Electronic batch record (EBR) refer to software that electronically stores and manages data for a given batch as well as the whole manufacturing process step-by-step. The software uses the existing enterprise resource planning (ERP) system to systematically produce a formal master batch record or electronic batch record. This stores all of the materials, processes and activities that went into producing a given product. Electronic batch records provide a seamless way to automatically assemble batch production data into a commonly organized electronic document. Thus, EBR helps replace paper records and keep an accurate track of all of the factors that have affected the batch. EBR solutions are principally used by the healthcare sector comprising pharmaceutical manufacturing and related research and development.
One of the most crucial concerns for pharmaceuticals sector is complying with the stringent regulations enforced different governing bodies such as Food & Drug Administration (FDA). This has significantly fueled the penetration of quality management solutions (such as EBR) across different healthcare organizations. The EBR software market is strongly supported by the rising pharmaceuticals manufacturing and research amongst these industries. With the growing quest for reducing errors as well as overheads along with effective process control, EBR software is set to continue witnessing steady demand over the following years. Factors such as advancing cloud technology, decreasing cost off digital storage and availability of variety of quality management software bundles too have contributed greatly to EBR software market.
Apart from the aforementioned factors, EBR software is also driven by their immense advantages as compared to the conventional paper-based manual batch record management. Due to minimal involvement of human resources, EBR software becomes highly convenient for recording process information.
Additionally, modern EBR software are now designed to be easily integrated with the existing ERP systems. This further facilitates and enhances the overall quality management system for pharmaceutical companies.
Some of the major companies profiled in the report include Siemens AG, Sparta Systems, Inc., QUMAS, SAP SE, Emerson Electric Company, Oracle Corporation, MAXLife Life Sciences Software, MasterControl, Inc., Honeywell International, Inc., Schneider Electric SE, ABB Ltd., Accelrys, Inc., Werum IT Solutions GmbH, Deem Sensing Technologies Pvt. Ltd., MetricStream, Inc., LZ Lifescience and others.
In 2020, the global electronic batch record software market was collectively led by pharmaceuticals and biotechnology segments, accounting for more than 60% of the overall market value generated worldwide. Pharmaceuticals and biotechnology industries are highly bound with regulations pertaining to process control, quality control and assurance. In order to comply with the regulations enforced by authorities, healthcare organizations are forced to embrace sophisticated technology solutions for seamless processes.
Batch record management is one of the most crucial aspects of pharmaceutical manufacturing and research designed to ensure optimum quality of the products. However, due to significant amount of errors and time consumed, manual batch record management has proven to be less effective. Being among the pioneer industries in terms of adopting advanced process automation technology, pharmaceuticals and biotechnology segments are expected to remain dominant in the market throughout the forecast period.
Pharmaceuticals and biotechnology segments are followed by food & beverages segment in the market. Due to continually growing adoption of process automation and quality management systems in food & beverages, the segment is projected to register the highest growth in the market over the forecast period. In addition, growing competition in the industry has compelled the manufacturers to ensure high quality production and process flow in their facilities. Subsequently, food & beverages has emerged among the most promising end-users for EBR software and related quality management solutions.
The overall electronic batch record software market growth is primarily dependent upon stringency of quality management regulations. In addition, penetration of process automation solutions, technology infrastructure and acceptance play a major role in supporting the market growth. In 2020, North America accounted for the largest share, in terms of value and penetration, of the overall EBR market worldwide. The market here is primarily governed by the U.S. accounting for more than 83% of the overall regional market value.
The U.S. healthcare industry is bound with stringent regulations leading to higher demand for related quality management solutions. In addition, the region enjoys presence of numerous leading quality management solution vendors such as Rockwell Automation, Inc., Honeywell-POMS, Sparta Systems, Inc., MasterControl, Inc., MetricStream, Inc. and several others. Comprehensive product offering by these companies across the entire quality management segment significantly encourages the consumers to adopt these solutions (such as EBR). In the following years, Asia Pacific is projected to register the highest growth across the global market. The growth can be attributed to increasing adoption of process automation along with rapidly growing healthcare sector here.
Historical & Forecast Period
This study report represents analysis of each segment from 2022 to 2032 considering 2023 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2024 to 2032.
The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.
Research Methodology
The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of Electronic Batch Record (EBR) Software market are as follows:
Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.
| ATTRIBUTE | DETAILS |
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| Research Period | 2022-2032 |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Year | 2022 |
| Unit | USD Million |
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Region Segment (2022-2032; US$ Million)
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Key questions answered in this report
