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

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Copy Option: No
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PharmSource - Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars - 2018 Edition

Summary

Biosimilars are drugs that are highly similar but not identical to branded innovator biologics: large molecule, immunogenic drugs produced from living cells. Innovator biologics are the first to be approved, and when their patent protection expires, biosimilars may be approved, in a similar way to small molecule branded drugs and their generics.

There are no clinically meaningful differences in quality, safety and efficacy between biosimilars and innovator biologics. The exact definition of a biosimilar varies by regulator.

Biosimilars bring competition to expensive innovator biologics and represent a cost-saving option for payers.

More than 50 biosimilars are approved in the EU, while the FDA lags behind with 17 approvals but is catching up fast. As more innovator biologics come off-patent in the near future, this will bring a huge opportunity for biosimilar companies and for biosimilar manufacturers.

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?

Scope

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.

READ MORE

Table Of Content

Scope

Table of Contents

1. Executive Summary 4

2. Introduction 6

3. The Biosimilar Opportunity 7

4. Approved Biosimilars 10

5. Market Penetration 29

Regional Variability in Biosimilar Uptake 32

Biosimilar vs. Innovator Market Share 34

New Patient Access 35

6. The Biosimilar Pipeline 36

7. Sourcing Arrangements for Biosimilars 42

Joint Ventures 48

Capacity and scale 52

API Segmentation 52

Geography and Partnerships 53

Analytic and Testing CDMOs 54

8. Notes on Methodology 56

9. Appendix 57

9.1 Bibliography 57

9.2 Primary Research - Key Opinion Leaders in this Report 58

9.3 Additional Tables 59

9.4 About the Authors 75


List Of Figure

List of Figures

Figure 1: Waves of Biosimilar Opportunity by EU Patent Expiry of Innovator Biologics 8

Figure 2: Market Share Forecast by Class for UC in the US, 2016 30

Figure 3: Biosimilars in Clinical Development 37

Figure 4: Biosimilar Clinical Development by Sponsor Type 39

Figure 5: Biosimilar Clinical Development by Sponsor HQ Location 40

Figure 6: Outsourcing of Biosimilar Approvals, EU 43

Figure 7: Proportion of API Outsourcing of Biosimilar Approvals, EU, Jan. 2009-Dec. 2018 44

Figure 8: Proportion of Dose Outsourcing of Biosimilar Approvals, EU, Jan. 2009-Dec. 2018 44

Figure 9: Outsourcing of Biosimilar Approvals, US 46

Figure 10: Proportion of API Outsourcing of Biosimilar Approvals, US 46

Figure 11: Proportion of Dose Outsourcing of Biosimilar Approvals, US 47

Figure 12: Manufacturing of FDA- and EMA-Approved Biosimilars by Molecule Type 50


List Of Table

List of Tables Table 1: FDA-Approved Biosimilars and Their API Manufacturing Contracts 11 Table 2: FDA-Approved Biosimilars and Their Dose Manufacturing Contracts 13 Table 3: FDA-Approved Biosimilars and Their Packaging Contracts 15 Table 4: EMA-Approved Biosimilars and Their API Manufacturing Contracts 17 Table 5: EMA-Approved Biosimilars and Their Dose Manufacturing Contracts 21 Table 6: EMA-Approved Biosimilars and Their Packaging Contracts 25 Table 7: Waves of Biosimilar Opportunity by EU Patent Expiry of Biologic Innovators 59 Table 8: Waves of Biosimilar Opportunity by US Patent Expiry of Biologic Innovators 67

Licence Rights

Single User License:
Report can be used by individual purchaser only

Site License:
Report can be shared by unlimited users within one corporate location, e.g. a regional office

Corporate User License: 
Report can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company

Section Purchase

To know more information on Purchase by Section, please send a mail to support@kenresearch.com

INQUIRE FOR COVID-19 IMPACT ANALYSIS

Products and Companies

Products

CDMO, CMO, Contract Manufacturing Organization, Contract Development and Manufacturing Organzation, Manufacturing, biosimilar, biologic


Companies

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 Putter & 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

TOLMAR

UCB

Ultragenyx Pharmaceutical

United Therapeutics

Vetter Pharma-Fertigung

Walvax Biotechnology

Wockhardt Contract Manufacturing

WuXi AppTec

Wuxi Biologics

Company Profile

Company Profile Title

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

Summary

Biosimilars are drugs that are highly similar but not identical to branded innovator biologics: large molecule, immunogenic drugs produced from living cells. Innovator biologics are the first to be approved, and when their patent protection expires, biosimilars may be approved, in a similar way to small molecule branded drugs and their generics.

There are no clinically meaningful differences in quality, safety and efficacy between biosimilars and innovator biologics. The exact definition of a biosimilar varies by regulator.

Biosimilars bring competition to expensive innovator biologics and represent a cost-saving option for payers.

More than 50 biosimilars are approved in the EU, while the FDA lags behind with 17 approvals but is catching up fast. As more innovator biologics come off-patent in the near future, this will bring a huge opportunity for biosimilar companies and for biosimilar manufacturers.

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?

Scope

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.

READ MORE

Scope

Table of Contents

1. Executive Summary 4

2. Introduction 6

3. The Biosimilar Opportunity 7

4. Approved Biosimilars 10

5. Market Penetration 29

Regional Variability in Biosimilar Uptake 32

Biosimilar vs. Innovator Market Share 34

New Patient Access 35

6. The Biosimilar Pipeline 36

7. Sourcing Arrangements for Biosimilars 42

Joint Ventures 48

Capacity and scale 52

API Segmentation 52

Geography and Partnerships 53

Analytic and Testing CDMOs 54

8. Notes on Methodology 56

9. Appendix 57

9.1 Bibliography 57

9.2 Primary Research - Key Opinion Leaders in this Report 58

9.3 Additional Tables 59

9.4 About the Authors 75


List Of Figure

List of Figures

Figure 1: Waves of Biosimilar Opportunity by EU Patent Expiry of Innovator Biologics 8

Figure 2: Market Share Forecast by Class for UC in the US, 2016 30

Figure 3: Biosimilars in Clinical Development 37

Figure 4: Biosimilar Clinical Development by Sponsor Type 39

Figure 5: Biosimilar Clinical Development by Sponsor HQ Location 40

Figure 6: Outsourcing of Biosimilar Approvals, EU 43

Figure 7: Proportion of API Outsourcing of Biosimilar Approvals, EU, Jan. 2009-Dec. 2018 44

Figure 8: Proportion of Dose Outsourcing of Biosimilar Approvals, EU, Jan. 2009-Dec. 2018 44

Figure 9: Outsourcing of Biosimilar Approvals, US 46

Figure 10: Proportion of API Outsourcing of Biosimilar Approvals, US 46

Figure 11: Proportion of Dose Outsourcing of Biosimilar Approvals, US 47

Figure 12: Manufacturing of FDA- and EMA-Approved Biosimilars by Molecule Type 50


List Of Table

List of Tables Table 1: FDA-Approved Biosimilars and Their API Manufacturing Contracts 11 Table 2: FDA-Approved Biosimilars and Their Dose Manufacturing Contracts 13 Table 3: FDA-Approved Biosimilars and Their Packaging Contracts 15 Table 4: EMA-Approved Biosimilars and Their API Manufacturing Contracts 17 Table 5: EMA-Approved Biosimilars and Their Dose Manufacturing Contracts 21 Table 6: EMA-Approved Biosimilars and Their Packaging Contracts 25 Table 7: Waves of Biosimilar Opportunity by EU Patent Expiry of Biologic Innovators 59 Table 8: Waves of Biosimilar Opportunity by US Patent Expiry of Biologic Innovators 67

Single User License:
Report can be used by individual purchaser only

Site License:
Report can be shared by unlimited users within one corporate location, e.g. a regional office

Corporate User License: 
Report can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company

To know more information on Purchase by Section, please send a mail to support@kenresearch.com

INQUIRE FOR COVID-19 IMPACT ANALYSIS

Products

CDMO, CMO, Contract Manufacturing Organization, Contract Development and Manufacturing Organzation, Manufacturing, biosimilar, biologic


Companies

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 Putter & 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

TOLMAR

UCB

Ultragenyx Pharmaceutical

United Therapeutics

Vetter Pharma-Fertigung

Walvax Biotechnology

Wockhardt Contract Manufacturing

WuXi AppTec

Wuxi Biologics