18th Annual Report and Survey on Biopharmaceutical Manufacturing Capacity and Production 2021

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Dec 10, 2021, 11:30 ET

DUBLIN, Dec. 10, 2021 /PRNewswire/ -- The "18th Annual Report and Survey on Biopharmaceutical Manufacturing Capacity and Production" report has been added to ResearchAndMarkets.com's offering.

The 2021 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.

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 18th in a series of annual biopharmaceutical manufacturing industry evaluations. This edition includes the joint industry expertise from the publisher, and many industry consultants and experts.

It also features an updated special supplement on Covid-19 Crisis-Impact on Bioprocessing, and Suppliers.

Key Topics Covered:

FUTURE OF BIOPROCESSING: EXPERTS' PERSPECTIVE

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

EMERGING ISSUES IN BIOPHARMACEUTICAL MANUFACTURING

Industry Trends in 2021
Budget Issues in 2021
Operational Changes
New Bioprocessing Products Development Opportunities in 2021
Cost-Cutting Actions & Development Timelines
Average Cost per Gram Recombinant Protein
Assay Development
Selecting Bioreactors in New Facilities
Selecting and Purchasing Commercial-Scale Bioreactors

CAPACITY UTILIZATION

Capacity Utilization Trends
Capacity Utilization: Biomanufacturers vs. CMOs
Capacity Utilization: U.S. vs. Western European Manufacturers
Respondents' Current Total Production Capacity
Discussion: Capacity Trends
Range of Titers with mAb Production

CURRENT AND FUTURE CAPACITY CONSTRAINTS AND QUALITY FACTORS

Current Capacity Constraints
Expected Capacity Constraints
Factors Impacting Future Production Capacity
Key Areas to Address to Avoid Future Capacity Constraints
Batch Failure Frequency in Biopharmaceutical Manufacturing
Primary Cause of Batch Failures, Percentages of Failures
Quality Problems in Biomanufacturing Attributed to Vendors
Discussion: Industry Trends

FUTURE CAPACITY EXPANSIONS

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

Current Outsourcing by Production System
Future Outsourcing Biotherapeutic Developers' Outsourcing,
Outsourced Activities in Biopharmaceutical Manufacturing
Critical Outsourcing Issues Selecting a CMO: (2018 data)
CMOs' Problems with Their Clients
Country Selections for International Outsourcing (Offshoring) of Biomanufacturing
Offshoring Trends
Discussion of Outsourcing and Offshoring

DISPOSABLES AND SINGLE-USE SYSTEMS IN BIOPHARMACEUTICAL MANUFACTURING

Use of Disposables and Single-Use Systems
Leachables and Extractables
Reasons for Increasing Use of Disposables & Single-Use Systems
Factors That May Restrict Use of Disposables
Suppliers' Expectations for Standards Setting Bodies
Single-Use Adoption Issues
Need for Single-use Sensors, and Bioreactor Attributes
Satisfaction with Single-Use Device Vendors
Single-Use Operations and Trends
Discussion: Single-use Bioprocessing

DOWNSTREAM PURIFICATION

Impact of Downstream Processing on Capacity
Specific Purification Step Constraints
Downstream Purification Issues
mAb Purification Capacity Estimates
New Downstream Processing Technologies
Improvements to Downstream Operations
Discussion: Industry Trends Upstream Expression Titer Trends and Impact on Downstream Operations

HIRING, EMPLOYMENT GROWTH, AND TRAINING IN BIOPHARMACEUTICAL MANUFACTURING

Hiring Trends
Hiring in 2026: 5-year Trends
Hiring Challenges Today
Training in Biopharmaceutical Manufacturing
Discussion: Training Industry Trends

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

Perfusion Operations and Continuous Bioprocessing Operational Issues
Perfusion Operations and Continuous Bioprocessing Trends
Discussion: Continuous Bioprocessing and Perfusion Trends
Cell and Gene Therapy Platforms

SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING AND LIFE SCIENCES

Demographics Areas of Involvement
Growth Rate of Sales by Suppliers
Discussion: Vendor and Industry Growth
Budget Issues and Problems Faced by Industry Suppliers
Cost Cutting Actions by Vendors
Problems Clients Have with Their Vendors
Vendor Expansion Plans
New Technology Areas in Development by Vendors
Sales Staff Training
Biopharma Vendors' Financial Outlook for 2021
CMO Pricing Changes for Biopharmaceutical Services
Discussion: Biopharma Suppliers Bioprocessing Vendors Will See Continued Market Growth

For more information about this report visit https://www.researchandmarkets.com/r/e94xw4

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