Vertical: HealthcareBase Year: 2019
Market Size (2019)
$7.43B
Projected (2027)
$10.52B
CAGR (2016–2027)
3.2%
Key Players
9+
Companion diagnostic (CDx) is an in vitro diagnostic testing kits majorly used by pharmaceutical companies for the development of personalized medicine. CDx tests provide information about the effective use of a corresponding therapeutic product by analyzing the genetic material. The factors driving the market growth include rising preference of personalized medicine, increasing collaboration among companies and drug-diagnostic co-development and increasing product approval by major players. However, factors such as lack of reimbursement in developing region and limited adaption of CDx and the presence of alternative therapies hamper the market growth.
The Companion Diagnostics Market market is projected to grow at a CAGR of 3.2% from 2016 to 2027.
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View Subscription PlansThe scope of the global companion diagnostics market study includes market size analysis and a detailed analysis of the manufacturer’s products and strategies. The market has been segmented based on products & services, technology, indication, end user, and region.
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View Subscription PlansOverview
The research starts with the extensive procurement process of data/information and statistics from company annual reports, government websites, statistic agencies, and paid databases. This information creates a base for the study. This information also helps to define the scope and to narrow down the area for study for the market. This raw information is processed and analyzed to extract crisp data points that currently affect or are likely to affect the industry over the forecast period. After analyzing the information, a proprietary statistical tool is used for market estimation & forecast, which generates the quantitative figures/sizes of the market/sub-segments in the current scenario as well as for over the forecast period.
After estimating the market sizes & estimates, numbers are verified with the industry participants and key opinion leaders. The wide network of industry participants performs a value addition in the research and verify the numbers & estimates of the study. In the last stage of the research process, a final report is prepared, which is then published on different websites as well as distributed through various channels. The below figure contains the different stages of the whole research performed to produce the report.
Data Mining
Data mining is one of the extensive stages of our research process. It involves the procurement of market data and related information through different verified & credible sources. This step helps to obtain the raw information about components in the industry and their deployment, the monetary process for different end-uses, the pool of market participants & the nature of the industry, and the scope of the study. The data mining stage comprises both primary as well as secondary sources of information.
Secondary Research
In the secondary research process, various sources are used to identify and gather industry trends and information for the research process. We at Wantstats have access to some of the most diversified and extensive paid databases, which give us the most accurate data/information on market sizes, components, and pricing. Mentioned below is a detailed list of sources that have been used for this study. Please note that this list is not limited to the names as mentioned; we also access other data sources depending on the need.
Primary Research
In the primary research process, in-depth primary interviews are conducted with the CXOs to understand the market share, customer base, pricing strategies, and other necessary information. Besides, in-depth primary interviews are conducted with the CXOs of companies, and others to validate the supply-side information. Moreover, various key industry participants from both the supply and demand side are interviewed to obtain qualitative and quantitative information on the market. In-depth interviews with key primary respondents, including industry professionals, subject matter experts (SMEs), industry consultants, and C-level executives of major companies, are conducted to obtain critical qualitative and quantitative information pertaining to the market, as well as to assess the prospects for market growth during the forecast period. Detailed information on these primary respondents is mentioned below.
Research Methodology for Market Size Estimation
Understanding and penetrating the market in terms of valuation is a crucial task in the process of business research. This again becomes significantly important while investing and choosing business opportunities. In this regard, we at Wantstats performs two ways market sizing approach simultaneously, namely top-down and bottom-up approaches. In this step, we place different data points, numeric attributes, information, and industry trends at an appropriate space to deduce the estimates & forecast values over the coming years. We use different mathematical models to estimate the market sizes of different economies and segments. Each of which is further summed up to define the total market.
We at Wantstats own a proprietary statistical tool for market estimations, which helps us to comprehend market size estimates & forecasts for different markets and industries.
Bottom-Up Approach
In the bottom-up approach, the revenue of key companies and their shares in the market are assessed to deduce the market size. More than 20 key players operating in the global companion diagnostics market are studied. The segmental revenue of each player is analyzed, and the size for the global companion diagnostics market is extracted from the segmental/product/service revenue with the help of secondary and primary research. The extracted size for the market is then validated with industry experts and partner consultants. This derived market size contributes to around 75% to 85% of the total global market share in terms of revenue for the companion diagnostics market. Using the data triangulation method, the overall global market size is estimated.
Top-Down Approach
The overall market size is then used in the top-down procedure to estimate the size of the other sub-markets with the help of percentage splits of the market segments from secondary and primary research. The demand-side analysis is conducted, in which the expenditure of significant industry players in each region is studied. The end-users considered in the scope of this research study contributes around 70% of the total spent in the companion diagnostics market.
The figure below depicts the process of market estimation using independent tools employed by our analysts to arrive at the sizing of the market.
As a part of the market engineering, both top-down and bottom-up approaches are utilized along with data triangulation models to derive and verify the market sizes and forecast over the coming years.
Data Triangulation
After arriving at the overall market sizes, the total market is divided into several segments and sub-segments. Again, the market breakdown and data triangulation procedures are implemented, wherever applicable, to complete the overall market engineering process and gather the exact statistics for all segments and sub-segments. The data is triangulated by studying various factors and trends from the demand and supply sides. Along with this, the market size is validated using the top-down and bottom-up approaches.
Validation
Validation is the most crucial stage of the report making the process. Validation via an intricately designed feedback process helps us finalize the sizing estimates and forecast for the final collation. Extensive primary research is performed to verify the information. This includes telephonic and personal interviews, e-mails, feedback forms, questionnaires, and polling options/answers with a group of relevant industry participants. Validation helps to duly check the authenticity of the key industry trends, market dynamics, company market share, different business models, and conclusions.
Base Year
2019
Historical Period
2016 – 2018
Forecast Period
2020 – 2027
Primary Interviews
150+
Historical data (2016–2019) and forecast period (2019–2027)
Our research process spans primary interviews with industry stakeholders combined with comprehensive secondary data analysis, validated through triangulation across multiple independent sources.
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View Subscription PlansThe global companion diagnostics market is a very lucrative, attractive, and profitable market, both for existing players as well as new entrants. At the same time, intense rivalry among existing competitors has been observed. Our analysis revealed that market players have adopted different strategies to increase their business and position in the global companion diagnostics market. In recent years, strategic movements made by major players were strategic agreements, acquisition, expansion, and product approvals, which have been used as market penetration strategies and to reduce competition. The major players in the global companion diagnostics market are F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Agilent Technologies, Inc., QIAGEN, Abbott, bioMérieux SA, Leica Biosystems Nussloch GmbH, Illumina, Inc., Myriad Genetics, Inc., ArcherDX, Inc., Foundation Medicine, Inc., NG Biotech, ICON plc, Invivoscribe, Inc., Abnova Corporation, and Guardant Health.
Companies are now entering into acquisitions, agreements, product launches, product approvals, and expansions to neutralize growing competition from customers, competitors, and to tackle the changing market dynamics.
There are numerous players operating in this market. There are a lot of large and small market players available in the market which provide a wide range of companion diagnostics. As there are many large and small players in the market, the market shares of these players are much differentiated.
F. Hoffmann-La Roche Ltd, Qiagen, Agilent Technologies, Thermo Fisher Scientific Inc., Icon Plc, and Myriad Genetics are some of the major players in the global companion diagnostics market, contributing to around 71% of the total market.
Threat of New Entrants
The threat of new entrants in the companion diagnostics market is moderate. The companion diagnostics market is growing, hence attracting many new entrants who are looking to make a profit. The entry barriers are high due to strict government norms and regulations which decreases the threat of new entrants. Small and medium-sized companies are creating their space and trying to capture the market share which is mostly untouched by major players. Easy distribution and product differentiations are increasing the threat of new entrants in the global companion diagnostics market.
Bargaining Power of Suppliers
Raw material providers are considered as the suppliers in the global companion diagnostics market. The bargaining power of suppliers is moderate as there is an increase in demand for the raw material by the medical device manufacturing companies. However, the number of suppliers is also high in the market, which is slightly decreasing the bargaining power of suppliers, as switching cost of the market players increases. The increasing prevalence of various diseases and the growing demand for companion diagnostic kit supports the bargaining power of suppliers.
Threat of Substitutes
The threat of substitutes in the global companion diagnostics market is high. The changing healthcare environment and new product development are increasing the threat of substitutes. For the assays, kits, & reagents segment, the threat of substitutes is relatively high as compared to other segments. Consumers tend to use the products which they are using for a long time. Brand loyalty and consumer involvement are decreasing the threat of new substitutes. The major brands are changing and developing the products as per the market need which is another factor that decreases the threat of substitutes. Additionally, there are a lot of substitutes for companion diagnostics, such as molecular diagnostics and in vitro diagnostics. Therefore, the threat of substitutes is high in the global companion diagnostics market.
Bargaining Power of Buyers
The bargaining power of buyers is moderate in the market. The pharmaceutical & biopharmaceutical companies and laboratories are the major buyers in the market.The bargaining power of the buyer can define how easily the buyer can get the products. Buyers in the companion diagnostics market can choose from different companies. Most of the companies are offering the same kind of products so the switching cost of the buyer is relatively low. In this market, buyers are commercial service providers, pharmaceutical companies, research laboratories that are highly skilled and aware of the products that increases the bargaining power of buyers.
Intensity of Rivalry
The intensity of rivalry in the global companion diagnostics market is moderate. Many top and small companies are competing and putting pressure on one another which ultimately decreases the profit. The competition between the companies is affecting the price of the products. Changing technology and market demand are increasing the intensity of the competition in this market. Innovative product development is giving the first movers advantage and most of the companies are following this path. Medium and small manufacturers are focusing more on production and distribution rather than new product development that again creates competition for major brands.
Market estimates by geography (2027)
InsightNorth America leads with $7.26B by 2027, while Asia-Pacific is projected to grow fastest at a 11.9% CAGR.
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View Subscription Plans| REGION | 2016 | 2019 | 2027 | CAGR | SHARE |
|---|---|---|---|---|---|
| North America | $1.36B | $2.62B | $7.26B | 11.1% | 39% |
| Europe | $1.05B | $2.01B | $5.80B | 11.2% | 31% |
| Asia-Pacific | $932.96M | $1.84B | $5.61B | 11.9% | 30% |
| South America | $0.05M | $0.04M | $0.04M | -2.0% | 0% |
| Middle East and Africa | $0.04M | $0.04M | $0.03M | -1.2% | 0% |
| Total | $3.34B | $6.48B | $18.67B | 3.2% | 100% |
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View Subscription PlansTotal Market Size
$10.52B
| APPLICATION | REVENUE ($B) | GROWTH RATE | MARKET PENETRATION |
|---|---|---|---|
| PD-1 Testing | $73.97B | 10.1% | 56% |
| HER2 Testing | $23.94B | 9.1% | 18% |
| EGFR Mutation Testing | $13.92B | 11.7% | 11% |
| ALK Rearrangement Testing | $12.72B | 8.6% | 10% |
| Others | $7.94B | 13.7% | 6% |
* Revenue projections based on 2025 estimates. Growth rates represent CAGR 2024–2030. Market penetration indicates current adoption rate within addressable market segments.
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Analytical insights on Companion Diagnostics Market covering market dynamics, competitive landscape, and strategic outlook.
The Companion Diagnostics Market market is projected to reach $10.52B by 2027, growing at 3.2% CAGR. The PD-1 Testing segment holds the largest share.
A companion diagnostic is an in vitro diagnostic medical kit. Through this test, the healthcare professional can determine whether a particular therapeutic product is effective to the patient or possess any serious side effects or risks.
The key factors driving the market growth are increasing R&D and drug-diagnostic co-development, growing preference for personalized medicine, and increasing technological advancement in the medical device industry. Also, the growing cases of various chronic diseases support the market growth. However, factors such as limited access to targeted therapeutics and CDx and lack of reimbursement in developing regions may hamper the market growth. The increasing use of CDx for different indication areas creates an opportunity to drive the companion diagnostics market.
Personalized or targeted medicine is one of the upcoming trends in medical innovation. It is one of the most significant fields that creates the need for companion diagnostics products. The healthcare providers are focusing on using CDx to develop new drugs based on specific genetic biomarkers in major fields like oncology, cardiac disease, inflammation, infectious diseases, central nervous system disorders, and many more to improve outcomes for patients. Personalized medicines are also used to treat the diseases caused due to mutation in a specific gene by targeting the specific mutation. To understand both the positive and negative effects of specific drugs or therapy on the patient’s body, the US FDA is working with drug and device manufacturers that are developing certain tests called companion diagnostics.
The growing prevalence of cancer across the globe is increasing the preference for targeted therapy which in turn is affecting the demand for CDx tests. According to Cancer Research UK, there were 17 million new cases of cancer across the world in 2018 in which case lung and breast cancer accounted for the largest share followed by colorectal and prostate cancer.
Additionally, healthcare organizations are involved in launching healthcare programs and platforms to develop better treatment options. For instance, the National Institute of Health has launched a program called “All of Us Research Program” which involves a group of at least one million volunteers from the US to provide inherited data, biological samples, and other health information. Such a large amount of data is used to detect new associations between health, environmental and lifestyle, to identify new potential biomarkers and disease classifications, to create a platform to assist trials of targeted therapies.
The increasing R&D activity and different healthcare programs to support the development of personalized or targeted medicine will increase the demand for companion diagnostic products.
The growing research and development activities in the healthcare industry creates an opportunity for new product development using CDx kits. Companion diagnostics is largely used in the development of personalized medicine for cancer patients. The growing R&D activities are diversifying the use of CDx for different therapeutic applications other than cancer. The researchers are working on inflammatory disease (e.g. irritable bowel disease and rheumatoid arthritis), Alzheimer’s disease and infectious diseases using CDx. There are limited companion diagnostic tests for infectious and other chronic diseases.Companies are getting involved in the testing of drugs for the treatment of various disorders creating wide opportunities for the companion diagnostics market to grow. According to the paper published by the National Center for Biotechnology Information (NCBI) in 2018, anti-infectious disease therapies for HIV acts as a new opportunity for CDx market.Additionally, on September 206 the NuSirt Biopharma and OWL Metabolomics entered into a collaboration to develop a blood-based CDx for NuSirt’s NS-0200, currently which is in Phase II trials for non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD).
Thus, the development of efficient medical products for the diagnosis, medication, and prevention of various diseases is greatly needed. The co-development of companion diagnostic devices and their corresponding therapeutic products provides new opportunities for safer and more effective therapies.
In most countries, delayed reimbursement or lack of funding for diagnostics acts as a key barrier for market growth. Reimbursement for companion diagnostic tests is a complex process. The complexity in the reimbursement process itself acts as a challenge for this market.
In molecular diagnosis, reimbursement is granted for the process or technology and not for the value. In this process, the single test may require multiple processes and sometimes the process repetitions get difficult for the payer to understand what they are paying for. The reimbursement is based on the current procedural terminology (CPT) code. These coding also possess different challenges in reimbursements and leads to delay in payments. The coding acts as a challenge due to the use of different technology for individual tests such as (e.g., immunohistochemistry (IHC), polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH) which increases the complexity. This complex coding structure can lead to insufficient reimbursements for some tests. The high cost of NGS-based CDx decreases the patient preference for the CDx test. Thus, the lack of reimbursement or low funding for diagnosis especially of cancer in the developing countries hamper the market growth.
Near-term growth will likely concentrate in modular bioreactor lines and closed-system media workflows that shorten validation cycles while preserving batch traceability.
Partnerships between CDMOs and instrumentation vendors should accelerate standard datasets for comparability across sites, improving forecasting models used in capacity planning.
Longer horizon, organoid and microphysiological adoption may reshape segment mix; teams that invest early in assay interoperability and cloud QC hooks are better positioned to capture upside without fragmenting their analytics stack.
Profiles of 105 companies operating in the Companion Diagnostics Market market, including revenue, employee count, and market positioning where available.
Showing 105 of 105 companies
Company Headquarters: Germany, Europe Founded: 1984 Workforce: 5,000 Company Working: Qiagen is a healthcare company that deals in sample and assay technologies for molecular diagnostics. The company operates through more than 35 offices spread in over 25 countries. It serves more than 500,000 customers across the globe. Its product portfolio spans through a full range of molecular testing applications. Qiagen’s products are used for extraction, purification, and stabilization of DNA, RNA, and protein from various biological samples. It has over 500 core products in its portfolio. The company is listed on the New York Stock and Frankfurt Prime Standard exchanges. It offers its products in various areas such as discovery & translational research, diagnostics & clinical research, next-generation sequencing, and instruments & automation.
Company Headquarters: Guipry, France Founded: 2012 Workforce: 50+ Company Working: NG Biotech (NGB) is into the development, manufacturing, and commercializing of rapid, mobile, and connected diagnostics to modernize diagnosis practice worldwide. The company specializes in research & development, manufacturing, and marketing of a new generation of multiplex, quantitative, and connected rapid diagnostics for biomarker analysis and/or therapy monitoring at the point of care. Its partners include Rennes Atalante Technopole, idea Ille & Vilaine Development, reseauentreprendere Bretagne, and medicine Paris.
Coty is a fragrance-led global beauty company and, by its own description, one of the world's largest beauty groups, with FY2026 net revenues of USD 5.81bn split roughly two-thirds Prestige (licensed and owned luxury fragrance, prestige cosmetics and skincare — Burberry, Hugo Boss, Calvin Klein, Chloé, Marc Jacobs, Davidoff, Kylie Cosmetics, Gucci until mid-2027) and one-third Consumer Beauty (mass color cosmetics such as CoverGirl, Rimmel, Max Factor and Sally Hansen; mass fragrance; and Brazilian body care). Its core competitive asset is an end-to-end fragrance platform — licensing, innovation, ~81% in-house manufacturing and global prestige distribution — that has produced blockbuster franchises such as Burberry Goddess. After five years of deleveraging under Sue Nabi, Coty entered 2026 in a reset: revenue and margins are declining, the Gucci licence exits a year early, mass color and Brazil are under strategic review, and new interim leadership is executing a "Coty.Curated" focus-and-simplify framework with leverage of 3.4x. --- **Company's own description (paraphrased from FY2026 10-K, Item 1).** Coty describes itself as one of the world's largest beauty companies with an iconic brand portfolio across fragrance, color cosmetics, and skin and body care. It states that it is focused on leveraging its leadership position and capabilities in global fragrances to fuel expansion, strengthening its presence in a limited number of structurally profitable and growing categories, and prioritising growth channels such as e-commerce and Travel Retail. Under the Coty.Curated framework it emphasises fewer, bigger initiatives, marketing sufficiency, supply reliability, consumer advocacy, more productive innovation and portfolio choices, a return to market-share growth, and AI-powered, data-driven operations. It is also evaluating its central organisation, manufacturing and asset base to resize after the Gucci exit. **What the company does.** Coty designs, manufactures (≈81% in-house, ≈19% via third-party manufacturers in FY2026), markets and distributes beauty products. The essential oils in its fragrances are generally sourced from specialist fragrance houses; Coty owns the brand development, juice selection/briefing, bottle and packaging design, filling and assembly, marketing and commercial execution. Principal raw materials are essential oils, alcohols and specialty chemicals (10-K FY2026). **Business model and revenue model.** **Value-chain position.** Coty sits between ingredient suppliers (fragrance houses, alcohol and packaging suppliers) and retailers. Its economic moat lies in (i) licence portfolio scale in prestige fragrance, (ii) innovation and launch capability (brief-to-shelf), and (iii) owned manufacturing in the U.S., Europe and Brazil. It is structurally exposed to licensors (who own the trademarks) and to concentrated retailers (Sephora, Ulta, Douglas, Walmart, drug chains, travel-retail operators). **End markets.** Prestige fragrance (core), prestige cosmetics (Kylie Cosmetics, Marc Jacobs Beauty, Gucci Beauty until FY2027), prestige skincare (Lancaster, philosophy), mass color cosmetics, mass fragrance and mists, mass skin & body care (concentrated in Brazil). **Independent characterisation.** Coty is effectively two businesses with very different economics: a high-quality, licence-dependent prestige fragrance franchise generating ~20% adjusted EBITDA margins (Prestige FY2026 adjusted EBITDA margin 20.5% per Q4 FY2026 call), and a structurally challenged mass color cosmetics/Brazil business whose segment adjusted EBITDA margin collapsed to the low single digits in FY2026 (derived). The 2025–2026 strategic actions (Wella exit, Gucci monetisation, Consumer Beauty review) are converting Coty into a narrower fragrance pure-play with lower leverage but higher licence concentration.
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Historical performance and future projections (2020–2030, USD Billion)
Market Size (USD Million)
