A diagnostic companion is a medical device that, when used as an in-vitro device, serves drug safety and efficacy information. A companion screening examination is performed to determine which patient may gain from a given medication or agree about the form of dose to prescribe. Companion diagnosis is now gaining momentum for the discovery of personalized medicine and drug treatment. Companion diagnosis is often used to evaluate the patient’s molecular profile that helps the patient decide which treatment is going to work. Companion diagnostic therapy relies on identifying a specific biomarker in the patient, and so the existence or lack of a biomarker decides how the patient can respond to the medication. Companion diagnostics enable drug manufacturers to reduce costs by reducing the target audience of people who are most likely to gain from the targeted therapy. Therefore, it is critical for partner diagnostics to rule out the risk of side effects and to reduce the health care expenses associated with treating side effects.
The global companion diagnostics market size was valued at USD 3.3 billion in 2019 and projected to reach USD 8.5 billion by 2027 at a CAGR of 12.55% due to the increasing prominence of personalized medicine and the rising global cancer incidence. The companion diagnostics industry’s development is mostly related to its multiple advantages, the rising need for tailored treatment, and the increasing value of customized medicine, which is projected to drive the global market at a significant growth rate. Furthermore, increasing the pervasiveness of diseases such as cancer and HIV fuel the growth of companion diagnostics as it helps to determine the specific dose and drugs of the patient. Moreover, the high incidence of diseases such as heart disease, HIV, etc., where patient-specific therapy is needed, is increasing demand for the partner’s diagnosis.
However, the rising price of companion diagnostic testing and the unpredictable reimbursement scenario in various regions directly impact market growth to a significant level.
The propelling demand for targeted therapy is projected to fuel the global companion diagnostics market worldwide, at a considerable rate. Some of the primary modalities in medicinal diagnosis (pharmacotherapy) for cancer is targeted therapy or molecularly guided therapy, and some are radioactive and cytotoxic chemotherapy. More excellent knowledge of an individual’s genetic characteristics or biomarkers may encourage the process of prescribing “the best medication for the right person at the right moment, at the proper dosage.” Many targeted therapies will label cancer cells, so they can be easier to identify and killed by the immune system. Some targeted therapies enable to strengthen the immune system to fight cancer stronger. In addition, with the development of genetic sequencing and genomics, drugs are broadly believed to be able to function differently in various people. Furthermore, the pharmaceutical and biopharmaceutical firms are actively seeking to incorporate screening systems for patient selection in the early phases of drug discovery to include the best applicant for targeted therapies, which are estimated to drive the global market.
The rise in the prevalence of cancer across the globe is anticipated to boost the global market. Cancer is a broad group of diseases that can begin in virtually any organ or body tissue. As mutated lymphocytes expand incoherently, go beyond their usual limitations to infiltrate neighboring body parts or spread to other regions. Cancer is the world’s second-largest cause of death, accounting for approximately 9.6 million deaths in 2018, or one in six deaths. In countries with sound health systems, survival levels in several forms in cancers are increasing due to affordable early diagnosis, effective screening, and care for patients. Cancer patients require tailored care as they respond differently to specific medications, and because subsequent diagnostics offer reliable details on the efficacy and protection of medicines in various populations, it is commonly used for cancer diagnosis.
The COVID-19 outbreak recently severely impacted the healthcare system of developed and developing economies. Companion diagnostics are growing to the frontline of diagnosis and medication development. The lockdown and social distancing constraints introduced in COVID-19 across countries have negatively affected the companion diagnostics goods supply chain. The COVID-19 pandemic has ravaged the globe and appears to be a significant research and development field for diagnostic test developers. Numerous methods tend to develop, including the usage of modified, customized medicine systems to meet the need for COVID-19. Diagnostic service suppliers are now changing workloads with emerging technologies to meet the demand for COVID-19 services. For instance, MiraDx has opened its CLIA-certified laboratory to provide test services for COVID-19.
Based on the product and services, the global companion diagnostics market is bifurcated into Assay kits & Reagents, and Software & Services. The assay kits & reagents segment is estimated to hold the largest share over the forecasted period of 2020-2027, across the globe, owing to the access in companion diagnostics of a broad spectrum of assays kits & reagents. In addition, the growing research funding, coupled with the development in the figure of drug detection activities, is estimated to boost the global market.
Based on the technology, the global companion diagnostics market is classified into Polymerase Chain Reaction (PCR), In Situ Hybridization (ISH), Next-Generation Sequencing (NGS), Immunohistochemistry (IHC), and Others. The polymerase chain reaction technology segment is projected to dominate the global market by 2027 to encourage the usage and widespread availability of PCR kits & reagents for accompanying diagnostic research. Additionally, the applications of PCR for high-throughput identification of gene mutants with small or low allheal frequencies is further anticipated to drive the global companion diagnostics market.
However, the next-generation sequencing technology segment is expected to have a significant growth rate due to the upgradation of technology in next-generation sequencing test kits.
Based on the indication, the global companion diagnostics market is segmented into Cardiovascular, Neurological Diseases, Cancer, Infectious Diseases, and Others. The cancer indication segment is estimated to dominate the market by 2027, owing to the rising number of cancer patients worldwide. The stigma of cancer continues to increase globally, trying to exert enormous health, emotional, and financial pressure on patients, friends, governments, and health systems.
However, the cardiovascular indication segment is predicted to have a substantial growth rate due to the increasing geriatric population, unhealthy lifestyle, and the presence of several innovative medications in clinical trials that are additional factors fuelling the global market development.
Based on the end-user, the global companion diagnostics market is segmented into Pharmaceutical & Biopharmaceutical Companies, Reference Laboratories, CROs, and Others. The pharmaceutical and biopharmaceutical company’s end-user segment is estimated to hold the largest share in the global market due to the widespread use of companion diagnostics in such sectors due to their growing popularity in developing drugs and the increasing significance of companion biological markers in diagnostics.
By geography, the global companion diagnostics market is segmented into North America, Europe, Asia Pacific, South America, and Middle East & Africa. North America is estimated to dominate the global market during the forecast period of 2020-2027, owing to the high incidence of cancer and other medical diseases and increasing national healthcare spending. In addition, the increasing technological advances focused on developing companion diagnostic tests for maintaining consistency like neurology are also estimated to hold the largest share of contagious diseases, which is projected to fuel the global companion diagnostic market.
Companies such as Danaher Corporation, NanoString Technologies, Almac Group, Roche, QIAGEN N.V., Abbott Laboratories Inc., Life Technologies, Hoffmann-La Roche AG, Illumina Inc., BioMérieux SA, Exosome Diagnostics Inc., Agilent Technologies Inc., Sysmex Corporation, Thermo Fisher Scientific Inc, Abnova Corporation, Myriad Genetics Inc., Guardant Health Inc., Icon Plc, Protagen Diagnostics, and Biogenex Laboratories Inc. are the key players in the global companion diagnostics market.
By Product & Services