diagnostics brochure
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Key launches 2013
Area Product name Description Market
Instruments/devices
Laboratories cobas 8100 next-generation modular pre-analytics EU
Diabetes Accu-Chek Insight next-generation insulin pump and blood glucose meter EU
Care Accu-Chek Active next-generation blood glucose meter with maltose-independent test strips EU
Life sciences GS FL X+ long amplicons software for long-read targeted sequencing for DNA variant detection WW
Tests/assays
Oncology Calcitonin immunoassay, supports medullary thyroid cancer diagnosis and monitoring EU
proGRP immunoassay, assists in the diagnosis of small cell lung cancer EU
EGFR PCR test, supports therapy selection for non-small cell lung cancer US
ER IHC tissue test for breast cancer diagnosis US
CINtec PLUS Cytology immunocytochemistry test for diagnosis of cervical pre-cancer EU
Infectious diseases MPX 2.0 PCR next-generation blood screening, multiplex test for HIV, HCV and HBV US
HCV 2.0 PCR next-generation HCV viral load test US
Transplantation Cyclosporin, Tacrolimus immunoassays for monitoring of immunosuppressive drug therapy EU
Sequencing SeqCap EZ Reagent Kits for sample preparation for targeted next-generation sequencing WW
EU = European Union; US = United States; WW = worldwide.
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Table of Contents
Roche DiagnosticsBusiness Strategy 2Facts and Figures 3Competitive Advantages 4Business Areas 5
Business Areas/UnitRoche Professional Diagnostics 6Roche Molecular Diagnostics 8Roche Tissue Diagnostics 10Roche Diabetes Care 12Roche Applied Science 14
Divisional Structure 16
2
Business Strategy
In vitro diagnostic (IVD) testing has long been a silent champion of healthcare, directing over 60% of clinical decision making, although it accounts for only 2% of global healthcare spending.
Increase testing efficiency
Roche develops solutions that continually improve the speed, accuracy and reliability of lab testing through automation, work-flow integration and information manage-ment. We enable labs to better handle expanding testing and data volumes. We further drive lab efficiency by providing our lab customers with modular solutions and complete test menus.
Roche Diagnostics differentiates itself in the marketplace through innovation in testing efficiency and medical value.
Provide true medical value
Ever more of our efforts are concentrated on exploiting advanced scientific knowledge and technological progress to increase the medical value of our offering. Medical value is delivered by tests for screening, diagnosis, prognosis, prediction or monitoring of disease, as well as by companion diagnostic tests used for treatment selection or response prediction to a specific drug. We prioritise those areas with the highest unmet medical need and devote substantial resources to acquiring the necessary intellectual property to develop new tests, and then to demonstrate their clinical utility and health economic benefit. With the advent of molecular diagnostics, totally new realms of detection are emerging.
Revalue Diagnostics
Molecular analysis of human DNA can con-firm the presence of disease genes, detect which altered genes and proteins are disturbing normal cell function, and, with a genetic profile of the patient, also predict whether he or she should respond well to specific drug therapy regimens. These newest diagnostic methods are not only redefining clinical testing, but they are also essential in the development of targeted molecular drugs. Diagnostics are integral to the new paradigm of Personalised Health-care and as the world market leader, Roche Diagnostics is leading the way forward and revaluing diagnostics.
2020
ds
•
•
• Deliver clinical evidence
•
• Offer complete enus
Improving medical value
Increasing testing efficiency
– Revalue Diagnostics– Focus on unmet needs– Access and create IP– Deliver clinical evidence
– Total lab solutions– Modular offering– Complete menus– Lab IT and workflow
Offering diagnostic tests along the entire healthcare chain
Healthy Asymptomatic disease Symptomatic disease Chronic disease/Cured
Risk assessmentPredisposition for developing disease
Screening/DiagnosisEarly detection
DiagnosisIdentifyingdisease
PrognosticPredict probable disease course
PredictionPredict response to a drugPersonalised Healthcare
MonitoringMonitor drug efficacy/ disease recurrence
IVD accounts for < 2% of total worldwide healthcare spending
Yet it Influences > 60% of critical decision-making
3
Ponce
Singapore
Tokyo
North America 26%
Professional Diagnostics 51%
Diabetes Care 25%
Molecular Diagnostics 11%
Applied Science 7%Tissue Diagnostics 6%
Latin America 8%
Asia-Pacific 15%
Japan 6%
EMEA (Europe, Middle East and Africa)
46%
North America 26%
Professional Diagnostics 51%
Diabetes Care 25%
Molecular Diagnostics 11%
Applied Science 7%Tissue Diagnostics 6%
Latin America 8%
Asia-Pacific 15%
Japan 6%
EMEA (Europe, Middle East and Africa)
46%Roche Abbott Siemens J&J Beckman bioMérieux
20%
11%10%
9%
8%
3%
Facts and Figures
2012Employees: 28,517Sales: 10,267 million CHFGrowth: 4% (local currency)
Position in IVD market
Sales by Business Area/Unit
Sales by region
Roche’s Diagnostics Division is the world’s leading supplier of in vitro diagnostics (IVDs). Performed in a laboratory or at the Point of Care on blood, tissue or other patient samples, IVDs are a critical source of objective information helping doctors detect and diagnose diseases, select appropriate treatments and monitor patient respon se to care. In addition, scientists use the Division’s research products to gain a better understanding of the causes of disease and to discover new treatments. Roche Diagnostics serves customers spanning the entire healthcare spectrum – from
hospitals and commercial medical labs to physicians and patients with conditions requiring them to self-test as well as the medical research institutions. The Division offers a wide range of techno-logies allowing the detection and analysis of a multitude of sample types on a large base of instruments installed worldwide. Roche’s IVD test menu is one of the broadest in the industry and is being expanded continually, drawing on the latest scientific advances. In 2012 Roche held approximately 20% of the global IVD market, which is valued at an estimated 48 billion US dollars in annual sales.
Source: Industry analyst report, Roche analysis, company reports, excludes Life Sciences and Insulin Pumps
Main Diagnostics Sites R&D/Manufacturing Regional hubs
100–500 employees* untill end of 2012
4
945,000,000 Elecsys tests sold in 2012
15,000,000 Accu-Chek Active meters sold worldwide
2,589,041 tests per day, 30 per second
90% satisfied customers
Total solution offering
Strong commercial presence
Leader in Personalised Healthcare
Competitive Advantages
DNA/RNA-based Protein-based Cell-based
EMEA
APAC
Japan
LATAM
NAM
EMEA
APAC
Japan
LATAM
NAM
Inflammation/Autoimmune
Metabolic diseases
Virology/MicrobiologyCardiology
OncologyWomen’s health
Hematology
Breadth of technologies
Active in all diagnostic segments
Completeness of menu
Present in over 130 countries
IT and workflow connectivity
Large installed base worldwide
Research labER/ICU
Hospital/Commercial lab
Physician’s office
Pathology lab Patient
With its leading Pharmaceuticals and Diagnostics businesses under one roof, no other company is better positioned to deliver Personalised Healthcare (PHC) than Roche. An unrestricted exchange of know-how and intellectual property, combined with the company’s breadth of diagnostic technologies, allows for fast assay development and technical validation. A robust research diagnostic is essential to identify patient subsets for clinical trials, and once the targeted medicine is in the marketplace, the approved IVD test is used for treatment selection, response prediction and therapeutic monitoring.
5
Innovation Excellence
Outlook 2013
In April 2013 Roche announced changes to the management and set-up of its life science business and its plans to restruc-ture the infrastructure by placing similar platform technologies and reagents for life science and clinical diagnostics customers under like governance bodies:
• PCR technology and Nucleic Acid related product lines will be managed out of the Roche Molecular Diagnostics business area. This includes the real-time PCR and
Business Areas
Business Area Structure 2012
In vitro Diagnostics Life Science
Professional DiagnosticsBusiness Area
Molecular DiagnosticsBusiness Area
Tissue DiagnosticsBusiness Area
Diabetes Care
Business Unit
Applied Science
Business Area
Private labs Hospital labs Hospital Point of Care Physician’s office
Molecular labs Blood-screening labs
Histopathology labs People with diabetesHospitalsHealthcare professionalsDiabetes nurse educators
Academia and Pharma Biotech research
– Serum work area/ immunoassays and clinical chemistry
– Point-of-care testing– Coagulation and
specialty testing– Workflow management
– Virology– Blood screening– Genomics/oncology– Microbiology– Women’s health
– Primary staining– Advanced staining– Workflow management– Digital pathology
– Blood glucose monitoring– Insulin delivery– Diabetes management
systems
– Nucleic acid DNA purification and gene expression
– Sequencing solutions– Custom Biotech and bio-
reagents
Business Areas / Unit are set up according to the fields of activities of our customers and are responsible for research and develop-ment, product portfolio management, global strategic direction and marketing, along with business development in their area of expertise.
Nucleic Acid Purification platforms and reagents, as well as nucleic acid related Biochemical Reagents
• The Custom Biotech portfolio, which includes platforms and reagents that are more closely aligned with our clinical chemistry portfolio, will move to the Professional Diagnostics business area.
As a consequence, the Applied Science business area will be integrated into Roche
Molecular Diagnostics and Roche Profes-sional Diagnostics as of the end of 2013. This restructuring better enables technol-ogy flow-through from life sciences to clinical diagnostics and enhances our responsiveness to scientific and market needs. It also builds synergies and lever-ages the commercial expertise in our IVD business areas to better address our customers’ needs.
6
Roche Professional Diagnostics
2012Employees: 1,130Sales: 5,165 million CHF
(51% of divisional sales)
Growth: 8% (local currency)
Market share
Professional diagnostics market
Sites Rotkreuz, Switzerland: Headquarters, Marketing, Medical Affairs, Business DevelopmentMannheim and Penzberg, Germany, and Indianapolis, IN, USA: R&D, Production, Quality, Clinical Trials, Regulatory Affairs
Disease areas Wide variety of indication fields, including oncology, virology, cardiovascular, inflammatory and infectious diseases
CustomersHospital and commercial labsLab networksPoint of Care including emergency rooms, intensive-care units, patients bedsides, physician’s offices, pharmacies, homes, blood banks
Best-sellers 2012 Immunoassays 2,321 million CHF (+15%)Clinical chemistry 1,514 million CHF (+5%)Coagulation monitoring 350 million CHF (+8%)
Roche Professional Diagnostics (RPD) is the largest Business Area. It is a leading supplier of solutions, instrument systems, tests, software and services that help laboratories deliver reliable results more efficiently and cost-effectively. It is also strengthening its position as a leader in the growing market for point-of-care testing products to support clinical decision- making close to the patient, in doctors’ offices, emergency rooms and other primary and specialty care settings.
Furthermore, RPD develops laboratory information, workflow and data manage-ment solutions as well as connectivity components to maximise laboratory efficiency.
In 2012 Roche had over 16% share of a growing global market worth 34.6 billion US dollars.
Roche 16.1%
Abbott 11.8%
Danaher 10.5%
J&J OCD 5.2%
Alere 4.2%
bioMérieux 4.5%
Siemens 15.2%
Others 32.5%
RPD portfolio
>100 immunoassays and applications>120 clinical chemistry tests>30 instruments with >100 modular combinations
Source: Industry analyst report, Roche analysis, company reports
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cobas 6000 analyzer series
cobas 8000 modular analyzer series
CoaguChek XS system
cobas u 411 analyzer
cobas p 501 post-analytical system
cobas b 101 system
Test on the market** Application
HE4 (human epididymal protein 4) immunoassay
ovarian cancer
PSA (prostate specific antigen) immunoassay
prostate cancer
HIV combi PT immunoassay HIV
Anti-HCV immunoassay Hepatitis C
TORCH panel of immunoassays Toxoplasmosis, other (syphilis), rubella, cytomegalovirus, herpes simplex
Troponin T / Troponin I tests Acute coronary syndrome
Test on the market** Application
IL-6, PCT and Tina-quant CRP immunoassays
Sepsis management
NT-proBNP test Heart failure
TSH (thyrotropin) test Thyroid function testing
FT4 (free thyroxine) test Hyperthyroidism and hypothyroidism
sFlt/PIGF immunoassay Pre-eclampsia
Vitamin D total test Determination of vitamin D level
HbA1c (glycated hemoglobin 1A) test Diabetes care
Multiplate system
cobas p 312 pre-analytical system
Key tests
Segments and products
Serum work area (SWA): immunoassays and clinical chemistryWith a broad portfolio of modular instruments, software and assays, SWA offers immunology and clinical chemistry systems for use by commercial labs, hospital core labs, medical centres, blood screening centres (in most countries outside US) and laboratory networks. The platforms can be combined in a flexible manner to fit the size of the lab and its required throughput. Platforms*: cobas 4000 analyzer series (low-volume labs), cobas 6000 analyzer series (mid-volume labs), cobas 8000 modular analyzer series (large-volume labs)
Point-of-care testingPoint-of-care (POC) testing meets the requirements for short turnaround times in critical care situations. Rapid determination of time-critical parameters (e.g. blood glucose, cardiac markers and blood gases) can accelerate decision-mak-ing in the emergency room or intensive-care units.Platforms*: CoaguChek systems (coagulation monitoring), Accu-Chek Inform II (blood glucose), cobas b 101 system (HbA1c and lipid testing), cobas h 232 system (point of care cardiac reader)
Specialty testingFor the urinalysis testing discipline RPD offers analyzers and test strips which enable testing of urine samples reliably and efficiently.Multiplate analyzer is a solution for rapid determination of a patient’s platelet function enabling to predict patient’s thrombotic and bleeding risk and to tailor anti-platelet therapies.Platforms*: Multiplate system, cobas u 411 analyzer
Workflow and IT managementCobas IT and workflow solutions enable our customers to leverage the maximum performance from their cobas instrument line-up including fully automated pre- and postanalytical workflow management. They benefit from a flexible workflow management across their laboratory organization and a close monitoring of their production for the highest testing efficiency and ultimately medical value.Platforms*: cobas p 312 pre-analytical system, cobas p 501 post-analytical system, cobas 8100 automated workflow series, cobas connection modules (CCM), cobas IT middleware, cobas IT 1000 application
* Non-exhaustive ** Not available in all markets
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Roche Molecular Diagnostics
2012Employees: 1,100Sales: 1,168 million CHF
(11% of divisional sales)
Growth: 4% (local currency)
Market position
Molecular diagnostics market
Sites Pleasanton, CA, USA: Headquarters, Marketing, R&DRotkreuz, Switzerland: Development, ProductionBranchburg, NJ, USA: Production
Disease areas Virology, Oncology, Blood screening, Women’s health, Microbiology
CustomersHospital and commercial labsBlood banks
TechnologiesPolymerase Chain Reaction (PCR)
Best-sellers 2012 Virology (HBV, HCV, HIV) 562 million CHF (+2%)Blood screening 323 million CHF (+5%)
Roche Molecular Diagnostics (RMD)develops and com mercialises advanced diagnostics and blood screening platforms and tests based on Roche’s proprietary real-time Polyme rase Chain Reaction (PCR) technology. PCR’s unique ability to exponentially amplify small amounts of target DNA has resulted in numerous diagnostic techniques which would otherwise be too time-consuming or impossible to perform.
Roche is a leader in the highly competitive molecular diagnostics market, valued at 4 billion US dollars and growing 7% annually.
Molecular Diagnostics market
Roche 32%
Abbott 7%
Qiagen 9%
Gen-Probe 10%BD 8%
Novartis 10%
bioMérieux 2%
Siemens 4%Cepheid 8%
Others 10%
RMD portfolio
> 10 instruments> 25 reagents (tests)
Source: Industry analyst report, Roche analysis, company reports
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Segments and products
VirologyViral infections rank among the biggest causes of death worldwide. Early detection and viral load identification (the quantity of virus in the blood) arecrucial for the right treatment decision regarding the drug, the therapy dose and the treatment duration. Moreover, monitoring of viral load during treatment is essential to observe treatment efficacy.Tests: HIV, HCV, HBV, CMVPlatforms*: cobas AmpliPrep/cobas TaqMan system, cobas AmpliPrep/cobas TaqMan 48 system, cobas p 630 analyzer
Blood screeningEach year, more than 80 million units of donated blood are stored and distributed worldwide. RMD provides blood banks with highly sensitive and automated real-time PCR tests to detect HIV, hepatitis, parvovirus and West Nile Virus, helping to ensure the highest safety for blood supplies. Tests: Multiplex HIV/HCV/HBV, Duplex B19V/HAV, West Nile Virus Platforms*: cobas s 201 system, cobas s 401 system
Genomics and oncologyCancer is an extremely complex disease, with many subtypes and variations that can influence disease progression and response to therapy. RMD’s gene-based tests help doctors better understand specific biologic factors to select the right therapy, thus enabling personalised healthcare.Tests: BRAF, KRAS, EGFR and PIK3CA mutation testsPlatforms*: cobas 4800 system
Microbiology Time is critical in the detection and identification of bloodstream infections typically caused by bacteria and fungi. Effective treatment depends on finding the source of infection and making appropriate decisions about antibiotics or antifungals quickly and efficiently.Tests: MRSA, Tuberculosis, Sepsis, HerpesPlatforms*: LightCycler analyzer, cobas TaqMan
Women’s healthThe Human papillomavirus (HPV) is the most prevalent cause of cervical cancer, one of the most common cancers in women worldwide with more than 25,000 dying each year. Demand for screening tests for both, HPV as well as C. trachomatis/ N. gonorrhoeae (CT/NG), which may cause pelvic inflammatory disease, is growing rapidly.Tests: HPV, CT/NGPlatforms*: cobas 4800 system
cobas TaqMananalyzer
cobas s 201 system
cobas z 480
cobas 4800 system
cobas TaqMan analyzer
Test on the market** Application
cobas 4800 BRAF V600 Mutation Test Melanoma
cobas KRAS Mutation Test Colorectal cancer
cobas EGFR Mutation Test Non-small cell lung cancer
cobas PIK3CA Mutation Test (RUO) *** Breast, colorectal and other solid tumors
cobas AmpliPrep/cobas TaqMan Dual Target HIV-1 Test, v 2.0
HIV
LightCycler MRSA Advanced Test Methicillin-resistant Staphylococcus aureus
cobas TaqScreen DPX Test Parvovirus B19/Hepatitis A
Test on the market** Application
cobas TaqScreen MPX Test, v 2.0 HIV-1 (Groups M&O), HIV-2, HCV, HBV
cobas TaqScreen West Nile Virus Test
West Nile Virus
cobas AmpliPrep/cobas TaqMan HCV Test, v 2.0
Hepatitis C
cobas AmpliPrep/cobas TaqMan HBV Test, v 2.0
Hepatitis B
LightCycler SeptiFast Test Sepsis
cobas 4800 CT/NG Test C. trachomatis and N. gonorrhoeae infection
cobas HPV Test Cervical cancer
Key tests
cobas AmpliPrepinstrument
cobas p 630instrument
LightCycler analyzer
* Non-exhaustive ** Not available in all markets *** For research use only
10
Roche Tissue Diagnostics
2012Employees: 1,500Sales: 631 million CHF
(6% of divisional sales)
Growth: 12% (local currency)
Market position
Advanced staining market
Roche Tissue Diagnostics (RTD) (Ventana Medical Systems, Inc. in North America) is a world-leading supplier of tissue-based cancer diagnostics. It develops and manu-factures medical diagnostic instruments, digital pathology solutions, image and workflow software and reagent systems that provide innovative automation technology for use in slide-based tissue diagnostics to aid in diagnosis of cancer and infectious disease.
In addition, the company offers premier workflow management solutions designed to improve laboratory workflow efficiency, providing automated safeguards to enhance the quality of patient healthcare. Its instru-ments and reagent systems are used in histology, cytology and drug discovery laboratories worldwide.
In 2012, Roche gained over 1% of market share to own 23% share of the tissue diagnostics market, which is valued at over 2.5 billion US dollars and grew approximately 7–8%.
Roche 45%
Abbott 14%
Leica 13%
Dako 18%
Abbott 11%
RTD portfolio
> 245 IHC antibodies 30 ISH probes10 instruments + 2 software solutions
Sources: Industry analyst report, Roche analysis, company reports
Sites Tucson, AZ, USA: Headquarters, R&D, ProductionMountain View, CA, USA: R&D, Marketing
Disease areas Oncology
CustomersHospital-based pathology laboratoriesAcademic pathology laboratoriesCommunity pathology laboratoriesReference pathology laboratoriesDrug discovery laboratories (pharma) Medical research centres
Technologies Immunohistochemistry (IHC)In situ hybridisation (ISH)Digital pathology and workflowSpecial staining
Best-sellers 2012Advanced tissue staining 518 million CHF (+13%)Primary tissue staining 59 million CHF (+13%)
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SyMPHONy
BenchMark ULTRA
VANTAGE
Key tests
VENTANA iScan HT scanner
BenchMark Special Stains
Segments and products
Primary stainingThe hematoxylin and eosin (H&E) staining process is the primary test run on
tissue samples entering the Antomical Pathology (AP) laboratory. The SyMPHONy
platform fully automates the H&E process including coverslipping. The SyMPHONy
system is the only H&E stainer that helps mitigate cross-contamination through
individual slide staining. The individual application of fresh reagents on each
slide produces high quality results, improving visualisation and discrimination
of microanatomic detail.
Platforms: SyMPHONy system
Special StainsSpecial stains are a fundamental aid in diagnosing a variety of illnesses, from infection to cancer. The BenchMark Special Stains system delivers complete baking-through-staining automation for special stains, to enhance stain quality and turnaround time. Eliminating manual processes and temperature batching with automated deparaffinisation and independent slide heating, the BenchMark Special Stains system improves workflow efficiency. This innovative platform also reduces patient and laboratory technician risk with individual slide staining and reduced exposure to harmful chemicals.Platforms: BenchMark Special Stains system
Advanced stainingAbout 20% of all slides entering a histology lab must undergo further advanced testing. Immunohistochemistry and in situ hybridisation allow visualisation of molecular targets on tissues, thus revealing the presence and properties of abnormal cells, DNA and RNA sequences.Platforms: BenchMark GX,BenchMark ULTRA and BenchMark XT IHC automated staining instruments, Discovery ULTRA and Discovery XT systems
Workflow managementThe VANTAGE workflow management system is the first of its kind in the industry. VANTAGE software and hardware tools and services automate, streamline and integrate lab work and information flow to help provide increased productivity and patient safety gains.Platforms: VANTAGE workflow management system
Digital pathology RTD provides comprehensive digital pathology solutions including slide scanning image acquisition, image management, advanced algorithms for image analysis, and comprehensive patient reporting. Full integration of digital pathology tools extends the benefits of automation and personalised healthcare solutions by providing even greater efficiencies, productivity, and diagnostic intelligence.Platforms /Software: iScan Coreo scanner, VENTANA iScan HT scanner (RUO), Virtuoso image and workflow management software, and Companion Algorithm image analysis software
Test on the market* Application
HER2neu (4B5) Image Analysis Software
Breast cancer
PR (1E2) Image Analysis Software Breast cancer
Ki-67 (30-9) Image Analysis Software Breast cancer
p53 (DO-7) Image Analysis Software Breast cancer
Test on the market* Application
SISH HER2 Probe** Breast/gastric cancer
ERG (EPR 3864) Rabbit Monoclonal Primary Antibody for IHC testing
Prostate cancer
* Not available in all markets ** Ex-US only
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Roche Diabetes Care
2012Employees: 5,500Sales: 2,566 million CHF
(25% of divisional sales)
Growth: -4% (local currency)
Sites Mannheim, Germany: Headquarters, R&D, ProductionIndianapolis, IN, USA; Yogneam Illit, Israel: R&D, Production
Disease areas Metabolic diseases/Diabetes
CustomersPeople with diabetesHospitalsHealthcare professionalsDiabetes nurse educators
Best-sellers 2012Blood glucose monitoring 2,476 million CHF (-5%)Insulin delivery systems 233 million CHF (+8%)
Roche Diabetes Care (RDC) develops and commercia lises blood glucose (bG) monitoring and insulin delivery systems that enable people with diabetes to manage their condition more effectively. The goal of diabetes therapy is to maintain the bG levels in a (near-)normal range and thus avoid diabetes-related complications.
RDC not only offers individual product innovations but integrated diabetes management solutions meeting the everyday needs of our customers for an optimised therapy management.
Roche is the industry leader with a 29% market share of a global bG monitoring market worth over 8 billion US dollars.
Roche 29.1%
Roche 13%
Abbott 14.6%Animas 11%
Smith 0.5%
Insulet 9%
Medtronic 67%
Blood glucose monitoring market Insulin delivery systems market
Lifescan 26.5%Bayer 14.6%
Others 15.2%
Market position
Blood glucose monitoring market Insulin delivery systems market
RDC portfolio
11 bG monitoring systems5 lancing devices3 insulin pump systems4 infusion sets for insulin pumps5 information management systems
Source: Industry analyst reports, Roche analysis, company reports
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Accu-Chek Aviva Expert
Accu-Chek Combo
Accu-Chek Mobile
Accu-Chek Active
Accu-Chek FlexLink
Accu-Chek Smart PixAccu-Chek 360° software
Accu-Chek NanoSmartView
Segments and products
Blood glucose monitoringBG meters are designed for self-monitoring of blood glucose, helping peoplewith diabetes keep the blood glucose levels in a (near-)normal range by adjusting their medication – especially their insulin doses – according to their individual needs.Platforms*: Meters: Accu-Chek Aviva, Accu-Chek Aviva Nano, Accu-Chek Nano SmartView, Accu-Chek Aviva Expert, Accu-Chek Performa, Accu-Chek Performa Nano, Accu-Chek Active, Accu-Chek Compact Plus, Accu-Chek MobileLancing systems: Accu-Chek Softclix, Accu-Chek Multiclix, Accu-Chek Fastclix
Insulin deliveryConnected to the body via an infusion set, insulin pumps deliver the exact amount of insulin required to cover a body’s physiological needs 24 hours a day. This offers enhanced flexibility and safety to people with diabetes. The newest portfolio additions combine the insulin pump with bG testing, a pump remote control and extensive data management features.Platforms*: Insulin pump systems: Accu-Chek Combo, Accu-Chek Spirit Infusion sets: Accu-Chek FlexLink, Accu-Chek TenderLink, Accu-Chek Rapid-D Link
Diabetes management systemsThe Accu-Chek information management systems not only facilitate the visualisation and assessment of individual blood glucose patterns, they also support the user’s decision-making. The built-in bolus advisor of the Accu-Chek Combo insulin pump system enables quick and easy determination of the right amount of insulin (bolus), which the pump subsequently and discretely delivers into the body at the push of a button.Platforms*: Accu-Chek 360° software, Accu-Chek Smart Pix
* Non-exhaustive
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Roche Applied Science
2012Employees: 400Sales: 737 million CHF
(7% of divisional sales)
Growth: -3% (local currency)
Market position
Life science served market
Sites Penzberg, Germany: Headquarters, R&D, Production, MarketingBranford, CT, USA: 454 Life SciencesMadison, WI, USA: Roche NimbleGenRotkreuz, Switzerland: Instrument development and production
CustomersLife Science research in academia, biotech and pharma
TechnologiesPolymerase Chain Reaction (PCR)DNA sequencingNucleic acid purification
Best-sellers 2012 Nucleic acid DNA purification and gene expression 233 million CHF (+5%)Genomics 126 million CHF (-19%)Custom Biotech 217 million CHF (+8%)
Roche Applied Science (RAS) is a world-class supplier of speciality biochemicals and producer of research reagents and systems for Life Science research. RAS is an established partner for research institutions, universities and pharmaceut-ical industry worldwide. Its products facilitate medical research in today’s most important avenues of exploration and provide tools for researching the cause of and predisposition for a disease. RAS products often represent the first entry into innovative bioanalytical tools and methods and have potential to one day be de-veloped for use as an IVD.
The global Life Science research served market, valued at 9.3 billion US dollars, grew approximately 4.5% in 2012. Roche has roughly a 8.5% share of this market.
RAS portfolio
> 2,000 test kits and reagents20 instruments
Qiagen 7%
Thermo Fisher 4.6%
Illumina 7.2%
BioRad 2.9%Roche 8.5% Life Technologies 26.5%
Sigma Aldrich 5.2%
Others 38.2%Source: Industry analyst report, Roche analysis, company reports
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Segments and products
Nucleic acid DNA purification and gene expressionGene expression research evaluates how a gene is used in the synthesis of a functional gene product which is in most cases a protein. Nucleic acid purification technology is used to isolate nucleic acids from manifold sample materials. Platforms*: MagNA Pure Compact, MagNA Pure LC, MagNA Pure 96, LightCycler 2.0, LightCycler 480, LightCycler 1536, LightCycler Nano
Sequencing solutionsDNA sequencing detects the exact order of the nucleotides and is the first step to understan ding how genes work together to direct growth, development and maintenance of an entire organism. Platforms*: Genome Sequencer FLX, GS Junior (powered by 454 sequencing technology)
Custom Biotech and bioreagentsWith experience and strong customer orientation, Custom Biotech supplies reagents and services customised to the quality and regulatory needs of pharmaceutical, diagnostic, and biotech industries, and bioreagents for research applications.Platforms*: Cedex Bio Bioprocess Analyzer
MagNA Pure 96
Genome Sequencer FLX GS Junior
Cedex Bio Bioprocess Analyzer
LightCycler NanoLightCycler 480
* Non-exhaustive
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Divisional Structure
Business AreasDiagnostics Regions
Global Functions
Business Unit
The Diagnostics Division is managed via a matrix organisation of Business Areas/Unit, Regions and Global Functions.
Regional Organisation
Global Functions
The regional organisations are responsible for all aspects of sales and marketing within the region and in the affiliated countries, for implementation of global processes at the regional level and for the company management in line with local regulations and practice.
To maximise efficiencies, a number of functions have been centralised globally. The four global functions support the Business Areas and Regional Organisations to drive business success within the division.
Regions Advantages of a Regional Set-up
– Asia-Pacific– EMEA (Europe, Middle East, Africa) – Japan – LATAM (Latin America)– North America
– Tailored market strategies– Innovative pricing models– Increase access to healthcare– Infrastructure Development– Customer Satisfaction
Global Operations Global Quality and Regulatory
Global Operations consists of three areas, Manufacturing, Supply Chain and Direct Procurement, and is responsible for the production and supply of Roche Diagnostic’s reagents, consumables, and many instruments. The global function manages a continuum of processes for all BAs to ensure customers receive the products they purchased on time and in full and is a key driver of excellence in operations in Diagnostics, maintaining a strong focus on process efficiency and profitability.
Global Quality and Regulatory is responsible for provision and maintenance of the resources, systems and processes at all levels of the organization necessary to ensure full compliance with requirements given by authorities and regulatory bodies in order to provide our customers and patients with reliable high-quality products and services. Furthermore, this function drives the submissions and approvals to bring our innovative product to the markets around the globe.
Global Platforms and Support Global Business Development
Global Platforms and Support (GPS) develops solutions – instruments, software and systems for laboratory diagnostics – according to customer requirements and in close cooperation with the Business Areas. Furthermore, GPS provides global service and support for Roche Diagnostics products.
Global Business Development concentrates on the development of divisional strategy and global business opportunities by obtaining timely access to exter-nal innovation through acquisitions, licensing and partnering. The unit monitors the marketplace for biomarkers and technologies for further development, and initiates divisional projects addressing issues strategically important for the fu-ture of the business.
Doing now what patients need next
We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.
We are Roche.
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Doing now what patients need next
We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.
We are Roche.
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