"Clinical trials have very detailed and precise processes and the logistical elements of these processes are critical. Recent revisions to the pharmaceutical industry's regulatory laws as well as improved patent laws in countries such as Japan, China and India, have led to the burgeoning clinical trials market in Asia."
The clinical trial market in Asia is booming. The pharmaceutical market grew by seven per cent on a global level to US$600 billion while sales in Asia grew by about nine to ten per cent. Looking forward for the next five years, the Asia Pacific region is expected to grow by up to 12 per cent annually.
To this end, we will see a corresponding growth of 20 per cent in the clinical trial market. Recent revisions to the pharmaceutical industry’s regulatory laws as well as improved patent laws in countries such as Japan, China and India, have led to the burgeoning clinical trials market in Asia.
The market in the US and Europe is very well developed and efficient but it is still facing its own set of challenges. One key challenge for clinical trials in Europe and the US is the increasing difficulty in recruiting patients to participate in clinical trials.
In contrast, the market in Asia is just emerging. Large population in Asian countries like India and China will facilitate the task of patient recruitment for clinical trials. This pool of naïve patients also offers the advantage of genetic diversity.
The other benefit to Asia is the lower costs of conducting clinical trials in the region as compared to Europe or the US – low cost has become the hallmark of Asian countries.
One of the strengths of the Asian clinical trial market is the availability of a large patient pool. Another is the availability of well-trained researchers and the willingness of both researchers and patient participants to be involved in global clinical trials. Furthermore, many major global players who recognize the potential of Asia early already have a presence in the region. This helps to ensure that the global standards are met.
Yet, as the pharmaceutical and clinical trial market continues to expand, there is a need to fill the gap to provide more trained researchers and technologists in Asia.
While some countries in the region are already showing promising signs of changes in regulations, it will take some time for them to keep pace with the industry’s global standards, for example, good laboratory practices. Due to a lack of homogenous and well-connected transportation network in Asia, the movement of samples to remote places also remains a challenge.
In Japan, the pharmaceutical and biotechnology market has experienced significant growth since the government relaxed data requirement rules for new drug registration in 2004. The clinical trial market was estimated to be worth more than $27 million in 2004, but by 2010, it is expected to grow almost seven fold to $180 million. A significant portion of this growth has come from international Contract Research Organizations (CROs), which have set up branches in Japan.
Since the deregulation of the industry, pharmaceutical companies have been able to outsource their clinical research to other countries, such as Korea and Taiwan, to increase efficiency and lower the overall costs of research and development.
As you know, clinical trials have very detailed and precise processes and the logistical elements of these processes are critical. TNT’s involvement in these processes concerns the transportation of testing kits to doctors carrying out the trials, as well as blood and urine samples to the laboratory following the successful administration of drugs to patients.
So, as you can see, the items we transport are both time and temperature sensitive, and our role is to maintain the integrity of each of these items throughout their journey. For example, from the time it is picked up from a clinic to the time it arrives at a laboratory to be tested.
For this to happen, it is essential that the packaging of these items is suitably tailored to ensure that the correct temperature is maintained throughout. Packaging materials also need to comply with international guidelines set by organizations such as the International Air Transport Association (IATA) to meet health and safety regulations.
Consequently, TNT has spearheaded the development of ‘MedPak’, an innovative packaging solution, designed to ensure the express distribution, security, safe handling and priority treatment of time-sensitive shipments of non-infectious specimens (like test tubes of blood and urine). Specifically developed for ambient diagnostic specimens, the Medpak’s secondary packaging meets all of IATA’s specifications, ensuring operator protection and compliance with all appropriate regulations.
To support the growth of the clinical trials sector in Asia, TNT launched ‘Clinical Express’, a suite of logistics services for the clinical trial logistics market in April 2004. Targeted at pharmaceutical companies, central laboratories and contract research organizations engaged in clinical research and drug development, Clinical Express offers two distinct levels of services – ‘Clinical Express Exclusive’, the global door-to-door service for diagnostic specimens under frozen conditions, and ‘Clinical Express Network’ for ambient diagnostic specimens.
Apart from providing our customers with a full suite of customized services, TNT also seeks to ensure that our team constantly upgrades its skill sets, and is always kept up-to-date with the most current knowledge of health, safety and customs regulations.
At TNT, we not only recognize the importance of clinical trial logistics but also are well positioned to meet the growth and challenges presented by the sector through our innovative solutions and ability to sustain and develop the services we provide.
The one comment I would like to make is that TNT will continue to anticipate the needs of the industry to provide even more sophisticated solutions to customers in the life sciences sector.
