The research study covers the present scenario and growth prospects of the global leukemia therapeutics market for 2016-2020. To calculate the market size, the report considers revenue generated from the sales of branded, generic, and off-label drugs used for the treatment of different types of leukemia. The report also considers the revenues expected to generate from the sales of drugs including the drugs that will be launched into the market, along with the decline in revenues from the patent expiries of the marketed drugs during the forecast period.
North America remains the largest market for leukemia therapeutics on account of advanced healthcare infrastructure and supportive healthcare policies leading to increasing patient awareness.
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Technavio healthcare and life sciences analysts highlight the following three factors that are contributing to the growth of the global leukemia therapeutics market:
- Special regulatory designations for drugs
- Technological advances in the monitoring of leukemia
- Application for expanded indication approvals
Special regulatory designations for drugs
A few marketed drugs treat diseases affecting a small percentage of the population such as leukemia. A small number of diagnosed individuals implies that there is a small market for the required drugs, so it may not be profitable for companies to develop these drugs as recovering the R&D expenses itself would be challenging. To compensate for this limitation and to encourage the development of such drugs, regions such as the US and the EU are awarding an orphan drug designation or breakthrough therapy designation to certain drugs.
Orphan drugs are provided with protocol assistance along with 10-year market exclusivity in the EU. In the US, this designation provides seven years of market exclusivity for the drug, apart from other incentives, which includes, tax credits for qualified clinical testing and exemptions from prescription drug user fees for orphan indications. Market exclusivity translates into commercially beneficial provisions that attract pharmaceutical companies to increase their focus on the R&D of drugs for these diseases. Generic drugs are prevented from market entry for the duration of this exclusivity, thereby protecting the market sales of the developed orphan drug.
Apart from the orphan designations, breakthrough therapy designation is also given to drugs that are developed for the treatment of life-threatening diseases with a high unmet need in the market by the US FDA. “Such designations help in the early market entry of the drugs into niche markets, thus profiting both the drug makers and the individuals, and thus drives the growth of the market,” says Sapna Jha, a lead analyst at Technavio for oncology research.
Technological advances in the monitoring of leukemia
Understanding the response to treatment is very important in determining the long-term treatment course in young and elder individuals with leukemia. Although it has been understood that monitoring BCR-ABL1 is important for the successful treatment of chronic myeloid (or myelogenous) leukemia (CML), there have been no US FDA-approved BCR-ABL1 monitoring assays available in the market. Recently, in July 2016, Asuragen received the US FDA’s premarket clearance for its QuantideX qPCR BCR-ABL IS Kit, a diagnostic kit used for the management of CML. This kit is now available in the US and Europe, and helps in obtaining sensitive and reproducible results, thus helping in the easy disease clearance with improved standard of care for the patients.
Similarly, many research studies are ongoing for the identification of biomarkers that assist in understanding the disease progression and subsequent management. For instance, researchers at Guangdong Medical College, Guangdong, China have identified that micro RNA (miRNAs) act as biomarkers for the detection of acute leukemias.
Thus, the advances in these technologies for the development of diagnostic kits and biomarkers will help in the identification of the progression or remission of the disease and thus help in the effective management.
Application for expanded indication approvals
There has been an increase in the R&D activities going on for the re-positioning of already marketed drugs for new indications in the global leukemia therapeutics market. This concept of re-positioning came into practice in the early 1990s and it originated from the possibility of different diseases sharing common molecular pathways. Companies are conducting clinical trials to determine the effectiveness of the drugs in all such related indications. As this process of drug re-positioning leading to extended indication is a low risk, high reward strategy, this should increase the scope of treatment and hence, help in increased market penetration.
“Such regulatory filings for extended approvals of the previously marketed drugs are expected to increase the recognition and acceptance of these drugs, thereby helping market growth,” says Sapna.
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