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Partnership Potential

 

As an emerging economy, Indonesia's GDP grew by 6.4 per cent in 2011, and is projected to have a steady growth of 6.3 per cent in 2012 and beyond. In the Asian region this will only be exceeded by China. Indonesia has been isolated to some extent from the current economic global turbulence, due to its domestic consumption - especially from the infrastructure sector - rather than dependence on exports, and is supported by sound economic foundations. With its 240 million inhabitants (the rate of population growth is currently 1.3 per cent and decreasing), its position as the world's fourth largest country by population and South East Asia's largest economy, and a nominal GDP of $825 billion, Indonesia is said to be the best performing economy in the region, with no significant slowdown estimated in the next two years. Together with a progressive regulatory landscape, Indonesia offers a vast market in which to conduct clinical trials.

Economic Outlook

The current figures for the Indonesian Stock Exchange reflect an increase in overall indices for the past five years, while 2011 displayed the best overall indices in the region.

A strong banking sector, vastly improved international reserves position and a healthy consumer outlook have increased the potential for investment. Investment is projected to grow at an average of 9.5 per cent in the coming years, with a focus towards the country's domestic consumer rather than export industry. Domestic demand will continue to be the main growth driver.

Factors such as the annual growth of the pharmaceutical market, coupled with a rising population and a relatively solid political and economic base, are expected to encourage multinationals to invest in the country. Sales of pharmaceutical products should also increase over the next 10 years, with sales of prescription drugs and over the counter medicines expected to grow from $2.79 billion to $7.93 billion.

Health Facts

Indonesia's gross birth rate is 21 per 1,000 inhabitants, which makes it the fourth highest within the Association of South-East Asian Nations, while its death rate is 6.9 per 1,000 inhabitants. The result is a fast-growing elderly population, which the WHO forecasts will reach 11.34 per cent (28.8 million people) by 2020. The current life expectancy is between 63 and 74 years on average.

As seen in other rising economic countries, where lifestyle is changing due to consumption patterns and sedentary habits, Indonesia has seen the death rate due to non-infectious diseases increase in the last decades, while causes of death from infectious diseases have decreased. In fact, the Indonesian Basic Health Research conducted by the Ministry of Health in 2007 has found that the 10 main causes of death are:

  • Stroke (15.4 per cent)
  • Tuberculosis (7.5 per cent)
  • Hypertension (6.8 per cent)
  • Trauma (6.5 per cent)
  • Perinatal disorders (6.0 per cent)
  • Diabetes (5.7 per cent)
  • Malignancies (5.7 per cent)
  • Liver diseases (5.1 per cent)
  • Ischaemic heart disease (5.1 per cent)
  • Lower respiratory tract infections (5.1 per cent) (2)

As in other countries, diseases due to metabolic syndrome are rising.

Indonesia's cancer mortality is the highest reported across South-East Asia, with a figure of 6.6 per cent.

Indonesia's Health System

Most healthcare costs are paid by the patient, as less than 20 per cent of the population is covered by public health insurance. During the past decades, government healthcare funding was focused on the eradication of infections. Although some infectious diseases have been brought under control, global pandemics of SARS, H5N1 and H1N1 became a challenge and are still considered a threat today. The governmentfs intentions to increase healthcare facilities have faced escalating difficulties with a series of natural disasters, including the tsunami of 2004. These are just some of the reasons why the domestic healthcare expenditure is growing relatively slowly (from $6.34 billion in 2005 to $14.11 billion in 2009) compared with what is actually possible.

Conducting Clinical Trials in Indonesia

Indonesia offers a number of incentives for health-related businesses looking to locate clinical trials:

Population and Ethnodiversity
Indonesia is home to more than 300 ethnic groups, spread over five main islands, each with its own culture and biological variatons.

Variety of Diseases
The main burden on Indonesia's healthcare services is the treatment of infectious diseases: TB, malaria and dengue fever among others, although cancer and cardiovascular disease are the main causes of death. Cancer as a cause of death is higher than elsewhere in the region. HIV in Indonesia is one of the fastest rising communicable diseases, with roughly five million clinical cases currently. The incidence of diabetes and other metabolic disorders is also rising as the population is increasingly adopting a western dietary lifestyle.

Effective Patient Recruitment
The emergence of specialised centres (such as cancer centres and hospitals, womenfs hospitals, orthopaedic hospitals, infectious disease hospitals) is also attracting sponsors to the area, especially in the larger cities with strong academic support. These centres support speedy recruitment of subjects. Emerging local CROs have effective networks with potential investigators in various therapeutic areas, and display broad geographical coverage that helps to speed up the process of selecting investigators and trial sites. However, patient education is a challenge, as the population is not accustomed to taking part in clinical trials, and this needs to be anticipated with more intensive briefing sessions by the clinical trial assistants.

Drug Naive Population
The population of Indonesia is more often undermedicated than overmedicated, as some populations, especially in the rural areas, have poor access to medication. The low drug expenditure, as well as low healthcare expenditure, is directly associated to the drug naivity of the population. Moreover, the use of alternative medicine has traditionally been a more cost-effective means of treatment, and has been passed from generation to generation. The National Agency for Drug and Food Control (NADFC) has published regulations for clinical trials in herbal medicines to foster the evidence-based use of traditional herbal medicine, classifying herbal medicines as completely traditional (known as ‘jamu’) at the lowest studied end, with standardised herbal medicine and phytopharmaca being the most intensively investigated.

Increasing Number of Trial Sites
The growth in trial sites is linked to the growth of medical schools, which are emerging throughout the country. As such, the numbers of investigators holding GCP certificates are also increasing. Intensive GCP courses are organised by professional bodies in the drug studies fields and are enthusiastically attended by clinical trial practitioners, as GCP is required for all medical research.

A Wealth of Specialists
With more than 70,000 doctors, including over 15,000 specialists, Indonesia has a large talent pool. The quality of trials is progressing with the rigid supervision of the sponsors and/or CRO involved.

Future Growth
From its macroeconomic potential, Indonesia is expected to continue its growth as it has shown resilience to the global financial crisis. Global and Local CRO Most of the largest global CROs are present and growing fast, while local CROs are emerging, offering complete services.

Regulatory Considerations

The NADFC has gained respect over the years with its commitment to regulating drug trials. Although it is still a challenge for this regulatory body to equal the developments of more established organisations, it is not stagnant in its progression. It has its own national GCP in place, which reflects ICH-GCP with some local additions. Timelines for drug trial approvals are predictable, and the wait time for clinical trial permits, which should take two weeks after all documents are completely submitted, may take one to three months, the reason usually being insufficient understanding of the required information. In some rare cases, the process may take as long as six months.

Figure 1 shows the growth and slight decrease in the number of clinical trials in Indonesia. There was a significant increase until 2008, followed by a decrease from 2009, particularly for Phase 1 and 2. This may be related to the implementation of the material transfer regulation, which limits the transportation of research samples out of the country, which came into effect that year. This limitation has now been partially overcome with the opening of a global central laboratory in the country and with clinical trial practitioners starting to get involved in the permit process.

Clinical Trial Outsourcing

The presence of CROs in Indonesia is quite a recent development, but becoming increasingly popular to investigators. Four of the big-five global CRO players are already present in Indonesia, some of which work in collaboration with local laboratories for increased expertise.

Sources:

World Bank, World Health Organisation, Business Monitor International, Indonesian Stock Exchange, National Agency for Food and Drug Control, Central Bureau of Statistics, Indonesian Ministry of Health, Prodia the CRO


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Endang Hoyaranda completed her Pharmacy education at the Bandung Institute of Technology in Bandung, West Java. Endang joined Prodia Clinical Laboratories in 1983 as Manager for Research and Development. When the organisation expanded in 2009, she was appointed President Director of Prodia Group. Endang also teaches Management, Entrepreneurship and Ethics at the Health Polytechnic and Hasanuddin University, and holds responsibility as Vice Chair at the Indonesian Institution for Laboratory Technologists Certification. She is also one of the founders of the Indonesian Association for the Study of Medicinals (IASMED) which was inaugurated in 2010. Email: endang.hoyaranda@prodia.co.id
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