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Growth Opportunities in Sterile Injectable Outsourcing

  • Report
  • 43 Pages
  • June 2022
  • Region: Global
  • Frost & Sullivan
  • ID: 5617348
Injectables constitute one of the fastest-growing segments in the pharmaceuticals space. Many drugs, including biologics, are going off-patent in the next 3 or 4 years, which will lead to an increase in the demand for generics and biosimilar injectables. The increase in onshoring and nearshoring biopharmaceutical products for COVID-19 and next-generation biologics has significantly increased the demand for aseptic fill-and-finish capacity and capabilities to meet the demand from various regions. All these factors have made sterile injectable drug product service outsourcing the most lucrative opportunity for contract development and manufacturing companies (CDMO)s. The sterile injectable outsourcing market is set to expand at a CAGR of 9.4%% from 2021 to 2026.

Accelerated project timeframes have prompted CDMOs to review their approach and consider strategies that support greater agility in fill-and-finish operations. The development and manufacturing of high-potency small molecules, less-soluble drugs, and targeted small molecules have allowed small-molecule CDMOs to showcase their capabilities and expertise to pharmaceutical partners. Similarly, biologic manufacturing requires advanced manufacturing/quality control technologies, equipment, and skill sets. Biopharma companies and innovative biotech players are increasingly outsourcing process development and manufacturing to CDMOs that possess excellent technologies and equipment.


In this report,the analyst offers:

  • Insights through market forecasts
  • Analysis by segment: small-molecule FDF and biologic drug product
  • Market trends, drivers, and restraints
  • CDMOs’ investment and expansion into injectable capacity
  • Opportunities that stakeholders can pursue

Table of Contents

1. Strategic Imperatives
  • Why is it Increasingly Difficult to Grow?
  • The Strategic Imperative 8™
  • The Impact of the Top 3 Strategic Imperatives on Sterile Injectables Outsourcing
  • Growth Opportunities Fuel the Growth Pipeline Engine™
2. Growth Opportunity Analysis
  • Key Takeaways
  • Scope of Analysis
  • Forecast Framework - CDMO
  • Forecast Methodology - Sterile Injectable Outsourcing
  • Forecast Assumptions
  • Key Growth Metrics
  • Growth Drivers
  • Growth Restraints
  • Revenue Forecast
  • Revenue Forecast by Product Type
  • Revenue Forecast Analysis
  • Therapeutic Area Overview
  • Supply Chain and the Evolving Role of Vendors
  • Recent Trends Driving Collaborations & Expansions
  • Capability Overview of Select CDMOs
  • CDMO Acquisitions and Sterile Injectable Capacity Expansion - US
  • CDMO Acquisitions and Sterile Injectable Capacity Expansion - Europe
  • CDMO Acquisitions and Sterile Injectable Capacity Expansion - APAC
  • Smartification of Injectable Delivery Device
3. Growth Opportunity Universe
  • Growth Opportunity 1: Flexible and Modular Aseptic Fill-and-Finish Capabilities
  • Growth Opportunity 2: Strategic Partnerships that Provide Integrated Injectable Drug Product and Device Service
  • Growth Opportunity 3: Cold-chain Capabilities that Support Next-gen Biologics
  • List of Exhibits
  • Legal Disclaimer