PharmSource - Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars - 2018 Edition
Biosimilars represent a promising solution to healthcare stakeholders and patients in bringing down the costs of biologics and thus providing some respite for cash-strapped payers. For this reason, they also offer the opportunity to treat more patients, and earlier, than more expensive innovator biologics.
The EMA has already approved 51 biosimilars, while the FDA lags behind with 17 approvals but is catching up in the eight years since it created a review pathway. These approvals mostly consist of recombinant proteins, the majority of which are monoclonal antibodies (mAbs).
As more innovator biologics reach their patent expiry, there is a greater opportunity for biopharmaceutical companies to develop biosimilars and for CMOs to benefit from the consequent manufacturing demand. These biologic patent expirations are occurring in four distinct waves. We are currently in the second wave of biologic patent expirations, with products including Humira (adalimumab), Herceptin (trastuzumab), and Remicade (infliximab) losing patent protection, leading to biosimilar approval applications.
The third and fourth waves of innovator biologic patents will expire in the next decade; in anticipation, drug makers are pursuing 106 biosimilars through clinical development for US and EU markets alone. This includes 15 biosimilars of Humira (adalimumab) and 19 biosimilar versions of Avastin (bevacizumab) alone. A full 57% (52) of those programs are in Phase III development or Pre-Registration stage.
The majority of these near-term development projects are in the hands of large-cap companies with the resources for potential significant in-house manufacturing capability. If CMOs are to benefit greatly from the coming third and fourth waves of biosimilars, with patents expiring from 2019, they will need to develop effective strategies to provide an attractive alternative to in-house manufacturing, and to stand out from their CMO competitors.
To assess the degree to which CMOs can benefit from the biosimilar boom, the report PharmSource - Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars - 2018 Edition, addresses the following questions:
Key Questions Answered
- What biosimilars are marketed in the US and EU?
- How is biosimilar manufacturing and packaging outsourced?
- What therapies are in the biosimilar pipeline?
- In what regions is biosimilar development concentrated?
- How does biosimilar manufacturing differ by molecule type?
- When will innovator biologic patents expire, allowing biosimilar development?
- What proportion of biosimilar manufacturing is kept in-house?
- How will contract analytical testing services be affected by the rise of biosimilars?
- To describe and evaluate the biosimilar market opportunity for CDMOs and CMOs
- To describe the network of CDMOs that currently manufacture for the biosimilar market
- To assess the outlook for buyers and sellers of contract manufacturing services for biosimilars, including factors influencing client decisions about whether to manufacture in-house or outsource
Detailed view of -
Reasons to buy
- Marketed Innovator Biologics.
- Marketed Biosimilars.
- Innovator Biologic Patent Expiries and Waves of Biosimilar Opportunity.
- Biosimilar Clinical Pipeline.
- Existing CDMO Contracts for Biosimilars for API, Dose and Packaging.
This 74-page report gives important, expert insight you won’t find in any other source. 20 tables and figures throughout the report illustrate major points and trends. This report is required reading for -
- CMO executives who must have deep understanding of the biosimilar marketplace to make strategic planning and investment decisions.
- Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management.
- Pharmaceutical and Biotech companies involved in the development of innovator biologics or biosimilars.
- Investors that need a deeper understanding of the market to identify and value potential investment targets.
- 1. Executive Summary
- 2. Introduction
- 3. The Biosimilar Opportunity
- 4. Approved Biosimilars
- 5. Market Penetration
- Regional Variability in Biosimilar Uptake
- Biosimilar vs. Innovator Market Share
- New Patient Access
- 6. The Biosimilar Pipeline
- 7. Sourcing Arrangements for Biosimilars
- Joint Ventures
- Capacity and scale
- API Segmentation
- Geography and Partnerships
- Analytic and Testing CDMOs
- 8. Notes on Methodology
- 9. Appendix
- 9.1 Bibliography
- 9.2 Primary Research - Key Opinion Leaders in this Report
- 9.3 Additional Tables
- 9.4 About the Authors
- List of Tables
- Table 1: FDA-Approved Biosimilars and Their API Manufacturing Contracts
- Table 2: FDA-Approved Biosimilars and Their Dose Manufacturing Contracts
- Table 3: FDA-Approved Biosimilars and Their Packaging Contracts
- Table 4: EMA-Approved Biosimilars and Their API Manufacturing Contracts
- Table 5: EMA-Approved Biosimilars and Their Dose Manufacturing Contracts
- Table 6: EMA-Approved Biosimilars and Their Packaging Contracts
- Table 7: Waves of Biosimilar Opportunity by EU Patent Expiry of Biologic Innovators
- Table 8: Waves of Biosimilar Opportunity by US Patent Expiry of Biologic Innovators
- List of Figures
- Figure 1: Waves of Biosimilar Opportunity by EU Patent Expiry of Innovator Biologics
- Figure 2: Market Share Forecast by Class for UC in the US, 2016
- Figure 3: Biosimilars in Clinical Development
- Figure 4: Biosimilar Clinical Development by Sponsor Type
- Figure 5: Biosimilar Clinical Development by Sponsor HQ Location
- Figure 6: Outsourcing of Biosimilar Approvals, EU
- Figure 7: Proportion of API Outsourcing of Biosimilar Approvals, EU, Jan. 2009-Dec. 2018
- Figure 8: Proportion of Dose Outsourcing of Biosimilar Approvals, EU, Jan. 2009-Dec. 2018
- Figure 9: Outsourcing of Biosimilar Approvals, US
- Figure 10: Proportion of API Outsourcing of Biosimilar Approvals, US
- Figure 11: Proportion of Dose Outsourcing of Biosimilar Approvals, US
- Figure 12: Manufacturing of FDA- and EMA-Approved Biosimilars by Molecule Type