Dallas, TX — (SBWIRE) — 10/04/2010 — Japan, the second single largest drug market in the world (historically known to be a land of innovation) is a leading nation in terms of scientific research, technology, machinery and medical research. Japan has been an industrially active nation ever since it adopted Western technology and gained industrial supremacy in the early years of the 20th century. In 2008, the services sector (72.1%) contributed the major portion of GDP growth in Japan followed by industries (26.4%) and agriculture (1.5%).
The regulatory environment that shaped the Japanese pharmaceutical market has changed significantly over the past decade. Many of the Japanese pharma companies had a considerable experience from a string of recent high profile acquisitions. Moreover, with strong cash reserves and the recent dramatic increase in the value of the yen (particularly against euro), this appetite for international acquisitions looks set to continue in the coming years.
Foreign companies are now increasingly developing a presence in Japan mostly in the field of R&D and marketing. In terms of domestic sales of prescription drugs, foreign companies have boosted their market share with Pfizer, Roche, Novartis and GSK making it to the top 10 list. This expansion into the Japanese pharmaceutical market has suffered occasional reversals such as Pfizer and Merck & Co. decision to close research facilities in 2006. Moreover in 2008, US biotech giant Amgen (in a $1.2bn deal with Takeda) also handed over the rights of 13 drugs to Takeda. But more recently, foreign multinationals are seeking to expand their presence in Japan mostly by retaining Japanese rights that formerly would have gone to domestic firms.
Key features of this report
The macroeconomic environment in Japan includes the population profile, disease burden, economic landscape and healthcare spending
Japanese healthcare system involving the recent developments in healthcare sector, health insurance system, Japanese drug regulatory system (covering IP protection, pricing and reimbursement, drug approval system and healthcare reforms) and future prospects of pricing & reimbursement system in Japan
Overview of the Japanese pharmaceutical market covering Japanese domestic pharmaceutical market, generic drug market, biotechnological challenges, key mergers & acquisitions and pipeline attractions through 2014
Forecasts and analysis of the leading products in the Japanese pharma market over the period 2008–14 spread across major indications and classes of treatments
Scope of this report
Develop insights for the Japanese pharmaceutical market, pricing & regulation and detailed epidemiological status of the common indications/risk factors in the country
Quickly understand how recent events are affecting the performance of major products, and how their marketers are confronting competitive challenges in the Japanese market
Gain up-to-date competitive intelligence across a wide-range of marketed products, R&D pipeline, market share data, sales forecast and competitive landscape for the major players in the Japanese pharmaceutical market
Understand which indications have the greatest potential to provide franchise growth, and how pharmaceutical companies are attempting to exploit these opportunities in Japan
Key Market Issues
Somatropin BS formed the first biosimilar to launch in Japan Novartis’s generic division Sandoz became the first company to launch a therapeutic biosimilar Somatropin BS (a recombinant form of human growth hormone Genotropin) in Japan. Initially approved in June 2009 in Japan, for the treatment of growth hormone deficiency in children, growth disturbance associated with Turner’s syndrome and chronic renal insufficiency, Sandoz already markets this product as Omnitrope in the EU, the US and a number of other markets.
Cervarix, Prevenar and Januvia formed the most awaited drugs to receive Japanese approval in 2009. In October 2009, GSK’s Cervarix (cervical cancer vaccine), Wyeth/Pfizer’s Prevenar (a pediatric pneumococcal conjugate vaccine) and Merck & Co’s DPP-IV inhibitor Januvia (sitagliptin) received the final marketing approval in Japan. Moreover, Cervarix also formed the first vaccine product to receive Japanese approval against human papillomavirus (HPV). Januvia was notable among the ministry’s other clearances, which will be co-marketed by Ono as Glactiv in Japan.
Key findings from this report.