Companion diagnostics (CDx) are medical devices that are used to identify patients who are most likely to benefit from a particular therapeutic product, such as a drug. CDx are increasingly being used in personalized medicine, which is a growing trend in healthcare.
According to Stratview Research, the global companion diagnostics market is expected to grow from USD 6.69 billion in 2022 to USD 13.55 billion by 2028, at a CAGR of 11.99% from 2023 to 2028. The market is driven by a number of factors, including the growing significance of companion diagnostics in drug development, rising incidence of cancer and growing adoption of targeted therapies, and increasing demand for personalized medicine.
Growth Drivers
The following are some of the key growth drivers of the companion diagnostics market:
- Growing significance of companion diagnostics in drug development: Companion diagnostics are playing an increasingly important role in drug development. They are used to identify biomarkers that can be used to predict patient response to a particular drug. This information can be used to design clinical trials more efficiently and to identify patients who are most likely to benefit from a particular drug.
- Rising incidence of cancer and growing adoption of targeted therapies: Cancer is one of the leading causes of death worldwide. The incidence of cancer is rising, and this is driving the demand for companion diagnostics. Companion diagnostics are used to identify biomarkers that can be used to diagnose cancer, predict patient response to treatment, and monitor the effectiveness of treatment. Targeted therapies are drugs that are designed to target specific biomarkers. Companion diagnostics are used to identify patients who are eligible for targeted therapies.
- Increasing demand for personalized medicine: Personalized medicine is a growing trend in healthcare. It is an approach to healthcare that takes into account individual variability in genes, environment, and lifestyle to tailor treatment to the individual patient. Companion diagnostics play a key role in personalized medicine by identifying biomarkers that can be used to guide treatment decisions.
Key Trends
The following are some of the key trends in the companion diagnostics market:
- Shift towards next-generation sequencing (NGS): NGS is a powerful technology that can be used to sequence DNA and RNA. NGS is being increasingly used in companion diagnostics to identify biomarkers that are associated with disease and treatment response.
- Growing use of liquid biopsy: Liquid biopsy is a non-invasive method of detecting cancer and other diseases by analyzing circulating tumor cells (CTCs) and other biomarkers in the blood. Liquid biopsy is being increasingly used in companion diagnostics to monitor tumor progression and response to treatment.
- Rise of companion diagnostics for infectious diseases: Companion diagnostics are also being developed for infectious diseases. These diagnostics can be used to identify patients who are infected with a particular pathogen and to predict their response to treatment.
Key Players
Some of the key players in the companion diagnostics market include:
- Roche Diagnostics
- Thermo Fisher Scientific
- Abbott Laboratories
- Danaher Corporation
- Myriad Genetics
- Illumina
- QIAGEN
- Bio-Rad Laboratories
- Becton, Dickinson and Company (BD)
- Hologic
- Agilent Technologies
- InVitae
Challenges
The following are some of the challenges facing the companion diagnostics market:
- High cost of development and validation: The development and validation of companion diagnostics can be expensive and time-consuming. This can be a barrier to entry for smaller companies.
- Regulatory barriers: Companion diagnostics are regulated by the US Food and Drug Administration (FDA) and other regulatory agencies. The regulatory process can be complex and time-consuming.
- Reimbursement challenges: Reimbursement for companion diagnostics can be a challenge. Payers may be reluctant to reimburse for companion diagnostics if they do not believe that they provide sufficient clinical value.
Opportunities
The following are some of the opportunities in the companion diagnostics market:
- Growing demand for personalized medicine: The growing demand for personalized medicine is creating new opportunities for companion diagnostics. Companion diagnostics play a key role in personalized medicine by identifying biomarkers that can be used to guide treatment decisions.
- Technological advancements: Technological advancements, such as the development of NGS and liquid biopsy, are creating new opportunities for companion diagnostics. These technologies can be used to develop more accurate and sensitive companion diagnostics.
Expanding applications: The applications of companion diagnostics are expanding beyond cancer. Companion diagnostics are being developed for infectious diseases, cardiovascular diseases, and other conditions. This is creating new growth opportunities for the companion diagnostics market.
