It's revival time for the pharmaceutical industry in the Land of Rising Sun. No matter whether it is in research and development, generics, APIs, formulations or outsourcing field, the Japanese pharma industry is all poised to enter into a new phase of development activities to match its status as the second largest pharmaceutical industry in the world after US. On one hand, the Japanese government has taken initiatives to make the rules and regulations lenient to propel the sluggish pharma sector in the country, while on the other hand, three mega pharma events are about to hit the country, providing the domestic pharma and biotech companies an opportunity to meet the global players and appraise them of the winds of change sweeping through the industry.
It is felt that high cost environment, extended time duration of clinical trails and stringent regulations have placed the Japanese pharma industry in the bad books of multinational and foreign companies. But the authorities concerned are making every effort to reverse the status quo to earn a good name and attract more players into the country's pharma scene. For instance, notwithstanding the reports of intended withdrawal of pharma majors like Pfizer and GlaxoSmithKline from the Japanese research and development scene, the government efforts to accelerate new drug approvals and the removal of compulsory local manufacturing have opened up more investment opportunities in the sector.
Japanese clinical trail business has been going through a tough time, largely due to high cost of trials, red tape, reluctance of patients to participate in the trails and extended trail duration. Indeed, these factors have made research and development activities a low key profile in the country. However, the government is determined to revitalize the sector and has introduced attractive incentives as part of its efforts. Usually, the clinical trials in Japan take an extended duration of 3.5 years, compared to the trial duration in the US and Europe, it is learnt.
What turns the clinical trails a costly and timely process in the country is the Japanese government's insistence on conducting of phase I-III pharmacokinetic (PK) clinical trails of the drug on Japanese population. However, this decision is largely concerned by inter-ethnic differences in dose-response between Japanese and Caucasian populations. Now the government is for examination of single-dose safety and PK in healthy Japanese volunteers before the start of the global study. This will allow for comparison of results with those of the non-Japanese to confirm there is no particular concern regarding increased risk in the Japanese population. Serious efforts are presently being made within Japan to achieve a cost and speed that is comparable to the US and Europe to attract more and more global clinical studies.
On its part, the Japanese Government has been doing all it could to bring the Japanese pharma industry in the forefront. In what can be termed as a major move, the former Japanese Prime Minister Junichiro Koizumi had laid down four progression paths to breath a new life into the lackluster clinical trail business in the country. They are:
■ The promotion of clinical trials in Japan, particularly on a global level and the establishment of a clinical trials issue review committee
■ A five-year plan for clinical trials
■ New guidelines for global studies
■ Improved resources for linical trial review processes
Apart, the reform plans emphasize on development of new infrastructure, education of both doctors and patients, improvement of GCP documentation process and investment in IT, it is learnt.
Generics story
It seems that the Japanese generics market is no more a low penetrated one. It is true that stringent rules and regulations had made it difficult for the foreign companies to market generic version of medicines in the country. The picture has changed with the cost pressures driving regulators to draft laws ensuring better acceptance of generics. Apart, the government has recently introduced new stable supply rules to create a more high profile, better-regarded local generic industry. This new stable supply rules are expected to be implemented by 2011, it is learnt. Also, domestic players like Sawai and Towa are trying to boost the image of the sector.
The Japanese government aims to raise the generic drugs share to about 40 per cent of the pharma market from the current 17 per cent. The Japanese generic market, which is valued at $3 billion and stands at 5 per cent of the total pharma market in value terms and 17 per cent by volume, is expected to grow to over $4.3 billion by 2008, it is learnt.
With liberalized regula-tory norms, more and more foreign companies are entering the Japanese generics market through acquisitions, mergers, partnerships or joint ventures. Earlier, overseas companies had to conduct clinical trails on medicines to get a marketing approval in Japan. Now, with the luxury of a ready manufacturing and marketing base as well as a strong distribution reach that have come through acquisitions, mergers, partnerships and joint ventures, the foreign companies, especially Indian companies are able to market a wide range of generics in Japan.
Outsourcing wind
The Japanese government policies are encouraging domestic pharma companies to explore cost cutting efforts to stave off competition from foreign companies. And rightly, the Japanese pharma firms have resorted to outsourcing trend to take advantage of the cost-benefits that it can bring to drug manufacturing and clinical trail activities.
The Japanese pharmaceutical industry has indicated that it is particularly eyeing India as a new hub to conduct its contract manufacturing and clinical trials. Already Eisai Chemicals has expressed its intention to set up a new manufacturing unit and R&D facility in India. The company is expected to build the proposed facility either at Visakhapatnam or Indore. Also, Mitsubishi Chemicals has set apart Rs1665 crore to expand the manufacturing capacity of purified teraphthalic acid (pta), a petrochemical used in plastic products, to 1,270,000 tonnes from 470,000 tonnes at its facility in Haldia.
It is anticipated that the Japanese contract manufacturing activities will double by 2009, as the outsourcing trend begins to take off in the country. Also, opportunities are opening up in the active ingredients and formulations segment or finished dosage forms segment.
Pharma festivals
As the Japanese pharma industry is on the path of major reformation, it is the right time to host events like Interphex, API and Int'l Bio Forum and Bio Expo in Japan. These events are expected to provide a platform for the Japanese players to meet the multinational and foreign players, share innovative ideas, exhibit and see new technologies, enter into alliances and make known the changes taking place in the domestic pharmaceutical industry to global players.
Organised by Reed Exhibitions, these three events will be held simultaneously at Tokyo Big Sight, Japan, from June 20-22, 2007. While Interphex Japan and Int'l Bio Forum and Bio Expo are into 20th and 6th editions, respectively, active pharmaceutical ingredients expo and conference (API Japan) is just entering into the city of rising sun.
Known as the Asia's largest pharmaceutical industry event, Interphex Japan is the perfect avenue for pharma companies to exhibit all kinds of equipment, systems and technology related to R&D and manufacturing. Interphex Japan 2007 will also feature pharma sourcing 2007, pharma pack 2007 and pharma IT 2007 to discuss latest trends in outsourcing market, pharma packaging industry and IT solutions.
Held along with Interphex Japan, Int'l Bio Forum and Bio Expo Japan is a meeting place for research support device manufacturers, reagent manufacturers, bio clusters, bio universities and bio ventures. To add to the tempo of the event, Int'l Bio Forum and Bio Expo Japan 2007 will feature bio academic forum and bio venture forum. While bio academic forum, which consists of 154 sessions, will act as a venue for presentations of the state-of-the-art research and unique technology, bio venture forum is expected to gather bio/drug discovery ventures, food/pharmaceutical manufacturers and bio-related companies from around the globe for technical presentations and business meetings and licensing and partnering.
This year, researchers from Osaka University, Tokyo University, Tohoku University, AIST and Waseda University are expected to take part and have presentations in bio academic forum. On the other hand, bio venture forum is expected to witness gathering of pharmaceutical, food, chemical manufacturers and biotechnology-related companies to look at venture trends and technologies.
The Japanese pharma industry will also see introduction of an international trade fair specialized in API, API Japan 2007. The event will provide a golden opportunity for business meetings and technical discussions with material suppliers and medical and cosmetic manufacturers around the globe. Visitors from China, India Singapore, Europe and USA are expected to be present at API Japan 2007. The event is expected to attract large number of visitors, as it is held along side Interphex Japan 2007.