survey report: the future of mes in iot and pharma 4

Survey Report:

The Future of MES in IoT and Pharma 4.0

Published November 2019 by: Industry of Things Voice a product of we.CONECT Global Leaders GmbH Reichenberger Str. 124 | 10999 Berlin | Germany Halfmann Goetsch Partner AG – an NNIT Group Company St. Alban-Vorstadt 94 | 4052 Basel | Switzerland

Survey Report: The Future of MES in IoT and Pharma 4.0

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Table of Content

1. Executive Summary ............................................................................................................................. 4

2. Study Profile ........................................................................................................................................ 5

3. Survey Results...................................................................................................................................... 6

3.1. Industries of respondents’ manufacturing business .................................................................... 6

3.2 Areas of MES implementation so far............................................................................................. 6

3.3 Areas of MES implementation in the next 3 years ........................................................................ 7

3.4 MES migration and upgrades ........................................................................................................ 7

3.5 Pharma 4.0 and / or production digitalization strategy ................................................................ 8

3.6 MES infrastructure on- or off-premise .......................................................................................... 8

3.7 Interoperability / integration of MES with other systems ............................................................ 9

3.8 Use of IoT devices in production ................................................................................................. 10

3.9 Types of IoT technologies used in production ............................................................................ 10

3.10 Virtual Reality or Augmented Reality for operator training ...................................................... 11

3.11 AI featured software in production ........................................................................................... 11

3.12 Expected disruptors for pharma production in the next five years .......................................... 12

3.13 Will MES be replaced by Pharma 4.0 / IoT? .............................................................................. 12

3.14 Outlook: The role of MES and IoT in pharmaceutical production in the future ....................... 13

4. Imprint ............................................................................................................................................... 14


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Table of Figures

Figure 1 Regional split of survey target group ........................................................................................ 5

Figure 2 Industry of respondents ............................................................................................................ 6

Figure 3 Areas of MES implementation ................................................................................................... 6

Figure 4 Area of implementation in the next 3 years ............................................................................. 7

Figure 5 MES migration or upgrade planned .......................................................................................... 7

Figure 6 Pharma 4.0 and / or production digitalization strategy ............................................................ 8

Figure 7 On- or off-premise system operation ........................................................................................ 8

Figure 8 Interoperability / integration of MES with other systems ........................................................ 9

Figure 9 Use of IoT devices in production ............................................................................................. 10

Figure 10 IoT technology used in production ........................................................................................ 10

Figure 11 Virtual Reality or Augmented Reality for operator training .................................................. 11

Figure 12 AI featured software in production ....................................................................................... 11

Figure 13 Expected disruptors for pharma production ......................................................................... 12

Figure 14 Will MES be replaced by Pharma 4.0 / IoT? .......................................................................... 12

Figure 15 Areas of support of MES and IoT in pharmaceutical production .......................................... 13


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This study was conducted by:

Halfmann Goetsch Partner AG (HGP) was acquired by NNIT in April 2019. NNIT is a leading international consultancy for the life sciences industry. NNIT is a partner for integrated IT services and solutions, digital transformation and compliance for the life science industry. The company provides advisory and consultancy services in the business areas of Laboratory, Regulatory Affairs, Production and Quality & Compliance. NNIT delivers end-to-end production IT services that help companies to design a Pharma 4.0

manufacturing IT and automation architecture to make the right decisions with their MES investments

to be ready for Pharma 4.0.

Industry of Things Voice addresses all aspects relating to the Internet of Things, IT, IoT, Cyber Security, Continuous Delivery and DevOps. As a platform, Industry of Things Voice gathers the latest information, case studies, innovation studies, videos, surveys and exclusive interviews on these topics shaping the future and gives most important opportunities & challenges their deserved space online. Industry of Things Voice is a product by we.CONECT Global Leaders based in Berlin, Germany.

Pharma MES is an award-winning global conference series hosted by we.CONECT Global Leaders with events in Berlin, Singapore and Boston. For the last 8 years, Pharma MES has been the number one knowledge exchange platform for pharma manufacturing, bringing together all stakeholders who play an active role in the pharma industry and life science scene.

http://www.hgp.ag/

https://www.industryofthingsvoice.com/webinar-aufzeichnung-next-generation-plm/

https://www.pharma-manufacturing-execution-system.com/


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1. Executive Summary

The concept of Manufacturing Execution Systems (MES) as a system to execute, monitor, track and report manufacturing operations in real time has been established in the pharmaceutical industry for more than 20 years. But is a system that was designed pre-IoT still the right system for the journey towards digitalization and Pharma 4.0? Industry of Things Voice, Pharma MES global conference series and HGP conducted a comprehensive industry survey about the expectations for MES solutions in the process of the full digitalization of the shop floor. In a 4-month-long online survey as well as in a live polling at the 2019 Pharma MES conference in Berlin, the study collected the insights of 272 MES and production experts in the pharma and life science industry. The study concludes with following key findings:

58% of respondents are pursuing a Pharma 4.0 and / or production digitalization strategy with a clear roadmap defined; 44% have even already started the implementation process

An overwhelming majority of 72% says the MES infrastructure will be operated with an on-premise server-based system rather than through a service or third party solution

The majority of respondents are not yet using IoT devices such as HoloLens, smart sensors or wearables in production. Of the respondents that do have IoT devices in place, 6 % use these connected to the MES system

As the most important disruptors for pharma production in the next five years the implementation of smart devices and smart machines were ranked highest, but closely followed by implementation of MES, Big Data, machine learning as well as the implementation of new regulatory requirements

80% of respondents believe MES will be the backbone of Pharma 4.0 in pharmaceutical production going forward

The results show that MES solutions are still perceived as critical in the upcoming years as they are today. New technologies and devices are expected impact and change the pharma production process but are not expected to replace MES solutions.


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2. Study Profile The target group for this survey were experts from Pharma production from around the world. These included MES system analysts, Directors of Pharmaceutical Production, product quality leaders, Heads of Supply Chain, Automation & System managers, Industry 4.0 Architects and further experts in the pharma and life science industry. Survey period: July 01 – October 30, 2019 Survey method: The online survey was promoted through email marketing and social media in

the community and networks of Industry of Things Voice and HGP. Furthermore, an additional polling was conducted with the expert delegate panel at the 2019 Pharma MES conference in Berlin, on September 19-20, 2019.

Survey responses: 272 The focus lay on companies from Europe, Asia and the USA, with 58% of targeted survey participants coming from Europe. These focus areas reflect HGP regions of operation, the Industry of Things Voice network and the community from the global Pharma MES series, which has been bringing together the pharma production and life science experts for the past 8 years and continues to grow steadily.

Figure 1 Regional split of survey target group

58%26%

16%

Europe USA Asia


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3. Survey Results

General Information

3.1. Industries of respondents’ manufacturing business

The majority of survey respondents have a background in pharmaceutical drug production (formulation). The survey showed that these mostly go hand in hand with other areas of the pharma production process and that packaging and biotech and chemical production were part of their area of expertise. Other areas of manufacturing represented by the survey participants in this survey include clinical trial production and vaccines.

Figure 2 Industry of respondents

3.2 Areas of MES implementation so far

Reflecting the participants’ industry backgrounds, the most frequent area of implementation of MES solution determined by the survey are pharmaceutical drug production and packaging. However, nearly a third of all respondents state that they are not working with MES systems in their production process.

Figure 3 Areas of MES implementation

65%

36%

33%

32%

20%

11%

12%

Pharmaceutical drug production (formulation)

Packaging

Biotech (drug substance)

Chemical (API) production

Medical devices

Cell and gene therapy

Other (Please specify):

5%

7%

9%

21%

26%

31%

36%

49%

0% 10% 20% 30% 40% 50% 60%



Medical devices



None

Packaging


(Multiple answers possible)



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3.3 Areas of MES implementation in the next 3 years

A large majority of respondents plan to implement MES solutions in one or more areas. This includes both first time implementation and expansion of implementation to additional areas of production. 9% percent have no implementation plans in the upcoming years. Other areas of implementation besides the ones stated below include serialization, clinical manufacturing and biological API production.

Figure 4 Area of implementation in the next 3 years

3.4 MES migration and upgrades

Confirming that the split in the industry of production with MES solutions and without is about 2/3 to 1/3, the survey shows that the implementation process can be realized with new MES solutions or updates and upgrades of existing solutions. When asked, whether there was a plan to migrate the current MES to a new major release (upgrade) or to another MES solution, these were the results:

We do not have an MES yet

Upgrade of current solution planned within next two years

No upgrade planned within next two years (only updates of current release)

Migration to new MES solution planned within next two years

Migration planned, but not decided if upgrade of current solution or

migration to new MES

34%

25%

17%

13%

11%

Figure 5 MES migration or upgrade planned


9%

9%

11%

14%

26%

32%

41%

52%

0% 10% 20% 30% 40% 50% 60%

None



Medical devices



Packaging



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3.5 Pharma 4.0 and / or production digitalization strategy

58% of companies maintain a Pharma 4.0 and / or production digitalization strategy; 44% have already started its implementation process. Considering also that digitalization has been defined at least as a mid-term management objective, this shows that Pharma 4.0 and production digitalization is a topic an overwhelming majority of companies have put on their agenda for the upcoming years. When asked if there was a Pharma 4.0 and / or production digitalization strategy in place, these were the results:

IoT Features

3.6 MES infrastructure on- or off-premise

70% of pharma production experts work with on-premise server-based systems to operate their MES solutions. Even with all SaaS and IaaS solutions with differing host-models combined, the service-based approach only accounts for 25%. Whether this will change in the next years, will remain to be seen.

Figure 7 On- or off-premise system operation

4%

4%

8%

9%

32%

70%

0% 10% 20% 30% 40% 50% 60% 70% 80%

IaaS solution (hosted by the MES solution provider)

IaaS solution (hosted by a cloud service provider)

IaaS solution (hosted by a third-party IT provider)

SaaS solution (MES as a service)

Centralized server infrastructure serving multiple sites

On-premise server-based system

Yes – strategy and roadmap are defined, and implementation has

started

Yes – strategy and roadmap are defined, implementation has not

started

No – no Pharma 4.0 / digitalization strategy planned

No – Pharma 4.0 / digitalization strategy is a short / mid-term

management objective

44%

14%

22%

19%

Figure 6 Pharma 4.0 and / or production digitalization strategy



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3.7 Interoperability / integration of MES with other systems

What role does the interoperability /integration of MES play for pharma companies? How does the significance vary with regard to individual systems? The table below grades the levels of importance as identified by the industry experts:

Figure 8 Interoperability / integration of MES with other systems

81%

43%

44%

34%

59%

75%

60%

40%

62%

27%

38%

39%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Corporate ERP instance

Localized ERP

Enterprise Manufacturing Intelligence (EMI)

Enterprise Asset Management (EAM)

LIMS (Laboratory Information Management)

DCS / SCADA / control systems

KPI data collection and visualization

Supply Chain Applications (APS)

Quality Management Systems (QMS)

HR or Learning Management System

Product Lifecycle Management (PLM)

Smart devices

not applicable not important optional important


10

3.8 Use of IoT devices in production

The integration of IoT devices is not yet wide-spread. If used at all, only 6 % are connected to the MES solution.

Figure 9 Use of IoT devices in production

3.9 Types of IoT technologies used in production

Of those devices which are in place, smart sensors and meters are most frequently used, usually in

combination with one or several technologies such Big Data analysis, augmented reality glasses and

machine learning. Other technologies in use are Robotic Process Automation (RPA).

Figure 10 IoT technology used in production

66%

28%

6%

No, we do not use IoT devices yetin production

Yes, we are using IoT devices, butnot connected to MES

Yes, we are using IoT devicesconnected to MES

0%

10%

20%

30%

40%

50%

60%

70%

3%

3%

3%

4%

9%

16%

19%

21%

29%

52%

0% 10% 20% 30% 40% 50% 60%

5G networks

Blockchain


Mixed Reality Applications (MiRA)

3D printers

Machine learning

Augmented reality glasses / HoloLens

Big data analysis

Smart sensors or smart meters

Not applicable


No, we do not use IoT devices yet in production

Yes, we are using IoT devices but not connected to MES

Yes, we are using IoT devices connected to MES


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3.10 Virtual Reality or Augmented Reality for operator training

Reflecting the results of the question on the implementation of IoT devices in 3.8, respondents state

that VR and AR are not yet commonly used for training purposes. 13% of rely on VR / AR for training,

whereas 23% are using other computer-based forms of training.

Figure 11 Virtual Reality or Augmented Reality for operator training

3.11 AI featured software in production

When asked about AI featured software in production, the survey shows a picture similar to that of

implementation of IoT devices: 84% of pharma production experts do not use these yet.

Figure 12 AI featured software in production

64%

23%

13%

No, we do not use VR / AR for training

No, we are using computer-based training for operators – no VR / AR

Yes, we are using VR / AR for operators training

84%

11%

5%

No, we do not use any AI featured software in production

Yes, we are using AI featured software in production – but only for non-GMP applications

Yes, we are using AI featured software in production – GMP and non-GMP applications


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3.12 Expected disruptors for pharma production in the next five years

There are several technologies which are expected to impact the pharma production process in the

upcoming 5 years. With 43%, smart devices and machines are considered to have the greatest impact

on production. Systems such as MES, cloud computing, machine learning are expected to impact the

industry as much as the introduction on new regulatory requirements. Other disruptive factors

determined by the survey respondents include cyber security. This shows that fundamental changes

are expected, the sources, however, are manifold.

Figure 13 Expected disruptors for pharma production

3.13 Will MES be replaced by Pharma 4.0 / IoT?

Despite the many disrupting factors and changes expected in the production process, MES continues

to be regarded as crucial in pharma production moving forward, as confirmed by 83% of industry

experts.

Figure 14 Will MES be replaced by Pharma 4.0 / IoT?

43%39%

36% 36% 36% 36% 34%

26%

18%

9%

2%

0%5%

10%15%20%25%30%35%40%45%50%

17%

83%

Yes, MES as a system will not play any major role in apharmaceutical factory in the future

No, MES will be the backbone of Pharma 4.0 inpharmaceutical production



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3.14 Outlook: The role of MES and IoT in pharmaceutical production in the future

When asked about the future role MES and IoT will play in supporting pharmaceutical production, the

pharma experts in this survey identify many areas which could be improved by these technologies.

These have been collected here and assigned a response category to show which factors were most

commonly named.

Figure 15 Areas of support of MES and IoT in pharmaceutical production

This shows that MES and IoT technologies can improve pharma production most by helping to reduce

errors and improve quality of the production process. New systems and technologies are regarded as

being complementary to existing ones, but can help to get a full picture of pharma production, make

the manufacturing processes smarter and allow for better integration and continuous production.

Overall, the systems are expected to increase the efficiency for the operator and production

businesses.

1%

3%

15%

17%

24%

30%

36%

42%

48%

54%

60%

0% 10% 20% 30% 40% 50% 60% 70%


Vendor kick start on IoT applications

MES functionality to transform into an IIoT environment

Any time audit readiness

Compliance with Regulatory requirements

Continuous production

Digital Transformation of production

Early release of batches

Improving Data integrity

Insight into Real time data

Reducing errors and improving quality


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4. Imprint

Survey: The Future of MES in IoT and Pharma 4.0 Published by: we.CONECTGlobal Leaders GmbH Industry of Things Voice Reichenberger Str. 124 10999 Berlin | Germany www.industryofthingsvoice.com Contact: Leonie Lawrence Digital Hubs Lead Editor Email: [email protected] Phone: +49 30 52 10 70 3 83 Halfmann Goetsch Partner AG – an NNIT Group Company St. Alban-Vorstadt 94 | CH-4052 Basel | Switzerland www.hgp-pharma-consulting.com Contact:

Thomas Halfmann

Global Head Production IT

Email: [email protected]

Phone: +41 61 5440 001

Annette Casper Marketing Manager Life Sciences Email: [email protected] Phone: +41 61 5440 004

COPYRIGHT © 2019 we.CONECT Global Leaders GmbH and Halfmann Goetsch Partner AG – an NNIT Group Company The pictures used are for illustration purposes only. They are not available for publication. All rights reserved. The contents of this report are intellectual property of we.CONECT Global Leaders GmbH and Halfmann Goetsch Partner AG and are subject to the applicable copyright laws.

http://www.industryofthingsvoice.com/

mailto:[email protected]

http://www.hgp-pharma-consulting.com/



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