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Other Biologics Outsourcing Global Market - Forecast to 2027

  • RnM2895594
    • |
  • 12 March, 2020
    • |
  • Global
    • |
  • 573 Pages
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  • IQ4I Research & Consultancy
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  • Other

The biologics outsourcing global market is expected to grow at double digit CAGR to reach $87.6 billion by 2027. 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 profits 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 2017, seven out of 10 blockbuster drugs were biologics outnumbering small molecule drugs. Some of the top selling biologics in 2017 includes Humira ($18.4 billion), Rituxan ($9.2 billion), Enbrel ($7.9 billion), and Herceptin ($7.4 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 18

  • 1.1 INTRODUCTION 18
  • 1.2 LANDSCAPE OF BIOLOGICS MARKET 19
  • 1.3 BIOLOGICS GLOBAL MARKET 24
  • 1.4 TOP DESTINATION FOR BIOLOGICS OUTSOURCING 25
    • 1.4.1 CHINA BIOLOGICS OUTSOURCING MARKET 25
    • 1.4.2 CHINA VS INDIA - BIOLOGICS MARKET 27
    • 1.4.3 REGULATIONS AND GOVERNMENT INITIATIVES 29
    • 1.4.4 CAPABILITIES AND TECHNOLOGIES 33

2 MARKET ANALYSIS 35

  • 2.1 INTRODUCTION 35
  • 2.2 FACTORS INFLUENCING MARKET 37
    • 2.2.1 DRIVERS AND OPPORTUNITIES 38
      • 2.2.1.1 Increased investment in R&D by pharmaceutical companies is increasing the outsourcing 38
      • 2.2.1.2 Adoption of biological therapies in disease management 38
      • 2.2.1.3 Successful collaboration and low cost for outsourcing 39
      • 2.2.1.4 Increasing biologics approvals in the past year 40
      • 2.2.1.5 Increasing chronic and autoimmune illnesses 41
      • 2.2.1.6 Increasing number of branded drugs going off-patent creates a

    scope for biosimilars 41

    • 2.2.1.7 Requirement of novel biologics therapeutics for rare diseases 42
    • 2.2.1.8 Increasing demand for antibody conjugates and bispecific antibodies 43
    • 2.2.1.9 Advanced technologies for screening, cell line engineering and bioprocessing 43
    • 2.2.1.10 Pharma companies restricting their global presence, reducing manpower,

lack of facilities for discovery and manufacturing of biologics 45

  • 2.2.2 RESTRAINTS AND THREATS 46
    • 2.2.2.1 Intense complexities in handling biologics 46
    • 2.2.2.2 Requirement of highly skilled technicians 47
    • 2.2.2.3 High cost of drug development process 48
    • 2.2.2.4 Challenges in oral formulations with biologics 48
    • 2.2.2.5 Stringent regulatory frameworks 49
    • 2.2.2.6 High capital and technical requirements to obtain gmp certifications 51
    • 2.2.2.7 Limited ip protection in developing regions 52
    • 2.2.2.8 High chances of end stage failure of drug 53
    • 2.2.2.9 Conflict of interest between pharmaceutical company and CRO 53

3 BIOLOGICS OUTSOURCING GLOBAL MARKET, MARKET ANALYSIS 55

  • 3.1 INTRODUCTION 55
  • 3.2 DISCOVERY AND PRE-CLINICAL DEVELOPMENT PROCESS 63
  • 3.3 BIOLOGICS OUTSOURCING GLOBAL MARKET, BY PRODUCT TYPE 73
    • 3.3.1 ANTIBODY 73
      • 3.3.1.1 Monoclonal antibody 75
      • 3.3.1.2 Bispecific antibody 80
      • 3.3.1.3 Antibody drug conjugates 82
      • 3.3.1.4 Others 83
    • 3.3.2 RECOMBINANT PROTEIN 85
      • 3.3.2.1 Fusion proteins 86
      • 3.3.2.2 Hormones 88
      • 3.3.2.3 Recombinant enzymes 89
      • 3.3.2.4 Others 90
    • 3.3.3 VACCINES 92
    • 3.3.4 OTHERS 95
      • 3.3.4.1 Gene therapy 96
      • 3.3.4.2 Cell therapy 99
      • 3.3.4.3 Others 100
  • 3.4 MARKET SHARE ANALYSIS 103
  • 3.5 COMPANY DEVELOPMENTS 107
    • 3.5.1 AGREEMENTS, PARTNERSHIPS & COLLABORATIONS 107
    • 3.5.2 NEW SERVICE LAUNCH 128
    • 3.5.3 EXPANSION 134
    • 3.5.4 ACQUISITIONS 139
    • 3.5.5 OTHER DEVELOPMENTS 143
  • 3.6 SERVICE COST ANALYSIS 147
    • 3.6.1 ANTIBODY PRODUCTION SERVICE COSTS 147
    • 3.6.2 CUSTOM MONOCLONAL ANTIBODY PRODUCTION SERVICE COSTS 150
    • 3.6.3 CUSTOM POLYCLONAL ANTIBODY PRODUCTION SERVICE COSTS 152
    • 3.6.4 PROTEIN PRODUCTION SERVICE COSTS 153
    • 3.6.5 ADDITIONAL ANTIBODY AND PROTEIN SERVICES 156
    • 3.6.6 GENE EDITTING SERVICES 158
    • 3.6.7 CAR-T/NK PLATFORM SERVICES 158

4 BIOLOGICS OUTSOURCING GLOBAL MARKET –

    ANIMAL MODEL SERVICES 162

    • 4.1 INTRODUCTION 162
      • 4.1.1 MARKET DYNAMICS 164
      • 4.1.2 COMPARISON MATRIX OF ANIMAL MODELS AND APPLICATIONS 166
      • 4.1.3 SMALL ANIMAL MODELS 169
      • 4.1.4 LARGE ANIMAL MODELS 172
    • 4.2 ETHICS AND REGULATIONS 176
    • 4.3 ALTERNATIVES TO ANIMAL MODELS 178
    • 4.4 OVERVIEW OF APPLICATIONS OF ANIMAL MODELS 180
    • 4.5 ANIMAL MODEL SERVICES GLOBAL MARKET, BY MOLECULE 184
    • 4.6 ANIMAL MODELS SERVICES REGIONAL MARKET 186
    • 4.7 ANIMAL MODEL SERVICES MARKET, BY SPEICES 188
    • 4.8 ANIMAL MODEL SERVICES GLOBAL MARKET, BY APPLICATION 190
    • 4.9 MARKET SHARE ANALYSIS 192
    • 4.10 COMPETITIVE LANDSCAPE 193
    • 4.11 COMPANY DEVELOPMENTS 207

    5 BIOLOGICS OUTSOURCING GLOBAL MARKET - BIOMANUFACTURING 223

    • 5.1 INTRODUCTION 223
    • 5.2 MARKET DYNAMICS 225
    • 5.3 IN HOUSE VS CMO CAPACITY 225
    • 5.4 CONTRACT BIOMANUFACTURING, BY PROCESS 229
      • 5.4.1 BIOMANUFACTURING BY MAMMALIAN CELL CULTURE 230
      • 5.4.2 BIOMANUFACTURING BY MICROBIAL CELL CULTURE 232
      • 5.4.3 BIOMANUFACTURING BY OTHER CELL CULTURE 234
    • 5.5 CONTRACT BIOMANUFACTURING GLOBAL MARKET, BY END USERS 235
      • 5.5.1 CONTRACT BIOMANUFACTURING OF DIAGNOSTICS 237
      • 5.5.2 CONTRACT BIOMANUFACTURING OF RESEARCH REAGENTS 238
      • 5.5.3 CONTRACT BIOMANUFACTURING OF THERAPEUTICS 239
    • 5.6 COMPETITIVE LANDSCAPE 247
      • 5.6.1 CAPACITY COMPARISON 247
      • 5.6.2 CONTRACT MANUFACTURING GLOBAL MARKET SHARE, BY LEADING PLAYERS 251
    • 5.7 COMPANY DEVELOPMENTS 252
      • 5.7.1 MERGER AND ACQUISITION BY CMOS 253
      • 5.7.2 COLLABORATIONS 257
      • 5.7.3 CAPACITY EXPANSIONS 262

    6 BIOLOGICS OUTSOURCING GLOBAL MARKET - CELL LINE DEVELOPMENT 267

    • 6.1 INTRODUCTION 267
      • 6.1.1 MARKET DYNAMICS 269
    • 6.2 CELL LINE DEVELOPMENT 271
      • 6.2.1 CELL LINE CONSTRUCTION 271
      • 6.2.2 HOST CELL LINE ENGINEERING 272
      • 6.2.3 EXPRESSION SYSTEM 272
      • 6.2.4 TRANSIENT GENE EXPRESSION 273
      • 6.2.5 STABLE CELL LINE DEVELOPMENT 273
      • 6.2.6 SCREENING 275
      • 6.2.7 UPSTREAM PROCESS DEVELOPMENT 275
    • 6.3 HOST CELL LINES 276
    • 6.4 CELL LINE DEVELOPMENT SERVICES MARKET, BY EXPRESSION SYSTEM 282
      • 6.4.1 MICROBIAL EXPRESSION SYSTEMS 284
      • 6.4.2 MAMMALIAN EXPRESSION SYSTEM 286
      • 6.4.3 OTHERS 287
    • 6.5 CELL LINE DEVELOPMENT SERVICES, BY CELL TYPE 287
      • 6.5.1 CHO 289
      • 6.5.2 MURINE/MOUSE MYELOMA 292
      • 6.5.3 BABY HAMSTER KIDNEY (BHK) CELLS 293
      • 6.5.4 HYBRIDOMA 293
      • 6.5.5 HUMAN EMBRYONIC KIDNEY (HEK) CELLS 294
      • 6.5.6 HUMAN EMBRYONIC RETINAL CELLS (PER.C6) 294
      • 6.5.7 OTHERS 295
    • 6.6 CELL LINE DEVELOPMENT SERVICES, BY APPLICATIONS 297
      • 6.6.1 RESEARCH 299
      • 6.6.2 BIOPRODUCTION 303
      • 6.6.3 DIAGNOSTICS 305
    • 6.7 KEY DEVELOPMENTS 317
    • 6.8 MARKET SHARE ANALYSIS 331

    7 COMPANY PROFILES 336

    • 7.1 ABZENA PLC 336
      • 7.1.1 OVERVIEW 336
      • 7.1.2 FINANCIALS 338
      • 7.1.3 SERVICE PORTFOLIO 341
      • 7.1.4 KEY DEVELOPMENTS 343
      • 7.1.5 SWOT ANALYSIS 347
    • 7.2 ADIMAB LLC. 348
      • 7.2.1 OVERVIEW 348
      • 7.2.2 FINANCIALS 348
      • 7.2.3 SERVICE PORTFOLIO 349
      • 7.2.4 KEY DEVELOPMENTS 350
      • 7.2.5 SWOT ANALYSIS 351
    • 7.3 ALBANY MOLECULAR RESEARCH, INC 352
      • 7.3.1 OVERVIEW 352
      • 7.3.2 FINANCIALS 352
      • 7.3.3 SERVICE PORTFOLIO 353
      • 7.3.4 KEY DEVELOPMENTS 355
      • 7.3.5 SWOT ANALYSIS 357
    • 7.4 BEIJING VITAL STAR BIOTECHNOLOGY CO. LTD. 358
      • 7.4.1 OVERVIEW 358
      • 7.4.2 FINANCIALS 358
      • 7.4.3 SERVICE PORTFOLIO 359
      • 7.4.4 KEY DEVELOPMENTS 359
      • 7.4.5 SWOT ANALYSIS 360
    • 7.5 BOEHRINGER INGELHEIM 361
      • 7.5.1 OVERVIEW 361
      • 7.5.2 FINANCIALS 363
      • 7.5.3 SERVICE PORTFOLIO 365
      • 7.5.4 KEY DEVELOPMENTS 366
      • 7.5.5 SWOT ANALYSIS 368
    • 7.6 CATALENT INC. 369
      • 7.6.1 OVERVIEW 369
      • 7.6.2 FINANCIALS 371
      • 7.6.3 SERVICE PORTFOLIO 373
      • 7.6.4 KEY DEVELOPMENTS 373
      • 7.6.5 SWOT ANALYSIS 376
    • 7.7 CHARLES RIVER LABORATORIES 377
      • 7.7.1 OVERVIEW 377
      • 7.7.2 FINANCIALS 379
      • 7.7.3 SERVICE PORTFOLIO 382
      • 7.7.4 KEY DEVELOPMENTS 385
      • 7.7.5 SWOT ANALYSIS 387
    • 7.8 CROWN BIOSCIENCES (JSR) 388
      • 7.8.1 OVERVIEW 388
      • 7.8.2 FINANCIALS 388
      • 7.8.3 SERVICE PORTFOLIO 388
      • 7.8.4 KEY DEVELOPMENTS 390
      • 7.8.5 SWOT ANALYSIS 393
    • 7.9 GENOWAY 394
      • 7.9.1 OVERVIEW 394
      • 7.9.2 FINANCIALS 395
      • 7.9.3 SERVICE PORTFOLIO 396
      • 7.9.4 KEY DEVELOPMENTS 396
      • 7.9.5 SWOT ANALYSIS 397
    • 7.10 GENSCRIPT BIOTECH CORPORATION 398
      • 7.10.1 OVERVIEW 398
      • 7.10.2 FINANCIALS 400
      • 7.10.3 SERVICE PORTFOLIO 402
      • 7.10.4 KEY DEVELOPMENTS 404
      • 7.10.5 SWOT ANALYSIS 406
    • 7.11 GL BIOCHEM 407
      • 7.11.1 OVERVIEW 407
      • 7.11.2 FINANCIALS 407
      • 7.11.3 SERVICE PORTFOLIO 407
      • 7.11.4 KEY DEVELOPMENTS 408
      • 7.11.5 SWOT ANALYSIS 409
    • 7.12 HORIZON DISCOVERY GROUP, PLC 410
      • 7.12.1 OVERVIEW 410
      • 7.12.2 FINANCIALS 412
      • 7.12.3 SERVICE PORTFOLIO 414
      • 7.12.4 KEY DEVELOPMENTS 417
      • 7.12.5 SWOT ANALYSIS 421
    • 7.13 JACKSON LABORATORY 422
      • 7.13.1 OVERVIEW 422
      • 7.13.2 FINANCIALS 423
      • 7.13.3 SERVICE PORTFOLIO 424
      • 7.13.4 KEY DEVELOPMENTS 425
      • 7.13.5 SWOT ANALYSIS 427
    • 7.14 SAMSUNG BIOLOGICS 428
      • 7.14.1 OVERVIEW 428
      • 7.14.2 FINANCIALS 430
      • 7.14.3 SERVICE PORTFOLIO 431
      • 7.14.4 KEY DEVELOPMENTS 432
      • 7.14.5 SWOT ANALYSIS 434
    • 7.15 JHL BIOTECH INC. 435
      • 7.15.1 OVERVIEW 435
      • 7.15.2 FINANCIALS 436
      • 7.15.3 SERVICE PORTFOLIO 437
      • 7.15.4 KEY DEVELOPMENTS 437
      • 7.15.5 SWOT ANALYSIS 438
    • 7.16 JOINN LABORATORIES CO. LTD 439
      • 7.16.1 OVERVIEW 439
      • 7.16.2 FINANCIALS 439
      • 7.16.3 SERVICE PORTFOLIO 439
      • 7.16.4 KEY DEVELOPMENTS 441
      • 7.16.5 SWOT ANALYSIS 442
    • 7.17 LONZA GROUP 443
      • 7.17.1 OVERVIEW 443
      • 7.17.2 FINANCIALS 445
      • 7.17.3 SERVICE PORTFOLIO 448
      • 7.17.4 KEY DEVELOPMENTS 449
      • 7.17.5 SWOT ANALYSIS 452
    • 7.18 MERCK KGAA 453
      • 7.18.1 OVERVIEW 453
      • 7.18.2 FINANCIALS 455
      • 7.18.3 PRODUCT PORTFOLIO 458
      • 7.18.4 KEY DEVELOPMENTS 460
      • 7.18.5 SWOT ANALYSIS 466
    • 7.19 PATHEON N.V. (THERMOFISHER SCIENTIFIC) 467
      • 7.19.1 OVERVIEW 467
      • 7.19.2 FINANCIALS 469
      • 7.19.3 SERVICE PORTFOLIO 471
      • 7.19.4 KEY DEVELOPMENTS 471
      • 7.19.5 SWOT ANALYSIS 474
    • 7.20 PHARMALEGACY LABORATORIES 475
      • 7.20.1 OVERVIEW 475
      • 7.20.2 FINANCIALS 475
      • 7.20.3 SERVICE PORTFOLIO 475
      • 7.20.4 KEY DEVELOPMENTS 481
      • 7.20.5 SWOT ANALYSIS 482
    • 7.21 PHARMARON 483
      • 7.21.1 OVERVIEW 483
      • 7.21.2 FINANCIALS 483
      • 7.21.3 SERVICE PORTFOLIO 484
      • 7.21.4 KEY DEVELOPMENTS 486
      • 7.21.5 SWOT ANALYSIS 487
    • 7.22 PROSCI INC. 488
      • 7.22.1 OVERVIEW 488
      • 7.22.2 FINANCIALS 488
      • 7.22.3 SERVICE PORTFOLIO 488
      • 7.22.4 KEY DEVELOPMENTS 491
      • 7.22.5 SWOT ANALYSIS 492
    • 7.23 PROTEOGENIX 493
      • 7.23.1 OVERVIEW 493
      • 7.23.2 FINANCIALS 493
      • 7.23.3 SERVICE PORTFOLIO 493
      • 7.23.4 KEY DEVELOPMENTS 495
      • 7.23.5 SWOT ANALYSIS 495
    • 7.24 PSYCHOGENICS, INC 496
      • 7.24.1 OVERVIEW 496
      • 7.24.2 FINANCIALS 496
      • 7.24.3 SERVICE PORTFOLIO 496
      • 7.24.4 KEY DEVELOPMENTS 498
      • 7.24.5 SWOT ANALYSIS 499
    • 7.25 JSR LIFE SCIENCES (SELEXIS SA) 500
      • 7.25.1 OVERVIEW 500
      • 7.25.2 FINANCIALS 500
      • 7.25.3 SERVICE PORTFOLIO 500
      • 7.25.4 KEY DEVELOPMENTS 501
      • 7.25.5 SWOT ANALYSIS 504
    • 7.26 SHANGHAI MEDICILON 505
      • 7.26.1 OVERVIEW 505
      • 7.26.2 FINANCIALS 505
      • 7.26.3 SERVICE PORTFOLIO 505
      • 7.26.4 KEY DEVELOPMENTS 508
      • 7.26.5 SWOT ANALYSIS 509
    • 7.27 SHANGPHARMA CORPORATION /SHANGHAI CHEMPARTNER 510
      • 7.27.1 OVERVIEW 510
      • 7.27.2 FINANCIALS 511
      • 7.27.3 SERVICE PORTFOLIO 511
      • 7.27.4 KEY DEVELOPMENTS 516
      • 7.27.5 SWOT ANALYSIS 517
    • 7.28 SINO BIOLOGICAL 518
      • 7.28.1 OVERVIEW 518
      • 7.28.2 FINANCIALS 518
      • 7.28.3 SERVICE PORTFOLIO 519
      • 7.28.4 KEY DEVELOPMENTS 523
      • 7.28.5 SWOT ANALYSIS 524
    • 7.29 SUNDIA MEDITECH CO., LTD. 525
      • 7.29.1 OVERVIEW 525
      • 7.29.2 FINANCIALS 525
      • 7.29.3 SERVICE PORTFOLIO 526
      • 7.29.4 KEY DEVELOPMENTS 529
      • 7.29.5 SWOT ANALYSIS 530
    • 7.30 SYNGENE INTERNATIONAL 531
      • 7.30.1 OVERVIEW 531
      • 7.30.2 FINANCIALS 532
      • 7.30.3 SERVICE PORTFOLIO 533
      • 7.30.4 KEY DEVELOPMENTS 544
      • 7.30.5 SWOT ANALYSIS 545
    • 7.31 TACONIC BIOSCIENCES 546
      • 7.31.1 OVERVIEW 546
      • 7.31.2 FINANCIALS 546
      • 7.31.3 SERVICE PORTFOLIO 546
      • 7.31.4 KEY DEVELOPMENTS 549
      • 7.31.5 SWOT ANALYSIS 552
    • 7.32 VIVA BIOTECH LTD. 553
      • 7.32.1 OVERVIEW 553
      • 7.32.2 FINANCIALS 553
      • 7.32.3 SERVICE PORTFOLIO 553
      • 7.32.4 KEY DEVELOPMENTS 558
      • 7.32.5 SWOT ANALYSIS 559
    • 7.33 WUXI BIOLOGICS (WUXI APPTEC) 560
      • 7.33.1 OVERVIEW 560
      • 7.33.2 FINANCIALS 561
      • 7.33.3 SERVICE PORTFOLIO 561
      • 7.33.4 KEY DEVELOPMENTS 569

    Summary:
    Get latest Market Research Reports on Biologics Outsourcing . Industry analysis & Market Report on Biologics Outsourcing is a syndicated market report, published as Biologics Outsourcing Global Market - Forecast to 2027. It is complete Research Study and Industry Analysis of Biologics Outsourcing market, to understand, Market Demand, Growth, trends analysis and Factor Influencing market.

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