Pharma Analysis &

Quality Control
Trends, Challenges and Outlook
2021 Global Survey Report
A collaboration between
The Analytical Scientist and MilliporeSigma

The life science business of Merck

KGaA, Darmstadt, Germany
operates as MilliporeSigma in the
U.S. and Canada.
 Welcome
to the Pharmaceutical Analysis and
Quality Control Trends Survey Report!

With the pharma value chain rapidly evolving – and with over a year of COVID-19 impact –
we felt it was an appropriate time to gather the thoughts of those working in pharmaceutical
analysis and quality control to uncover the main challenges and trends. When exploring the
effect of this rapid evolution on pharma analysis & QC, four key points emerge:

1. An ever-growing proportion of biotherapeutics

2. The importance of partnering and outsourcing
3. Increasingly complex method development
4. The need for speed in terms of higher throughput, real-time release,
and continuous manufacturing

Gaining a better understanding of these trends by listening to the people “on the ground”
is important to advancing the field; therefore, MilliporeSigma and The Analytical Scientist
decided to partner on the development and dissemination of a benchmarking survey.

With over 200 qualified respondents balanced across regions, functions, roles, and company
types, we believe the results of our survey to be meaningful – and we are happy to share
this report of our findings to stimulate thinking in your organization and the pharmaceutical
community at large.

We look forward to hearing how you make use of these data and your feedback in general.

Best wishes,

Wayne K. Way, Ph.D.

Pharma Analysis & QC Strategy
MilliporeSigma, Bellefonte, PA,
an affiliate of Merck, KGaA Darmstadt, Germany
wayne.way@milliporesigma.com

Lee Noyes
Publisher, The Analytical Scientist
lee.noyes@texerepublishing.com

2 Trends, Challenges and Outlook in Pharma Analysis & Quality Control | 2021 Global Survey Report
Executive summary
Today’s pharmaceutical industry is in a constant state of change, proactively and reactively
adjusting pipelines and production while optimizing efficiency and bottom line in global
markets buffeted by the pandemic, supply chain, regulatory, and demand uncertainties.
Given the rapidly evolving pharma value chain in this turbulent environment, we felt it was
an appropriate time to gather the thoughts of those working in pharmaceutical analysis
and quality control to uncover the main challenges and trends.

To understand more about the trends from the people in the field, MilliporeSigma and
The Analytical Scientist partnered on the development and dissemination of a
benchmarking survey. The survey included over 200 qualified respondents balanced across
regions, functions, roles, and company types.

Results of the survey identified multiple challenges and suggested improvements within
the pharma Analysis & QC and method development areas that reflect major industry
trends in throughput, reliability, efficiency, and modernization. We found that among
survey respondents, the areas of major interest ranged widely from lab management, to
technological improvement, to environmental issues.

The strong interest in improving laboratory efficiency points to the need for better
instrumentation, reagent/consumable reliability, training, and digitalization.

3
Key findings

The survey respondents identified

a number of important pharma
In staffing, the survey Overall, consumables
industry trends with the top
found that most labs (58%) and capital
three (based either on “extreme”
expect to maintain expenditures (44%)
importance or by combining very
(50%) or increase were most likely
or extremely important) being
(36%) headcount to see significant
real-time release, the need for
while also seeing a budget increases,
higher throughput, and continuous
serious need for better while outsourcing was
manufacturing. Environmental
training (77%). primarily flat (51%).
monitoring impact and green
production were also included.

Large pharma placed

Not enough staff, access to Notably, 71% of small,
greatest importance
instruments/instrument downtime, medium and large
on the need for higher
workflow inefficiencies, access to pharma companies
throughput, with
consumables represent the most viewed continuous
77% of respondents
frequently occurring bottlenecks, manufacturing as “very
stating it was “very or
while suggested solutions center or extremely important”
extremely important”
around modernization and (compared with an
(compared with an
adequately trained staff. average of 56%).
average of 62%).

The survey results

Instrumentation, columns, Digitalization of lab
demonstrate that all
and filters top the list of information is still
forms of partnerships are
most common problems surprisingly low (62% still
prevalent; less than 13%
with reproducibility – with using paper/Excel) given
of respondents do not
21% reporting issues at the accessibility of digital
participate in any type
least weekly. connectivity solutions.
of partnership.

4 Trends, Challenges and Outlook in Pharma Analysis & Quality Control | 2021 Global Survey Report
Methods

The Life Science Business of MilliporeSigma

and The Analytical Scientist distributed
an online survey to pharma analysis &
QC experts in pharma related companies
across all regions of the world. Additionally,
advertisements with links to the survey were
displayed on the European Pharmaceutical
Review, the American Pharmaceutical
Review, The Analytical Scientist, and the
SigmaAldrich.com websites.
The survey was initially deployed
on March 4, 2021 and closed on
March 31, 2021. A total of 216 respondents
answered questions regarding trends in
pharmaceutical and quality control analysis.
A team of market researchers from
MilliporeSigma and The Analytical Scientist
compiled and interpreted the data for
this report.

5
Respondent Demographics

Please select your region: Please select what best describes your organization:
3% 4%
8%
26% North America Small/Medium Pharma
26%
8%
Western Europe 38% Large Pharma

Latin America CRO/CDMO

10%
Eastern Europe Emerging Biotech

5% Asia Govt/Academic

Africa/Middle East Other

22%

19% 32%

North America

Small/Medium Pharma
Western Europe
Large Pharma
Latin America
CRO/CDMO

Eastern Europe Emerging Biotech

Asia Govt/Academic

Other
Africa/Middle East

The survey delivered a well-balanced geographical
response. Small-to-medium sized organizations were
best represented across all regions except Asia,
which was more weighted toward multi-national large
pharma. As expected, North America and Western
Europe had strong representation in Emerging Biotech.
Contract organizations (CRO/CDMO) were equally
weighted at around 10% across the four major regions
but not represented in Eastern Europe or Africa/
Middle East.

6 Trends, Challenges and Outlook in Pharma Analysis & Quality Control | 2021 Global Survey Report
Please describe your role within your organization: Please select what best describes the function of
your department:

8% 8% 7%
Drug Discovery
6% Individual Contributor 6%
Method Development

38% Group Leader/Manager Non-Clinical

23%
Development/Formulation
Director
QC/Manufacturing
Executive
Compliance

Purchasing
8%
47% 48%

The organizational role of survey respondents reflects
the standard structure within the pharma/biotech
industry. Individual Contributors and Group Leaders
make up the majority of responses (85% in total).
In accordance with the design and target scope of
the survey, the majority of respondents self-identified
as working in Quality Control/Manufacturing (48%);
the next highest representation was in Method
Development (23%).

For those respondents who work on specific modalities,

the percentage of time spent on those modalities is shared:

Cell and
ADC Gene Vaccine mAb Small Molecule
6% Therapy 16% 19% 51%
10%

The reported percent time spent on different modalities
reflects the current trends in pharmaceutical research and
manufacturing. Of those that focus on these five specific
modalities, 51% of the time (means average) is spent
on small molecules. Vaccines and monoclonal antibodies
(mAbs) account for 16 and 19%, respectively. The higher-
than-expected representation of vaccines was likely
boosted by COVID-19 vaccine research and development,
which has thankfully resulted in approved vaccines
from Pfizer, Moderna, Johnson & Johnson, AstraZeneca,
and others.

Other areas of focus cited by respondents:

7
Lab Size and Staffing
What is the size of your department? How do you forecast the change in your department
size in the next 12 months?
13%
20%
1-5 Significantly decrease 1%

6-10

21% 11-20 Decrease 5%

21-50
Stay the same 51%
20% 50+

Increase 36%
25%

Significantly increase 8%

A wide range of department sizes are represented
by the survey respondents. When reviewing the
responses by geography or department type, several
findings become worth noting: method development
departments were the largest on average; drug
discovery and non-clinical development report the
smallest department sizes. By geography, North
America reports the smallest departments on average,
while Asia reports the largest departments.
In forecasting department size changes, there appears
to be an overall trend towards adding headcount, with
1 in 12 respondents expecting a significant increase.
Regionally, the emerging markets of Latin America,
Eastern Europe, and Asia were more likely to expect
significant increases in headcount. Only respondents in
purchasing expected a significant decrease.

Rank your staffing challenges from most challenging to least challenging

Training 25% 30% 22% 13% 5% 5%

Complexity in tasks 16% 19% 30% 15% 16% 5%

3%

Sufficient resources 22% 13% 21% 29% 12%

Turnover 22% 19% 15% 14% 16% 15%

Recruitment /Lack of 12% 12% 8% 12% 16% 42%

expertise in market
4%

Diversity 8% 5% 17% 36% 31%

Extremely challenging Very challenging Challenging Moderately challenging Slightly challenging Not challenging

Training tops the list of staffing challenges.
Interestingly, better trained people are also a top
scorer in what would remove bottlenecks or improve
lab efficiency (see page 14). The second most serious
staffing challenge is “complexity in tasks,” which may
be linked to the need for better training or ease of use
in terms of methods or instrumentation (notably, the
need to modernize instrumentation also scored highly
in aspects that would boost lab efficiency).

8 Trends, Challenges and Outlook in Pharma Analysis & Quality Control | 2021 Global Survey Report
Budget Expectations
How do you foresee the following budgets being affected in the next 12 months?

1%
Consumables 5% 36% 46% 12%

3%

Capital expeditures 12% 41% 36% 8%

4%

4%
Outsourcing budget 16% 51% 26%

Travel budget 15% 24% 44% 13% 5%

Significantly decrease Decrease Stay the same Increase Significantly increase

Overall, consumables and capital expenditures were expected mid-pandemic were most noted for significant
most likely to see significant budget increases, while reductions. By geography, Asia had the highest
outsourcing was primarily flat. Travel budgets, as expectations in terms of budget increases.

9
Importance of Trends
How important are the following trends in pharmaceutical analysis and QC?

3%
Real-time release 5% 18% 38% 37%

4%
2%
Need for higher throughput 21% 38% 35%

Continuous manufacturing 7% 5% 17% 37% 34%

Digital notebooks/data management 5% 5% 23% 38% 30%

Increasing regulatory hurdles 5% 7% 21% 38% 28%

High potency APIs 10% 10% 19% 34% 27%

More complex APIs/formulations 9% 14% 23% 30% 25%

Outsourcing 6% 16% 40% 26% 13%

Not at all important Slightly important Moderately important Very important Extremely important

Despite all trends being considered important, the
top three most important trends (based either on
“extreme” importance or by combining very or
extremely important) were real-time release, the need
for higher throughput, and continuous manufacturing.
Contrary to expectations, outsourcing sits at the bottom
of the list (though is still considered moderately, very, or
extremely important by over 78% of respondents); the
lower importance may be representative of
manufacturing as “very or extremely important”
(versus an average of 69%). In fact, respondents from
Asia considered all trends to be more important than
respondents from other regions.
Real-time release was considered most important by
respondents in compliance and QC/manufacturing, with
83 and 80% (respectively) considering real-time release
as “very or extremely important” (versus an average
of 69%).

1. the fact that only 10% of respondents were from
CRO/CDMOs (that said, respondents from this
group were least likely to rank outsourcing as
“extremely important”).
2. a perception that outsourcing is now in a “steady
state” rather than a “trend,” as such.
From a geographical point of view, continuous
manufacturing was considered to be most important by
respondents from Asia, where 84% viewed continuous
The need for lab data digitalization ranked relatively
high with the hope of improved operational efficiency
and easier compliance, reflecting the trend toward
digital interconnectivity in other industries.
Microbiological analysis for QC is also of significant
interest. Environmental impact as well as green
production are also being considered.

continued on next page

10 Trends, Challenges and Outlook in Pharma Analysis & Quality Control | 2021 Global Survey Report
Importance of Trends (continued)

Other trends mentioned by respondents include:

“Microbiological Trends. And analysis “Control of environmental impacts,

of continuous environmental green production, for us it’s
monitoring and product biocharge extremely important.”
control is a useful tool to reduce the - Method Dev, CRO/CDMO
risk of final product contamination.”
- Compliance Manager, CRO/CDMO

“Compliance and paperless process.”

- QC Scientist, Large Pharma

11
Emphasis on Trends

What emphasis does your organization place on following trends?

Need for higher throughput 5% 6% 25% 32% 33%

Real-time release 7% 9% 21% 33% 30%

Continuous manufacturing 9% 7% 20% 35% 29%

Increasing regulatory hurdles 5% 6% 27% 34% 28%

High potency APIs 12% 12% 22% 34% 21%

Digital notebooks/data management 7% 12% 27% 32% 22%

More complex APIs/formulations 13% 13% 23% 34% 18%

Outsourcing 9% 16% 33% 28% 13%

Not at all important Slightly important Moderately important Very important Extremely important

Contrary to the “Importance of Trends” (where real- Notably, 71% of small, medium and large pharma
time release was considered most important), when companies viewed continuous manufacturing as “very
respondents considered their own organizations’ or extremely important” (compared with an average
emphasis, the need for higher throughput tops the list. of 56%).

Large pharma placed greatest importance on the need Respondents from Asia stood out from the crowd in
for higher throughput, with 77% of respondents stating terms of high potency APIs; here, 82% thought HPAPIs
it was “very or extremely important” (compared with were “very or extremely important” versus an average
an average of 62%). of only 53% for all other geographies.

12 Trends, Challenges and Outlook in Pharma Analysis & Quality Control | 2021 Global Survey Report
Productivity Bottlenecks

What type of bottlenecks slow down productivity in your lab and how often do these occur?

Not enough staff 12% 17% 21% 26% 24%

Access to instruments/
instrument downtime 8% 20% 28% 26% 18%

Workflow inefficiencies 10% 14% 25% 29% 23%

Access to consumables 9% 15% 27% 31% 19%

Access to samples 8% 13% 13% 25% 41%

Overall capacity 9% 12% 30% 28% 21%

Not enough training 8% 10% 23% 29% 30%

Daily Weekly Monthly Quarterly Never/Does not apply

Not enough staff, access to instruments/instrument bottlenecks (when combining daily and weekly totals).
downtime, workflow inefficiencies, access to Perhaps unsurprisingly, respondents are least likely to
consumables represent the most frequently occurring be waiting for more samples.

Other bottlenecks affecting productivity that were mentioned:

“Robustness of Electronic boards

“The pitfall that we find many of QC Instruments (Specifically LC, “Poor Instruction documents
times is when we analyze GC, ICP-MS, LC-MS etc.) like Specification,
purities, to find impurities of a and suitability at SOP and STP.”
high percentage.” various geographies of World.”
- QC Manufacturing,
- Purchasing Manager - QC Manufacturing, Large Pharma
Large Pharma

13
Removing Bottlenecks; Boosting Lab Efficiency
What would improve/remove bottlenecks or boost lab efficiency? Select all that apply.

Investment in more modern instrumentation 65%

Better trained people 65%

Increased automation 53%

Digital solutions 49%

More people 44%

Higher quality consumables/reagents 39%

Specially designed lab 37%

Other 10%

Two bottlenecks or challenges that are consistently respondents were considering their own training needs
represented across the survey are: rather than the overall needs of the department.

1. insufficient numbers of (adequately trained) staff
2. access to instruments/downtime (represented here
by the need to modernize instrumentation).
Interestingly, “not enough training” was considered the
factor least likely to cause bottlenecks; presumably,
Increased automation (53%) is ranked higher than
more people (44%) – interesting, when considered
alongside the main productivity bottleneck of “not
enough staff.”

Other bottleneck improvements mentioned were related to larger laboratory size, better protocols,
improved support, supply chain and product availability:

“Good support from external “Better technical support for

service providers.” maintenance of equipment.”
- Compliance Manager - QC/Manufacturing, Emerging Biotech

“Detailed with simple step wise “Better digital integration (and

SOP/STP.” related) software.”
- QC manufacturing,
- QC/Manufacturing, Emerging Biotech
Small/Mid-Size Pharma

“Consumables availability on short

notice eg. when problematic lots
are found.”
- Purchasing Dpt, Large Pharma

14 Trends, Challenges and Outlook in Pharma Analysis & Quality Control | 2021 Global Survey Report
Partnerships

What type of partnerships does your department participate in? Select all that apply.

Internal 56%

Vendors/suppliers (instruments/consumables) 50%

Government/regulatory bodies 42%

Academic 35%

Other Pharma Companies 34%

Consultant 24%

CRO/CDMO 20%

We do not participate in partnerships 13%

Charities/NPOs 5%

Other 2%

The survey results demonstrate that most labs have at
least one partnership, ranging from internal to external
academic and commercial forms and even charities;
less than 13% of respondents do not participate in any
type of partnership.
Vendors/suppliers are the most common form of
external partnerships – and 82% of respondents
considered their relationship with vendors/suppliers to
be very or extremely important.
Surprisingly, only 20% of the respondents in the
survey collaborate with CRO/CDMOs, indicating those
relationships may be important, but not widespread
throughout an organization. Notably, emerging biotech
companies were more likely to partner with CRO/
CDMOs (31%) than small/mid/large pharma.
Geographically, respondents from Asia were four times
more likely to have partnerships with other pharma
companies (59%) than respondents from North
America (15%).

15
Product Reproducibility

For those respondents who face reproducibility challenges, how often do these product groups cause issues?

Chromatography columns 8% 13% 16% 26% 37%

Instrumentation 7% 14% 15% 23% 41%

Filters 11% 10% 14% 26% 40%

Chemical reagents 6% 8% 16% 31% 40%

Solvents 6% 10% 11% 25% 48%

Wet chemistry/titration 8% 8% 10% 34% 41%

Cell culture reagents 6% 11% 7% 36% 40%

Reference standards 10% 4% 10% 28% 48%

PCR reagents 5% 9% 9% 33% 44%

Daily Weekly Monthly Quarterly Once or twice a year

Chromatography columns are the most cited Daily issues with filters are more often cited in earlier
consumable to cause issues with reproducibility stages of development.
on a combined daily, weekly and monthly basis.
Reference standards were also noted as causing issues
Interestingly, the issue was more prevalent in QC/
early in discovery and method development but were
Manufacturing than in method development, indicating
seen as more robust in QC/manufacturing.
that more work may need to be done ahead of
transferring methods into QC.

16 Trends, Challenges and Outlook in Pharma Analysis & Quality Control | 2021 Global Survey Report
Product Group Validation
For those respondents who perform validation on specific product groups, how often does your laboratory
validate these product groups?

Chromatography columns 14% 9% 19% 19% 40%

Solvents 17% 8% 17% 18% 41%

Filters 11% 11% 14% 19% 44%

Wet chemistry/titration 12% 9% 22% 41%

16%

Chemical reagents 13% 7% 17% 24% 40%

Cell culture reagents 5% 8% 18%

22% 46%

Reference standards
9% 8% 13% 16% 53%

PCR reagents
9% 2% 16% 25% 48%

Instrumentation
9% 4% 14% 16% 58%

Daily Weekly Monthly Quarterly Once or twice a year

Mirroring issues with reproducibility, chromatography
columns appeared to be validated on a more frequent
basis than other product groups. Interestingly, despite
being the second most likely product group to cause
issues with reproducibility, instrumentation was less
frequently validated than other product groups.
Other product groups mentioned in comments were cell
culture/growth media and internal standards.

17
Product Purchase Factors
When purchasing new products, how important are each of these factors?

Compatibility 47%

Technical service/support 36%

Supply chain reliability 33%

Ease of use/adoption 45%

Cost 31%

Prior experience 49%

Reputation/brand 41%

Cutting-edge features 36%

Not at all important Slightly important Moderately important Very important Extremely important

Overall, compatibility and technical service/support top
the list (based on “very and extremely important”),
closely followed by supply chain reliability and ease of
use/adoption.
Analysis by department shows that ease of use and
supply chain reliability are the most important factors
for QC/Manufacturing, while prior experience and
compatibility were cited as most important by method
development. Reputation/brand was considered most
important in the discovery segment.
Perhaps unsurprisingly, 83% of individuals from
purchasing departments ranked “cost” as “very or
extremely important” versus an average of 74%.
Quality and availability were also cited by respondents.

Data Tracking
How does your lab track and store the majority of its data, protocols, and records of reagents or samples?
Select all that apply. Note: LIMS = laboratory information management system
62% 62%

29%

14%

Paper Excel or LIMS Other

similar

Globally, paper and Excel (or similar) still outreach Among other tracking tools cited by respondent, SAP
the implementation of LIMS across all organizations, ranks first, followed closely by internal lab notebooks,
departments, and geographies; clearly, confidence in software, quality and availability of data.
implementing a digital compliance trail is still lacking.

18 Trends, Challenges and Outlook in Pharma Analysis & Quality Control | 2021 Global Survey Report
What Keeps You Up at Night?
We ended the survey by asking respondents, “What keeps you up at night?” and we received a
wide range of answers. Of course, the pandemic was mentioned, though not as frequently as we
would have expected. Others kept their responses in line with the topic at hand and brought up
work-related concerns to training, data, supply chain issues and product issues.

Delightfully, some respondents made us smile with lighthearted comments, such as “Stephen
King” or disruptive family members.

19
 About the Report Sponsors
About the Life Science Business of MilliporeSigma
The life science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma
in the U.S. and Canada, has 19,000 employees and 72 manufacturing sites worldwide, with a
portfolio of more than 300,000 products enabling scientific discovery, improving quality of life for
patients, fostering the success of customers and helping to meet global challenges.

With a mission to streamline and improve the efficiency of analytical processes and methods, the
organization has extensive expertise in developing advanced laboratory water solutions, sample
filtration, smart chemicals, consumables, instrumentation, biomonitoring and overarching digital
connectivity for research, industrial, pharmaceutical, and medical applications.

SigmaAldrich.com/PharmaQC

About The Analytical Scientist

From environmental testing to the –omics, pharma to food, The Analytical Scientist
(theanalyticalscientist.com) focuses on the people, technology, and innovations shaping
measurement science.

We cover analytical science by telling stories – delving into the hopes, fears, motivations, and
aspirations of the key figures in the field.

Take one minute to tell us

if you agree with the outcome of
this survey.

SigmaAldrich.com/PharmaQCSurvey

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