Companion Diagnostics Market Analysis and Forecast to 2031: By Product & Services (Assays, Kits & Reagents, Software & Services), Technology (Polymerase Chain Reaction, Next-Generation Sequencing, In Situ Hybridization, Immunohistochemistry, Others), Indi

Companion Diagnostics Market Analysis and Forecast to 2031: By Product & Services (Assays, Kits & Reagents, Software & Services), Technology (Polymerase Chain Reaction, Next-Generation Sequencing, In Situ Hybridization, Immunohistochemistry, Others), Indication (Cancer, Neurological Disorders, Cardiovascular Diseases, Infectious Diseases, Others), End User (Pharmaceutical & Biopharmaceutical Companies, Reference Laboratories, Contract Research Organizations, Others), and Region

The global companion diagnostics market was valued at USD 5.9 billion in 2021 and it is anticipated to grow at a CAGR of 11.8% during the forecast period to reach up to USD 18.0 billion by 2031.

Companion diagnostics is a medical device used along with therapeutic drugs to analyze the effect & applicability of drugs on a specific human body. Companion diagnostics are developed along with drugs for selecting or excluding groups of patients based on the characteristics of which they respond to the therapy. This device helps the healthcare professional to analyze whether a particular treatment is beneficial to the patient.

Global Companion Diagnostics Market Scope and Report Structure

Market Trends and Drivers

The key factor such as the growing requirement for targeted medicine is boosting the growth of the market. With advances in genetic sequencing and genomics, it is now extensively believed that drugs can show varying outcomes in different individuals. A better understanding of the genetic characteristics or biomarkers of an individual can promote the practice of administering ‘the right drug, at the right time, at the right dose, for the right person. Pharmaceutical and biopharmaceutical companies are regularly attempting to implement patient-selection diagnostic frameworks in the earlier stages of drug development to provide targeted therapies to the right candidate. This further boosted the growth of the companion diagnostics market.

Similarly, the increasing demand for next-generation sequencing is also refueling the market during the forecast period. NGS-based companion diagnostic target to unlock molecular information from each patient's tumor genome to guide treatment decisions for cancer therapies. Next-generation sequencing detects multiple biomarkers for multiple drug therapies in a shorter time frame as compared to other sequencing techniques. The use of NGS panels for biomarker measurement in one test has the potential to help in the treatment of various types of cancers. The various technological advancements in NGS also provide market players with an immediate competitive edge over players providing other technologies such as PCR, ICH, and ISH. Owing to that, major market players are focusing on developing companion diagnostic products based on NGS.

Market Restraints and Challenges

The key factor hindering the market growth is the lack of awareness of companion diagnostics testing. It is important to build awareness amongst patients, clinicians, and the public regarding the importance of clinical trials. To increase awareness among clinicians, providing special access to the reputable, evidence-based latest information on these new cancer medicines can be helpful. To improve public awareness, increasing access to a common and trusted source of truth is essential. Several publishing houses coupled with industry players provide monthly journals and information leaflets. Stakeholders have also focused on awareness initiatives to ensure patients and providers can access and understand the benefits of companion diagnostics.

Global Companion Diagnostics Market Segmentation

The report analyses the global companion diagnostics market based on product & services, technology, indication, end user, and region.

Global Companion Diagnostics Market by Products & Services

Based on products & services, it is segmented into assays, kits & reagents, software and services. The assay, kits & reagents accounted for the largest share of the companion diagnostics market in 2021. The factors such as the availability of a wide range of products coupled with the increasing use of assays and kits in different therapeutic areas are boosting the growth of the market.

Global Companion Diagnostics Market by Technology

Based on technology, it is segmented into a polymerase chain reaction, next-generation sequencing, In situ hybridization, immunohistochemistry, and others. The PCR segment is likely to dominate the market during the forecast period. Ease of use coupled with the widespread availability of PCR kits & reagents in companion diagnostic testing and growing applications of PCR in the high-throughput detection of mutants with a limited or low allele frequency of genes are some factors boosting the market growth.

Global Companion Diagnostics Market by Indication

Based on indication, it is segmented into cancer, cardiovascular diseases, neurological diseases, infectious diseases, and others. The cancer segment is likely to dominate the market during the forecast period. Factors such as the growing role of companion diagnostics in the personalized medicine treatment for cancer coupled with the increasing utility of biomarkers in the diagnosis of cancer are boosting the market growth.

Global Companion Diagnostics Market by End User

Based on the end user, it is segmented into pharmaceutical & biopharmaceutical companies, reference laboratories, contract research organizations, and others. The pharmaceutical & biopharmaceutical companies segment is likely to dominate the market during the forecast period. The key factors such as the growing use of companion diagnostics owing to their increasing prominence in drug development coupled with the increasing importance of companion diagnostic biomarkers are boosting the market growth.

Geographical Analysis of Companion Diagnostics Market

Region-wise, it is studied across North America, Europe, Asia Pacific, and the Rest of the World. The North American region is likely to dominate the market during the forecast period. The key factors such as the presence of many leading companion diagnostic vendors & national clinical laboratories coupled with the easy accessibility to technologically advanced devices and instruments, and the highly developed healthcare system in the US and Canada.

Major Players in Companion Diagnostics Market

COVID-19 Impact

The emergence of the COVID-19 pandemic has changed the delivery of medical care across the globe. The raised pressure owing to the rising rate of hospitalization of COVID-19 patients had led to the re-profiling of many hospitals and departments for treating patients with COVID-19. The COVID-19 outbreak led to curfews and lockdown across the globe, leading to many diagnostic and treatment procedures had been cancelled or postponed around the world, comprising as many as 2.3 million cancer surgeries according to one study. Clinical trials in oncology have also been affected, with about 170 studies suspended owing to Covid-19, according to a report by Evaluate Vantage. It has mild-moderately affected the growth of the companion diagnostics market. As stringencies with respect to curfews and social distancing become more liberal, the demand is expected to grow, creating a deficit in the market. Still, a resurgence in testing numbers is being seen as countries gradually ease restrictions on movement. Additionally, the demand for companion diagnostic tests is on the rise for the early detection and screening of chronic diseases. These tests also help reduce the side-effects of drugs, improve patient outcomes, provide high diagnostic accuracy and specificity, reduce pharmacotherapy variability, and identify the most-effective targeted therapy options. They are also associated with higher drug development success.

Recent Developments

• May 2021: QIAGEN N.V. (Germany) expanded the therascreen KRAS Kit.
• May 2020: Medical and Biological Laboratories Co. Ltd., announced that it has launched an in vitro diagnostic kit for the genetic disease Spinal Muscular Atrophy. The MEBCDX AAV9 test kits, was licensed from Quest Diagnostics.
• May 2019: QIAGEN N.V. launched the therascreen PIK3CA RGQ PCR kit in PIQRAY therapy in the U.S. to enhance its product portfolio in the Companion Diagnostics Market.
• April 2019: Roche Diagnostics acquired TIB Molbiol Group. This acquisition will enhance Roche’s broad portfolio of molecular diagnostics solutions with a wide range of assays for infectious diseases, such as identifying SARS-CoV-2 variants.

Frequently Asked QuestionsQ. How big is the companion diagnostics market?Ans. The global companion diagnostics market size was USD 5.9 Billion in 2021 and is anticipated to reach USD 18.0 Billion in 2031, growing at a rate of 11.8% from 2022 to 2031.Q. What is the companion diagnostics market growth rate?Ans. The growth rate of the companion diagnostics market is 11.8% from 2022 to 2031.Q. Which region holds a major market share for the companion diagnostics market?Ans. North America holds a major market share of the companion diagnostics market in 2021.Q. Which segment accounted for the largest companion diagnostics market share?Ans. By technology, the PCR segment accounted for the largest companion diagnostics market share.Q. Who are the key players in the companion diagnostics market?Q. What are the factors driving the companion diagnostics market growth?Ans. The major factors driving the growth of the market are the increasing demand for next-generation sequencing.Q. What are the key growth strategies of companion diagnostics market players?Ans. The key growth strategies of companion diagnostics market players are product launch and product approval.Q. Which region will provide more business opportunities for the companion diagnostics market during the forecast period?Ans. The Asia-Pacific region will provide more business opportunities for the companion diagnostics market during the forecast period.

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