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 USD 2,627.0 million in 2023 to reach an anticipated valuation of USD 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) | USD 2,627.0 million |
| Electronic Batch Records Market Anticipated Forecast Value (2033) | USD 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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The market growth is attributed to several factors, such as:
Major Restraints for Electronic Batch Records
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 USA, accounting for maximum regional market value.
The healthcare industry in the USA 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 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.
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 Million. The main investors are the University of Leuven and The Faktory Fund.
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:
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:
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| 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 USD 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 |
The market is anticipated to expand at a CAGR of 12.8% through 2033.
The market has the potential to attain a revenue of USD 8,786.4 million by 2033.
The need to improve workflow and efficiency in industries, the rise of information technology, and the adoption of ERPs complement market growth.
Strict government regulations and lack of identification of requirements hinder market growth.
North America is likely to lead the market by generating significant revenue.
| Market Value for 2024 | USD 18.82 billion |
|---|---|
| Market Value for 2034 | USD 34.34 billion |
| Market CAGR (2024 to 2034) | 6.20% |
| Market Value (2022) | USD 43.74 Billion |
|---|---|
| Market Value (2032) | USD 103.55 Billion |
| Market CAGR (2022 to 2032) | 9% |
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Electronic Batch Records Market
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