In late 2022, we surveyed a group of life science professionals to gather a comprehensive view of the industry’s approach to IoT and Industry 4.0. With pharma, biotech, generics manufacturers, and researchers all represented, we were able to get a clearer picture of the expectations, plans, goals, and methods of the industry as a whole, providing insight into what the future holds for life science manufacturers.
Questions and Answers
Please rank-order the type of technology standard in which your company is investing over the next 12-18 months.
What we learned: Our respondents are primarily investing in SaaS-based solutions, followed by on-prem technology then managed services. Though the rankings are clear, they are close, indicating that the industry as a whole is taking a broad approach to investment.
SaaS-Based solutions/application
- 1st investment priority: 44%
- 2nd investment priority: 22%
- 3rd investment priority: 34%
On-prem technology
- 1st investment priority: 35%
- 2nd investment priority: 38%
- 3rd investment priority: 27%
Managed services
- 1st investment priority: 25%
- 2nd investment priority: 38%
- 3rd investment priority: 38%
Which of the following statements best describes your company's progress toward digitally transforming your manufacturing?
What we learned: The broadest segment of respondents are just beginning their journey into digital transformation. Only about 1 in 3 companies have a dedicated budget for exploring digital transformation.
What are your top five concerns (in order of importance) when considering smart equipment and software systems providers for your plant operations?
What we learned: Data integrity and integration capability are the most important concerns for our respondents. These two concepts go hand-in-hand for assuring data quality, revealing the importance the industry assigns to ensuring accuracy.
The top five concerns are:
- Data Integrity: 77%
- Integrations to source systems: 63%
- Pharma expertise: 50%
- GxP compliance: 47%
- End-to-end process coverage: 40%
What is the main operational challenge you are experiencing when implementing Pharma 4.0 Technologies? (Pharma 4.0 is a framework for adapting digital strategies to the unique contexts of pharmaceutical manufacturing)
What We Learned: Most of our respondents are chiefly concerned about their ability to integrate new systems into old, as they don’t want to lose historical data or capabilities.
- Integrating new and existing data systems: 43%
- Management buy-in: 23%
- Lack of required skills: 16%
- Behavioral changes: 14%
Have you applied, or do you have a plan in the near future (6-12 months from now) to apply Artificial Intelligence (AI) to GxP data to improve manufacturing performance and outcomes?
What We Learned: Respondent opinion is neatly split on the introduction of AI in the near-term. Based on previous answers regarding data quality, AI analysis is likely not fully trusted for manufacturing data.
- Yes: 52%
- No: 48%
Which of these statements reflects how far along you are in your journey towards Pharma 4.0?
What We Learned: Most of our respondents are either still managing processes using spreadsheets or lack central management capabilities. Only about 1 in 4 respondents has centralized data, and less than 1 in 10 has real-time visibility. Due to rigid regulations, new technology adoption has always been slow for pharma manufacturers. These answers demonstrate that.
- Most of our processes are still managed on paper or spreadsheets: 41%
- We have digitized most of our manual records, but we still do not have a single source of truth as a data source: 30%
- We have the ability to centralize data from sensors and devices and analyze the data: 15%
- We have the visibility of manufacturing processes in real-time, and can predict how this is going to progress: 9%
- We are in the process of reducing human intervention, moving towards a full adaptive plant: 5%
How much has the pandemic changed your company's perspective on the digitization of manufacturing facilities?
What We Learned: The vast majority of respondents are investing in more digital capabilities due to the pandemic. About 1 in 10 plan to focus on externalizing to CMOs and CDMOs. For most respondents, the pandemic will have a lasting impact on their processes and will likely drive further innovation.
- It has made us rethink how much more to invest in building all digital capabilities for manufacturing: 44%
- It has changed our strategy substantially and we are investing to movie some or all of our operations to the Cloud: 35%
- It has not had a material impact on our manufacturing operations: 12%
- We plan to externalize more manufacturing to CMO’s and CDMO’s who can meet our future needs: 9%
Please rank the areas below in order of importance. Which areas would benefit the most from increased digitization?
What We Learned: Plant floor and supply chain management are considered to be most apt for digitization. Quality control was the most popular second choice for our respondents. Equipment maintenance and packaging are considered to be less likely to benefit from digital technologies, as they are physical processes.
Would your company prefer to partner with one vendor that can offer an end-to-end solution, or with established leaders for each of the required pieces (data ingestion, analytics, predictive maintenance, etc.) to drive its transformation towards pharma 4.0?
What We Learned: Our respondents generally prefer an all-in-one approach to pharma 4.0, but there are still many that prefer specialists in each sector (data ingestion, analytics, predictive maintenance, etc.). As end-to-end solutions are still relatively rare for pharma 4.0, this preference is likely rooted in previous experience.
- Vendor that can offer an end-to-end platform based solution: 66%
- Established technology providers for each step in the process: 34%
In order of importance, please rank the top four areas your company has been prioritizing, based on the adoption of Pharma 4.0 technologies?
What We Learned: No one answer was selected much more frequently than the rest, again demonstrating that pharmaceutical manufacturers tend to approach industry 4.0 in unique ways. In order, but with fairly equal weights, our respondents listed:
- Data management platform
- Electronic batch records
- Unifying data and breaking silos
- Advanced Analytics
- Data Ingestion/IIoT
- Predictive maintenance
- AI and ML
- Other
How important is it to your company to work with a vendor with an in-depth understanding of Life Science regulations / process optimization vs. broad experience across manufacturing in other industries?
What We Learned: Our respondents typically expect a broad swath of experience from their vendors, but there are still many that prioritize compliance or industry experience.
- Both types of experience are equally important to us: 43%
- We prioritize knowledge of pharma compliance requirements: 34%
- We prioritize overall experience in Industry 4.0: 23%
If you work in a pharma company or sponsor, which were the three most important factors when deciding which contract manufacturer (CDMO/CMO) to work with?
What We Learned: Despite the countless unique approaches to pharma 4.0, dedication to quality standards remains a common thread for pharma manufacturers. While reduced prices, reputation, and time-to-market play significant roles, standards most often take top priority. The top five are:
- Quality standards
- Price-lowering costs
- Industry reputation
- Product time to market
- State-of-the-art facilities
Parting Thoughts: In the course of the survey, our team gained a better idea of what really drives digital transformation for the life sciences. While technology adoption remains scattered across different methodologies, the answers given in this survey indicate that the mainstream adoption of Pharma 4.0 is well underway. In coming years, we expect to see a more standardized approach being developed, but in the meantime, industry leaders are showing a great deal of ambition and innovation as they introduce technology that works within the confines of GxP compliance.
Catherine Balistreri
Head of Marketing
catherine.balistreri@aizon.ai
