全球連續製藥市場：增長機會

連續製造可以幫助製藥公司顯著加快其化學和製造過程，縮短整體製造時間表，尤其是對於關鍵的救命藥物。 製藥行業已將該技術應用於有限的過程，例如可能含有有毒試劑的批處理過程以及涉及電化學和光化學反應的放大反應。 通過引入過程分析技術 (PAT) 和數字孿生等技術改進實時決策，將能夠更好地控制批次和 CM 等製造過程。

本報告審視了全球製藥連續製造市場，並提供了市場概覽、戰略要務、增長機會等。

內容

戰略要務

• 為什麼增長越來越難？
• 戰略要務
• 三大戰略要務對連續製藥行業的影響
• 增長機會加速增長管道引擎

增長機會分析

• 分析範圍
• 細分
• 市場趨勢分析
• 批量製造和 CM（連續製造）
• 引入 CM 的好處
• 供應商生態系統
• 司機
• 抑制生長

CM市場場景

• CM- 採用時間表 (FDA)
• CM 增長的當前市場情景
• CM-技術概述

投資趨勢 - 合作與擴張

• 投資趨勢 - 合作夥伴關係和擴張
• 擴大/收購設施
• 夥伴關係/協作

增長機會分析 - 全球醫藥 CM 市場

• 增長指數
• 預測假設
• 全球醫藥市場
• 收入預測
• 收入預測分析
• 區域視角

增長機會分析 - 內部與外包

增長機會分析 - 小型與大型

增長機會分析 - API 和藥物

增長機會分析 - 競爭評估

競爭對手概況 - 提供 CM 服務的 CDMO

• Cambrex Corporation - 概覽
• SK Biotek - 概覽
• Corden Pharma-概覽
• Patheon（Thermo Fisher Scientific）- 概述
• 藥明生物 - 概覽
• Fujifilm Diosynth Biotechnologies-Overview

CM設備製造商

• CM 設備製造商

成長機會

• 增長機會 1 - 在亞太地區推廣 CM
• 增長機會 2 - 專注於流程自動化以提高生產力
• 增長機會 3 - 用於基因治療 - 病毒載體 CM

下一步

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.

Table of Contents

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)

Next Steps

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• Why Frost, Why Now?
• List of Exhibits
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