DUBLIN--(BUSINESS WIRE)--The "PharmSource - Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars - 2018 Edition" report has been added to ResearchAndMarkets.com's offering.
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.
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?
Key Benefits
- 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
Scope
- 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.
Key Topics Covered:
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
Companies Mentioned
- AbbVie
- Amgen
- APEIRON Biologics
- Apotex
- Aptevo Therapeutics
- AstraZeneca
- Baxter International
- Bayer
- Bayer Healthcare
- Beijing Fogangren Bio-Pharm Tech
- Boehringer Ingelheim BioXcellence
- Boehringer Ingelheim
- Bristol-Myers Squibb
- BTG
- Catalent
- Celgene
- Cook Pharmica
- CSL
- Dompe Farmaceutici
- Eli Lilly
- Elusys Therapeutics
- Emergent BioSolutions
- Endo International
- F. Hoffmann-La Roche
- GE Healthcare
- Gedeon Richter
- Gene Techno Science
- Genentech
- Genor BioPharma
- GlaxoSmithKline
- Ipsen
- Ironwood Pharmaceuticals
- Jazz Pharmaceuticals
- Johnson & Johnson
- KBI Biopharma
- Kyowa Hakko Kirin
- La Jolla Pharmaceutical Company
- LG Chem
- MedImmune
- Merck & Co / MSD
- Merck KGaA
- Mustafa Nevzat Pharmaceuticals
- Mylan
- Novartis
- Novartis International
- Novelion Therapeutics
- Novo Nordisk AS
- Octapharma
- Ono Pharmaceutical Co
- Pall Corp
- Patheon
- PCI Pharma Services
- Pfizer
- rEVO Biologics
- Richter Gedeon
- Richter-Helm Biologics & Co.
- Samsung Bioepis
- Samsung BioLogics
- Sandoz
- Sanofi
- Servier
- Shanghai Mab Venture Biopharm
- ShangPharma Corporation
- Shenzen Techdow Pharmaceutical Co.
- Shire
- Sicor Biotech
- SK Chemicals
- Spectrum Pharmaceuticals
- Syngene International
- ThromboGenics NV
- TOLMAR
- UCB
- Wockhardt Contract Manufacturing
- WuXi AppTec
- Wuxi Biologics
For more information about this report visit https://www.researchandmarkets.com/research/nxs8l7/2018_pharmsource?w=4
