The name of our company defines our services, strengths, and values. Since the inception, we have endeavoured to research, analyze and present the critical market data with great attention to details.
Personalized medicine is one of the emerging approaches improvising disease treatment and prevention by taking individual variability in the genes, environment, and lifestyle into account. This approach allows healthcare professionals and researchers to accurately depict which treatment and prevention strategies would work for a particular disease in a particular group of people. Preventive or therapeutic interventions can then be directed to those who will benefit most from targeted intervention, thereby maximizing benefit and minimizing cost and complications. Personalized or precision medicine medical treatment model considers individual differences in patients’ genomes, environments, and lifestyles. It provides doctors and medical researchers the ability to customize healthcare—with medical decisions, practices, and products – for individual patients. Most of the organizations conducting precision medicine have been focused on cancer. In addition, precision medicine is being conducted in other areas such as neurological and cardiovascular diseases.
Advances in personalized medicine have already led to powerful discoveries and several new FDA-approved treatments that are tailored to specific characteristics of individuals. FDA’s Center for Drug Evaluation and Research (CDER) approved 59 new molecular entities (NMEs) i.e. new drugs, agents, or therapeutic biologics in 2018. Of the 59, the Personalized Medicine Coalition (PMC) classified 25 of them (42%) as personalized medicines. The number of personalized medicines approved annually had topped 20 percent since 2014, when PMC classified 21% of NMEs as personalized medicines. The Coalition classified 28% of NMEs as personalized medicines in 2015, 27% in 2016, and 34% in 2017.
Thus, with the inclination towards personalized healthcare and growth in the emergence of rare diseases, the healthcare and research organizations are facing challenges posed by high costs and lengthy timelines of delivering medicines to patients as the development of new pharmaceutical entity is time-consuming, extremely costly, and of high risk with little chance of successful outcome. For instance, a study published by the Tufts Center for the Study of Drug Development published in the Journal of Health Economics in May 2019 gave an estimated cost of USD 2.6 billion. This has increased from USD 802 million in 2003 to ~USD 1 billion in 2013, resulting in a 145% increase in the ten-year study gap.
Realizing the importance of personalized medicine, the leading pharmaceutical players are increasing their focus towards PMs. For instance, in July 2019, a Chicago-based conglomerate, GE Healthcare (U.S.), opened the GE Cell and Gene Therapy Asia Technology Center to train scientists in precision medicine-driven biopharma techniques. In July 2018, Centrillion Biosciences (U.S.) partnered with WeDoctor (China) to provide genomic analyses to patients. According to API Research, there were ~53,000 such devices in use as of 2017, and there will be 3.1 million as of 2021. With more devices connected to AI-based predictive analytics models, hospitals will save USD 52 billion in 2021, led by North America with USD 21 billion in savings.
Apart from this, pharmaceutical companies are conducting clinical trials to gain approval from regulatory bodies, which is considered an essential part of the drug development process. However, the increasing cost and time-consuming clinical trials discourage pharmaceutical companies from conducting drug development, limiting patients’ access to novel treatments. Thus, due to the high cost of drug development and clinical trials, many companies are looking for possible ways to cut down the cost of clinical trials and avoid drug development barriers to accelerate the drug development process. The adoption of real-world evidence helps simplify access and address some of the burdens while also providing a better understanding of medicines used in the ‘real world.’
In addition, since its emergence from November 2019, the coronavirus pandemic has put a tremendous burden on the healthcare sector all over the world. Real-world evidence solutions provide valuable insights to understand better, monitor, and prepare for the challenges caused by this pandemic. Regarding this pandemic, there is a generation of tremendous data that includes research data and patient data. Thus, the major goal of human research on COVID-19 to determine whether any currently marketed pharmacologic interventions could be effective in preventing infection or lessening the severity of the infection. This includes both progression to and treating severe acute respiratory syndrome-coronavirus-2 (SARS- CoV-2), which causes people to be hospitalized and often results in death. RCTs are now underway to evaluate existing and new therapies. Thus there are opportunities for non-randomized RWE to provide information in the interim and answer additional real-world questions that are not addressed in the studies.
In addition to shaping future clinical trials, RWD generated and collected during the COVID-19 pandemic can be used to evaluate investigational medical devices and extend marketing approvals. This is leading to the expansion of the RWE solutions market in the upcoming years at a CAGR of 19.1% to reach USD 5.57 billion by 2027, according to Meticulous Research®.
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