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Cleaning Validation Software for Pharma Market by Type (Software, Services) by Application (Pharma and Biotechnology Companies, CRO, Research Institutes): Growth, Future Prospects, and Competitive Analysis, 2015 – 2027

Summary
Table Of Content

Market Insights

Cleaning validation software is used to ensure a cleaning process that eliminates microbial and chemical residues of the passive, active, or detergent elements from the equipment used to manufacture various pharmaceuticals. The leading pharmaceutical manufacturers are increasingly adopting cleaning validation software. Cleaning validation carries a high level of importance and hence needs to be undertaken in a highly precise manner as prescribed by the various regulatory authorities. Cleaning validation software is of great help in complying with these regulatory guidelines by assisting these companies in achieving cleaning to predetermined and accepted levels. The

Cleaning Validation Software for Pharma Marketis projected to garner a market value of USD 1,091.15 million in 2027, growing from USD 509.43 million in 2020. It is anticipated to grow at a CAGR of over 11.25% during the forecast period.

Key Market Drivers and Restraints

The rising demand for cleaning validation software in the pharma industry can be attributed to stringent regulatory measures. Stringent regulatory measures by various regulatory bodies have been forcing pharmaceutical manufacturers to adopt the cleaning validation software. As a result, FDA warnings related to cross-contamination increased significantly from 5% in 2015 to 20% in 2020. Such cross-contamination of pharma manufacturing can result in significant losses of time, money, efforts, etc. Such cross-contamination is the result of inappropriate cleaning validation of manufacturing equipment or aids. Moreover, this software helps the organization manage time, workforce productivity, information security, efficient business processes, and controlling compliance, which are projected to drive the growth of the global market during the forecast period. In addition, rapid technological advancements such as cloud computing and big data, pharma supply chains, and increased pharmaceutical regulatory scrutiny are also expected to drive the global cleaning validation software market.

Secondly, cleaning validation is a very critical and complicated process. Cleaning validation software has greatly contributed to simplifying such a complicated process. Cleaning validation not only simplifies the process but also facilitates access to the data easily. Unlike the manual cleaning validation process, cleaning validation software offers a platform that stores equipment and product-related data instead of maintaining the traditional spreadsheet format.

The price of cleaning validation software varies drastically based on its functionality and features, the number of users, deployment, services offered by the company, duration, etc. The average annual cost for cleaning validation software ranges between USD 35,000 to USD 50,000. A large number of small and medium size pharma and biotech companies are still adhering to the manual cleaning validation process. Therefore, offering this software for an affordable price.

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Impact of COVID 19

The appearance of the mutant COVID-19 virus has put meaningful pressure on the pharma industry. Healthcare professionals are striving to develop medicines to counter this virus. During this, the COVID-19 outbreak has been a key catalyst for the adoption and growth of cleaning validation software. Cleaning validation software development systems have adopted a more agile development framework to respond more rapidly to changing demands. Whereas COVID-19 has more heavily impacted other markets, software development is persevering and taking advantage of new niches.

North America to Rule the Global Cleaning Validation Software for Pharma Market

The North American market is projected to account for the highest revenue share in the global cleaning validation software for the pharma market because of the ever-rising adoption of cloud computing and the Internet of Things (IoT) in the region. Stringent implementation of regulations in the region is also one of the major factors compelling major pharma players to exhibit increasing willingness to have cleaning validation software in place. Automation is also growing in popularity in the region, driving the demand for cleaning validation software and expected to keep North America at the forefront of this industry.

Software Segment to drive the Global Cleaning Validation Software for Pharma Market

Software and Services are the two major segments of the Cleaning Validation Software for Pharma Market. In 2020, the Software segment accounted for the two third share of Cleaning Validation Software for the Pharma Market. However, the Services segment is anticipated to grow at a steady CAGR during the forecast period. With the increasing installed base, the service segment is gaining ground across the world.

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Pharma and Biotechnology Companies are Expected to Act as a major Revenue Stream.

Pharma and Biotechnology Companies and CROs are some major types of Applications. Pharma and Biotechnology Companies segment accounted for the largest share 2020 of the Cleaning Validation Software for the Pharma Market 2020. CRO segment held over 20% share in 2020. Cleaning validation software is mainly focusing on research & development. Kneat Solutions is a paperless cleaning validation software “Kneat Gx,” which digitalizes the whole Cleaning Validation process during the cycle-time, carrying compelling productivity, Product life cycle, and compliance developments. This software allows managing cleaning validation life cycle initial with requirements through to the Validation of Final Reports in one easy-to-use solution. Documentation is easy with Kneat Gx through pre-approved templates and active data sharing, which reduces the time required to generate a document and decreases human errors by removing the need to move data among documents. Additional productivities are gained because the Kneat Gx work development does not need transporting physical documents, and these documents cannot be damaged or lost.

Major companies are focusing on offering after-sales services to attract clients. For instance, Ofni Systems proactively provides rigorous training to help end-users efficiently handle cleaning validation software. It also helps its clients with detailed training materials and 24/7 assistance to overcome any problem.

1.Preface

1.1.Report Description
1.1.1.Purpose of the Report
1.1.2.Target Audience
1.1.3.USP and Key Offerings
1.2.Research Scope
1.3.Research Methodology
1.3.1.Phase I – Secondary Research
1.3.2.Phase II – Primary Research
1.3.3.Phase III – Expert Panel Review
1.3.4.Approach Adopted
1.3.4.1.Top-Down Approach
1.3.4.2.Bottom-Up Approach
1.3.5.Assumptions
1.4.Market Segmentation

2.Executive Summary
2.1.Market Snapshot: Global Cleaning Validation Software for Pharma Market

3.Market Dynamics
3.1.Introduction
3.1.1. Global Cleaning Validation Software for Pharma Market Value, 2015-2027, (US$ Bn)
3.2.Market Dynamics
3.2.1.Key Growth Trends
3.2.2.Major Industry Challenges
3.2.3.Key Growth Pockets
3.3.Attractive Investment Proposition,2020
3.3.1.Type
3.3.2.Application
3.3.3.Geography

4.Market Positioning of Key Players, 2020
4.1.Company market share of key players, 2020
4.2.Top 6 Players
4.3.Top 3 Players
4.4.Major Strategies Adopted by Key Players
4.5.Market Positioning of Key Players
4.6.Product Benchmarking
4.7.List of Key Distributors
4.8.Cleaning Validation Software Brands

5.COVID 19 Impact Analysis
5.1.Global Cleaning Validation Software for Pharma Market Pre Vs Post COVID 19, 2019 – 2027
5.2.Impact on Import & Export
5.3.Impact on Demand & Supply

6.North America
6.1.North America Cleaning Validation Software for Pharma Market, by Country, 2015-2027(US$ Bn)
6.1.1.U.S.
6.1.2.Canada
6.1.3.Mexico
6.2.North America Cleaning Validation Software for Pharma Market, by Type, 2015-2027(US$ Bn)
6.2.1.Overview
6.2.2.Software
6.2.3.Services
6.3.North America Cleaning Validation Software for Pharma Market, By Application, 2015-2027(US$ Bn)
6.3.1.Overview
6.3.2.Pharma and Biotechnology Companies
6.3.3.CRO
6.3.4.Research Institutes

7.Europe
7.1.Europe Cleaning Validation Software for Pharma Market, by Country, 2015-2027(US$ Bn)
7.1.1.UK
7.1.2.France
7.1.3.Germany
7.1.4.Italy
7.1.5.Russia
7.1.6.Spain
7.1.7.Belgium
7.1.8.Netherland
7.1.9.Austria
7.1.10.Sweden
7.1.11.Poland
7.1.12.Denmark
7.1.13.Switzerland
7.1.14.Rest of Europe
7.2.Europe Cleaning Validation Software for Pharma Market, by Type, 2015-2027(US$ Bn)
7.2.1.Overview
7.2.2.Software
7.2.3.Services
7.3.Europe Cleaning Validation Software for Pharma Market, By Application, 2015-2027(US$ Bn)
7.3.1.Overview
7.3.2.Pharma and Biotechnology Companies
7.3.3.CRO
7.3.4.Research Institutes

8.Asia Pacific
8.1.Asia Pacific Cleaning Validation Software for Pharma Market, by Country, 2015-2027(US$ Bn)
8.1.1.China
8.1.2.Japan
8.1.3.South Korea
8.1.4.India
8.1.5.Australia
8.1.6.New Zealand
8.1.7.Taiwan
8.1.8.Southeast Asia
8.1.9.Central Asia
8.1.10.Rest of Asia Pacific
8.2.Asia Pacific Cleaning Validation Software for Pharma Market, by Type, 2015-2027(US$ Bn)
8.2.1.Overview
8.2.2.Software
8.2.3.Services
8.3.Asia Pacific Cleaning Validation Software for Pharma Market, By Application, 2015-2027(US$ Bn)
8.3.1.Overview
8.3.2.Pharma and Biotechnology Companies
8.3.3.CRO
8.3.4.Research Institutes

9.Latin America
9.1.Latin America Cleaning Validation Software for Pharma Market, by Country, 2015-2027(US$ Bn)
9.1.1.Brazil
9.1.2.Argentina
9.1.3.Peru
9.1.4.Chile
9.1.5.Colombia
9.1.6.Rest of Latin America
9.2.Latin America Cleaning Validation Software for Pharma Market, by Type, 2015-2027(US$ Bn)
9.2.1.Overview
9.2.2.Software
9.2.3.Services
9.3.Latin America Cleaning Validation Software for Pharma Market, By Application, 2015-2027(US$ Bn)
9.3.1.Overview
9.3.2.Pharma and Biotechnology Companies
9.3.3.CRO
9.3.4.Research Institutes

10.Middle East
10.1.Middle East Cleaning Validation Software for Pharma Market, by Country, 2015-2027(US$ Bn)
10.1.1.UAE
10.1.2.KSA
10.1.3.Israel
10.1.4.Turkey
10.1.5.Iran
10.1.6.Rest of Middle East
10.2.Middle East Cleaning Validation Software for Pharma Market, by Type, 2015-2027(US$ Bn)
10.2.1.Overview
10.2.2.Software
10.2.3.Services
10.3.Middle East Cleaning Validation Software for Pharma Market, By Application, 2015-2027(US$ Bn)
10.3.1.Overview
10.3.2.Pharma and Biotechnology Companies
10.3.3.CRO
10.3.4.Research Institutes

11.Africa
11.1.Africa Cleaning Validation Software for Pharma Market, by Country, 2015-2027(US$ Bn)
11.1.1.South Africa
11.1.2.Egypt
11.1.3.Nigeria
11.1.4.Rest of Africa
11.2.Africa Cleaning Validation Software for Pharma Market, by Type, 2015-2027(US$ Bn)
11.2.1.Overview
11.2.2.Software
11.2.3.Services
11.3.Africa Cleaning Validation Software for Pharma Market, By Application, 2015-2027(US$ Bn)
11.3.1.Overview
11.3.2.Pharma and Biotechnology Companies
11.3.3.CRO
11.3.4.Research Institutes

12.Global
12.1.Global Cleaning Validation Software for Pharma Market, by Type, 2015-2027(US$ Bn)
12.1.1.Overview
12.1.2.Software
12.1.3.Services
12.2.Global Cleaning Validation Software for Pharma Market, By Application, 2015-2027(US$ Bn)
12.2.1.Overview
12.2.2.Pharma and Biotechnology Companies
12.2.3.CRO
12.2.4.Research Institutes

13.Company Profiles
13.1.Ofni Systems
13.2.LeucineTech
13.3.SafetyCulture
13.4.ValGenesis
13.5.Novatek International
13.6.Kneat
13.7.EResidue
13.8.Auditrunner
13.9.USDM
13.10.Kaye Inc

List of Figures
FIG. 1Global Cleaning Validation Software for Pharma Market: Research Methodology
FIG. 2Market Size Estimation – Top Down & Bottom up Approach
FIG. 3Global Cleaning Validation Software for Pharma Market Segmentation
FIG. 4Global Cleaning Validation Software for Pharma Market, by Type, 2019 (US$ Bn)
FIG. 5Global Cleaning Validation Software for Pharma Market, by Application, 2019 (US$ Bn)
FIG. 6Global Cleaning Validation Software for Pharma Market, by Geography, 2019 (US$ Bn)
FIG. 7Attractive Investment Proposition, by Geography, 2019
FIG. 8Global Market Positioning of Key Cleaning Validation Software for Pharma Market Manufacturers, 2019
FIG. 9Global Cleaning Validation Software for Pharma Market Value Contribution, By Type, 2020 & 2027 (Value %)
FIG. 10Global Cleaning Validation Software for Pharma Market, by Software, Value, 2015-2027 (US$ Bn)
FIG. 11Global Cleaning Validation Software for Pharma Market, by Services, Value, 2015-2027 (US$ Bn)
FIG. 12Global Cleaning Validation Software for Pharma Market Value Contribution, By Application, 2020 & 2027 (Value %)
FIG. 13Global Cleaning Validation Software for Pharma Market, by Pharma and Biotechnology Companies, Value, 2015-2027 (US$ Bn)
FIG. 14Global Cleaning Validation Software for Pharma Market, by CRO, Value, 2015-2027 (US$ Bn)
FIG. 15Global Cleaning Validation Software for Pharma Market, by Research Institutes, Value, 2015-2027 (US$ Bn)
FIG. 16U.S. Cleaning Validation Software for Pharma Market, 2015-2027 (US$ Bn)
FIG. 17Rest of North America Cleaning Validation Software for Pharma Market, 2015-2027 (US$ Bn)
FIG. 18U.K. Cleaning Validation Software for Pharma Market, 2015-2027 (US$ Bn)
FIG. 19Germany Cleaning Validation Software for Pharma Market, 2015-2027 (US$ Bn)
FIG. 20France Cleaning Validation Software for Pharma Market, 2015-2027 (US$ Bn)
FIG. 21Rest of Europe Cleaning Validation Software for Pharma Market, 2015-2027 (US$ Bn)
FIG. 22Japan Cleaning Validation Software for Pharma Market, 2015-2027 (US$ Bn)
FIG. 23China Cleaning Validation Software for Pharma Market, 2015-2027 (US$ Bn)
FIG. 24India Cleaning Validation Software for Pharma Market, 2015-2027 (US$ Bn)
FIG. 25Rest of Asia Pacific Cleaning Validation Software for Pharma Market, 2015-2027 (US$ Bn)
FIG. 26Middle East & Africa Cleaning Validation Software for Pharma Market, 2015-2027 (US$ Bn)
Latin America Cleaning Validation Software for Pharma Market, 2015-2027 (US$ Bn)

List of Tables
TABLE 1Market Snapshot: Global Cleaning Validation Software for Pharma Market
TABLE 2Global Cleaning Validation Software for Pharma Market, by Type, 2015-2027 (US$ Bn)
TABLE 3Global Cleaning Validation Software for Pharma Market, by Application, 2015-2027 (US$ Bn)
TABLE 4Global Cleaning Validation Software for Pharma Market, by Application, 2015-2027 (US$ Bn)
TABLE 5Global Cleaning Validation Software for Pharma Market, by Geography, 2015-2027 (US$ Bn)
TABLE 6North America Cleaning Validation Software for Pharma Market, by Type, 2015-2027 (US$ Bn)
TABLE 7North America Cleaning Validation Software for Pharma Market, by Application, 2015-2027 (US$ Bn)
TABLE 8North America Cleaning Validation Software for Pharma Market, by Country, 2015-2027 (US$ Bn)
TABLE 9Europe Cleaning Validation Software for Pharma Market, by Type, 2015-2027 (US$ Bn)
TABLE 10Europe Cleaning Validation Software for Pharma Market, by Application, 2015-2027 (US$ Bn)
TABLE 11Europe Cleaning Validation Software for Pharma Market, by Country/Region, 2015-2027 (US$ Bn)
TABLE 12Asia Pacific Cleaning Validation Software for Pharma Market, by Type, 2015-2027 (US$ Bn)
TABLE 13Asia Pacific Cleaning Validation Software for Pharma Market, by Application, 2015-2027 (US$ Bn)
TABLE 14Asia Pacific Cleaning Validation Software for Pharma Market, by Country/Region, 2015-2027 (US$ Bn)
TABLE 15Latin America Cleaning Validation Software for Pharma Market, by Type, 2015-2027 (US$ Bn)
TABLE 16Latin America Cleaning Validation Software for Pharma Market, by Application, 2015-2027 (US$ Bn)
TABLE 17Latin America Cleaning Validation Software for Pharma Market, by Country/Region, 2015-2027 (US$ Bn)
TABLE 18Middle East Cleaning Validation Software for Pharma Market, by Type, 2015-2027 (US$ Bn)
TABLE 19Middle East Cleaning Validation Software for Pharma Market, by Application, 2015-2027 (US$ Bn)
TABLE 20Middle East Cleaning Validation Software for Pharma Market, by Country/Region, 2015-2027 (US$ Bn)
TABLE 21Africa Cleaning Validation Software for Pharma Market, by Type, 2015-2027 (US$ Bn)
TABLE 22Africa Cleaning Validation Software for Pharma Market, by Application, 2015-2027 (US$ Bn)
TABLE 23Africa Cleaning Validation Software for Pharma Market, by Country/Region, 2015-2027 (US$ Bn)
TABLE 24Ofni Systems: Company Snapshot (Company Overview; Type Portfolio; Financial; Key Developments)
TABLE 25LeucineTech: Company Snapshot (Company Overview; Type Portfolio; Financial; Key Developments)
TABLE 26 SafetyCulture: Company Snapshot (Company Overview; Type Portfolio; Financial; Key Developments)
TABLE 27ValGenesis: Company Snapshot (Company Overview; Type Portfolio; Financial; Key Developments)
TABLE 28Novatek International: Company Snapshot (Company Overview; Type Portfolio; Financial; Key Developments)
TABLE 29 Kneat: Company Snapshot (Company Overview; Type Portfolio; Financial; Key Developments
TABLE 30, EResidue: Company Snapshot (Company Overview; Type Portfolio; Financial; Key Developments
TABLE 31Auditrunner: Company Snapshot (Company Overview; Type Portfolio; Financial; Key Developments
TABLE 32USDM: Company Snapshot (Company Overview; Type Portfolio; Financial; Key Developments
Kaye Inc: Company Snapshot (Company Overview; Type Portfolio; Financial; Key Developments

Frequently Asked Questions

Which are the different types of cleaning validation software in pharma by Type?

Software, Services, are major types of cleaning validation software in pharma, out of which software segment dominated the global market. Cleaning validation software is used in pharma organizations to invoice entry, expiry management, inventory management, sales bill, and reordering, scheduled drug index, and help pharmacies run their businesses easily.

Who are the key players in the global industry?

Some of the major players operating in cleaning validation software in pharma include, Novatek International, Kneat, eResidue, Auditrunner, Ofni Systems, LeucineTech, SafetyCulture, ValGenesis, USDM and Kaye Inc. These five players collectively accounted for over 45% share in the global market.

Which is the fastest growing Application segment for global industry?

Pharma and Biotechnology Companies is the largest application of cleaning validation software in Pharma. The CRO segment held over 20% share in 2020.

Which is the leading regional market for global industry?

North America hold the largest share owing to large demand of cleaning validation software in several pharma industries

What are the major challenges for the global cleaning validation software in Pharma?

There are four major challenges such as Product Residue Problems, Equipment Problems, Cleaning Process Problems and Laboratory Problems. Product Residue Problems: chemical and physical properties of residue are not used as a basis for cleaning, due to a lack of scientific understanding. Equipment Problems: There are two key equipment problems that outbreak cleaning validation professionals. One is the lack of attention to non-uniform pollution transfer. Another problem was determining the most d

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