qiagen_ivd testing market

8/8/2019 Qiagen_IVD Testing Market

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- 1 -QIAGEN Analyst Conference, February 13, 2007 Sample and Assay Technologies

QIAGEN Sample and Assay Technologies

2007 Analyst Meeting

Peer M. Schatz

Chief Executive Officer


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Safe Harbor Statement:Certain of the statements contained in this presentation may be consideredforward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, asamended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extentthat any of the statements contained herein relating to QIAGEN's products and markets and operatingresults are forward-looking, such statements are based on current expectations that involve a numberof uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associatedwith management of growth and international operations (including the effects of currencyfluctuations), variability of operating results, the commercial development of the DNA sequencing,genomics and synthetic nucleic acid-related markets, as well as the nucleic acid-based moleculardiagnostics, applied testing markets and genetic vaccination and gene therapy markets, competition,rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's products(including fluctuations for certain events including funding, budgets, and others), difficulties insuccessfully adapting QIAGENs products to integrated solutions and producing such products, theability of QIAGEN to identify and develop new products and to differentiate its products fromcompetitors, and the integration of acquisitions of technologies and businesses. For furtherinformation, refer to the discussion in reports that QIAGEN has filed with or furnished to the U.S.Securities and Exchange Commission (SEC).

Note:In the attached presentation, QIAGEN will use the term molecular diagnostics. The use of thisterm is in reference to certain countries, such as the United States, limited to products subject toregulatory framework. Current QIAGEN molecular diagnostics products are 34 EU CE IVD assays, 3EU CE IVD sample preparation products, 1 510k PAX RNA product, 9 China SFDA IVD assays and98 general purpose reagents.

Forward Looking Statements


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A Well Defined Core CompetencyLeveraged into Multiple Markets

Molecular Diagnostics Applied Testing Life Science Research- Academia- Industry


Common Core Addressing 3 Markets

Sample and AssayTechnologies


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Sample and Assay Technologies

DNASample Technologies

RNASample Technologies

DNAAssay Technologies

RNAAssay Technologies

RNAiAssay Technologies

ProteinAssay Technologies

RegulatedAssay Technologies

ProteinSample Technologies

RegulatedSample Technologies

SAMPLETECHNOLOGIES

ASSAYTECHNOLOGIES

Leading Integrated Complete

AutomationOf Assay Technologies

AutomationOf Sample Technologies



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ScaleLeveraging Technologies Into Multiple Markets

Olerup SSP Kits

QIAplex Assays

artusAssays

QuantiTect Assays

RT-PCR Reagents

Taq Polymerases

PAXgene

Allprep Protein/RNA Kit

QIAquick

RNeasy

QIAamp

QIAprep

Product Example

yesnoyesHLA+HSE

yesyesyesPathogen Multiplex Detection

yesyesyesPathogen Detection

yesnonoGene Expression

Closed Platforms

yesyesyesReal-time PCR

yesyesyesEndpoint PCR

Open Platforms

Assay TechnologiesyesnoyesSample Stabilization

yesyesnoSample Preparation, Protein

yesyesyesSample Preparation, PCR

yesyesyesSample Preparation, RNA

yesyesyesSample Preparation, gDNA, viral DNA

yesnonoSample Preparation, Plasmid

Sample Technologies

Life ScienceResearch

AppliedTesting

MolecularDiagnostics

Representative but not complete list



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Customer focused Scaleable Critical mass

One core multiple channels

Globally aligned Sales and Marketing

Diagnostic

VeterinaryForensics

Food

PharmaBiotech

Basic research

Biomed research

DiagnosticsSales

Specialists

ATSales

Developers

PharmaKAMs

Life Sciences

Sales

DiagnosticMarketing Manager

Applied TestingMarketing Manager

PharmaMarketing Manager

Life Sciences

Marketing Manager

CustomerSalesMarketing

We are

Life ScienceSales

PharmaKey Account Manager

Applied TestingSales Developer

Molecular DxSales

Channel Segmentation



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Automation of Sample and Assay TechnologiesAll Volumes - All Markets

Molecular diagnostics

Applied testing

Low throughput applications (1-6 samples)

Highest process safety and ease of usethrough

pre-filled reagents application cards

BioRobot EZ1

For every laboratory

Low to mid throughput system for fullyautomated purification of nucleic acidsor proteins using QIAGEN spin kits.

Molecular diagnostics

Applied testing

Life Science research

Lowmid throughput (1-12 samples per run)

QIAcube

BioRobot Universal

Widest range of applications for samplepreparation and assay setup. Microtiter-format consumables.

Molecular diagnostics (e.g. PreAnalytiX)

Applied testing

Life Sciences

Medium-high throughput (up to 384 samples per run)

BioRobot MDx

Sample preparation and assay setup forMDx applications (CE-IVD compliance) inEurope as well as MDx research.

Molecular diagnostics (e.g. PreAnalytiX)

Applied testing

Life science research: clinical development

Medium-high throughput (up to 384 samples per run)

Representative but not complete list



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QIAGEN Leading in Molecular Diagnostics

Strong In-House Capabilities - Core Competence

QIAGEN Leading in Molecular Diagnostics

Proven standard in sample and assay technologies

Unparalleled range of applications in sample technologies

Largest molecular diagnostics assay portfolio Certified applications and systems

QIAGEN portfolios in regulated markets

Sample technologies (including de novo 510k approvals)

Assay technologies artusassays

PG Biotech assays

QIAplex (Genaco) multiplex assays

QIAGEN Regulatory Group

Significantly expanded in 2004 and early 2006

Regulatory and clinical affairs in USA, Europe and China

Molecular Diagnostics



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Yates RR. New intervention strategies for reducing antibiotic resistance.Chest 1999;115:24S-27S.

Piquette RK. A targeted review of vancomycin use. Can J Hosp Pharm 1991;44:83-7.

25 bn

400 bn

Diagnostics Pharmaceuticals

Approx. US$100 bn wasted due to incorrect therapy

Example: antibiotics

approx. US$25 billion market (human)

approx. 50% probably not effective wrong application Resistances approx. US$50 billion in costs approx. 20,000 casualties

Diagnostics

approx. 5% ofpharmaceutical

industry approx. 1% of

Health Care

Diagnostics Untapped PotentialMolecular

Diagnostics


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- 1 0 -QIAGEN Analyst Conference, February 13, 2007 Sample and Assay Technologies

QIAGEN Regulatory Strategy

Genaco Assays: Regulatory strategy and timeline

Plan: Two assays to be submitted to FDA 2007, three in 2008

Plan: CE marks for all panels throughout 2007/2008

Milestones in Expanding MDx Leadership


2007 2008

H5N1 Staphplex Resplex IUS:FDA 510K

Resplex II

Europe:CE Marking

All panels throughout 2007/2008

HAI


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From Patient Sample To Clinical ResultsQIAGEN Provides Advanced Sample And Assay Technologies

Broad Portfolio - StreamlinedBroad Portfolio - Streamlined

DiagnosticResults

Patientsample Sample technologies Assay technologies

Sample

StabilizationStorage

SampleCollection

Endpoint andReal-time PCR

reagents

Closedassays

(e.g. artus)

QIAplex(Multiplexing)



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CAGR =15%+

Projected MDx Market Sector Growth Unique Subsector of Clinical Testing

Fast growing area in in-vitro diagnostics

Market 2006 2.4bn with projectedCAGR of 15%+

MDx with high value & high marginproducts (unlike traditional Dx)

Technologies are covered by extensive IP

Holds promise of pharmacogenomics

Technologies can be leveraged in

Academia, Pharma and Applied Testing New tests in oncology and other fields

yield room for further growth

In Bn US$

Molecular DiagnosticsGrowth by Segments 2004 - 2010

Source: Divers Market Research


2,1

2,4

4,2

3,7

3,2

2,8

0,0

1,0

2,0

3,0

4,0

5,0

2005 2006 2007 2008 2009 2010


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QIAGEN Expanding in Applied Testing

Proven Industry Standards Fuel Molecular Testing in Applied Markets

Applied Testing

QIAGEN Expanding in Applied Testing

Long experience in complex sample processing

Proven industry standards in sample and assay technologies

Certified applications

QIAGEN portfolios

Sample technologies

Assay technologies (artusassays, PG assays)

QIAGEN Partner in Applied Testing, includes VLA (British Veterinary Laboratories Agencies)

Vetsuisse Faculty, University of Bern, Switzerland

QIAGEN Outlook

Veterinary diagnostics focus in 2007 Exciting product launches in 2007

- sample technologies incl. automated solutions- assays

AppliedTesting


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Applied TestingMarket Entry Barriers And Market Size & Growth Of Segments

(1) Evalution parameters: regulatory, competition, customer willingness to change

Speed of Adoption (1)

MarketGrowth

High Medium Low

Human ID

Vet

QC Pharma & PCP

Food Pathogen

Biosecurity

Food GMO

0%

10%

20%

30%

40%

0 1 2 3

Forensics

$1 billion

NAT AndTraditional

Market Size 2008

AppliedTesting


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QIAGEN Standard in Life Science Research

Life Science Research

QIAGEN Standards in Life Science Research

QIAGEN leads in sample and assay technologies

Creating standards early

Large component of academia is biomedical research

Pharma research and development go molecular Core to strategy in MDx and Applied Testing

QIAGEN portfolios

Sample technologies

Assay technologies: (include: RNAi, PCR, real-time PCR,closed test assays)

QIAGEN Partner of Pharma

QIAGEN products in > 100 clinical trials

Clinical research: exciting milestones and growth

QIAGEN Outlook

Academia: stable growth, regional differences

Pharma actively using new clinical development paradigms

Life Sciences

At the Forefront of Science Creating Standards Early


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Molecular Diagnostics Applied Testing Life Science Research- Academia- Industry


Common Core Addressing 3 Markets

A Well Defined Area of Expertise - Multiple MarketsOutlook


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0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2006 2010 2015

Applied Testing

MDx

Pharma/BiotechAcademia

Development of Customer SegmentsAs Percentage of Revenues

40%

25%

25%

10%

29%

21%

34%

16%

18%

14%

43%

25%

Molecular Diagnostics Customers Could Represent the Largest

Revenue Share in Three Years From Now

Estmated CAGRs2006-2015:

Academia 3%

Pharma/Biotech 6%Molecular Dx 20%Applied Testing 25%

Applied Testing

Molecular Diagnostics

Life Science Research

Note: this graph is for demonstration only and is projecting currently assumed market growth rates

Outlook


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Focused on Executing our Strategy

Innovation

- 67 new products launched in 2006

- 42 new products in sample technologies

- 25 new products in assay technologies

- Exciting pipeline in sample and assay technologies

Customer focus - premium partner for

- MDx

- Applied testing

- Life Sciences (pharma + academia)

Growth

- Industry-leading organic growth

- Integration of catalytic acquisitions well on track

- Further acquisitions in sample and assay technologies

- Geographical presence (Asia, India, South America,

Eastern Europe)

Well Laid-Out Mission Exciting Future

Outlook

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