The global pharmaceutical industry is evolving with the rising need for novel therapies in the changing disease landscape. As a result of rising prevalence of chronic infectious diseases as well as growing cancer incidence, market needs are shifting from traditional small molecules to large molecules. This study presents an overview of the global biologics Contract Development and Manufacturing Organization (CDMO) landscape with an emphasis on the key trends and growth opportunities across the global biologics outsourcing market. It also highlights the shifting focus and investments of pharma/biotech participants toward BioCDMOs for innovative biologics discovery, development, and manufacturing.
With the changing market landscape, BioCDMOs are shifting toward providing value-added services by establishing themselves as a one-stop-shop for their pharma clients. These companies are adopting advanced manufacturing technologies such as single-use/disposable bioreactors, continuous, POD manufacturing, and so on with the integration of IT-based solutions implementing the Industrial Internet of Things (IIoT) by means of strategic collaborations and partnerships. Larger participants are resorting to Mergers and Acquisitions (M&As) in order to gain specific therapeutic and technical expertise from smaller, niche BioCDMOs. While the US and Europe are key markets, the outsourcing trend is slowly shifting toward APAC with several new entrants providing cost-effective drug development services.
The study aims at identifying some key growth opportunities such as biosimilars co-development, designer cell lines, bioanalytical development and services, and so on that are set to drive the market over the next 5 years. It provides revenue forecasts of the global BioCDMO market as well as a breakdown by type of cell culture (mammalian versus microbial) and service type (drug substance versus drug product). The study highlights some of the key market drivers and restraints that will affect the overall growth of the market. Additionally, it provides an insight into leading disruptive technology trends such as improvements in upstream and downstream technologies, advances in lyophilisation, and increased application of Process Analytical Technologies (PAT) that are shaping the future of the BioCDMO industry. The study also highlights some emerging business models such as expanding services of CMOs into early stage of drugs, emergence of virtual biotech, out-licensing, and risk sharing between pharma and CMOs that are disrupting traditional business models.
Key Issues Addressed
- Is the biologic contract manufacturing market growing, how long will it continue to grow and at what rate?
- What are the fastest growing segments of the biologics contract development and manufacturing market?
- What growth opportunities exist in the biologics contract development and manufacturing industry?
- What are the key drivers and restraints affecting the growth of CDMOs?
- What are the key challenges that CDMOs are likely to face in the near and long-term future? How can CDMOs strategize to overcome these hurdles?
- In what ways is the biologics contract manufacturing industry likely to change to meet industry trends and dynamics?
- Which are the game-changing companies and what are the disruptive technologies and business models? How do CDMOs position their assets with pharma companies?
1. Executive Summary
1.1 Key Findings
1.2 Scope and Segmentation
1.3 Key Questions This Study Will Answer
1.4 Market Engineering Measurements
1.5 CEO’s Perspective
1.6 8 Big Market Themes for BioCDMO Market
1.7 Defining Trends in the Biologics CDMO Market
1.8 Executive Summary-3 Big Predictions
2. Market Overview
2.1 Market Overview
2.3 Pharmaceutical Outsourcing Value Chain
2.4 Market Segmentation
2.5 Global Market Perspective
2.6 Macro Trends - Biologics Development and Manufacturing
2.7 Technology Trends-Biologics Development and Manufacturing
2.8 Emerging CDMO Business Model
2.9 Changing Business Model - Rise in Virtual Pharma
2.10 Virtual Pharma - Change Makers in the Pharma and Biotech Outsourcing Ecosystem
2.11 Virtual Biotech Companies Enabled by Outsourcing
3. Competitive Playbook
3.1 Game-changing BioCDMO Companies
3.2 New Market Opportunities
3.3 Snapshot of Competitive Landscape
3.4 Competitive Playbook - Market Share Analysis
4. Drivers, Restraints and Trends-Total BioCDMO Market
4.1 Market Drivers
4.2 Market Restraints
4.3 Entry Barriers of Biologics CDMO Markets
4.4 Global CDMO Market - Key Trends
4.5 Disruptive Technology Trends Across the BioCDMO Market
4.6 Benefits of Disposable Over Stainless Steel Bioreactors
4.7 Comparative Analysis of Single-use/Disposable and Traditional Large-capacity Stainless Steel Bioreactors
4.8 Comparative Analysis of Perfusion and Batch Manufacturing
4.9 CDMO by Technology
4.10 Comparative Analysis of Mammalian Versus Microbial Cell Culturing
5. Forecast and Trends-Total BioCDMO Market
5.1 Market Engineering Measurements
5.2 Forecast Assumptions
5.3 Revenue Forecast
5.4 Revenue Forecast Discussion
5.5 CDMO Outsourcing Potential
5.6 Outsourcing Trends and Rationale
5.7 Higher Outsourcing Penetration
6. Segment Analysis-Forecast and Trends
6.1 Revenue Forecast by Service Type
6.2 Percent Revenue Forecast by Service Type
6.3 Revenue Forecast Discussion by Service Type
6.4 Revenue Forecast by Cell Culture Type
6.5 Percent Revenue Forecast by Cell Culture Type
6.6 Revenue Forecast Discussion by Cell Culture Type
7. Growth Opportunities and Companies to Action
7.1 Transformation in Industry Ecosystem
7.2 5 Major Growth Opportunities
7.3 Growth Opportunity 1 - IIoT in Manufacturing
7.4 Growth Opportunity 2 - Designer Cell Lines
7.5 Growth Opportunity 3 - Biosimilar Co-development
7.6 Growth Opportunity 4 - Single-Use/Disposable Manufacturing
7.7 Growth Opportunity 5 - Bioanalytical Development & Services
7.8 Strategic Imperatives for Success and Growth
8. Customer and End-user Analysis
8.1 Key Characteristics Influencing CDMO Selection
8.2 Stated Versus Unstated Importance of CDMO Selection Factors
8.3 Stated Versus Unstated Importance of CDMO Selection Factors Discussion
9. The Last Word
9.1 The Last Word - 3 Big Predictions
9.2 Legal Disclaimer
10.1 Drivers Explained
10.2 Restraints Explained
10.3 Market Engineering Methodology
10.4 List of Vendors Included in this Research
10.5 List of Exhibits