바이오 제조용 인공지능(AI) : 기술과 세계 시장

Scope and Coverage Overview

This report examines the role of artificial intelligence (AI) as a transformative layer within modern biomanufacturing systems. It positions AI as a critical enabling technology supporting the transition toward more efficient, scalable, and digitally integrated biological production platforms. The analysis focuses on how AI addresses core challenges associated with biomanufacturing complexity, process variability, regulatory constraints, and industrial scalability across multiple sectors, with emphasis on commercial manufacturing operations rather than R&D or clinical development activities.

Technology Scope

The report defines AI solutions in biomanufacturing from both a market segmentation perspective and a functional, process-oriented perspective.

At the highest level, the market is segmented into two primary categories:

• AI software, consisting of standalone or modular solutions.
• AI-enabled integrated platforms, consisting of end-to-end systems combining software with hardware, automation, or execution layers.

In addition, the report analyzes AI solutions based on their functional role within the biomanufacturing value chain, identifying several core categories:

• AI-enabled process data infrastructure and manufacturing analytics, focusing on data integration, contextualization, lifecycle analytics, and externally connected manufacturing.
• AI-integrated biosensing and smart measurement systems, enabling real-time monitoring and interpretation of biological signals.
• AI-based predictive modeling and process monitoring systems, including soft sensing, batch prediction, and anomaly detection.
• AI-enabled digital twins, integrating mechanistic and data-driven models for data gap filling, simulation, scenario testing, and closed-loop process control.
• AI-supported optimization, control, and decision-support systems, enabling real-time, multi-objective optimization, and human-in-the-loop, semi-autonomous decision-making.
• AI-enabled process improvement and manufacturing innovation technologies, including generative AI and agentic reasoning for process improvement and upgrades.
• AI-enabled integrated automation and robotic execution systems, translating AI-driven insights into autonomous manufacturing actions.

Each technology category is evaluated in terms of deployment status, scalability, and role within biomanufacturing environments.

Application and Industry Coverage

The report assesses AI adoption across multiple biomanufacturing sectors, including:

• Healthcare and biopharmaceutical manufacturing
• Chemicals and plastics
• Energy
• Food and beverage
• Agriculture
• Emerging sectors such as textiles, defense, and space-based manufacturing

Analysis includes both established applications and emerging use cases, highlighting differences in adoption levels, regulatory intensity, and economic drivers.

Market and Industry Analysis

The study provides global analysis of the AI in biomanufacturing market, including:

• Market size and forecasts by AI solution type, technology class, application, and region
• Industry trends shaping adoption, including digitalization, regulatory evolution, and automation strategies
• Comparison of AI software versus AI-enabled integrated platforms and their respective roles in manufacturing systems

Competitive Landscape

The report features a detailed competitive analysis covering over 60 companies across the AI biomanufacturing ecosystem, such as:

• Leading software providers (e.g., Aizon, Cognite, TetraScience, Seeq, DataHow)
• Integrated platforms and industrial automation providers (e.g., Siemens, Sartorius, Emerson, Rockwell Automation, Honeywell)
• AI-native and emerging technology firms (e.g., Quartic.ai, Katalyze AI, Fero Labs, BioprocessAI)
• AI infrastructure providers (Nvidia, Microsoft, OpenAI)
• Biomanufacturers and contract manufacturers scaling up AI (Amgen, Pfizer, BASF, WuXi Biologics, Samsung Biologics).

Company coverage includes detailed profiles for key vendors, along with shorter summaries for additional specialized or emerging players, highlighting technology positioning, sector focus, and competitive strategies.

Intellectual Property and Regulatory Coverage

The report provides:

• Patent analysis covering AI-driven biomanufacturing technologies, highlighting key applicants, innovation trends, and technology concentration areas
• Regulatory analysis examining frameworks in the United States, Europe, Asia Pacific, and other regions, with particular focus on GMP compliance, data integrity, and AI governance

Geographic Scope and Time Horizon

Geographic coverage is global, including analysis of:

• North America
• Europe
• Asia Pacific
• Rest of the world

Market forecasts and industry trends are provided for the 2024–2031 period, with 2026 as the base year for detailed market estimates.

What This Report Does Not Cover

• AI-driven drug discovery, early-stage R&D, clinical development, or purely service-based AI offerings
• Consumer-facing adoption analysis unrelated to manufacturing technologies
• Proprietary manufacturing process parameters or confidential operational data
• Detailed plant-level engineering specifications or equipment design

Table of Contents

EXECUTIVE SUMMARY

INTRODUCTION

• BIOMANUFACTURING AND ITS APPLICATIONS
  • APPLICATIONS OF BIOMANUFACTURING
• STRUCTURAL COMPLEXITY OF BIOMANUFACTURING PROCESSES
• ROLE OF AI IN BIOMANUFACTURING

TECHNOLOGY STATUS

• OVERVIEW OF AI TECHNOLOGIES USED IN BIOMANUFACTURING
  • AI-ENABLED PROCESS DATA INFRASTRUCTURE AND MANUFACTURING ANALYTICS
  • AI-INTEGRATED BIOSENSING AND SMART MEASUREMENT SYSTEMS
  • AI-BASED PREDICTIVE MODELING AND PROCESS MONITORING SYSTEMS
  • AI-ENABLED DIGITAL TWINS
  • AI-SUPPORTED OPTIMIZATION, CONTROL, AND DECISION-SUPPORT SYSTEMS
  • AI-ENABLED PROCESS IMPROVEMENT AND MANUFACTURING INNOVATION TECHNOLOGIES
  • AI-ENABLED INTEGRATED AUTOMATION AND ROBOTIC EXECUTION SYSTEMS
• PATENT ANALYSIS

COMPETITIVE LANDSCAPE

• INTRODUCTION TO COMPANY PROFILES
• COMPANY PROFILES – AI-ENABLED BIOMANUFACTURING SOLUTIONS
  • AI SOFTWARE
  • AI-ENABLED INTEGRATED PLATFORMS
  • RECENT INDUSTRY EVENTS
• COMMERCIAL USE CASES OF AI IN BIOMANUFACTURING
• REGIONAL LANDSCAPE
  • UNITED STATES
  • EUROPE
  • ASIA PACIFIC
  • REST OF THE WORLD
• INDUSTRY CHALLENGES FOR AI IN BIOMANUFACTURING
• DATA QUALITY
• TALENT ACQUISITION

GLOBAL MARKET ANALYSIS

• GLOBAL MARKET SUMMARY FOR AI IN BIOMANUFACTURING
  • GLOBAL MARKET BY AI SOLUTION TYPE
  • INDUSTRY TRENDS
  • GLOBAL MARKET BY TECHNOLOGY CLASS
  • GLOBAL MARKET BY APPLICATION
  • GLOBAL MARKET BY REGION
• AI SOFTWARE
• AI-ENABLED INTEGRATED PLATFORMS

METHODOLOGY AND CREDENTIALS

• METHODOLOGY
• ANALYST CREDENTIALS
• ABOUT AMG NEWTECH
• CONTACT