PCR in Companion Diagnostics Market
Number of pages: 100 | Report Format: PDF | Published date: March 07, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
|
Report Attribute |
Details |
|
Market Size Value in 2022 |
US$ 3.7 billion |
|
Revenue Forecast in 2031 |
US$ 12.1 billion |
|
CAGR |
13.8% |
|
Base Year for Estimation |
2022 |
|
Forecast Period |
2023-2031 |
|
Historical Year |
2021 |
|
Segments Covered |
Type, Indication, End-user, and Region |
|
Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global PCR in companion diagnostics market was valued at US$ 3.7 billion in 2022 and is expected to register a revenue CAGR of 13.8% to reach US$ 12.1 billion by 2031.
PCR in Companion Diagnostics Market Fundamentals
Companion diagnostics is a test that matches a patient with a particular medication or biological treatment. For instance, a companion diagnostic test may determine whether a tumor carries a particular gene mutation or biomarker the medication targets. This helps to determine if the patient should receive the drug or not. The primary reason for pharmacotherapy variability, which can be of considerable magnitude, is frequently caused by disease heterogeneity. The approach that patients with comparable diagnoses react to the same pharmacological intervention varies greatly in terms of both efficacy and safety. However, things are gradually changing due to the development of molecular diagnostics and the ensuing improved knowledge of disease mechanisms. A growing number of predictive biomarker tests have been created in recent years to direct the usage of targeted cancer treatments. The drug-diagnostic co-development approach creates companion diagnostics concurrently with the drug. The effectiveness of a treatment plan or the possibility of severe side effects can be determined using complementary diagnostic tests. Most medicines that come with a diagnostic test are cancer medications that target particular tumor abnormalities. Companion diagnostics improve clinical trial design, shorten the research cycle, and boost commercial success. It lowers the price of needless medical care. Additionally, it reduces danger and improves therapeutic effectiveness. For patients, it allows safer, more successful treatment with more confidence and less inconvenience.
A specific DNA section is amplified in a lab setting using polymerase chain reaction (PCR), which enables the detection of minute amounts of DNA. This method is frequently applied in tests to diagnose inherited illnesses, cancer, and infectious diseases. The efficiency of PCR in companion diagnostics is one of its most important benefits. The pace at which PCR technology produces amplicons allows it to produce results compared to other techniques, such as culturing. In addition to the incredible efficacy, PCR methods are useful in identifying mutations that require protracted cultivation or have difficulty growing in vitro. Furthermore, testing is more affordable in these circumstances owing to PCR technology, which needs less DNA material than other tests.
[576575]
PCR in Companion Diagnostics Market Dynamics
PCR in companion diagnostics is useful in personalized diagnostics as they have several benefits. One of the main benefits of PCR in companion diagnostics is that they make it easier for doctors to pinpoint the patients who are likely to profit from the provided therapy. PCR has many applications in molecular biology and biochemistry, including the study of gene expression, the discovery of mutations, forensic investigation, and pathogen detection. Quantitative real-time (RT) PCR is increasingly used to evaluate copy numbers from total yield. Using PCR in companion diagnostics can assist doctors in deciding on the best course of treatment for each patient by finding genetic mutations or biomarkers linked to a particular illness. This may result in both lower healthcare costs and improved patient results. As the number of new products receiving clearance rises, more tests and forms of therapy are being used, boosting market expansion.
Key manufacturers are concentrating on the development of innovative tests, which drive the expansion of the PCR in companion diagnostics market. Moreover, the market is expanding due to the novel PCR kits produced by major players. This test helps to find non-small cell cancer patients who are candidates for treatment. Results for each PCR are available in about an hour. This implies that findings can be delivered to clinicians in time. The PCR, for instance, has been demonstrated to, on average, cut the time to results from traditional testing techniques by 84%. Therefore, clinical professionals can more effectively focus therapy with quick responses on thorough panels. PCR has been found to decrease procedures such as endoscopies, X-rays, CT scans, and ultrasounds. Quick results can also help reduce downstream testing. The advantages of PCR testing for therapeutic and workflow purposes may also have financial effects. Possible cost-saving measures include lowering the usage of antibiotics, shortening hospital stays, and reducing the number of diagnostic procedures. Simple automated platforms can use cost-effectiveness, high sensitivity, and specificity, three key factors driving market revenue growth. The PCR can also identify the sequencing of many unknown disease etiologies.
However, despite growing acceptance, there is no established benchmark for determining reimbursement policies for a companion diagnostic test by using PCR. Reimbursement is determined on a case-by-case basis. Furthermore, PCR in companion diagnostics lacks a uniform regulatory structure. The regulation and clinical growth of companion diagnostics, which are crucial for sensitivity and specificity when choosing a course of treatment, present several challenges. Furthermore, false positive PCR results may harm both high- and low-prevalence settings. The likelihood of harm and prevalence should be considered when choosing testing strategies.
PCR in Companion Diagnostics Market Ecosystem
The global PCR in companion diagnostics market is analyzed from four perspectives: type, indication, end-user, and region.
PCR in Companion Diagnostics Market by Type
[56456]
Based on the type, the global PCR in companion diagnostics market is segmented into RT-PCR and qPCR.
The RT-PCR segment accounted for the largest revenue share of global PCR in companion diagnostics market in 2022. RT-PCR is very sensitive to changes in genes and extremely specific. It is more accurate and precise than other techniques to be beneficial for companion diagnostics. RT PCR can measure gene expression and verify that some genes manifest themselves differently, which helps to eliminate errors in companion diagnostics. RT PCR amplifies particular nucleic acid sequences and concurrently measures their concentration using commercially available fluorescence-detecting thermocyclers. In the same PCR machine, target sequences are amplified and measured. RT PCR can measure the quantity of DNA or RNA without internal standards. Target sequences can be quantified more precisely when the amplified DNA can be measured during the exponential period of the PCR when none of the reaction components are in limited quantities. The initial concentration of target DNA can be measured using RT PCR over five or six orders of magnitude. Moreover, RT PCR offers several significant benefits, such as the ability to measure DNA concentrations over a wide range, sensitivity, processing of numerous samples at once, and providing immediate results. RT PCR is particularly helpful in big commercial laboratories that process many similar-type samples.
However, qPCR is spreading quickly among researchers in the field of oncology due to its potential applicability to numerous study fields. With small sample handling, qPCR enables extremely sensitive quantification of DNA and transcriptional gene levels in hours. The recent influx of reports utilizing qPCR in cancer research attests to the technological transition from an experimental instrument to the industry scientific standard.
PCR in Companion Diagnostics Market by Indication
Based on the indication, the global PCR in the companion diagnostics market is segmented into cancer, neurological diseases, and infectious diseases.
The cancer segment accounted for the largest revenue share of global PCR in the companion diagnostics market in 2022. Technological and biological advances supply molecular targets for detecting and treating complex illnesses such as cancer. For thorough tumor profiling, various assays are required due to the diversity of genomic alterations implicated in malignancy. To maintain the integrity of RNA for analysis, some novel molecular classifications of tumors based on gene expression demand a paradigm shift in specimen processing. DNA and protein, which are more durable markers, are easily managed in the clinical laboratory. Gene duplications and deletions can be identified using quantitative RT PCR.
Small mutations down to single base changes can be found by melting curve studies performed right after PCR. These methods are getting simpler, quicker, and multiplexable. Thus, RT PCR is a good choice for studying cancer markers. Recent advancements in oncology studies must be implemented in clinical settings. This necessitates the development of objective, reliable, and affordable molecular techniques for use in clinical trials and, ultimately, everyday life. In the clinical laboratory, RT PCR has appealing characteristics for tumor profiling.
After receiving initial treatment, many people with leukemia or any other cancer experience full clinical remission. Many of these patients will ultimately experience relapses due to tumor cells not being picked up during routine staging procedures. By employing more sensitive molecular techniques to identify levels of disease burden below the resolution threshold of conventional pathology, the study of minimal residual disease seeks to redefine the concept of tumor remission. A relative rise in the relapse rate is linked to the qualitative PCR-based identification of such cases. Therefore, the global increase in the cancer patient population and the need for better diagnostics and treatment use of PCR in companion diagnostics is encouraging.
PCR in Companion Diagnostics Market by End-user
Based on the end-user, the global PCR in the companion diagnostics market is segmented into pharmaceutical and biopharmaceutical companies, reference laboratories, CROs, and others.
The pharmaceutical & biopharmaceutical companies segment accounted for the largest revenue share of the global PCR in the companion diagnostics market in 2022. PCR method has been proven helpful in pharmaceutical and biopharmaceutical companies for companion diagnostics. Genetic engineering also uses this method to develop advanced treatment strategies after an accurate diagnosis. The primary factor driving the global PCR in companion diagnostics market is the need to develop novel therapeutics. It is employed to locate genes linked to particular phenotypes, such as genetic diseases. The pharmaceutical and biotechnology industries regularly evaluate the microbial load of raw materials and finished supplies. In the pharmaceutical industry, sophisticated analytical techniques such as PCR have been extensively used for quality control analysis. A PCR-based assay is used to identify the sterility of pharmaceutical samples using highly conserved bacterial ribosomal DNA sequences.
PCR in Companion Diagnostics Market by Region
Based on the region, the global PCR in companion diagnostics market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America accounted for the largest revenue share of the global PCR in the companion diagnostics market in 2022. The market was dominated by North America, with the United States emerging as a major contributor. The usage of companion diagnostics is an important treatment decision technique for various oncology drugs, as evidenced by how the FDA classifies these assays in terms of risk. Companion diagnostics clinical trials have risen to prominence in the pharmaceutical industry as they help to improve clinical success rates. The testing kit was in high demand for identifying those who had various diseases.
Companion diagnostic technology has undergone a transformation owing to molecular diagnosis. PCR has emerged as a preferred technique for rapidly and precisely identifying diseases. Key factors likely to propel the market during the forecast period include expansion by top PCR product makers in the Asia Pacific region by strengthening the distribution system and new product launches in the regional countries. Furthermore, the rising incidence of cancer and infectious diseases has increased demand for the usage of the PCR technique in diagnosing these diseases in Asia Pacific.
PCR in Companion Diagnostics Market Competitive Landscape
Many organizations emphasize introducing novel therapeutics, obtaining approval for those products, and participating in other activities, such as awareness programs, as key development strategies. Furthermore, the market classified partnerships, acquisitions, and various other types of collaboration as better growth strategies. Given the rising global demand for PCR in companion diagnostics, these steps have increased the likelihood of future profitable growth prospects.
The key participants in the global PCR in companion diagnostics market are:
PCR in Companion Diagnostics Market Strategic Developments
To match a patient with a particular medication or treatment, a specific DNA segment is amplified in a lab setting using PCR, which enables the detection of minute amounts of DNA that helps to identify the specific mutation.
Increasing technological advancements and emerging diseases such as cancer and infectious disease are the key trends governing the global PCR in companion diagnostics market.
Key companies operating the global PCR in companion diagnostics market are Qiagen, Agilent Technologies, F. Hoffmann-La Roche Ltd, bioMérieux Sweden AB, and Ventana Medical Systems.
High cost and lower proofing efficacy are the main factors hindering global market revenue growth.
The global PCR in companion diagnostics market is expected to grow at a revenue CAGR of 13.8% during the forecast period from 2023 to 2031.
*Insights on financial performance are subject to the availability of information in the public domain