Nearly 50% of Prescribed Drugs/Therapies Fail to Show Adequate Clinical Benefits
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.
Table of Contents
Executive Summary
Chapter Summary:
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 the 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 until 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.
Companies Mentioned
- AB-Biotics
- ANGLE
- ARIAD Pharmaceuticals
- ARUP Laboratories
- AVEO Oncology
- AbbVie
- Abbott Laboratories
- Abcam
- Abnova
- Acobiom
- AdnaGen
- Advanced Cell Diagnostics
- Agena Bioscience
- Agendia
- Agilent Technologies
- Agios Pharmaceuticals
- Alere
- Allele Frequency Community
- Allergan
- Almac
- Alpha Laboratories
- AltheaDx
- Altona Diagnostics
- Amgen
- Amoy Diagnostics
- Angsana Molecular & Diagnostics Laboratory
- Applied Spectral Imaging
- ArcherDX
- Arno Therapeutics
- Array BioPharma
- Arrayit
- Assurex Health
- Astellas Pharma
- AstraZeneca
- Asuragen
- Avant Diagnostics
- Bayer
- BeiGene
- BioGenex
- BioMarin
- Biocartis
- Biodesix
- Biotype Diagnostic
- Bliss Biopharmaceutical
- Blueprint Medicines
- Boehringer Ingelheim
- Bristol-Myers Squibb
- CANbridge Life Sciences
- CBLPath
- Cancer Genetics
- Celgene
- Cell Signaling Technology
- Clovis Oncology
- Corgenix
- Counsyl
- Daiichi Sankyo
- DalCor Pharmaceuticals
- Definiens
- Dian Diagnostics Group
- Eli Lilly
- Epic Sciences
- Epizyme
- European Organization for the Research and Treatment of Cancer
- Exact Sciences
- Exiqon
- Exosome Diagnostics
- Ferring Pharmaceuticals
- Five Prime Therapeutics
- Flagship Biosciences
- Flatiron Health
- Foundation Medicine
- Galmed Pharmaceuticals
- GenDx
- GeneCast Biotechnology
- Genomas
- Genomic Health
- Genoptix
- Genosity
- Gilead Sciences
- GlaxoSmithKline
- Guangzhou KingMed Diagnostics Group
- Guardant Health
- HTG Molecular Diagnostics
- HalioDx
- Halozyme Therapeutics
- Hitachi
- Horizon Discovery
- IDbyDNA
- IQVIA
- Idera Pharmaceuticals
- Ignyta
- Illumina
- Immuron
- InDex Pharmaceuticals
- Incyte
- IndivuTest
- Inotrem
- Invivoscribe
- Janssen Biotech
- Jiangsu Hengrui Medicine
- Johnson & Johnson
- Lab21
- LabCorp
- Labceutics
- Leica Biosystems
- Life Technologies
- LipoScience
- Locus Biosciences
- Loxo Oncology
- Luminex
- Luxcel Biosciences
- MDxHealth
- Medical & Biological Laboratories
- Medivation
- Merck
- Merrimack Pharmaceuticals
- MetaStat
- MicroMatrices
- Mirati Therapeutics
- MolecularMD
- Monogram Biosciences
- Mount Sinai Health System
- Myriad Genetics
- N-of-One
- NanoString Technologies
- National Institute of Pathology
- NeoGenomics
- NeuMoDx Molecular
- Nichirei Biosciences
- Novartis
- Novo Nordisk
- NuSirt Biopharma
- OWL Metabolomics
- OmicSoft
- OmniSeq
- OncoMed Pharmaceuticals
- Ono Pharmaceutical
- PerkinElmer
- Pfizer
- Philips
- Phoenix Molecular Designs
- Pierre Fabre
- ProSciento
- Protagen
- Puma Biotechnology
- Q2 Solutions
- QED Therapeutics
- QIAGEN
- Quest Diagnostics
- R-Biopharm
- Resonance Health
- Riken Genesis
- Roche
- SRL Diagnostics
- STATdx
- Sanofi
- Sarah Cannon Research Institute
- School for Oncology and Developmental Biology
- Seahorse Bioscience
- Shuwen Biotech
- Siemens Healthineers
- Singulex
- Sividon Diagnostics
- Spectrum Pharmaceuticals
- Streck
- Sysmex
- TESARO
- Takeda Pharmaceuticals
- Teva Pharmaceutical
- The Jackson Laboratory
- Therawis Diagnostics
- Thermo Fisher Scientific
- Tokai Pharmaceuticals
- Turning Point Therapeutics
- USC Michelson Center for Convergent Bioscience
- Unilabs
- Vivia Biotech
- Walgreens
- Wondfo
- XCR Diagnostics
- bioMérieux
- uBiome
Methodology
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