Antivirals play their part in reshaping the viral diagnostics market

Antiviral drugs to treat HIV, HCV and HBV will be key drivers of the in vitro diagnostics market in the years ahead, says a new publication from Clinica

Viral diagnostics represent a key sector within the $19 billion in vitro diagnostics sector and are forecast to exhibit substantial growth over the next decade, writes Lindsay Brooks. A new study from Clinica Reports, New Trends in Viral Diagnostics, says that a key market driver will be the emergence of new anti viral drugs to treat human immunodeficiency virus (HIV), hepatitis C virus (HCV) and hepatitis B virus (HBV).

The world viral load tests market for HCV and HBV, worth around $200 million, will grow by some 20-30% in the coming five years as new drugs, such as immunomodulators, enter the market. The reported increasing prevalence of hepatitis will push the HCV testing market. Some four million people are infected with the disease in the US; this is four times the number of people living with AIDS.

The worldwide HIV viral load test market, currently worth around $220 million, will experience annual growth of up to 10% over the next five years before flattening out. The growth in the nucleic acid testing (NAT) industry has mirrored the profile of immunoassay testing market between the 1970s and 1990s, in just five years, essentially due to viral diagnostics.

Aside from NAT, other sectors anticipated to experience the most significant growth in the next 5-10 years include: point-of-care (POC) testing; rapid results and laboratory automation; and gene chip technologies. These sectors will be strongly influenced by geographical region. For instance, the developed regions, such as the US, Western Europe, and Japan embrace technological advancements, such as molecular diagnostics.

The blood screening market has been stimulated, with many developed countries now testing for HIV, HVC and HBV using NAT. New technologies have been essential, as an estimated 200,000-300,000 cases of HIV are missed annually. This is because the disease is not advanced enough to trigger positive results. NAT tests are more sensitive and reduce the serological window between infection and detection.

Gen-Probe is the leading company in this field, with a claimed 70% share of the US blood pool testing market held by its transcription mediated amplification (TMA) HIV-1/HCV test. Around two million blood donations are screened for HBV, HCV and HIV using NAT in the UK each year.

The new technologies, such NAT, require greater automation, greater cost-effectiveness and become more user friendly before they become viable options for clinical laboratories. With a growing trend towards laboratory consolidation, buyers are attracted to the high-throughput, fully automated immunoassay systems, which have large test menus.

Reimbursement issues and cost-containment policies will impact the growth of the industry, particularly in Europe, with many new technologies suffering as governments attempt to control healthcare expenditure. In Germany, the planned introduction of the Diagnosis Related Groups (ie case-based) system of reimbursement has already had repercussions on the national in vitro diagnostics industry.

Since new regulations were announced (Clinica No 915, pp 1-2), the German diagnostics industry association, the VDGH (Verband der Diagnostica-Industrie) has observed that infectious disease tests instigated by GPs, including hepatitis C-amplification tests, have fallen by 53%. The overall trend shows a shift in laboratory tests from GPs to hospitals, although this displacement may not compensate for the fall in GPs-instigated tests.

The HPV testing market is dominated by Digene's Hybrid Capture II HPV test. HPV is thought to be responsible for 99% of all cancers. The test is used in conjunction with Cytyc's ThinPrep Pap smear test, and is currently used as a reflex test for ASCUS and borderline smears. The HPV test market could grow by 25% each year, as the test is introduced for high-risk cases and countries introduce it as part of their cervical cancer screening programmes. The UK is conducting pilot studies on liquid-based cytology smears and reflex HPV tests.

POC and rapid results products are growing in popularity as they meet the criteria for reducing healthcare expenditure, as well as essential for criteria for theranostic and disease managed treatment programmes. POC viral load monitoring is estimated to be worth $100 million, and is on the brink of rapid expansion owing to HCV viral load testing. Virco, ViroLogic and Viralliance all market and develop phenotypic viral resistance tests. They remain unproven, however. "They are still relatively new to the diagnostics arena and yet to really prove their value" says Dr Esther Race, operations director of Viralliance.

Market analysts were expecting the genotyping market to begin growing as of late 2000. Affymetrix, which specialises in GeneChip technology, in areas such as gene expression monitoring and genotyping, envisages a time period close to two years before the industry comes into fruition. Affymetrix is the leading player in the biochip market, with the GeneChip HIV PRT Plus Probe Arrays.

Trinity Biotech believes that the first company to gain FDA approval for rapid HIV testing will make a huge impact on the market. Trinity Biotech, Medmira, Abbott, OraSure Technologies and Bio-Rad are all currently submitting approval data to the Centers for Disease Control and Prevention (CDC) and the FDA. These tests should overcome the problem of patients not returning to clinics to learn laboratory test results.

Growth areas for rapid results testing include Latin America, Africa, Russia, the Middle East (Saudi Arabia), Poland and Venezuela. Germany has now slowed down due to restructuring of its healthcare system. India will be a difficult market to penetrate, where local suppliers offer far cheaper alternatives - for as little as $1 - in a region with fewer regulatory barriers. In Europe, many smaller companies will struggle for survival when trying to adapt to regulations imposed by the EU IVD Directive.

Bernard Branson, the Director of HIV at the CDC envisages huge growth in this sector, as rapid tests will be used in a variety of areas, including on prenatal women and in hospital accident and emergency rooms.

Major growth in Latin America

The Latin American region is considered by most leading diagnostics companies to be the major emerging market. The region has become more accessible in the wake of the Mercosur and the NAFTA (North American Free Trade) agreements. The Global Harmonization Task Force (GHTF) is establishing links with Latin America and with India, another emerging market.

India, and China, are also viewed as showing good market potential within the diagnostics industry. Companies such as Becton Dickinson are adding significant resources to these regions. China has been described as the "big unknown", by Gen-Probe. This market could have enormous potential.

The WHO's UNAIDS group estimates that over half a million Chinese are living with AIDS. However, if the problem is left unchecked, there could be ten million HIV infections by 2010, according to the Chinese National Centre for AIDS Prevention and Control. Even a 10% market gain would be significant, bearing in mind the sheer size of the population. Importing into China should ease, with the Chinese government currently bidding to join the World Trade Organization.

In China, doctors work in an atmosphere where over-prescribing of diagnostic tests is common; this is a lucrative market for hospitals. Furthermore, the availability of state-of-the-art diagnostic services, such as NAT testing, often determines a hospital's reputation. The government's health policy for reforming township health clinics will boost the POC and rapid results viral diagnostics market.

ELISA-based products represent two-thirds of the Indian diagnostics market. The market for HIV, HCV and HBV testing is expected to reach $62 million by 2002, with ELISA product sales increasing by over 15% annually, driven by the high prevalence of HIV and hepatitis.

Africa, with an AIDS epidemic of vast proportions, desperate for both diagnostics and AIDS treatment, does not have the infrastructure to support such demand. The latest NAT tests are not suitable for the social and economic environment. Diagnostic tests need to be easy to use, portable and cheap. Calypte Biomedical Corp has successfully penetrated the African market, with its HIV-1 antibody urine test. The test is performed in mobile clinics, and is a convenient means of testing where non-medical staff can obtain samples.

The report covers factors influencing the viral diagnostics markets, such as regulations, reimbursements, healthcare systems and expenditure, and epidemiology. The report also profiles 20 players within the viral diagnostics industry, providing details of each company's product portfolio, annual results for the past five years, R&D pipeline and business strategy.

* For details about the Clinica report, New Trends in Viral Diagnostics, contact Clinica Reports at the address shown on page 2 of this issue.