Will Asia Become the Global Hub for Oncology Clinical Trials?

Pharma IQ

Asia is widely touted as being the rising star of the pharmaceutical industry. Large patient pools, lower costs and rapidly developing expertise make it a key location for research and development, while the large populations present a huge market opportunity.

Oncology is also predicted to be a key growth segment for the pharmaceutical industry in the coming years, making it perhaps the next logical step that companies will look to Asia for the development of their cancer therapies.

Asia has previously been described as being "on the cusp of a major cancer epidemic of unprecedented proportions". According to figures from the Lancet Asia Medical Forum, cancer cases on the continent are expected to rise from 3.5 million in 2002 to 8.1 million in 2020 unless healthcare strategies undergo a change.

Major players within the pharmaceutical industry are therefore expanding their presence in the key markets accordingly. GlaxoSmithKline recently launched its Revolade and Votrientdrugs in the Indian market, which are expected to benefit as many as 2,000 patients, albeit at lower costs than in other markets.

C T Renganathan, vice president – pharmaceutical, said: "These prices are 25 to 30 percent lower in India if compared with prices in the US.

He added: "Though GSK is relatively new in the oncology segment, these two products will able to push GSK's share by 2-3 percent in coming years."

Both drugs were originally launched within the European market, but pharmaceutical companies are also increasingly exploring the opportunities for the development of oncology therapies targeted specifically at the Asian mark, and undertaking research and development activities within the region accordingly.

Aslan Pharmaceuticals and Array BioPharma recently announced a licence agreement to develop Array’s HER2 / EGFR inhibitor, ARRY-543 for solid tumours, which is currently entering a phase two clinical trial.

The company is to globally develop the therapy through proof of concept with a programme that initially focuses on gastric cancer patients in Asia.

Gastric cancer presents a significant public health challenge in East Asia, with patients suffering from locally advanced, metastatic and recurrent disease given a median survival period of just 11 months.

Robert E Conway, chief executive officer of Array Biopharma, said: "ASLAN's creative development strategy of leveraging Asia to conduct clinical development is particularly compelling for ARRY-543 due to the high prevalence of patients with gastric cancer in Asia."

The growth of oncology clinical trials in Asia is also being fuelled by expansion within the biosimilars market. Dr Reddy’s, Cipla and Lupin are among those launching biosimilars in the Indian market and Cipla is planning on launching an oncology-based biosimilar in the country by the end of 2011/12.

According to a report by Standard Chartered Bank, the regulatory environment in Asia is making it a key target for the expansion of biosimilars, the development of which is expected to increase as patents expire.

"Most generics companies are expected to focus currently on emerging markets (including markets like India) for product launches, as regulatory pathways are cleaner in these markets, with incremental strategies for markets like the EU," the Business Standard quoted the report as saying.

And it is no longer just India and China where companies are looking for clinical trials. Malaysia, Hong Kong, Taiwan, Thailand, Singapore, South Korea and the Philippines are now being seen as targets for clinical trials.
A report by Cutting Edge Information, entitled Emerging Markets Clinical Trials: Asia, identified that each of these markets is now being valued for their unique qualities. It gave the example of a company which won approval for a new indication for an investigational compound, based on a trial in which 30 percent of the patients were enrolled in the Philippines.

The BRIC nations, including India and China, continue to attract their fair share of clinical trials, however.

Adam Bianchi, chief operating officer at Cutting Edge Information, noted: "Drug companies are looking at BRIC and other countries for access to approximately three billion potential new clinical trial volunteers.

"That's several times the medically eligible patient population in established markets."

It also paints a positive picture of Asia's future in the field of oncology clinical trials.