Eastern Europe Attracting Clinical Trials
Eastern Europe is becoming the next focal point for the global pharmaceutical industry. A high number of clinical trials are taking place in Russia, and the number is expected to grow in coming years.
Currently, 38,000 patients are enrolled in clinical trials in Russia, and more CROs are setting up operations in Russia.
Russia is attracting more clinical trials due to the simplification of legal regulations and the implementation of GCP and other international standards.
Overall, Eastern Europe is increasingly attracting foreign pharmaceutical investments due to the relatively low costs and fast recruitment of patients for clinical trials.
Romania, Turkey, Bulgaria, Russia, and the Ukraine are particularly attractive, with Romania, Russia, and the Ukraine being the most popular clinical trial sites.
These three countries have large development potential due to their populations (140m in Russia, 46m in Ukraine and 22m in Romania).
Patient recruitment rates are between two and ten times faster, with a 50% savings compared to the US. Trials in these countries have tripled here in the past three years.
Currently, Russia has one third of the total Central and Eastern European market, but all of the countries have seen significant growth in the past years. Since 2006, the pharma markets in Russia and the Ukraine increased their value by one third, while the Romanian market grew by one fifth.
Source: Outsourcingpharma, May 29, 2008.
France: Pharma Industry Needs to
Change
32,000 Jobs Could be Lost
France is being hit by hard economic times, as evident in the French pharmaceutical industry, with 32,000 jobs at risk between 2005 and 2015.
The job cuts are the result of official bodies failing to adopt a "proactive" approach to the challenges facing the French industry.
However, jobs could be saved and the overall number of jobs lost could be reduced to just 10,000 if the industry would timely respond to pricing pressures, generic competition, changing areas of growth, the rise of biotechnology and globalization.
To be proactive, the country needs to maintain its current small chemical molecule production sites via management of product life cycles in the existing sites. Additionally, France could creation of hubs for medicinal product manufacture as well as focus on biologics. The French industry is expert at vaccine development as exemplified by Sanofi-Aventis.
Already, the French industry has moved to become more biologics-centric. France Biotech has called on French President Nicolas Sarkozy to introduce new tax regimes for innovative companies.
Investment in the biologics sector has increased in the past several years, from €167m in 2005 to €625m from January to mid-September 2007.
However, the French biologics industry still lags behind, with France Biotech placing it third or fourth in Europe in September 2007.
Source: outsourcingpharma, May 19, 2008.
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Japan: Growth for Contract Manufacture
In 2005, Japan changed its Pharmaceutical Affairs Law to allow Japanese license holders to outsource 100% of drug manufacturing. Previously, the law had required part of the process to be conducted in Japan.
This change in law could potentially revolutionize the global contract manufacture market.
Prior to the law change, many Japanese manufacturers held on to the belief that if they had to conduct part of the process in-house, they might as well keep the whole process in-house.
Now, Japanese firms are starting to look to foreign markets for APIs. About 30% of Japanese firms make APIs in-house or source them in Japan, compared to 90% in Europe and North America. Meanwhile, 7% of Japanese firms source APIs from overseas and 44% source from both Japan and foreign countries.
Japanese firms outsourcing APIs go first to Europe, followed by China, North America, India, Korea, South East Asia and Latin America.
Additionally, international firms are now trying to enter the lucrative Japanese domestic market, which is ranked second in the world to the US. However, Japanese market entry has several drawbacks, including cost and quality regulations.
Japan has very stringent expectations in terms of quality and cleanliness in the world and anything less than perfection is simply not tolerated. Products that may be acceptable to a global market but do not pass Japanese quality and specification standards.
To overcome these obstacles, foreign manufacturers can take the help of Japanese contract manufacturers in producing a product that is in line with what Japanese consumers expect on a cosmetic level.
Japanese value the appearance, and pharmacists, doctors, consumers will complain if drugs manufactured outside Japan do not look like the Japanese products or have cosmetic flaws that would be overlooked outside the country.
Recalls of foreign products are also higher because the basis for a drug recall in Japan is more stricter than any other country. “For example, a hair in a drug package would trigger a lot recall in Japan where as anywhere else this would not be considered necessary. The general rule is that if a foreign material found in a drug or packaging is living or it has been living, the product is recalled.”
Because it is very difficult and expensive for a foreign manufacturer to meet packaging and appearance needs for the Japanese market, it is ideal for foreign manufacturers to partner with Japanese contract manufacturers to package products appropriately for the Japanese market.
The contract manufacturing industry in Japan is still at the ground stage but experiencing increased growth. The market size was valued at 220bn Yen in 2004 and is projected to reach 520bn Yen by 2009.
Currently , there are around 100 contract manufacturers in Japan, but most of these operate contract manufacture as a supplement to their existing core businesses, which are typically generics firms.
There are approximately 10 firms are dedicated solely to contract manufacturing organizations: Bushu Pharmaceuticals, Akiyama Jyozai, Toyobo, MP-Technopharma, Mochida Pharmaceutical Plant, Tanabe Seiyaku Yamaguchi.
Source: outsourcingpharma, May 19, 2008.
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