세계의 의약품 제조 자동화 시장 예측(-2032년) - 컴포넌트별, 자동화 모드별, 용도별, 최종사용자별, 지역별 분석

According to Stratistics MRC, the Global Automation in Pharmaceutical Manufacturing Market is accounted for $13.5 billion in 2025 and is expected to reach $28.7 billion by 2032 growing at a CAGR of 11.3% during the forecast period. Automation in pharmaceutical manufacturing involves integrating robotics, process control systems, and data analytics to streamline production of medicines, vaccines, and biologics. It enhances precision, consistency, and regulatory compliance by automating formulation, filling, packaging, and quality control. Automation reduces human intervention, minimizing contamination risks and operational errors. It accelerates production cycles while ensuring high product quality. The market grows due to increasing demand for pharmaceuticals, regulatory scrutiny, and the need for scalable, efficient production methods amid rising global health challenges.

Market Dynamics:

Driver:

Increasing demand for efficient drug production

The industry faces immense pressure to reduce time-to-market for new therapies while managing complex production workflows. Automation directly addresses this by enhancing production line throughput, minimizing human error, and ensuring batch-to-batch consistency. Furthermore, it enables manufacturers to optimize resource utilization and lower long-term operational costs. This relentless pursuit of efficiency, driven by competitive and economic pressures, is a fundamental catalyst for investing in automated systems, from robotic process automation to integrated control systems.

Restraint:

High investment in automation equipment

A significant barrier to market entry and expansion is the substantial capital expenditure required for automation infrastructure. This includes not only the initial outlay for sophisticated robotics, manufacturing execution systems (MES), and specialized hardware but also the ancillary costs for system integration, validation, and employee training. Moreover, the total cost of ownership presents a considerable financial challenge, particularly for small and mid-sized enterprises (SMEs). This high investment threshold can delay ROI calculations and necessitates long-term strategic planning, thereby restraining widespread adoption across all tiers of pharmaceutical manufacturers.

Opportunity:

Expansion of biopharmaceutical production

The rapid growth of the biopharmaceutical sector, encompassing biologics, monoclonal antibodies, and cell and gene therapies, presents a substantial opportunity for automation. These complex products require stringent environmental controls, precise process parameter management, and aseptic processing conditions that are ideally managed by automated and closed systems. Automation ensures the high fidelity and reproducibility necessary for these sensitive processes. Additionally, the scalability challenges inherent in bioproduction can be effectively mitigated through flexible and modular automation solutions, opening a new and high-value market segment for automation vendors.

Threat:

Cybersecurity threats in connected systems

As pharmaceutical manufacturing embraces Industry 4.0, the convergence of operational technology (OT) with information technology (IT) creates vulnerabilities to cyber-attacks. Connected automation systems, while efficient, are potential targets for breaches that could lead to intellectual property theft, operational shutdown, or catastrophic manipulation of process parameters compromising drug safety and efficacy. A successful attack not only poses a direct threat to patient health but also risks severe regulatory non-compliance and reputational damage. Consequently, the evolving sophistication of cyber threats remains a critical concern for the industry's digital transformation.

Covid-19 Impact:

The COVID-19 pandemic acted as a profound catalyst for the pharmaceutical automation market. It exposed critical vulnerabilities in global supply chains and highlighted the urgent need for agile and resilient manufacturing capabilities. The unprecedented demand for vaccines and therapeutics accelerated the adoption of automation to rapidly scale up production while maintaining social distancing protocols in facilities. This crisis underscored the value of automated systems in ensuring business continuity, thereby compelling many manufacturers to fast-track their digitalization and automation strategies to future-proof their operations against similar disruptions.

The hardware segment is expected to be the largest during the forecast period

The hardware segment is expected to account for the largest market share during the forecast period due to its fundamental role as the physical backbone of any automation setup. This segment includes essential components such as robotics arms, automated workcells, sensors, controllers, and assembly lines. These tangible assets require significant capital investment and are the primary enablers of automated processes on the factory floor. The continued necessity for these core components to establish initial automation capabilities, coupled with their high cost relative to software and services, solidifies hardware's dominant position in the overall market revenue.

The quality control and regulatory compliance segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the quality control and regulatory compliance segment is predicted to witness the highest growth rate. This is driven by the pharmaceutical industry's non-negotiable requirement to adhere to stringent Good Manufacturing Practice (GMP) guidelines set by agencies like the FDA and EMA. Automation in this segment, through technologies like machine vision for inspection and automated sampling systems, drastically reduces human error and provides robust, data-rich audit trails. Moreover, the increasing complexity of drug products makes manual quality checks insufficient, thereby fueling the demand for advanced, automated compliance solutions to ensure patient safety and streamline regulatory approvals.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share. This dominance is attributed to the presence of a well-established pharmaceutical industry, a high concentration of leading market players, and early technological adoption. Furthermore, the stringent regulatory framework enforced by the U.S. FDA compelling manufacturers to implement advanced processes for quality assurance acts as a key driver. The region's robust financial capacity to invest in high-cost automation technologies and a strong focus on researching complex biologics solidify its position as the revenue leader in this market.

Region with highest CAGR:

Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR. This accelerated growth is fueled by the expanding pharmaceutical manufacturing footprint in countries like India and China, which are major global hubs for API and generic drug production. Governments in the region are actively promoting industrial automation through initiatives like "Industry 4.0" and "Make in India." Additionally, increasing investments from multinational corporations seeking cost-effective production alternatives, coupled with rising domestic demand for high-quality medicines, are driving the rapid modernization and automation of manufacturing facilities across the region.

Key players in the market

Some of the key players in Automation in Pharmaceutical Manufacturing Market include Siemens, Rockwell Automation, KUKA, Becton Dickinson and Company, Capsa Healthcare, Omnicell, Baxter International, Yuyama, ScriptPro, Swisslog Healthcare, SYNTEGON, IMA Group, GEA Group, FANUC, Themis Automation, Turck, Bausch+Strobel, and Sartorius.

Key Developments:

In July 2025, Capsa Healthcare acquired BlueBin, integrating predictive analytics and Kanban-based supply chain systems to enhance clinical supply management.

In June 2025, Pharbaco achieved GMP-EU compliance by implementing advanced automation and energy-efficient cleanroom solutions, utilizing FactoryTalk(R) Historian for environmental data analysis.

In February 2025, Siemens announced its Xcelerator Smart Lab Ecosystem, which revolutionizes lab and cleanroom design with modular, plug-and-play infrastructure. This solution can accelerate lab design by up to 80% while ensuring compliance with pharmaceutical standards.

In January 2025, BD and Biosero announced a collaboration to integrate robotic arms with BD's flow cytometry instruments, aiming to accelerate drug discovery and development.

Components:

• Hardware
• Software
• Services

Mode of Automations Covered:

• Semi-Automatic Systems
• Fully Automatic Systems

Applications Covered:

• Drug Discovery and Development
• Clinical Trials
• Production and Processing
• Quality Control and Regulatory Compliance
• Logistics and Inventory Management

End Users Covered:

• Pharmaceutical Companies
• Biotechnology Companies
• Contract Development & Manufacturing Organizations (CDMOs / CMOs)
• Research and Academic Institutions

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Application Analysis
• 3.7 End User Analysis
• 3.8 Emerging Markets
• 3.9 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Automation in Pharmaceutical Manufacturing Market, By Component

• 5.1 Introduction
• 5.2 Hardware
  • 5.2.1 Robots
  • 5.2.2 Control Systems
  • 5.2.3 Sensors and Instrumentation
  • 5.2.4 Drives and Motors
  • 5.2.5 Other Hardware
• 5.3 Software
  • 5.3.1 Manufacturing Execution System (MES)
  • 5.3.2 Laboratory Information Management System (LIMS)
  • 5.3.3 Enterprise Resource Planning (ERP)
  • 5.3.4 Distributed Control System (DCS) Software
  • 5.3.5 Process Analytical Technology (PAT) Software
  • 5.3.6 Plant Asset Management (PAM) Software
• 5.4 Services
  • 5.4.1 Integration & Consulting Services
  • 5.4.2 Maintenance & Support Services

6 Global Automation in Pharmaceutical Manufacturing Market, By Mode of Automation

• 6.1 Introduction
• 6.2 Semi-Automatic Systems
• 6.3 Fully Automatic Systems

7 Global Automation in Pharmaceutical Manufacturing Market, By Application

• 7.1 Introduction
• 7.2 Drug Discovery and Development
• 7.3 Clinical Trials
• 7.4 Production and Processing
  • 7.4.1 Active Pharmaceutical Ingredients (API) Manufacturing
  • 7.4.2 Formulation and Fill-Finish
  • 7.4.3 Packaging and Labeling
• 7.5 Quality Control and Regulatory Compliance
• 7.6 Logistics and Inventory Management

8 Global Automation in Pharmaceutical Manufacturing Market, By End User

• 8.1 Introduction
• 8.2 Pharmaceutical Companies
• 8.3 Biotechnology Companies
• 8.4 Contract Development & Manufacturing Organizations (CDMOs / CMOs)
• 8.5 Research and Academic Institutions

9 Global Automation in Pharmaceutical Manufacturing Market, By Geography

• 9.1 Introduction
• 9.2 North America
  • 9.2.1 US
  • 9.2.2 Canada
  • 9.2.3 Mexico
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 Italy
  • 9.3.4 France
  • 9.3.5 Spain
  • 9.3.6 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 Japan
  • 9.4.2 China
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 New Zealand
  • 9.4.6 South Korea
  • 9.4.7 Rest of Asia Pacific
• 9.5 South America
  • 9.5.1 Argentina
  • 9.5.2 Brazil
  • 9.5.3 Chile
  • 9.5.4 Rest of South America
• 9.6 Middle East & Africa
  • 9.6.1 Saudi Arabia
  • 9.6.2 UAE
  • 9.6.3 Qatar
  • 9.6.4 South Africa
  • 9.6.5 Rest of Middle East & Africa

10 Key Developments

• 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 10.2 Acquisitions & Mergers
• 10.3 New Product Launch
• 10.4 Expansions
• 10.5 Other Key Strategies

11 Company Profiling

• 11.1 Siemens
• 11.2 Rockwell Automation
• 11.3 KUKA
• 11.4 Becton Dickinson and Company
• 11.5 Capsa Healthcare
• 11.6 Omnicell
• 11.7 Baxter International
• 11.8 Yuyama
• 11.9 ScriptPro
• 11.10 Swisslog Healthcare
• 11.11 SYNTEGON
• 11.12 IMA Group
• 11.13 GEA Group
• 11.14 FANUC
• 11.15 Themis Automation
• 11.16 Turck
• 11.17 Bausch+Strobel
• 11.18 Sartorius