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Splitting Molecules, Easing Diagnostics

10-15BThe emergence and growth of personalised and pharmacogenomic medicine is providing tremendous revenue 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) industry in particular is emerging as a powerful healthcare player with tremendous potential. MDx are a class of in vitro diagnostic (IVD) tests that identify nucleic acids, such as DNA. Molecular diagnostic tests may identify nucleic acids that are the genetic material of foreign organisms or the genetic markers of an individual patient. New genes and biomarkers are continually being identified and clinically validated, increasing the 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, fast turnaround time, easy workflow and relatively low-cost compared to other techniques. While many companies offer tests that detect only one or a few genetic changes, some companies have now developed tests capable of detecting large numbers of these changes. Many companies are taking their tests through the traditional diagnostics market strategy of gaining FDA clearance, while others have chosen a different strategy and are offering tests through their own CLIA-certified laboratories. These and other dynamics are effecting rapid change in this evolving field.

Market Dynamics

The global molecular diagnostics analyzers and reagents market is witnessing a period of profound growth. The growth is coming from different regions and markets. The various application and technological sub-segments of molecular diagnostics are also giving the market a big push. The increase in the ageing population and incidences of various chronic diseases are driving the demand of molecular diagnostics world over. The industry is getting a push from every side and many factors collectively are fuelling the growth in this industry.10-15A

Molecular diagnostics is a vital and dynamic field in which yesterday’s new technologies and platforms are today becoming populated with novel, diverse, and useful content. According to a report published by Transparency Market Research, the global molecular diagnostics analyzers and reagents market is anticipated to expand at a CAGR of 11.1 per cent during the period from 2013 to 2019 to reach a value of US$ 8.7 billion by the end of the
forecast period.

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 prevalence 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.

Market Share

Geographically, the United States and EMEA (Europe, Middle East and Africa) markets are the most advanced in terms of 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 under pressure. Under such circumstances, the role (TMA) of preventive medical 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 such 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
  • Influenza
  • Pneumonia
  • Trichomonas Vaginalis
  • Genital Mycoplasma
  • Herpes Simplex Virus
  • Norovirus
  • Rotavirus
  • Tuberculosis
  • Meningitis

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.

Major Players

Nine companies control more than 75 per cent of the global molecular diagnostics market including:

  • Roche Diagnostics
  • Qiagen NV
  • Gen-Probe Incorporated
  • Abbott Diagnostics
  • Siemens
  • Becton Dickinson
  • Cepheid
  • bioMérieux
  • 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 laboratories—600 hospital and 200 independent—now 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.

Roche and Signature Diagnostics:
Roche has acquired Signature Diagnostics for an undisclosed price. The deal is designed to strengthen Roche’s cancer diagnostics effort with Signature’s expertise in both biobanks and next-generation sequencing (NGS) assays, and is the pharma giant’s fifth deal in less than a year focused on molecular diagnostics and data analysis. Signature will be integrated into Roche’s Sequencing Unit and will continue to focus on expanding its genomic signature portfolio. And in April 2014, Roche snapped up IQuum for US$ 275 million upfront and up to US$ 175 million in product-related milestones, with the intent of strengthening its offerings in molecular diagnostics.
Qiagen Netherlands and CLC bio:
Last year, Qiagen purchased CLC bio, which specializes in bioinformatics analysis software. CLC bio’s primary products are CLC Genomics Workbench, which it describes as a comprehensive and user-friendly analysis package for analysing, comparing, and visualizing next-generation sequencing (NGS) data, and CLC Genomics Server, a flexible enterprise-level infrastructure and analysis backbone for NGS data analysis. CLC bio provides bioinformatics solutions for NGS, which can analyse and visualise genomic, transcriptomic, and epigenomic data from all major NGS platforms.
More importantly, CLC’s IT solutions allow nonprogrammers to build resequencing workflows through a graphical user-interface, allowing biologists, clinicians, and other scientists to intuitively build workflows and visualise their datasets through all stages of the analysis at their desks.
PDI, Inc. and Red Path Integrated Pathology:
PDI, Inc., a leading healthcare commercialization company, acquired Red Path Integrated Pathology, a molecular diagnostics company helping physicians better manage patients at risk for certain types of gastrointestinal cancers through its proprietary Pathfinder platform. PDI acquired all of the outstanding shares of Red Path. The Pathfinder testing platform has tremendous untapped potential to deliver a much-needed improvement in diagnostic options for oncologists, gerontologists, pathologists and patients – particularly in pancreatic cancer and other gastrointestinal-related cancers.
Leica Bio-systems and Kreatech Diagnostics:
Leica Bio-systems, which focuses on workflow solutions and automation for cancer diagnostics, added a maker of DNA fluorescent in-situ hybridization (FISH) probes to its portfolio with its 2013 acquisition of molecular diagnostics company Kreatech Diagnostics. The
acquisition, according to Leica, will help support future development of personalized medicine by research and drug-development companies. A provider of probes and target labeling reagents for micro-arrays, Kreatech will be tasked with developing targeted bio-marker menus for
Leica’s instrument platforms. bioMérieux and BioFire Diagnostics: French diagnostics powerhouse bioMérieux acquired privately held U.S. molecular diagnostics company Bio Fire Diagnostics Inc. last September for US $450 million. Specializing in molecular diagnostics, Bio-fire is the inventor, manufacturer, and marketer of the multiplex PCR Film Array system, a simple and rapid
molecular biology solution designed for the diagnosis of infectious diseases.
Illumina and Advanced Liquid Logic:
Last July, Illumina acquired Advanced Liquid Logic (ALL), a provider of liquid-handling solutions. ALL has developed a proprietary, electrowetting-based digital microfluidics technology that performs complex laboratory protocols by manipulating small droplets within a sealed disposable cartridge. Illumina hopes that this technology will enable the delivery of the simplest and most efficient sample-to- answer NGS workflow.
Exosome Diagnostics and Eli Lilly:
Exosome Diagnostics, a developer of bio-fluid-based molecular diagnostics tests, announced last September that it had entered into a collaboration agreement with drug giant Eli Lilly and Co. Centered on cancer PGx bio-marker discovery and validation using Exosome Diagnostic’s proprietary EXO50 nucleic acid extraction kit, the arrangement allows Lilly to gain early access to Exosome Diagnostics’ technology in order to aid in the identification of key gene mutations and expression levels in blood that may be correlated with drug response and disease recurrence.
Illumina and Global Genomics Group (G3):
Sequencing and array technology specialist Illumina entered into a partnership last year with life sciences company G3 with the objective of “investigating novel biomarkers and biological pathways involved in the development and diagnosis of cardiovascular diseases.” The agreement states that Illumina will perform whole genome sequencing for the ongoing Genetic LOci and the Burden of Atherosclerotic Lesions (GLOBAL) clinical study, a large, prospective, international effort focusing on cardiovascular disease biomarkers and drug target discovery that organizers say has the potential to transform how clinicians look at heart disease.
Life Technologies/Thermo Fisher Scientific US and Merck Serono:
Last July, pharmaceutical company Merck Serono entered into a collaboration with biotech- focused Life Technologies—which has since been acquired by Thermo Fisher Scientific—to create new companion diagnostic products. “The nonexclusive agreement covers current and future companion diagnostics projects, with an initial oncology scheme providing the foundation for a long-term collaboration across a potentially broad range of Life [Technologies’] instrument platforms and therapeutic areas,” according to the press release.

These partnerships and acquisitions, in each case, illustrate the trend of IVD companies looking to expand 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.

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