Contract Dose Manufacturing universe, includes companies that actively promote themselves as Contract Manufacturing Organizations (CMOs) that produce a client’s pharmaceutical finished dosage form for supply to the highly regulated markets of the US, Canada, EU, and Japan. The motivation for pharma companies outsourcing their manufacturing is often to do with lacking expertise, equipment, or cost reduction (especially for small to mid-sized CMOs) in development of their product’s API or dose. For clinical dose manufacturing, there is a high risk associated with the pipeline drug product and as such using a CMO for this mitigates risk for pharma companies that may otherwise have to invest in equipment and facilities.
Most commercial dose companies have solid dose manufacturing facilities, as new products become molecularly complex issues arise such as those surrounding bioavailability and formulation (delivery technologies are becoming increasingly important) for products that are often have poor solubility or are highly potent (Hickman et al. 2018). As batches are becoming smaller due to an increasing use of orphan drugs and drugs for patient sub populations such as pediatrics, the ability for flexible and small-scale is becoming particularly desirable.
These two trends will affect consolidation trends for CMOs as certain technologies are increasingly sought after and will also affect dose related revenue growth as many CMOs will not have the capabilities to provide the desired service for a changing drug product in a decreasing patient population. It is predicted that dose related CMO revenues will grow more slowly than for their API counterparts. Many dose CMOs will have to improve their formulation and drug delivery technologies to compete for clients with products that are often have poor solubility or are highly potent
The report "PharmSource - Contract Dose Manufacturing Industry by the Numbers: Composition, Size, Market Share and Outlook - 2018 Edition", characterizes the contract dose manufacturing industry along a number of quantitative dimensions, including number and type of participants, market size, market shares of the top CMOs, and profitability.
Some of the Key Questions Answered in this report include:
- What is the geographic reach of Dose CMOs?
- What are the 2017 revenues generated by Contract dose manufacturing industry?
- What are the components of revenue change for Contract Dose Manufacturers?
- What is the breakdown of 2017 revenues by different dosage forms?
- What are the characteristics of the largest dose CMOs?
- How did the revenue growth of Contract Dose manufacturers in 2017 compare to Contract API manufacturers?
- What proportion of approved NDAs have had their Dose manufacture outsourced between 2008-2017?
- What is the outlook for the dose CMO industry?
- What Dose CMO M&A deals occurred in 2017?
- To describe and evaluate the dose market; segmented by type of growth and dosage form contributions
- To describe and assess the M&A environment for Dose CMOs
- To assess the outlook for buyers and sellers of contract manufacturing services for commercial dose, including the supply/demand balance
- Overview of dose contract revenue market size, the components of growth and dosage form specific revenues for CMOs providing pharmaceutical finished dosage form for supply to the highly regulated markets of the US, Canada, EU and Japan.
- Detailed view of dose CMO M&A deals and services gained for commercial dose manufacturing, established from the PharmSource Contract Service Providers database.
- Assessment of dose CMO industry size and structure.
- Characterising types of dosage form manufacture provided by the leading dose CMOs.
This 47-page report gives an important expert quantitative analysis on the contract dose manufacturing industry. Findings are based on the industry’s most comprehensive database of the dose CMO industry (PharmSource’s Database of Contract Service Providers and Financial Database) this analysis is driven by a proprietary model of the dose manufacturing industry, which is continuously updated and refined. The 8 tables and 10 figures throughout the report illustrate major points and trends. This report is required reading for:
- CMO executives and strategic decision-makers: improves understanding of the dose CMO industry and a critical input for strategic planning efforts.
- Sourcing and procurement executives in bio/pharmaceutical companies: improving understanding of crucial components of the supply base that will provide insights for supplier selection and management.
- Private equity investors: they can deeper understanding of the dose CMO market and important insight for identifying potential investment targets.
2 Industry Size and Structure
Definition of the Dose CMO Universe
3 Major Developments Affecting Industry Structure
4 Industry Size and Growth
5 CMO Market Shares
Characteristics of the Largest CMOs
6 Analyzing Recent Dose CMO Industry Performance
The Outlook for the Dose CMO Industry
Methodology for Market Size & Growth Estimates
Industry Cost of Goods
Primary Research - Key Opinion Leaders Interviewed for this Report
About the Authors
List of Tables
Table 1: Summary of CMO Facility Acquisition Activity, 2012-2017
Table 2: CMO Acquisitions of Bio/Pharmaceutical Company Facilities, 2017
Table 3: CMO Acquisitions of Bio/Pharmaceutical Companies, 2017
Table 4: CMO Acquisitions of Other CMOs, 2017
Table 5: Private Equity Investments in the Dose CMO Industry, 2012-2017
Table 6: Percentage of Commercial Dose CMOs thatOffer Clinical Dose Manufacture, by Revenue Tier
Table 7: Revenue Composition and Strategic Orientation of Leading CMOs, 2017
Table 8: Geographical Reach of Dose CMO Universe
List of Figures
Figure 1: Geographic Reach of the Dose CMO Universe, 2017
Figure 2: Dose CMOs by Revenue, 2017
Figure 3: Dose CMO Market Size, 2009-2017
Figure 4: Components of Growth for Dose CMOs, 2016-2017
Figure 5: Dose CMO Dosage Form Segments in 2017 ($B)
Figure 6: Dose CMO Industry Market Share by Company Size, 2017
Figure 7: Bio/Pharma Services Sector Performance
Figure 8: Organic Revenue Growth for Public CMOs
Figure 9: Breakdown of NMEs & Outsourced NMEs Approved for Global Bio/Pharma Companies, 2008-2017
Figure 10: Breakdown of US Orphan Drug Approvals, 2008-2017
- 3M Drug Delivery Systems
- ABC Farmaceutici
- Acino Holding AG
- ACS Dobfar
- Adare Pharmaceuticals
- Aenova (Swiss Caps/Dragenopharm)
- Akiyama Jyozai
- Alfa Wasserman
- Alpex Pharma