Outsourcing clinical research as an avenue for export diversification in Bangladesh

Infographic: TBS

There are several under-appreciated competences in Bangladesh that have quietly improved our living standards without receiving the kind of fanfare or wealth that the captains of the ready-made garments industry have. 

Consider the rapidity with which an entirely new crop like dragon fruit was introduced into farms and markets, significantly increasing earnings for Bangladeshi farmers. Many Bangladeshis fail to appreciate the amount of local technical competence and infrastructure in agronomy, established during the Green Revolution, that makes these and many other efforts possible. 

In a similar fashion, icddr,b has built up considerable local capacity to carry out large clinical trials at a scale that is quite unique for Global South countries. In 2023, icddr,b carried out a trial of oral cholera vaccine in Mirpur, enrolling more than 250,000 patients. This means that icddr,b has sufficient trained personnel - research nurses, physicians, scientists - to administer vaccines, collect accurate clinical data and perform statistical analysis for over 250,000 patients. 

Contract research organizations (CROs) are business-to-business service providers that carry out clinical trials (and other forms of research) on behalf of clients, usually pharmaceutical companies. 

Clinical trials have become an increasingly burdensome and expensive component of drug development. A 2017 analysis published in Nature estimated that the median cost of a single Phase III clinical trial was $21.4 million. Outsourcing this work to CROs reduces costs for pharmaceutical companies and allows smaller biotech startups to bring new drugs to market without having to build their own clinical trials infrastructure. 

According to Statista, the global CRO market stood at $57 billion in 2022 and is projected to reach $108 billion by 2032. More than 80% of the market is currently concentrated in North America and Europe but the fastest growth is occurring in the Asia-Pacific region, which can offer a combination of lower labour costs, large patient populations and well-developed clinical infrastructure.

India has been particularly successful in developing its CRO sector. Starting in the early 2000s, the government of India introduced a number of forward-looking regulatory changes to promote the development of this sector. The Drugs and Cosmetics Act Amendment in 2005 aligned clinical trial regulations with international Good Clinical Practice (GCP) standards and established clearer guidelines for ethical approvals. 

In 2019 clinical trials were further streamlined through the New Drugs and Clinical Trials Rules, which reduced the timeline for clinical trial approvals, created strict guidelines for pharmacovigilance and established clearer rules on compensation mechanisms for trial participants. The strategic approach taken by the government of India to promote the CRO sector has led to substantial investment - an Indian government report estimates that their domestic CRO market will reach $2.5 billion in size by 2030, starting from only  ~$100 million when these policies were initiated in the early 2000s. 

The global CRO market stood at $57 billion in 2022 and is projected to reach $108 billion by 2032. More than 80% of the market is currently concentrated in North America and Europe but the fastest growth is occurring in the Asia-Pacific region, which can offer a combination of lower labour costs, large patient populations and well-developed clinical infrastructure.

The Bangladeshi government has failed to provide the same degree of regulatory support for the CRO sector and the industry remains very underdeveloped. There are only 20 officially registered CROs in Bangladesh, including icddr,b itself, in comparison to more than 1500 registered CROs in India. Large multinationals in the CRO sector such as IQVIA have an established presence in India, but are completely absent in Bangladesh. 

In contrast to manufacturing, which we tend to fetishise, this kind of clinical services outsourcing barely registers in public conversations about export diversification. This is unfortunate - with its large population density and well-developed human capital in clinical research, Bangladesh has several comparative advantages in this area. Policymakers in Bangladesh should investigate clinical trials regulations in India further to see how they could be adapted to our local context to promote investment. 

While state policy catches up, there is much scope for disruptive innovation in the private sector to facilitate the development of clinical research outsourcing in Bangladesh.One area where entrepreneurs could start to create a foundation for CRO growth is through the harmonization of private medical data into secure, integrated electronic health records that feed into patient databases and matchmaking services for clinical trials. 

There is an enormous unmet global need for more clinical trial participants. Patient recruitment can introduce long delays to drug development for rare diseases, such as most forms of cancer. There are >14 million people above the age of 50 today in Bangladesh, and likely a substantial fraction of them have a disease with currently ongoing clinical trials.

Access to clinical trials, facilitated by matchmaking services, could provide these individuals with access to modern medical care and act as an alternative to medical tourism. Ethical issues could be avoided by restricting matchmaking to trials where the comparison is to the current standard of care instead of placebo controls. Secure patient databases with harmonised, accurate medical information would also attract interest from multinational CROs and pharmaceutical companies, as these data are very valuable both for clinical trial recruitment and precision medicine. 

The challenge in Bangladesh is that our healthcare system is very fragmented and many households rely heavily on medical tourism. As a result an individual's medical history is dispersed across disparate healthcare providers. Thus there is scope for private IT companies to harmonise personal medical data - clinical test results, medical imaging, drug prescriptions, diagnostic codes - from disparate healthcare providers into a single integrated software system. 

Using automated document and image analysis, this process could theoretically be as simple as patients taking photos of medical documents on a smartphone. Over time these systems could be integrated with DNA sequencing data and create a foundation for a national biobank and precision medicine in Bangladesh. 

Clinical data aggregation involves sensitive issues of medical privacy. Harmonising our standards for medical privacy with legal frameworks like HIPAA in America or the more stringent GDPR in the EU will be essential if we want to outsource these data to multinationals. 

Policymakers and entrepreneurs in Bangladesh must explore these issues further. Forward-looking policy could turn Bangladesh into a regional hub for clinical research outsourcing and data aggregation. 

Sketch: TBS

Zain Ali is currently doing a PhD in genetics at Lund University, Sweden