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Description:
The 2015 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production is the most recent study of biotherapeutic developers and contract manufacturing organizations' current and projected future capacity and production. The report contains the industry's definitive, quantitative analysis and includes 12 years of biopharma trends as well as a review of current opportunities and in-depth coverage by several subject matter experts of critical issues affecting the industry.

This report's 468 pages of data-rich analysis are spread over 13 chapters containing more than 200 graphs and charts. The survey includes responses from 237 responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations from 28 countries. The methodology also includes responses from an additional 164 direct suppliers of raw materials, services and equipment to this industry.

Summary:
The 12th Annual Report and Survey of Biopharmaceutical Manufacturing provides over 12 years of global trend analysis to help your decision-making. The Biopharmaceutical Report covers many critical areas including: industry growth, downstream processing, single use systems, outsourcing, capacity, fill-finish operations, quality management, hiring and much more! Detailed monograph discussions from industry experts are also included, covering the events that have shaped the past year and evaluations of how they will affect, or create trends that will shape biopharmaceutical manufacturing over the next 5 years. This year's edition also includes for the first time a chapter on Fill-and-Finish operations; over the past few years, advances in technologies, drug delivery, and single-use applications have increasingly made this segment an area of interest for innovation.

Top trends identified include:
- Focus today is on manufacturing and productivity
- Operations budgets are growing, from R&D to new capital equipment
- Single-use systems and disposable devices among the new bio-innovations most in demand
- U.S. and EU are stepping up their Biosimilars pipeline
- Hiring growing rapidly in key areas; 51% of companies unable to hire the right PD staff
- China is now the #1 "potential" outsourcing destination
- Suppliers are increasing their R&D and focus on improved productivity
- Fill-Finish operations are going high-tech and single-use
- Bioprocessing is getting better as failure rates have been almost cut in half over the past 8 years

Table Of Contents

12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production
Methodology xxiii
CHAPTER 0: Demographics 1
Respondents' Area of Involvement 1
Respondents' Titles 3
Respondents' Facility Locations .4
Respondents' Areas of Biopharmaceutical Manufacturing Operations 6
Respondents' Production Operations, Phase of Development 8
Employees at Facility . 11
Batches Run at Facility per Year 12
CHAPTER 1: INTRODUCTION AND DISCUSSION 15
1-1 INTRODUCTION: THE BIOPHARMACEUTICAL INDUSTRY 15
1-2 Some Biopharmaceutical Market Trends .17
1-3 Market Potential .19
1-4 Biopharmaceutical RandD Pipelines .20
1-5 Biosimilars Are a Large Part of the Pipeline .26
1-6 U.S. AND WORLD BIOPHARMACEUTICAL AND RECOMBINANT
PROTEIN/mAb MARKETS .27
Overall Health of the Biopharmaceutical Sector 28
U.S. Industry Leadership Continues 30
Biopharmaceuticals in the Rest-of-the-World .31
1-7 Biopharmaceutical Markets by Product Class 34
mAbs are the Leading Product Classes 34
1 -8 Biopharmaceutical Blockbusters .36
1-9 Commercial Product Expression Systems 37
1-10 Animal Derived Products and Biopharmaceuticals 39
1-11 Cost-containment and Price Controls 39
1-12 Future Trends in the Biopharmaceutical Industry .40
1-13 Overview of Biopharmaceutical Market Trends .41
CHAPTER 2: Overview of Critical Issues in Bioprocessing .45
2-1 Protein A Resins Continue to Serve Monoclonal Antibodies
Manufacture Well, While Incremental Improvements Continue .46
2-2 Biosimilars: Review of Progress in 2014 51
2-3 Bioassays: A Critical and Commonly Outsourced
Part of Biopharmaceutical Development 54
2-4 Facility Contamination: Behavioral-Based Intervention .60
2-5 Alternatives to Protein A .63
2-6 The Use of Membrane Chromatography throughout a Product's Life Cycle 72
2-7 Continuous Bioprocessing and Perfusion: Single-use Technology
Aiding to Increase Adoption .77
2-8 Bioprocessing Equipment and Service Supplier Mergers
and Acquisitions, 2014 81
2-9 The Bioprocessing Equipment Supply Chain: Materials
in Single-use Products are the Weakest Link 84
CHAPTER 3: Emerging Issues in Biopharmaceutical Manufacturing .89
3-1 Industry Trends in 2015 .89
Productivity and Innovation 89
3-2 Budget Issues in 2015 .91
Budget Change Comparisons .94
3-3 Operational Changes .97
3-4 New Bioprocessing Products Development Opportunities in 2015 98
Innovations in Single-use/Disposable Equipment 100
Discussion of Needed Single-use Innovations .100
Other Areas for Innovation .102
New Product Development Focus, From 2010 to 2015 .102
New Product Development Areas: Biotherapeutic Developers vs. CMOs 104
New Product Development Areas: U.S. vs. Western Europe and ROW .106
3-5 Factors in Biomanufacturing Creating Improvements .108
Factors Improving Biomanufacturing Performance, 2010 - 2015 110
Factors Improving Biomanufacturing Performance, Biotherapeutic
Developers vs. CMOs 112
Factors Improving Biomanufacturing Performance, U.S. vs. Western
Europe vs. ROW 114
3-6 Cost-Cutting Actions and Development Timelines .116
Cost-Cutting Changes: Specifi c to Outsourcing . 118
3-7 Assay Development .119
3-8 Perfusion Operations Issues 121
Discussion 125
Selecting Bioreactors in New Facilities 126
3-9 Discussion: Perfusion Operations and Continuous Bioprocessing Trends .129
Continuous Bioprocessing: Trends and Opportunities .129
3-10 Discussion: Industry Trends and Issues 131
Industry Growth and Adaptation .131
Cost Cutting Trends 131
Trends in Assay Development .132
Trends in Speeding Development and Approval Timelines 132
Trends in Bioprocessing Industry Desires for Improved Products and Services .133
CHAPTER 4: Capacity Utilization . 135
4-1 Capacity Utilization Trends 135
Capacity Utilization Defi nitions .135
Relevance of Capacity Utilization 136
Capacity Utilization in Biomanufacturing, 2015 137
Capacity Utilization Changes Since 2004 .138
Average Growth Rate in Capacity Utilization, 2006-2015 140
4-2 Capacity Utilization: CMOs vs. Biotherapeutic Developers .141
4-3 Capacity Utilization: U.S. vs. Western European Manufacturers .144
4-4 Respondents' Current Total Production Capacity .145
Mammalian Cell Culture .145
Estimated Bioreactor Capacity Distribution, Biotherapeutic
Developers and CMOs 148
Biopharmaceutical Developers/Manufacturers as CMOs 150
Microbial Fermentation Capacity .150
Yeast Production Capacity .152
Insect Cells Production Capacity .153
4-5 Discussion: Current State of Capacity Utilization.154
Future Capacity Issues 155
4-6 Range of Titers for MAb Production .156
Annual Mab Titer Change, 2008-2015 .158
4-7 Discussion: Capacity and Industry Trends 159
Capacity Utilization 159
CHAPTER 5: Current and Future Capacity Constraints 165
5-1 Current Capacity Constraints .165
Respondents Experiencing No Capacity Constraints 167
Respondents' Perception of Capacity Constraints, 2004-2015 167
Perception of Capacity Constraints: Biotherapeutic Developers vs. CMOs .170
Capacity Constraints: U.S. vs. Western European Biotherapeutic
Developers and CMOs 172
5-2 Expected Capacity Constraints 174
Respondents' Expectations of Capacity Constraints by 2020 174
Expected Capacity Constraints by 2020: Comparing 2004 to 2015 Data 176
Expected Capacity Constraints by 2020: CMOs vs. Biotherapeutic Developers .178
Expected Capacity Constraints by 2020: U.S. vs. Western Europe180
5-3 Factors Impacting Future Production Capacity 181
Factors Creating Future Capacity Constraints .181
Factors Creating Future Capacity Constraints, 2008 vs. 2015 183
Factors Creating Future Capacity Constraints: Biotherapeutic
Developers vs. CMOs 185
CMOs' Capacity Bottleneck Projections, in Retrospect .188
Biotherapeutic Developers' Capacity Bottleneck Projections, in Retrospect .189
Factors Creating Capacity Constraints: U.S. vs. Western European Respondents 190
5-4 Key Areas to Address to Avoid Future Capacity Constraints 192
Analysis of Areas to Avoid Capacity Constraints: Changing Perspectives,
2006-2015 194
Key areas to Address to Avoid Capacity Constraints;
Biomanufacturers vs. CMOs: 2015 vs. Recent Years 196
Key Areas to Address to Avoid Capacity Constraints: U.S. vs. Western Europe .199
5-5 Discussion 201
Overall Capacity Constraints .202
CHAPTER 6: Future Capacity Expansions . 207
6-1 Planned Future Capacity Expansions 207
Planned Future Capacity Expansions, 2009-2020 .208
Planned Future Capacity Expansions by 2020; CMOs vs. Biotherapeutic
Developers .210
Planned Five-Year Capacity Expansions; U.S. vs. Western European
Manufacturers 212
Planned Future Capacity Expansions of >100% 214
CHAPTER 7: Outsourcing Trends in Biopharmaceutical Manufacturing . 217
Why Outsource? 217
Critical Outsourcing Operations .217
Relating Outsourcing to Workforce Reduction .218
Strategic Manufacturing Planning 218
Future Projections 219
7-1 Current Outsourcing by Production System .220
Summary of Findings: .221
Facilities Currently Outsourcing No Production (All Production “In-house”),
2006-2015 223
7-2 Future Outsourcing 225
Biotherapeutic Developers' Outsourcing, 2020 Projections, by System 225
Biotherapeutic Developers Outsourcing Some Production in 2020 .227
7-3 Outsourced Activities in Biopharmaceutical Manufacturing .229
Comparison of Biomanufacturers' Outsourcing, (2010-2020) 231
Increased Outsourced Activities, 24-month Projections 233
Outsourcing Activities Projected at ‘Signifi cantly Higher Levels', Comparison
of 2010-2015 Trends 235
Average Percentage of Activities Outsourced Today .237
Comparison of Outsourcing Activities, 2010-2015 .239
Change in Spending on Outsourcing Activities 241
7-4 Critical Outsourcing Issues 242
Selecting a CMO: 2015 .242
Selecting a CMO, 2006-2015 .244
Changes in Critical Issues when Considering a CMO, 2006-2015 246
CMOs' Problems with Clients .248
7-5 Country Selections for International Outsourcing (Off-shoring) of
Biomanufacturing 250
U.S. vs. Western European Respondents' Outsourcing Destinations .252
Western European Respondents' Outsourcing Destinations .257
5-Year Projection for Biomanufacturing International Outsourcing/Off-shoring .260
Offshoring Trends .261
5-Year Projection for Percentages of Biomanufacturing International
Outsourcing/Off-shoring .262
Some respondent comments 263
7-6 Discussion: 264
Selecting a CMO 267
CHAPTER 8: Disposables and Single-Use Systems in Biopharmaceutical
Manufacturing 271
8-1 Use of Disposables and Single-Use Systems .271
Disposables Applications in Biopharmaceutical Manufacturing .271
Trends in Disposable Applications: 2006-2015 274
Annual Growth Rate for Disposables Market Penetration / Usage 276
9-year Growth in Disposables Applications, Percentage-point Gains 278
Disposable Use by Stage of Production/Application .279
Use of Disposables: CMOs vs. Biotherapeutic Developers 281
Leachables and Extractables .283
Paying for LandE Testing .284
8-2 Reasons for Increasing Use of Disposables and Single-Use Systems 285
Reasons for Increased Use of Disposables, 2006 through 2015 287
Reasons for Increased Use of Disposables: Biotherapeutic Developers vs.
CMOs .289
Single Most Critical Reason for Increasing the Use of Disposables 291
8-3 Factors That May Restrict Use of Disposables .293
Factors That May Restrict Use of Disposables: Trends 2006-2015 .295
Factors that May Restrict Use of Disposables: CMOs vs. Biotherapeutic
Developers .297
Most Critical Reasons for Restricting Use of Disposables .299
Most Important Reasons for Not Increasing Use of Disposables, 2008-2015 .301
Most Important Reasons for Restricting Use of Disposables: Biotherapeutic
Developer vs. CMO .303
Top Reasons for Not Increasing the Use of Disposables: U.S. vs. European
Respondents 305
8-4 Standards Setting for Disposable,
Single-use Systems .307
Standardizing Single-use Designs .307
Standardization Factors, 2013-2015 308
Suppliers' Expectations for Standards Setting Bodies .310
8-5 Budgets for Disposable Systems .311
Annual Growth Rate in Budgets for Single-use Components
2007-2013 311
8-6 Disposable Adoption Issues, Need for Single-use Sensors, and
Bioreactor Attributes .312
Single-Use Adoption Issues .312
Single-use Adoption Factors, U.S. vs Western Europe 313
Single-Use Sensor Technologies .314
8-7 Recycling and Disposal of Single-use Plastics .316
Waste Disposal of Single-use Devices 316
Meeting Respondents' Demands for Recycling .316
8-8 Satisfaction with Vendors of Disposables for Biopharmaceutical
Manufacturing 317
Single-Use Attribute Importance Analysis 319
Percentage of Unit Operations that are Single-use .322
Distribution of Responses 323
8-9 Discussion .324
Single-use Advantages 324
Growth in the Use of Single-use Systems .325
Downstream Single-use Systems Use .326
CMOs' Use of Single-use Equipment .326
Downstream Bottlenecks Persist .327
Modular: The Next Trend after Single-use? 327
Single-use Equipment Sourcing, Quality Issues, and LandE Testing 328
CHAPTER 9: Downstream Purifi cation 335
9-1 Impact of Downstream Processing
on Capacity .335
Impact of Downstream Processing on Capacity, Biopharmaceutical
Developers vs. CMOs .338
Impact of Downstream Processing on Capacity, U.S. vs. Western
European Biomanufacturers 340
9-2 Specifi c Purifi cation Step Constraints .342
Changes in Impact on Capacity of Purifi cation Steps, 2008-2015 .344
Specifi c Purifi cation Step Constraints, U.S. vs. Western European
Biomanufacturers .345
9-3 Downstream Purifi cation Issues Facing the Industry Today .346
Protein A and Alternatives 346
Changes in Perception of Protein A and Alternatives .347
Protein A Downstream Purifi cation Issues, U.S. vs. Western Europe 348
9-4 mAb Purifi cation Capacity Estimates; Current Upstream Production
Titer vs. Max Capacity .349
9-5 New Downstream Processing Technologies .352
New Downstream Processing Solutions; 2010 - 2015 354
New Downstream Processing Technologies; Biotherapeutic
Developers vs. CMOs 356
New Downstream Processing Technologies; U.S. vs. Western Europe 358
9-6 Improvements to Downstream Operations 360
Comparison of New Downstream Technology Implementation;
Biomanufacturers vs. CMOs 362
Comparison of New Downstream Technology Investigations;
U.S. vs. W. Europe vs. ROW .364
9-7 Discussion 366
Upstream Expression Titer Trends and Impact on Downstream Operations .366
Downstream Processing Solutions 366
CHAPTER 10: Quality Issues, Batch Failures, and PAT in Biopharmaceutical
Manufacturing 371
Introduction 371
10-1 Hurdles to Implementing Process Analytical Technology, 2008-2015 .372
PAT Adoption Will Increase 374
10-2 Batch Failure Frequency in Biopharmaceutical Manufacturing 375
10-3 Primary Cause of Batch Failures and Percentages of Failures .377
10-4 Quality Problems in Biopharmaceutical Manufacturing
Attributed to Vendors .382
10-5 Automation Implementation 384
Comparison of Implementation Plans 2009 - 2013 384
10-6 Quality Initiative Implementation 386
Comparison of Quality Initiative Implementation, 2009 - 2015 387
10-7 Global Quality Supply Management .389
Quality Supply Management-US vs. W. Europe 390
10-8 Discussion 391
Hurdles Hindering Implementation of PAT .391
Batch Failures Due to Single-Use Adoption or Continued Stainless Steel Use? .392
Quality Problems Traced to Vendors .392
Process Information Needs and Value Drive Automation .393
Quality Initiatives Are Becoming Commonplace and the New Industry Norm .393
Challenges to Implementing PAT, QbD and other Quality Initiatives 394
Supply Management Issues with Single-use Systems 394
CHAPTER 11: Hiring, Employment Growth, and Training in Biopharmaceutical
Manufacturing 395
Introduction 395
11-1 Hiring Trends 396
11-2 Hiring in 2020: 5-year Trends .397
11-3 Hiring Challenges Today 398
Hiring Diffi culties; 2010 - 2015 .400
Hiring Diffi culties: U.S. vs. Western Europe .402
U.S. vs. Western Europe Hiring Trends .402
11-4 Training in Biopharmaceutical Manufacturing 404
Changes in Training for New Manufacturing Employees, 2009-2015 406
11-5 Discussion .407
Options Developing for Bioprocessing Training .407
Continued Growth in Biopharmaceutical Manufacturing Jobs .409
CHAPTER 12: Fill and Finish 411
Introduction 411
12-1 Demographics 411
Areas of Involvement . 411
Geographic Location, Facilities 412
12-2 Trends in Aseptic Bioprocessing Capacity 413
An Analysis of US and European In-house Capacity and
Capacity Utilization .413
Problems in Estimating Capacity 415
Current Fill-Finish Trends .415
Recent Industry Trends 417
Future Fill and Finish Trends .418
Suppliers' Innovation Trends 418
Industry Capacity Data .419
12-3 Discussion 421
Voice of Industry 421
CHAPTER 13: Suppliers to Biopharmaceutical Manufacturing and Life Sciences . 425
Introduction 425
13-1 Demographics 425
Areas of Involvement .425
Location of Vendor Sales 428
Respondents' Primary Job 430
13-2 Growth Rate of Sales by Suppliers 431
Average Industry Growth Rate, By Segment .433
Vendor Sales Growth Rates, by Industry Segment, 2007 to 2015 .434
Supplier Annual Sales, Distribution 436
13-3 Discussion .437
13-4 Budget Issues and Problems Faced by Industry Supplier .438
Budget Challenges in 2015 438
Vendor Average Budget Changes for 2009 -2015 .440
Vendor Pricing Changes 442
Future Price Changes 443
13-5 Cost Cutting Actions by Vendors .444
Cost Cutting Actions, By Segment .446
13-6 Problems Clients Have With Their Vendors .448
Vendor Expansion Plans 450
Biopharma Vendor Business Trends, 2010 vs 2015 452
Top New Technology Areas in Development by Vendors .454
13-7 Discussion: Supplier Budget Issues .458
13-8 Sales Staff Training 459
Days of Training Provided .459
Areas where Training May Help Sales Staff Perform, Trends
2010 - 2015 460
Clients' Demands on Vendors 462
Biopharma Vendors' Outlook for 2015 .464
13-9 Discussion 465
Bioprocessing Vendors Will See Continued Market Growth 465
Single-use Systems Are Increasingly Driving Sales 465
Trends Favor Increased Vendor Sales .466
Vendors are Offering More Services, Going for Larger Sales 467

FIGURES
Fig 0.1: Area of Primary Involvement in Biopharmaceutical Manufacturing, 2010 to 2015 2
Fig 0.2: Respondents' Job Responsibilities, 2011 - 2015 .3
Fig 0.3: Facility Location .4
Fig 0.4: Facility Location, by Region .5
Fig 0.5: Biopharmaceutical Manufacturing Systems, (2007-2015) Trends .7
Fig 0.6: Phase of Development of Surveyed Respondents.9
Fig 0.7: Phase of Development of Surveyed Respondents, 2015 (US vs Western Europe) .10
Fig 0.8: Distribution of Employees at Facility, and Organization .11
Fig 0.9: Distribution of Total Batches Run at Facility Last Year, by Scale of Production .13
Fig 1.1: Investigational Drugs: Large Molecule (Protein Therapeutics),
Worldwide, 2010 - 2015 .21
Fig 1.2: Current Worldwide Pipeline and Launched Products, Large Molecules,
January 2015 .23
Fig 1.3: Current Worldwide Pipeline and Launched Products, Large Molecules,
January 2015 .24
Fig 2.1: Scanned Excerpt from an FDA Form 483 61
Fig 2.2: Antibody binding capacities on two prototype mixed mode membranes
from Natrix Separations. 74
Fig 2.3: Example of chromatographic like separation achieved on a mixed mode
membrane from Natrix Separations. .75
Fig 3.1: SINGLE most important biomanufacturing trend or operational area, 2014-2015 90
Fig 3.2: Biomanufacturers' Budget Shifts in 2015 .92
Fig 3.3: Approximate Average Change in Biomanufacturers' Budgets for 2015 93
Fig 3.4: Average Biomanufacturers' Budget Change, 2009-2015 96
Fig 3.5: New Product Development Focus Areas .99
Fig 3.6: New Product Development Areas of Interest: 2010 - 2015 103
Fig 3.7: New Product Development Areas of Interest: Biotherapeutic
Developers vs CMOs .105
Fig 3.8: New Product Development Areas of Interest: US vs Western Europe and ROW 107
Fig 3.9: Factors in Biomanufacturing Performance Creating “Signifi cant” or
“Some” Improvements .109
Fig 3.10: Factors in Biomanufacturing Performance Creating “Signifi cant” or
Some” Improvements: 2010 - 2015 .111
Fig 3.11: Factors in Biomanufacturing Performance Creating “Signifi cant” or
“Some” Improvements: Biomanufacturers vs. CMOs 113
Fig 3.12: Factors in Biomanufacturing Performance Creating “Signifi cant” or
“Some” Improvements: U.S. vs Western Europe vs. Rest of World .115
Fig 3.13: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months”
Comparing 2011-2015 .117
Fig 3.14: Cost-Cutting Changes, Outsourced Jobs, by Segment, and Geography .118
Fig 3.15: Biomanufacturing Assay ‘Areas' Urgently Requiring New, Improved
Testing Methods, 2011 -2015.120
Fig 3.16: Perfusion Operations Issues: Perfusion vs. Batch-Fed Processes (2014 data) 123
Fig 3.17: Perfusion Operations Issues: Comparison 2010 - 2014 .124
Fig 3.18: Likelihood of Implementing bioreactor, by type (2014 data)127
Fig 3.19: Likelihood of Implementing Single-use Bioreactors, Clinical Scale, 2012-2014 .128
Fig 4.1: Capacity Utilization, By System137
Fig 4.2: Capacity Utilization, By System, 2004-2015 139
Fig 4.3: Change in Capacity Utilization, CAGR, 2006-2015140
Fig 4.4: Capacity Utilization, By System, Biotherapeutic Developer vs. CMOs 143
Fig 4.5: Capacity Utilization, By System, U.S. vs Western Europe .144
Fig 4.6: Current Production Capacity Distribution, Mammalian Cell Culture 146
Fig 4.7: Production Capacity Distribution, Mammalian Cell Culture, 2011-2015 147
Fig 4.8: Current Production Capacity Distribution, Microbial Fermentation 151
Fig 4.9: Current Production Capacity Distribution, Yeast 152
Fig 4.10: Current Production Capacity Distribution, Insect Cells 153
Fig 4.11: Mammalian Cell Culture Capacity Estimates 2003-2014 .154
Fig 4.12: Microbial Fermentation Capacity Estimates 2003-2014.155
Fig 4.13: Range of Titres for Mabs Obtained at Various Production Scales, Distribution .157
Fig 4.14: Average Mab Titre Trend 2008-2015 158
Fig 5.1: Capacity Constraints, by Stage of Production .166
Fig 5.2: Capacity Constraints, 2004 through 2015 168
Fig 5.3: Capacity Constraints Trends, 2004-2015 .169
Fig 5.4: Capacity Constraints, Biotherapeutic Developers vs. CMOs 171
Fig 5.5: Capacity Constraints, U.S .vs. Western Europe .173
Fig 5.6: Expectations of Capacity Constraints; by Stage of Production;
Five-year Projections .175
Fig 5.7: Expectations of Capacity Constraints: Five-year Projections Made in 2004-2015 177
Fig 5.8: Expectations of Capacity Constraints: Five-year Projections Made in
2004 thru 2020 (Trend Line) .178
Fig 5.9: Five-year Projections for Capacity Constraints: Biotherapeutic
Developers vs. CMOs 179
Fig 5.10: Five-year Projections for Capacity Constraints: U.S. vs. Western Europe 180
Fig 5.11: Factors Creating Future Capacity Constraints 182
Fig 5.12: Factors Creating Future Capacity Constraints, 2008-2015 184
Fig 5.13: Factors Creating Future Capacity Constraints: Biotherapeutic
Developers vs. CMOs 186
Fig 5.14: Factors Creating Future Capacity Constraints, U.S. vs. Western
European Biomanufacturers 191
Fig 5.15: Key areas to Address to Avoid Capacity Constraints 193
Fig 5.16: Key areas to Address to Avoid Capacity Constraints; 2006-2015 195
Fig 5.17: Key Areas to Address to Avoid Capacity Constraints;
Biomanufacturers vs. CMOs .198
Fig 5.18: Key areas to Address to Avoid Capacity Constraints; U.S. vs. Western Europe .200
Fig 6.1: Industry Average Planned Production Increase by 2020 207
Fig 6.2: Planned Future Capacity Expansion: 5-year Estimates, 2009 through 2020 .209
Fig 6.3: Planned Future Capacity Expansion: 5-year Estimates; Biotherapeutic
Developers vs. CMOs 211
Fig 6.4: Planned Future Capacity Expansion: 5-year Estimates; U.S. vs. Western Europe 213
Fig 6.5: Percent of Respondents Projecting Production Increases of over 100% by 2020;
5-year Trend .215
Fig 7.1: Current Percent Production Outsourced; by System, 2015 .222
Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production,
2006-2015 224
Fig 7.3: Future Outsourcing: Percent Production Outsourced; by System, in 2020 .226
Fig 7.4: Five-year Projections: % Biotherapeutic Developers Planning to Outsource
at Least Some Production; Projections made 2007-2015 .228
Fig 7.5: Percent of Biomanufacturers Outsourcing at Least Some Activity Today 230
Fig 7.6: Percent of Biomanufacturers Outsourcing at Least Some Activity, 2010 - 2015 232
Fig 7.7: Outsourcing Activities Projected to be Done at ‘Signifi cantly Higher Levels'
Next 2 Years .234
Fig 7.8: Outsourcing Activities Projected to be Done at ‘Signifi cantly Higher Levels'
in 2 Years, 2010 - 2015 Trends 236
Fig 7.9: Current Outsourcing: Average Percentage of Activity Outsourced Today .238
Fig 7.10: Estimated Average Percent of Activity Outsourced by Facilities, 2010 thru 2015 .240
Fig 7.11: Change in Spending on Outsourcing for RandD or Manufacturing, 2012 - 2015 .241
Fig 7.12: Outsourcing Issues: BioManufacturing by Contract Manufacturing
Organizations .243
Fig 7.13: Important Outsourcing Issues: BioManufacturing by Contract Manufacturing
Organizations, Trends 2006-2015 245
Fig 7.14: Important Outsourcing Issues: Response Shifts Over Time 2006-2015,
Percentage Point Differences 247
Fig 7.15: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs,
2010-2013 249
Fig 7.16: Country Selections as Destination for International Outsourcing of .
BioManufacturing (All Respondents) .251
Fig 7.17: Percent U.S. Respondents Considering Country as ‘Possible'
Outsourcing Destination 253
Fig 7.18: Percent U.S. Respondents Considering Country as “Strong Likelihood” or
“Likelihood” as Outsourced Capacity Destination .255
Fig 7.19: Percent Western European Respondents Considering Country as ‘Possible'
Outsourcing Destination 258
Fig 7.20: Percent European Respondents Considering Country as “Strong Likelihood”
or “Likelihood” as Outsourced Capacity Destination .259
Fig 7.21: Percent of Biomanufacturing Operations Off-shored
(International Outsourcing) within 5 Years .260
Fig 7.22: Percent Biomanufacturers Performing at Least “Some” of the following as
International Outsourcing/Off-shoring during Next 5 Years .261
Fig 7.23: Estimated % Operations Done as International Outsourcing/Off-shoring during
Next 5 Years .262
Fig 8.1: Usage of Disposables in Biopharmaceutical Manufacturing, any Stage
of RandD or Manufacture 273
Fig 8.2: Usage of Disposables in Biopharmaceutical manufacturing, any Stage
of RandD or Manufacture; 2006-2015 .275
Fig 8.3: Average Annual Growth Rate, Disposables, 2006-2015 277
Fig 8.4: 9-Year Percentage-Point Change in First-Usage of Disposables, 2006-2015 .278
Fig 8.5: Usage of Disposables in Biopharmaceutical Manufacturing, by Stage of
Manufacture (RandD Through Commercial Manufacture) 280
Fig 8.6: Usage of Disposables in Biopharmaceutical Manufacturing;
Biotherapeutic Developer vs. CMO .282
Fig 8.7: Value of Useable Leachables and Extractables Data 284
Fig 8.8: Reasons for Increasing Use of Disposable System Components in 2015 .286
Fig 8.9: Reasons for Increasing Use of Disposable System Components, 2006-2015 288
Fig 8.10: Reasons for Increasing Use of Disposable System Components,
Biotherapeutic Developers vs. CMOs 290
Fig 8.11: Single Most Critical Reason for Increasing Use of Disposables, 2009 - 2015 .292
Fig 8.12: Reasons for Restricting Use of Disposables 294
Fig 8.13: Factors Restricting Use of Disposables, 2006-2015 296
Fig 8.14: Factors Restricting Use of Disposables, Biotherapeutic Developer vs. CMO .298
Fig 8.15: Top Reasons for Not Increasing Use of Disposables, 2015 .300
Fig 8.16: Top Reasons for Not Increasing Use of Disposables, 2008-2015 .302
Fig 8.17: Top Reasons for Not Increasing Use of Disposables, Biotherapeutic
Developer vs. CMO304
Fig 8.18: Top Reasons for Not Increasing Use of Disposables, U.S. vs. Western Europe .306
Fig 8.19: Single-use/Disposables Standardization Factors 308
Fig 8.20: Single-use/Disposables Standardization Factors, 2013-2015 .309
Fig 8.21: Single-use / Disposable Device Adoption Factors.312
Fig 8.22: Single-use / Disposable Device Adoption Factors; U.S. vs Western Europe 313
Fig 8.23: Need for Improved Single-Use Sensors, 2012-2015 .315
Fig 8.24: Single-use Product Vendor Satisfaction Factors, 2008 - 2015 .318
Fig 8.25: Importance of Single-use Product Attributes vs Level of Vendor Satisfaction .320
Fig 8.26: Percentage Point Gap between Importance of SUS Product Attributes
and Level of Satisfaction 321
Fig 8.27: Estimated Percentage of Facilities' Unit Operations That Are “Single-use”
(2014 vs 2015) .322
Fig 8.28: Distribution of Responses, % Single-use Devices in Biomanufacturing 323
Fig 9.1: Impact of Downstream Processing on Overall Capacity, 2008-2015 .337
Fig 9.2: Impact of Downstream Processing on Overall Capacity; Biotherapeutic
Developers vs. CMOs 339
Fig 9.3: Impact of Downstream Processing on Overall Capacity;
U.S. vs. Western Europe 341
Fig 9.4: Impact on Capacity of Depth, Chromatography and UF Purifi cation Steps 343
Fig 9.5: Impact on Capacity of Purifi cation Steps: Experiencing at “Signifi cant” or
“Severe” Constraints, 2008 - 2015 .344
Fig 9.6: Impact on Capacity of Purifi cation Steps, U.S. vs. Western Europe 345
Fig 9.7: Issues Regarding Protein A Usage 346
Fig 9.8: Issues Regarding Protein A Usage, 2009 - 2015 .347
Fig 9.9: Issues Regarding Protein A Usage; U.S. vs. Western Europe .348
Fig 9.10: mAb Operations: Current Upstream mAb Production Titer
(Distribution of Responses) 350
Fig 9.11: Bioreactor Yield at which DOWNSTREAM mAb Purifi cation Train
Becomes Bottlenecked 351
Fig 9.12: New Downstream Processing Solutions .353
Fig 9.13: New Downstream Processing Solutions Comparison 2010-2015 355
Fig 9.14: New Downstream Processing Solutions; Biotherapeutic Dev. vs. CMO 357
Fig 9.15: New Downstream Processing Solutions; U.S. vs. Western Europe359
Fig 9.16: Improving Downstream Operations, 2011 - 2015 361
Fig 9.17: Improving Downstream Operations; Biomanufacturers vs. CMOs 363
Fig 9.18: Improving Downstream Operations (U.S. vs. Western Europe vs. ROW) 365
Fig 10.1: Hurdles Hindering Implementation of PAT (2008 - 2015) 373
Fig 10.2: Batch Failure Frequency Distribution, 2009 - 2015 376
Fig 10.3: Average Rates of Failure, by Primary Cause, and Scale of Manufacture 378
Fig 10.4: Average Rates of Failure, by Primary Cause, and Phase of
Manufacturing 2009 - 2015 (Commercial Manufacture) 379
Fig 10.5: Average Rates Failure, by Primary Cause, and Phase of
Manufacturing 2009 - 2015 (“Clinical” Scale) 381
Fig 10.6: Quality Problems Traced to Vendors; 2008 - 2015 383
Fig 10.7: Quality Initiatives Implemented Currently, or within Next 12 Months .386
Fig 10.8: Quality Initiative to be Implemented in “Next 12 Months,”
Comparing 2009 - 2015 .388
Fig 11.1: New Hires in Biopharmaceutical Manufacturing (2015) 396
Fig 11.2: New Hires in Biopharmaceutical Manufacturing (2020) 397
Fig 11.3: Areas Where Hiring Diffi culties Exist in Biopharmaceutical Operations 399
Fig 11.4: Areas Where Hiring Diffi culties Exist in Biopharmaceutical Operations;
2010 - 2015 401
Fig 11.5: Areas Where Hiring Diffi culties Exist in Biopharmaceutical Operations,
U.S. vs. Western Europe 403
Fig 11.6: Training for New Operations/Manufacturing Employees 405
Fig 11.7: Changes in Training for New Operations/Manufacturing Employees,
2009 - 2015 406
Fig 12.1: Fill-Finish Operation Type 411
Fig 12.2: Fill-Finish Operation Location .412
Fig 12.3: Fill-Finish Capacity Utilization Averages (12th Annual Report data)414
Fig 12.4: Most Important Trends in Fill-Finish 416
Fig 12.5: Novel Fill-Finish Technologies; Implementation Plans within 2 Years 420
Fig 13.1: Area of Biopharmaceutical Involvement, Vendor .426
Fig 13.2: Area of Biopharmaceutical Involvement, Vendor Comparison 2010 to 2015 427
Fig 13.3: Geographic Locations in which Vendors Currently Actively Sell
Products or Services, 2008 - 2015 429
Fig 13.4: Respondents' Primary Job Function 430
Fig 13.5: Average Annual Vendor Sales Growth Rate, 2007 - 2015 .431
Fig 13.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution 432
Fig 13.7: Average Annual Vendor Segment Sales Growth Rates, 2015 .433
Fig 13.8: Average Annual Vendor Sales Growth Rate, 2007 - 2015, by Segment 435
Fig 13.9: Vendors' Approx Annual Sales to Biopharmaceutical Segment % 436
Fig 13.10: Vendors' Average Budget Change for 2015 439
Fig 13.11: Vendors' Average Budget Change for 2009 - 2015, Summary 441
Fig 13.12: Vendors' Average Pricing Changes (2015 responses) 442
Fig 13.13: Vendors' Average Pricing Changes, 2009-2014 Actual and 2015 projected 443
Fig 13.14: Actions undertaken to reduce overall costs, prior 12 months, 2011 - 2015 445
Fig 13.15: Actions undertaken to reduce overall costs in past 12 months, By Segment447
Fig 13.16 (See Fig 10.6; recap): Quality Problems Traced to Vendors 449
Fig 13.17: Biopharma Business and Marketing Plans, 2015 451
Fig 13.18: Biopharma Business and Marketing Plans, 2010-2015 .453
Fig 13.19: Top New Technologies or New Product Development Areas .455
Fig 13.20: Areas Where Training May Help Sales Staff Perform Better; 2010 - 2015 .461
Fig 13.21: Client Demands of Vendors, Service and Support, 2012 - 2015 .463
Fig 13.22: Vendors' Optimism; Financial Performance 2011-2014, and Projected
Performance in 2015 464

TABLES
Table: 1.1 Biologics (Large Molecule), Worldwide, through January 2015 22
Table 1.2: Worldwide Pipeline, Large Molecules, 2008-2015 .25
Table 1.3: Number of Products in U.S. and European Markets* .27
Table 1.4: Summary of Worldwide Biopharmaceutical Revenue Growth by
Product Class, 2007 and 2014 .34
Table 1.5: Blockbuster Biopharmaceutical Products* 36
Table 1.6: Expression Systems/Host Cells for U.S./EU-Marketed
Cultured Biopharmaceuticals 38
Table 3.1: Areas of Signifi cant Projected Budget Percentage Increases for
Biomanufacturing, Past Years: .95
Table 4.1: Distribution of Mammalian Cell Culture Capacity, Product Manufacturers .148
Table 4.2: Compound Annual Change in Mab Titre, 2008-2015 159
Table 7.1: Percent of U.S.-based Respondents Indicating Country as a
“Strong Likelihood” or “Likelihood” as Outsourcing Destination, 2009-2014 256
Table 7.2: Percent of European-based Respondents Indicating Country as a
“Strong Likelihood” or “Likelihood” as Outsourcing Destination, 2011-2014 259
Table 8.1: Suppliers' Expectations for Who Should be Setting Standards for SUS 310
Table 9.1: Percent experiencing “Serious” or “Some” capacity problems due to
downstream processing 2008-2015 .338
Table 9.2: Percent U.S. vs. Western Europe facilities experiencing
“Serious” capacity problems due to downstream processing, 2009-2015 .340
Table 9.3: Percent U.S. vs. Western Europe facilities not expecting to see
bottlenecks due to downstream processing, 2008-2015 340
Table 9.4: Current Upstream Production Titer vs. Max Capacity 349
Table 10.1: Batch Failures, Average Weeks Between Failures, per Facility, 2008-2015 375
Table 11.1 Percentage New Hires, by Area; 2008 - 2015 .397
Table 13.1: Selected “Other” Responses, New Technology Areas in Development 456
Table 13.2: Average Vendor Sales and Technical Training Days, 2011 - 2013 459

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