Companion Diagnostics Market: Current Analysis and Forecast (2021-2027)

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The companion diagnostics market is expected to witness a CAGR of around 16% during the forecast period (2021–2027). Companion diagnostic is a diagnostic test used as a companion to a therapeutic drug to determine its applicability to a specific person. Moreover, the demand for companion diagnostic tests is on the rise for the early detection and screening of various cancers such as breast cancer, lung cancer, colorectal cancer, gastric cancer, melanoma, and chronic diseases also. In addition, growing research and development activities in the laboratories are also expected to drive the demand for companion diagnostics over the forecast period. For instance, according to ILAC MRA (International Laboratory Accreditation Cooperation) and Signatories, in 2021, almost 85,000 laboratories, almost 13,000 inspection bodies, over 600 proficiency testing providers, and 250 reference material producers were accredited globally.  

Some of the major companies operating in the companion diagnostics market include Labcorp Drug Development, Agilent Technologies, Myriad Genetic Laboratories Inc, Qiagen, Roche Molecular Systems Inc, Abbott, Foundation Medicine Inc, Ventana Medical Systems Inc, Illumina Inc, Life Technologies Corporation

Insights Presented in the Report

“Amongst indication, the breast cancer category accounted for the significant share in the market in 2020”

Based on indication, the companion diagnostics market is segmented into breast cancer, lung cancer, colorectal cancer, gastric cancer, and others. Among these, the breast cancer category is anticipated to witness a lucrative growth rate during the forecast period. This is mainly due to the rising cases of cancer, and in the geriatric population because most of the breast cancers occur in women over the age of 50. Moreover, companion diagnostics are also helpful in the treatment and diagnosis of lung, prostate, colon, rectal, and skin cancer. For instance, according to the American Cancer Society (ACS), in 2022, around 26,380 new cases of stomach cancer and around 11,090 deaths from this type of cancer are reported in the U.S.  

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“Amongst technology, the real-time-polymerase chain reaction category is expected to witness the significant CAGR during the forecast period”

Based on technology, the companion diagnostics market is segmented into real-time-polymerase chain reaction (RT-PCR), gene sequencing, In situ hybridization, and others. The real-time-polymerase chain reaction (RT-PCR) category is anticipated to witness a considerable growth rate during the forecast period. This is mainly due to the RT-PCR technique being effective in detecting cancer and chronic diseases with ease and accuracy. Moreover, major market companies are working on the development of new products and technologies these factors are also contributing to the growth of this market during the forecast period. For instance, in addition, in July 2021, Labcorp launched therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who are eligible for therapy with LUMAKRAS (sotorasib), a novel therapeutic option developed by Amgen.  

“North America to witness significant growth during the forecast period”

For a better understanding of the market, the report provides a detailed analysis of major regions and countries including North America (U.S., Canada, Rest of North America); Europe (Germany, U.K., France, Spain, Italy, Rest of Europe); Asia-Pacific (China, India, Japan, Rest of Asia-Pacific) and Rest of World. North America accounted for a considerable market share during the forecast period. The large hospital administration of the patients, rising demand for diagnostic devices due to the surge of cancer & chronic disease, and the presence of medical device manufacturers in the region. These factors will drive the growth of the market during the forecast period in the region. For instance, according to the California Institute for Regenerative Medicine (CIRM) prostate cancer is the second leading cause of cancer death among men in the U.S., with a 60% occurrence rate in men over the age of 65. Approximately 61,860 patients are expected to die from prostate cancer in California in the year 2021.

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Reasons to buy this report:

• The study includes market sizing and forecasting analysis validated by authenticated key industry experts.
• The report presents a quick review of overall industry performance at one glance.
• The report covers an in-depth analysis of prominent industry peers with a primary focus on key business financials, product portfolio, expansion strategies, and recent developments.
• Detailed examination of drivers, restraints, key trends, and opportunities prevailing in the industry.
• The study comprehensively covers the market across different segments.
• Deep dive regional level analysis of the industry.

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Research Methodology

Research Methodology for the Companion Diagnostics Market Analysis (2021-2027)

Analyzing the historical market, estimating the current market, and forecasting the future market of the companion diagnostics market were the three major steps undertaken to create and analyze the adoption of the companion diagnostics market in major regions globally. Exhaustive secondary research was conducted to collect the historical market numbers and estimate the current market size. Secondly, to validate these insights, numerous findings and assumptions were taken into consideration. Moreover, exhaustive primary interviews were also conducted, with industry experts across the value chain of the companion diagnostics market. Post assumption and validation of market numbers through primary interviews, we employed a top-down/bottom-up approach to forecasting the complete market size. Thereafter, market breakdown and data triangulation methods were adopted to estimate and analyze the market size of segments and sub-segments of the industry pertains to. Detailed methodology is explained below:

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Analysis of Historical Market Size

Step 1: In-Depth Study of Secondary Sources:

Detail secondary study was conducted to obtain the historical market size of the companion diagnostics market through company internal sources such as annual reports & financial statements, performance presentations, press releases, etc., and external sources including journals, news & articles, government publications, competitor publications, sector reports, third-party database, and other credible publications.

Step 2: Market Segmentation:

After obtaining the historical market size of the companion diagnostics market, we conducted a detailed secondary analysis to gather historical market insights and share for different segments & sub-segments for major regions. Major segments are included in the report as an indication and technology. Further country-level analyses were conducted to evaluate the overall adoption of testing models in that region.

Step 3: Factor Analysis:

After acquiring the historical market size of different segments and sub-segments, we conducted a detailed factor analysis to estimate the current market size of the companion diagnostics market. Further, we conducted factor analysis using dependent and independent variables such as various indication and technology of the companion diagnostics market. A thorough analysis was conducted for demand and supply-side scenarios considering top partnerships, mergers and acquisitions, and business expansion, in the companion diagnostics market sector across the globe.

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Current Market Size Estimate & Forecast

Current Market Sizing: Based on actionable insights from the above 3 steps, we arrived at the current market size, key players in the companion diagnostics market, and market shares of the segments. All the required percentage shares split, and market breakdowns were determined using the above-mentioned secondary approach and were verified through primary interviews.

Estimation & Forecasting: For market estimation and forecast, weights were assigned to different factors including drivers & trends, restraints, and opportunities available for the stakeholders. After analyzing these factors, relevant forecasting techniques i.e., the top-down/bottom-up approach were applied to arrive at the market forecast for 2027 for different segments and sub-segments across the major markets globally. The research methodology adopted to estimate the market size encompasses:

• The industry’s market size, in terms of revenue (USD) and the adoption rate of the companion diagnostics market across the major markets domestically
• All percentage shares, splits, and breakdowns of market segments and sub-segments
• Key players in the companion diagnostics market in terms of solutions offered. Also, the growth strategies adopted by these players to compete in the fast-growing market

Market Size and Share Validation

Primary Research: In-depth interviews were conducted with the Key Opinion Leaders (KOLs) including Top Level Executives (CXO/VPs, Sales Head, Marketing Head, Operational Head, Regional Head, Country Head, etc.) across major regions. Primary research findings were then summarized, and statistical analysis was performed to prove the stated hypothesis. Inputs from primary research were consolidated with secondary findings, hence turning information into actionable insights.

Split of Primary Participants in Different Regions

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Market Engineering

The data triangulation technique was employed to complete the overall market estimation and to arrive at precise statistical numbers for each segment and sub-segment of the companion diagnostics market. Data was split into several segments & sub-segments post studying various parameters and trends in the areas of indication and technology in the companion diagnostics market.

The main objective of the companion diagnostics market Study

The current & future market trends of the companion diagnostics market were pinpointed in the study. Investors can gain strategic insights to base their discretion for investments on the qualitative and quantitative analysis performed in the study. Current and future market trends determined the overall attractiveness of the market at a regional level, providing a platform for the industrial participant to exploit the untapped market to benefit from a first-mover advantage. Other quantitative goals of the studies include:

• Analyze the current and forecast market size of the companion diagnostics market in terms of value (USD). Also, analyze the current and forecast market size of different segments and sub-segments
• Segments in the study include areas of indication and technology.
• Define and analysis of the regulatory framework for the companion diagnostics market industry.
• Analyze the value chain involved with the presence of various intermediaries, along with analyzing customer and competitor behaviors of the industry.
• Analyze the current and forecast market size of the companion diagnostics market for the major region.
• Major regions and countries studied in the report include North America (U.S., Canada, Rest of North America); Europe (Germany, U.K., France, Spain, Italy, Rest of Europe); Asia-Pacific (China, India, Japan, Rest of Asia-Pacific) and Rest of World.
• Company profiles of the companion diagnostics market and the growth strategies adopted by the market players to sustain in the fast-growing market
• Deep dive regional level analysis of the industry

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