Companion Diagnostics Market is segmented by Product & Service (Assay, Kit, Software & Service), Technology (PCR, NGS, ISH, IHC), Indication (Breast, Lung & Gastric Cancer, Neurological Disease), End-User (Pharma Companies, CRO), and Region (North America, Europe, Asia-Pacific, Middle East & Africa)

Companion Diagnostic is a medical device utilized to provide information needed for a safe and efficient use of a corresponding biological product or drug. The process of using this device requires proper training and handling accompanied by advanced diagnostic technologies to efficiently carry out tests. This device is very sensitive which may lead to variables that can significantly affect the results.

The Companion Diagnostics market is projected to reach USD 6.33 billion by 2031 from USD 3.7 billion in 2022 at 12.9% CAGR.

Market Opportunities and Growth Drivers

The leading driver of growth in this market is the advancement in genetic sequencing and genomics. Different drugs work on different people so proper administration, diagnosis, understanding and essential technologies to support the companion diagnostic device will make it easier for the market to grow significantly.

Another growth driver is the increasing demand for targeted therapy. Most pharmaceutical and biopharmaceutical companies are still trying to implement patient-selection diagnostic frameworks in early phases of developing a drug so that targeted therapies can be provided to the right candidates.

Growth opportunity comes in the form of an increasing demand for the next generation sequencing. NGS companion diagnostic tests aim to unlock molecular information needed to determine a patient’s tumor genome. With this kind of sequencing, diagnosis can be very efficient and time saving. This has the potential of aiding the process of treating various types of cancers.

Restraint: Shortage of trained professionals

The common restraint in the companion diagnostics market is the shortage of able and trained professionals who are knowledgeable in operating and carrying out the tests. This kind of technology has complex and technical process that demands resources that are well-trained.

Companion diagnostic device assays are very sensitive--so a mishandling and lack of information to operate such can contribute to variables that can negatively affect the results. These assays are sensitive to the quantity and purity of the samples, so even a small deviation can cause errors and inferences. This will then be a restraint in terms of carrying out the purpose of the device effectively-- which in turn, would cause the decrease in demand in the market.

Challenges brought upon by COVID-19 pandemic

Another apparent restraint is the negative impact brought upon by the pandemic because of the lock downs and implemented protocols which may have disrupted the supply chain, distribution and manufacturing in facilities of prominent companies. This can be considered a big set back in the growth of the diagnostic devices market because if manufacturing and distribution of products are affected, production and sales will also be negatively affected making it for challenging for these companies to meet demands of end users.

Key Findings in the Companion Diagnostics Market

Companion diagnostics market is segmented in terms of products & services, technology, indication, end user, and region.

Polymerase chain reaction segment is projected to dominate the market in 2022. The large share can be attributed to the availability of PCR kits and its ease of use. Growing applications of PCR in detecting mutants with a limited or low allele frequency of genes, and PCR turnaround time is high compared to other technologies are also its attributes.

In terms of end users, pharmaceutical and bio-pharmaceutical companies can be accounted for having the largest share in the companion diagnostics market in 2022. the large share can be attributed to the increase in demand of using the companion diagnostic bio makers. Personalized medicines for certain target candidates in targeted therapies are the expected drivers of growth in this market.

Country Analysis: Asia Pacific having the highest CAGR

During the forecast period (2022-2031), Asia Pacific region will have the highest growth since this region is estimated to grow at the highest CAGR. Prevalence of cancer cases, advancements in genomics research and proteomics, investments made by pharmaceutical and biotechnology companies are attributes that drive the growth of companion diagnostics market.

Companion Diagnostics Market Key Players

The globally established key players in this market are as follows, Roche Diagnostics, Agilent Technologies, Qiagen, Thermo Fisher, and Abbott Laboratories.

Report Highlights
• Historical data available (as per request)
• Estimation/projections/forecast for revenue and unit sales (2022 – 2031)
• Data breakdown for every market segment (2022 – 2031)
• Gross margin and profitability analysis of companies
• Price analysis of each product type
• Business trend and expansion analysis
• Import and export analysis
• Competition analysis/market share
• Supply chain analysis
• Client list and case studies
• Market entry strategy

Industry Segmentation and Revenue Breakdown

Product & Service Analysis (Revenue, USD Million, 2022 - 2031)

• Assay kits & Reagents
• Software & Services

Technology Analysis (Revenue, USD Million, 2022 - 2031)

• Polymerase Chain Reaction (PCR)
• In Situ Hybridization (ISH)
• Next-Generation Sequencing (NGS)
• Immunohistochemistry (IHC)
• Others (Multiplex Assay and Cellular Imaging Technologies)

Indication Analysis (Revenue, USD Million, 2022 - 2031)

• Cardiovascular
• Neurological Diseases
• Cancer
• Breast Cancer
• Lung Cancer
• Colorectal Cancer
• Melanoma
• Gastric Cancer
• Infectious Diseases
• Others (inflammatory and inherited diseases)

End User Analysis (Revenue, USD Million, 2022 - 2031)

• Pharmaceutical & Biopharmaceutical Companies
• Reference Laboratories
• CROs
• Others (Physicians, Hospitals, Academic Medical Centers, Payers)

Region Analysis (Revenue, USD Million, 2022 – 2031)

• United States
• Canada
• Mexico
• France
• Germany
• Italy
• Spain
• United Kingdom
• Russia
• China
• India
• Philippines
• Malaysia
• Australia
• Austria
• South Korea
• UAE
• Qatar
• Saudi Arabia
• Japan
• Africa
• Rest of World

Available Versions:
• United States Companion Diagnostics Industry Research Report
• Europe Companion Diagnostics Industry Research Report
• Asia Pacific Companion Diagnostics Industry Research Report

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