Companion Diagnostics Market (2 Edition), 2019-2030

Companion Diagnostics Market (2 Edition), 2019-2030

The introduction of personalized medicine has brought about a paradigm shift within the healthcare sector. Over the years, many cases have been identified where conventional treatment options have failed to demonstrate any therapeutic benefit. It is estimated that nearly 50% of prescribed drugs / therapies fail to show adequate clinical benefits. In fact, adverse drug-related reactions / side effects are reported to be the fourth leading cause of death in the US. To mitigate challenges associated with adverse drug reactions, there are multiple therapeutic products in the market, and many more under development, which have been tailored to effectively treat disease with unique molecular / genetic signatures.

Personalized therapies demand companion diagnostics to make physicians aware of patients’ unique genetic profiles, thereby, enabling them to make informed decisions. A study of nearly 200 unique pharmacological interventions, across 670 clinical trials, concluded that the likelihood of a lead compound passing through all the phases of clinical development and eventually getting approved is only 11%. The same study highlighted that correlating disease-specific biomarker data with therapeutic susceptibility and using this information to recruit patients for clinical research demonstrated a six fold increase in trial success rates. It is also worth highlighting that companion diagnostic guided drug development efforts have been estimated to help reduce clinical trial costs by almost 60%.

Since the approval of the HercepTest™ (in 1998) for identifying patients for treatment with trastuzumab, over 50 companion diagnostics have been developed for various drugs. Further, several companies have also undertaken initiatives to develop biomarker-based therapeutics for other disease indications, such as infectious diseases, neurological disorders and metabolic disorders. Industry stakeholders are forging strategic alliances with diagnostic developers to develop diagnostic solutions for a diverse array of drugs / therapies. Such initiatives are focused on improving clinical trial success rates, and subsequently optimizing R&D expenditure in the pharmaceutical industry.

SCOPE OF THE REPORT
The “Companion Diagnostics Market (2nd Edition), 2019-2030” report features an extensive study of the current market landscape and the likely adoption of these diagnostic tests over the next decade. The study features an in-depth analysis, highlighting the capabilities of the various stakeholders in this domain. In addition to other elements, the study includes:

A detailed assessment of the current market landscape of companies offering companion diagnostics, including information on their geographical location, corresponding drug(s) / drug class, affiliated biomarker, assay technique involved (in situ hybridization (ISH), immunohistochemistry (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR) and others), therapeutic area (oncological disorders, infectious diseases, metabolic disorders, neurological disorders, inflammatory disorders and others) and the type of sample required (tumor tissue, blood, bone marrow and others).

Detailed profiles of developers of companion diagnostics (shortlisted on the basis of the strength of product portfolio), featuring an overview of the company, its financial information (if available), a detailed description of companion diagnostics available / under development and recent collaborations. In addition, each profile includes a list of the likely strategies that may be adopted by these players to support future growth.

A detailed brand positioning analysis of leading industry players (shortlisted on the basis of strength of product portfolio), highlighting the current perceptions regarding their proprietary brands, taking into consideration several relevant aspects, such as strength of product portfolio, geographical presence / reach, recent collaborations, diversity in therapeutic focus and overall market position of each company.

An analysis of the partnerships and collaborations pertaining to companion diagnostics, featuring a comprehensive set of analyses based on various parameters, such as the type of partnership, affiliated biomarkers, therapeutic areas and the most active players.

A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in this domain.

A discussion on various steps of the development operations, namely research and development, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing / sales activities, of a companion diagnostic and the cost requirements across each of the aforementioned stages.

A comprehensive analysis of completed, ongoing and planned clinical trials featuring the key biomarkers across different type of therapies and cancer indications. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, key indications, type of therapy, biomarkers evaluated, enrolled patient population and regional distribution of trials.

One of the key objectives of the report was to estimate the existing market size and the future opportunity for companion diagnostics developers, over the next decade. Based on multiple parameters, such as the disease incidence, adoption of companion diagnostic tests and the likely prices, we have provided informed estimates on the evolution of the market for the period 2019-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] different therapeutic areas (oncological disorders (breast cancer, colorectal cancer, leukemia, lymphoma, melanoma, non-small cell lung cancer and ovarian cancer) and non-oncological disorders (Alzheimer’s disease and HIV/AIDs), [B] important assay techniques (in situ hybridization (ISH), immune histochemistry (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR) and others) and [C] key geographical regions (US, EU5, Japan, China and Australia). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in this study were also influenced by discussions conducted with stakeholders in this domain. All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the current state of the market for companion diagnostics, in the short-mid term and long term.

Chapter 3 is an introductory chapter that highlights the importance of companion diagnostics in relation to personalized medicine. The chapter describes the approaches used to develop a companion diagnostic, along with information on the various analytical techniques used in such tests. It also provides details on key market drivers and challenges within this industry.

Chapter 4 provides a list of companion diagnostics designed for different drugs. It includes information on the corresponding drug(s) / drug class and detailed analysis on the affiliated biomarker, assay technique involved (in situ hybridization (ISH), immunohistochemistry (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR) and others), therapeutic area (oncological disorders, infectious diseases, metabolic disorders, neurological disorders, inflammatory disorders and others), the type of sample required (tumor tissue, blood, bone marrow and others) and the developer details (such as company size and location of company headquarters).

Chapter 5 provides detailed profiles of some of the leading stakeholders in this field (shortlisted on the basis of the strength of product portfolio). Each profile presents a brief overview of the company, financial information (if available), product portfolio, recent collaborations and an informed future outlook.

Chapter 6 provides an elaborative brand positioning analysis of the leading industry players (shortlisted on the basis of the strength of product portfolio) highlighting the current perceptions regarding their proprietary brands across their companion diagnostic portfolio, taking into consideration several aspects, such as strength of product portfolio, geographical presence / reach, recent collaborations, diversity in therapeutic areas and the overall market positioning of the players.

Chapter 7 features an elaborate analysis and discussion of the various collaborations and partnerships that have been inked amongst players since 2014. It includes a brief description of various types of partnership models (which include acquisitions, licensing agreements, product development and commercialization agreements, research and development agreements, distribution and supply agreements, service alliances and other agreements) that have been adopted by stakeholders in this domain. It also includes a schematic representation that showcases the companies that have established the maximum number of alliances, highlighting key technologies and disease indications.

Chapter 8 provides information on the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in this domain. The chapter qualitatively assesses the various companion diagnostics-related needs of these stakeholders, highlighting their respective perspectives regarding the importance of each need.

Chapter 9 presents a value chain analysis featuring a discussion on various steps of the development operations, namely R&D development, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing activities, of a companion diagnostic and the cost requirements across each of the aforementioned stages.

Chapter 10 provides a comprehensive clinical trial analysis of completed, ongoing and planned studies of various therapies for oncological disorders being sponsored by the top pharmaceutical players. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, key indications, type of therapy, biomarkers evaluated, enrolled patient population and regional distribution of trials

Chapter 11 features a comprehensive market forecast analysis, highlighting the likely growth of companion diagnostics till the year 2030. We have provided inputs on the likely distribution of the opportunity based on the type of therapeutic area (oncological disorders (breast cancer, colorectal cancer, leukemia, lymphoma, melanoma, non-small cell lung cancer and ovarian cancer) and non-oncological disorders (Alzheimer’s disease and HIV)), key contributing technologies (in situ hybridization (ISH), immune histochemistry (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR) and others), different regions North America (the US), Europe (the UK, Spain, Italy, France and Germany) and Asia Pacific (Japan, China and Australia).

Chapter 12 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it captures the evolutionary trends that are likely to determine the future of this segment of the companion diagnostics industry.

Chapter 13 is a collection of interview transcript(s) of discussions held with industry stakeholders, wherever the participants didn’t request anonymity.

Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 15 is an appendix, which contains a list of companies and organizations mentioned in this report.

LIST OF COMPANIES

The following companies and organizations have been mentioned in the report:

1. AB-Biotics
2. Abbott Laboratories
3. AbbVie
4. Abcam
5. Abnova
6. Acobiom
7. AdnaGen
8. Advanced Cell Diagnostics
9. Agena Bioscience
10. Agendia
11. Agilent Technologies
12. Agios Pharmaceuticals
13. Alere
14. Allergan
15. Allele Frequency Community
16. Almac
17. Alpha Laboratories
18. AltheaDx
19. Altona Diagnostics
20. Amgen
21. Amoy Diagnostics
22. ANGLE
23. Angsana Molecular & Diagnostics Laboratory
24. Applied Spectral Imaging
25. ArcherDX
26. ARIAD Pharmaceuticals
27. Arno Therapeutics
28. Array BioPharma
29. Arrayit
30. ARUP Laboratories
31. Assurex Health
32. Astellas Pharma
33. AstraZeneca
34. Asuragen
35. Avant Diagnostics
36. AVEO Oncology
37. Bayer
38. BeiGene
39. Biocartis
40. Biodesix
41. BioGenex
42. BioMarin
43. bioMérieux
44. Biotype Diagnostic
45. Bliss Biopharmaceutical
46. Blueprint Medicines
47. Bristol-Myers Squibb
48. Boehringer Ingelheim
49. CANbridge Life Sciences
50. Cancer Genetics
51. CBLPath
52. Celgene
53. Cell Signaling Technology
54. Clovis Oncology
55. Corgenix
56. Counsyl
57. Daiichi Sankyo
58. DalCor Pharmaceuticals
59. Definiens
60. Dian Diagnostics Group
61. Eli Lilly
62. Epic Sciences
63. Epizyme
64. European Organization for the Research and Treatment of Cancer
65. Exact Sciences
66. Exiqon
67. Exosome Diagnostics
68. FALCO biosystems
69. Ferring Pharmaceuticals
70. Five Prime Therapeutics
71. Flagship Biosciences
72. Flatiron Health
73. Foundation Medicine
74. Galmed Pharmaceuticals
75. GenDx
76. GeneCast Biotechnology
77. Genomas
78. Genomic Health
79. Genoptix
80. Genosity
81. Gilead Sciences
82. GlaxoSmithKline
83. Guardant Health
84. Guangzhou KingMed Diagnostics Group
85. HalioDx
86. Halozyme Therapeutics
87. Hitachi
88. Horizon Discovery
89. HTG Molecular Diagnostics
90. IDbyDNA
91. Idera Pharmaceuticals
92. Ignyta
93. Illumina
94. Immuron
95. Incyte
96. InDex Pharmaceuticals
97. IndivuTest
98. Inotrem
99. Invivoscribe
100. IQVIA
101. Janssen Biotech
102. Jiangsu Hengrui Medicine
103. Johnson & Johnson
104. Lab21
105. Labceutics
106. LabCorp
107. Leica Biosystems
108. Life Technologies
109. LipoScience
110. Locus Biosciences
111. Loxo Oncology
112. Luminex
113. Luxcel Biosciences
114. MDxHealth
115. Medical & Biological Laboratories
116. Medivation
117. Merck
118. Merrimack Pharmaceuticals
119. MetaStat
120. MicroMatrices
121. Mirati Therapeutics
122. MolecularMD
123. Monogram Biosciences
124. Mount Sinai Health System
125. Myriad Genetics
126. NanoString Technologies
127. National Institute of Pathology
128. NeoGenomics
129. NeuMoDx Molecular
130. Nichirei Biosciences
131. N-of-One
132. Novartis
133. Novo Nordisk
134. NuSirt Biopharma
135. OmicSoft
136. OmniSeq
137. OncoMed Pharmaceuticals
138. Ono Pharmaceutical
139. OWL Metabolomics
140. PerkinElmer
141. Pfizer
142. Philips
143. Phoenix Molecular Designs
144. Pierre Fabre
145. ProSciento
146. Promega
147. Protagen
148. Puma Biotechnology
149. Q2 Solutions
150. QED Therapeutics
151. QIAGEN
152. Quest Diagnostics
153. R-Biopharm
154. Resonance Health
155. Riken Genesis
156. Roche
157. Sanofi
158. Sarah Cannon Research Institute
159. School for Oncology and Developmental Biology
160. Seahorse Bioscience
161. Shuwen Biotech
162. Siemens Healthineers
163. Singulex
164. Sividon Diagnostics
165. Spectrum Pharmaceuticals
166. SRL Diagnostics
167. STATdx
168. Streck
169. Sysmex
170. Takeda Pharmaceuticals
171. Teva Pharmaceutical
172. TESARO
173. The Jackson Laboratory
174. Therawis Diagnostics
175. Thermo Fisher Scientific
176. Tokai Pharmaceuticals
177. Turning Point Therapeutics
178. uBiome
179. Unilabs
180. USC Michelson Center for Convergent Bioscience
181. Vivia Biotech
182. Walgreens
183. Wondfo
184. XCR Diagnostics