14th Annual Biopharma Manufacturing Capacity and Production

  • ID: 4319239
  • Report
  • 476 Pages
  • Bioplan Associates Inc
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14th Annual Biopharma Manufacturing Capacity and Production Report:
Industry's most detailed, leading study of biotherapeutic developers and contract manufacturing organizations' current and projected future capacity and production.

Report Coverage:

  • Biosimilars pipeline in development
  • In-depth analysis of key data, capacity, production trends, and benchmarks
  • Budget trends and impact of current economic environment
  • Expression system advances
  • Downstream purification problems and issues
  • Current and projected industry bottlenecks
  • Capacity utilization and current production levels
  • How capacity bottlenecks are being resolved
  • Production trends and implications for industry
  • Outsourcing trends
  • International offshoring through 2021
  • Range of titres, growth
  • Disposables: Spending growth; downstream uses; L&E's; reasons for increasing/ restricting; budget increases; vendor satisfaction
  • Disposables: Compare innovators vs CMOs & US vs Europe
  • Batch failure rates & trends
  • Selecting a CMO - Problems & solutions
  • Quality management & PAT implementation
  • Hiring and employment growth
  • Supplier growth rates
  • Much more...

By the Numbers:

  • 227 biotherapeutic developers & CMOs; US vs European & Global Biomanufacturing
  • 131 industry vendors and direct suppliers of materials
  • 25 Countries represented
  • 476 Pages
  • 13 Chapters
  • 200+ Graphs and 28 Tables
  • Subject Matter Experts providing analysis
  • 30+ Independent Sponsoring Organizations
Note: Product cover images may vary from those shown
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1: Introduction And Discussion
1.1 Introduction: The Biopharmaceutical Industry
1.2 Current Status and Market Trends
1.3 Market Potential
1.4 Biopharmaceuticals and Biosimilars in the Pipeline
1.5 Biopharmaceutical Approvals Generic
1.6 Global Biopharmaceutical and Recombinant Protein/mAb Markets

  • Overall Health of the Biopharmaceutical Sector
  • US Industry Leadership Continues
  • Biopharmaceuticals in the Rest-of-the-World

1.7 Biopharmaceutical Markets by Product Class

  • mAbs are the Leading Product Classes

1.8 Biopharmaceutical Blockbusters
1.9 Commercial Product Expression Systems
1.10 Animal Derived Products and Biopharmaceuticals
1.11 Cost-Containment and Price Controls
1.12 Future Trends in the Biopharmaceutical Industry
1.13 Overview of Biopharmaceutical Market Trends

2: Overview of Critical Issues in Bioprocessing
2.1 China’s Advances in Global Biopharma and Bioprocessing
2.2 India’s Importance to the Global Biopharma Industry
2.3 Economic Models for Media and Buffer Prep Operations
2.4 Overview of Capacity Utilization and Capacity Trends among CMOs
2.5 Demand for Improved Downstream Bioprocessing Technologies
2.6 Cell Therapy and Gene Therapy Manufacturing Capacity Trends
2.7 Current and Future Trends in Biosimilars Manufacturing Costs
2.8 Bioprocessing Demands of Industry Suppliers are Evolving

3: Emerging Issues in Biopharmaceutical Manufacturing
3.1 Industry Trends in 2017

  • Introduction
  • Productivity and Cost Reductions

3.2 Budget Issues in 2017

  • Budget Change Comparison

3.3 Operational Changes
3.4 New Bioprocessing Products Development Opportunities in 2017

  • Upstream New Product Areas of Need
  • Trends: Upstream New Product Areas of Need 2010.2017
  • Downstream New Product Areas of Need
  • Trends: Downstream New Product Areas of Need 2010.2017
  • Other New Product Areas of Need
  • Trends: Other General New Product Areas of Need 2010.2017
  • 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: US 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, US vs Western
  • Europe vs ROW (2015 Data)

3.6 Cost-Cutting Actions & Development Timelines (2016 data)

  • Cost-Cutting Changes: Specific to Outsourcing (2016 data)

3.7 Average Cost per Gram Recombinant Protein
3.8 Assay Development
3.9 Continuous Bioprocessing Operations Issues

  • Perfusion vs Batch Fed Bioprocessing

3.10 Discussion
3.11 Perfusion Operations and Continuous Bioprocessing Trends

  • Continuous Bioprocessing: Trends and Opportunitie

3.12 Selecting Bioreactors in New Facilities
3.13 Supplier-End-User Technical Relationships
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

4: Capacity Utilization
4.1 Capacity Utilization Trends

  • Capacity Utilization Definitions
  • Relevance of Capacity Utilization
  • Capacity Utilization in Biomanufacturing, 2017
  • Capacity Utilization Changes Since 2004
  • Average Growth Rate in Capacity Utilization, 2006-2017

4.2 Capacity Utilization: CMOs vs Biotherapeutic Developers
4.3 Capacity Utilization: US 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
  • Yeast Production Capacity
  • Insect Cells Production Capacity

4.5 Current State of Capacity Utilization

  • Future Capacity Issues

4.6 Range of Titers for mAb Production

  • Annual mAb Titer Change, 2008-2017

4.7 Discussion: Capacity and Industry Trends

  • Capacity Utilization

5: Current and Future Capacity Constraints
5.1 Current Capacity Constraints

  • Respondents Experiencing No Capacity Constraints
  • Respondents’ Perception of Capacity Constraints, 2004.2017
  • Perception of Capacity Constraints: Biotherapeutic Developers vs CMOs
  • Capacity Constraints: US vs Western European Biotherapeutic
  • Developers & CMOs

5.2 Expected Capacity Constraints

  • Respondents’ Expectations of Capacity Constraints by 2022
  • Expected Capacity Constraints by 2022: Comparing 2004 to 2017 Data
  • Expected Capacity Constraints by 2022: CMOs vs Biotherapeutic Developers
  • Expected Capacity Constraints by 2022: US vs Western Europe

5.3 Factors Impacting Future Production Capacity

  • Factors Creating Future Capacity Constraints
  • Factors Creating Future Capacity Constraints, 2008 vs 2017
  • 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: US vs Western European Respondents

5.4 Key Areas to Address to Avoid Future Capacity Constraints

  • Analysis of Areas to Avoid Capacity Constraints: Changing
  • Perspectives, 2006-2017
  • Key areas to Address to Avoid Capacity Constraints; Biotherapeutic
  • Developers vs CMOs
  • Key Areas to Address to Avoid Capacity Constraints: US vs Western Europe

5.5 Discussion

  • Overall Capacity Constraints

6: Future Capacity Expansions
6.1 Planned Future Capacity Expansions

  • Planned Future Capacity Expansions, 2009.2022
  • Planned Future Capacity Expansions by 2022; CMOs vs Biotherapeutic Developers
  • Planned Five-Year Capacity Expansions; US vs Western European Manufacturers
  • Planned Future Capacity Expansions of >100%

7: Outsourcing Trends in Biopharmaceutical Manufacturing

  • Why Outsource?
  • Strategic Manufacturing Planning
  • Future Projections

7.1 Current Outsourcing by Production System

  • Facilities Currently Outsourcing No Production (All Production “In-house”), 2006-2017

7.2 Future Outsourcing

  • Biotherapeutic Developers’ Outsourcing, 2022 Projections, by System
  • Biotherapeutic Developers Outsourcing Some Production in 2022

7.3 Outsourced Activities in Biopharmaceutical Manufacturing

  • Comparison of Biomanufacturers’ Outsourcing, (2010.2017)
  • Increased Outsourced Activities, 24.month Projections
  • Outsourcing Activities Projected at ‘Significantly Higher Levels’, Comparison of 2010.2017 Trends
  • Average Percentage of Activities Outsourced Today
  • Comparison of Outsourcing Activities, 2010.2017
  • Change in Spending on Outsourcing Activities

7.4 Critical Outsourcing Issues

  • Selecting a CMO: 2017
  • Selecting a CMO, 2006.2017
  • Changes in Critical Issues when Considering a CMO, 2008.2017

7.5 CMOS’ Problems with Their Clients
7.6 Country Selections for International Outsourcing (Off-shoring) of

  • Biomanufacturing
  • US 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

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: 2006.2017
  • 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, 2015 vs 2016

8.3 Reasons for Increasing Use of Disposables & Single-Use Systems

  • Reasons for Increased Use of Disposables, 2006 through 2015
  • Reasons for Increased Use of Disposables: Biotherapeutic
  • Developers vs CMOs
  • 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, 2008.2017
  • Most Important Reasons for Restricting Use of Disposables: Biotherapeutic
  • Developer vs CMO
  • Top Reasons for Not Increasing the Use of Disposables: US vs Western
  • Europe Respondents

8.5 Standards Setting for Disposable, Single-use Systems

  • Standardizing Single-use Designs
  • Standardization Factors, 2013.2015
  • Suppliers’ Expectations for Standards Setting Bodies

8.6 Budgets for Disposable Systems
8.7 Need for Single-use Sensors, and Bioreactor Attributes

  • Single-Use Adoption Issues
  • Single-use Adoption Factors, US vs Western Europe
  • Single-Use Sensor Technologies

8.8 Recycling and Disposal of Single-use Plastics

  • Waste Disposal of Single-use Devices
  • Meeting Respondents’ Demands for Recycling

8.9 Satisfaction with Single-use Device Vendors

  • Single-Use Attribute Importance Analysis
  • Single-use Suppliers’ Delivery Problems, 2013.2017

8.10 Single Use Operations and Trends

  • Percentage of Unit Operations that are Single-Use
  • Distribution of Responses

8.11 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

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, US vs Western European
  • Biomanufacturers

9.2 Specific Purification Step Constraints

  • Changes in Impact on Capacity of Purification Steps, 2008.2017
  • Specific Purification Step Constraints, US 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, US 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 - 2017
  • New Downstream Processing Technologies; Biotherapeutic
  • Developers vs CMOs
  • New Downstream Processing Technologies; US vs Western Europe

9.6 Improvements to Downstream Operations

  • Comparison of New Downstream Technology Implementation;
  • Biomanufacturers vs CMOs
  • Comparison of New Downstream Technology Investigations;
  • US vs W Europe vs ROW

9.7 Discussion

  • Upstream Expression Titer Trends and Impact on Downstream Operations
  • Downstream Processing Solutions

10: Quality Issues, Batch Failures, and PAT in Biopharmaceutical

  • Manufacturing

10.1 Hurdles to Implementing Process Analytical Technology

  • Trends in PAT, 2008.2017
  • PAT Adoption Will Increase

10.2 Batch Failure Frequency in Biopharmaceutical Manufacturing
10.3 Primary Cause of Batch Failures, Percentages of Failures
10.4 Quality Problems in BioManufacturing Attributed to Vendors
10.5 Automation Implementation

  • Comparison of Implementation Plans 2009 - 2013

10.6 Quality Initiative Implementation

  • Comparison of Quality Initiative Implementation, 2009 - 2017

10.7 Global Quality Supply Management

  • Quality Supply Management-US vs W Europe

10.8 Discussion

  • Hurdles Hindering Implementation of PAT
  • Batch Failures Due to Single-Use Adoption or Continued Stainless Steel Use?
  • Quality Problems Traced to Vendors
  • Process Information Needs and Value Drive Automation
  • Quality Initiatives Are Becoming Commonplace and the New Industry Norm
  • Challenges to Implementing PAT, QbD and other Quality Initiatives
  • Supply Management Issues with Single-Use Systems

11: Hiring, Employment Growth, and Training in Biopharmaceutical

  • Manufacturing
  • Introduction
  • Trends in New Hires, by Area; 2008 - 2017

11.1 Hiring Trends

11.2 Hiring in 2022: 5.year Trends
11.3 Hiring Challenges Today

  • Hiring Difficulties; 2010 - 2017
  • Hiring Difficulties: US vs Western Europe
  • US vs Western Europe Hiring Trends

11.4 Training in Biopharmaceutical Manufacturing

  • Changes in Training for New Manufacturing Employees, 2009 - 2017

11.5 Discussion

  • Options Developing for Bioprocessing Training
  • Continued Growth in Biopharmaceutical Manufacturing Jobs

12: Fill and Finish

  • Introduction

12.1 Demographics

  • Areas of Involvement
  • Geographic Location, Facilities

12.2 Trends in Fill-Finish and Related Bioprocessing Capacity

  • Analysis of US and European In-house Capacity and Capacity Utilization
  • 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

12.4 Discussion

  • Voice of Industry

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 2017
  • 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 2017
  • Vendor Average Budget Changes for 2009 - 2017
  • 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 - 2017

13.8 New Technology Areas in Development by Vendors

  • Suppliers’ Development of Innovative Technologies
  • Suppliers’ R&D Budget Spending for Innovative Technologies

13.9 Sales Staff Training

  • Days of Training Provided
  • Areas where Training May Help Sales Staff Perform, Trends
  • 2010 - 2017
  • Clients’ Demands on Vendors

13.10 Biopharma Vendors’ Financial Outlook for 2017
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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