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Advancements in Continuous Manufacturing Technology, Necessary to Meet New Demand in the Orphan Drugs Segment and Personalized Medicine, Will Give a New Growth Vector to CMOs
02-Dec-2019
North America
Market Research
MEF6-01-00-00-00
HC03238-GL-MR_23770
Traditionally, CMOs have thrived by aggregating demand and delivering benefits of economies of scale. However, with the fading era of blockbuster drugs dispensed to large patient pools and shift to precision medicine, focus on niche indications, and increased R&D in biologics, pharma sponsors are increasingly turning to CMOs as strategic partners instead of contractors. Sponsors are looking for partnerships to not only append their existing capacity and get access to new markets, but also to mitigate risk and bring overhaul in manufacturing technologies. Consequently, safety, efficacy, and product quality are outweighing cost-saving considerations.
CMOs are also stepping up to the growing demand by investing in containment technology to meet HPAPI demand, introducing distributed manufacturing to take manufacturing closer to the patient, and adopting continuous manufacturing and digitization of processes. For example, CMOs are partnering with third-party vendors for layered analytics with the aim of optimizing processes, introducing preventive maintenance, and making supply chains transparent. This research service covers these technology trends with case examples of how some CMOs are ahead of the curve in adopting these technologies.
This study also covers the global market for pharmaceutical contract manufacturing for Active Pharmaceutical Ingredient (API) and Finished Dosage Form (FDF) manufacturing. It provides a comprehensive and critical analysis of subsectors, including generic APIs, novel APIs, HPAPIs, solid dosage forms, and injectable dosages. The study also examines top developed and emerging national markets, challenges in each of these markets, and hidden opportunities. For example, in the US, where generic drug penetration is heavy at almost 80% and China, India, Russia, and Mexico where levels are as high as 90%, the CMO market has reached saturation and, therefore, CMOs can explore opportunities in lifecycle management of legacy products and redesigning synthesis routes to create high-tech generics.
This study also captures sponsors’ outlook for outsourcing by products and by stage of drug lifecycle and the new engagement models being sought. In conjunction with the opportunities in product selection and manufacturing technologies, the study also has a detailed discussion on opportunities in the packaging segment in the light of new serialization requirements, track-and-trace solutions designed to reduce to counterfeit medicine, primary and secondary packaging to meet regional and local regulatory requirements, as well as opportunities to collaborate with CROs for new drug development. The study also discusses the impact of ongoing consolidation, profiles of leading CMOs, key CMOs to watch for, and, most importantly, the interest of private equity firms in the segment.
Key Issues Addressed
- What is the total market size and projected growth of the global pharmaceutical contract manufacturing market? Which are the largest growth segments to be pursued?
- How are the various regions around the globe positioned to monetize the market opportunities? What are the key regional barriers to entry?
- Which are the biggest opportunities for small- and mid-sized companies in the highly fragmented market? What are the key challenges in the near and mid term?
- How are business models evolving across the value chain and impacting the different stakeholders?
- How are product offerings in this market likely to emerge? What is the rate of innovation adoption, and how is it solving the unmet needs of customers?
- Which are the key game-changing companies in the segment and how are they riding the growth curve?
Author: Khushbu Jain
Purpose of this Study
5-step Process to Transformational Growth
Key Findings
Key Findings (continued)
Key Questions this Study will Answer
Market Engineering Measurements
Big Market Themes
Strategic Imperatives for Success and Growth
Key Trends Impacting the CMO Industry
Scope and Geographic Segmentation
Segmentation
Vendor Landscape
Key Market Drivers
Expanding Role of CMOs in the Pharma Value Chain
Capex Growth Trends
CMOs—An Answer to the Drug Shortage Epidemic
Key Market Restraints
Implications of Global Policy Changes
Global Outlook
Main Global Trends
Rejuvenated Pipelines Driving Growth
Declining but Continued Growth in the Generics Segment
Outsourcing Outlook by End User
Outsourcing by Stage of Development
New Technology Trends Revolutionizing Manufacturing
Growing Impetus in Continuous Manufacturing
3D Printing—Manufacturing the Drug Closer to the Patient
CMO Engagement Models
Evolving Business Model
Methodology and Assumptions
Market Engineering Measurements
Revenue Forecast by Product Type
Revenue Forecast by Region
API CMO Market—Revenue Forecast by Customer Base
API CMO Market—Revenue Forecast by Region
Revenue Forecast Discussion
API Landscape
FDF CMO Market—Revenue Forecast by Formulation Type
FDF CMO Market—Revenue Forecast by Region
Revenue Forecast Discussion
Revenue Forecast Discussion (continued)
US API CMO Market—Revenue Forecast by Customer Base
US FDF CMO Market—Revenue Forecast by Formulation Type
Germany API CMO Market—Revenue Forecast by Customer Base
Germany FDF CMO Market—Revenue Forecast by Formulation Type
Growth Driver—Clinical Trials
UK API CMO Market—Revenue Forecast by Customer Base
UK FDF CMO Market—Revenue Forecast by Formulation Type
France API CMO Market—Revenue Forecast by Customer Base
France FDF CMO Market—Revenue Forecast by Formulation Type
Italy API CMO Market—Revenue Forecast by Customer Base
Italy FDF CMO Market—Revenue Forecast by Formulation Type
Spain API CMO Market—Revenue Forecast by Customer Base
Spain FDF CMO Market—Revenue Forecast by Formulation Type
Scandinavia API CMO Market—Revenue Forecast by Customer Base
Scandinavia FDF CMO Market—Revenue Forecast by Formulation Type
Benelux API CMO Market—Revenue Forecast by Customer Base
Benelux FDF CMO Market—Revenue Forecast by Formulation Type
India API CMO Market—Revenue Forecast by Customer Base
India FDF CMO Market—Revenue Forecast by Formulation Type
China API CMO Market—Revenue Forecast by Customer Base
China FDF CMO Market—Revenue Forecast by Formulation Type
Barriers to Serving Regulated Markets
Japan API CMO Market—Revenue Forecast by Customer Base
Japan FDF CMO Market—Revenue Forecast by Formulation Type
Competitive Environment
Market Share Analysis
Revenues of Key Companies
Manufacturing Footprint
Key Companies to Watch
Key Companies to Watch (continued)
Key Companies to Watch (continued)
Key Themes in the Collaboration/Expansion Landscape
Expansion Assessment
Collaboration Assessment
Collaboration Assessment (continued)
Thermo Fisher and Patheon—Redefining One-stop-shop
Growing PE Interest—The Required Leverage for Scale-up
Major Growth Opportunities
Growth Opportunity 1—Controlled Substances
CMOs Positioned to Capitalize on Medical Marijuana Market
Growth Opportunity 2—Scalable Smart Packaging
Addressable Market Opportunity—Smart Packaging
Illustrative Smart Packaging Solutions
Amplifying Smart Packaging Utility—Trek Therapeutics Uses Ambrosus’ Blockchain Solution for Quality Control
Growth Opportunity 3—Manufacturing FDF in MENA
MENA Regional Developments
Examples of Strategies at Work
Key Companies to Watch in the MENA Region
Growth Opportunity 4—High Potency API
HPAPI Market Potential
Growth Opportunity 5—Smart Manufacturing
Top Technologies to Watch For
Case Study of IIoT Implementation—Decisyon’s Solution
Growth Opportunity Matrix
Top 3 Predictions for the Market
Winning Strategies for CMOs
Legal Disclaimer
Abbreviations
Appendix—Medical Cannabis
Appendix—Pharma and Biotech Market in MENA Region
Leading ICT Participants Active in Life Science
API CMO Evolution Path
FDF CMO Industry Evolution
Growth Denominators
Growth Opportunity—Alleviating Data Integrity Issues
Data Integrity Statistics
List of Exhibits
List of Exhibits (continued)
List of Exhibits (continued)
List of Exhibits (continued)
List of Exhibits (continued)
List of Exhibits (continued)
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Key Issues Addressed
- What is the total market size and projected growth of the global pharmaceutical contract manufacturing market? Which are the largest growth segments to be pursued?
- How are the various regions around the globe positioned to monetize the market opportunities? What are the key regional barriers to entry?
- Which are the biggest opportunities for small- and mid-sized companies in the highly fragmented market? What are the key challenges in the near and mid term?
- How are business models evolving across the value chain and impacting the different stakeholders?
- How are product offerings in this market likely to emerge? What is the rate of innovation adoption, and how is it solving the unmet needs of customers?
- Which are the key game-changing companies in the segment and how are they riding the growth curve?
Author: Khushbu Jain
| Deliverable Type | Market Research |
|---|---|
| No Index | No |
| Podcast | No |
| Author | Khushbu Jain |
| Industries | Healthcare |
| WIP Number | MEF6-01-00-00-00 |
| Is Prebook | No |
| GPS Codes | 9600-B1,9571-B1,99BF-B1,99C1-B1,9568-B1,9611-B1 |
Growth Opportunities in the Global Pharmaceutical Contract Manufacturing Organization Market (CMO), Forecast to 2024
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