The Pharmaceutical Manufacturing Software Market Size is valued at USD 2.9 Bn in 2023 and is predicted to reach USD 5.5 Bn by the year 2031 at an 8.6% CAGR during the forecast period for 2024-2031.
Pharmaceutical manufacturing software is the backbone of the pharmaceutical industry because it helps to streamline and ensures the processes go in line with such rigid regulatory standards. The applications involved include inventory management, batch tracking, recipe management, process automation, and quality control functions. Aggregated, these functions allow pharmaceutical manufacturing companies to monitor their production processes effectively and assert control. The core functionalities such as tracking raw materials, overseeing production batches, and managing complex formulations provide consistent quality and regulations.
Use of pharmaceutical manufacturing software is highly encouraged in the context of such a stringent regulatory environment. For instance, the FDA and the EMA would need an adequate and step-by-step record of every process-from raw material purchase to product delivery. Software solutions support these needs through proper record-keeping and traceability, supporting companies in their quest to fulfill the demands of compliance. Predictive analytics and real-time monitoring also added functionalities, as advancements in AI and machine learning added to overall efficiency in compliance and operations.
The pharmaceutical manufacturing software market is segmented by deployment type, application, and end user. By deployment type the market is segmented on-cloud, on-premise. By application market is categorized into large enterprises, small and midsize enterprises. By end user the market is categorized into biopharmaceutical companies, medical device companies, contract research organizations, academic research institutions, others.
The on-cloud deployment of pharmaceutical manufacturing software is changing the face of the industry from cost-effective, highly accessible, scalable, and secure data-protection solutions to the current needs of this industry. Cloud solutions eliminate the need for physical infrastructure and therefore lower the cost of operation and make advanced technology available for this through a subscription model. This setup allows teams to work remotely and collaborate effortlessly-a stark need in today's fast-paced, decentralized work environment. Cloud solutions provide unparalleled scalability, so pharmaceutical companies can scale resources rapidly based on market demand or regulatory requirements. Their data centers also provide encryption of all data and will be safe with multi-factor authentication; thus, they allow for compliance with regulatory standards by keeping automated documentation and audit trails for quicker inspection and reduced compliance overhead.
The biopharmaceutical segment within the pharmaceutical manufacturing software market is experiencing rapid growth due to factors such as rising demand for biologics, vaccines, and advanced therapies driven by aging populations and chronic disease prevalence. Biopharmaceutical manufacturing involves a rather complex process of cell culture and purification, therefore requiring appropriate software that will enable real-time monitoring and batch tracking to facilitate complexity management compliance. Additionally, the stringent regulatory requirements that emphasize the presence of a QMS and automated compliance documentation continue to drive the demand for software solutions that integrate data sharing and communication. Also, the rise of CMOs-which most biopharmaceutical companies use for cost-effectiveness and flexibility-and further supports the direction of the high demand for software solutions that can be of help in smoothening data sharing and communication.
North America has the largest share in the pharmaceutical manufacturing software market due to the region's many big pharmaceutical companies, of which a large number are in the U.S. and Canada, that invest in complex technologies for maximizing efficiency. The regulatory environment is also quite harsh in the region, with agencies such as the FDA requiring software that can help support Good Manufacturing Practices (cGMP) compliance, ensure proper documentation, and auditing among other requirements. Further, due to high health expenses in North America, pharmaceutical companies can afford to keep a considerable share of budget towards automation and process optimization technologies. This fast adoption of digital transformation tools, such as cloud-based solutions and data analytics, allows for the monitoring of real-time situations and access to facilities located remotely, and further enables data-driven decision-making to take full advantage of operational efficiency in pharma manufacturing.
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Report Attribute |
Specifications |
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Market Size Value In 2023 |
USD 2.9 Bn |
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Revenue Forecast In 2031 |
USD 5.5 Bn |
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Growth Rate CAGR |
CAGR of 8.6% from 2024 to 2031 |
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Quantitative Units |
Representation of revenue in US$ Bn and CAGR from 2024 to 2031 |
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Historic Year |
2019 to 2023 |
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Forecast Year |
2024-2031 |
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Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
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Segments Covered |
By Deployment Type, Application, End User, and By Region |
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Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
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Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; South Korea; Southeast Asia |
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Competitive Landscape |
Oracle Corporation, Pegasystems Inc, MasterControl Inc., Veeva Systems Inc, Siemens AG, Honeywell International Inc, Werum IT Solutions GmbH, Dassault Systèmes, Emerson Electric Co, Rockwell Automation Inc., Parsec Automation Corp, ABB Ltd, Aspen Technology Inc, Schneider Electric SE, Körber AG, Sparta Systems Inc., QAD Inc., Kinaxis Inc. |
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Customization Scope |
Free customization report with the procurement of the report, Modifications to the regional and segment scope. Geographic competitive landscape. |
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Pricing and Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
Chapter 2. Executive Summary
Chapter 3. Global Pharmaceutical Manufacturing Software Market Snapshot
Chapter 4. Global Pharmaceutical Manufacturing Software Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Porter's Five Forces Analysis
4.7. Incremental Opportunity Analysis (US$ MN), 2024-2031
4.8. Global Pharmaceutical Manufacturing Software Market Penetration & Growth Prospect Mapping (US$ Mn), 2023-2031
4.9. Competitive Landscape & Market Share Analysis, By Key Player (2023)
4.10. Use/impact of AI on Pharmaceutical Manufacturing Software Industry Trends
Chapter 5. Pharmaceutical Manufacturing Software Market Segmentation 1: By Deployment Type, Estimates & Trend Analysis
5.1. Market Share by Deployment Type, 2023 & 2031
5.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2019 to 2031 for the following Deployment Type:
5.2.1. On-cloud
5.2.2. On-premise
Chapter 6. Pharmaceutical Manufacturing Software Market Segmentation 2: By Application, Estimates & Trend Analysis
6.1. Market Share by Application, 2023 & 2031
6.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2019 to 2031 for the following Applications:
6.2.1. Large Enterprises
6.2.2. Small and Midsize Enterprises
Chapter 7. Pharmaceutical Manufacturing Software Market Segmentation 3: By End User, Estimates & Trend Analysis
7.1. Market Share by End User, 2023 & 2031
7.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2019 to 2031 for the following End User:
7.2.1. Biopharmaceutical Companies
7.2.2. Medical Device Companies
7.2.3. Contract Research Organizations
7.2.4. Academic Research Institutions
7.2.5. Others
Chapter 8. Pharmaceutical Manufacturing Software Market Segmentation 4: Regional Estimates & Trend Analysis
8.1. Global Pharmaceutical Manufacturing Software Market, Regional Snapshot 2023 & 2031
8.2. North America
8.2.1. North America Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by Country, 2024-2031
8.2.1.1. US
8.2.1.2. Canada
8.2.2. North America Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by Deployment Type, 2024-2031
8.2.3. North America Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by Application, 2024-2031
8.2.4. North America Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by End User, 2024-2031
8.3. Europe
8.3.1. Europe Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by Country, 2024-2031
8.3.1.1. Germany
8.3.1.2. U.K.
8.3.1.3. France
8.3.1.4. Italy
8.3.1.5. Spain
8.3.1.6. Rest of Europe
8.3.2. Europe Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by Deployment Type, 2024-2031
8.3.3. Europe Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by Application, 2024-2031
8.3.4. Europe Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by End User, 2024-2031
8.4. Asia Pacific
8.4.1. Asia Pacific Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by Country, 2024-2031
8.4.1.1. India
8.4.1.2. China
8.4.1.3. Japan
8.4.1.4. Australia
8.4.1.5. South Korea
8.4.1.6. Hong Kong
8.4.1.7. Southeast Asia
8.4.1.8. Rest of Asia Pacific
8.4.2. Asia Pacific Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by Deployment Type, 2024-2031
8.4.3. Asia Pacific Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by Application, 2024-2031
8.4.4. Asia Pacific Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by End User, 2024-2031
8.5. Latin America
8.5.1. Latin America Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by Country, 2024-2031
8.5.1.1. Brazil
8.5.1.2. Mexico
8.5.1.3. Rest of Latin America
8.5.2. Latin America Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by Deployment Type, 2024-2031
8.5.3. Latin America Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by Application, 2024-2031
8.5.4. Latin America Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by End User, 2024-2031
8.6. Middle East & Africa
8.6.1. Middle East & Africa Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by country, 2024-2031
8.6.1.1. GCC Countries
8.6.1.2. Israel
8.6.1.3. South Africa
8.6.1.4. Rest of Middle East and Africa
8.6.2. Middle East & Africa Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by Deployment Type, 2024-2031
8.6.3. Middle East & Africa Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by Application, 2024-2031
8.6.4. Middle East & Africa Pharmaceutical Manufacturing Software Market Revenue (US$ Million) Estimates and Forecasts by End User, 2024-2031
Chapter 9. Competitive Landscape
9.1. Major Mergers and Acquisitions/Strategic Alliances
9.2. Company Profiles
9.2.1. Oracle Corporation
9.2.1.1. Business Overview
9.2.1.2. Key Product/Service Offerings
9.2.1.3. Financial PerApplicationance
9.2.1.4. Geographical Presence
9.2.1.5. Recent Developments with Business Strategy
9.2.2. Pegasystems Inc
9.2.3. MasterControl Inc.
9.2.4. Veeva Systems Inc
9.2.5. Siemens AG
9.2.6. Honeywell International Inc
9.2.7. Werum IT Solutions GmbH
9.2.8. Dassault Systèmes
9.2.9. Emerson Electric Co
9.2.10. Rockwell Automation Inc.
9.2.11. Parsec Automation Corp
9.2.12. ABB Ltd
9.2.13. Aspen Technology Inc
9.2.14. Schneider Electric SE
9.2.15. Körber AG
9.2.16. Sparta Systems Inc.
9.2.17. QAD Inc.
9.2.18. Kinaxis Inc.
9.2.19. Other Prominent Players
Pharmaceutical Manufacturing Software Market by Deployment Type -
Pharmaceutical Manufacturing Software Market by Application -
Pharmaceutical Manufacturing Software Market by End User -
Pharmaceutical Manufacturing Software Market by Region-
North America-
Europe-
Asia-Pacific-
Latin America-
Middle East & Africa-
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
