Global Pharmaceutical Continuous Manufacturing Market, Growth Opportunities

PUBLISHED: February 3, 2023

PAGES: 90 Pages

DELIVERY TIME: 1-2 business days

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Description

Regulatory Acceptance Propelling Continuous Manufacturing Investments through Partnerships and In-house Expansions

Continuous manufacturing (CM) is a method for manufacturing end-to-end pharmaceutical products on a single, uninterrupted production line. While batch manufacturing requires transporting, testing, and refeeding materials from one process to the next, continuous processes execute all testing, feeding, and processing inline at a single manufacturing site. The global pharma industry is slowly shifting its focus from primary care to specialty medicine and rare diseases. To modify research and development (R&D) models to address and adapt to challenges associated with rare, ultra-rare, and specialty diseases, the strategy is changing from being present in a few large segments to many small segments and exploring new disease areas with high unmet needs.

CM helps pharma companies significantly speed up the chemistry and manufacturing processes, which can cut down on the overall manufacturing timelines, especially in critical life-saving drugs. To date, the US Food and Drug Administration (FDA) has approved the manufacture of over 7 drugs using continuous processes, which started off from only one product less than 4 years ago. In 2020 alone, the FDA approved 4 new drugs to be manufactured using CM. Alongside the FDA, health authorities in Canada, Europe, Australia, Japan, Switzerland, and New Zealand have approved CM application for the production of solid oral dosage forms, indicating the growing acceptance of the technology worldwide.

With such nascent technology, the pharma industry has been applying the technique for processes that are off limits for batch processes, which might include toxic reagents, and for scale-up reactions that include electrochemical or photochemical reactions. Implementing technologies, such as process analytical technology (PAT) and digital twins, for improved real-time decision making will allow for the better control of manufacturing processes, including batch and CM.

Considering the large-scale benefits of flexibility and timeline management and a quantifiable reduction in the cost of manufacturing through automated processes and better resource management, CM is expected to witness large-scale adoption in the form of integrated processes. Furthermore, the ecosystem is currently focused on pharma companies that take the majority share, in terms of setting up facilities. Contract development and manufacturing organizations (CDMOs), however, are slowly expanding their facilities by collaborating with CM platform vendors, with system integrators and automation experts providing additional support in the optimization manufacturing value chain. In the coming years, as the regulatory and operational benefits become more realized, CDMOs and pharma companies will likely continue enhancing and building their CM capabilities and expertise to remain competitive.

Product Code: PE0B-52

Strategic Imperatives

Why is it Increasingly Difficult to Grow?
The Strategic Imperative 8™
The Impact of the Top 3 Strategic Imperatives on the Pharmaceutical Continuous Manufacturing (CM) Industry
Growth Opportunities Fuel the Growth Pipeline Engine™

Growth Opportunity Analysis

Scope of Analysis
Segmentation
Market Trend Analysis
Market Trend Analysis (continued)
Batch Manufacturing versus CM
Batch Manufacturing versus CM (continued)
Benefits of Adopting CM
Vendor Ecosystem
Growth Drivers
Growth Restraints

CM Market Scenario

CM-Adoption Timeline (FDA)
CM-Adoption Timeline (FDA) (continued)
Current Market Scenario of CM Growth
CM-Technology Overview

Investment Trends-Partnerships and Expansions

Investment Trends-Partnerships and Expansions
Facility Expansions/Acquisitions
Facility Expansions/Acquisitions (continued)
Facility Expansions/Acquisitions (continued)
Facility Expansions/Acquisitions (continued)
Partnerships/Collaborations
Partnerships/Collaborations (continued)
Partnerships/Collaborations (continued)
Partnerships/Collaborations (continued)

Growth Opportunity Analysis-Global Pharmaceutical CM Market

Growth Metrics
Forecast Assumptions
Forecast Assumptions (continued)
Global Pharmaceutical Market
Revenue Forecast
Revenue Forecast Analysis
Revenue Forecast Analysis (continued)
Regional Perspective

Growth Opportunity Analysis-In-house versus Outsourced

Revenue Forecast-In-house versus Outsourced
Percent Revenue Forecast-In-house versus Outsourced
Revenue Forecast Analysis-In-house versus Outsourced
Revenue Forecast Analysis-In-house versus Outsourced (continued)

Growth Opportunity Analysis-Small Molecules versus Large Molecules

Revenue Forecast-Small Molecules versus Large Molecules
Percent Revenue Forecast-Small Molecules versus Large Molecules
Revenue Forecast Analysis-Small Molecules versus Large Molecules

Growth Opportunity Analysis-Drug Substance versus Drug Product

Revenue Forecast-DS versus DP (Large Molecules)
Revenue Forecast-API versus FDF (Small Molecules)
Revenue Forecast Analysis by Segments

Growth Opportunity Analysis-Competitor Assessment

Competitive Environment
Key Competitors by Region-End Users

Competitor Profiles-CDMOs Providing CM Services

Cambrex Corporation-Overview
Cambrex Corporation-Overview (continued)
SK Biotek-Overview
SK Biotek-Overview (continued)
Corden Pharma-Overview
Corden Pharma-Overview (continued)
Patheon (Thermo Fisher Scientific)-Overview
Patheon (Thermo Fisher Scientific)-Overview (continued)
Wuxi Biologics-Overview
Wuxi Biologics-Overview (continued)
Fujifilm Diosynth Biotechnologies-Overview
Fujifilm Diosynth Biotechnologies-Overview (continued)

CM-Equipment Manufacturers

CM-Equipment Manufacturers
CM-Equipment Manufacturers (continued)

Growth Opportunity Universe

Growth Opportunity 1-Capability Expansion for CM in APAC
Growth Opportunity 1-Capability Expansion for CM in APAC (continued)
Growth Opportunity 2-Focus on Process Automation for Enhanced Productivity
Growth Opportunity 2-Focus on Process Automation for Enhanced Productivity (continued)
Growth Opportunity 3-Viral Vector CM for Gene Therapy
Growth Opportunity 3-Viral Vector CM for Gene Therapy (continued)