The emergence and growth of personalised andÂ pharmacogenomic medicine is providing tremendous revenueÂ opportunities for molecular diagnostics industry, writes Anshuman Ojha of Elets News Network (ENN)
Advancing technologies are pushing the diagnostics industry to the fore, and the molecular diagnostics (MDx)Â industry in particular is emerging as a powerful healthcare player with tremendous potential. MDx are aÂ class of in vitro diagnostic (IVD) tests that identify nucleic acids, such as DNA. Molecular diagnostic testsÂ may identify nucleic acids that are the genetic material of foreign organisms or the genetic markers of anÂ individual patient. New genes and biomarkers are continually being identified and clinically validated, increasing theÂ number of different tests available. The requisite technology and instruments are advancing in tandem.
Molecular diagnostic tests continue to be the fastest growing segment within the IVD space, driven by high sensitivity,Â fast turnaround time, easy workflow and relatively low-cost compared to other techniques. While many companies offerÂ tests that detect only one or a few genetic changes, some companies have now developed tests capable of detecting largeÂ numbers of these changes. Many companies are taking their tests through the traditional diagnostics market strategyÂ of gaining FDA clearance, while others have chosen aÂ different strategy and are offering tests through their ownÂ CLIA-certified laboratories. These and other dynamicsÂ are effecting rapid change in this evolving field.
The global molecular diagnostics analyzers and reagentsÂ market is witnessing a period of profound growth. TheÂ growth is coming from different regions and markets.Â The various application and technological sub-segmentsÂ of molecular diagnostics are also giving the market a bigÂ push. The increase in the ageing population and incidencesÂ of various chronic diseases are driving the demand ofÂ molecular diagnostics world over. The industry is gettingÂ a push from every side and many factors collectively areÂ fuelling the growth in this industry.
Molecular diagnostics is a vital and dynamic field inÂ which yesterdayâs new technologies and platforms areÂ today becoming populated with novel, diverse, and usefulÂ content. According to a report published by TransparencyÂ Market Research, the global molecular diagnosticsÂ analyzers and reagents market is anticipated to expandÂ at a CAGR of 11.1 per cent during the period from 2013 toÂ 2019 to reach a value of US$ 8.7 billion by the end of the
Reagents occupy the largest market share and will also register the maximum growth rate in the forecasted period 2013-2019. These reagents include assays that detect and diagnose diseases and are also used as biomarkers that predict the biological properties of the potential drug compounds. Based on end users, hospitals was the largest segment in 2014, whereas reference laboratories will grow at the highest CAGR between 2013 and 2019. Reference laboratories carry out complex, specialised, and obscuretests. The government regulations to cut down healthcare costs will lead to the rise in the reference laboratories segment. Therefore, reference laboratories are estimated to grow at highest CAGR.
The government regulations to cut down healthcare costs will lead to the rise in the reference laboratories segment
The infectious diseases market segment dominates the global molecular diagnostics market based on application, holding 60 per cent of the overall market. The market for genomics and for blood donor screening jointly hold the remaining portion of the industry. The rising prence of hospital acquired infections (HAI) has stimulated the market for molecular diagnosis in the field of infectious diseases, resulting in the rise of the HAI testing market within the segment. This market is expected to grow at a CAGR of 15.1 per cent during the forecast period. Additionally, the rise in the incidence of cervical cancer caused by human papilloma virus (HPV) is giving rise to HPV testing, supporting the infectious diseases market segment. The HPV testing market is expected to develop at a CAGR of 14.8 per cent between 2013 and 2019. Furthermore, the markets for HLA typing testing and oncology testing within the genomics segment are also anticipated to register a rapid growth rate during the forecast period.
The future growth is expected to come from genetic testing, blood screening testing and neurological testing.
Geographically, the United States and EMEA (Europe, Middle East and Africa)Â markets are the mostÂ advanced in terms ofÂ adoption of molecular testing and make up the majority of the existing market.
However, Japanese molecular diagnostics market is promising with the ageing population and a declining birth rate is putting the whole Japanese healthcare system underÂ pressure. Under suchÂ circumstances, the role (TMA) of preventive medicalÂ care is increasingly important.
China and India molecular diagnostics market is one of the lucrative markets to rollout the diagnosis business. Rapid economic advancement of China and India has led to an increase in the purchasing power of a growing segment of the populace. This coupled with an emerging mindset toward wellness, preventive medicine, and access to cutting-edge products and services and makes the future outlook extremely positive for this new field in clinical care. The provision of new and cutting-edge molecular tests is likely to be followed by greater affordability with prices coming down due to return on investment, competition, and technology advancement.
The technologies that constitute molecular diagnostics–like first-generation amplification, DNA probes, fluorescent in situ hybridization (FISH), second- generation biochips and micro-fluidics, next-generation signal detection, biosensors, and molecular labels are influencing the discovery of therapeutic molecules, the screening and diagnosis of patients, and the optimisation of drug therapy.
Molecular Diagnostics Testing – Next Level
In the current medical diagnostics market, molecular diagnostics in infectious disease testing offers one of the most promising areas for growth and innovation. The confluence of breakthroughs in genomics and proteomics–along with the development of microarray devices to measure analytes in the blood–has led to this revolutionary market development. Specifically, molecular diagnostics offers the power of advanced analytical techniques to diagnose infectious diseases. Whereas before, the detection of many infectious agents was slow and expensive due to reliance upon culturing methods, researchers are now at the cusp of overcoming suchÂ limitations via the use of nucleic acid-mediated molecular diagnostics testing.
The infectious diseases market segment dominates the global MDx market, holding 60 per cent of the overall market
New molecular diagnostic tests are regularly introduced to the market for screening or diagnosing a wide range of patient types for numerous diseases. Manufacturers are rapidly introducing molecular diagnostic tests for additional types of infectious disease. Following is a list of such tests that are relatively new to the market:
- West Nile Virus
- Clostridium Difficile (C-diff)
- Methicillin-resistant Staphylococcus Aureus (MRSA)
- Respiratory Syncytial Virus
- Trichomonas Vaginalis
- Genital Mycoplasma
- Herpes Simplex Virus
Clostridium Difficile and MRSA, two tests for healthcare-associated infections (HAI), have seen the highest level of adoption. In the U.S. alone, direct medical costs attributed to HAIs total as much as US $34 billion. This creates the incentive for providers to use molecular diagnostic-based screens for risk mitigation.
Nine companies control more than 75 per cent of the global molecular diagnostics market including:
- Roche Diagnostics
- Qiagen NV
- Gen-Probe Incorporated
- Abbott Diagnostics
- Becton Dickinson
- Beckman Coulter
Roche tops the list of large molecular diagnostics companies with an extensive product portfolio including molecular diagnostic tests for oncology, virology, microbiology, and blood screening.
Approximately 800 medical laboratoriesâ600 hospital and 200 independentânow perform high-volume testing requiring automated molecular diagnostic testing platforms and systems for simplifying and accelerating specimen preparation.
The rapidly changing and increasingly competitive landscape of diagnostics continues to stimulate increased demand for molecular testing, particularly in the area of infectious disease. Consequently, accelerating advances in technology and genetic and proteomic research are sure to reveal new and untapped opportunities in molecular diagnostic testing.
Acquisitions and Joint Ventures
When collaboration is not possible or not desired by both parties, an outright buy is often the preferred tactic. A dynamic market also encourages players to bolster their offerings with acquisitions, collaborations, and licensing agreements. The following deals in molecular diagnostics are of particular interest, though scores of mergers have occurred in the past year.
These partnerships and acquisitions, in each case, illustrate the trend of IVD companies looking to expandÂ their footprint by obtaining access to technologies and capabilities they presently do not have in-house. No let down in such collaborations and acquisitions is anticipated any time soon. According to Kalorama Information, one can expect to soon see a steady stream of molecular tests and technologies come to market.
Direct medical costs attributed to hospital acquired infections total as much as US $34 billion
Molecular testing has proven its worth in the area of infectious diseases, but the great promise of personalised medicine in oncology and some chronic diseases has yet to come to fruition. Throughout the developed world, healthcare payers have looked at these tests with great scrutiny and are cutting reimbursement rates.
This tenuous environment will continue for the foreseeable future as companies learn to promote the value of their tests for improved patient care that will save the healthcare system money. Rapid growth of genomics knowledge and technology is expected to continue, and with it more life-saving applications in medical science. While analytical instrument companies will remain at the forefront of developing new technologies for scientific applications, commercializing the technologies for clinical diagnostics applications will require an increasingly complex commercial infrastructure.