Bangladesh Clinical Research: A Future Regional Hub for Contract Research Organizations?

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Bangladesh has established a sizeable pharmaceutical industry since its independence. Fought hard and supported by many, it contained a tendency toward fierce nationalism—  still the institutional basis for the Bangladesh Nationalist Party, one of the leading political parties in the country.

Over the last couple decades however, it has become intensely market-oriented—to some a “remarkable success story” and perhaps to others too unregulated some could argue.

Its local industry generally produces generic drugs and is highly self-sufficient. Research and development for branded pharmaceuticals has been minimal.  Industries are morphing and maturing, and companies are embracing international standards for quality assurance for example. The country has nearly 165 million making it one of the world’s most populated. There is a large patient pool and great need for clinical research as a care option as Bangladesh struggles with systemic poverty and adverse health conditions.

Times are changing in Bangladesh. An intensely market-based economy now, it is now the 42nd largest GDP in the world; 31st largest by purchasing power parity and is classified among the Next Eleven emerging market middle income economies and a Frontier market. According to the IMF Bangladesh was the second fastest growing economy in the world back in 2016 at 7.1%  The Bangladesh finance sector is the second largest in the subcontinent.  A big portion of its GDP is via exports such as textiles and agriculture, but the country has experienced considerable industrial growth. Strategically important for the region, Bangladeshi seaports provide maritime access to landlocked regions and countries. Income distribution like many developing regions is highly unequal. Rampant poverty pervades especially in rural areas or in urban slums.

WHO on Bangladesh

The World Health Organization reports that the country suffers from shortages of and geographic mal-distribution of human resources for health. With an estimated 3.05 physicians per 10,000 population and 1.07 nurses per 10,000 population, there is a severe gap between sanctioned and filled health worker positions.  28% of the treatment provided in government health facilities is through alternative medicine (Ayurveda, Unami, Homeopathy), yet even there by 2011 there was a 50% vacancy rate for alternative medicine providers.

Health workers are concentrated in urban secondary and tertiary hospitals—however, 70% of the population lives in rural areas hence compounding access problems.  Major challenges according to WHO:

  • Overly centralized health system
  • Weak government structure & regulatory framework
  • Weak management & institutional capacity in the Ministry of Health and Family Welfare
  • Fragmented public service delivery
  • Inefficient allocation of public resources
  • Lack of regulation of the private sector (employs 58% of physicians)
  • Shortage of health workers and high turnover and absenteeism of health workers
  • Poor maintenance of health facilities and medical equipment

By 2014 a report titled “Health System in Bangladesh: Challenges and Opportunities” found the health system is heavily reliant on a government or public sector for financing and for overall policy and delivery mechanisms.  Although the health system faces severe challenges it seems to receive little priority in terms of national resource allocation. Only about 3% of GDP is spent on health services.  A big chunk of spend comes from patient out of pocket and the country’s people are overwhelmingly poor.

Despite severe problems Bangladesh is making some progress in pursuing health-related Millennium Development Goals (MDGs) particularly MDG 4 and MDG 5 the authors conclude.  Until there is a proactive and dynamic stewardship of the health policy it will continue to struggle.

Pharmaceutical Industry in Bangladesh

The Bangladesh Association of Pharmaceutical Industries (BAPI) reports that there is an upward trend in the domestic market for pharma products with a market size of approximately $2 billion by 2015 according to BAPI.
According to a recent article, it is one of the few under-developed countries that meets nearly 100% of its demand for pharmaceutical products through local companies—again a big percentage of this comes through alternative treatments. Bangladesh pharma products are exported to 199 countries generating approximately $100 million last year.  Local Bangladesh companies experience a healthy local investor demand.

A recent report notes 11.09% of total Dhaka Stock Exchange (DSE) turnover originates from the local pharmaceutical sector.  Exports totaled $103.5 million in 2017. The same report stated that the industry has grown from 2012 to 2017 at CAGR 15%. Local firms are largely protected from foreign competitors—for example from its giant neighbor India next door, due to nationalized policies involving import restrictions. The country has 31 publicly traded (listed) companies in the sector.

Lank Bangla Investment Ltd. recently listed the top ten pharma companies; they hold 68.5% of market share while the top 20 hold 86.33%.

Market share includes:

Square Pharmaceuticals                                                            17.73%

Incepta                                                                                     10.21%

Beximco                                                                                   8.39%

Opsonin                                                                                    5.54%

Renata                                                                                      4.97%

Healthcare Pharma                                                                   4.57%

ACI                                                                                           4.43%

Aristopharma                                                                            4.38%

Eskayef                                                                                     4.36%

Acme                                                                                        3.91%

Square Pharmaceuticals is the number one positioned company nationwide.  Founded in 1958, it is one of the top conglomerates in Bangladesh. It develops and distributes hundreds of products.
According to Wikipedia its pharmaceutical industry includes the following numbers:

Allopathic Drug Manufacturers              199

Ayurvedic Drug Manufacturers              172

Unani Drug Manufacters                        500

Herbal Drug Manufacturers                   29

Homeopathic & Biochemic Mfg              28

Clinical Research

 Drug Regulatory Authority

Drug approvals are controlled by the Directorate General of Drug Administration (DGDA). This agency sits under the Ministry of Health & Family Welfare, Government of the People’s Republic of Bangladesh. It is the drug regulatory authority for the country. They supervise all drug regulations and approvals nationwide.  They produce annual reports which are available to the public.

Clinical Trials Published in U.S. DataBase

TrialSite News staff conducted a review of active clinical trials in the NIH’s Clinicaltrials.gov. According to published data we found the following:

  • 7 active industry trials
  • 62 active academic & other trials
  • 5 active trials involving U.S. government agencies
  • Total number of active studies 80

We reviewed all clinical trials that have ever been reported to the U.S. government-sponsored data base and that totaled 281 studies.  A number of commercial and non-profit sponsors are active in the country including GlaxoSmithKline and the Bill and Melinda Gates Foundation not to mention European, Canadian and American academic medical centers involved with a number of research endeavors.

TrialSite News reviewed its robust proprietary research site database for totals of Bangladesh-based research sites. The following research sites exist in the “TrialSite Network:”

Note as part of our TrialSite Network, we maintain contact database of investigators and staff, their expertise and assets within Bangladesh (and for all countries). TrialSite News is dedicated to transparency and openness and can provide contacts for any party interested (for non-commercial purposes).

Future Global Hub for CRO Activity?

A few different reports exist online touting the potential for Bangladesh as having potential as a future regional hub for CRO activity. Wasif Ali Khan presented “Bangladesh: Can be a potential new hub for global CROs for global clinical trials” to the 4th International Conference on Clinical Trials in 2017.

Mr. Khan noted Bangladesh is attractive as a regional hub due to large patient population and diverse disease profiles. However he noted until recently there was little sufficient infrastructure to support clinical research.  Mr. Kahn presented that in a recent lupus nephritis (LN) trial conducted in over 80 sites from 23 countries Bangladesh was included as second tier when recruitment was materially slow with the first tier.  LN is a rare disease that requires the use of global recruitment.

He reported for this study, the sponsor was able to secure central as well as site IRB approvals in 4 months. The country enrollment maximum was 25 patients; however due to positive experiences with quality, care and responsiveness ultimately 46 patients (or 17.4%) were recruited from Bangladesh sites out of a total of 265. In this particular study 80% of clinical studies fail to meet deadlines.  Often 50%+ of sites recruit 1 or no patients.

With over 165 million and with an enormous amount of treatment naïve patients (not as common in the West); increasing number of lifestyle diseases comparable to the West due to changing economy (privatization, etc.) not to mention a professional health class well versed in English and UK traditions, Mr. Khan believes the country holds considerable potential.

Conclusion

Although still considerably impoverished, Bangladesh is rapidly producing considerable wealth. It is the 42nd largest economy in the world. It has a dynamic, entrepreneurial culture and thriving industries. It has underinvested in health care and needs to put forth a strategic vision to build its health care infrastructure with the economic gains it accumulates.  It represents considerable future potential as a regional hub for contract research organization activity, but this is still several years away due to a number of factors described within. It has about 80 active studies and an emerging research site community.