many aspects of patient care including prevention, profiling of diseases, personalized healthcare and point of need testing
• Applied Testing – government or industry customers using
molecular technologies in fields such as forensics, veteri- nary diagnostics and food safety testing
• Pharma – drug discovery, translational medicine and clinical
development efforts of pharmaceutical and biotechnology companies
• Academia – researchers exploring the secrets of life such as
the mechanisms and pathways of diseases, and in some cases translating that research into drug targets or commer- cial applications
Molecular Diagnostics
The ability of advanced diagnostic technologies to unlock molecular information from patients is changing the practice of medicine, while creating a significant and growing market for nucleic acid sample preparation and assay technology products. The dissemination of PCR and other amplification
[3] Net Sales by Customer Classes
7 % 8 % 20 % 19 % 26 % 24 % 32 % 15 % 37 % 23 % 19 % 8 % 11 % 12 % 39 % 2011 2012 2013 Molecular Diagnostics
Other Molecular Diagnostics U.S. HPV Life Sciences Applied Testing Pharma Academia C OR POR A TE G O V ER N A NC E ES U LT S
technologies has brought nucleic acid-based diagnostics into routine use in healthcare around the world, and next-genera- tion sequencing (NGS) is in the early days of further trans- forming healthcare.
Technologies for molecular diagnostics can be used to identify and profile microorganisms, cancer cells, bacteria and viruses by searching for their specific nucleic acid sequences or to characterize previously unknown DNA sequences related to human diseases. Commercial applications for molecular diag- nostics are multiplying as researchers identify new biologi- cal markers for disease and develop novel technologies for detection and analysis of those diagnostic clues from the human body.
The molecular diagnostics market, with sales estimated by industry experts at approximately $ 5 billion in 2013, is still a small part of the global in vitro diagnostics market, but it is the fastest growing segment at a projected compound annual growth rate of 10 % or more. Market penetration is still low in the U.S., other developed countries and emerging markets. However, given the advantages of precise genetic informa- tion over traditional tests, QIAGEN expects the molecular diag- nostics market to provide significant growth opportunities over the long term.
Growth in the Molecular Diagnostics customer class is built upon four strategies for fighting disease, and QIAGEN is targeting each of these fields with a range of dedicated products and tailored marketing:
• Prevention – using advanced technologies to screen
non-symptomatic patients as a preventive strategy, such as testing women for HPV to protect from cervical cancer or screening patients for latent TB infection to guard against active TB disease.
• Profiling – testing symptomatic patients to profile the precise
type of disease, for example screening patients for various viral or bacterial infections that involve blood-borne diseases and healthcare-acquired infections, and in particular in at-risk
patient groups, such as those having undergone organ transplantation.
• Personalized Healthcare – determining which patients are
most likely to respond positively to particular therapies, in- cluding landmark QIAGEN tests for testing the mutation status of genes such as KRAS, EGFR, BRAF and others that influ- ence the effectiveness and safety profile of novel medicines for treatment of various cancers and other diseases.
• Point of Need – enabling on-site diagnosis in physician
practices, emergency rooms, remote field areas, and other settings where a laboratory infrastructure is not accessible and fast turnaround is required.
QIAGEN offers one of the broadest portfolios of molecular technologies for human healthcare. Success in Molecular Diagnostics depends on the ability to analyze purified nucleic acid samples from a variety of sources, including blood, tissue, body fluids and stool, on automated systems that can handle hundreds of samples concurrently. Other key factors are the range of assays targeting various diseases and biomarkers, convenience and ease of laboratory workflow, versatility, relia- bility and standardization of the nucleic acid processing and detection procedures.
One of the largest prevention markets is screening for HPV, a viral infection that is the primary cause of cervical cancer, which kills about 270,000 women a year worldwide. We are the global leader in HPV screening technologies, with our market-leading “gold standard” digene HC2HPV Test and our emerging careHPV Test for use in low-resource regions of the world. In the U.S., we sell our HPV products primarily for two FDA-approved indications: adjunctive primary screening with a Pap test for women aged 30 and older, and follow-up testing of inconsistent Pap test results in women of any age. In Europe and the rest of the world, HPV screening is growing based on clinical evidence and policy initiatives aimed at fighting cervical cancer.
The early-warning QuantiFERON®-TB Gold test, which de-
disease in vulnerable populations, has become an important growth driver since QIAGEN’s 2011 acquisition of the prod- uct with its developer, the Australian firm Cellestis Ltd. Ap- proximately one-third of the world’s population is estimated by the World Health Organization (WHO) to be infected with the tuberculosis bacterium but does not exhibit any symptoms, a condition known as latent TB. However, about 5-10 % of those patients with latent TB at some point are estimated to be at risk of developing active tuberculosis, a potentially life-threat- ening contagious disease that typically spreads from one active patient to 10 to 20 other people. The potential global market for latent TB detection is estimated at up to $ 1 billion. In Profiling, we offer an extensive range of Sample & Assay Technologies for use in the diagnosis of patients for various infectious diseases. We are expanding this portfolio of assays and seeking regulatory approvals in additional markets. In 2013
we received European approvals of assays for detection of
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), as well as the healthcare-associated infection Claustridium
difficile. In 2012, our assay for detection of influenza A / B was approved for U.S. marketing by the FDA. A key element of our global content expansion is the use of these assay technologies on the QIAsymphony automation platform. In Personalized Healthcare, we offer companion diagnostics to guide the selection of medicines in treating cancer and other diseases based on a broad portfolio of more than
30 biomarkers. In July 2013, QIAGEN achieved our second companion diagnostics approval from the FDA and introduced the therascreen®EGFRRGQPCR Kit for use in patients with
non-small cell lung cancer (NSCLC); the therascreen®KRAS
RGQ PCR Kit for use in patients with metastatic colorectal cancer, approved by the FDA in July 2012, has gained wide acceptance among healthcare providers and laboratories.
QIAGEN’s global leadership position in Personalized Health- care includes Japan, where regulators approved the thera
screen KRAS and EGFR kits in 2011, and Europe, where
QIAGEN offers more than 10CE-marked assays for person- alized healthcare applications. QIAGEN has more than
15 projects under way to co-develop and market companion diagnostics with leading pharmaceutical and biotechnolo-
gy companies. We have collaborative projects with high-pro- file companies such as Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb / ImClone, Eli Lilly, Pfizer and Sanofi. Ongoing acquisitions of biomarkers and other technologies contribute to our expanding co-development relationships. A key element of the global expansion in Personalized Healthcare is the ability of labs to efficiently use these assay technologies on our QIAsymphony platform.
We market a range of automation systems designed for low, medium, and high-throughput nucleic acid sample prepara- tion and handling tasks in laboratories performing molecular diagnostics. The flagship platform is QIAsymphony, based on its unique characteristics. Nucleic acid samples purified on our instruments are ready for use in the demanding and sen- sitive downstream assays performed in molecular diagnostic applications. We offer closed and open assay technologies. (Open assay technologies contain PCR reagents to identify molecules of choice. Closed assays, diagnostics with pre- defined targets, include multiplexing and other pathogen or genetic mutation detection assays such as tests for HIV, tuber- culosis, influenza or hepatitis.) We market assays directly to end customers via QIAGEN’s sales channels, and selected assays through major diagnostic partners with complementary customer groups or other agreements with companies to broaden the distribution of our products.