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Growth Opportunities in the Global Pharmaceutical Contract Manufacturing Organization Market (CMO) - Forecast to 2024

  • Report

  • 144 Pages
  • December 2019
  • Region: Global
  • Frost & Sullivan
  • ID: 4876650

Advancements in Continuous Manufacturing Technology, Necessary to Meet New Demand in the Orphan Drugs Segment

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?

Table of Contents

1. Executive Dashboard
  • Purpose of this Study
  • 5-step Process to Transformational Growth
  • Key Findings
  • Key Questions this Study will Answer
  • Market Engineering Measurements
  • Big Market Themes
  • Strategic Imperatives for Success and Growth
  • Key Trends Impacting the CMO Industry


2. Market Overview
  • 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


3. Market Dynamics
  • 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


4. Revenue Forecast
  • Methodology and Assumptions
  • Market Engineering Measurements
  • Revenue Forecast by Product Type
  • Revenue Forecast by Region


5. Revenue Forecast - API
  • API CMO Market - Revenue Forecast by Customer Base
  • API CMO Market - Revenue Forecast by Region
  • Revenue Forecast Discussion
  • API Landscape


6. Revenue Forecast - FDF
  • FDF CMO Market - Revenue Forecast by Formulation Type
  • FDF CMO Market - Revenue Forecast by Region
  • Revenue Forecast Discussion


7. Revenue Forecast - US
  • US API CMO Market - Revenue Forecast by Customer Base
  • US FDF CMO Market - Revenue Forecast by Formulation Type


8. Revenue Forecast - Germany
  • Germany API CMO Market - Revenue Forecast by Customer Base
  • Germany FDF CMO Market - Revenue Forecast by Formulation Type
  • Growth Driver - Clinical Trials


9. Revenue Forecast - UK
  • UK API CMO Market - Revenue Forecast by Customer Base
  • UK FDF CMO Market - Revenue Forecast by Formulation Type


10. Revenue Forecast - France
  • France API CMO Market - Revenue Forecast by Customer Base
  • France FDF CMO Market - Revenue Forecast by Formulation Type


11. Revenue Forecast - Italy
  • Italy API CMO Market - Revenue Forecast by Customer Base
  • Italy FDF CMO Market - Revenue Forecast by Formulation Type


12. Revenue Forecast - Spain
  • Spain API CMO Market - Revenue Forecast by Customer Base
  • Spain FDF CMO Market - Revenue Forecast by Formulation Type


13. Revenue Forecast - Scandinavia
  • Scandinavia API CMO Market - Revenue Forecast by Customer Base
  • Scandinavia FDF CMO Market - Revenue Forecast by Formulation Type


14. Revenue Forecast - Benelux
  • Benelux API CMO Market - Revenue Forecast by Customer Base
  • Benelux FDF CMO Market - Revenue Forecast by Formulation Type


15. Revenue Forecast - India
  • India API CMO Market - Revenue Forecast by Customer Base
  • India FDF CMO Market - Revenue Forecast by Formulation Type


16. Revenue Forecast - China
  • China API CMO Market - Revenue Forecast by Customer Base
  • China FDF CMO Market - Revenue Forecast by Formulation Type
  • Barriers to Serving Regulated Markets


17. Revenue Forecast - Japan
  • Japan API CMO Market - Revenue Forecast by Customer Base
  • Japan FDF CMO Market - Revenue Forecast by Formulation Type


18. Competitive Landscape
  • Competitive Environment
  • Market Share Analysis
  • Revenues of Key Companies
  • Manufacturing Footprint
  • Key Companies to Watch
  • Key Themes in the Collaboration/Expansion Landscape


19. Key Collaboration Agreements in the Contract Manufacturing Market
  • Expansion Assessment
  • Collaboration Assessment
  • Thermo Fisher and Patheon - Redefining One-stop-shop
  • Growing PE Interest - The Required Leverage for Scale-up


20. Growth Opportunities
  • 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


21. The Last Word - Strategic Considerations for Staying on the Growth Trajectory
  • Top 3 Predictions for the Market
  • Winning Strategies for CMOs
  • Legal Disclaimer


22. Appendix
  • 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

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Decisyon
  • Patheon
  • Thermo Fisher
  • Trek Therapeutics