15th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

Date: April 1, 2018
Pages: 511
Price:
US$ 895.00
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Publisher: BioPlan Associates, Inc.
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: 18B83BBCB7FEN
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15th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production
The 2018 15th 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. This report’s 511 pages of data-rich analysis will help improve your decision-making in biomanufacturing operations, with in-depth analysis of capacity, production trends, benchmarks, and much more.

In-depth analysis and summary of the key survey findings, trends and implications for industry-wide biomanufacturing capacity and biotherapeutic production. Comparison of production by biotherapeutic developers and contract manufacturing organizations. Current and future potential industry bottlenecks. Trend analysis in this 15th in a series of annual biopharmaceutical manufacturing industry evaluations. This edition includes the joint industry expertise from BioPlan Associates, and many industry consultants and experts.
CHAPTER 0: DEMOGRAPHICS

Introduction
0-1 Respondents’ Area of Involvement
0-2 Respondents Qualifications
0-3 Facility Locations
0-4 Areas of Biopharmaceutical Manufacturing Operations
0-5 Production Operations, Phase of Development
0-6 Employees at Facility
0-7 Batches Run at Facility per Year
0-8 Single Use Bioreactor Capacity, In Use at Site
0-9 Stainless Steel Bioreactor Capacity, In Use at Site

CHAPTER 1: INTRODUCTION AND DISCUSSION

1-1Introduction:The Pharmaceutical and Biopharmaceutical Industries
1-2Current Status and Market Trends
1-3 Market Potential
1-4 Biopharmaceuticals and Biosimilars in the Pipeline
FDA Biopharmaceutical Approvals
1-5 Global Biopharmaceutical and Recombinant Protein/MAb Markets
Overall Health of the Biopharmaceutical Sector
U.S. Industry Leadership Continues
Biopharmaceuticals in the Rest-of-the-World
1-6 Biopharmaceutical Markets by Product Class
Monoclonal antibodies (mAbs) are the Leading Product Classes
1-7 Animal Derived Products and Biopharmaceuticals
Report and Survey of Biopharmaceutical Manufacturing Capacity and Production
1-8 Future Trends in the Biopharmaceutical Industry
1-9 Future Biopharmaceutical Market Trends

CHAPTER 2: FUTURE OF BIOPROCESSING: EXPERTS’ PERSPECTIVE

2-1 Cell and Gene Therapy – Future of Bioprocessing
2-2 Continuous Processing – Present and Future Challenges
2-3 China and Asia’s position in Global Bioproduction
2-4 Intersection of Biopharma and Small Pharma: Small Molecule Manufacturing Lessons for a New Industry
2-5 Upstream and Downstream Biologics Manufacturing: Mapping the Future Challenges and Trends
2-6 Suppliers’ Contributions to Bioprocessing Advances
2-7 Contract Manufacturing’s Contributions to Bioprocessing Advances
2-8 Worldwide Biopharmaceutical Manufacturing Capacity Analysis:Growth Continues Across the Board
2-9 China’s Advances in Global Biopharma and Bioprocessing: A 10-year Projection on Need for Quality Improvements

CHAPTER 3: EMERGING ISSUES IN BIOPHARMACEUTICAL MANUFACTURING

3-1 Industry Trends in 2018
Introduction
Productivity and Cost Reductions
3-2 Budget Issues in 2018
Budget Change Comparisons
3-3 Operational Changes
3-4 New Bioprocessing Products Development Opportunities in 2018
Upstream New Product Areas of Need
Trends: Upstream New Product Areas of Need 2010-2018
Downstream New Product Areas of Need
Trends: Downstream New Product Areas of Need 2010-2018
Other New Product Areas of Need
Trends: Other General New Product Areas of Need 2010-2018
Innovations in Single-use/Disposable Equipment
Discussion of Needed Single-use Innovations
Other Areas for Innovation
New Product Development Areas:Biotherapeutic Developers vs. CMOs
New Product Development Areas:U.S. vs. Western Europe and ROW
3-5 Factors in Biomanufacturing Creating Improvements
Factors Improving Biomanufacturing Performance, 2010 - 2015
Factors Improving Biomanufacturing Performance, Biotherapeutic Developers vs. CMOs (2015 Data)
Factors Improving Biomanufacturing Performance, U.S. vs. Western Europe vs. ROW (2015 Data)
3-6 Cost-Cutting Actions & Development Timelines (2016 data)
Cost-Cutting Changes: Specifi c to Outsourcing (2016 data)
3-7 Average Cost per Gram Recombinant Protein
3-8 Assay Development
Biomanufacturing Assay Required; Biomanufacturers vs. CMOs (2016 data)
3-9 Perfusion Operations and Continuous Bioprocessing Operations Issues
Perfusion vs. Batch Fed Bioprocessing
3-10 Perfusion Operations and Continuous Bioprocessing Trends
Continuous Bioprocess and Process Intensification
3-11 Discussion
Continuous Bioprocessing: Trends and Opportunities
Perfusion: Trends and Opportunities
3-12 Cell and Gene Therapy Platforms
Cell and Gene Therapy Manufacturing Advancements
Cell and Gene Therapy Manufacturing Improvements, Systems, Platforms and Infrastructure
3-13 Selecting Bioreactors in New Facilities (2017 data)
3-14 Discussion:Industry Trends and Issues
Industry Growth and Adaptation
Cost Cutting Trends
Trends in Assay Development
Trends in Speeding Development and Approval Timelines
Trends in Bioprocessing Industry Desires for Improved Products and Services

CHAPTER 4: CAPACITY UTILIZATION

4-1 Capacity Utilization Trends
Capacity Utilization Definitions
Relevance of Capacity Utilization Capacity Utilization in Biomanufacturing, 2018
Capacity Utilization Changes Since 2004
Average Growth Rate in Capacity Utilization, 2006-2018
4-2 Capacity Utilization: CMOs vs. Biotherapeutic Developers
4-3 Capacity Utilization: U.S. vs. Western European Manufacturers
4-4 Respondents’ Current Total Production Capacity
Mammalian Cell Culture
Estimated Bioreactor Capacity Distribution, Biotherapeutic Developers and CMOs
Biopharmaceutical Developers/Manufacturers as CMOs
Microbial Fermentation Capacity
Cell or Gene Therapy Capacity
Yeast Production Capacity (2016)
Insect Cells Production Capacity (2016)
4-5 Discussion: Capacity Trends
4-6 Range of Titers with mAb Production
Annual mAb Titer Changes, 2008-2018
4-7 Discussion: Capacity and Industry Trends
Capacity Utilization

CHAPTER 5: CURRENT AND FUTURE CAPACITY CONSTRAINTS

5-1 Current Capacity Constraints
Respondents Experiencing No Capacity Constraints
Respondents’ Perception of Capacity Constraints, 2004-2018
Perception of Capacity Constraints:Biotherapeutic Developers vs. CMOs
Capacity Constraints:U.S. vs. Western European Biotherapeutic Developers & CMOs
5-2 Expected Capacity Constraints 210 Respondents’ Expectations of Capacity Constraints by 2023
Expected Capacity Constraints by 2023: Comparing 2004 through 2018 Data
Expected Capacity Constraints by 2023:CMOs vs. Biotherapeutic Developers
Expected Capacity Constraints by 2023:U.S. vs. Western Europe
5-3 Factors Impacting Future Production Capacity
Factors Creating Future Capacity Constraints
Factors Creating Future Capacity Constraints, 2008 vs. 2018
Factors Creating Future Capacity Constraints:Biotherapeutic Developers vs. CMOs
CMOs’ Capacity Bottleneck Projections, in Retrospect
Biotherapeutic Developers’ Capacity Bottleneck Projections, in Retrospect
Factors Creating Capacity Constraints: U.S. vs. Western European Respondents
5-4 Key Areas to Address to Avoid Future Capacity Constraints
Analysis of Areas to Avoid Capacity Constraints: Changing Perspectives, 2006-2018
Key areas to Address to Avoid Capacity Constraints; Biotherapeutic Developers vs. CMOs
Key Areas to Address to Avoid Capacity Constraints: U.S. vs. Western Europe
5-5 Discussion
Overall Capacity Constraints

CHAPTER 6: FUTURE CAPACITY EXPANSIONS

6-1 Planned Future Capacity Expansions
Planned Future Capacity Expansions, 2009-2023
Planned Future Capacity Expansions by 2023; CMOs vs. Biotherapeutic Developers
Planned Five-Year Capacity Expansions; U.S. vs. Western European Manufacturers
Planned Future Capacity Expansions of >100%

CHAPTER 7: OUTSOURCING TRENDS IN BIOPHARMACEUTICAL MANUFACTURING

Why Outsource?
Relating Outsourcing to Workforce Reduction
Strategic Manufacturing Planning
Future Projections
7-1 Current Outsourcing by Production System
Facilities Currently Outsourcing No Production (All Production “In-house”), 2006-2018
7-2 Future Outsourcing
Biotherapeutic Developers’ Outsourcing, 2023 Projections, by System
Biotherapeutic Developers Outsourcing Some Production in 2023
7-3 Outsourced Activities in Biopharmaceutical Manufacturing
Comparison of Biomanufacturers’ Outsourcing, (2010-2018)
Increased Outsourced Activities, 24-month Projections
Outsourcing Activities Projected at ‘Significantly Higher Levels’, Comparison of 2010-2018 Trends
Average Percentage of Activities Outsourced Today
Comparison of Outsourcing Activities, 2010-2018
Change in Spending on Outsourcing Activities
7-4 Critical Outsourcing Issues
Selecting a CMO:2018
Selecting a CMO, 2006-2018
Changes in Critical Issues when Considering a CMO, 2006-2018
7-5 CMOs’ Problems with Their Clients
7-6 Country Selections for International Outsourcing (Off-shoring) of Biomanufacturing
U.S. vs. Western European Respondents’ Outsourcing Destinations
Western European Respondents’ Outsourcing Destinations
5-Year Projection for Biomanufacturing International Outsourcing/Off-shoring
7-7 Offshoring Trends
5-Year Projection for Percentages of Biomanufacturing International Outsourcing/Off-shoring
7-8 Discussion of Outsourcing and Offshoring
Selecting a CMO

CHAPTER 8: DISPOSABLES AND SINGLE-USE SYSTEMS IN BIOPHARMACEUTICAL MANUFACTURING

8-1 Use of Disposables and Single-Use Systems
Disposables Applications in Biopharmaceutical Manufacturing
Trends in Disposable Applications: 2006-2018
Annual Growth Rate for Disposables Market Penetration/Usage
10-year Growth in Disposables Applications, Percentage-point Gains
Disposable Use by Stage of Production/Application
Use of Disposables:CMOs vs. Biotherapeutic Developers
8-2 Leachables and Extractables
Paying for L&E Testing, 2018 vs. 2016
8-3 Reasons for Increasing Use of Disposables & Single-Use Systems
Reasons for Increased Use of Disposables, 2006 through 2015
Single Most Critical Reason for Increasing the Use of Disposables
8-4 Factors That May Restrict Use of Disposables
Factors That May Restrict Use of Disposables: Trends 2006-2015
Factors that May Restrict Use of Disposables: CMO’s vs. Biotherapeutic Developers
Most Critical Reasons for Restricting Use of Disposables
Most Important Reasons for Not Increasing Use of Disposables, 2008-2018
Most Important Reasons for Restricting Use of Disposables: Biotherapeutic Developer vs. CMO
Top Reasons for Not Increasing the Use of Disposables: U.S. vs. Western Europe Respondents
8-5 Suppliers’ Expectations for Standards Setting Bodies
8-6 Need for Single-use Sensors, and Bioreactor Attributes
Single-Use Adoption Issues
Single-use Adoption Factors, U.S. vs. Western Europe
8-7 Satisfaction with Single-use Device Vendors
Single-Use Attribute Importance Analysis
Single-use Suppliers’ Delivery Problems, 2013-2018
8-8 Single Use Operations and Trends
Percentage of Unit Operations that are Single-Use
Distribution of Responses
8-9 Discussion of Single-use Bioprocessing
Single-use Advantages
Growth in the Use of Single-use Systems
Downstream Single-use Systems Use
CMOs’ Use of Single-use Equipment
Downstream Bottlenecks Persist
Modular:The Next Trend after Single-Use
Single-use Equipment Sourcing, Quality Issues, and L&E Testing

CHAPTER 9: DOWNSTREAM PURIFICATION

9-1 Impact of Downstream Processing on Capacity
Impact of Downstream Processing on Capacity, Biopharmaceutical Developers vs. CMOs
Impact of Downstream Processing on Capacity, U.S. vs. Western European Biomanufacturers
9-2 Specific Purification Step Constraints
Changes in Impact on Capacity of Purification Steps, 2008-2018
Specific Purification Step Constraints, U.S. vs. Western European Biomanufacturers
9-3 Downstream Purification Issues
Protein A and Alternatives
Changes in Perception of Protein A and Alternatives
Protein A Downstream Purification Issues, U.S. vs. Western Europe
9-4 mAb Purification Capacity Estimates
Upstream Production Titer vs. Max Capacity
9-5 New Downstream Processing Technologies
New Downstream Processing Solutions; 2010 – 2018
New Downstream Processing Technologies; Biotherapeutic Developers vs. CMOs
New Downstream Processing Technologies; U.S. vs. Western Europe
9-6 Improvements to Downstream Operations
Comparison of New Downstream Technology Implementation; Biomanufacturers vs. CMOs
Comparison of New Downstream Technology Investigations; U.S. vs. W. Europe vs. ROW
9-7 Discussion
Upstream Expression Titer Trends and Impact on Downstream Operations
Downstream Processing Solutions

CHAPTER 10: QUALITY ISSUES, BATCH FAILURES, AND PAT IN BIOPHARMACEUTICAL MANUFACTURING

10-1 Quality Initiative Implementation
Comparison of Quality Initiative Implementation, 2009 - 2018
Quality Initiatives Are Becoming Commonplace and the New Industry Norm
Challenges to Implementing PAT, QbD and other Quality Initiatives
10-2 Hurdles to Implementing Process Analytical Technology
Trends in PAT, 2008-2018
PAT Adoption Will Increase
10-3 Batch Failure Frequency in Biopharmaceutical Manufacturing
10-4 Primary Cause of Batch Failures, Percentages of Failures
Quality Problems Traced to Vendors
Process Information Needs and Value Drive Automation
10-5 Quality Problems in BioManufacturing Attributed to Vendors
10-6 Discussion
Supply Management Issues with Single-Use Systems

CHAPTER 11: HIRING, EMPLOYMENT GROWTH, AND TRAINING IN BIOPHARMACEUTICAL MANUFACTURING

Introduction
No Substitute for on-the-job Training
11-1 Hiring Trends
Trends in New Hires, by Area; 2008 – 2018
11-2 Hiring in 2023: 5-year Trends
11-3 Hiring Challenges Today
Hiring Difficulties; 2010 - 2018
11-4 Training in Biopharmaceutical Manufacturing
Changes in Training for New Manufacturing Employees, 2009-2018
11-5 Intersection of Biopharma and Small Pharma
Large-molecule Biomanufacturing Benefi tting from Small-molecule Experienc
11-6 Discussion
Options Developing for Bioprocessing Training
Continued Growth in Biopharmaceutical Manufacturing Jobs

CHAPTER 12: FILL AND FINISH

Introduction
Innovation in Fill-Finish
Outsourcing Fill/Finish
12-1 Demographics
Areas of Involvement
12-2 Trends in Fill-Finish and Related Bioprocessing Capacity
Analysis of US and European In-house Capacity and Capacity Utilization (2017 data)
Challenges in Estimating Fill-Finish Capacity
12-3 Current Fill-Finish Trends
Recent Industry Trends
Future Fill and Finish Trends
Suppliers’ Innovation Trends
Industry Capacity Data
New Technology Implementation in Fill-Finish (2017 data)
12-4 Discussion

CHAPTER 13: SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING AND LIFE SCIENCES

Introduction
13-1 Demographics
Areas of Involvement
Location of Vendor Sales
Respondents’ Primary Job
13-2 Growth Rate of Sales by Suppliers
Average Industry Growth Rate, By Segment
Vendor Sales Growth Rates, by Industry Segment, 2007 to 2018
Supplier Annual Sales, Distribution
13-3 Discussion of Vendor and Industry Growth
13-4 Budget Issues and Problems Faced by Industry Suppliers
Budget Challenges in 2018
Vendor Average Budget Changes for 2009 -2018
Vendor Pricing Changes
Future Price Changes
Supplier Budget Issues
13-5 Cost Cutting Actions by Vendors
Cost Cutting Actions, By Segment
13-6 Problems Clients Have with Their Vendors
13-7 Vendor Expansion Plans
Biopharma Vendor Business Trends, 2010 vs. 2018
13-8 New Technology Areas in Development by Vendors
Suppliers’ Development of Innovative Technologies
Suppliers’ R&D Spending/Budgets for New Products/Services
13-9 Sales Staff Training 502 Days of Training Provided
Areas where Training May Help Sales Staff Perform, Trends 2010 - 2018
Clients’ Demands on Vendors
13-10 Biopharma Vendors’ Financial Outlook for 2018
13-11 Discussion of Biopharma Suppliers
Bioprocessing Vendors Will See Continued Market Growth
Single-use Systems Are Increasingly Driving Sales
Trends Favor Increased Vendor Sales
Vendors are Offering More Services, Going for Larger Sales
Biopharma Suppliers in Emerging Regions
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