
TABLE 65 GENSCRIPT BIOTECH CORPORATION: TOTAL REVENUE AND  R&D EXPENSES, (2014-2016) ($MN) 376
TABLE 66 GENSCRIPT BIOTECH CORPORATION: TOTAL REVENUE, BY SEGMENTS, (2014-2016) ($MN) 377
TABLE 67 GENSCRIPT BIOTECH CORPORATION: TOTAL REVENUE, BY GEOGRAPHY, (2014-2016) ($MN) 378
TABLE 68 HORIZON DISCOVERY GROUP: TOTAL REVENUE AND  R&D EXPENSES, (2014-2016) ($MN) 388
TABLE 69 HORIZON DISCOVERY GROUP: TOTAL REVENUE, BY SEGMENTS, (2014-2016) ($MN) 389
TABLE 70 HORIZON DISCOVERY GROUP: TOTAL REVENUE, BY GEOGRAPHY, (2014-2016) ($MN) 390
TABLE 71 LONZA GROUP: TOTAL REVENUE AND  R&D EXPENSES (2014-2016) ($MN) 412
TABLE 72 LONZA GROUP: TOTAL REVENUE,  BY SEGMENT, (2014-2016) ($MN) 413
TABLE 73 LONZA GROUP: TOTAL REVENUE,  BY GEOGRAPHY (2014-2016) ($MN) 414
TABLE 74 MERCK KGAA: TOTAL REVENUE AND  R&D EXPENSES, (2014-2016) ($MN) 421
TABLE 75 MERCK KGAA: TOTAL REVENUE, BY SEGMENTS, (2014-2016) ($MN) 422
TABLE 76 MERCK KGAA: TOTAL REVENUE, BY GEOGRAPHY, (2014-2016) ($MN) 423
TABLE 77 PATHEON N.V.: TOTAL REVENUE AND  R&D EXPENSES (2014-2016) ($MN) 432
TABLE 78 PATHEON N.V.: TOTAL REVENUE,  BY SEGMENT, (2014-2016) ($MN) 433
TABLE 79 SHANGHAI CHEMPARTNER: TOTAL REVENUE AND  R&D EXPENSES, (2014-2016) ($MN) 471
TABLE 80 SYNGENE INTERNATIONAL: TOTAL REVENUE AND  R&D EXPENSES, (2014-2016) ($MN) 487
TABLE 81 SYNGENE INTERNATIONAL: TOTAL REVENUE, BY GEOGRAPHY, (2014-2016) ($MN) 488
TABLE 82 WUXI APPTEC: TOTAL REVENUE AND  R&D EXPENSES, (2014-2016) ($MN) 515

LIST OF FIGURES

FIGURE 1 TOP SELLING DRUGS AND APPROVALS, SMALL MOLECULES VíS BIOLOGICS, 2012-2016 21
FIGURE 2 TOP 30 BIOLOGICS PATENT EXPIRY, 2013-2038 AND RISE OF BIOSIMILARS 22
FIGURE 3 BIOLOGICS PIPELINE FROM PRECLINICAL TO REGISTRATION FOR EMERGING DISEASE AREAS 24
FIGURE 4 OUTLOOK OF BIOLOGICS GLOBAL MARKET (2015-2025) 26
FIGURE 5 OUTLOOK OF CHINA BIOLOGICS AND BIOLOGICS OUTSOURCING MARKET (2015-2025) 28
FIGURE 6 CHINA VS INDIA 31
FIGURE 7 MARKET DYNAMICS 39
FIGURE 8 BIOLOGICS OUTSOURCING GLOBAL MARKET REVENUE,  BY REGION (2015-2025) ($BN) 60
FIGURE 9 BIOLOGICS OUTSOURCING GLOBAL MARKET REVENUE, BY PRODUCT, (2016 VíS 2025) ($BN) 63
FIGURE 10 BIOLOGICS IN PIPELINE, BY TYPE (%) 67
FIGURE 11 DISCOVERY BIOLOGICS OUTSOURCING MARKET, BY SERVICES 2016 (%) 72
FIGURE 12 DISCOVERY BIOLOGICS OUTSOURCING MARKET, BY SERVICE TYPE, 2016 ($MN) 73
FIGURE 13 BIOLOGICS IN PIPELINE, BY PHASE (%) 76
FIGURE 14 BIOLOGICS OUTSOURCING GLOBAL MARKET REVENUE,  BY PHASE (2016 VíS 2025) ($BN) 77
FIGURE 15 ANTIBODY OUTSOURCING GLOBAL MARKET SHARE, BY PRODUCT TYPE, (2016 VíS 2025) (%) 80
FIGURE 16 OTHERS GLOBAL MARKET SHARE, BY PRODUCT TYPE, (2016 VíS 2025) ($BN) 100
FIGURE 17 BIOLOGICS OUTSOURCING GLOBAL MARKET REVENUE, BY END-USERS (2016 VíS 2025) ($BN) 107
FIGURE 18 BIOLOGICS OUTSOURCING  GLOBAL MARKET SHARE ANALYSIS, BY MAJOR PLAYERS, 2016 108
FIGURE 19 RECENT DEALS IN BIOLOGICS OUTSOURCING 112
FIGURE 20 GENOME COMPARISON 149
FIGURE 21 DROT: ANIMAL MODELS 150
FIGURE 22 ANIMAL PROFILES 153
FIGURE 23 COMMON ANIMAL MODELS 154
FIGURE 24 ADVANTAGES AND DISADVANTAGES OF RODENT MODELS 155
FIGURE 25 ADVANTAGES AND DISADVANTAGES OF NHP 161
FIGURE 26 PRINCIPLES OF 3RS 162
FIGURE 27 PERCENTAGE OF ANIMALS USED IN DIFFRENT STAGES OF PHARMACUTICAL DEVELOPMENT 167
FIGURE 28 ANIMAL MODEL SERVICE GLOBAL MARKET,  BY REGION ($MN) 170
FIGURE 29 ANIMAL MODEL SERVICE GLOBAL MARKET,  BY TYPE OF ANIMAL SPECIES ($MN, %) 172
FIGURE 30 ANIMAL MODEL SERVICE GLOBAL MARKET,  BY APPLICATION ($MN, %) 174
FIGURE 31 ANIMAL MODEL SERVICE OUTSOURCING GLOBAL MARKET SHARE (%) 175
FIGURE 32 COMPANY DEVELOPMENTS 187
FIGURE 33 MARKET DYNAMICS OF CONTRACT BIOMANUFACTURING GLOBAL MARKET 198
FIGURE 34 INDUSTRY PIPELINE FOR SMALL MOLECULE VíS BIOLOGICS 199
FIGURE 35 GLOBAL MANUFACTURING CAPACITY, CGMP VíS NON-CGMP, INHOUSE VíS CMO, 2016 201
FIGURE 36 CAPACITY UTILIZATION OF CONTRACT MANUFACTURING ORGANIZATIONS, BY STAGE (L) 203
FIGURE 37 CAPACITY COMPARISON OF MAMMALIAN, MICROBIAL AND OTHER CULTURE SYSTEMS (L) 205
FIGURE 38 BIO-MANUFACTURING OUTSOURCING GLOBAL MARKET,  BY END USERS ($BN) 210
FIGURE 39 OUTLOOK OF BIOLOGICS CMO GLOBAL MARKET, BY REGION ($BN) AND PRODUCTION IN METRIC TONS, 2016 219
FIGURE 40 CAPACITY COMPOSITION OF TOP 10 CONTRACT MANUFACTURING ORGANIZATIONS (L) 222
FIGURE 41 MARKET SHARE ANALYSIS BY CONTRACT MANUFACTURING MAJOR PLAYERS, 2016 226
FIGURE 42 KEY DEALS (2016-2017) 227
FIGURE 43 MARKET DYNAMICS OF CELL LINE DEVELOPMENT 239
FIGURE 44 CELL LINE DEVELOPMENT SERVICES MARKET, BY REGION, (2016) ($MN) 241
FIGURE 45 NUMBER OF APPROVED BIOLOGICS BY CELL LINE TYPE (2012-2016) 250
FIGURE 46 CELL LINE DEVELOPMENT SERVICES MARKET, BY EXPRESSION SYSTEM, (2016 VS 2025) ($MN) 252
FIGURE 47 EXPRESSION SYSTEMS OF SOME APPROVED BIOLOGICS 254
FIGURE 48 CELL LINE DEVELOPMENT SERVICES MARKET, BY CELL TYPE, (2016 VS 2025) ($MN) 256
FIGURE 49 CELL LINE TYPE OF SOME APPROVED BIOLOGICS 259
FIGURE 50 CELL LINE TYPE OF SOME APPROVED BIOLOGICS MODALITIES AND CELL LINE TYPE 264
FIGURE 51 CELL LINE DEVELOPMENT SERVICES MARKET, BY APPLICATION, (2016 VS 2025) ($MN) 266
FIGURE 52 KEY DEVELOPMENTS OF CELL LINE DEVELOPMENT MARKET PLAYERS, 2015-2017 284
FIGURE 53 MARKET SHARE ANALYSIS, BY CELL LINE DEVELOPMENT MAJOR PLAYERS (2016) 306
FIGURE 54 OVERVIEW: ABZENA PLC 311
FIGURE 55 SWOT: ABZENA PLC 318
FIGURE 56 SWOT: ADIMAB LLC 324
FIGURE 57 OVERVIEW: ALBANY MOLECULAR RESEARCH INSTITUTE 326
FIGURE 58 SWOT: ALBANY MOLECULAR RESEARCH, INC 333
FIGURE 59 SWOT: BEIJING VITAL STAR BIOTECHNOLOGY CO. LTD. 336
FIGURE 60 BOEHRINGER INGELHEIM REVENUE OVERVIEW 338
FIGURE 61 SWOT: BOEHRINGER INGELHEIM 343
FIGURE 62 OVERVIEW: CATALENT INC. 345
FIGURE 63 SWOT: CATALENT INC. 353
FIGURE 64 OVERVIEW: CHARLES RIVER LABORATORIES 355
FIGURE 65 SWOT: CHARLES RIVER LABORATORIES 364
FIGURE 66 SWOT: CROWN BIOSCIENCES 369
FIGURE 67 OVERVIEW: GENOWAY 371
FIGURE 68 SWOT: GENOWAY 373
FIGURE 69 OVERVIEW: GENSCRIPT BIOTECH CORPORATION 375
FIGURE 70 SWOT: GENSCRIPT BIOSCIENCES CORPORATION 382
FIGURE 71 SWOT: GL BIOCHEM 385
FIGURE 72 OVERVIEW: HORIZON DISCOVERY GROUP, PLC 387
FIGURE 73 SWOT: HORIZON DISCOVERY GROUP, PLC 396
FIGURE 74 SWOT: JACKSON LABORATORY 400
FIGURE 75 SWOT: INNOVENT BIOLOGICS 402
FIGURE 76 SWOT: JHL BIOTECH INC. 406
FIGURE 77 SWOT: JOINN LABORATORIES CO. LTD 409
FIGURE 78 OVERVIEW: LONZA GROUP 411
FIGURE 79 SWOT: LONZA GROUP 418
FIGURE 80 OVERVIEW: MERCK KGAA 420
FIGURE 81 SWOT: MERCK KGAA 429
FIGURE 82 OVERVIEW: PATHEON N.V. 431
FIGURE 83 SWOT: PATHEON N.V. 436
FIGURE 84 SWOT: PHARMALEGACY 442
FIGURE 85 SWOT: PHARMARON 446
FIGURE 86 SWOT: PROSCI. INC. 449
FIGURE 87 SWOT: PROTEOGENIX 452
FIGURE 88 SWOT: PSYCOGENICS INC 457
FIGURE 89 SWOT: SELEXIS SA 461
FIGURE 90 SWOT: SHANGHAI MEDICILON 469
FIGURE 91 SWOT: SHANGHAI CHEMPARTNER 477
FIGURE 92 SWOT: SINO BIOLOGICAL 483
FIGURE 93 SWOT: SUNDIA MEDITECH COMPANY LTD 485
FIGURE 94 SWOT: SYNGENE INTERNATIONAL 505
FIGURE 95 SWOT: TACONIC BIOSCIENCES 509
FIGURE 96 SWOT: VIVA BIOTECH LTD 513
FIGURE 97 SWOT: WUXI APPTEC 526

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