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The companion diagnostics (CDx) development market size is projected to grow from $892 million in 2025 to $1,796 million by 2035, registering at a CAGR of 7.3%
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De marktomvang en het marktaandeel zijn gecategoriseerd op basis van Technology Type (Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Microarray, Sanger Sequencing, Mass Spectrometry) and Application (Oncology, Cardiology, Neurology, Infectious Diseases, Rare Diseases) and End-User (Hospitals, Diagnostic Laboratories, Pharmaceutical Companies, Research Institutes, Contract Research Organizations (CROs)) and geografische regio’s (Noord-Amerika, Europa, Azië-Pacific, Zuid-Amerika, Midden-Oosten en Afrika)
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In 2023, the global Companion Diagnostics (CDx) Development Services Market was valued at approximately USD 5.3 billion and is projected to witness significant growth, with a forecasted CAGR of 15.2% from 2024 to 2032. The rising prevalence of personalized medicine and advancements in molecular diagnostics are major factors driving this growth.
The increasing focus on personalized medicine is one of the primary growth drivers for the Companion Diagnostics (CDx) Development Services Market. Personalized medicine emphasizes tailored healthcare solutions based on individual genetic profiles, and CDx plays a crucial role in identifying the right treatment for patients. By facilitating the selection of specific therapies that are most likely to yield positive clinical outcomes, CDx reduces trial and error in treatment plans, thus improving patient care and reducing overall healthcare costs. This alignment with personalized medicine is further bolstered by growing investments in genomic research and biotechnology, which continuously enhance the capabilities and applications of CDx.
Another significant growth factor is the rising incidence of chronic and infectious diseases, which necessitates the development of more precise diagnostic tools. Conditions such as cancer, cardiovascular diseases, and infectious diseases require accurate and early diagnosis to improve treatment outcomes. CDx services provide the necessary tools to not only diagnose but also monitor the progression and response to therapies. This ability to fine-tune treatment regimens based on real-time patient data is becoming increasingly essential in managing complex diseases, thereby driving demand for CDx development services.
Regulatory advancements and supportive policies are also pivotal in promoting the growth of the CDx development services market. Regulatory bodies like the FDA and EMA have been proactive in establishing frameworks that support the co-development of CDx and therapeutic drugs. Guidelines that streamline the approval process and encourage collaborations between diagnostic and pharmaceutical companies have significantly reduced the time to market for new therapies. This regulatory support fosters innovation and ensures that safe and effective diagnostic tools are available to patients faster.
Regionally, North America holds the largest share of the companion diagnostics market, driven by the presence of major pharmaceutical companies and advanced healthcare infrastructure. Additionally, strong governmental support for precision medicine initiatives and high healthcare expenditure further contribute to market growth in this region. Europe follows closely, where countries like Germany, the UK, and France are significant players due to their robust R&D capabilities and favorable regulatory environments. The Asia Pacific region is expected to witness the fastest growth rate, attributed to increasing healthcare investments, rising awareness about personalized medicine, and growing incidences of chronic diseases.
The service type segment in the CDx development services market includes Assay Development, Analytical Validation, Clinical Trial Support, Regulatory Support, and Others. Assay Development is a critical component of CDx services, involving the creation of tests that can detect specific biomarkers related to diseases. This service is essential for developing diagnostic tests that are both accurate and reliable, ensuring that they can be effectively used in clinical settings. The demand for assay development is high due to the continuous need for innovative diagnostic solutions that can address emerging health challenges.
Analytical Validation plays a crucial role in confirming that the diagnostic tests developed are reliable, reproducible, and accurate. This process involves rigorous testing and validation against established standards, ensuring that the assays can consistently produce the same results under different conditions. The importance of analytical validation cannot be overstated, as it provides the necessary assurance to healthcare providers and patients that the diagnostic tools are dependable. This segment is growing due to the increasing complexity of diagnostic tests and the need for stringent quality control.
Clinical Trial Support services are indispensable for the successful development and approval of CDx tools. These services include patient recruitment, data management, and statistical analysis, all of which are essential for demon
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This analysis presents a rigorous exploration of financial data, incorporating a diverse range of statistical features. By providing a robust foundation, it facilitates advanced research and innovative modeling techniques within the field of finance.
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Regular updates are recommended to maintain the accuracy and relevance of the data
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The size and share of this market is categorized based on Type (PCR, In-situ Hybridization, Immunohistochemistry, Sequencing, ) and Application (Oncology, Neurological Disorders, Cardiovascular Disease, Immunological Disorders, ) and geographical regions (North America, Europe, Asia-Pacific, South America, Middle-East and Africa).
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Report of Pharmacogenomics Technology/Theranostics/Companion Diagnostics (CDx) is covering the summarized study of several factors encouraging the growth of the market such as market size, market type, major regions and end user applications. By using the report customer can recognize the several drivers that impact and govern the market. The report is describing the several types of Pharmacogenomics Technology/Theranostics/Companion Diagnostics (CDx) Industry. Factors that are playing the major role for growth of specific type of product category and factors that are motivating the status of the market.
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The North America Pharmacogenomics Technology/Theranostics/Companion Diagnostics (CDx) report provides a detailed analysis of emerging investment pockets, highlighting current and future market trends. It offers strategic insights into capital flows and market shifts, guiding investors toward growth opportunities in key industry segments and regions.
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The global pharmacogenomics technology, theranostics & companion diagnostics (CDx) market size was USD 9.59 Billion in 2023 and is likely to reach USD 26.73 Billion by 2032, expanding at a CAGR of 14.7% during 2024–2032. The market growth is attributed to the increasing acceptance and awareness of personalized medicine across the globe.
Rising awareness and acceptance of personalized medicine are driving the pharmacogenomics technology, theranostics & companion diagnostics (CDx) market. Healthcare shifts from a one-size-fits-all approach to a tailored treatment strategy, as these technologies play pivotal roles. They enable the identification of the most effective therapeutic strategies based on individual genetic profiles, improving patient outcomes and reducing healthcare costs. This trend toward personalized healthcare is driving demand for advanced diagnostic solutions that accurately predict drug responses and optimize treatment protocols.
The use of artificial intelligence is likely to boost the pharmacogenomics technology, theranostics & companion diagnostics (CDx) market. AI algorithms excel at processing vast datasets quickly, identifying patterns that are not apparent to human analysts. This capability is crucial in the development of personalized medicine, as it allows for the rapid interpretation of complex genetic information, leading to accurate predictions about how individuals respond to specific drugs.
Furthermore, AI supports the design of advanced diagnostic tools that predict patient responses to various treatments, thereby streamlining the development of effective therapeutic strategies. AI technology continues to advance, and its integration into this field is set to deepen, further driving innovation and improving outcomes in personalized healthcare.
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The companion diagnostics market revenue is estimated to be reach $6 billion by 2030, driven by the companion diagnostics for oncology market segment.
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The North American companion diagnostics (CDx) devices market is experiencing robust growth, projected to reach a significant market size driven by a confluence of factors. The 18.50% CAGR from 2019-2033 indicates a rapidly expanding market, fueled primarily by the increasing prevalence of cancer and other chronic diseases requiring targeted therapies. Advancements in technologies such as immunohistochemistry (IHC), polymerase chain reaction (PCR), and next-generation sequencing (NGS) are enabling more precise diagnosis and personalized treatment strategies, directly impacting the demand for CDx devices. The market is segmented by technology (IHC, PCR, ISH, RT-PCR, Gene Sequencing, Others), indication (lung, breast, colorectal cancer, leukemia, melanoma, others), and geography (primarily focusing on the United States, Canada, and Mexico within North America). The significant presence of major players like Abbott Laboratories, Roche, and Thermo Fisher Scientific indicates a mature but highly competitive landscape, with ongoing innovation and strategic partnerships driving further growth. The high cost of some CDx technologies and regulatory hurdles related to their approval present some challenges, but the overall market trajectory remains strongly positive. This growth is further supported by the increasing adoption of personalized medicine, which necessitates accurate companion diagnostics to guide treatment decisions. The strong presence of large pharmaceutical and diagnostic companies in North America, coupled with robust healthcare infrastructure and increased research funding, creates a favorable environment for CDx market expansion. The United States, as the largest market segment within North America, is likely to dominate due to its higher prevalence of cancer, advanced healthcare technology, and substantial investment in research and development. While Canada and Mexico show growth potential, the US market will likely continue to be the primary driver of the overall North American CDx market in the foreseeable future. The market will continue to see consolidation and strategic acquisitions as companies seek to expand their product portfolios and market reach. Recent developments include: In January 2023, QIAGEN entered into an exclusive strategic partnership with Helix o advance companion diagnostics for hereditary diseases such as cardiovascular, metabolic, neurodegenerative, auto-immune diseases, and others. Under the terms of the agreement, QIAGEN will be the exclusive marketing and contracting partner in the United States for Helix's companion diagnostic services., In December 2022, QIAGEN received the United States FDA approval for its therascreen KRAS RGQ PCR kit as a companion diagnostic test to Mirati Therapeutic's drug KRAZATI (adagrasib) for non-small cell lung cancer (NSCLC).. Key drivers for this market are: Increasing Demand and Awareness for Personalized Medicine and Targeted Therapy, Increasing Cases of Adverse Drug Reactions; Technological Advancements in the Devices. Potential restraints include: Increasing Demand and Awareness for Personalized Medicine and Targeted Therapy, Increasing Cases of Adverse Drug Reactions; Technological Advancements in the Devices. Notable trends are: The In-situ Hybridization (ISH) Segment is Expected to Exhibit the Fastest Growth Rate over the Forecast Period.
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The report offers Pharmacogenomics Technology & Theranostics & Companion Diagnostics (CDx) Market Dynamics, Comprises Industry development drivers, challenges, opportunities, threats and limitations. A report also incorporates Cost Trend of products, Mergers & Acquisitions, Expansion, Crucial Suppliers of products, Concentration Rate of Steel Coupling Economy. Global Pharmacogenomics Technology & Theranostics & Companion Diagnostics (CDx) Market Research Report covers Market Effect Factors investigation chiefly included Technology Progress, Consumer Requires Trend, External Environmental Change.
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BCC Research Market Report provides an overview of Companion Diagnostics Market analysis of the current trends, along with industry growth drivers, opportunities, restraints, and challenges.
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Companion diagnostics Market is forecasted to grow at a rate of 18.9%, from market size of USD 2.43 billion in 2019 to reach USD 9.72 billion by 2027.Companion diagnostics industry report classifies global market by share, trend, and on the basis of technology, disease indication, application & region | Companion diagnostics (CDx) Market
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According to Cognitive Market Research, the Companion Diagnostics market business would expand at a compound annual growth rate (CAGR) of XX% from USD XX billion in 2023 to USD XX billion by 2032
Companion diagnostics (or CDx) are medical examinations or tools that provide vital information required to use a related treatment product—usually targeted therapy or customized medicine—safely and effectively
The Polymerase Chain Reaction Sector Will Lead Supported by New Product Launch and Regulatory Approvals
Given the rising incidence of cancer and the attention major players are paying to developing cutting-edge testing for cancer medications, it is projected that the cancer segment will have a commanding market share for companion diagnostics
Partnerships with Manufacturers That Contributed to the Pharmaceutical & Biopharmaceutical Companies Segment's Significant Share
North America holds the largest share of the global companion diagnostics market and is anticipated to grow significantly during the course of the forecast period
In terms of global market growth rate, the Asia-Pacific area is anticipated to have the biggest increase
Market Dynamics
Key Drivers for the Companion Diagnostics Market
Increasing number of cancer patients is expected to favour market expansion
In recent years, there has been a notable increase in the occurrence of cancer. Effective CDx are becoming more and more necessary as the number of cancer cases rises. This is because genetic testing gives doctors precise information regarding treatment protocols and a clear picture of patients' malignancies. Consequently, the growing incidence of cancer is driving up sales of CDx products. Statistics on cancer in Canada show that 229,200 new cases of cancer were detected in the country in November 2021. Furthermore, 2.26 million new instances of breast cancer and 2.21 million cases of lung cancer were reported globally in 2022, according to the World Health Organization (WHO). Additionally, in response to a growing demand, innovative tests are being created to identify particular kinds of mutations. The U.S. FDA approved Guardant360 CDx in August 2020.Using Next-Generation Sequencing (NGS) technology, our first liquid biopsy companion diagnostic identifies patients with particular types of mutations of the Epidermal Growth Factor Receptor (EGFR) gene in metastatic Non-Small Cell Lung Cancer (NSCLC). Moreover, compared to conventional chemotherapy and radiation, targeted medicines offer cancer patients more effective and less hazardous therapeutic options. It is crucial to remember that not all patients respond well to the same targeted medicine, and some may develop resistance over time. To determine which patients will benefit most from a particular targeted medication, companion diagnostics can be used to locate resistance mutations. The increasing prevalence of cancer and the expanding use of targeted therapies are anticipated to fuel the companion diagnostics market's expansion during the forecast period.
Rising adoption and importance of personalized treatment is elevating the market growth
Personalized medicine is the practice of adjusting medical care to each patient's unique characteristics. Personalized medications are accurate and specially designed for each patient to provide better therapy depending on the body's reaction and susceptibility to illness. Personalized medicine can reduce side effects and costs associated with therapy while simultaneously improving patient outcomes and quality of life. In personalized medicine, companion diagnostics are essential because they help determine the best course of action and dose for each patient based on their genetic profile or expression of biomarkers. Personalized medicine is not a new idea—it has been used in medical therapy for many years. In fact, its application has grown with time. In recent years, customized medicine has grown at an accelerated rate due to the introduction of new technology. Nonetheless, a long history of scientific study and medical practice forms the basis of these advancements. Therefore, rather than representing a sudden, radical shift in medical practice, customized medicine can be understood as an evolution of it. As new technologies and discoveries are made, the field of customized medicine will continue to advance, building on its ...
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Report of Companion Diagnostics (CDx) Development Services Market is covering the summarized study of several factors encouraging the growth of the market such as market size, market type, major regions and end user applications. By using the report customer can recognize the several drivers that impact and govern the market. The report is describing the several types of Companion Diagnostics (CDx) Development Services Industry. Factors that are playing the major role for growth of specific type of product category and factors that are motivating the status of the market.
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Explore the benefits of CDX fire-rated plywood, a fire-resistant building material ideal for construction projects. Learn about its structural strength, moisture tolerance, and installation guidelines.
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The companion diagnostics (CDx) market for oncology is experiencing robust growth, driven by the increasing prevalence of cancer, advancements in targeted therapies, and a rising demand for personalized medicine. This market, estimated at $5 billion in 2025, is projected to exhibit a Compound Annual Growth Rate (CAGR) of 15% from 2025 to 2033, reaching an estimated market value of $15 billion by 2033. This significant expansion is fueled by several key factors. Firstly, the development of novel targeted therapies necessitates the use of companion diagnostics to identify patients who will most likely benefit from these treatments, thus improving treatment efficacy and reducing adverse effects. Secondly, regulatory bodies worldwide are increasingly emphasizing the importance of CDx in the approval and labeling of new oncology drugs, further driving market growth. Technological advancements in PCR and NGS platforms are also contributing significantly to the sector's expansion, enabling faster, more accurate, and more cost-effective diagnostic testing. However, challenges remain, including the high cost of CDx tests, limited reimbursement policies in certain regions, and the need for robust infrastructure to support widespread implementation. The market is segmented by technology, with Polymerase Chain Reaction (PCR) and Next-Generation Sequencing (NGS) representing the dominant technologies. NGS, although currently a smaller segment, is poised for accelerated growth due to its ability to analyze multiple biomarkers simultaneously and provide comprehensive genomic information. Geographically, North America currently holds a substantial market share, followed by Europe and Asia Pacific. The growth in these regions is anticipated to be further driven by increased healthcare spending, rising cancer incidence rates, and the growing adoption of personalized medicine strategies. Key players like Agilent Technologies, Illumina, Roche, BioMérieux, and Thermo Fisher Scientific are actively shaping the market through strategic partnerships, acquisitions, and the development of innovative CDx solutions. The continued expansion of the oncology CDx market is expected to be positively impacted by increasing investment in research and development, along with ongoing efforts to improve access to affordable and accessible diagnostics globally.
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Companion Diagnostics Market size was valued at USD 5.43 Billion in the year 2024, and it is expected to reach USD 13.34 Billion in 2031, at a CAGR of 13.11% over the forecast period of 2024 to 2031.Global Companion Diagnostics Market DriversCancer and Other Chronic Diseases Are Becoming More Common:Accurate and individualized treatment strategies are required due to the rising incidence of cancer and other chronic illnesses. The identification of patients who are most likely to benefit from particular medications is a fundamental function of companion diagnostics (CDx), which in turn drives demand.Progress in Customized Healthcare:One major factor is the shift to personalized medicine, which adjusts care to each patient's unique needs. In order to guarantee that patients receive the most effective medications, companion diagnostics make it possible to identify biomarkers and genetic profiles.Technological Advancements:Companion diagnostics has greatly improved due to the rapid breakthroughs in genomes, proteomics, and molecular diagnostics. Next-generation sequencing (NGS) and liquid biopsy technologies are examples of innovations that are expanding the capabilities and precision of CDx examinations.Support and Approvals from Regulations:Companion diagnostics are becoming more and more important, according to regulatory organizations like the EMA in Europe and the FDA in the United States. The market is expanding thanks to expedited approval procedures and precise rules for the creation and application of CDx.Partnerships & Collaborations:Companion diagnostics are being developed and commercialized thanks to strategic partnerships between pharmaceutical companies and diagnostic manufacturers. In order to ensure a more comprehensive approach to therapy, these collaborations frequently center on co-developing medications and related diagnostics.
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The companion diagnostics (CDx) market is experiencing robust growth, projected to reach a substantial size, driven by the increasing prevalence of cancer and other chronic diseases, the rising demand for personalized medicine, and ongoing technological advancements. The market's Compound Annual Growth Rate (CAGR) of 12.42% from 2019-2024 indicates a significant upward trajectory, fueled by the adoption of innovative diagnostic techniques like next-generation sequencing (NGS) and advanced molecular assays. This allows for precise identification of disease subtypes and facilitates tailored treatment strategies, optimizing patient outcomes and reducing healthcare costs. The market segmentation reveals a strong demand across various cancer indications, with lung, breast, and colorectal cancers being major contributors. Technological advancements in immunohistochemistry (IHC), polymerase chain reaction (PCR), and in-situ hybridization (ISH) are key drivers, allowing for more accurate and efficient diagnostics. North America and Europe currently hold significant market share due to well-established healthcare infrastructure and high adoption rates of advanced technologies, but Asia-Pacific is expected to show rapid growth in the coming years due to increasing healthcare spending and rising awareness of personalized medicine. Competition in the market is intense, with major players like Abbott, Roche, Qiagen, and Thermo Fisher Scientific vying for market dominance through continuous innovation and strategic partnerships. The future of the CDx market hinges on several factors. Further development and integration of artificial intelligence (AI) and machine learning (ML) in diagnostic platforms will lead to improved accuracy, faster turnaround times, and reduced costs. The increasing availability of high-throughput sequencing technologies will enable larger-scale genomic profiling, leading to a more comprehensive understanding of disease mechanisms and personalized treatment strategies. Regulatory approvals for new CDx tests and the expansion of reimbursement policies for these tests will be crucial in accelerating market penetration. The development of companion diagnostics for less common cancers and other chronic diseases will also provide significant growth opportunities. Despite the challenges posed by high development costs and regulatory hurdles, the long-term outlook for the companion diagnostics market remains positive, driven by the significant unmet medical need for personalized and precise diagnostic solutions. Recent developments include: April 2024: Roche received approval of the CE Mark for the VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx to identify metastatic breast cancer patients with low HER2 expression who can be given ENHERTU (trastuzumab deruxtecan) as a targeted treatment., April 2024: Transcenta Holding Limited collaborated with Agilent Technologies to develop Claudin18.2 (CLDN18.2), a companion diagnostic, to support the TranStar301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment in patients with CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma., February 2024: Roche signed an agreement with PathAI, a global company active in AI-powered technology for pathology. Under the terms of this agreement, PathAI will exclusively work with Roche Tissue Diagnostics (RTD) to develop AI-enabled digital pathology algorithms in the companion diagnostics space.. Key drivers for this market are: Companies Promoting Personalized Medicine and Targeted Therapy as a New Treatment Option, Increasing Cases of Adverse Drug Reactions; Co-development of Drug and Diagnostic Technologies. Potential restraints include: Companies Promoting Personalized Medicine and Targeted Therapy as a New Treatment Option, Increasing Cases of Adverse Drug Reactions; Co-development of Drug and Diagnostic Technologies. Notable trends are: The Lung Cancer Segment is Expected to Witness Significant Growth Over the Forecast Period.
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The size of the Europe Companion Diagnostics Market market was valued at USD 1.29 Million in 2023 and is projected to reach USD 2.39 Million by 2032, with an expected CAGR of 9.23% during the forecast period. Europe companion diagnostics market is centered on diagnostic tests that aim at finding patients who are most likely to benefit from a given therapeutic product or avoid possible side effects. These diagnostics are particularly essential in the area of the so called ‘pharmacogenomics’, where the treatment plan is adjusted to genetics of the patient and his/her disease. The former is applied in oncology to link the patient to the correct therapy type, and other fields such as cardiovascular and infection disease. Some of the trends that are evident in the European market include the rising use of companion diagnostics in clinical trials, molecular diagnostics and the growing acceptance of the use of personalized medicine. Other potential growth factors include further development of genomic technologies as well as extensive use of such tools as data analytics. Recent developments include: August 2022: BD (Becton, Dickinson, and Company) announced a collaboration agreement with Labcorp for creating a framework to develop, manufacture, market, and commercialize flow cytometry-based companion diagnostics (CDx) intended to match patients with life-changing treatments for cancer and other diseases., May 2022: Agilent Technologies Inc. announced that its PD-L1 IHC 22C3 pharmDx, Code SK006, is now EU CE-IVD-marked for use in cervical cancer. PD-L1 IHC 22C3 pharmDx can be used as an aid in identifying cervical cancer patients for whom treatment with KEYTRUDA (pembrolizumab) may be appropriate., May 2022: Illumina, Inc., a global leader in DNA sequencing and array-based technologies, announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight Oncology (TSO) Comprehensive (EU) test., April 2022: Amoy Diagnostics Co. announced that they have entered into a master collaboration agreement with AstraZeneca in China, Europe, and Japan, for developing and commercializing AmoyDx assays that may cover any type of indication or biomarker for companion diagnostic (CDx) use with AstraZeneca medicines.. Key drivers for this market are: Rising Demand for Personalized Medicine and Targeted Therapy, Rise in Biomarker Discovery; Rising Prevalence of Chronic Diseases. Potential restraints include: High Cost of Drug Development and Associated Clinical Trials, High Reimbursement Issues Associated with Personalized Medicines. Notable trends are: Immunohistochemistry Segment is Estimated to Register Significant Growth over the Forecast Period..
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The companion diagnostics (CDx) development market size is projected to grow from $892 million in 2025 to $1,796 million by 2035, registering at a CAGR of 7.3%