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Shifting Sands

As the pressure to improve the productivity of clinical development programmes mounts on pharmaceutical companies, the current landscape for locating cost-effective clinical trials continues to evolve. One region attracting attention is the Middle East and North Africa.

The volume of industry-sponsored clinical trials (CTs) has grown significantly over the past 10 to 15 years in many emerging regions, driven by a search for higher site productivity and cost reduction. However, the Middle East, Turkey and North Africa (MENA) – with a combined population of approximately 600 million (larger than Central and Eastern Europe or Latin America (LA)) – attracted less than 0.4 per cent of the annual volume of global CT patients (excluding Israel) and patient-related biopharma development spend (just over $100 million in 2010).There are clear signs that the flow of CTs to MENA is likely to increase significantly, driven largely by biopharma’s need to support sales and marketing in this high-growth region by earmarking a percentage of its global development spend for this region.This factor, combined with the search for special patient populations and search for new sites with higher productivity, is expected to bring an estimated $1 billion of annual CT revenues to the region within a decade – almost a 10-fold increase from the current levels.

Driving Factors for Globalisation of CTs

During the past 10 to 15 years, biopharma has increasingly moved parts of its development programmes outside of the traditional markets of North America and western Europe (WE), driven primarily by efforts to boost productivity of pharma development in search of ways to shorten CT duration and reduce cost per patient (1,2).The ongoing geographic shift away from the traditional CT markets of North America and WE still continues (1,3,4).

Analysis of the Geographic Distribution of CTs: Contribution of Emerging Markets, including MENA

Table 1 summarises the geographic distribution of CT patients and sites. Several conclusions can be drawn from these data:

  1. The vast majority of CT sites (78 per cent) and patients (65 per cent) still come from developed countries; emerging regions capture 22 per cent of the CT sites and almost 35 per cent of patients
  2. The clear winner among the emerging regions is CEE and the Commonwealth of Independent States (CIS), which captured 41 per cent of the emerging markets patient share, ahead of LA (28 per cent), Asia (16 per cent), Africa (almost nine per cent, mainly driven by South Africa) and MENA (excluding Israel; only one per cent of the emergingmarket share)
  3. Countries performing well in the global patient recruitment competition managed to attract significant patient recruitmentrelated pharma R&D inflows: CEE + CIS, almost $5 billion; LA, $3.2 billion; Asia, $1.8 billion; Africa, about $1 million; and MENA (excluding Israel), just over $100 million
  4. CT patient – enrolment density in core CEE (excluding CIS) is ahead of WE and close to the US levels, followed by LA, Africa, Asia and MENA (excluding Israel), which have CTdensity levels (versus the US) of 17, three, two and one per cent, respectively
  5. Productivity of CT sites (aggregated average number of patients per site) in emerging regions is almost two times higher than that of the developed countries

Considering pharma’s serious R&D productivity challenges, one obvious conclusion that can be drawn from these figures is that the industry needs to significantly increase the participation of emerging markets to achieve noteworthy global productivity gains.

MENA Today and the Changes Ahead

During the past three decades, pharma enjoyed periods of significant growth in the developed markets, with sales growth outperforming GDP growth, and there was little motivation to look elsewhere. Eventually, pharma searched for higher productivity and cost savings by looking at some of the emerging markets for inclusion in CTs; eastern Europe, LA and emerging Asia (initially mainly India) have been considered. MENA has been largely overlooked primarily due to negative perceptions about the region (particularly in the US), which have been fuelled by international media coverage of the region, associated with images of war, terrorism, religious extremism and violation of women’s rights.

Motivation of Pharma: Three Sources of CT Growth in the Middle East

Pharma Sales and Marketing Interest
Today the situation is very different. All global pharmaceutical companies recognise the importance of emerging markets and are driving strategies with regional medical directors in emerging markets who report directly to global heads of emerging markets.With that comes the much stronger voice of MENA.With MENA’s expected 10 to 15 per cent growth in annual pharma sales in the coming years, it is seen globally as the number two or three emerging market growth opportunity (after emerging Asia) (5). Regional directors tasked with maximising sales growth across MENA are now demanding a fair share of R&D projects for their region to help them strengthen their image in the market as research-focused companies, as well as to provide a strong argument in their discussions with governments regarding marketing authorisation applications, pricing and reimbursement. The above picture is not a hypothetical scenario but confirmed in discussions with regional pharma directors.

Special Patient Populations and High Disease Prevalence
MENA has the second highest prevalence of diabetes in the world, and a high prevalence of genetic disorders (over 700 have been catalogued) due to consanguineous marriages, which lead to a high prevalence of rare diseases (6), many with orphan status, including Gaucher’s disease, Fabry disease, Behcet’s disease, thalassaemia and sickle cell anaemia. Obesity levels and the prevalence of cardiovascular disease across the region are very high (and rising) and cancer – historically with lower prevalence than in the industrialised world – is also on the rise. Finally, there is also a high prevalence of hepatitis (especially hepatitis C in Egypt) and a growing incidence of asthma (7,8).

Search for Higher Site Productivity
Historically the main reason that pharma looked for CT patients outside of the traditional markets was for access to patients in order to speed up development of large global programmes. MENA, with low CT-density levels (see Table 1), has more to offer than just patients, including highly centralised healthcare systems with many worldclass facilities, high interest of hospitals, the motivation of doctors (investigators) to participate, governments and institutions taking proactive steps to attract clinical research,Western-trained investigators with excellent command of English, and hospital source documents (with the exception of Turkey) in English (or French).

MENA CT-Market Potential

Within the next decade MENA has the potential to increase its portion of global patient recruitment-related pharma R&D spend from the current 0.4 per cent ($130 million) to between 2.6 per cent ($850 million) and 3.8 per cent – which equates to $1.2 billion (assuming pharma marketing/sales interests within the region will drive CT placement decision-making). Achieving the conservative level of growth requires an annual CT growth of 20 per cent. This is modest considering the current low level of global CT patients (less than 0.4 per cent) versus pharma-market significance (2.5 to 3 per cent of global pharma sales with strong growth potential), coupled with very low CTdensity levels. Significantly higher market growth levels have been seen in CEE during 1995 to 2005.

Rather than adding internal R&D headcount within the region, pharma is either outsourcing conduct of studies across the region to CROs, or staffing some key (clinical research management positions) in-house and in-sourcing monitors, CT assistants, and, in some cases, regional/country study managers. This represents a significant opportunity for CROs to capture 60 to 80 per cent penetration levels of the addressable market (equal to $300 to 500 million of annual regional CRO revenue potential in 10 years) versus typical global CRO market penetration levels of 24 to 29 per cent (9).This would imply incremental global CRO market size growth of approximately one per cent as some of the work (assuming three to four per cent of global patients) moves from regions with CRO market penetration levels of 20 per cent to a region with CRO market penetration levels of 60 to 80 per cent.

Are the Middle East and Turkey Prepared to Accommodate Growth?

The markets are variable in terms of potential and readiness. Some are already in a state of CT readiness (for example,Turkey, Egypt, Jordan and Lebanon); whereas others may be less ready but appear on biopharma’s priority list (for example, Saudi Arabia and UAE). Some of the countries in North Africa – primarily Algeria and Morocco – are also on pharma’s wishlist. In the following chapter, the four most significant regional pharma markets will be introduced: Turkey, Saudi Arabia, UAE and Egypt.

Turkey
With a population of 75 million (and growing) and a well-performing, sizeable economy,Turkey is firmly on the radar of all multinational corporations (MNCs), including pharma, as one of the top global emerging-markets opportunities. Within the MNC structures,Turkey is usually part of the European reporting structure. However, in terms of the current stage of CT development and future growth potential,Turkey shares many characteristics of MENA, which are low current CT-density levels, high pharma interest and high residual growth potential.

The government has now set R&D advancement as one of its priority areas and has resolved some of the historical problems by recently introducing a law on CTs and a new regulation that includes many of the components of the EU directive on CTs.The government is also committed to tackling the problems with payments to investigators.Turkey’s hospitals are also well prepared to absorb additional CT work, and most universities have established clinical research units.

Egypt
With a population of more than 80 million, and rising rapidly, Egypt is the most populous Arabic country in MENA and was one of the four most significant regional markets: during 2010, with 50 per cent of MNCs reporting double-digit growth (10). Although affected by the recent political turmoil, most companies have weathered the crisis well, and more than 50 per cent are forecasting doubledigit growth for 2012 (10). In pharma, 50 per cent of the companies are expecting growth, and more than 20 per cent expect double-digit growth.

Egypt also has a strong focus on education. In Cairo alone more than 5,000 medical school students graduate each year from the universities and their education is conducted in English.

MOH of Egypt has now a wellestablished process for review of CT applications (the Commission under Central Administration for Research and Health Development), with regular meetings and predictable CT application-review timelines.

In an effort to attract industrysponsored clinical research, some leading universities – including Alexandria University and Cairo University – have responded by creating clinical research departments. Although the highest quality CTs can be conducted in Egypt, it is important to acknowledge that the majority of investigators who produce excellent results with high data quality are clinical research-naïve (or at least Phase 2 to 3). Due to the low volume of CTs conducted across MENA, one cannot expect that investigators will be highly experienced. Here, as in any emerging market, medical professionals with strong patient bases need to be identified and trained to become expert clinical trialists – if this is coupled with high quality clinical monitoring, excellent site productivity and data quality are guaranteed.

Saudi Arabia
Saudi Arabia is the ‘number two’ priority, after Turkey, within MENA for many MNCs.This is driven by a relatively large population of 25 million, and strong oil revenues.The government has also been investing heavily in healthcare. In an effort to reduce hydrocarbon dependency, the government set up a comprehensive National Science and Innovation Plan in 2002, which consists of 16 priority science and technology areas, including biotechnology,medical and health.

More than 50 per cent of MNCs reported double-digit revenue growth in 2010, and 2011 looks even stronger with more than 65 per cent of MNCs reporting double-digit growth. Expectations for 2012 remain strong, with more than 50 per cent forecasting double-digit growth (10). Due to the significant government healthcare spend, pharma companies are doing even better, with all recently surveyed pharma companies reporting double digit-growth projections in 2011 (10).

During 2010, the newly formed Saudi FDA (SFDA) – tasked with regulating CTs – issued a guidance on conduct of CTs in the country, mandating review of all CTs by the SFDA and registering all on-going trials conducted in Saudi Arabia. SFDA also recently introduced a requirement for CRO licensing.

While these recent changes resulted in delays in the start up of studies, it is anticipated that these issues will be resolved soon, as the leading universities and research institutions are applying pressure on SFDA to streamline their processes. SFDA has been listening to both academia and industry and addressing many of the demands raised.

UAE
Driven primarily by strong oil exports and significant cash reserves, the UAE has largely overcome the real estate bubble collapse in Dubai. With a population of just under five million, the majority being expats, the UAE remains one of the top four priority markets in MENA after Turkey and Saudi Arabia and comparable to Egypt. More than 50 per cent of MNCs reported double-digit revenue growth in 2010, and almost 50 per cent are projecting double-digit growth in 2011, with a similar forecast for 2012 (10). Pharma outperformed other industries with more than 80 per cent reported double-digit growth during 2010, and approximately 80 per cent forecasting double-digit growth in 2011, with strong growth projections in 2012 (10).

While the UAE is a key regional market for pharma, from a CT point of view the UAE has difficulty competing with the larger markets.The two largest emirates – Abu-Dhabi and Dubai – have been positioning themselves in the biomedical research field.Dubai, for example, has created Healthcare City and DuBiotech Free Zones to attract health- and research-focused companies. The main obstacle for the UAE to move into the CT mainstream is absence of a UAE-wide CT focus, and implementation of corresponding UAE-wide CT processes and regulations.

Conclusion

Globalisation of CTs, which started more than 15 years ago, is expected to continue and expand as pharmaceutical companies strive to increase the productivity of their clinical development programmes. In addition, as biopharma looks to drive sales in the emerging markets, there is an increasing realisation that this needs to be supported by a corresponding increase in the percentage of global CTs performed in these markets.The combination of these two factors is likely to reshape the current map of CTs, with MENA being among the regions with strongest growth potential of its CT market.The most significant CT markets across MENA are likely to be Turkey, Egypt and Saudi Arabia, followed by Jordan, Lebanon, Gulf cluster (UAE,Qatar, Kuwait), Algeria,Tunisia and Morocco. As pharma are unlikely to build full fledged clinical research departments across the region, this represents a significant CRO opportunity.

Acknowledgement

Preparing this article would not have been possible without expert data collection and data mining performed by Silke Reschenauer.

References

  1. European Medicines Agency, Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA, EMA/712397/2009, London, May 2010
  2. Glickman SW, McHutchinson JG, Peterson ED, Cairns CB, Harrington RA, Califf RM and Schulman KA, Ethical and scientific implications of the globalisation of clinical research, New England Journal of Medicine 360(8): pp816-823, 2007
  3. Karlberg JPE, Uninterrupted globalisation of industry sponsored clinical trials, Clinical Trial Magnifier 2: pp79-94, 2009
  4. Karlberg JPE, The establishment of emerging trial regions, Clinical Trial Magnifier 4: pp7-23, 2011
  5. Fitzsimmons LD, Clinical convergence: spotlight on South America, Africa and the Middle East, R&D Directions: pp19-23, November/December 2009
  6. Al-Gazali L, Hamamy H and Al- Arrayad S, Genetic disorders in the Arab world, BMJ 333: p831, 2006
  7. Abraham R, MENA: The dawn of a new era, Applied Clinical Trials: pp36-42, April 2011
  8. Kermani F, How to run clinical trials in the Middle East, SCRIP: pp1-8, February 2010
  9. UBS Investment Research, New Coverage – CROs: Down, But Not Out, Contract Research Organisations: pp1-40, December 2009 (available at www.ubs.com/investmentresearch)
  10. CEEMEA Business Group, MEA business benchmarking survey June 2011, CEEMEA Business Group, 1 July 2011

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Vladimir Misik is the Senior Regional Director, Middle East, Clinical Operations at Quintiles and is responsible for the clinical development in the Middle East. Vladimir joined Quintiles in 1998 as Business Development Director Central & Eastern Europe (CEE). Recognising business opportunities in the emerging Middle East region in 2006, Vladimir spearheaded the expansion of Quintiles clinical operations in the Middle East. Vladimir holds PhD in Biophysics and Pharmacology and MS in Biophysics and Solid State Physics. He is author of more than 60 research articles and book chapters in peer-reviewed journals. Email: vladimir.misik@quintiles.com
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