North America Manufacturing Execution System (MES) In Life Sciences Market Forecast to 2033 - COVID-19 Impact and Regional Analysis by Offering (Software and Services), Deployment (On-Premises and Cloud), Organization Size (SMEs and Large Enterprises), and Application (Pharmaceutical, Biotechnology, and Medical Devices)
The North America manufacturing execution system in life sciences market is expected to grow from US$ 1,128.71 million in 2023 to US$ 3,360.73 million by 2033. It is estimated to grow at a CAGR of 11.5% from 2023 to 2033.
Need for Compliance with Regulatory Framework Fuels North America Manufacturing Execution System (MES) In Life Sciences Market
The pharmaceutical & medical device manufacturing industry is highly regulated, and non-compliance can lead to severe ramifications. In January 2023, the US District Court for the Southern District of Florida entered a consent decree of permanent injunction against LGM Pharma LLC, an importer and distributor of active pharmaceutical ingredients (API) used by the company’s customers to manufacture and/or compound finished drug products. The consent decree set a strict timetable for the firm to comply with current good manufacturing practice (cGMP) requirements under the Federal Food, Drug, and Cosmetics Act (FD&C Act). The decree allows the US Food and Drugs Administration (FDA) to take appropriate action, including ordering the company to cease receiving, labelling, holding, and/or distributing any or all drug substances, in the event the FD&C Act, its implementing regulations, or the consent decree is further violated. Again, in January 2023, the FDA issued a letter to Mohawk Laboratories (Division of NCH Corporation) stating that the consumer hand sanitizer manufactured at its Irving, Texas facility had impurities of acetaldehyde and acetal at unacceptable levels and hence violated Current Good Manufacturing Practice (cGMP) requirements. The FDA recommended engaging a consultant qualified as outlined in 21 CFR 211.34 to assist the company in meeting CGMP requirements. It further recommended that the consultant perform a comprehensive audit of the firm’s operation for CGMP compliance and evaluate the completion and efficacy of their corrective actions and preventive actions (CAPA) before the company pursues a resolution of compliance status with the FDA.
Manufacturing execution systems (MES) are solutions that aid pharmaceutical and medical device manufacturers to easily comply with such regulations while capturing details on each step of the manufacturing process. The FDA requires every medical device manufacturer to maintain Design History File (DHF) and Device History Records (DHR) to ensure that DHRs for each batch, lot, or unit can further help demonstrate that the device is manufactured as per the Device Master Record (DMR) and the requirements of this devices. DHR includes all the details pertinent to manufacturing a medical device, while DHF demonstrates the history of how the product was designed. The data was traditionally recorded on paper, which consisted of production travellers and other documentation. However, these paper-oriented processes expose companies to unnecessary risks, including in-process deviations and non-conformances, which can lead to product quality issues in the field. Modern MES have built-in features that enforce production processes and capture information associated with production records. Such integrations of features into the MES that ensure compliance with the regulatory framework boost the demand for MES in the pharmaceutical & medical device manufacturing industry.
North America Manufacturing Execution System (MES) In Life Sciences Market Overview
The North America manufacturing execution system (MES) in life sciences market has been segmented into the US, Canada, and Mexico. North America is one of the developed regions. Pharmaceuticals, biotechnology, and many other industries in the region are known for the adoption of highly advanced technologies and automated operations. Pharmaceutical, medical device manufacturing, and biotechnology companies are implementing MES to improve the productivity and management of their production units. Companies such as Abbot, Baxter International, Genitope Corporation, and Merck & Co. Merck have implemented Elan’s MES software for improving the functionality of their production units, as well as for supporting factory automation. 10 years back, Terumo Americas implemented the MES—Camstar Medical Device Suite—in its cardiovascular division located in Ashland, Massachusetts. The aim was to streamline the overall quality and manufacturing process, improve productivity, and reduce nonconformance reports (NCRs) and complaints by 40–60%. In 2018, the company took a digital transformation initiative for the management of business logistics and manufacturing operations; under this, it selected SAP S/4HANA as an enterprise resource planning (ERP) system. Additionally, Terumo Americas selected Siemens as its strategic partner for manufacturing operations management (MOM), implementing Siemens Opcenter Execution, an evolved version of the Camstar solution. Moreover, MES solutions in the pharmaceuticals industry replace the conventional paper-based execution process, along with controlling, monitoring, and documenting the manufacturing process digitally in real time through the entire production cycle. MES maintains the effective flow of information between manufacturing systems and other departments, as well as facilitates the execution of production orders, quality check, machine status, and much more.
North America Manufacturing Execution System (MES) In Life Sciences Market Revenue and Forecast to 2033 (US$ Million)
North America Manufacturing Execution System (MES) In Life Sciences Market Segmentation
The North America manufacturing execution system in life sciences market is segmented into offering, deployment, organization size, application, and country.
Based on offering, the North America manufacturing execution system in life sciences market is segmented into software and services. The services segment held a larger share of the North America manufacturing execution system in life sciences market in 2023.
Based on deployment, the North America manufacturing execution system in life sciences market is segmented into on-premises and cloud. The cloud segment held a larger share of the North America manufacturing execution system in life sciences market in 2023.
Based on organization size, the North America manufacturing execution system in life sciences market is segmented into SMEs and large enterprises. The large enterprises segment held the largest share of the North America manufacturing execution system in life sciences market in 2023.
Based on application, the North America manufacturing execution system in life sciences market is segmented into pharmaceutical, biotechnology, and medical devices. The medical devices segment held the largest share of the North America manufacturing execution system in life sciences market in 2023.
Based on country, the North America manufacturing execution system in life sciences market is segmented into the US, Canada, and Mexico. The US dominated the share of the North America manufacturing execution system in life sciences market in 2023.
Apprentice FS Inc; Atachi Systems; ATS Global B.V.; Emerson Electric Co; LZ Lifescience Limited; POMS Corporation; Rockwell Automation Inc; Schneider Electric SE; and Siemens AG are the leading companies operating in the North America manufacturing execution system in life sciences market.
1. Introduction
1.1 Scope of the Study
1.2 The Insight Partners Research Report Guidance
1.3 Market Segmentation
1.3.1 North America Manufacturing Execution System in Life Sciences Market – By Offering
1.3.2 North America Manufacturing Execution System in Life Sciences Market – By Deployment
1.3.3 North America Manufacturing Execution System in Life Sciences Market – By Organization Size
1.3.4 North America Manufacturing Execution System in Life Sciences Market – By Application
1.3.5 North America Manufacturing Execution System in Life Sciences Market – By Country
2. North America Manufacturing Execution System in Life Sciences Market – Key Takeaways
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. North America Manufacturing Execution System in Life Sciences Market – Market Landscape
4.1 Overview
4.2 North America PEST Analysis
4.3 Ecosystem Analysis
4.4 Expert Opinion
5. North America Manufacturing Execution System in Life Sciences Market – Key Market Dynamics
5.1 Market Drivers
5.1.1 Need for Compliance with Regulatory Framework
5.1.2 Requirement of Accurate Real-Time Data in Production Management Process
5.2 Market Restraints
5.2.1 High Cost and Lack of Flexibility
5.3 Market Opportunities
5.3.1 Rising Application in Cell and Gene Therapy Sector
5.4 Future Trends
5.4.1 Shift from Legacy to Modern MES
5.4.2 Rise in Adoption of Pharma 4.0
5.5 Impact Analysis of Drivers and Restraints
6. Manufacturing Execution System in Life Sciences Market – North America Analysis
6.1 North America Manufacturing Execution System in Life Sciences Market Overview
6.2 North America Manufacturing Execution System in Life Sciences Market – Revenue and Forecast to 2033 (US$ Million)
7. North America Manufacturing Execution System in Life Sciences Market Analysis – By Offering
7.1 Overview
7.2 North America Manufacturing Execution System in Life Sciences Market, By Offering (2022 and 2033)
7.3 Software
7.3.1 Overview
7.3.2 Software: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
7.4 Services
7.4.1 Overview
7.4.2 Services: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
8. North America Manufacturing Execution System in Life Sciences Market Analysis – By Deployment
8.1 Overview
8.2 North America Manufacturing Execution System in Life Sciences Market, By Deployment (2022 and 2033)
8.3 On-Premises
8.3.1 Overview
8.3.2 On-Premises: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
8.4 Cloud
8.4.1 Overview
8.4.2 Cloud: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
9. North America Manufacturing Execution System in Life Sciences Market Analysis – By Organization Size
9.1 Overview
9.2 North America Manufacturing Execution System in Life Sciences Market, By Organization Size (2022 and 2033)
9.3 SMEs
9.3.1 Overview
9.3.2 SMEs: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
9.4 Large Enterprises
9.4.1 Overview
9.4.2 Large Enterprises: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
10. North America Manufacturing Execution System in Life Sciences Market Analysis – By Application
10.1 Overview
10.2 North America Manufacturing Execution System in Life Sciences Market, By Application (2022 and 2033)
10.3 Pharmaceutical
10.3.1 Overview
10.3.2 Pharmaceutical: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
10.4 Biotechnology
10.4.1 Overview
10.4.2 Biotechnology: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
10.5 Medical Devices
10.5.1 Overview
10.5.2 Medical Devices: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
11. North America Manufacturing Execution System in Life Sciences Market Analysis – By Country
11.1 Overview
11.1.1 North America Manufacturing Execution System in Life Sciences Market, by Country, 2022 & 2033 (%)
11.1.1.1 US: North America Manufacturing Execution System in Life Sciences Market – Revenue and Forecast to 2033 (US$ Million)
11.1.1.1.1 Overview
11.1.1.1.2 US: North America Manufacturing Execution System in Life Sciences Market – Revenue and Forecast to 2033 (US$ Million)
11.1.1.1.3 US: North America Manufacturing Execution System in Life Sciences Market, by Offering, 2022–2033 (US$ Million)
11.1.1.1.4 US: North America Manufacturing Execution System in Life Sciences Market, by Deployment, 2022–2033 (US$ Million)
11.1.1.1.5 US: North America Manufacturing Execution System in Life Sciences Market, by Organization Size, 2022–2033 (US$ Million)
11.1.1.1.6 US: North America Manufacturing Execution System in Life Sciences Market, by Application, 2022–2033 (US$ Million)
11.1.1.2 Canada: North America Manufacturing Execution System in Life Sciences Market – Revenue and Forecast to 2033 (US$ Million)
11.1.1.2.1 Overview
11.1.1.2.2 Canada: North America Manufacturing Execution System in Life Sciences Market – Revenue and Forecast to 2033 (US$ Million)
11.1.1.2.3 Canada: North America Manufacturing Execution System in Life Sciences Market, by Offering, 2022–2033 (US$ Million)
11.1.1.2.4 Canada: North America Manufacturing Execution System in Life Sciences Market, by Deployment, 2022–2033 (US$ Million)
11.1.1.2.5 Canada: North America Manufacturing Execution System in Life Sciences Market, Organization Size, 2022–2033 (US$ Million)
11.1.1.2.6 Canada: North America Manufacturing Execution System in Life Sciences Market, by Application, 2022–2033 (US$ Million)
11.1.1.3 Mexico: North America Manufacturing Execution System in Life Sciences Market – Revenue and Forecast to 2033 (US$ Million)
11.1.1.3.1 Overview
11.1.1.3.2 Mexico: North America Manufacturing Execution System in Life Sciences Market – Revenue and Forecast to 2033 (US$ Million)
11.1.1.3.3 Mexico: North America Manufacturing Execution System in Life Sciences Market, by Offering, 2022–2033 (US$ Million)
11.1.1.3.4 Mexico: North America Manufacturing Execution System in Life Sciences Market, Organization Size, 2022–2033 (US$ Million)
11.1.1.3.5 Mexico: North America Manufacturing Execution System in Life Sciences Market, by Application, 2022–2033 (US$ Million)
12. Industry Landscape
12.1 Overview
12.2 Market Initiatives, Expansions, and Strategic Developments
12.3 New Product/Feature Development
12.4 Mergers and Acquisitions
12.5 Agreements, Collaborations, and Joint Ventures
13. Company Profiles
13.1 Apprentice FS Inc
13.1.1 Key Facts
13.1.2 Business Description
13.1.3 Products and Services
13.1.4 Financial Overview
13.1.5 SWOT Analysis
13.1.6 Key Developments
13.2 ATS Global B.V.
13.2.1 Key Facts
13.2.2 Business Description
13.2.3 Products and Services
13.2.4 Financial Overview
13.2.5 SWOT Analysis
13.2.6 Key Developments
13.3 Atachi Systems
13.3.1 Key Facts
13.3.2 Business Description
13.3.3 Products and Services
13.3.4 Financial Overview
13.3.5 SWOT Analysis
13.3.6 Key Developments
13.4 Emerson Electric Co
13.4.1 Key Facts
13.4.2 Business Description
13.4.3 Products and Services
13.4.4 Financial Overview
13.4.5 SWOT Analysis
13.4.6 Key Developments
13.5 LZ Lifescience Limited
13.5.1 Key Facts
13.5.2 Business Description
13.5.3 Products and Services
13.5.4 Financial Overview
13.5.5 SWOT Analysis
13.5.6 Key Developments
13.6 POMS Corporation
13.6.1 Key Facts
13.6.2 Business Description
13.6.3 Products and Services
13.6.4 Financial Overview
13.6.5 SWOT Analysis
13.6.6 Key Developments
13.7 Rockwell Automation Inc
13.7.1 Key Facts
13.7.2 Business Description
13.7.3 Products and Services
13.7.4 Financial Overview
13.7.5 SWOT Analysis
13.7.6 Key Developments
13.8 Schneider Electric SE
13.8.1 Key Facts
13.8.2 Business Description
13.8.3 Products and Services
13.8.4 Financial Overview
13.8.5 SWOT Analysis
13.8.6 Key Developments
13.9 Siemens AG
13.9.1 Key Facts
13.9.2 Business Description
13.9.3 Products and Services
13.9.4 Financial Overview
13.9.5 SWOT Analysis
13.9.6 Key Developments
14. Appendix
14.1 About The Insight Partners
14.2 Word Index
LIST OF TABLES
Table 1. North America Manufacturing Execution System in Life Sciences Market – Revenue and Forecast to 2023 (US$ Million)
Table 2. US: North America Manufacturing Execution System in Life Sciences Market, by Offering – Revenue and Forecast to 2033 (US$ Million)
Table 3. US: North America Manufacturing Execution System in Life Sciences Market, by Deployment – Revenue and Forecast to 2033 (US$ Million)
Table 4. US: North America Manufacturing Execution System in Life Sciences Market, by Organization Size – Revenue and Forecast to 2033 (US$ Million)
Table 5. US: North America Manufacturing Execution System in Life Sciences Market, by Application – Revenue and Forecast to 2033 (US$ Million)
Table 6. Canada: North America Manufacturing Execution System in Life Sciences Market, by Offering – Revenue and Forecast to 2033 (US$ Million)
Table 7. Canada: North America Manufacturing Execution System in Life Sciences Market, by Deployment – Revenue and Forecast to 2033 (US$ Million)
Table 8. Canada: North America Manufacturing Execution System in Life Sciences Market, Organization Size – Revenue and Forecast to 2033 (US$ Million)
Table 9. Canada: North America Manufacturing Execution System in Life Sciences Market, by Application – Revenue and Forecast to 2033 (US$ Million)
Table 10. Mexico: North America Manufacturing Execution System in Life Sciences Market, by Offering – Revenue and Forecast to 2033 (US$ Million)
Table 11. Mexico: North America Manufacturing Execution System in Life Sciences Market, by Deployment – Revenue and Forecast to 2033 (US$ Million)
Table 12. Mexico: North America Manufacturing Execution System in Life Sciences Market, Organization Size – Revenue and Forecast to 2033 (US$ Million)
Table 13. Mexico: North America Manufacturing Execution System in Life Sciences Market, by Application – Revenue and Forecast to 2033 (US$ Million)
Table 14. List of Abbreviation
LIST OF FIGURES
Figure 1. North America Manufacturing Execution System in Life Sciences Market Segmentation
Figure 2. North America Manufacturing Execution System in Life Sciences Market Segmentation, By Country
Figure 3. North America Manufacturing Execution System in Life Sciences Market Overview
Figure 4. Services Held Largest Share Of Offering Segment In North America Manufacturing Execution System in Life Sciences Market
Figure 5. The US Is Expected to Show Remarkable Growth During the Forecast Period
Figure 6. North America: PEST Analysis
Figure 7. Expert Opinion
Figure 8. North America Manufacturing Execution System in Life Sciences Market: Impact Analysis of Drivers and Restraints
Figure 9. North America Manufacturing Execution System in Life Sciences Market – Revenue and Forecast to 2033 (US$ Million)
Figure 10. North America Manufacturing Execution System in Life Sciences Market Revenue Share, By Offering (2022 and 2033)
Figure 11. Software: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
Figure 12. Services: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
Figure 13. North America Manufacturing Execution System in Life Sciences Market Revenue Share, By Deployment (2022 and 2033)
Figure 14. On-Premises: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
Figure 15. Cloud: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
Figure 16. North America Manufacturing Execution System in Life Sciences Market Revenue Share, By Organization Size (2022 and 2033)
Figure 17. SMEs: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
Figure 18. Large Enterprises: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
Figure 19. North America Manufacturing Execution System in Life Sciences Market Revenue Share, By Application (2022 and 2033)
Figure 20. Pharmaceutical: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
Figure 21. Biotechnology: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
Figure 22. Medical Devices: North America Manufacturing Execution System in Life Sciences Market – Revenue, and Forecast to 2033 (US$ Million)
Figure 23. North America Manufacturing Execution System in Life Sciences Market, by Key Country – Revenue (2022) (US$ Million)
Figure 24. US: North America Manufacturing Execution System in Life Sciences Market – Revenue and Forecast to 2033 (US$ Million)
Figure 25. Canada: North America Manufacturing Execution System in Life Sciences Market – Revenue and Forecast to 2033 (US$ Million)
Figure 26. Mexico: North America Manufacturing Execution System in Life Sciences Market – Revenue and Forecast to 2033 (US$ Million)
- Apprentice FS Inc
- Atachi Systems
- ATS Global B.V.
- Emerson Electric Co
- LZ Lifescience Limited
- POMS Corporation
- Rockwell Automation Inc
- Schneider Electric SE
- Siemens AG
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