PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2018 Edition

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This report is the 8th edition of our long running analysis of the CMO Industry, using NDA approvals as the primary indicator of performance. CMO Scorecard is critical for benchmarking the performance of the CMO industry and the relative performance of major CMOs.

Scope

Who should buy this report?

This 43-page report gives important, expert insight you won’t find in any other source. 28 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 injectables 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.
  • Private equity investors that need a deeper understanding of the market to identify and value potential investment targets.

Companies mentioned

3M

Abbvie

ACS Dobfar

Actavis

Adare Pharmaceuticals

Aenova Group

Aesica Pharmaceuticals

Afton Scientific Corp.

Ajinomoto Althea

Ajinomoto Co.

Akorn

Albany Molecular Research Inc.

Alcami

Alkermes ...

3M

Abbvie

ACS Dobfar

Actavis

Adare Pharmaceuticals

Aenova Group

Aesica Pharmaceuticals

Afton Scientific Corp.

Ajinomoto Althea

Ajinomoto Co.

Akorn

Albany Molecular Research Inc.

Alcami

Alkermes

Alliance Medical Products

Almac Group

Alpex Pharma

APL

ARx LLC

ASM Aerosol-Service AG

AstraZeneca

Avara Pharmaceutical Services

Aveva Drug Delivery Systems

B. Braun Melsungen AG

Banner Life Sciences

Bausch & Lomb Pharmaceuticals

Baxter BioPharma Solutions

Baxter International

Bayer Healthcare

BioRamo LLC

BioReliance

Boehringer Ingelheim BioXcellence

Boehringer Ingelheim GmbH

Bristol-Myers Squibb

BSP Pharmaceuticals

Bushu Pharmaceuticals

CAF-DCF

Capsugel

Catalent Pharma Solutions

Cenexi

Cerovene

Chemo

Cipla

Colep

Confab Laboratories

Cook Pharmica LLC

CPL Contract Pharmaceuticals Limited

Debiopharm Research & Manufacturing SA

Delpharm

DPT Laboratories

Ei Inc.

Emergent BioSolutions

Excella Pharma Source

Exela Pharma Sciences

Exelead

Famar

Fareva Holding

Ferndale Labs & Contract Manufacturing

Ferrer Internacional

Fresenius Kabi

Frike Group

Galephar SA

Gedeon Richter

Gilead Sciences

Gland Pharma Limited

GlaxoSmithKline

Glenmark

Grifols

Groupe Panpharma

Halo Pharmaceutical

Hameln Pharmaceuticals GmbH

Holopack Verpackungstechnik GmbH

IDT Biologika GmbH

Importfab Inc.

Instituto Bioclon S.A. de C.V.

Intas Pharmaceuticals Ltd.

James Alexander Corporation

Japan Tobacco Inc.

Jetpharma SA

Jubilant HollisterStier Contract Manufacturing & Services

Kemwell Biopharma

KP Pharmaceutical Technology

Kremers Urban Pharmaceuticals

Laboratoires Théa

Lehigh Valley Technologies Inc.

Lifecore Biomedical

Lonza Netherlands?

LTS Lohmann

LTS Lohmann Therapie-Systeme AG

Lyne Laboratories

Lyophilization Services of New England

Medimmune

Mikart

Mipharm

Mitsubishi Tanabe Pharma Corporation

MonoSol Rx

Mustafa Nevzat Pharmaceuticals

Mylan

Nerviano Medical Sciences

Nexgen Pharma

NextPharma Technologies

Nipro Pharma Corp.

Nordmark Arzneimittel GmbH & Co. KG

Norwich Pharma Services

Nova Laboratories Ltd

Nuvo Research

Orion Corporation

Pari Pharma

Patheon

PCI Pharma Services

Perrigo

Pfizer

Pharmaceutical Manufacturing Research Services Inc.

Pharmaceutics International

Pharmaceutics International Inc

Pharmascience Inc.

Pierre Fabre

Pierrel SpA

Pillar5 Pharma Inc.

Piramal Pharma Solutions

Porton Biopharma Limited

QS Pharma

Rechon Life Science

Recipharm

Recro Pharma Inc.

Renaissance

Rentschler Biopharma SE

Rivopharm S.A.

Rosemont Pharmaceuticals

Rottendorf

Rottendorf Pharma GmbH

Sanico NV.

Sanofi

Sanquin Blood Supply Foundation

Siegfried

Sintetica

Sirton Pharmaceuticals SpA

Steri-pharma LLC

Sterigenics

Swedish Orphan Biovitrum AB

Synerlab Group

Tapemark

Teligent

The Ritedose Corporation

Tris Pharma

Unither Pharmaceuticals

University of Iowa Pharmaceuticals

UPM Pharmaceuticals

Valeant Pharmaceuticals International

Vectura

Vetter Pharma International

Vifor Pharma

Wockhardt Contract Manufacturing

Woodfield Pharmaceutical

Zydus Cadila

Table of Contents

1. Executive Summary 5

2. Introduction 6

3. NDA Approvals Overview 6

4. US Versus EU Approval Performance 8

5. Outsourced Dose Manufacture 9

6 ...

1. Executive Summary 5

2. Introduction 6

3. NDA Approvals Overview 6

4. US Versus EU Approval Performance 8

5. Outsourced Dose Manufacture 9

6. Special Product Categories 13

7. Outsourcing by Global Bio/Pharma Companies 17

8. CMO Performance 19

9. Outsourced API Approvals 21

10. What It Means 24

11. Notes on Methodology 25

12. Appendix 27

List of tables

Table 1: Outsourced NDA Approvals by Dosage Form 12

Table 2: Outsourcing by Sponsor Type and FDA Approval Type 2012–2017 13

Table 3: API ...

Table 1: Outsourced NDA Approvals by Dosage Form 12

Table 2: Outsourcing by Sponsor Type and FDA Approval Type 2012–2017 13

Table 3: API CMOs Receiving NME Approvals in 2017 23

Table 4: 2017 CBER Approvals Included in the Analysis 27

Table 5: 2017 Outsourced Dose Approvals 27

Table 6: Dose CMOs Receiving Contracts for FDA Approvals in 2008–2017 31

Table 7: 2017 Outsourced API Approvals 35

Table 8: Dose CMOs Manufacturing NDAs Approved 2017 39

Table 9: MHRA Approvals in 2017 42

List of figures

Figure 1: NDA Approvals 2008–2017 7

Figure 2: NDA Approvals by Sponsor Type 2008–2017 8

Figure 3: EMA Approvals 2012–2017 9

Figure ...

Figure 1: NDA Approvals 2008–2017 7

Figure 2: NDA Approvals by Sponsor Type 2008–2017 8

Figure 3: EMA Approvals 2012–2017 9

Figure 4: Share of NDA Approvals Outsourced 2008–2017 10

Figure 5: NDA Approvals Outsourced 2008–2017 10

Figure 6: Dose Outsourcing of Small and Large Molecule APIs 2008–2017 11

Figure 7: Outsourcing of NME Approvals by Sponsor Type 12

Figure 8: Outsourcing of Non-NME NDA Approvals by Sponsor Type 13

Figure 9: Outsourcing of Orphan NMEs 2008–2017 14

Figure 10: Outsourcing of Fast Track NMEs 2011–2017 15

Figure 11: Outsourcing of Breakthrough NMEs 2013–2017 15

Figure 12: NMEs Requiring Special Handling 2008–2017 16

Figure 13: Approval and Outsourcing of NMEs Utilizing Advanced Formulation Technologies 2011–2016 17

Figure 14: Global Bio/Pharma Outsourcing Propensity 2008–2017 18

Figure 15: Trends in Global Bio/Pharma NDA Outsourcing 2008–2017 19

Figure 16: Breakdown in Composition of Outsourced NMEs 2008–2017 by Sponsor Type 20

Figure 17: Breakdown in Composition of Outsourced Non-NME NDAs 2008–2017 by Sponsor Type 21

Figure 18: Outsourcing of API for NME Approvals 2008–2017 22

Figure 19: ANDA Approvals 2008–2017 41

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Overall, a very thorough report

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