Cover Image
Market Research Report
Product code
1021577

2021 Report and Survey of Biopharmaceutical Manufacturing Capacity and Production: A Study of Biotherapeutic Developers and Contract Manufacturing Organizations, 18th Edition

Published: | BioPlan Associates, Inc. | 491 Pages | Delivery time: 1-2 business days

Price

Back to Top
2021 Report and Survey of Biopharmaceutical Manufacturing Capacity and Production: A Study of Biotherapeutic Developers and Contract Manufacturing Organizations, 18th Edition
Published: April 30, 2021
BioPlan Associates, Inc.
Content info: 491 Pages
Delivery time: 1-2 business days
  • ALL
  • Description
  • Table of Contents
Description

INTRODUCTION

survey respondents included diverse biopharmaceutical and bioprocessing senior managers, executives and scientists covering a spectrum involved in biopharmaceutical development and manufacturing, including those within CMOs.

This is an international project done annually, with this now the 18th year edition. We solicit and receive survey responses from individuals at organizations around the world. This year includes input from individuals based in 25 countries.

In addition, in Chapter 12, we separately present responses from bioprocessing suppliers and vendors. As in previous years, responses are from companies of all sizes and types worldwide. Respondents have a broad range of responsibilities, but all respondents had to qualify as involved with bioprocessing/manufacturing in some way.

The diversity of survey respondents supports providing a comprehensive view of the industry from those most involved in managing biopharmaceutical manufacturing activities worldwide. Resulting survey data offer a means for understanding the industry and its future course. The breakdown of results by organization class, such as CMOs vs. biotherapeutic manufacturers/ therapeutic developers, provides further insights into major segments of the industry. These two types of organizations have different business drivers, risk profiles, costs of capital, etc.

RESPONDENTS' AREA OF INVOLVEMENT

For this year's 2021 survey, we asked in which area of biopharmaceutical manufacturing is your organization currently involved.

Of the 147 biopharmaceutical manufacturers and contract manufacturing organizations responding to this year's survey, 24.5% were primarily involved in "Process development for biopharmaceutical manufacturing," down from 29.2% in 2020, but overall consistent with previous year trends. 19.7% were primarily involved in "Large-scale cell culture production for therapeutics," down 10 percentage points from 29.2% in 2020. In past years, we have seen this % hovering in the 20s.

Overall, we see decreases this year in the top three areas, but increases in other categories. Respondents involved with "Large-scale contract manufacturing (CMO) for biopharmaceuticals" increased to 9.5%, up from 9.2% in 2020. "Large-scale microbial fermentation for therapeutics" respondents were at 8.8% this year, up five percentage points from 3.8% in 2020.

ABOUT THE AUTHORS:

Tony Hsaio, Senior Product Manager for Single-Use Technologies, BioProduction, Thermo Fisher Scientific

Tony Hsiao currently serves as the Senior Product Manager for Single-Use Technologies in Thermo Fisher Scientific's Bioproduction group. His focus is on new product development for bioprocessing customers. He also drives the addition of novel bioprocessing technologies and alternative applications to expand utility across our product platforms. He holds a Ph.D. and M.S. in Biomedical Engineering from the University of Utah, and a B.S. in Chemical Engineering from Brigham Young University.

Maik W. Jornitz, President and CEO, G-CON Manufacturing

Maik W. Jornitz, President and CEO of G-CON Manufacturing Inc., is a technical expert with over 30 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published 11 books, 18 book chapters and over 100 scientific papers. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces.

Stefan R. Schmidt, COO/Head of Operations, BioAtrium AG

Dr. Stefan R. Schmidt currently serves as COO/Head of Operations at BioAtrium AG, a Lonza and Sanofi JV in Switzerland. Previously he held the position as CSO and other senior executive roles at Rentschler Biopharma with overall responsibilities for development, production, and innovation. Before that, he was CSO at ERA Biotech in Barcelona, directing the company's R&D efforts.

Christoph Winterhalter, Senior Vice President, Business Development, AGC Biologics

Dr. Christoph Winterhalter has 25 years of experience in Life Science and serves currently as Senior Vice President Business Development at AGC Biologics, a global biopharmaceutical CDMO with sites in US, EU, and Japan. Before that he was heading Business Development globally at Rentschler Biopharma with a strong contribution to the tremendous growth phase from 2013-2017 were sales more than tripled.

Table of Contents

TABLE OF CONTENTS

METHODOLOGY

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

  • 1-1 Definition of 'Biopharmaceutical' 1-1 Sector/Market Overview
    • The Biopharma(ceutical) Industry is Losing its Core Identity
    • The Industry Continues to Mature
    • Pharmaceutical Industry Dependence on Biopharmaceuticals
  • 1-2 Biopharmaceutical Industry Status and Market Trends
    • Bioprocessing is Increasing in Developing Countries
  • 1-3 Pharma Industry is Shifting to Biopharmaceuticals
  • 1-4 Global Biopharmaceutical Market Trends
    • Overall Health of the Biopharmaceutical Sector
    • U.S. Industry Leadership Continues
    • Biopharmaceuticals in the Rest-of-the-World
  • 1-5 Biopharmaceutical Markets by Product Class
    • Monoclonal Antibodies (mAbs) are the Leading Product Class
  • 1-6 Animal Derived Products and Biopharmaceuticals
  • 1-7 Future Trends in the Biopharmaceutical Industry

CHAPTER 2: FUTURE OF BIOPROCESSING: EXPERTS' PERSPECTIVE

  • 2-1 COVID-19 Impact on Bioprocessing: From the Beginning of the Pandemic through Recovery
  • 2-2 FDA Biopharmaceutical Approvals in 2020
  • 2-3 Scaling Up Gene Therapy Manufacturing with Single-Use Technology
  • 2-4 Manufacturing Facility Change Needs in a New Era of Therapies
  • 2-5 Process Intensification in the CMO World
  • 2-6 Cell & Gene Therapy CMO Landscape Including Industry Consolidation via M&A
  • 2-7 China-based Bioprocessing CMOs: Status and Prospects

CHAPTER 3: EMERGING ISSUES IN BIOPHARMACEUTICAL MANUFACTURING

  • 3-1 Industry Trends in 2021
    • Introduction
    • Productivity and Cost Reductions
    • Novel Bioprocessing Systems/Innovations
  • 3-2 Budget Issues in 2021
    • Budget Change Comparisons
    • Top Bioprocessing Budget Expenditures
  • 3-3 Operational Changes
  • 3-4 New Bioprocessing Products Development Opportunities in 2021
    • Upstream New Product Areas of Need
    • Trends: Upstream New Product Areas of Need 2010-2021
    • Downstream New Product Areas of Need
    • Trends: Downstream New Product Areas of Need 2010-2021
    • Other General New Product Areas of Need
    • Trends: Other General New Product Areas of Need 2010-2021
    • Innovations in Single use/Disposable Equipment
    • Discussion of Needed Single-use Innovations
    • Other Areas for Innovation
    • New Product Development Areas: Biomanufacturers vs. CMOs
    • New Product Development Areas: U.S. vs. Western Europe and ROW
  • 3-5 Discussion
  • 3-6 Cost-Cutting Actions & Development Timelines
    • Cost-Cutting Changes: Specific to Outsourcing
    • Factors Impacting Reduction in Cost of Goods
  • 3-7 Average Cost per Gram Recombinant Protein
  • 3-8 Assay Development
    • Biomanufacturing Assay Required; Biomanufacturers vs. CMOs
  • 3-9 Selecting Bioreactors in New Facilities
  • 3-10 Selecting and Purchasing Commercial-Scale Bioreactors
    • Largest Stainless Steel Bioreactor Capacity Purchase in Two Years (2023)
    • Largest Single-Use Bioreactor Capacity Purchase in Two Years (2023)
  • 3-11 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, 2021
    • Capacity Utilization Changes Since 2006
    • Average Growth Rate in Capacity Utilization, 2006-2021
  • 4-2 Capacity Utilization: Biomanufacturers vs. CMOs
  • 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
    • The Largest Capacity Facilities
    • Biopharmaceutical Capacity Expansions Continue
    • Biopharmaceutical Developers/Manufacturers as CMOs
    • The Major CMOs in Terms of Facilities and Capacity
    • Cell and Gene Therapy Capacity
  • 4-5 Discussion: Capacity Trends
  • 4-6 Range of Titers with mAb Production
    • Annual mAb Titer Changes, 2008-2021
  • 4-7 Discussion: Capacity and Industry Trends
    • Capacity Utilization

CHAPTER 5: CURRENT AND FUTURE CAPACITY CONSTRAINTS AND QUALITY FACTORS

  • 5-1 Current Capacity Constraints
    • Respondents Experiencing No Capacity Constraints
    • Respondents' Perception of Capacity Constraints, 2004-2021
    • Perception of Capacity Constraints: Biomanufacturers vs. CMOs
    • Capacity Constraints: U.S. vs. Western European Biotherapeutic Developers & CMOs
  • 5-2 Expected Capacity Constraints
    • Respondents' Expectations of Capacity Constraints by 2026
    • Expected Capacity Constraints by 2026: Comparing 2004-2021 Data
    • Expected Capacity Constraints by 2026: Biomanufacturers vs. CMOs
    • Expected Capacity Constraints by 2026: U.S. vs. Western Europe
  • 5-3 Factors Impacting Future Production Capacity
    • Factors Creating Future Capacity Constraints
    • Factors Creating Future Capacity Constraints, 2008-2021
    • Factors Creating Future Capacity Constraints: Biomanufacturers vs. CMOs
    • CMO 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, 2006-2021
    • Key areas to Address to Avoid Capacity Constraints; Biomanufacturers vs. CMOs
    • Key Areas to Address to Avoid Capacity Constraints: U.S. vs. Western Europe
  • 5-5 Batch Failure Frequency in Biopharmaceutical Manufacturing
  • 5-6 Primary Cause of Batch Failures, Percentages of Failures
    • Quality Problems Traced to Vendors
    • Demand for Automation
  • 5-7 Quality Problems in Biomanufacturing Attributed to Vendors
  • 5-8 Discussion: Industry Trends
    • Overall Capacity Constraints

CHAPTER 6: FUTURE CAPACITY EXPANSIONS

  • 6-1 Planned Future Capacity Expansions
    • Planned Future Capacity Expansions, 2009-2026
    • Planned Future Capacity Expansions by 2026: CMOs vs. Biotherapeutic Developers
    • Planned Five-Year Capacity Expansion: U.S. vs. Western European Manufacturers
    • Planned Future Capacity Expansions

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"), 2006-2021
  • 7-2 Future Outsourcing Biotherapeutic Developers' Outsourcing, 5-Year/2026 Projections, by System
    • Biotherapeutic Developers Outsourcing Some Production in 2026
  • 7-3 Outsourced Activities in Biopharmaceutical Manufacturing
    • Comparison of Biomanufacturers' Outsourcing, (2010-2021)
    • Increased Outsourced Activities, 24-month Projections
    • Outsourcing Activities Projected at "Significantly Higher Levels," Comparison of 2010-2021 Trends
    • Average Percentage of Activities Outsourced Today, 2021
    • Comparison of Outsourcing Activities, 2010-2021
    • Change in Spending on Outsourcing Activities
  • 7-4 Critical Outsourcing Issues Selecting a CMO: (2018 data)
    • Selecting a CMO
    • Changes in Critical Issues when Considering a CMO
  • 7-5 CMOs' Problems with Their Clients
  • 7-6 Country Selections for International Outsourcing (Offshoring) of Biomanufacturing
    • U.S. vs. Western European Respondents' Outsourcing Destinations
    • Western European Respondents' Outsourcing Destinations
  • 5-Year Projection for Biomanufacturing International Outsourcing/Offshoring
  • 7-7 Offshoring Trends
  • 5-Year Projection for Percentages of Biomanufacturing International Outsourcing/Offshoring
    • Outsourcing to New Regions (2020 data)
  • 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: 2006-2021
    • Average Annual Growth Rate for Disposables: Market Penetration/Usage
    • 15-Year Average Growth in Disposable 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
    • Single Most Critical Reason for Increasing the Use of Disposables (2018 data)
  • 8-4 Factors That May Restrict Use of Disposables
    • Most Critical Reasons for Restricting Use of Disposables
    • Most Important Reasons for Not Increasing Use of Disposables, 2008-2019
    • Cell-Culture Problems due to Single-Use Devices
    • Recycling of Disposables
    • Most Important Reasons for Restricting Use of Disposables: Biotherapeutic Developers vs. CMOs
    • Top Reasons for Not Increasing the Use of Disposables: U.S. vs. Western Europe
  • 8-5 Suppliers' Expectations for Standards Setting Bodies
  • 8-6 Single-Use Adoption Issues
    • Single-Use Adoption Issues (2018 data)
    • Single-use Adoption Factors, U.S. vs. Western Europe (2018 data)
  • 8-7 Need for Single-use Sensors, and Bioreactor Attributes
    • Single-Use Sensor Technologies (2012-2017, 2019) Data
  • 8-8 Satisfaction with Single-Use Device Vendors
    • Single-Use Attribute Importance Analysis
    • Single-Use Suppliers' Delivery Problems, 2013-2021
  • 8-9 Single-Use Operations and Trends
    • Percentage of Unit Operations that are Single-Use
    • Distribution of Responses
  • 8-10 Discussion: Single-use Bioprocessing
    • Single-use Advantages
    • Growth in the Use of Single-use Systems
    • Downstream Single-use Systems Usage
    • 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
    • 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, 2008-2021
    • 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; 2010-2021
    • 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: Industry Trends Upstream Expression Titer Trends and Impact on Downstream Operations
    • Downstream Processing Solutions

CHAPTER 10: HIRING, EMPLOYMENT GROWTH, AND TRAINING IN BIOPHARMACEUTICAL MANUFACTURING

  • Introduction
  • No Substitute for on-the-job Training
  • 10-1 Hiring Trends
    • Trends in New Hires, by Area; 2008-2021
  • 10-2 Hiring in 2026: 5-year Trends
  • 10-3 Hiring Challenges Today
    • Hiring Difficulties; 2010-2021
    • U.S. and Western Europe Hiring Difficulties
  • 10-4 Training in Biopharmaceutical Manufacturing
    • Changes in Training for New Manufacturing Employees, 2009-2018
  • 10-5 Discussion: Training Industry Trends
    • Options Developing for Bioprocessing Training
    • Continued Growth in Biopharmaceutical Manufacturing Jobs

CHAPTER 11: NEW METHODS: CONTINUOUS AND PROCESS INTENSIFICATION, CELL AND GENE THERAPIES

  • Introduction to Continuous Processing
  • Adoption of Continuous Bioprocessing
  • Implementation of Continuous Bioprocessing
  • Continuous Processing - Present and Future Challenges
  • Designing the continuous processing facility
  • Continuous Bioprocess and Process Intensification
  • 11-1 Perfusion Operations and Continuous Bioprocessing Operational Issues
    • Perfusion vs. Batch Fed Bioprocessing
  • 11-2 Perfusion Operations and Continuous Bioprocessing Trends
  • 11-3 Discussion: Continuous Bioprocessing and Perfusion Trends
    • Perfusion: Progress in Adoption
  • 11-4 Cell and Gene Therapy Platforms
    • Cell and Gene Therapy Manufacturing Advancements (2018 data)

CHAPTER 12: SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING AND LIFE SCIENCES

  • Introduction
  • 12-1 Demographics Areas of Involvement
    • Location of Vendor Sales
    • Respondents' Primary Job
  • 12-2 Growth Rate of Sales by Suppliers
    • Average Industry Growth Rate, By Segment
    • Supplier Annual Sales, Distribution
  • 12-3 Discussion: Vendor and Industry Growth
  • 12-4 Budget Issues and Problems Faced by Industry Suppliers
    • Budget Challenges in 2021
    • Vendor Average Pricing Changes
  • 12-5 Cost Cutting Actions by Vendors
  • 12-6 Problems Clients Have with Their Vendors
  • 12-7 Vendor Expansion Plans
    • Biopharma Vendor Business Trends
    • Biopharma Vendor Business Trends, 2010-2021
  • 12-8 New Technology Areas in Development by Vendors
    • Suppliers' Development of Innovative Technologies
    • Suppliers' R&D Spending/Budgets for New Products/Services
  • 12-9 Sales Staff Training
    • Days of Training Provided by Suppliers
    • Areas where Training May Help Sales Staff Perform, Trends 2010-2021
    • Clients' Demands on Vendors
  • 12-10 Biopharma Vendors' Financial Outlook for 2021
  • 12-11 CMO Pricing Changes for Biopharmaceutical Services
  • 12-12 Discussion: Biopharma Suppliers Bioprocessing Vendors
    • Will See Continued Market Growth
    • Single-use Systems Continue to Drive Sales
    • Trends Favor Increased Vendor Sales
    • Vendors are Offering More Services, Going for Larger Sales
    • Biopharma Suppliers in Emerging Regions

FIGURES

  • Fig 0.1: Area of Primary Involvement in Biopharmaceutical Manufacturing, 2010 - 2021
  • Fig 0.2: Respondents' Job Responsibilities, 2011-2021
  • Fig 0.3: Facility Location, 2021
  • Fig 0.4: Facility Location, by Region
  • Fig 0.5: Biopharmaceutical Manufacturing Systems, (2007-2021) Trends
  • Fig 0.6: Phase of Development of Surveyed Respondents, 2006-2021
  • Fig 0.7: Phase of Development of Surveyed Respondents (U.S. vs. Western Europe)
  • Fig 0.8: Distribution of Employees at Facility, and Organization
  • Fig 0.9: Distribution of Total Batches Run at Facility Last Year, by Scale of Production
  • Fig 0.10: Distribution of Largest SINGLE-USE Bioreactor Capacity
  • Fig 0.11: Distribution of Largest STAINLESS Bioreactor Capacity
  • Fig 2.1: Long-term Effects of Covid-19 on Bioprocessing
  • Fig 2.2: "New Normal" in Bioprocessing Post Covid-19
  • Fig 2.3: FDA Approvals of New Biopharmaceutical Products 1982-2020
  • Fig 2.4: Regions of Approval Recipient Companies
  • Fig 2.5: Leading Countries of Approval Recipient Companies
  • Fig 2.6: Process Intensification Strategies
  • Fig 2.7: Process Intensification in USP
  • Fig 2.8: Process Intensification Optimization in DSP
  • Fig 2.9: Breakdown of WuXi Biologics Deals in Mid-2020
  • Fig 2.10: China as Destination of Outsourcing of Bioprocessing for U.S.-Based Companies
  • Fig 2.11: Country Selections as Destination for International Outsourcing of Biomanufacturing (All Respondents), in the Next Five Years (2026)
  • Fig 2.12: IND Applications to US/FDA from Chinese Developers8
  • Fig 2.13: Therapeutics Development Projects Applying for INDs in US and China8
  • Fig 3.1: SINGLE Most Important Biomanufacturing Trend or Operational Area, 2014-2021
  • Fig 3.2: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months (2021)
  • Fig 3.3: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months (Biomanufacturers vs. CMOs)
  • Fig 3.4: Biomanufacturers' Budget Shifts, 2021
  • Fig 3.5: Approximate Average Change in Biomanufacturers' Budgets (2021)
  • Fig 3.6: Average Biomanufacturers' Budget Change, 2009-2021
  • Fig 3.7. New Expenditures Focus Areas
  • Fig 3.8: New Product Development-Upstream Focus Areas, 2021
  • Fig 3.9: Upstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts (2010-2021)
  • Fig 3.10: Downstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts, 2021
  • Fig 3.11: New Product Development-Downstream Focus Areas (2010-2021)
  • Fig 3.12: New Product Development -- General Focus Areas, Biomanufacturers & CMOs, 2021
  • Fig 3.13: New Product Development -- General Focus Areas, 2010-2021
  • Fig 3.14: Top 10 New Product Development Areas of Interest: Biomanufacturers vs. CMOs
  • Fig 3.15: Top 10 New Product Development Areas of Interest: U.S. vs. Western Europe and ROW
  • Fig 3.16: Cost-Cutting Changes: Actions Undertaken During "Past 12 Months" Comparing 2011-2016, 2019-2021
  • Fig 3.17: Cost-Cutting Changes, Outsourced Jobs, by Segment, and Geography (2011-2016, 2019-2021)
  • Fig 3.18: Factors That Will Have the Greatest Impact on Reducing Your Cost of Goods for Biotherapeutic Products
  • Fig 3.19: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2021
  • Fig 3.20: Biomanufacturing Assay "Areas" Urgently Requiring New, Improved Testing Methods, 2011-2015, 2018-2019 (2019 data)
  • Fig 3.21: Biomanufacturing Assay "Areas" Urgently Requiring New, Improved Testing Methods; Biomanufacturers vs. CMOs (2019 data)
  • Fig 3.22: Largest Commercial-Scale Bioreactor Expected in the Next 2 Years (2023)
  • Fig 3.23: Top Options for Bioreactor Platforms at Commercial Scale
  • Fig 3.24: Distribution of Largest Stainless Steel Bioreactor Capacity (Next 2 Years)
  • Fig 4.1: Capacity Utilization, By System, 2021
  • Fig 4.2: Capacity Utilization, By System, 2006-2021
  • Fig 4.3: Change in Capacity Utilization, CAGR, 2006-2021
  • Fig 4.4: Capacity Utilization, By System, Biomanufacturers vs. CMOs, 2021
  • Fig 4.5: Capacity Utilization, By System, U.S. vs. Western Europe, 2021
  • Fig 4.6: Current Production Capacity Distribution, Mammalian Cell Culture
  • Fig 4.7: Production Capacity Distribution, Mammalian Cell Culture, 2011-2021
  • Fig 4.8: Bioprocessing Concentration, Capacity Data, 2021
  • Fig 4.9: Current Production Capacity Distribution, Microbial Fermentation
  • Fig 4.10: Current Production Capacity Distribution, Cell Therapy
  • Fig 4.11: Current Production Capacity Distribution, Gene Therapy
  • Fig 4.12: Range of Titers for mAbs Obtained at Various Production Scales, Distribution
  • Fig 4.13: Average mAb Titer Trend 2008-2021
  • Fig 5.1: Capacity Constraints, by Stage of Production
  • Fig 5.2: Capacity Constraints, 2004-2021
  • Fig 5.3: Capacity Constraints Trends, 2004-2021
  • Fig 5.4: Capacity Constraints, Biotherapeutic Developers vs. CMOs
  • Fig 5.5: Capacity Constraints, U.S. vs. Western Europe
  • Fig 5.6: Expectations of Capacity Constraints by Stage of Production: Five-year Projections
  • Fig 5.7: Expectations of Capacity Constraints: Five-year Projections, 2004 thru 2021
  • Fig 5.8: Expectations of Capacity Constraints: Five-year Projections, 2004 thru 2021 (Trend Line)
  • Fig 5.9: Five-year Projections for Capacity Constraints: Biotherapeutic Developers vs. CMOs (2026)
  • Fig 5.10: Five-year Projections for Capacity Constraints: U.S. vs. Western Europe (2026)
  • Fig 5.11: Factors Creating Future Capacity Constraints in Five Years (by 2026)
  • Fig 5.12A: Factors Creating Future Capacity Constraints, 2008-
  • Fig 5.12B: Factors Creating Future Capacity Constraints, 2008-2021
  • Fig 5.13: Factors Creating Future Capacity Constraints: Biotherapeutic Developers vs. CMOs
  • Fig 5.14: Factors Creating Future Capacity Constraints, U.S. vs. Western European Biomanufacturers
  • Fig 5.15: Key Areas to Address to Avoid Capacity Constraints
  • Fig 5.16A: Key Areas to Address to Avoid Capacity Constraints; 2006-2021
  • Fig 5.16B: Key areas to Address to Avoid Capacity Constraints; 2006-2021
  • Fig 5.17: Key Areas to Address to Avoid Capacity Constraints; Biomanufacturers Developers vs. CMOs
  • Fig 5.18: Key Areas to Address to Avoid Capacity Constraints; U.S. vs. Western Europe
  • Fig 5.19: Batch Failure Frequency Distribution, 2009-2021
  • Fig 5.20: Average Rates of Failure, by Primary Cause, and Phase of Manufacture, 2021
  • Fig 5.21: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009-2021 ("Commercial Manufacture")
  • Fig 5.22: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009-2021 ("Clinical" Scale)
  • Fig 5.23: Quality Problems Traced to Vendors; 2008-2018 (2018 data)
  • Fig 6.1: Industry Average Planned Production Increase by 2026
  • Fig 6.2: Planned Future Capacity Expansion: Five-Year Estimates, 2009--2026
  • Fig 6.3: Planned Future Capacity Expansion: Five-year Estimates: Biotherapeutic Developers vs. CMOs, by 2026
  • Fig 6.4: Planned Future Capacity Expansion: Five-Year Estimates: U.S. vs. Western Europe, by 2026
  • Fig 6.5: Percentage of Respondents Projecting Production Increases over 100% by 2026: 5-year Trend
  • Fig 7.1: Current Percent Production Outsourced; by System, 2021
  • Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production, 2006-2021
  • Fig 7.3: Future Outsourcing: Percent Production Outsourced; by 2026, by System
  • Fig 7.4: Five-year Projections: % Biotherapeutic Developers Planning to Outsource at Least Some Production; Projections made 2007-2021
  • Fig 7.5: Percent of Biomanufacturers Outsourcing at Least Some Activity Today (2021)
  • Fig 7.6A: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010-2021
  • Fig 7.6B: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010-2020
  • Fig 7.7: Outsourcing Activities Projected to be Done at "Significantly Higher Levels" in 2 Years
  • Fig 7.8A: Outsourcing Activities Projected to be Done at "Significantly Higher Levels" in 2 Years, 2010-2021 Trends
  • Fig 7.8B: Outsourcing Activities Projected to be Done at "Significantly Higher Levels" in 2 Years, 2010-2021 Trends
  • Fig 7.9: Current Outsourcing: Average Percentage of Activity Outsourced Today (2021)
  • Fig 7.10A: Estimated Average Percent of Activity Outsourced by Facilities, 2010-2021
  • Fig 7.10B: Estimated Average Percent of Activity Outsourced by Facilities, 2010-2021
  • Fig 7.11: Change in Spending on Outsourcing for R&D or Manufacturing, 2012-2021
  • Fig 7.12: Outsourcing Issues: Biomanufacturing by Contract Manufacturing Organizations (2018 data)
  • Fig 7.13: Important Outsourcing Issues: Biomanufacturing by Contract Manufacturing Organizations, Trends 2006-2018 (2018 data)
  • Fig 7.14: Important Outsourcing Issues: Response Shifts Over Time 2006-2018, Percentage Point Differences
  • Fig 7.15: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs, 2018
  • Fig 7.16: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs, 2010-2013; 2018
  • Fig 7.17: Country Selections as Destination for International Outsourcing of Biomanufacturing (All Respondents), in the Next Five Years (2026)
  • Fig 7.18A: Percent U.S. Respondents Considering Country as "Possible" Outsourcing Destination, over Next Five Years (2026)
  • Fig 7.18B: Percent U.S. Respondents Considering Country as 'Possible' Outsourcing Destination, over Next Five Years (2026)
  • Fig 7.19: Percent U.S. Respondents Considering Country as "Strong likelihood" or "Likelihood" as Outsourced Capacity Destination, Next Five Years, 2026
  • Fig 7.20A: Percent Western European Respondents Considering Country as "Possible" Outsourcing Destination, Next Five Years (2026)
  • Fig 7.20B: Percent Western European Respondents Considering Country as 'Possible' Outsourcing Destination, Next Five Years (2026)
  • Fig 7.21: Percent European Respondents Considering Country as "Strong likelihood" or "Likelihood" as Outsourced Capacity Destination, over Next Five Years (2026)
  • Fig 7.22: Percent of Biomanufacturing Operations Offshored (International Outsourcing) within 5 Years (2026)
  • Fig 7.23: Percent Biomanufacturers Performing at Least "Some" International Outsourcing/Offshoring during Next Five Years (2011-2021)
  • Fig 7.24: Estimated % Operations Done as International Outsourcing/Offshoring during Next Five Years (2011-2021)
  • Fig 7.25 Factors Considered MOST IMPORTANT for Outsourcing to New Regions, such as China, India, and Brazil (2020 data)
  • Fig 8.1: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture
  • Fig 8.2A: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture: 2006-2021
  • Fig 8.2B: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture: 2006-2021
  • Fig 8.3: Average Annual Growth Rate, Disposables, 2006-2021
  • Fig 8.4: 15-Year Percentage-Point Change in First Usage of Disposables, 2006-2021
  • Fig 8.5: Usage of Disposables in Biomanufacturing by Stage of Manufacture (R&D--Commercial)
  • Fig 8.6: Usage of Disposables in Biopharmaceutical Manufacturing: Biotherapeutic Developers vs. CMOs
  • Fig 8.7: Willingness to Pay for Useable Leachables and Extractables Data (2018 Data)
  • Fig 8.8: Single Most Critical Reason for Increasing Use of Disposables, 2009- 2018
  • Fig 8.9: Top Reasons for Not Increasing Use of Disposables (2019 data)
  • Fig 8.10A: Top Reasons for Not Increasing Use of Disposables, 2008-2019
  • Fig 8.10B: Top Reasons for Not Increasing Use of Disposables, 2008-2019
  • Fig 8.11: Cell Culture Problems Due to Single-Use Devices
  • Fig 8.12: Single-use Recycling; Respondents' Desires for Disposal vs. Actual Disposal Process (2020 data)
  • Fig 8.13: Top Reasons for Not Increasing Use of Disposables, Biotherapeutic Developers vs. CMOs (2019 data)
  • Fig 8.14: Top Reasons for Not Increasing Use of Disposables, U.S. vs. Western Europe (2019 data)
  • Fig 8.15: Suppliers' Perception of Organizations Responsible for Establishing Standards for Single-use Devices (2017 data)
  • Fig 8.16: Single use / Disposable Device Adoption Factors (2018 data)
  • Fig 8.17: Single-use / Disposable Device Adoption Factors; U.S. vs. Western Europe (2018 data)
  • Fig 8.18: Need for Improved Single-Use Sensors, 2012-2017, 2019 (2019 data)
  • Fig 8.19: Single-Use Product Vendor Satisfaction Factors, 2008-2021
  • Fig 8.20: Importance of Single-Use Product Attributes vs. Level of Vendor Satisfaction
  • Fig 8.21: Percentage Point Gap between Importance of SUS Product Attributes and Level of Satisfaction, 2013-2021
  • Fig 8.22: Estimated Percentage of Facilities' Unit Operations that Are "Single-Use" (2014-2021)
  • Fig 8.23: Distribution of Responses, % Single-Use Devices in Biomanufacturing
  • Fig 9.1: Impact of Downstream Processing on Overall Capacity, 2008-2021
  • Fig 9.2: Impact of Downstream Processing on Overall Capacity; Biotherapeutic Developers vs. CMOs
  • Fig 9.3: Impact of Downstream Processing on Overall Capacity; U.S. vs. Western Europe
  • Fig 9.4: Impact on Capacity of Depth, Chromatography and UF Purification Steps
  • Fig 9.5: Impact on Capacity of Purification Steps: Experiencing at "Significant" or "Severe" Constraints, 2008-2021
  • Fig 9.6: Impact on Capacity of Purification Steps, U.S. vs. Western Europe
  • Fig 9.7: Issues Regarding Protein A Usage
  • Fig 9.8: Issues Regarding Protein A Usage, 2009-2017, 2020-2021
  • Fig 9.9: Issues Regarding Protein A Usage; U.S. vs. Western Europe
  • Fig 9.10: mAb Operations: Upstream Production Titer (Distribution of Responses, 2014 -2016, 2018-2021 Data)
  • Fig 9.11: Bioreactor Yield at Which DOWNSTREAM Purification Train Becomes Bottlenecked
  • Fig 9.12: New Downstream Processing Solutions, 2021
  • Fig 9.13A: New Downstream Processing Solutions Comparison: 2010-2021
  • Fig 9.13B: New Downstream Processing Solutions Comparison: 2010-2021
  • Fig 9.14: New Downstream Processing Solutions: Biotherapeutic Developers vs. CMOs (2021)
  • Fig 9.15: New Downstream Processing Solutions: U.S. vs. Western Europe
  • Fig 9.16: Improving Downstream Operations, 2011-2019 (2019 data)
  • Fig 9.17: Improving Downstream Operations: Biomanufacturers vs. CMOs (2019 data)
  • Fig 9.18: Improving Downstream Operations (U.S. vs. Western Europe vs. ROW) (2019 data)
  • Fig 10.1: New Hires in Biopharmaceutical Manufacturing (2021)
  • Fig 10.2: Estimated Hiring, by Area, 2008-2020
  • Fig 10.3: New Hires in Biopharmaceutical Manufacturing (2026)
  • Fig 10.4: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations
  • Fig 10.5A: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations; 2010-2021
  • Fig 10.5B: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations; 2010-2021
  • Fig 10.6: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, U.S. vs. Western Europe
  • Fig 10.7: Training for New Operations/Manufacturing Employees (2018 data)
  • Fig 10.8: Average Annual Changes in Training for New Operations/Manufacturing Employees, 2009-2018
  • Fig 11.1: Changing the way culture is viewed
  • Fig 11.2: Example of an Operational Workflow Diagram for an Upstream Process
  • Fig 11.3: Triangle of Pharmaceutical Facility Design
  • Fig 11.4: The QbD Principles as Laid Out by ICH Q8 And Q11
  • Fig 11.5: Future of Continuous Bioprocessing and Process Intensification
  • Fig 11.6: Perfusion Operations Issues: Comparison 2010 -- 2016, 2020 (2020 data)
  • Fig 11.7: Concerns Over Perfusion Processes vs. Batch-fed Processes in Bioprocessing
  • Fig 11.8: Facilities Evaluating CBP Technologies Over Next 12 months (Upstream), 2016-2021
  • Fig 11.9: Facilities Evaluating CBP Technologies Over Next 12 months (Downstream), 2016-2021
  • Fig 11.10: Future Cell and Gene Therapy Platforms (2019 data)
  • Fig 11.11: Cell and Gene Therapy Manufacturing Advancements in 5 Years (2023) to Avoid Bottlenecks (2018 data)
  • Fig 11.12: Most Needed Cell & Gene Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure
  • Fig 11.13: Most Needed Cell & Gene Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019 - 2021)
  • Fig 11.14: Cell and Gene Therapy Plans for GMP and Commercial Manufacturing
  • Fig 11.15: Cell and Gene Therapy Capacity Plans for In-House Bioprocessing Facilities Next Five Years (2025)
  • Fig 11.16: Commercial Manufacturing of Cell Therapies, 2021
  • Fig 11.17: Commercial Manufacturing of Gene Therapy Vectors and Products, 2021
  • Fig 12.1: Area of Biopharmaceutical Involvement, Vendor
  • Fig 12.2: Area of Biopharmaceutical Involvement, Vendor Comparison 2010-2021
  • Fig 12.3A: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell, 2008-2021
  • Fig 12.3B: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell, 2008-2021
  • Fig 12.4: Respondents' Primary Job Function, 2021
  • Fig 12.5: Average Annual Vendor Sales Growth Rate, 2007-2021
  • Fig 12.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution
  • Fig 12.7: Average Annual Vendor Segment Sales Growth Rates, 2021
  • Fig 12.8: Average Annual Vendor Sales Growth Rate, 2007-2021, by Segment
  • Fig 12.9: Vendors' Approx. Annual Sales to Biopharmaceutical Segment %, 2012-2021
  • Fig 12.10: Vendors' Average Budget Change, 2021
  • Fig 12.11: Vendors' Average Budget Change for 2009-2021, Summary
  • Fig 12.12: Vendors' Average Pricing Changes, Last Year (2020)
  • Fig 12.13: Vendors' Average Pricing Changes, 2009-2020 Actual and 2021 projected
  • Fig 12.14: Actions Undertaken to Reduce Overall Costs, Prior 12 Months, 2011-2017 (2017 data)
  • Fig 12.15: Actions Undertaken to Reduce Overall Costs, Past 12 Months, By Segment (2017 data)
  • Fig 12.16: (See Fig 5.23: Quality Problems Traced to Vendors; 2008-2018): Quality Problems Traced to Vendors (2018 data)
  • Fig 12.17: Impact of COVID-19 Pandemic on Vendors, 2021
  • Fig 12.18: Biopharma Business and Marketing Plans, 2021
  • Fig 12.19: Biopharma Business and Marketing Plans, 2010-2021
  • Fig 12.20A: Top New Technologies or New Product Development Areas
  • Fig 12.20B: Top New Technologies or New Product Development Areas
  • Fig 12.21: Plans for Launching Significant, Truly Novel Bioprocessing Advances (2017 data)
  • Fig 12.22: R&D Spending/Budgets for New Products/Services, 2021
  • Fig 12.23: Days of Sales Staff Training Provided
  • Fig 12.24: Areas Where Training is Considered as Needed; 2010-2021
  • Fig 12.25: Client Demands of Vendors, Service and Support, 2012-2021
  • Fig 12.26: Vendors Views of Financial (Sales) Outlook for Next Year, 2011-2021
  • Fig 12.27: Average CMOs Service Price Shifts over the Past 12 Months, 2021
  • Fig 12.28: CMOs Service Price Shifts Over Past 12 Months, Distribution

TABLES

  • Table 0.1 Areas of Biopharmaceutical Manufacturing Operations
  • Table 1.1 Number of Biopharmaceutical Products in U.S. and European Markets*
  • Table 1.2 Summary of Worldwide Biopharmaceutical Revenue Growth by Product Class, 2007 and 2021
  • Table 2.1 Interviewees' Perspectives Regarding the Long-term Effects of the Covid-19 Pandemic
  • Table 2.2: Effect of Covid-19 Response on Daily Bioprocessing Operations
  • Table 2.3 FDA Biopharmaceutical Approvals, 2020
  • Table 2.4 Non-biopharmaceutical (Synthetic) Biopharmaceutical-like Product Approvals
  • Table 2.5 Primary Approval Recipient Companies and The Region and Country of Their Main Headquarters
  • Table 2.6 Expected outcome of process intensification
  • Table 2.7 Approved CGT products (excluding cord blood cell therapies)
  • Table 2.8 Recent M&A activities in the CGT space of CMO
  • Table 2.9 CGT capabilities after M&A
  • Table 2.10 Commercial Scale Contract Manufacturing Deals with China-based CMOs5
  • Table 3.1 Areas of Significant Projected Budget Percentage Increases for Biomanufacturing, 2021 and Past Years
  • Table 3.2 Average Cost per Gram Recombinant Protein
  • Table 4.1 Western European Biomanufacturers' Average Capacity Utilization
  • Table 4.2 U.S. Biomanufacturers' Average Capacity Utilization
  • Table 4.3 Leading Biopharma Company Capacity
  • Table 4.4 Regional distribution of Total Worldwide*
  • Table 4.5 Bioprocessing CMOs, Their Number of Facilities Worldwide and Estimated Total Capacity*
  • Table 4.6 Compound Annual Change in mAb Titers, 2008-2021
  • Table 5.1 Severe or Significant Capacity Constraints, by Stage of Production, 2009-2021
  • Table 5.2 Severe and Significant Capacity Constraints Today, U.S. vs. W. Europe, 2010-2021
  • Table 6.1 Western European Biomanufacturers' Five-Year Projected Increases
  • Table 6.2 U.S. Biomanufacturers' Five-Year Projected Increases
  • Table 7.1 Respondents Reporting No Outsourced Production (i.e., all in-house manufacturing), 2009-2021
  • Table 7.2 Respondents Outsourcing up to 50% of Production, Mammalian and Microbial Systems, 2009-2021
  • Table 7.3 Respondents Outsourcing Over 50% of Production, Mammalian and Microbial Cell Systems, 2009-2021
  • Table 7.4 Plant and Insect Cells, 2015-2021
  • Table 7.5 Non-U.S. Respondents indicating U.S. as potential outsourcing destination
  • Table 7.6 Percent of U.S.-based Respondents Indicating Country as a " Strong likelihood" or "Likelihood" as Outsourcing Destination, 2009-2021
  • Table 7.7 Percent of European-based Respondents Indicating Country as a "Strong likelihood" or "Likelihood" as Outsourcing Destination, 2011-2021
  • Table 9.1 Percent experiencing "Serious" or "Some" capacity problems due to downstream processing 2008-2021
  • Table 9.2 Percent U.S. vs. Western Europe facilities experiencing "Serious" capacity problems due to downstream processing, 2009-2021
  • Table 9.3 Percent U.S. vs. Western Europe facilities not expecting to see bottlenecks due to downstream processing, 2008-2021
  • Table 9.4 Upstream Production Titer vs. Max Capacity, 2020 Data
  • Table 12.1 Selected "Other" New Technology Areas in Development
  • Table 12.2 Average Vendor Sales and Technical Training Days, 2011-2013, 2019-2021