Electronics Batch Records Market Trends And Forecasts Report 2025-2035: Pharma, Biotech And Food Industries Drive Adoption Amid GMP Compliance, AI Integration And Rising Quality Demands

(MENAFN- GlobeNewsWire - Nasdaq) The electronic batch records market is driven by increased demand for automation in the pharmaceutical industry and stricter regulatory requirements. Key growth areas include integrated systems and web/cloud-based solutions, with North America currently dominating the market and Asia-Pacific expected to grow rapidly.

Dublin, Sept. 29, 2025 (GLOBE NEWSWIRE) -- The "Electronics Batch Records Market Industry Trends and Global Forecasts to 2035: Distribution by Type of Electronic Batch Record System, Deployment Mode, Purpose of Electronic Batch Record, Geographical Regions and Leading Players" report has been added to ResearchAndMarkets's offering.

The global electronic batch records market size is currently valued at USD 1.28 billion and is projected to reach USD 9.62 billion by 2040, growing at a CAGR of 14.4% during the forecast period.

Electronic batch records (EBR) are digital solutions designed to track, streamline, and automate manufacturing processes. These systems capture, monitor, and store production data for every batch on the production line, ensuring transparency and adherence to quality standards across the entire manufacturing lifecycle. Currently, the electronic batch records are widely used in various sectors, such as pharmaceuticals, biotechnology, healthcare, and the food and beverage industry, where regulatory compliance and quality assurance are critical.

Moreover, the traditional manual batch records pose several challenges that can disrupt manufacturing processes, as they are more prone to human error and can lead to potential violations of regulatory standards. To overcome these challenges, many manufacturers have adopted electronic batch records in order to enhance their product quality while minimizing the operational and production costs. Further, the introduction of 21 CFR Part 11 compliance standards by the US Food and Drug Administration in 1990, aimed at reinforcing Good Manufacturing Practices (GMPs) marked a significant step toward the adoption of digital batch manufacturing solutions, underscoring the importance of EBR systems.

Growing safety concerns, stricter regulatory requirements, and the demand for scientific validation have accelerated the need for advanced EBR solutions. In addition, the increasing emphasis on quality, the shift toward multi-product manufacturing strategies, the integration of advanced technologies, and the emergence of artificial intelligence in EBR systems are expected to drive further growth in this market.

Electronic Batch Records Market: Key Segments

Integrated Systems are Likely to Hold the Largest Share in the Electronic Batch Records Market During the Forecast Period

Based on the type of electronic batch record systems, the global market is segmented into integrated systems and standalone systems. Currently, the integrated systems segment leads the overall market. Further, it is important to highlight that this trend is unlikely to change in the future as well. This can be attributed to the fact that these systems have the capability to improve the efficiency and productivity of manufacturing processes, while reducing the compliance cost and manual errors.

Electronic Batch Records Market for Web-Based / Cloud-Based Deployment Mode is Likely to Grow at a Relatively Faster Pace During the Forecast Period

Based on the deployment mode, the global electronic batch records market is segmented across web-based / cloud-based segment and on-premises. Presently, the market is dominated by the revenues generated through on-premises segment. However, the revenues generated by web-based / cloud-based deployment mode are anticipated to grow at a higher CAGR during the forecast period.

Quality Management Hold the Largest Share in the Electronic Batch Records Market

Based on the purpose of electronic batch records, the global market is segmented into batch management, process improvement / process management and quality management. Presently, the quality management segment accounts for the largest market share, and this trend is unlikely to change in the future as well owing to the widespread awareness of quality control and maintaining the accuracy and reliability of manufacturing batch records.

North America Accounts for the Largest Share in the Market

In the current scenario, North America is likely to capture the largest market share. Further, it is worth highlighting that the market in Asia-Pacific is expected to grow at a relatively high CAGR during the forecast period.

Electronic Batch Records Market: Research Coverage

• Electronic Batch Records Systems Landscape: The report features a list of system providers engaged in the electronic batch records domain, along with analyses based on [A] year of establishment, [B] company size, and [C] location of headquarters.
• Company Competitiveness Analysis: An insightful competitiveness analysis of the virtual clinical trials companies in this domain, based on various relevant parameters, such as [A] company strength, [B] portfolio strength, and [C] end user.
• Company Profiles: Comprehensive profiles of key industry players in the electronic batch records domain, featuring information on [A] company overview, [B] financial information (if available), [C] solutions portfolio, [D] recent developments, and [E] future outlook statements.
• Partnerships and Collaborations: A detailed analysis of partnerships inked between stakeholders in the electronic batch records market, since 2021, based on several relevant parameters, such as [A] year of partnership, [B] type of partnership, [C] type of partner, [D] purpose of electronic batch record, [E] end user, [F] most active players (in terms of number of partnerships), and [G] geography.
• Recent Initiatives: A detailed analysis of the various initiatives undertaken in the electronic batch records domain, based on several relevant parameters, such as [A] year of initiative, [B] type of initiative, [C] purpose of electronic batch record, [D] key features, [E] end user, [F] most active players (in terms of number of recent initiatives), and [G] geography.

Electronic Batch Records Market: Key Insights

• Presently, around 115 electronic batch record solutions are offered by companies across the globe; majority of the electronic batch solution providers are headquartered in Europe.
• Close to 95% electronic batch records focus on quality management; nearly 60% of these EBRs are developed for automation in the pharmaceutical industry.
• A steady growth in the partnership activity has been observed in recent years; technology utilization agreements have emerged as the most prominent partnering model.
• More than 60% of the recent initiatives within EBR domain were focused on the launch of new solutions; notably, 83% of the solutions launched / upgraded are incorporated with real-time tracking / traceability.
• Driven by the escalating demand for automated solutions and growing regulatory compliance, the electronic batch record market is poised to rise steadily in the foreseeable future.
• The market is anticipated to grow at an annualized rate (CAGR) of 14.4% by 2040; the integrated systems segment is expected to capture the majority share (close to 80%) of the market.

Players in the Electronic Batch Records Market Profiled in the Report Include:

• ABB
• AmpleLogic
• Ant Solutions
• Datex
• Ecubix
• InstantGMP
• Korber
• Sapio Sciences
• Scigeniq
• Siemens
• Solulever
• Supertech Instrumentation
• Thermo Fisher Scientific
• Tulip Interfaces
• Yokogawa

Report Scope:

Type of Electronic Batch Record System

• Integrated System
• Standalone System

Deployment Mode

• On-Premises
• Web-based / Cloud-based

Purpose of Electronic Batch Record

• Batch Management
• Process Improvement / Process Management
• Quality Management

Geographical Regions

• North America
• Europe
• Asia-Pacific
• Middle East and North Africa
• Latin America

Additional Benefits

• Complimentary PPT Insights Packs
• Complimentary Excel Data Packs for all Analytical Modules in the Report
• 15% Free Content Customization
• Detailed Report Walkthrough Session with Research Team
• Free Updated report if the report is 6-12 months old or older

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Attachments

• Electronic Batch Records Market
• Electronic Batch Providers
• Partnerships and Collaborations

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