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Insights / Case studies / Healthcare & Life Sciences

Illustrative case study · Healthcare & Life Sciences

Europe’s labs run fewer analyzers, and more controls on each one.

Whether to build a direct sales team in Europe was the decision facing a diagnostics company that makes quality control materials, and it needed sizing inputs for North America and Europe first. The report, delivered in 13 days, rests on interviews with 250 lab managers and QC leads.

Illustrative scenario
Samplen = 250

Illustrative report

Clinical Lab QC Materials Sizing

How hard do labs run their analyzers, which tests drive control spend, and how do North America and Europe differ?

Study architecture

01
Gauge capacityAnalyzer counts, capacity in use and expansion plans
02
Index the spendControl runs and spend across four test categories
03
Split the regionsRun rates, run triggers and independent supply by region

Scope

A region with fewer analyzers can still hold more open volume if its labs run more controls and buy more of them outside the instrument maker.

Sample

250

Hospital, reference and independent clinical labs in North America and Europe.

Research by UserCue
Study typeMarket assessment
ScenarioIllustrative
QC materials sizing · Executive reportExecutive summary

Executive summary

Europe runs fewer analyzers but more controls on each, and spends most with independent suppliers

The 250 lab managers and QC leads describe analyzers running at 72% of capacity, with more room in Europe. Immunoassay leads control spend while routine chemistry leads the run count. European labs run controls 1.4 times as often per analyzer, so per lab their volume reaches 95% of North America’s, and they spend 59% of their control budget with independent suppliers.

72%n = 250
of analyzer capacity in use on a typical shift
32%n = 250
plan to add an analyzer within two years
1.4×Europe vs N. Am.
control runs per analyzer per shift
59%n = 120
of European control spend goes to independent suppliers

Figures rounded. Base n = 250 labs, one respondent per lab, unless stated.

Top lines

1Analyzers run at 72% of capacity, with more room in EuropeCapacity in use and expansion plans03
2Immunoassay leads control spend, and routine chemistry leads the run countControl spend and runs by test category04
3European labs run controls 1.4 times as often per analyzerRun rates and what triggers extra runs05
4Europe puts 59% of control spend with independent suppliersIndependent supply by region and fleet06
5Sample, screener and checksWho took part and how each lab qualified07
AAppendixQuestion flow and sizing input tables09

Sample

250 lab managers and QC leads

Segments

130 North America, 120 Europe

Method

AI-moderated interviews, QC log inputs

Labs

Hospital, reference and independent

Illustrative report. The company, scenario, and all figures are fictional.

Illustrative report02
Illustrative reportExecutive summary

Illustrative example. The company, scenario, and all figures are fictional. They show UserCue’s method and deliverable format. They do not come from any client study.

The engagement

Illustrative scenario
Delivered in
13

days, with the report, the data file and a live readout.

Interviews
250

Lab managers and QC leads who sign off on each lab’s control plan.

Audiences
2

130 labs in North America and 120 in Europe.

Method
Index

Control runs from QC logs and spend from purchase records, indexed by category.

The brief
Client

A diagnostics company that makes quality control materials

Decision

Whether to staff a direct sales team in Europe

Stage

Market sizing, before a regional investment

How we ran it
Approach

AI-moderated interviews with sizing inputs read from QC logs

Measured

Capacity in use, control runs and spend, independent supply

Sample

Hospital, reference and independent labs in two regions

Headline figures

Capacity72%

of analyzer capacity is in use on a typical shift, across 250 labs

Run rate1.4×

as many control runs per analyzer in Europe as in North America

Independent share59%

of European control spend goes to independent suppliers, against 37% in North America

The question

Is Europe big enough for a sales team of its own?

The company sold its controls through its own team in North America and through distributors in Europe. A direct European team made sense only if labs there ran and bought enough independent controls, so the study asked the person who sets each lab’s control plan, in both regions.

1

How much of their analyzer capacity do labs use today?

2

Which test categories drive the most control spend?

3

How do North American and European labs differ in control use and supply?

What we did

How the study ran, start to finish.

  1. 1Kickoff

    A European sales team, or distributors.

    Is European demand for independent controls big enough to justify a dedicated sales team there? The kickoff turned it into three questions: the share of analyzer capacity labs use, which test categories drive control spend, and how the two regions differ.

  2. 2Design

    Two regions, sizing inputs from QC logs.

    One person per lab took part, the manager or QC lead who signs off on its control plan: 130 in North America, 120 in Europe. Capacity, usage, mix and spend questions fed a sizing model, with control runs read from each lab’s QC log.

  3. 3Fielding

    250 labs, numbers and reasons.

    Each lab lead gave numbers and reasons by voice or text, at a 24-minute median; any control run above the minimum prompted a question on its trigger. The researcher read all 287 and removed 37 for contradictions, duplicate identities or bench roles, leaving 250.

  4. 4Analysis

    European analyzers run more controls.

    The researcher sorted control runs and spend by test category and region to see where demand concentrates. European labs run controls 1.4 times as often per analyzer as North American labs, and spend 59% of their control budget with independent suppliers.

  5. 5Readout

    Europe spends 59% with independents.

    The researcher talked the commercial team through a 31-page report in a live readout, alongside the inputs workbook for their sizing model and usage indexes by category and region. The company approved a direct European sales team, leading with immunoassay controls.

What we found

Four findings from the report.

Summary

Labs run their analyzers at 72% of capacity, with more room in Europe. Immunoassay leads control spend even though routine chemistry runs more controls. European labs run controls 1.4 times as often per analyzer, so per lab their control volume reaches 95% of North America’s on fewer analyzers, and they spend 59% of their control budget with independent suppliers.

QC materials sizing · Executive reportTop line 1
1

Top line 1 of 4

Analyzers run at 72% of capacity, with more room in Europe

1 Q3. Roughly what share of your analyzers’ rated capacity do you use on a typical shift? Numeric, n = 250.

2 Q4. Do you plan to add an analyzer in the next two years? Single select, n = 250.

Each lab reported the share of rated analyzer capacity it uses on a typical shift. Across 250 labs, analyzers run at 72% of capacity: 77% in North America and 66% in Europe1. By lab type, reference labs run closest to their ceiling at 81%, against 73% for hospital labs and 63% for independents. 32% of all labs plan to add an analyzer within two years, while European labs say they could take on more testing first.

72%n = 250
of analyzer capacity in use on a typical shift
77%n = 130
in North American labs
66%n = 120
in European labs
32%n = 250
plan to add an analyzer within two years

Analyzer capacity in use, by region and lab type

Share of rated capacity in use on a typical shift

50100All labsn = 25072%North American labsn = 13077%European labsn = 12066%Hospital labsn = 11273%Reference labsn = 6481%Independent labsn = 7463%

Plan to add an analyzer within two years (n = 250)

Expansion plans32%25%43%
YesUndecidedNo

Labs running above 85% of capacity

North American labs (n = 130)39%European labs (n = 120)22%

Capacity in use is self-reported against each analyzer’s rated throughput, averaged across a lab’s analyzers. Lab types sum to the 250 labs.

Supporting evidence

  • Reference labs run closest to their ceiling: 81%, against 73% for hospital labs and 63% for independents. § 3.2
  • European labs with spare capacity add testing before they add instruments. § 3.32
Illustrative report03
QC materials sizing · Executive reportTop line 2
2

Top line 2 of 4

Immunoassay leads control spend, and routine chemistry leads the run count

1 Q5 to Q8. Control runs per shift and yearly control spend by test category, read from QC logs and purchase records, n = 250.

Each lab read its control runs and spend for four test categories from its QC log and purchase records. Indexed to the top category, immunoassay accounts for the most control spend, with routine chemistry at 841. Routine chemistry runs the most controls, 48% of all runs, yet each run costs less. Hematology and molecular follow, and molecular rises fastest in planned spend.

100index
immunoassay, the top category by control spend
84index
routine chemistry, second by spend
48%of all runs
routine chemistry’s share of control runs, the largest
29index
molecular, smallest by spend and rising fastest

Control spend by test category, indexed to the top one

Control spend index, top category = 100 (n = 250)

50100Immunoassay100Routine chemistry84Hematology47Molecular29

Share of all control runs, by category (n = 250)

Run count48%27%17%
Routine chemistryImmunoassayHematologyMolecular

Fastest-rising control spend over the next two years

  1. 1Molecular
  2. 2Immunoassay
  3. 3Hematology

Spend index rescaled so the top category = 100; values are relative and do not sum to 100. Run shares are lab-weighted averages of runs per shift.

Supporting evidence

  • Immunoassay controls cost more per run, so a smaller run count still leads spend. § 4.2
  • Molecular is the smallest category by spend today and rises fastest in planned spend. § 4.3
Illustrative report04
QC materials sizing · Executive reportTop line 3
3

Top line 3 of 4

European labs run controls 1.4 times as often per analyzer

1 Q9. Control runs per analyzer per shift, read from the lab’s QC log, n = 250.

2 Q9b. What triggers control runs above your minimum? Multi-select, asked of the 147 labs that run them (86 Europe, 61 North America).

Europe has fewer analyzers per lab, yet each one runs more controls. European labs log 2.8 control runs per analyzer per shift, against 2.0 in North America1, so per lab, Europe’s control volume reaches 95% of North America’s. 72% of European labs run controls above their minimum; the 86 that do most often name accreditation rules (62%) and new reagent lots (48%).

2.8n = 120
control runs per analyzer per shift in Europe
2.0n = 130
control runs per analyzer per shift in North America
62%n = 86
of European labs running extra controls cite accreditation rules
95%per lab
European control volume against North America’s

What triggers control runs above the minimum

Triggers of extra control runs, European labs (n = 86)

50100Accreditation rules62%New reagent lot48%After maintenance or repair41%Out-of-range patient result27%Shift handover17%

Run controls above the minimum

European labs (n = 120)72%North American labs (n = 130)47%

Top trigger, North American labs running extra controls (n = 61)

Top trigger44%31%25%
New reagent lotAccreditation rulesOther

Runs per analyzer per shift are averaged across each lab’s analyzers from its QC log. Triggers asked of labs that run controls above their minimum; multi-select, shares do not sum to 100.

Supporting evidence

  • Accreditation rules lead the extra runs in Europe; reagent lot changes lead in North America. § 5.22
  • European labs average 3.8 analyzers to North America’s 5.6, so per lab their control volume reaches 95%. § 5.3
Illustrative report05
QC materials sizing · Executive reportTop line 4
4

Top line 4 of 4

Europe puts 59% of control spend with independent suppliers

1 Q12. Roughly what share of your control spend goes to independent suppliers rather than the instrument maker? Numeric, n = 250.

Labs split control spend between the instrument maker and independent suppliers. European labs put 59% of their control spend with independent suppliers, against 37% in North America1, and 48% across all 250 labs. Of the 188 labs that buy any independent controls, 66% value one control that runs across analyzer brands.

59%n = 120
of European control spend goes to independent suppliers
37%n = 130
of North American control spend goes to independent suppliers
48%n = 250
of all labs’ control spend goes to independent suppliers
66%n = 188
of independent buyers value one control across analyzer brands

Share of control spend with independent suppliers

Share of control spend with independent suppliers

50100All labsn = 25048%European labsn = 12059%North American labsn = 13037%Mixed analyzer fleetsn = 10763%

Why labs buy independent controls (n = 188)

One control across brands66%Steady from lot to lot53%Lower cost per run41%

Analyzer fleets, all labs (n = 250)

Fleet makeup43%57%
More than one makerOne maker

Shares are of each lab’s control spend, averaged across labs. Reasons asked of the 188 labs that buy any controls from independent suppliers; multi-select.

Supporting evidence

  • Mixed analyzer fleets put the most with independents: 63% of their control spend. § 6.2
  • Labs whose analyzers all come from one maker spend most of their control budget with that maker. § 6.3
Illustrative report06
Top line 1 of 4 · page 03Illustrative report · top line 1 of 4 · swipeIllustrative report
1
Question 1 · Capacity

Analyzers run at 72% of capacity, with more room in Europe.

Labs use 72% of their analyzer capacity on a typical shift: 77% in North America and 66% in Europe. Reference labs run closest to their ceiling, and 32% of all labs plan to add an analyzer within two years.

All labs72%
North American labs77%
European labs66%
Share of analyzer capacity in use · n = 250
2
Question 2 · Spend

Immunoassay leads spend, though chemistry runs more controls.

Immunoassay accounts for the most control spend, with routine chemistry second at an index of 84. Routine chemistry runs the most controls, 48% of all runs, yet each run costs less, so its spend trails. Molecular is smallest today and rising fastest.

Immunoassay100
Routine chemistry84
Hematology47
Molecular29
Control spend index, top category = 100 · n = 250
3
Question 3 · Run rates

European labs run controls 1.4 times as often per analyzer.

European labs log 2.8 control runs per analyzer per shift, against 2.0 in North America, and most often name accreditation rules and new reagent lots as triggers for the extra runs. Per lab, Europe’s control volume reaches 95% of North America’s on fewer analyzers.

2.8Europe, runs per analyzer per shift
2.0North America
Control runs per analyzer per shift · n = 120 vs n = 130
4
Question 3 · Supply

Europe puts 59% of control spend with independent suppliers.

European labs put 59% of their control spend with independent suppliers, against 37% in North America and 48% across all 250 labs. Labs running analyzers from more than one maker put the most with independents, 63% of their control spend.

European labs59%
All labs48%
North American labs37%
Share of control spend with independent suppliers · n = 250
“On paper we are a small lab. Count our control runs and we look like a big one.”
Laboratory QC lead · Illustrative quote

Illustrative quotes

Three themes behind the numbers.

Run triggers
“Every new reagent lot means another round of controls, and the auditors want to see all of it. Some shifts our QC log grows faster than our patient worklist.”
QC lead
Mixed fleets
“We have analyzers from three makers. One control that runs on all of them saves us from tracking three sets of lots.”
Laboratory manager
Spare capacity
“We could add a third more testing without buying anything new. What we cannot add is staff time for more QC.”
Laboratory director

What the diagnostics company did

Three moves made with the report.

1The team · from finding 4

Staffed a direct sales team in Europe.

European accounts moved off distributors to the company’s own team, aimed first at labs that already spend most of their control budget with independent suppliers.

2The lead line · from finding 2

Led with immunoassay controls.

Immunoassay, the top category by control spend, opens the European catalog, with molecular controls next as planned spend rises.

3The pitch · from finding 3

Sold to the run triggers.

Sales material now opens with accreditation rules and reagent lot changes, the two reasons European labs most often give for extra control runs.

Illustrative example. The company, scenario, and all figures are fictional. They show UserCue’s method and deliverable format. They do not come from any client study.

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