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PharmSource - Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars - 2018 Edition

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  • 74 Pages
  • December 2018
  • Region: Global
  • GlobalData
  • ID: 4720468
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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?

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


Detailed view of -
  • 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.

Reasons to Buy
  • 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.

Table of Contents

1. Executive Summary2. Introduction3. The Biosimilar Opportunity4. 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

Companies Mentioned

A selection of companies mentioned in this report includes:

  • AbbVie

  • Accord Healthcare

  • Advanced Accelerator Applications

  • Aeterna Zentaris

  • Aetos Biologics

  • Alexion Pharmaceuticals

  • Allpack

  • AlphaMab

  • Amgen

  • APEIRON Biologics

  • Apotex

  • Aptevo Therapeutics

  • AstraZeneca

  • Baxter International

  • Bayer

  • Bayer Healthcare

  • Beijing Fogangren Bio-Pharm Tech

  • Biogen

  • BioMarin Pharmaceutical

  • BioReliance

  • Boehringer Ingelheim BioXcellence

  • Boehringer Ingelheim

  • Bristol-Myers Squibb

  • BTG

  • Catalent

  • Celgene

  • Celltrion

  • Chiesi Farmaceutici

  • Chugai Pharmaceutical Co

  • Clinuvel Pharmaceuticals

  • Coherus BioSciences

  • Cook Pharmica

  • CSL

  • Dompe Farmaceutici

  • Eli Lilly

  • Elusys Therapeutics

  • Emergent BioSolutions

  • Endo International

  • F. Hoffmann-La Roche

  • Ferring International Center

  • Finox Biotech

  • GE Healthcare

  • Gedeon Richter

  • Gene Techno Science

  • Genentech

  • Genor BioPharma

  • GlaxoSmithKline

  • Grunenthal Group

  • Horizon Pharma

  • IDT Biologika

  • Intas Pharmaceuticals

  • Ipsen

  • Ironwood Pharmaceuticals

  • Jazz Pharmaceuticals

  • Johnson & Johnson

  • KBI Biopharma

  • Kyowa Hakko Kirin

  • La Jolla Pharmaceutical Company

  • LG Chem

  • MabPlex International

  • MannKind Corp

  • Medac

  • Medice Arzneimittel Pütter & Co.

  • 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

  • Pharming Group

  • Polymun Scientific Immunbiologische Forschung

  • Portola Pharmaceuticals

  • Protalix BioTherapeutics

  • Regeneron Pharmaceuticals

  • Rentschler Biopharma

  • rEVO Biologics

  • Richter Gedeon

  • Richter-Helm Biologics & Co.

  • Samsung Bioepis

  • Samsung BioLogics

  • Sandoz

  • Sanofi

  • ScinoPharm Taiwan

  • Seattle Genetics

  • Serenity Pharmaceuticals

  • Servier

  • Shanghai Mab Venture Biopharm

  • ShangPharma Corporation

  • Shenzen Techdow Pharmaceutical Co.

  • Shire

  • Sicor Biotech

  • SK Chemicals

  • Spectrum Pharmaceuticals

  • Stada Arzneimittel

  • Sun Pharma Advanced Research Company

  • Swedish Orphan Biovitrum

  • Synergy Pharmaceuticals

  • Syngene International

  • TaiMed Biologics

  • Teva Pharmaceutical Industries

  • The Medicines Company

  • Theratechnologies

  • ThromboGenics NV


  • UCB

  • Ultragenyx Pharmaceutical

  • United Therapeutics

  • Vetter Pharma-Fertigung

  • Walvax Biotechnology

  • Wockhardt Contract Manufacturing

  • WuXi AppTec

  • Wuxi Biologics