IEKView：Toward Precision Medicine; A Niche for Taiwanese Players
Since the phrase “precision medicine” was mentioned in 2011 by the United States National Research Council (NRC) in its report "Toward Precision Medicine”, the US, UK, China, France, and Korea have directed significant investments in research and infrastructure related to precision medicine. In July 2017, the Food and Drug Administration (FDA) approved the first companion diagnostic product centered on Next Generation Sequencing (NGS), marking the beginning of the precision medicine era with gene sequencing results being used as the basis of medication decisions.
The modern medical system administers treatments based on symptom descriptions and the findings of routine examinations. This approach can deal with most illnesses but has been ineffective in terms of early diagnostics, precise treatment and risk control for genetic diseases, cancers, communicable and chronic diseases.
Precision medicine is about the offering of tailored preventive and therapeutic measures to patients by taking into account the differences in genetic profiles, social environments and lifestyles and applying molecular biology tools in complex disease analytics. The purpose is to ensure the optimal treatment for all the sub-groups of patients for different diseases by staying on top of the incidence, progression and genetic variances.
Precision medicine aims to provide patients with bespoke and suitable doses of medication at the right time on the basis of complete disease information. The insight gained from biobanks and genome analytics on parameters regarding treatments, daily activities and follow-up care enable not only personalized treatments, but also disease risk control and health promotion. This is the ultimate goal of precision medicine.
There are a wide range of new diagnostic techniques required for precision medicine to enhance the treatment efficiency and even disease prevention. Examples are Next Generation Sequencing (NGS), liquid biopsy diagnostics, sample preparation, platform for co-development of drug and companion diagnostics, and gene/ physiological data analytics.
Companion Diagnostics as the Top Priority for Precision Medicine
Companion diagnostics as the direct tool for treatment strategies nowadays is the first priority for precision medicine. Research in 2002 indicated that the response rate from patients grouped by the biomarker HER2 to Trastuzumab, the target drug used in the first-line therapy, increased from 7% (without biomarker tested) to 34% (grouped with biomarker). This shows the dramatic improvement of medication precision and effectiveness from using biomarker grouping.
Meanwhile, the clinical statistics released in 2016 by the U.S. Biotechnology Industry Organization suggests that biomarker can increase the success rates of drug development toward clinical trials. The success rates of clinical developments with biomarkers are three times of those without biomarkers throughout the clinical trial stage. These biomarkers become companion diagnostic products when the drugs get to market.
Companion diagnostics have already been widely used for the screening and selection of cancer drugs and pharmacovigilance. As the development of companion diagnostics and precision medical drugs are interrelated, the pharmaceutical companies and diagnostics providers collaborate more closely.
Next Generation Sequencing (NGS) Drives the Rapid Growth of Genetic Analytics
Biopsy has been widely used for genetic sequencing to unveil the complex causes of diseases in order to establish a full picture for treatment strategies.
In addition, liquid biopsy has attracted significant attention as the sensitivity of Next Generation Sequencing (NGS) and circulating cell separation techniques improves over time. As liquid biopsy supports periodic sampling and tracking, more use cases will emerge for the detection and inspection of genetic diseases and the follow-up post treatment. This, in combination with genetic profiling, can serve as the basis for comprehensive and precise treatment strategies.
The rapid progress of Next Generation Sequencing (NGS) has slashed the cost of human genome sequencing from $7.14m in 2007 to $1,363 in 2015. The cost reduction has opened up the possibility of many applications and contributed to the rapid rise of genome profiling and analytic services.
Accurate sequencing is the foundation for precise diagnostics. This requires the integration with a plethora of biomedica information tools for contrasting, comparisons and analysis, in order to convert a massive amount of sequencing data into complete and personalized medication advice.
With the maturing of artificial intelligence technology and the support from advancing hardware and software, many vendors have launched products and services for biomedical information analytics. In addition to helping pharmaceutical companies in the development of biomarker/diagnostic products and target therapeutics, such services/products are being used in precise diagnostics and personalized drug administering.
Taiwanese Industry Players Should Establish R&D Platforms Based on Its IVD Industry and Focus on Specific Disease Applications
Given the foundation of the in vitro diagnostics sector in Taiwan, the industry could refer the footsteps of international companion diagnostics companies to build R&D platforms for specific disease applications, as well as for liquid biopsy and multiplexed assay.
Some companies in Taiwan seek to enter the Next Generation Sequencing (NGS) market by leveraging their advantages in semiconductors and electronics. However, the oligopoly structure of the market and the acceptance of Taiwanese brands pose challenges. It is suggested that Taiwanese players may seek cooperation with academic and research institutions in R&D for next-generation technologies. Efforts should focus on the products and applications that require high speeds, long sequencing fragments, and high fault tolerance. This will enable the capturing of business opportunities for new applications in the international market.
Currently, Taiwanese companies are active in the upper, mid and downstream of precision medicine. However, they are all in the early stages, and their activities are rather scattered across the value chain. In fact, most of these companies are start-ups or small-to-mid sizes. More collaborations domestically and overseas are necessary in order for the industry to grow and prosper.