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

Powered by

All the vital news, analysis, and commentary curated by our industry experts.

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.


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.

ACS Dobfar
Adare Pharmaceuticals
Aenova Group
Aesica Pharmaceuticals
Afton Scientific Corp.
Ajinomoto Althea
Ajinomoto Co.
Albany Molecular Research Inc.
Alliance Medical Products
Almac Group
Alpex Pharma
ASM Aerosol-Service AG
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
Boehringer Ingelheim BioXcellence
Boehringer Ingelheim GmbH
Bristol-Myers Squibb
BSP Pharmaceuticals
Bushu Pharmaceuticals
Catalent Pharma Solutions
Confab Laboratories
Cook Pharmica LLC
CPL Contract Pharmaceuticals Limited
Debiopharm Research & Manufacturing SA
DPT Laboratories
Ei Inc.
Emergent BioSolutions
Excella Pharma Source
Exela Pharma Sciences
Fareva Holding
Ferndale Labs & Contract Manufacturing
Ferrer Internacional
Fresenius Kabi
Frike Group
Galephar SA
Gedeon Richter
Gilead Sciences
Gland Pharma Limited
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
Mitsubishi Tanabe Pharma Corporation
MonoSol Rx
Mustafa Nevzat Pharmaceuticals
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
PCI Pharma Services
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
Recro Pharma Inc.
Rentschler Biopharma SE
Rivopharm S.A.
Rosemont Pharmaceuticals
Rottendorf Pharma GmbH
Sanico NV.
Sanquin Blood Supply Foundation
Sirton Pharmaceuticals SpA
Steri-pharma LLC
Swedish Orphan Biovitrum AB
Synerlab Group
The Ritedose Corporation
Tris Pharma
Unither Pharmaceuticals
University of Iowa Pharmaceuticals
UPM Pharmaceuticals
Valeant Pharmaceuticals International
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. 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

Frequently asked questions

PharmSource – CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2018 Edition thematic reports
Currency USD

Can be used by individual purchaser only


Can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company

Undecided about purchasing this report?

Enquire Before Buying Request a Free Sample

Get in touch to find out about multi-purchase discounts
Tel +44 20 7947 2745

Every customer’s requirement is unique. With over 220,000 construction projects tracked, we can create a tailored dataset for you based on the types of projects you are looking for. Please get in touch with your specific requirements and we can send you a quote.

Sample Report

PharmSource – CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2018 Edition was curated by the best experts in the industry and we are confident about its unique quality. However, we want you to make the most beneficial decision for your business, so we offer free sample pages to help you:

  • Assess the relevance of the report
  • Evaluate the quality of the report
  • Justify the cost

Download your copy of the sample report and make an informed decision about whether the full report will provide you with the insights and information you need.

Below is a sample report to understand what you are buying

See what our customers are saying

“The GlobalData platform is our go-to tool for intelligence services. GlobalData provides an easy way to access comprehensive intelligence data around multiple sectors, which essentially makes it a one-for-all intelligence platform, for tendering and approaching customers.

GlobalData is very customer orientated, with a high degree of personalised services, which benefits everyday use. The highly detailed project intelligence and forecast reports can be utilised across multiple departments and workflow scopes, from operational to strategic level, and often support strategic decisions. GlobalData Analytics and visualisation solutions has contributed positively when preparing management presentations and strategic papers.”

Business Intelligence & Marketing Manager, SAL Heavy Lift

“COVID-19 has caused significant interference to our business and the COVID-19 intelligence from GlobalData has helped us reach better decisions around strategy. These two highlights have helped enormously to understand the projections into the future concerning our business units, we also utilise the project database to source new projects for Liebherr-Werk to use as an additional source to pitch for new business.”

Market Analyst & Management, Liebherr-Werk

Your daily news has saved me a lot of time and keeps me up-to-date with what is happening in the market, I like that you almost always have a link to the source origin. We also use your market data in our Strategic Business Process to support our business decisions. By having everything in one place on the Intelligence Center it has saved me a lot of time versus looking on different sources, the alert function also helps with this.

Head of Key Accounts, Saab AB

Having used several other market research companies, I find that GlobalData manages to provide that ‘difficult-to-get’ market data that others can’t, as well as very diverse and complete consumer surveys.

Marketing Intelligence Manager, Portugal Foods

Our experience with GlobalData has been very good, from the platform itself to the people. I find that the analysts and the account team have a high level of customer focus and responsiveness and therefore I can always rely on. The platform is more holistic than other providers. It is convenient and almost like a one stop shop. The pricing suite is highly competitive and value for our organisation.

I like reports that inform new segments such as the analysis on generation Z, millennials, the impact of COVID 19 to our banking customers and their new channel habits. Secondly the specialist insight on affluent sector significantly increases our understanding about this group of customers. The combination of those give us depth and breadth of the evolving market.

I’m in the business of answering and helping people make decisions so with the intelligence center I can do that, effectively and efficiently. I can share quickly key insights that answer and satisfy our country stakeholders by giving them many quality studies and primary research about competitive landscape beyond the outlook of our bank. It helps me be seen as an advisory partner and that makes a big difference. A big benefit of our subscription is that no one holds the whole data and because it allows so many people, so many different parts of our organisation have access, it enables all teams to have the same level of knowledge and decision support.

Head of Customer Insight and Research, Standard Chartered

“I know that I can always rely on Globaldata’s work when I’m searching for the right consumer and market insights. I use Globaldata insights to understand the changing market & consumer landscape and help create better taste & wellbeing solutions for our customers in food, beverage and healthcare industries.

Globaldata has the right data and the reports are of very high quality compared to your competitors. Globaldata not only has overall market sizes & consumer insights on food & beverages but also provides insights at the ingredient & flavour level. That is key for B2B companies like Givaudan. This way we understand our customers’ business and also gain insight to our unique industry”

Head of Consumer Sensory Insights, Givaudan

GlobalData provides a great range of information and reports on various sectors that is highly relevant, timely, easy to access and utilise.  The reports and data dashboards help engagement with clients; they provide valuable industry and market insights that can enrich client conversations and can help in the shaping of value propositions. Moreover, using GlobalData products has helped increase my knowledge of the finance sector, the players within it, and the general threats and opportunities.

I find the consumer surveys that are carried out to be extremely beneficial and not something I have seen anywhere else. They provided an insightful view of why and which consumers take (or don’t) particular financial products. This can help shape conversations with clients to ensure they make the right strategic decisions for their business.

One of the challenges I have found is that data in the payments space is often piecemeal. With GD all of the data I need is in one place, but it also comes with additional market reports that provide useful extra context and information. Having the ability to set-up alerts on relevant movements in the industry, be it competitors or customers, and have them emailed directly to me, ensures I get early sight of industry activity and don’t have to search for news.

Senior Account Manager, TSYS
Immuno-oncology in pharma: neoepitope prediction
$250 | December 2023
Innovation in pharma: transdermal drug delivery
$250 | November 2023
Go even deeper with GlobalData Intelligence Center

Every Company Report we produce is powered by the GlobalData Intelligence Center.

Subscribing to our intelligence platform means you can monitor developments at PharmSource – CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2018 Edition in real time.

  • Access a live PharmSource – CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2018 Edition dashboard for 12 months, with up-to-the-minute insights.
  • Fuel your decision making with real-time deal coverage and media activity.
  • Turn insights on financials, deals, products and pipelines into powerful agents of commercial advantage.