Molecular diagnostics is a set of analytical tools used to interpret biomarkers in an individual’s genome.
The technology has led to advances in treatment and research, enhancing and revolutionizing medical care for a wide range of health conditions.
One of the most promising applications of molecular diagnostics is oncology—it is used for screening, therapy selection, diagnosis, and relapse monitoring of cancer.
Currently, the demand for cancer research therapy in complex molecular tumor diagnostics is high. The genetic analysis of samples using next-generation sequencing technologies helps researchers detect genetic changes and patterns in tumor tissues, ultimately helping physicians determine the most effective treatment options for individuals.
Market size and forecast
The global oncology molecular diagnostics market was valued at $1.26 billion in 2014 and is expected to reach $2.86 billion by 2019, growing at a CAGR of 17.8%.
Molecular diagnostics is a transformative and dynamic area of diagnostics, however the relative newness of the field means that there are nearly as many challenges facing adoption of this technology as there are reasons behind its growth.
Market drivers
High demand for personalized medicines
A one-size-fits-all approach is hardly ever the best tactic, and this is especiallytrue for cancer treatment. Treatments that are tailored to a specific individual are in high demand, leading many pharmaceutical companies to develop personalized medicines for better patient care.
Since these personalized treatments rely heavily on information from an individual’s genome, demand in this segment is expected to help sustain market growth through the forecast period.
Rapid developments in molecular diagnostics
Technological advancements are coming hard and fast in the molecular diagnostics market: The integration of diagnostic methods with advanced IT and data analytics is minimizing the complexity of assays and further analysis, and the use of nanotechnology for developing molecular diagnostic products will help increase the efficiency of diagnostic methods and results.
Use of biomarkers
Increasingly sophisticated research into nucleic acid expression, proteomics, and gene sequencing has led to the development of biomarkers—hormones, genes, proteins, and other molecular entities that detect the presence or absence of diseases based on their pharmacological or physiological processes.
These biomarkers can be used to:
- Recognize individuals who are at a higher threat of developing disease
- Predict the clinical response and outcome of the disease
- Elucidate the biological pathways affected by the disease
- Identify people who are most likely to respond to specific therapeutic interventions
- Determine patients who will develop side effects to treatment
Market challenges
Ethical, privacy, and practical issues
People are getting more and more protective of their personal information, and genetic testing has taken this to a whole new level—there is a general fear that information provided for research purposes could end up in the hands of commercial entities.
This brings up questions surrounding the ethical use of a person’s genetic information: Can it be used for further drug development, and how much access should a patient have to their own information?
These are some of the questions that governments and regulatory bodies are seeking to answer, but these concerns could be a big hurdle for market growth over the next few years.
Insurance coverage and reimbursement issues
Despite the strong value proposition of molecular diagnostics for oncology, the low insurance reimbursement levels provided for these tests and insufficient coverage for associated treatments often discourage patients from pursuing these options.
For instance, Medicare in the US previously provided reimbursements for molecular diagnostic tests under the code stacking method. According to this method, the total expenditure on separate tests was compiled and paid for by patients, who were later reimbursed upon the submission of authenticated bills. In 2013, Medicare dissolved this policy, as many test laboratories were exploiting this payment scheme.
Lack of skilled technicians
It’s often said that in medicine, expertise and new technology tend to mutually exclusive concepts.
Advanced molecular diagnostic methods are complex and require a thorough understanding of device mechanisms for effective use. In addition, data obtained from the system can be difficult to interpret without adequate training.
While there are definitely experts operating in the field, the use of this technology in oncology is still relatively new, meaning that a lot of medical professionals just don’t have the technical expertise in this area.
But as molecular diagnostics takes a more permanent place in oncology, more and more doctors will be equipped with the proper training to provide care in this area, which will ultimately result in market growth.
