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November 2024
The companion diagnostic technologies market was estimated at US$ 2.78 billion in 2023 and is projected to grow to US$ 9.06 billion by 2034, rising at a compound annual growth rate (CAGR) of 11.34% from 2024 to 2034. The increasing demand for personalized medicines, rising incidences of cancer and other chronic disorders, and technological advancements drive the market.
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A companion diagnostic (CDx) is a test that provides information about the safe and effective use of a corresponding drug or biological product. It also gives an idea about the patients most likely to benefit from a particular therapeutic product. CDx involves an in vitro diagnostic (IVD) device or an imaging tool. The test can be performed on different biological samples including a tissue biopsy or blood/plasma or bone marrow samples using different genomic technologies such as next-generation sequencing and qPCR or protein-based technologies such as immunohistochemistry.
The increasing demand for personalized medicines and the development of targeted therapies potentiate the market. CDx tests represent more targeted and personalized medicine for multiple diseases. It gives prior information about the side effects and the desired therapeutic effect of a drug after administration. The growing research and development and the increasing number of clinical drugs for cancer and other chronic disorders increase the likelihood of using CDx.
The demand for precision medicine is becoming more and more prevalent, especially in oncology. It is reported that around 40% of the drug development pipeline is dedicated to rare cancer diseases, where next-generation biotherapeutics such as cell and gene therapy are being used more frequently. CDx are important tools in the practice and application of precision medicine. In 2022, 12 novel personalized medicines were approved by the US FDA. CDx plays a crucial role in optimizing patient outcomes and reducing healthcare costs by ensuring that therapies are tailored to individual patient profiles. A report indicates that CDx-guided drug development can cut the cost of clinical trials by 60%.
The major challenge of the market is the complex pathway for the development of CDx. Strategic business challenges can complicate the path to the development of CDx. This can cost the company time, resources, and revenue. Another major challenge is the high cost of the CDx. The cost can range from several hundred to several thousand dollars, limiting the affordability of many lower- and middle-income groups.
North America held the largest share of the companion diagnostic technologies market in 2023. The increasing demand for precision medicines, favorable government policies, increasing investment & collaborations, and the presence of key players drive the market. The increasing cases of cancer also boost the development of CDx. In June 2023, the US FDA issued guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” a pilot program to provide greater transparency regarding performance characteristics that certain tests for oncology biomarkers used to select certain oncology drug treatments should meet. Canada’s Drug Agency also introduced the first phase of process improvements related to companion diagnostics. The market is also driven by technological advancements and innovations in genomic and proteomic testing.
Asia-Pacific is anticipated to grow at the fastest rate in the companion diagnostic technologies market during the forecast period. The growing research and development, rising incidences of cancer and other chronic disorders, and increasing investments & collaborations drive the market. The Chinese government established a regulatory pathway for the development and approval of CDx. The increasing cases of cancer demand the development of precision medicines and CDx. In China, approximately 4.8 million new cancer cases were reported in 2022. The incidence of cancer in India and Japan was found to be 1.4 million and 1 million, respectively, in 2022.
The increasing awareness about genomic and proteomic testing, as well as government policies to support genomics and proteomics, augment the market. In October 2023, the Chinese government launched a multi-billion RMB 30-year proteomics research initiative. Additionally, the Japan Agency for Medical Research and Development (AMED) established a three-year continuing financial support system to spur genomic research on the pathogenesis of diseases and the development of therapeutic drugs.
By type, the immunohistochemistry segment held a significant share of the companion diagnostic technologies market in 2023. Immunohistochemistry (IHC) is a technique used to detect the presence of antigens in a tissue sample using antibodies. IHC is widely used in disease diagnosis, biological research, and drug development. It is a simple and cost-effective technique that has applications in biomarker assessment in oncology, diagnosis of infectious diseases, and evaluate neurodegenerative disorders.
By application, the cancer segment held a dominant presence in the companion diagnostic technologies market in 2023. The increasing incidences of cancer, stringent regulatory guidelines, and growing research and development potentiate the segment growth. Currently, there are 51 CDx tests approved by the US FDA, the majority of which are for hematological malignancies and solid tumors. Additionally, out of 170 approved indications for companion diagnostics, only three are for non-oncology drugs.
By application, the central nervous system segment is expected to grow at the fastest rate in the companion diagnostic technologies market during the forecast period. The rising geriatric population, increasing prevalence of neurodegenerative disorders like Alzheimer’s and Parkinson’s disease, and increasing collaborations promote the segment’s growth. CDx using next-generation sequencing technologies are developed for neurodegenerative drugs.
Randy Evans, Vice President of Medical Affairs at BD Biosciences, commented that several companies should collaborate during the early development stage to achieve strategic harmony among industry players and align with the mandates of external regulatory authorities. He also stated that CDx can provide a competitive advantage for biopharma as the number of therapeutic options increases. Additionally, using a multimodal approach (e.g., genomic and proteomic) could lead to even better outcomes by enabling a more personalized approach.
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November 2024
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