USD 5.57 billion
Global Companion Diagnostics Market Size, Share, Growth Analysis, By Technology(Polymerase chain reaction (PCR), next-generation sequencing), By End Use(Pharmaceutical & biopharmaceutical companies, reference laboratories) - Industry Forecast 2024-2031
Report ID:
SQMIG35A2649 |
Region:
Global |
Published Date: April, 2024
Pages:
157
|
Tables:
66 |
Figures:
75
Global Companion Diagnostics Market Insights
Global Companion Diagnostics Market size was valued at USD 5.57 billion in 2019 and is poised to grow from USD 6.27 billion in 2023 to USD 16.08 billion by 2031, growing at a CAGR of 12.5% in the forecast period (2024-2031).
The purpose of companion diagnostics is to find out who needs treatment. Technological breakthroughs are providing tremendous momentum to the development of companion diagnostics, opening up new avenues that allow for treating disease. The companion diagnostics field is marked by the burgeoning demand for more effective treatment of patients. Positively affecting the outlook for companion diagnostics, it also provides healthcare providers and their patients with confidence about treatment outcomes. This differs from current treatment methods which lack accuracy in results as well as process efficiency. This increase in tailored medicine exposure, along with the growing need for targeted treatments, provides impetus to develop personalized CDx and further grow the companion diagnostics market size. CDx tests have high sensitivity, are cheap in comparison to conventional pharmaceuticals, and offer the possibility of accurate results quickly. These advantages drive companion diagnostics market growth. Genetic sequencing and genomics breakthroughs have now long made it common knowledge that the same medication can interact differently with various people. To deliver focused therapeutics to the right target, pharmaceutical and biopharmaceutical firms are constantly striving during drug development to implement patient-selection diagnostic frameworks in their earliest stages. The same phenomenon is expected to greatly extend the growth of companion diagnostics over the next few years.
Market snapshot - 2024-2031
Global Market Size
Growth Rate
12.5% CAGR
Companion Diagnostics Market, By Type/Application, 2020 (%)
Companion Diagnostics Market, By Geography, 2021 - 2027
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Global Companion Diagnostics Market Segmental Analysis
Global Companion Diagnostics Market is segmented on the basis of technology, end use, and region. By technology, the market is segmented into polymerase chain reaction (PCR), next-generation sequencing, in situ hybridization, immunohistochemistry, and other technologies. By end use, the market is segmented into pharmaceutical & biopharmaceutical companies, reference laboratories, contract research organizations, and other end users. By region, the market is segmented into North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.
Analysis By Technology
Stiff competition within the companion diagnostics market, PCR technology occupies a leading position thanks to molecular biology techniques that have already been adopted on other fronts and are thus easy for people to get used to using. For example, PCR can be used to amplify fragments of pathological genes and thus identify people who have genetic variations or mutations for certain diseases. Additionally, given its reliability and sensitivity as well as the ability to obtain quantitative results, PCR has become essential in companion diagnostics--interpretive practice by pharmaceutical companies related to oncology drugs. Its extensive range of applications and already recognized market path give it significant position.
Among the various types of companion diagnostics, NGS is the fastest-growing segment. The reason for such rapid growth is the ability of NGS technology to simultaneously process large amounts of genes and discover new biomarkers. The NGS approach gives complete and detailed results, so it would be very useful for profiling diseases like cancer which involve a wide range of genetic variations. This capacity of NGS to deliver in-depth genomic information also dovetails with the trend toward precision medicine, making it suited for a role in companion diagnostics. With the price of NGS falling and its scope of applications increasing, it is expected to play a key part in promoting personalized medicine. It could also be seen as having great potential for spurring growth in the companion diagnostics market.
Analysis By End Use
The pharmaceutical and biopharmaceutical companies segment is usually the most important (in terms of both market size as well as end-use) part of the companion diagnostic industry. This dominance is due in part to the fact that companion diagnostics are an integral component of drug development and commercialization. Pharmaceutical manufacturers use companion diagnostics to find patients who are most likely to benefit from a given therapy, assisting in the creation of precision and individualized medication. Not only do these diagnostics aid in patient stratification for clinical trials, they are also an essential step toward obtaining regulatory approvals. Relying on precision medicine as the pressure to develop companion diagnostics grows more and more intense, pharmaceutical companies are still urgently pouring money into diagnostic development. The position of this segment is therefore becoming increasingly secure.
A common scenario in these affairs is that the CROs (contract research organizations) segment of the companion diagnostics market grows at its fastest. CROs provide outsourced research services to pharmaceutical, biotech, and medical device companies. Clinical trial companies are now offering to conduct companion diagnostics for drug trials, and the field is growing by the month. In particular, as companion diagnostics become increasingly integrated into the clinical research process in all stages of drug development--from discovery and preclinical trials to late-phase trial confirmation procedures--CROs are taking on an even more important mission. Its flexibility, expertise and efficiency in the development of companion diagnostics help to explain why this part has developed so quickly. With the cooperation between CROs and pharmaceutical companies becoming increasingly intense, companion diagnostics services in this area will only continue to grow.
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Global Companion Diagnostics Market Regional Insights
The highest revenue producer is North America because American people have a high incidence of many forms of cancer. Geographically, North America accounted for 45.6 % of revenue share in 2022. By the end of that forecast period, North America is expected to have a higher market. Their high rate of incidence among the American population is driving the North American market. The incidence of cancer patients in Canada is on the rise. In Canada, according to the Canadian Cancer Society's estimates, one out of every four deaths is due to cancer. Canadian Cancer Researchers predict that Australia will see an additional 229,200 new cases of cancer this year (846,753 total). This means there are going to be even more deaths.
The compound diagnostics market is growing rapidly, and Asia-Pacific has begun to appear as a promising regional prospect for players in the industry. These factors, such as a large population to begin with, growing knowledge about companion diagnostics, and healthcare infrastructure investments all add up together to explain why this is an attractive region. Together, these factors help to foster a fertile environment for the use of and integration with companion diagnostics. The high Asia-Pacific population base means a large patient pool and ample market for companion diagnostics. With growing recognition of the importance of companion diagnostics, the region seeks to move in this direction as awareness grows here about matchmaking. This rising consciousness also serves the further growth of Asian-Pacific companion diagnostics.
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Global Companion Diagnostics Market Dynamics
Drivers
Growing need for targeted medicines
- Now that genetic sequencing and genetics are getting better by the day, it is generally thought to be true that drugs may produce different effects in each person. Through genetic profiling, we can gain a deeper understanding of who this right person is and what kind of drug to use at the moment that could offer maximum effectiveness. The idea of subjecting patients to diagnostic tests in the early stages to prescribe a drug that will be curative for only one is being tested continually by pharmaceutical and biopharmaceutical companies who are working on developing effective drugs earlier. This is also expected to contribute further toward market development.
Restraints
High cost of immunotherapy treatment
- Although immunotherapy has great potential in the fight against cancer, its high price means that access hasn't been maximized. Perhaps physicians should instead switch to combining therapies; in some cases, this alone might be enough to raise the treatment period from five months of intensive therapy, and upwards of three years. Therefore, the longer the assignment period in this instance, the more costly it is. Furthermore, personalized immunotherapies are expensive. For instance, the CAR T-cell treatment KYMRIAH (approved by regulatory authorities in Japan and also sold under Regeneren™), manufactured by Novartis Pharmaceuticals has a price range of US $ 373 – 475 thousand per patient. Every CAR T-cell treatment is developed for the individual patient, and extremely expensive lab resources are required. Therefore, for just the drug itself, it can climb to around US $ 60,00 per patient. Cancer immunotherapies can easily eclipse the cost needed for other forms of treatment, like chemotherapy or radiation therapy. Therefore, the market expansion will rely largely on high-price immuno-oncology therapies.
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Global Companion Diagnostics Market Competitive Landscape
In recent years, personalized medicine and custom treatments have risen to the fore in medical circles worldwide. The global market for companion diagnostics is expanding rapidly as a result of this trend. Their use of companion diagnostics aimed at identifying specific biomarkers or genetic variations to guide the selection of appropriate therapies is targeted toward improving medical treatment for individual patients. With the rise of precision medicine, however, companion diagnostics are being produced in tandem with therapeutic drugs by pharmaceutical companies entering into partnerships and alliances with diagnostic firms. The makers of drugs and diagnostic tests are actively engaged in strategic alliances, mergers & acquisitions, and technological milestones to position themselves for the market in companion diagnostics. And they do not want to lose out on opportunities created by changing customer demands that go with a revolution toward person-centered health care.
Top Player’s Company Profile
- F. Hoffmann-La Roche Ltd. (Switzerland)
- Qiagen NV (Netherlands)
- Abbott Laboratories Inc. (US)
- Agilent Technologies Inc. (US)
- bioMérieux SA (France)
- Thermo Fisher Scientific Inc. (US)
- Illumina, Inc. (US)
- Myriad Genetics, Inc. (US)
- Roche Diagnostics International Ltd. (Switzerland)
- Sysmex Corporation (Japan)
- Novartis AG (Switzerland)
- Becton, Dickinson and Company (US)
- Danaher Corporation (US)
- Qiagen Manchester Ltd. (UK)
- Merck KGaA (Germany)
- Bio-Rad Laboratories, Inc. (US)
- Covance Laboratories GmbH (Germany)
- GenMark Diagnostics, Inc. (US)
- Personalis, Inc. (US)
- Exact Sciences Corporation (US)
Recent Developments
- In October 2022, F. Hoffmann-La Roche Ltd’s companion diagnostic — PATHWAY, enables the detection of patients with HER2 low metastatic breast cancer who are appropriate targets for treatment by its antibody drug conjugate ENHERTU (HER2-directed antibody drug conjugate) was approved last year by the U.S. Food & Drug Administration (FDA).
- In October 2022, HMNC Brain Health raised series F funding of US $ 14.2 million to further the development of such precision psychiatry, where drugs are developed alongside companion diagnostics that help identify which types of patients would benefit from them (i.e., selecting treatment populations).
- In July 2022, Almac Diagnostic Services and AstraZeneca extended their CDx partnership into new disease indications, as reported in a recent feature on genomeweb. This partnership, targeting multiple indications for chronic diseases has put the roles of Next Generation Sequencing (NGS) and quantitative polymerase chain reaction technologies in a somewhat new light upon soliciting market demand.
Global Companion Diagnostics Key Market Trends
- More Breakthroughs in Sequencing to Fuel the Market Upswing NextGen sequencing technology looks set for further improvements that should spur significant market growth. Clinicians are testing the number of responsible genes; to do so, they examine each patient's tumor by using a technology called Next-Generation Sequencing (NGS). It is also high output on a short time scale and it has the NGS technique, which means that technological developments are being made. For instance, as a paper published by the Centers for Disease Control and Prevention observes, in the past five years next-generation sequencing has gone from research to clinical practice. Furthermore, many important players are entering with high-tech testing products. Therefore, developments such as next-generation sequencing to find genetic abnormalities that aid in the treatment of certain diseases are new trends for companion diagnostics. For example, earlier in 2022 Illumina Inc. joined forces with SomaLogic Operating Co., Inc. to enable the company's proteomics assay product -SomaScan-to create an integrated oncology testing solution by being made available for use across each of its high throughput next generation sequencing platforms now and into the future.
Global Companion Diagnostics Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Component types team that Collects, Collates, Co-relates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
According to our analyses, the market for companion diagnostics is also growing fast in response to the rising use of personalized medicine and precision drugs throughout medical practice. With healthcare moving toward more personalized forms of treatment, companion diagnostics become an essential factor in defining biomarkers and genetic variations for individual patients to help guide policies on therapy. Understanding the genetic underpinnings of diseases and subsequently developing companion diagnostics to assist in accurate patient stratification is what drives this market. Other key factors pushing market growth are a general increase in oncology research, and rising rates of chronic disease leading to increased demand for more precise diagnostic technologies. Next Generation Sequencing (NGS) and polymerase chain reaction (PCR). Big players like Roche Diagnostics, Abbott Laboratories, and Thermo Fisher Scientific have all been busily hedging their bets through strategic cooperation, acquisitions, or the development of technologies to strengthen their positions in this rapidly changing environment. Also, evolving regulatory backing for companion diagnostics as well as an increasing understanding of their value among the healthcare community are driving market development.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 5.57 billion |
| Market size value in 2031 | USD 16.08 billion |
| Growth Rate | 12.5% |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
|
| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
| Historical Year | 2019 |
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Global Companion Diagnostics Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Global Companion Diagnostics Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Global Companion Diagnostics Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Global Companion Diagnostics Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Global Companion Diagnostics Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Global Companion Diagnostics Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
Global Companion Diagnostics Market Report Snapshots
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