Flow Cytometry 2013 A Focus of Sales Growth

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1 Flow Cytometry 2013 A Focus of Sales Growth February 2013 Sample Data Biopharm Reports Biopharm Reports, Tamarisk House, High Street, Colne, Cambridgeshire PE28 3ND United Kingdom, 1

2 Flow Cytometry 2013 A Focus of Sales Growth 1. Conduct of Study Sample Data 2

3 1. INTRODUCTION Between June 2012 and February 2013, Biopharm Reports carried out a global study of Flow Cytometry (hereafter referred to as FC 2013). The findings of this study are presented in this report THIS STUDY FC 2013 is an independent global study of FC and investigated current and evolving markets, expanding areas and opportunities for sales growth in the FC field. Focussed on individuals who use FC in the laboratory, this study examined current FC end user practices, preferences, developments and emerging applications, together with market considerations and future use. This study was carried out to identify areas of growth in the FC field, to assist FC developers and vendors to better understand and support current and evolving needs and to help scientists compare their own practices with others, and gain insights into emerging technologies and applications. This FC study was designed for scientists or managers who use FC in their everyday activities, but excluding FC commercial developers and vendors (for the avoidance of bias). Overall, 386 individuals took part, of which 277 were selected as qualifying participants. 1.2 FOCUS REPORTS FC 2013 generated more than 200,000 end user market data points on the FC field, and this allows the analysis of specific market areas, in our Focus Reports. These reports allow one or two specific areas to be selected and then analysed against other areas of the study. For example, 'cost per sample' or 'market growth' can be analysed according to field, method or application. By focusing on specific market areas in this way, Focus Reports offer additional value and cost savings. To discuss an area of interest from the FC 2013 market study, please contact John Bates (jbates@biopharmreports.com). 1.3 QUESTION DESIGN The following questions were presented to a database of scientists working in the FC field. 3

4 Q.1 FC Users Do you use flow cytometry, either as a research scientist, research manager, clinician or physician? (Options: Yes, No) Q.2 Participants Name, organisation, department, job title, address, country and organisation type (Options: University, Research Institute, Small or Medium Sized Company, Large International Company, Clinic or Hospital, Government Organisation, Veterinary Organisation or other). Q.3 Fields Please select the main field in which you use FC methods. Options: Biotechnology, Chemicals, Clinical or Hospital, Defense, Diagnostics (Medical), Energy, Environmental, Food and Drink, Forensics, Geology, Government, Healthcare, Natural Products, Pharmaceuticals, Research Institute, Security, University or other. Q4. Purpose Please estimate (as a percentage, %) how much of your FC activities relate to the following purposes (more than one option can be selected) Options1: Clinical research, Routine diagnostics, Routine screening, Clinical trials, Treatment monitoring, Diagnostics research, Disease research, Drug R&D, Drug targets, Pathology, Toxicology or other. If other, please indicate (Options2: 0%, 1%, 2%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%) [NB: Options presented relating to the purpose of using FC were specific for the field selected by participants in question 3. The above options are provided as an example, in this case relating to clinical and hospital only]. Q5. General Activities How would you describe your professional role, relating to your use of flow cytometry? Options1: Research Scientist or Research Manager, Physician or Clinician or other. 4

5 Q6. Main Activities Please estimate (as a %) how much of your flow cytometry activities are spent in the following areas Options1: Running routine (validated) cytometric tests, Developing new cytometric tests, Qualitative discovery or other Options2: 0%, 1%, 2%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100% Q7. Therapeutic Area Please indicate the therapeutics areas to which your flow cytometry activities relate (more than one option can be selected). Options1: Arthritis, Autoimmune Diseases, Bone Metabolism, Cancer, Cardiovascular, Central Nervous System, Dentistry, Dermatology, Endocrine, Gastrointestinal, Genito urinary System, Haematology, Infections, Inflammation, Metabolic Disorders, Musculoskeletal Disorders, Nutrition, Obstetrics and Gynaecology, Ophthalmology, Pain, Psychiatry, Respiratory, Skin, other or not applicable Q8. Main Diseases What are the two main diseases to which your flow cytometry activities relate? Q9. Samples What sample types do you study using flow cytometry (more than one option can be selected)? Options1: Animal tissues, Cerebrospinal fluid, Bone Marrow, Human tissues, Microbiological materials, Pathology samples, Plant materials, Lymph, Saliva, Urine, Whole blood or other. Q10. Current General Applications Which of the following flow cytometry general applications do you use (more than one option can be selected)? Options1: ADME Studies, Toxicity studies, Apoptosis, Bacteria analysis, Bacterial membrane potential, Bead based immunoassays, Cell adherence, Cell cycle, Cell signalling, Cell sorting, Cellular kinetics, DNA and RNA content, Protein expression, FRET, Immunophenotyping, Intracellular calcium flux, Membrane asymmetry, Mitochondrial membrane potential, Multicolour Flow Cytometry, Necrosis, Organelle function, Protein expression and localization, Rare event analysis, Stem cell research, T Cell immunology, Transgenic products (e.g. GFP) or other. 5

6 Q11. Future General Applications Please estimate how much (as a %) your use of the following flow cytometry general applications will change (increase or decrease) over the next 3 years (more than one option can be selected). Options1: ADME Studies, Toxicity studies, Apoptosis, Bacteria analysis, Bacterial membrane potential, Bead based immunoassays, Cell adherence, Cell cycle, Cell signalling, Cell sorting, Cellular kinetics, DNA and RNA content, Protein expression, FRET, Immunophenotyping, Intracellular calcium flux, Membrane asymmetry, Mitochondrial membrane potential, Multicolour Flow Cytometry, Necrosis, Organelle function, Protein expression and localization, Rare event analysis, Stem cell research, T Cell immunology, Transgenic products (e.g. GFP) or other. Options2: > 50%, 50%, 40%, 30%, 20%, 10%, 5%, 0, +5%, +10%, +20%, +30%, +40%, +50%, >+50% Q12. Current Clinical Applications Which of the following flow cytometry clinical applications do you use (more than one option can be selected)? Options1: Cell counting, Cell function, Cell pigments, Cell Proliferation, Cell surface antigens (e.g. CD markers), Cell viability, Diagnosis of haematologic malignancies, DNA ploidy, Enzymatic activity, Infectious diseases, Intracellular antigens, Minimal residual disease, Monitoring AIDS patients, Monitoring chemotherapy, Multidrug Resistance (MDR), Organ or stemcell transplantation, Platelet function analysis, Transfusion medicine, Volume and morphology of cells or other. Q13. Future Clinical Applications Please estimate how much (as a %) your use of the following flow cytometry clinical applications will change (increase or decrease) over the next 3 years (more than one option can be selected). Options1: Cell counting, Cell function, Cell pigments, Cell Proliferation, Cell surface antigens (e.g. CD markers), Cell viability, Diagnosis of haematologic malignancies, DNA ploidy, Enzymatic activity, Infectious diseases, Intracellular antigens, Minimal residual disease, Monitoring AIDS patients, Monitoring chemotherapy, Multidrug Resistance (MDR), Organ or stem cell transplantation, Platelet function analysis, Transfusion medicine, Volume and morphology of cells or other Options2: > 50%, 50%, 40%, 30%, 20%, 10%, 5%, 0, +5%, +10%, +20%, +30%, +40%, +50%, >+50% 6

7 Q14. Main Applications What are your two main clinical applications of flow cytometry? Q15. New Applications What new flow cytometry clinical applications do you anticipate using over the next three years? Q16. Emerging Applications What emerging flow cytometry clinical applications offer promise in your field? Q17. Current Company Suppliers Which of the following companies supply flow cytometers to your laboratory (more than one option can be selected)? Options1: Amnis (Millipore), Apogee Flow, Applied Bioscience, BD, Beckman Coulter, BioCytex, Bio Rad, CytonomeST, DVS Sciences, icyt (Sony), IntelliCyt, Life Technologies, Luminex, Miltenyi, Partec, PointCare, Stratedigm, Sysmex, TTP LabTech, Union Biometrica or other. Q18. Future Company Suppliers Please estimate how much (as a %) your flow cytometry activities using instruments from the following companies, will change (increase or decrease) over the next 3 years (more than one option can be selected) Options1: Amnis (Millipore), Apogee Flow, Applied Bioscience, BD Beckman Coulter, BioCytex, Bio Rad, CytonomeST, DVS Sciences, icyt (Sony), IntelliCyt, Life Technologies, Luminex, Miltenyi, Partec, PointCare, Stratedigm, Sysmex, TTP LabTech, Union Biometrica or other Options2: > 50%, 50%, 40%, 30%, 20%, 10%, 5%, 0, +5%, +10%, +20%, +30%, +40%, +50%, >+50% Q19. Main Flow Cytometer Which flow cytometer do you use most frequently? Q20. Strengths What is the main strength of the flow cytometer previously indicated (how is it meeting your needs in this area)? 7

8 Q21. Weaknesses What is the main weakness of the flow cytometer previously (how is it failing to meet your needs in this area)? Q22. Reagents or Assays Which companies are the two main suppliers of your flow cytometry reagents or assays? Q23. Sample Preparation What are the two main sample preparation techniques you use, relating to flow cytometry? Q24. Software What is your preferred data analysis (off line) software in the flow cytometry field? Q25. Challenges Please indicate the measurement or parameter that presents the greatest technical challenge (qualitatively or quantitatively), relating to your use of flow cytometry. Please indicate the sample type and flow cytometer used. Indicate: FC Parameter, Sample Type (Matrix) and Flow Cytometer Used. Q26. Main Reasons What is the main technical challenges relating to this measurement or parameter, using the flow cytometry method indicated above? Q27. Required Innovation On a scale of 1 to 10 (where 1 = least important and 10 = most important), please indicate in which of the following areas that innovation is most required, relating to flow cytometry (more than one option can be selected). Options1: Automation, Detectors, Fluidics, Lasers/Light Sources, Offline (Analysis) software, Online Data handling, Qualitative selectivity, Quantitative sensitivity, Reagents, Sample preparation or other Options2: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 8

9 Q.28 Disease Biomarkers Do you use flow cytometry methods to measure or discover disease biomarkers? (Options: Yes, No) Q.29 Main Disease Biomarkers What are the main two disease biomarkers that you investigate, using flow cytometry? Q30. Disease Biomarker Clinical Utility Relating to your use of flow cytometry for the study of disease biomarkers, please estimate (as a %) how much of your methods relate to the following biomarker clinical utilities. Options1: Disease prognosis, Disease susceptibility or risk, Disease stage or severity, Drug discovery, Early detection of disease, Clinical trial endpoint, Guiding treatment, Response to therapy, Safety or toxicity factors or other Options2: 0%, 1%, 2%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100% Q31. Financial Budgets Please estimate your annual financial budget relating to your flow cytometry activities. Options1: <$1 k, $1 $2.5k, $2.5 $5k, $5 $10k, $10 $25k, $25 $50k, $50 $100k, $100 $250k, $250 $500k, $500k $1 million, $1 million $2.5 million, $2.5 million $5 million, > $5 million. Q32. Costs per Sample Please estimate your average analysis costs per sample, using flow cytometry. Options1: <$1, $1 $, $2 $3, $3 $4, $4 $5, $5 $7, $7 $10, $10 $15, $15 $25, $25 $40, $40 $60, $60 $100, $100 $150, $150 $200, $200 $250, > $250. Q33. Budget Breakdown Please estimate the breakdown (in % terms) of your annual financial budget for flow cytometry, in the following areas. Options1: Reagents and consumables, System control (data handling) software, Data analysis (offline) software, Flow cytometer instruments, Sample preparation and related instrumentation, Ancillary systems/instrumentation, General overheads, Instrument 9

10 servicing/repair, Staff salaries or other Options2: 0%, 1%, 2%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100% Q34. Overall Financial Budget Please estimate how much your overall annual financial budget for the use of flow cytometry will change (either increase or decrease), over the next three years. Options1: Reagents and consumables, System control (data handling) software, Data analysis (offline) software, Flow cytometer instruments, Sample preparation and related instrumentation, Ancillary systems/instrumentation, General overheads, Instrument servicing/repair, Staff salaries or other Options2: > 50%, 50%, 40%, 30%, 20%, 10%, 5%, 0, +5%, +10%, +20%, +30%, +40%, +50%, >+50%. Q35. Consumables In terms of overall financial costs to your laboratory or clinic, what are the two main consumables that are directly associated with your flow cytometry activities? Q36. Quality Control Guidelines/Procedures Please indicate the main quality control guidelines or procedures to which you work, in the flow cytometry field. 1.4 QUALIFYING PARTICIPANTS In total, 386 individuals participated in this study, of which 277 contributed to the findings presented in this report. Participants were excluded if they: a) answered No to question Q.1 of this study b) provided incomplete personal contact details, which prevented them from being tracked to the organisation in which they carry out FC c) were developers or vendors, operating in the FC field (this exclusion was necessary for the avoidance of bias) d) used an incorrect address (tested using standard inspection techniques) 10

11 Flow Cytometry 2013 A Focus of Sales Growth 2. Study Participants Sample Data 11

12 2.1 THIS CHAPTER This chapter presents background information relating to FC end users, who participated in FC COUNTRIES Qualifying individuals (n=277) who participated in FC 2013 work in 53 countries. Of these, USA, Italy, Brazil, France and the UK were the largest participating countries (see Figure 2.1 and Table 2.1). Figure 2.1 Countries and numbers of individuals who participated in FC 2013 Brazil: 19 (7%) France: 18 (6%) UK: 16 (6%) Germany: 14 (5%) Italy: 34 (12%) USA: 35 (13%) Poland: 14 (5%) Spain: 13 (5%) Canada: 9 (3%) Table 2.1 Countries and numbers of individuals who participated in FC 2013 Country No. USA 35 Italy 34 Brazil 19 France 18 UK 16 Germany 14 Poland 14 Spain 13 Canada 9 Sweden 9 Portugal 8 China 5 Rest of World: 105 (38%) 12

13 Table 2.1 Countries and numbers of individuals who participated in FC 2013 Norway 5 Austria 4 Belgium 4 China 4 Hungary 4 India 4 Croatia 3 Greece 3 Netherlands 3 Russia 3 Argentina 2 Australia 2 Czech Rep 2 Denmark 2 Egypt 2 Iran 2 Ireland 2 Japan 2 Libya 2 México 2 New Zealand 2 Romania 2 Switzerland 2 Tunisia 2 Turkey 2 Bulgaria 1 Cameroon 1 Colombia 1 Estonia 1 Finland 1 Israel 1 Lithuania 1 Malawi 1 Rep Korea 1 Saudi Arabia 1 Singapore 1 Slovakia 1 South Africa 1 Thailand 1 Ukraine 1 Uruguay 1 13

14 2.3 REGIONS Regionally, European countries were the leading contributors to FC 2013 and together represented 62% of participants (see Figure 2.2). Figure 2.2 Global regions of individuals who participated in FC 2013 Europe: 173 (62%) Rest of World: 60 (22%) 2.4 ORGANISATIONS North America: 44 (16%) More than 90% of participants in FC 2013 are employed by four different organisation types, namely Universities. Research Institutes, Clinics & Hospitals and Small and Medium Sized Enterprises (SMEs) (see Figure 2.3). Figure 2.3 Organisation types of individuals who participated in FC 2013 University: 152 (55%) Veterinary: 2 (1%) Large International Cos: 4 (1%) Other: 6 (2%) Government: 7 (3%) Res Institute: 58 (21%) SMEs: 12 (4%) Clinics/ Hospitals: 36 (13%) 14

15 Table 2.2 Organisation types of individuals who participated in FC 2013 Organisations % Participants University Res Institute Clinics/ Hospitals SMEs Government Other Large International Cos Veterinary FIELDS FC 2013 participants worked in 12 fields, of which research institutes, universities, medical diagnostic, biotechnology and clinics & hospitals were the largest groups. Together these represented 86% of participants (see Figure 2.4 and Table 2.3). Figure 2.4 Fields of individuals who participated in FC Research Institute: 88 (31%) University: 60 (22%) Rest: 13 (5%) Government: 3 (1%) Diagnostics: 31 (11%) Biotech: 29 (11%) Pharmaceuticals: 5 (2%) Environmental: 6 (2%) Healthcare: 11 (4%) Clinical/Hospital: 29 (11%) 15

16 Table 2.3 Fields and numbers of individuals who participated in FC 2013 Field % Participants Research Institute University Diagnostics (Medical) Biotechnology Clinical or Hospital Healthcare Environmental Pharmaceuticals Government Energy Food and Drink Natural Products Chemicals Defense Forensics Geology Security Other

17 Flow Cytometry 2013 A Focus of Sales Growth 9. FC Applications Sample Data 17

18 9.1 This Chapter This chapter presents study findings on the use of general flow cytometry applications, both currently and over the next three years ( ), by individuals who participated in FC Current Applications Study question: Which of the following flow cytometry general applications do you use (more than one option can be selected)? Options: ADME studies, apoptosis, bacteria analysis, bacterial membrane potential, bead based immunoassays, cell adherence, cell cycle, cell signalling, cell sorting, cellular kinetics, DNA and RNA content, FRET, immunophenotyping, intracellular calcium flux, membrane asymmetry, mitochondrial membrane potential, multicolour flow cytometry, necrosis, organelle function, protein expression, protein expression and localization, rare event analysis, stem cell research, T cell immunology, toxicity studies, transgenic products (e.g. GFP) or other Future Applications ( ) Study question: Estimate how much (as a %) your use of the following flow cytometry general applications will change (increase or decrease) over the next 3 years (more than one option can be selected). Options1: ADME studies, apoptosis, bacteria analysis, bacterial membrane potential, bead based immunoassays, cell adherence, cell cycle, cell signalling, cell sorting, cellular kinetics, DNA and RNA content, FRET, immunophenotyping, intracellular calcium flux, membrane asymmetry, mitochondrial membrane potential, multicolour flow cytometry, necrosis, organelle function, protein expression, protein expression and localization, rare event analysis, stem cell research, T cell immunology, toxicity studies, transgenic products (e.g. GFP) or other Options2: > 50%, 50%, 40%, 30%, 20%, 10%, 5%, 0, +5%, +10%, +20%, +30%, +40%, +50%, > +50%. 18

19 9.1.3 Results Current General Applications Of 27 general flow cytometry applications considered. the top five specified by end users were multicolour flow cytometry, immunophenotyping, apoptosis, T cell immunology and cell cycle. Collectively, these represented almost 44% of all applications (see Figure 9.1). Overall, the top ten flow cytometry applications indicated by participants, represented more than 70% of the applications used. See Table 9.1 Figure 9.1 Top ten general flow cytometry applications, indicated by individuals who participated in FC 2013 Apoptosis: 9.3% T Cell immunology: 7.4% Immunophenotyping: 10.0% Cell cycle: 6.6% Cell sorting: 6.2% Multicolour FC: 10.5% Cell signalling: 5.8% Protein expression: 5.5% DNA and RNA content: 4.8% Other: 33.9% 19

20 Table 9.1 General applications of flow cytometry, indicated by individuals who participated in FC 2013 General Applications Percentage Use (%) Multicolour Flow Cytometry 10.5 Immunophenotyping 10 Apoptosis 9.3 T Cell immunology 7.4 Cell cycle 6.6 Cell sorting 6.2 Cell signalling 5.8 Protein expression 5.5 DNA and RNA content 4.8 Stem cell research 4.2 Bead based immunoassays 3.1 Mitochondrial membrane potential 3 Rare event analysis 3 Transgenic products (e.g. GFP) 2.8 Protein expression and localization 2.6 Necrosis 2.3 Intracellular calcium flux 2.2 Toxicity studies 2 Cell adherence 1.8 Bacteria analysis 1.3 Cellular kinetics 1.3 Organelle function 1.2 Membrane asymmetry 1.1 FRET 0.6 Bacterial membrane potential 0.5 Other 1 ADME Studies 0 20