Clinical research is one of the main areas of investment from research-based pharmaceutical companies into Bulgaria and the country is positioning itself as a clinical trials hub for the entire CEE region. Furthermore, the Bulgarian government has shown great willingness towards continuing developing this area; ensuring the growth of clinical research in Bulgaria moving forward.

“Clinical trials are a key area of investment from research-based companies being valued at USD 350 million of investment in Bulgaria in 2015.”

Deyan Denev, ARPharM

Despite only holding 7.5 million inhabitants, Bulgaria is considered one of Europe’s clinical research hubs and, in 2015, was ranked 25th in the world for clinical research according to the US FDA. Around 190 new studies are launched annually in the country with an average of about 12,000 patients per year enrolled in such programs. Moreover, Bulgaria focuses mainly on advanced-stage clinical research, with phase III and phase IV trials dominating the landscape.

Deyan Denev, executive director of the Bulgarian Association of Research Based Pharmaceutical Manufacturers (ARPharM), explains that “clinical trials are a key area of investment from research-based companies being valued at USD 350 million of investment in Bulgaria in 2015.” In terms of performance, the growth of clinical trials in Bulgaria has been between five and ten percent on an annual basis over recent years.

Nonetheless, despite the attractive growth of clinical studies in the country, there are some challenges that clinical research players have to face such as strict regulation and “the deficit of Real World Insights (RWI), which means that there is a lack of information of actual and updated epidemiological data,” adds Kalin Tochev from IQVIA (formerly QuintilesIMS). One way to resolve this lack of data is a wider rollout of digital solutions. As Hristo Sabev, director of clinical engagement at PPD Bulgaria, opines, “all industry should help the government to advance towards digitalization – as E-health is a clear priority of the Ministry of Health – since it will create a positive impact on all stakeholders, from patients to government and industry.”

Expanding on the selling points of Bulgaria as a clinical research hub, Sabev points to  “Firstly, the number of highly-educated professionals with university degrees, postgraduates, Masters, and PhDs, as well as strong languages skills. Secondly, the labor costs and the taxation framework are quite attractive versus any other country in the region – which drastically minimizes the costs of running clinical trials here. Thirdly, Bulgaria is within the EU and therefore the regulation is homogenized with EU standards. Fourthly, the patient recruitment and the operational rhythm are quite efficient, which drastically reduces the timelines.”

Looking at some key examples in the industry, research-based pharmaceutical companies are strongly committed to conducting either in-house or externalized clinical research studies in Bulgaria. Ekaterina Karpuzova, country commercial lead pharmaceuticals at Bayer, stresses “As an innovator player, we are very much committed to developing clinical research and Bulgaria plays a key role in the global clinical research of Bayer due to its clinical expertise, fast patient enrollment, and strict clinical guidelines. In fact, Bulgaria is positioned by Bayer in the top tier in absolute numbers conducting not only in-house but also outsourced clinical trials.”

Putting the spotlight on the only pure biotech player in the country, “Amgen has invested more than USD 10 million in Bulgaria in clinical research during the last couple of years and, in terms of projects, we are currently running 20 clinical development initiatives for both innovative molecules and new indications” shares country director Krassimira Chemishanska.

Additionally, looking at one of the leading players in the country, “Novartis has a well-reputed pipeline with over 200 products in clinical development and I can confirm that there are no major clinical developments in which Bulgaria has not been involved” confirms country president Hristo Trunchev, who is also chairman at ARPharM. “We, as an industry, are also giving the opportunity to Bulgarian physicians to participate in global research projects through our clinical trials conducted in the country, which gives them a strong educational background, and also increases patients’ access to innovative treatments,” he concludes.

Looking ahead, the government is eager to continue developing the clinical research arena since, besides its economic value, such investments contribute to the system in other ways such as medical education, opportunity to physicians to collaborate in global scale projects, patients’ access to innovative treatments, and others. Hence, IQVIA’s Tochev concludes “our predictions in this front are that clinical research will continue growing at a high single digit rate in the coming years.”