This article was also published on PharmaPhorum
Singapore, a small island nation in the South China Sea with a population of 5.5 million, has recently become a hot spot for sophisticated pharmaceutical research and manufacturing. In 2013, the country had an average purchasing power parity (PPP) per-capita GDP of over $61,000, about $10,000 more than in the U.S.
Healthcare expenditure in Singapore was over $12 billion in 2013, representing 6% of GDP and approximately equal to healthcare spending in Thailand — which has a population 12 times as large. Total healthcare spending is expected to sky rocket to almost $22.5 billion by 2018. Per-capita healthcare expenditure has increased almost 300% over the past decade to more than $2,400 in 2013, second only to Japan in the Asian region. The country’s healthcare system was ranked #6 worldwide by the World Health Organization (WHO).
Singapore also brings together a well-developed infrastructure and logistics network, strong intellectual property (IP) laws, a record of safety, a good regulatory environment, and active government support of the biomedical industry. For drug companies looking for an Asian country in which to manufacture pharmaceuticals, expand R&D, or sell their products, Singapore is a good choice.
SINGAPORE’S PHARMACEUTICAL MARKET
The pharmaceutical market in Singapore is valued at almost $1 billion, about one-fourth the size of the Philippine market — which has a population of over 100 million. Over the past two decades, Singapore has worked to create a solid foundation for the biomedical industry, with over 30 public-sector research institutes under the Ministry of Health (MOH) and the Agency for Science, Technology and Research (A*STAR). These include the Bioinformatics Institute, Genome Institute, Institute of Bioengineering & Nanotechnology, Bioprocessing Technology Institute, Institute of Medical Biology, Institute of Molecular and Cell Biology and the Singapore Institute for Clinical Sciences.
Singapore has also promoted public-private research institutes — such as with Bayer, Roche, Siena Biotech, Novartis, and GlaxoSmithKline (GSK) — as well as supporting the development of clinical contract research organizations (CROs). The government spent $2 billion investing in biomedical capabilities and infrastructure over the previous decade and earmarked more than $3 billion to support biomedical enterprises and research from 2011-2015.
There are a few domestic Singaporean pharmaceutical companies that are also successful in Singapore. For example, A. Menarini Asia-Pacific, formerly Invida, is a pharmaceutical company that was founded in 2005 in Singapore. In addition to its headquarters in Singapore, it has almost a dozen locations in other Asian countries, marketing branded pharmaceuticals, medical devices, and biotechnology to hospitals, pharmacies, and clinics. The company also has partnerships with a variety of multinational drug companies based in the U.S., EU and Japan.
FOREIGN DRUG COMPANIES IN SINGAPORE
More than 30 of the top global biomedical sciences firms — including Novartis, Eli Lilly, Takeda and GSK — have a R&D presence in Singapore. Of the top 10 biopharmaceutical companies, 7 manufacture some of their products in Singapore and 8 have regional headquarters in Singapore. GSK, Baxter and Roche all launched their first-in-Asia commercial production facilities in Singapore in 2009. Some companies, such as Merck, Pfizer, Sanofi-Aventis and Abbott, have chosen Singapore as their global manufacturing base. Within 5 years, Singapore will have 8 biologics production facilities — worth $2 billion.
Foreign biomedical companies spent approximately $500 million on R&D in Singapore last year, up from $40 million a decade ago. Nationally, public and private organizations spend almost $1.2 billion on biomedical R&D every year, with several thousand private- and public-sector researchers. In 2013, biomedical firms in Singapore manufactured products worth $25 billion, up from $5 billion in 2000.
For example, Thermo Fisher Scientific recently opened a new, 38,000 square foot production plant in Singapore. According to the company’s Biosciences President, “Our new Singapore facility further strengthens our global presence, expands our manufacturing infrastructure and establishes local production capabilities to meet increased demand for biologic drug discovery and development in Asia.”
Also, Novartis started building a new biologics production facility in February 2013, investing over $500 million. The plant should be operational by 2017. In Singapore, Novartis also has its Asia-Pacific head office, Institute for Tropical Diseases (NITD), a pharmaceutical manufacturing site and two production plants. Novartis is one of Singapore’s top 3 biomedical investors, with almost $1 billion invested in pharmaceutical and healthcare products.
Recently, Amgen also began constructing its first Asian manufacturing facility in Singapore. The company plans to spend $200 million building the plant, which will be completed in 2015 and licensed in 2016. At the groundbreaking ceremony, Amgen’s Executive Vice President of Operations said, “Singapore’s rich talent pool and friendly business environment made it an ideal place to invest in a world-class manufacturing facility and to underscore our global expansion efforts.”
PHARMACEUTICAL REGULATIONS AND APPROVALS
Foreign drug companies must receive a product license before they can export to or sell their drugs in Singapore. The dossier for this license must be either in the Association of Southeast Asian Nations (ASEAN) Common Technical Document (ACTD) format or the Common Technical Document (CTD) format developed by the International Conference on Harmonisation (ICH). Both a generic drug application (GDA) and a new drug application (NDA) are available. Applications are electronic, through the Pharmaceutical Regulatory and Information System (PRISM).
Although Singapore has a highly developed pharmaceutical regulatory system, it is very difficult for innovative drugs to be approved without prior approvals in other key markets. Recently, Singapore’s Health Sciences Authority (HSA) accepted several innovative drug product dossiers without previous approvals in other countries.
However, the HSA has not released any information on these innovative products, since it is confidential. Also, there have not been any press releases or other information on these innovative products made public by the pharmaceutical companies involved. Therefore, the names of these products, their indications and approval times are all unknown.
In general, companies with innovative products should unofficially communicate with the HSA regarding their applications, prior to submittal. Companies wishing to apply for approval of an innovative product that has not received marketing authorization in another country should submit a full dossier in Singapore at the same time as they submit their application to other key global regulatory agencies — such as the U.S. FDA or Japanese PMDA. There have been cases in which the HSA will perform a joint evaluation of the dossier with other regulatory agencies that have received the same application. In this way, a foreign drug company can best comply with Singapore’s requirement of prior market approval in another country while still getting their innovative product onto the market in Singapore as quickly as possible.
Furthermore, there is not a product designation system for orphan drugs in Singapore. So, when registering orphan drugs, a new drug application (NDA) must be submitted.
This article was originally published on PharmaPhorum (http://www.pharmaphorum.com/articles/singapores-pharmaceutical-industry-2014-update).