Sample Pages. Companion Diagnostics Market,

Transcription

1 Sample Pages Companion Diagnostics Market,

2 This page is intentionally left blank Copyright 2013 Roots Analysis Private Ltd. All rights reserved. No part of this report should be copied or reproduced in any format without the prior consent of Roots Analysis. The Company accepts no liability, whatsoever, for the actions of third party in this respect.

3 Roche Laboratories had the Most Number of Successful Companion Diagnostics As can be seen from Table 10.4 and Figure 3.4, Roche Laboratories, Novartis and Pfizer were three of the most successful companies in the companion drugs market in Roche was the most active SAMPLE PAGES company in the companion drugs market, with four successful targeted therapies namely Herceptin, Tarceva, Zelboraf, and Vesanoid. These four drugs together booked sales of USD 7,932 MM in 2012, as a result of which Roche captured 35.1% of the entire market. The company also has a rich pipeline of companion drugs. FIGURE 3.4 Companion Drugs Market, by Leading Companies (USD MM, %) 8,771, 38.8% 7,932, 35.1% Roche Laboratories Novartis Pfizer Others 248, 1.1% 5,673, 25.1% Source: Roots Analysis Novartis with two drugs, Imatinib and Nilotinib had a market share of 25.1%, with these drugs generating sales of USD 5,673 MM. Pfizer was the third leading company, with two targeted therapies associated with a companion diagnostic - Xalkori and Selzentry. Xalkori was approved in August 2011 and recorded sales of USD 71.5 MM. Pfizer s other companion drug Selzentry, an anti- HIV medication, recorded sales of USD 176 MM 1. In addition, there are several other companies, such as Celgene, Eli Lilly, Eisai, GSK, and Bristol Myers Squibb, with approved companion drugs. These have been clubbed in the Others category. 1 At the time of report publication, 2012 data for Selzentry was unavailable; as such, we have used 2011 data for the purposes of our analysis Copyright 2013 Roots Analysis Private Ltd. Page 34

4 3.4.1 Trastuzumab (Herceptin): A Successful Example of Personalised Medicine FIGURE 3.6 Herceptin Sales, (USD MM) 7,000 6,000 5,000 4,715 4,862 5,217 5,944 6,281 4,000 3,000 3,135 4,046 2,000 1,000-1,726 1, Dako HercepTest Vysis PathVysion FISH DAKO Her2 FISH pharmdx Invitrogen SPOT-Light HER2 CISH Ventana assays Source: Company Annual Report, Roots Analysis Herceptin, although an example of a successful personalised medicine product, could have achieved significantly higher sales with better diagnostic market preparation. Diaceutics, a UK based consulting company, estimates that Genentech's lack of upfront investment of USD 10 MM - USD 20 MM in driving test adoption and standardisation of the companion diagnostic has potentially cost between USD 2 BN - USD 3 BN in lost revenue in the US alone. SAMPLE PAGES Despite the wide adoption, HER2 testing has been criticised for various reasons, including: 1. Implementation problems including storing and sending samples 2. Complexity of result interpretation 3. Physicians being dragged into test reimbursement issues 4. Slow turnaround of results 5. Insensitive testing techniques Copyright 2013 Roots Analysis Private Ltd. Page 44

5 4.7 Marketed Companion Diagnostics, 2012 There are now several companion diagnostic tests available in the market, some of which are listed in Table 4.1 below. TABLE 4.1 List of Marketed Companion Diagnostic Tests, Companion Drug Cetuximab, Panitumumab Gefitnib Erlotinib Crizotinib Biomarker Diagnostic Test Manufacturer /LDT EGFR ALK Dako EGFR pharmdx Dako VeriStrat Biodesix LDT EGFR mutation testing Lab21 LDT Therascreen EGFR Mutation Detection RGQ Qiagen EGFR 29 Mutations Detection Amoy Diagnostics Abbott ALK test/vysis ALK Break Apart FISH probe kit Abbott Molecular EML4-ALK companion diagnostic test Lab21 LDT Dasatinib SAMPLE Imatinib PAGES Nilotinib Lapatinib Trastuzumab Pertuzumab Rasburicase Philadelphia chromosome/ BCR- ABL Her2/neu G6PD Maraviroc CCR5 Trofile Assay BCR/ABL - t(9;22) by RT-PCR Genzyme Genetics LDT Asuragen/ Life BCR/ABL1 Quant Test Technologies Corporation PathVysion HER-2 DNA Probe Abbott Molecular Dako HER2 FISH pharmdx Dako Denmark A/S Dako HercepTest Dako Denmark A/S SPOT-Light HER2 CISH Life Technologies Corporation InSite Her-2/neu Mouse Monoclonal Antibody (Clone CB11) kit Bond Oracle Her2 IHC System BioGenex Laboratories Leica Biosystems PATHWAY Her 2 (Clone 4B5) Ventana Medical Systems HER2 CISH PharmDx Dako Denmark INFORM HER2 DUAL ISH DNA Ventana Medical Probe Cocktail Systems BinaxNow G6PD Inverness Medical (Checks for fatal side effects) Innovations Monogram Biosciences LDT Denileukin diftitox CD LDT Lenalidomide Chromosome 5q Vysis EGR1 FISH Probe Abbott LDT Arsenic Trioxide PML/RARα Tretinoin translocation - - LDT Source: Roots Analysis 2 Continued on the next page Copyright 2013 Roots Analysis Private Ltd. Page 64

6 5.7 Regional Markets for Companion Diagnostics, Table and Figure 5.7 show our forecasts for the companion diagnostics market in the US, Japan, Germany, France, Italy, Spain, the UK and rest of the world for the period All other European countries apart from EU5 are included in the Rest of the World forecast in this Table. FIGURE 5.7 Companion Diagnostics Market, Short-Mid Term Forecast: , by Leading Countries (USD MM) 1, Rest of the World UK Spain Italy France Germany Japan US Source: Roots Analysis We expect the sales of companion diagnostics in the US market to increase to USD 406 MM in 2018, SAMPLE PAGES growing at a CAGR of 31.3% during the period (Table and Figure 5.7). Growth in the US market will be higher compared to Europe. The primary reasons driving this constant growth will be the increase in market penetration of the recently approved diagnostics and launch of new products. Most of the growth will begin after 2015, as this market has attracted several pharmaceutical companies and diagnostic companies to enter in to partnerships for development of new companion tests post The US will continue to be the biggest individual market for companion diagnostics. Table and Figure 5.8 outline the long term forecast ( ) for this market. We expect the CAGR of the total market to be 26.4% during this period. Copyright 2013 Roots Analysis Private Ltd. Page 72

7 FIGURE 6.1 Abbott Laboratories Sales, by Business Segments (USD MM, %) 2,907, 7.3% 3,071, 7.7% 4,292, 10.8% 6,471, 16.2% 23,133, 58.0% Pharmaceuticals Nutritionals Diagnostics Vascular Others Source: Company Annual Report; Roots Analysis SAMPLE The Diagnostics segment of the company is further categorised PAGES into core laboratory, point of care, and molecular diagnostics. Companion diagnostic tests sold by the company are a part of the molecular diagnostics business. It is estimated that the molecular diagnostics segment generated sales of USD 445 MM in Table and Figure 6.2 provide breakdown of the Diagnostics segment. FIGURE 6.2 Abbott Laboratories Sales, 2012 Diagnostics Segment (USD MM, %) 445, 10.4% 348, 8.1% Core Laboratory Diagnostics Molecular Diagnostics Point of Care Diagnostics 3,499, 81.5% Source: Company Annual Report; Roots Analysis Copyright 2013 Roots Analysis Private Ltd. Page 84

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