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Molecular Diagnostics - Revolution or Hype

  • ID: 28452
  • Report
  • January 2003
  • HBS Medical Limited
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Molecular diagnostic technologies offer the potential for moving from diagnostics to prognostics.

But what is “molecular diagnostics?

By definition, it includes all tests and methods to identify a disease or the predisposition for a disease analyzing Dna- or RNA of an organism.

Still, the market for molecular diagnostics is difficult to estimate as it overlaps with the in vitro diagnostic market and is less well defined than the pharmaceutical or device markets.

But in the post era of accomplishing the “Human Genome Project”, molecular diagnostics is ready to get its due as the legitimate future business trend in healthcare.

The genomic discovery will fuel the diagnostic marketplace because every gene-based therapeutic might need an accompanying (molecular) diagnostic test.

At approximately 30,000 genes for the human genome and with an estimated diagnostic significance of about 5%, the commercialization of 1,500 gene-based tests can be expected.

The way is paved by infectious disease testing and blood banking applications, but pharmacogenetic, predisposition diagnostics and molecular cancer diagnostics applications will follow soon and post strong numbers in the years to come.

Cancer for instance, represents a set of diseases with vast unmet clinical need for improved diagnostics and therapeutics. Cancer in the developed western countries with a prevalence between 1.0 and 1.5% depicts a large market with a high potential for R& D and fields like therapy specific diagnostics (theranostics).

Those segments with significant revenue potential will benefit from the advantages the molecular technologies present: sensitivity, specificity and speed.

In addition, non-invasive or minimal-invasive procedures to obtain the material for those tests will facilitate the implementation. Cross-benefits like almost instant diagnostic results, more targeted therapies and shorter hospitalization times constitute higher costs for molecular test in comparison to traditional analyses like microbiology today. But molecular diagnostics will help to abate cost for diagnosis, therapy and healthcare altogether in the middle-term.

If the expiration of the basic Pcr-licence in 2005 will affect prizes for molecular diagnostic tests remains to be seen, but prizes will drop clearly with the gradually automation of the tests.
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<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">1.Executive Summary 5</P>

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<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">2. Introduction<SPAN style="mso-spacerun: yes">   </SPAN>10</P>

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<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">3. The Current Situation – Public</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Environment & Politics in Europe 17</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">3.1 Public Awareness 17</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">3.1.1 Who is the public 18</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">3.1.2 How to reach the end user 21</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">3.2 Patent situation… 22</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">3.3 Standardisation & Quality Measures 25</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">3.3.1 Harmonization of Standards 25</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">3.3.2 Molecular Diagnostics – quick and</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">impeccable? 28</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">3.3.3 Standardized tests – two sites of a</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">coin 30</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">3.3.4 Who defines the standard? 32</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">3.4 Reimbursement & Prices 33</P>

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<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">4. The Market of Molecular Diagnostics 39</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">4.1 Overview 39</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">4.2 Nucleic acid purification 50</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">4.2.1 The Market 50</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">4.2.2 Driver & Restraints 53</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">4.2.3 Forecasting 55</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">4.3 Nucleic acid Amplification 56</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">4.3.1 The Market 56</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Amplification in infectious disease 57</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Amplification in blood screening 58</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Amplification in genetic testing 58</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">4.3.2 Amplification methods 59</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Polymerase Chain Reaction 59</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">non-PCR amplification techniques 62</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Automation of Amplification Methods 64</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">4.3.4 Driver and Restraints 66</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">4.3.5 Forecasting 68</P>

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<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">5. NAT Applications 71</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">5.1. Blood testing and infectious diseases 71</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">5.1.1 The Market 71</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">5.1.2 Market Influences and Forecast 75</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">5.2. Cancer… 77</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">5.2.1 The Market 77</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">5.2.2 Market Influences and Forecast 79</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">5.3 SNPs - advantage of being a little different 80</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">5.3.1 The Market 80</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">5.3.2 Market Influences and Forecast 84</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">5.4 Food diagnostics 87</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">5.4.1 The Market 87</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">5.4.2 Strategies and Forecasting 89</P>

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<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">6. Trends in Molecular Diagnostics 93</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">6.1 Pharmacogenomics 93</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">6.1.1 The Market 93</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">6.1.2 Market Influences and Forecast 96</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">6.2 DNA Microarrays 101</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">6.2.1 The Technique 101</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">6.2.2 The Market 102</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Identification of sequence 102</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">SNPs 103</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Determination gen expression level 104</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">6.2.3 Emerging Markets of DNA Arrays 103</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Pharmacogenomics 105</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Cancer 106</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Microbiology 107</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Human leukocyte antigen typing 108</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Neonatal screening 108</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">6.2.4 Drivers and restraints 108</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">6.2.5 Forecast 112</P>

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<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">7. Asia – Market of Chance 115</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">7.1 The Market overview 115</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">7.2 Selected Asian markets… 117</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">7.2.1 The Elite 117</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Japan 117</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Australia and New Zealand 118</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">7.2.2 Developing Markets 118</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">China 119</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">India 120</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">7.3 Outlook 122</P>

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<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">8. Companies 124</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">8.1. Merger & Acquisitions 124</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">8.1.1 The Situation 124</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">8.1.2 Merger 125</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Advantages 125</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Disadvantages 125</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Examples 125</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">8.1.3 Alternatives 126</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Strategic allies 126</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Collaborations 126</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Examples 127</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">8.2 Company profile 128</P>

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<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Today, progress in the field of molecular diagnostics does not find a well prepared market. For most technologies and applications, implementation in the clinical area is slow. Even with a high percentage of patients willing to pay for genetic testing, a clear restraint is the current reimbursement policy in most European countries. As a consequence, making headway in the molecular diagnostics field will require not only significant financial investment, but also time and patience. Although innovative start-up companies like ARTUS GmbH, Germany are well recognized in that business, most of the news copy is generated by established industry players like Roche AG, or Bayer Diagnostics, who have formed powerful business units to focus entirely on molecular technologies.</P>

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<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">What drives that business is:</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt"> <o:p></o:p></P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">- The personalization of diagnosis and therapy by the identification of genes associated with complex diseases, optimizing the drug response and reducing side effects and failure rates (pharmacogenetics).</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">- The need for faster methods to diagnose disease states and medical disorders early and to give a powerful and reliable tool for fast therapy decisions (automatization).</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">- The need for automated and easy to handle methods, combining optimized sample preparation, analysis and data evaluation in one (Lab-in-a-box).</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">- The need to contain or decrease costs in the healthcare system without compromise on accuracy or reliability. </P>

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<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Public awareness will play a key role in developing the molecular market. Consumer driven mandates may bring genetic testing into a number of laboratories faster than many medical practitioners are willing to take it on, although molecular applications clearly have the capacity to impact upon medical diagnosis. A “yes or no decision” obtained by traditional diagnostics like the blood glucose test, results in clear implications for the therapy of probably diabetes. For most of the molecular tests however, the outcome indicates a risk that can vary between 10 and 50% for diseases like cancer or certain predispositions. What to make out of it touches ethical issues. Hereditary diseases with a 100% correlation between genotype and phenotype like cystic fibrosis will have an initiator function and can lead the way for service oriented routine diagnostic laboratories. Strong regulatory oversight mechanisms will be needed to strengthen the public and legislative confidence in genotyping tests. Even for tests that have been suitably validated, healthcare professionals who lack the training to interpret the results or counsel patients on the implications of probabilistic risk outcomes, can damage the confidence in the merits of molecular diagnostic tests. As a result, necessary education and counselling guidelines must be made available by companies and the clinical testing-laboratories for both healthcare professionals and patients.</P>

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<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt"><SPAN style="mso-spacerun: yes"> </SPAN>If companies are willing to take risks in the beginning and are able to make their journey to a long-term horizon, they will be successful when the market begins to mature further - a market that will generate royalties and sales three to four times faster than the drug market by having a lower failure rate than therapeutics. Clearly, the growth rate for molecular diagnostics in general will be double-digit with PCR applications having the biggest share. But while being foolproof, tests and technologies must become simpler. Performing such diagnostics from an operator with little or no training will help to drive down the costs. </P>

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<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">For start-up companies, the market is tight: patents and licences for nearly all existing applications promising utilizable markers are claimed. The same holds true for molecular techniques with the PCR remaining the workhorse for molecular genetic analysis. Several modifications such as homogenous amplification assays and parallel detection on DNA microarrays further increase the throughput. This picture won’t change considerably with the expiration of the basic PCR licence, owned by Hoffmann La Roche AG, Switzerland.</P>

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<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">Most of the molecular testing is currently being performed using home-brew methods. Even so, exotic applications (i.e. pathogen detection) or alternative techniques can become successful by filling market niches. Cash-cow-products have to be applicable with today’s existing platform technologies. Without some commonality among the available test formats, clinical laboratories are unlikely to invest - neither in the</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">instrumentation nor applications or staff necessary to perform molecular testing. Quality assurance and standardisation will have a major impact on molecular</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">diagnostics – especially for DNA-chip technologies.</P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt"> <o:p></o:p></P>

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt">In summary, molecular tools have a wide range of potential applications - one of the reasons that optimism for the field is so great. The revolution in diagnostics takes place already – with the urgent need to use what the market on molecular diagnostics is able to offer.</P>
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