Electronic Batch Records Market Outlook (2023 to 2033)

The global electronic batch records market is projected to grow at a CAGR of 12.8% during the forecast period. The market is expected to exceed US$ 2,627.0 million in 2023 to reach an anticipated valuation of US$ 8,786.4 million by 2033.

Electronic batch records (EBRs) ensure that drugs and other pharmaceutical products are manufactured safely and efficiently. In the world of strong auditing and compliance, detailed, verifiable records are the foundation of any manufacturing process. This might increase the demand for electronic batch records.

In addition to reducing the cost, automated batch records provide paperless solutions by replacing paper batch records and provide easier tracking of the automated batch history through the online environment. Manual record keeping can adversely affect product quality in the entire production process, and even slight changes in production sequence can cause products to be detained in quarantine until the review has been completed.

Attributes Details
Electronic Batch Records Market Value (2023) US$ 2,627.0 million
Electronic Batch Records Market Anticipated Forecast Value (2033) US$ 8,786.4 million
Electronic Batch Records Market Projected Growth Rate (2023 to 2033) 12.8%

Pharmaceutical manufacturing, research and development, and other healthcare industry sectors are the principal users of EBR solutions. Pharmaceutical companies are constantly challenged by the strict regulations enforced by different governing bodies such as the Food & Drug Administration (FDA).Pharmaceutical manufacturing, research and development, and other sectors of the healthcare industry are the principal users of EBR solutions. Pharmaceutical companies are constantly challenged by the strict regulations enforced by different governing bodies such as the Food & Drug Administration (FDA).

As a result, quality management solutions (such as EBR) have become increasingly prevalent across different healthcare organizations in the last few years. This is expected to surge the demand for electronic batch records during the forecast period.

Among these industries, the pharmaceutical manufacturing and research industry are among the strongest supporters of EBR software. It is predicted that EBR software would continue to be in demand from companies across the globe over the next few years due to increasing demand for reducing errors and overheads and ensuring effective process control.

For the EBR software market to thrive, factors such as the advancement of cloud technology, the decrease in the cost of digital storage, and the availability of a variety of quality management software bundles have all played a significant role.

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Electronic Batch Records Market Dynamics

The market growth is attributed to several factors, such as:

  • Reduction in Human Resource Costs: Many industries are planning to shift to automation because they will be able to reduce overall human resource costs, which is a major driver for the market.
  • Improvement in Workflow: The need to improve workflow and efficiency in industries, the rise of information technology, and the adoption of ERPs alongside electronic batch records may also be a major drivers influencing the market for electronic batch records. This is expected to increase the demand for electronic batch records.
  • Increasing Productivity: The greatest success factor of any organization is always the people involved, and companies can greatly boost their productivity by providing an easy-to-use UI that connects internal employees with the right information and even external business partners with the right information.

Major Restraints for Electronic Batch Records

  • Strict Government Regulations: Fraud detection and the requirement for adequate testing before implementation are some of the challenges associated with the electronic batch records market. It is also necessary to comply with government standards and regulations and handle multiple manufacturing styles, as every industry has its characteristic data models.
  • Lack of Identification of Requirements: Pharmaceutical companies have different policies, practices, and working methods. There cannot be a single EBR solution for every organization. Incorrectly designed systems that do not take specific requirements into account can end up causing more problems than they are worth.

Regional Insights

North America Dominates the Global Electronic Batch Records Market

North America accounted for the largest share of value and penetration of the overall EBR market worldwide, accounting for 35.5% of the market share. The market here is primarily governed by the U.S., accounting for maximum regional market value.

The healthcare industry in the U.S. faces strict regulations, resulting in a higher demand for quality management solutions. Additionally, the region is home to numerous leading quality management solution vendors such as Rockwell Automation, Inc., Honeywell-POMS, Sparta Systems, Inc., MasterControl, Inc., and MetricStream, Inc. leading quality management solution vendors such as Rockwell Automation, Inc., Honeywell-POMS, Sparta Systems, Inc., MasterControl, Inc., and MetricStream, Inc.

Europe to Register Rapid Growth Pace in the Electronic Batch Records Market

Europe is predicted to hold a share of 22.7% of the global market for electronic batch records. In Europe, electronic batch records are growing steadily, with the sector of information and communication technologies (ICTs) contributing the most to market growth.

Food & beverage manufacturing in the region is expected to grow substantially due to the widespread adoption of quality management systems and process automation. Moreover, manufacturers have had to ensure high-quality production and process flow in their facilities due to growing competition in the industry.

Sudip Saha
Sudip Saha

Principal Consultant

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Start-Up Ecosystem

Start-up Ecosystem in the Electronic Batch Records Market

Currently, no start-ups work exclusively for the electronics batch records market. But there is a start-up where the EBR is used as one of the aspects of supporting the main business.

MYCELLHUB is a SaaS platform for data management and analytics in biotech and pharma. It believes in revolutionizing the way cell production processes are organized.

However, the management of work instructions for the manufacturing and QC processes is conducted by MYCELLHUB’s electronic batch records. This proves to be highly critical for improving data integrity. The seed round funding for MYCELLHUB took place on 12th September’19, and it managed to raise €1.1 Mn. The main investors are the University of Leuven and The Faktory Fund.

Electronic Batch Records Market: Competitive Landscape

The electronic batch records market is highly fragmented due to numerous manufacturers in developed and emerging regions. Companies in the market are increasingly investing in research and development to develop new and innovative techniques to provide innovative software solutions.

By implementing software for electronic batch records in regulated industries, manufacturing plants are transitioning from paper-driven to smart digital factories.

Some of the recent developments are:

  • In July 2022, Mitsubishi Power and Emerson software and Technologies signed a deal for an advanced clean energy storage hydrogen hub.In July 2022, Mitsubishi Power and Emerson software and technologies signed a deal for an advanced clean energy storage hydrogen hub.
  • In September 2022, Siemens announced it would equip Egypt’s second-largest city with ADMS and smart metering infrastructure.
  • In January 2023, Emerson, a global leader in software and engineering, formed a partnership with ZAETHER, an enterprise venture transformation digital consultant and outcomes provider, with a view to deliver comprehensive software, consulting, and support solutions to aid life science leaders enact transformative change for more flexibility and adaptability.
  • In May 2023, Rockwell Automation collaborated with Avid Solutions to aid businesses more efficiently and effectively produce green hydrogen.

The main players operating in the global authoring tool market include:operating in the global authoring tool market include:

Rockwell Automation Inc. (NYSE: ROK) has over 40 years of experience as a global leader in industrial automation and digital transformation. More than 255,000 Rockwell Automation employees are dedicated to customers in more than 100 countries. On May 31, 2022, Plex was acquired by Rockwell Automation.

Some other major key players of Electronic Batch Records are:

  • Emerson Electric Co
  • ABB
  • Schneider Electric SE
  • Siemens AG
  • Accelyrs
  • SAP SE

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Scope Of the Report

Attributes Details
Growth Rate CAGR of 12.8% from 2023 to 2033
Base Year for Estimation 2022
Historical Data 2018 to 2022
Forecast Period 2023 to 2033
Quantitative Units Revenue in US$ million and CAGR from 2023 to 2033
Report Coverage Revenue Forecast, Volume Forecast, Company Ranking, Competitive Landscape, Growth Factors, Trends and Pricing Analysis
Segments Covered

By End-User, Region

Regions Covered North America; Latin America; The Asia Pacific; MEA; Europe
Key Countries Profiled The United States, Canada, Brazil, Argentina, Germany, The United Kingdom, France, Spain, Italy, Nordics, BENELUX, Australia & New Zealand, China, India, GCC, South Africa
Key Companies Profiled Rockwell Automation; Emerson Electric Co; ABB; Schneider Electric SE; Siemens AG; Accelyrs; SAP SE
Customization Available Upon Request

Key Segments Profiled in the Electronic Batch Records Market Survey

By End-User:

  • Pharmaceuticals
  • Life sciences
  • Automobile
  • Others

By Region:

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

Frequently Asked Questions

What is the Growth Rate of the Electronic Batch Records Market?

The market is anticipated to expand at a CAGR of 12.8% through 2033.

What is the Growth Potential of the Electronic Batch Records Market?

The market has the potential to attain a revenue of US$ 8,786.4 million by 2033.

What Factors Contribute to the Growth of the Electronic Batch Records Market?

The need to improve workflow and efficiency in industries, the rise of information technology, and the adoption of ERPs complement market growth.

What Hinders Growth in the Electronic Batch Records Market?

Strict government regulations and lack of identification of requirements hinder market growth.

Which Regional Electronic Batch Records Market is to Lead the Market?

North America is likely to lead the market by generating significant revenue.

Table of Content
1. Executive Summary
    1.1. Global Market Outlook
    1.2. Demand-side Trends
    1.3. Supply-side Trends
    1.4. Technology Roadmap Analysis
    1.5. Analysis and Recommendations
2. Market Overview
    2.1. Market Coverage / Taxonomy
    2.2. Market Definition / Scope / Limitations
3. Market Background
    3.1. Market Dynamics
        3.1.1. Drivers
        3.1.2. Restraints
        3.1.3. Opportunity
        3.1.4. Trends
    3.2. Scenario Forecast
        3.2.1. Demand in Optimistic Scenario
        3.2.2. Demand in Likely Scenario
        3.2.3. Demand in Conservative Scenario
    3.3. Opportunity Map Analysis
    3.4. Investment Feasibility Matrix
    3.5. PESTLE and Porter’s Analysis
    3.6. Regulatory Landscape
        3.6.1. By Key Regions
        3.6.2. By Key Countries
    3.7. Regional Parent Market Outlook
4. Global Market Analysis 2018 to 2022 and Forecast, 2023 to 2033
    4.1. Historical Market Size Value (US$ Million) Analysis, 2018 to 2022
    4.2. Current and Future Market Size Value (US$ Million) Projections, 2023 to 2033
        4.2.1. Y-o-Y Growth Trend Analysis
        4.2.2. Absolute $ Opportunity Analysis
5. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By End-User
    5.1. Introduction / Key Findings
    5.2. Historical Market Size Value (US$ Million) Analysis By End-User, 2018 to 2022
    5.3. Current and Future Market Size Value (US$ Million) Analysis and Forecast By End-User, 2023 to 2033
        5.3.1. Pharmaceuticals
        5.3.2. Life sciences
        5.3.3. Automobile
        5.3.4. Others
    5.4. Y-o-Y Growth Trend Analysis By End-User, 2018 to 2022
    5.5. Absolute $ Opportunity Analysis By End-User, 2023 to 2033
6. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region
    6.1. Introduction
    6.2. Historical Market Size Value (US$ Million) Analysis By Region, 2018 to 2022
    6.3. Current Market Size Value (US$ Million) Analysis and Forecast By Region, 2023 to 2033
        6.3.1. North America
        6.3.2. Latin America
        6.3.3. Western Europe
        6.3.4. Eastern Europe
        6.3.5. South Asia and Pacific
        6.3.6. East Asia
        6.3.7. Middle East and Africa
    6.4. Market Attractiveness Analysis By Region
7. North America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
    7.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2018 to 2022
    7.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2023 to 2033
        7.2.1. By Country
            7.2.1.1. U.S.
            7.2.1.2. Canada
        7.2.2. By End-User
    7.3. Market Attractiveness Analysis
        7.3.1. By Country
        7.3.2. By End-User
    7.4. Key Takeaways
8. Latin America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
    8.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2018 to 2022
    8.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2023 to 2033
        8.2.1. By Country
            8.2.1.1. Brazil
            8.2.1.2. Mexico
            8.2.1.3. Rest of Latin America
        8.2.2. By End-User
    8.3. Market Attractiveness Analysis
        8.3.1. By Country
        8.3.2. By End-User
    8.4. Key Takeaways
9. Western Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
    9.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2018 to 2022
    9.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2023 to 2033
        9.2.1. By Country
            9.2.1.1. Germany
            9.2.1.2. U.K.
            9.2.1.3. France
            9.2.1.4. Spain
            9.2.1.5. Italy
            9.2.1.6. Rest of Western Europe
        9.2.2. By End-User
    9.3. Market Attractiveness Analysis
        9.3.1. By Country
        9.3.2. By End-User
    9.4. Key Takeaways
10. Eastern Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
    10.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2018 to 2022
    10.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2023 to 2033
        10.2.1. By Country
            10.2.1.1. Poland
            10.2.1.2. Russia
            10.2.1.3. Czech Republic
            10.2.1.4. Romania
            10.2.1.5. Rest of Eastern Europe
        10.2.2. By End-User
    10.3. Market Attractiveness Analysis
        10.3.1. By Country
        10.3.2. By End-User
    10.4. Key Takeaways
11. South Asia and Pacific Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
    11.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2018 to 2022
    11.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2023 to 2033
        11.2.1. By Country
            11.2.1.1. India
            11.2.1.2. Bangladesh
            11.2.1.3. Australia
            11.2.1.4. New Zealand
            11.2.1.5. Rest of South Asia and Pacific
        11.2.2. By End-User
    11.3. Market Attractiveness Analysis
        11.3.1. By Country
        11.3.2. By End-User
    11.4. Key Takeaways
12. East Asia Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
    12.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2018 to 2022
    12.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2023 to 2033
        12.2.1. By Country
            12.2.1.1. China
            12.2.1.2. Japan
            12.2.1.3. South Korea
        12.2.2. By End-User
    12.3. Market Attractiveness Analysis
        12.3.1. By Country
        12.3.2. By End-User
    12.4. Key Takeaways
13. Middle East and Africa Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
    13.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2018 to 2022
    13.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2023 to 2033
        13.2.1. By Country
            13.2.1.1. GCC Countries
            13.2.1.2. South Africa
            13.2.1.3. Israel
            13.2.1.4. Rest of MEA
        13.2.2. By End-User
    13.3. Market Attractiveness Analysis
        13.3.1. By Country
        13.3.2. By End-User
    13.4. Key Takeaways
14. Key Countries Market Analysis
    14.1. U.S.
        14.1.1. Pricing Analysis
        14.1.2. Market Share Analysis, 2022
            14.1.2.1. By End-User
    14.2. Canada
        14.2.1. Pricing Analysis
        14.2.2. Market Share Analysis, 2022
            14.2.2.1. By End-User
    14.3. Brazil
        14.3.1. Pricing Analysis
        14.3.2. Market Share Analysis, 2022
            14.3.2.1. By End-User
    14.4. Mexico
        14.4.1. Pricing Analysis
        14.4.2. Market Share Analysis, 2022
            14.4.2.1. By End-User
    14.5. Germany
        14.5.1. Pricing Analysis
        14.5.2. Market Share Analysis, 2022
            14.5.2.1. By End-User
    14.6. U.K.
        14.6.1. Pricing Analysis
        14.6.2. Market Share Analysis, 2022
            14.6.2.1. By End-User
    14.7. France
        14.7.1. Pricing Analysis
        14.7.2. Market Share Analysis, 2022
            14.7.2.1. By End-User
    14.8. Spain
        14.8.1. Pricing Analysis
        14.8.2. Market Share Analysis, 2022
            14.8.2.1. By End-User
    14.9. Italy
        14.9.1. Pricing Analysis
        14.9.2. Market Share Analysis, 2022
            14.9.2.1. By End-User
    14.10. Poland
        14.10.1. Pricing Analysis
        14.10.2. Market Share Analysis, 2022
            14.10.2.1. By End-User
    14.11. Russia
        14.11.1. Pricing Analysis
        14.11.2. Market Share Analysis, 2022
            14.11.2.1. By End-User
    14.12. Czech Republic
        14.12.1. Pricing Analysis
        14.12.2. Market Share Analysis, 2022
            14.12.2.1. By End-User
    14.13. Romania
        14.13.1. Pricing Analysis
        14.13.2. Market Share Analysis, 2022
            14.13.2.1. By End-User
    14.14. India
        14.14.1. Pricing Analysis
        14.14.2. Market Share Analysis, 2022
            14.14.2.1. By End-User
    14.15. Bangladesh
        14.15.1. Pricing Analysis
        14.15.2. Market Share Analysis, 2022
            14.15.2.1. By End-User
    14.16. Australia
        14.16.1. Pricing Analysis
        14.16.2. Market Share Analysis, 2022
            14.16.2.1. By End-User
    14.17. New Zealand
        14.17.1. Pricing Analysis
        14.17.2. Market Share Analysis, 2022
            14.17.2.1. By End-User
    14.18. China
        14.18.1. Pricing Analysis
        14.18.2. Market Share Analysis, 2022
            14.18.2.1. By End-User
    14.19. Japan
        14.19.1. Pricing Analysis
        14.19.2. Market Share Analysis, 2022
            14.19.2.1. By End-User
    14.20. South Korea
        14.20.1. Pricing Analysis
        14.20.2. Market Share Analysis, 2022
            14.20.2.1. By End-User
    14.21. GCC Countries
        14.21.1. Pricing Analysis
        14.21.2. Market Share Analysis, 2022
            14.21.2.1. By End-User
    14.22. South Africa
        14.22.1. Pricing Analysis
        14.22.2. Market Share Analysis, 2022
            14.22.2.1. By End-User
    14.23. Israel
        14.23.1. Pricing Analysis
        14.23.2. Market Share Analysis, 2022
            14.23.2.1. By End-User
15. Market Structure Analysis
    15.1. Competition Dashboard
    15.2. Competition Benchmarking
    15.3. Market Share Analysis of Top Players
        15.3.1. By Regional
        15.3.2. By End-User
16. Competition Analysis
    16.1. Competition Deep Dive
        16.1.1. Rockwell Automation
            16.1.1.1. Overview
            16.1.1.2. Product Portfolio
            16.1.1.3. Profitability by Market Segments
            16.1.1.4. Sales Footprint
            16.1.1.5. Strategy Overview
                16.1.1.5.1. Marketing Strategy
        16.1.2. Emerson Electric Co
            16.1.2.1. Overview
            16.1.2.2. Product Portfolio
            16.1.2.3. Profitability by Market Segments
            16.1.2.4. Sales Footprint
            16.1.2.5. Strategy Overview
                16.1.2.5.1. Marketing Strategy
        16.1.3. ABB
            16.1.3.1. Overview
            16.1.3.2. Product Portfolio
            16.1.3.3. Profitability by Market Segments
            16.1.3.4. Sales Footprint
            16.1.3.5. Strategy Overview
                16.1.3.5.1. Marketing Strategy
        16.1.4. Schneider Electric SE
            16.1.4.1. Overview
            16.1.4.2. Product Portfolio
            16.1.4.3. Profitability by Market Segments
            16.1.4.4. Sales Footprint
            16.1.4.5. Strategy Overview
                16.1.4.5.1. Marketing Strategy
        16.1.5. Siemens AG
            16.1.5.1. Overview
            16.1.5.2. Product Portfolio
            16.1.5.3. Profitability by Market Segments
            16.1.5.4. Sales Footprint
            16.1.5.5. Strategy Overview
                16.1.5.5.1. Marketing Strategy
        16.1.6. Accelyrs
            16.1.6.1. Overview
            16.1.6.2. Product Portfolio
            16.1.6.3. Profitability by Market Segments
            16.1.6.4. Sales Footprint
            16.1.6.5. Strategy Overview
                16.1.6.5.1. Marketing Strategy
        16.1.7. SAP SE
            16.1.7.1. Overview
            16.1.7.2. Product Portfolio
            16.1.7.3. Profitability by Market Segments
            16.1.7.4. Sales Footprint
            16.1.7.5. Strategy Overview
                16.1.7.5.1. Marketing Strategy
        16.1.8. Sparta Systems
            16.1.8.1. Overview
            16.1.8.2. Product Portfolio
            16.1.8.3. Profitability by Market Segments
            16.1.8.4. Sales Footprint
            16.1.8.5. Strategy Overview
                16.1.8.5.1. Marketing Strategy
        16.1.9. Datex Corporation
            16.1.9.1. Overview
            16.1.9.2. Product Portfolio
            16.1.9.3. Profitability by Market Segments
            16.1.9.4. Sales Footprint
            16.1.9.5. Strategy Overview
                16.1.9.5.1. Marketing Strategy
        16.1.10. Honeywell international
            16.1.10.1. Overview
            16.1.10.2. Product Portfolio
            16.1.10.3. Profitability by Market Segments
            16.1.10.4. Sales Footprint
            16.1.10.5. Strategy Overview
                16.1.10.5.1. Marketing Strategy
17. Assumptions & Acronyms Used
18. Research Methodology
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