Companion Diagnostics Market

The Global Companion Diagnostics market was valued at USD 5.59 Billion in 2022 and is projected to reach USD 13.74 Billion by 2030 at a CAGR (Compound Annual Growth Rate) of 11.90% over the forecast period.

Premium Insights

A medical tool called a companion diagnostic is used in conjunction with therapeutic medications to assess how well they work and how they affect a particular human body. Drugs are produced along with Companion Diagnostics to exclude or include groups of patients based on the traits with which they respond to therapy. This tool aids the medical practitioner in determining if a given course of therapy is in the patient's long-term interests.

As of 2021, Roche's Cobas EGFR Mutation Test v2 companion diagnostic for EGFR tyrosine kinase inhibitor for lung cancer treatment gained FDA clearance. A clinical test called Companion Diagnostic (CDx) was created in conjunction with a therapeutic medicine to identify patients who will respond and won't get to it. This is done to determine which patient groups can or cannot be treated with the matching medicine. Practitioners can ensure patient safety by using CDx to assist them in assessing therapeutic medications' advantages, drawbacks, and dangers.

Nowadays, it is commonly accepted that different people respond to medications differently because of advancements in genetic sequencing and genomics. The technique of giving "the correct drug, at the right time, at the right dose, for the right person" can be advanced by understanding a person's genetic traits or "biomarkers." To give focused therapeutics to the appropriate candidate, pharmaceutical and biopharmaceutical companies continuously work to adopt patient-selection diagnostic frameworks in the early stages of drug development. This helps the market for Companion Diagnostics grow even more.

‹›

Report Coverage & Deliverables

PDF report & online dashboard will help you understand:

• Real-Time Data Updates:
• Competitor Benchmarking
• Market Trends Heatmap
• Custom Research Queries
• Market Sentiment Analysis
• Demographic and Geographic Insights

Book Demo

Get Access Now

Furthermore, The high cost of immunotherapy has restricted patient access, even though it has shown tremendous promise in treating cancer. Instead, doctors might decide that it is more effective to combine therapies, which might increase the length of the course of treatment from five months to almost three years. In this instance, the cost increases as the duration increases. Additionally, individualized immunotherapies are expensive. Examples include Kymriah, a Novartis-authorized CAR T-cell therapy, and YESCARTA, a Gilead Sciences-approved CAR T-cell therapy, which range in price from USD 373,000 to USD 475,000 per patient, depending on the kind of cancer being treated. With significant lab resources, each CAR-T cell treatment is created precisely for the patient. As a result, each patient will pay an average of $60,000 for the medicine. Cancer immunotherapies can be far more expensive than other treatment choices like chemotherapy or radiation therapy. Thus, it is anticipated that the market for Companion Diagnostics will have slow growth due to the high cost of immuno-oncology medicines.

Top Market Trends

1. The Prevalence of Chronic Diseases Is Rising.: When choosing to treat lung cancer with targeted medicines, companion diagnostic exams (CDXs) are regarded as essential. Lung cancer patients who receive Companion Diagnostics as part of their initial therapy live longer than those who are not examined. The rising number of oncology companion diagnostic tests for the condition and the high incidence rate of non-small cell lung cancer (NSCLC) are likely to drive growth globally.

2. Modern sequencing identifies several biomarkers: NGS-based symptomatic diagnostics aims to make atomic data from each patient's growing genome available to inform treatment decisions for diseases. Compared to other sequencing techniques, cutting-edge sequencing identifies several biomarkers for various drug therapies in a shorter time. The use of NGS boards for biomarker assessment in a single test can aid in the treatment of many different diseases. The various cutting-edge developments in NGS also give market companies a swift advantage over competitors offering other innovations like PCR, ICH, and ISH. Given NGS, most market competitors are concentrating on developing companion demonstration products.

3. Improvements in the latest technologies: The next-generation sequencing-based companion diagnostic tests aim to coordinate treatment choices for disease medications by opening nuclear information from each persistent development genome. Compared to previous sequencing methodologies, front-end sequencing detects various biomarkers for diverse medications in a shorter time. Utilizing NGS sheets for biomarker assessment in a single test may aid in treating various ailments. Additionally, the many creative levels of advancement in NGS give market companies a quick advantage over competitors offering other pathways like PCR, ICH, and ISH. As a result, key market players are concentrating on creating illustrated goods while considering NGS.

Market Segmentation

The Companion Diagnostics Market is segmented based on the segmentation categories- Product & Service, Technology, Indication, End User, and Region. Based on Product & Service, the market is segmented into Assays, Kits & Reagents, and Software & Services. Furthermore, based on Technology, the market is segmented into Polymerase Chain Reaction, Next-Generation Sequencing, In Situ Hybridization, Immunohistochemistry, Other. Moreover, based on Indication, the market is divided into Cancer, Neurological Disorders, Cardiovascular Diseases, Infectious Diseases, and Other Indications. Based on End Users, the market is further categorized into Pharmaceutical & Biopharmaceutical Companies, Reference Laboratories, Contract Research Organizations, and Other End Users. In addition, based on Region, the market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

Based on Technology

Polymerase Chain Reaction (PCR) is a significant revenue contributor because of its high sensitivity, specificity, and cost-effectiveness.

The market category with the greatest share is Polymerase Chain Reaction (PCR), and growth is anticipated throughout the projection period. Simple automated systems can use cost-effectiveness, high sensitivity, and specificity, three key factors driving market expansion. Additionally, PCR, another crucial driver of this section, can identify the sequencing of many diseases with unidentified aetiologies. However, the next-generation sequencing market is anticipated to expand quickly throughout the forecast period because of important benefits like increased sensitivity to detect low-frequency variants, the quick turnaround for large sample volumes, simultaneous sequencing of hundreds to thousands of genes or gene regions, etc.

Based on Indication

Cancer Holds the Largest Share in the Market Growing Use of Biomarkers in Cancer Diagnosis

In 2021-22, the Cancer category dominated the market with the highest revenue share. The factors include the expanding use of biomarkers in cancer diagnosis and the growing importance of Companion Diagnostics in personalized medicine. Significant changes in gene sequence and expression patterns have been found in cancer research, which can serve as the foundation for targeted therapy. In addition, various malignancies have various biomarkers for which Companion Diagnostics have been created. Numerous cancer types, including lung, colorectal, breast, and blood cancers, which are the leading cause of mortality, require Companion Diagnostics.

Based on End-User

Drug and biotechnology Accounted for the Majority of Revenue Share Due to increasing prominence in medication development.

The Drug and biotechnology category dominated the global Companion Diagnostics market in 2021-22, and it is anticipated that it will continue to hold this position throughout the forecast period. The market for Companion Diagnostics was more heavily dominated by pharmaceutical and biotechnology companies. The growing prominence of Companion Diagnostics in drug development and the growing significance of companion analytic biomarkers indicate their expanding use.

Based on Region

North America is the Largest Revenue Contributor because the American population has a high prevalence of many types of cancer.

In 2021-22, North America had the highest revenue share of 45.6%. During the forecasting period, North America is anticipated to grow the market. The high incidence of various cancers among the American population drives the North American market. In Canada, the number of cancer patients is steadily increasing. The Canadian Cancer Society estimates that cancer is responsible for about 28.2% of fatalities in Canada. According to Canadian Cancer Researchers, there will be an increase of 229,200 new instances of cancer in Canada, of which 84,600 cancer patients will pass away.

Competitive Landscape

The global Companion Diagnostics market is dominated by companies such as Abbott Laboratories Molecular Inc., Agilent (Dako Denmark A/S), and ARUP Laboratories Inc. because of their unique products, financial stability, strategic advances, and global reach. The participants are focusing their efforts on promoting R&D. Some of the key players in the Global Companion Diagnostics Market include- Abbott Laboratories Molecular Inc. (U.S.), Agilent (Dako Denmark A/S) (U.S.), ARUP Laboratories Inc. (U.S.), BioMerieux (France), Danaher Corporation (Leica Microsystems) (Germany), Foundation Medicine Inc. (U.S.), Myriad Genetics Inc. (U.S.), Roche (Ventana Medical Systems Inc.) (U.S.), Thermo Fisher Scientific (Life Technologies Corporation) (Germany), QIAGEN N.V. (Germany), to name a few.

Recent Market Developments

● In July 2022, Almac Diagnostic and AstraZeneca CDx partnered. They intend to use NGS and qPCR to investigate new disease areas.

● In May 2021, A companion diagnostic was approved for use in the United States to help identify patients with non-small cell lung cancer (NSCLC) who could benefit from LUMAKRASTM (sotorasib), a recently approved therapy developed and marketed by Amgen Inc., QIAGEN N.V. announced the expansion of companion diagnostic (CDx) claims for the therascreen KRAS RGQ PCR Kit (therascreen KRAS Kit) (AMGN).

Segmentation of the Global Companion Diagnostics Market