Global Pharmaceutical Continuous Manufacturing Market, Growth Opportunities

Global Pharmaceutical Continuous Manufacturing Market - Growth Opportunities, Analysis, Forecast, North America, 2023

Regulatory Acceptance Propelling Continuous Manufacturing Investments through Partnerships and In-house Expansions - Pharmaceutical Manufacturing Trends, Continuous Manufacturing of Pharmaceuticals,Global Pharmaceutical Industry Growth

RELEASE DATE
03-Feb-2023
REGION
North America
Deliverable Type
Market Research
Research Code: PE0B-01-00-00-00
SKU: HC03637-NA-MT_27447
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Description

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.

Author: Aarti Siddhesh Chitale

Table of Contents

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™

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—Adoption Timeline (FDA)

CM—Adoption Timeline (FDA) (continued)

Current Market Scenario of CM Growth

CM—Technology Overview

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 Metrics

Forecast Assumptions

Forecast Assumptions (continued)

Global Pharmaceutical Market

Revenue Forecast

Revenue Forecast Analysis

Revenue Forecast Analysis (continued)

Regional Perspective

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)

Revenue Forecast—Small Molecules versus Large Molecules

Percent Revenue Forecast—Small Molecules versus Large Molecules

Revenue Forecast Analysis—Small Molecules versus Large Molecules

Revenue Forecast—DS versus DP (Large Molecules)

Revenue Forecast—API versus FDF (Small Molecules)

Revenue Forecast Analysis by Segments

Competitive Environment

Key Competitors by Region—End Users

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 (continued)

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)

Your Next Steps

Why Frost, Why Now?

List of Exhibits

Legal Disclaimer

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. Author: Aarti Siddhesh Chitale
More Information
New Title Global Pharmaceutical Continuous Manufacturing Market - Growth Opportunities, Analysis, Forecast, North America, 2023
New Subtitle Regulatory Acceptance Propelling Continuous Manufacturing Investments through Partnerships and In-house Expansions - Pharmaceutical Manufacturing Trends, Continuous Manufacturing of Pharmaceuticals,Global Pharmaceutical Industry Growth
Deliverable Type Market Research
Author Aarti Siddhesh Chitale
Industries Healthcare
No Index No
Is Prebook No
Keyword 1 global pharmaceutical industry
Keyword 2 pharmaceutical market
Keyword 3 pharmaceutical industry growth
Podcast No
WIP Number PE0B-01-00-00-00