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

Powered by

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

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 from the GlobalData Pharma Intelligence Center Drugs Database and Regulatory Milestones Tracker Database:

• marketed innovator biologics

• marketed biosimilars

• innovator biologic patent expiries and waves of biosimilar opportunity

• biosimilar clinical pipeline

Detailed view from the GlobalData PharmSource Contract Service Providers database:

• existing CDMO contracts for biosimilars for API, dose and packaging

Reasons to Buy

The report will enable you to:

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

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

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

Table

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

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

Frequently asked questions

PharmSource – Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars – 2018 Edition thematic reports
Currency USD
$4,995

Can be used by individual purchaser only

$14,985

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

reportstore@globaldata.com
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 – Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars – 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
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 – Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars – 2018 Edition in real time.

  • Access a live PharmSource – Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars – 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.