«Unfortunately for world populations, the future for infectious disease testing looks bright. Twenty well-known diseases – including tuberculosis (Tb), measles, Chagas, malaria, and cholera – have reemerged or spread geographically since 1973, often in more virulent and drug-resistant forms». These are the very words with which Kalorama Information diagnostic analyst Shara Rosen introduced the company’s World Market for Infectious Disease Diagnostic Tests report in November, 2013. Headquartered in Rockwell, Maryland, the firm has been focusing for more than 30 years on market researches for the medical industry and its above-mentioned publication would also consider that «of the seven biggest killers worldwide, tuberculosis, malaria, hepatitis, and, in particular, Hiv/Aids continue to surge, with Hiv/Aids and Tb likely to account for the overwhelming majority of deaths from infectious diseases in developing countries by 2020». Nonetheless, good news is that, according to Kalorama, «improvements in detection time and the development of accurate rapid screening tests permits more effective treatment choices, which is a positive sign for the market for in vitro diagnostics (or: Ivd) test products». So that by the end of this decade, as researchers considered, «the emphasis will be on rapid screening tests to detect pathogens and nucleic acid tests to hone in on the appropriate treatment to be given». And in fact it is Shara Rosen’s opinion that «Increasing incidence of infectious disease is expected to make the market for infectious disease tests among the most dynamic in the in vitro diagnostics industry». And such evidences allowed the Rockwell-based firm to forecast, some fifteen months ago, that «the world market for infectious disease tests», which was already «estimated at 14.5 billion Us dollars in 2012» should then «grow at a slightly higher rate than the rest of the diagnostics market».
The growth of molecular diagnostics
In more recent times, back in mid-December, 2014, other analysts focused on the same issues by pointing out that «unique disease outbreaks across the globe are escalating the demand for screening and spurring the infectious disease diagnostic market». As a part of its Life sciences growth partnership service program, the San Antonio -Texas – based market research company Frost & Sullivan released a new report entitled Analysis of the Global Infectious Disease Diagnostics Market in which it stated that «the market earned revenue of 7.91 billion Us dollars in 2013» and then estimates this «to reach 12.77 billion dollars in 2018», with «Hepatitis B, hepatitis C, tuberculosis, and sepsis tests» set to become, according to experts, «the major revenue generators». Especially, Frost & Sullivan took into account two major forms of diagnostic tests and researches – molecular diagnostics is the first one, immunodiagnostics the latter – believing that the overall market will anyway continue to develop, «as unmet technological needs lead to the creation of faster, more capable platforms». Respectively, molecular diagnostics is about to display the fastest and most impressive growth rates in this scenario, «clocking», as observers wrote, «a compound annual growth of 15.30 percent. Although these tests remain expensive», in fact, «their efficiency and accuracy strengthen their use case». While on the other hand, «immunodiagnostics is another segment that continues to expand rapidly, owing to cost-effective tests as well as the prevalence of hospital-acquired infections, like sepsis and Mrsa (or Methicillin-resistant Staphylococcus aureus). Life sciences industry analyst «Molecular methods and immunodiagnostics are expected to complement each other as the need for accurate and rapid diagnostic tests rises», said Frost & Sullivan Life sciences industry analyst Aish Vivekanandan, who soon afterwards turned to consider the challenges that both producers and scientists will have to face in order to gain the opportunities the market is about to display. Economic and regulatory issues are in fact among the most critical.
Big opportunities for Big pharma
It is Frost & Sullivan’s opinion that in developed countries a growing trend is represented by the growing popularity of decentralized and rapid tests, but that at the same time the emerging regions still have to deal with the problem of higher costs. Also, as the company underlined, «stringent regulations further complicate product development and marketing». Furthermore, «the low awareness of products among consumers across regions» is another matter of concern, since researches in the diagnostics sector also happen to require massive investments. This is the reason why analysts at the San Antonio-headquartered multi-national believe «companies must invest in clinical studies to prove the efficacy of their products and raise awareness among evidence-driven consumers, especially in the clinical field». As a result, industry analyst Ais Vivekanandan found out that many of the operators Frost & Sullivan interviewed in its inquiry appear to be «focusing their research on top industry requirements such as product automation, rapidity, specificity and accuracy». And, he added, «companies are striving to expand the scope of diseases their products cover also in order to establish their foothold in the global infectious disease diagnostics market». While other sources, such as Dublin-headquartered Research and Markets, predicted the infectious disease diagnostics scenario could rise «at a Compound annual growth rate of 7.9% to reach 18.15 billion dollars by 2019, from 12.42 billion dollars in 2014», a variety of producers are already setting up their strategies to enter the market or to become more aggressive and competitive in the landscape. And their business is about to be driven by the spreading of some well-known re-emerging enemies. The trend was recently witnessed by Wisconsin-based Lucigen Corp, that recently managed to raise some 2 million dollars «from angel investors» to «fund tests needed to win regulatory approval for its rapid molecular diagnostic technology that will initially target Ebola and Clostridium difficile (C Diff)», as sources reported. The company, established in 1998 and already able to develop «a nucleic-acid based test that it says can identify pathogens within 30 minutes using a blood sample and a battery-powered instrument the size of a laptop», is now allegedly about to launch a clinical trial on some 1,000 C Diff patients, and is also looking forward to obtaining the Food and drug administration’s emergency use approval to introduce its rapid Ebola-detection system. On the opposite side of the Atlantic Ocean, the French provider Novacyt, that last year acquired UK-based Lab21’s diagnostic products and services, has announced it has raised 3.1 million euros in a private equity placement that also involved Alto Invest, in order to penetrate new Asian markets and build a sales network in China. But a significant part of the budget should also be addressed to the development of a new generation molecular diagnostic platform targeting Aspergillis and Pneumocystis’ fungal infections, in first place, building upon Lab21’s expertise too. Finally, Italian producer DiaSorin has officially launched its sixth molecular diagnostic test based on the proprietary platform Liaison Iam. The previous Liaison Iam-based tests were designed to address such diseases as Bk Virus (Iam Bkv), Varicella Zoster Virus (Iam Vzv), Toxoplasmosis (Iam Toxo), Parvovirus (Iam Parvo) and Cytomegalovirus (Iam Cmv). The newborn solutions will instead focus on Herpes Simplex Type 1 and 2 (Hsv-1; Hsv-2) and that will possibly help the company boost its business well over the 430 million euros revenue it earned in 2013.