Overview

Bulgaria’s Outlook for Healthcare & Life Sciences

In Bulgaria, health policy priorities and national programs are determined by the Council of Ministers and executed through implementation of National Health Strategy. At district level all health policies are implemented by the Regional Health Inspectorates. The main actors are the National Assembly and its Parliamentary Healthcare Committee representing the legislative power; the Council of Ministers and the Ministry of Health representing the executive power; and the National Health Insurance Fund and the professional organizations representing the public and non-government sector. The Bulgarian Drug Agency (BDA) is a specialized state regulatory authority reporting to the Minister of Health exercising supervision over the quality, safety and efficacy of drugs (incl. biological) and of medical devices. The BDA is responsible for authorizing and registering drugs and medical devices to be launched in the market. In April 2019 the U.S. Food and Drug Agency confirmed the capability of the BDA to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States.

The Bulgarian Ministry of Health (MoH) is responsible for the overall supervision of the healthcare system, drafting health legislation, developing national health policy and implementing programs aimed at improving the health of the population, budget and financial control. National health policy is executed through the activities of 28 Regional Health Boards. The MoH operates the emergency care network, 28 hygiene-epidemiological inspectorates, number of national research centers, including centers for hygiene, medical ecology & nutrition, health information, pharmaceuticals institute, public health and healthcare financing, tertiary care centers and hospitals specializing in acute care, psychiatry, pulmonary diseases and rehabilitation. There are several medical universities in operation in Sofia, Varna, Plovdiv, Pleven and Stara Zagora. These institutions are largely autonomous.

The national healthcare budget in 2022 reached record USD 3.5 billion. The budget for drugs is at USD 888 million which is also the largest for Bulgaria. Although health spending per capita is low it consumes a significant share of GDP and out-of-pocket payments are the highest in the EU. In general pharmaceuticals and inpatient care absorb the majority of health spending with very few resources dedicated to long-term care and prevention.

Bulgaria’s healthcare sector is funded principally through the compulsory health insurance system operated by the Bulgarian Health Insurance Fund (BHIF). The Fund collects contributions from the working population and the government makes payments on behalf of those exempt, such as the elderly, the unemployed and dependents. 

Healthcare Best Prospects

Pharmaceuticals

In 2021 although all measures and mechanisms introduced by the Ministry of Health aiming at curbing the spending for pharmaceuticals in combination with the global COVID-19 crisis the Bulgarian pharmaceutical market grew with 8.5 percent reaching USD 2.7 billion, according to data provided by IQVIA.

The growth is mainly due to the development of the hospital market which grew with 25 percent reaching USD 450 million and specifically some oncology categories. Pharmacies market segment also grew with 5.8 percent accounting for USD 1.85 billion in revenue. Products without prescriptions grew 7.8 percent reaching USD 600 million which was mainly due to increase in spending for dietary and sports nutrition.

Major U.S. drug manufacturers present in the market include AbbVie, Amgen, Eli Lilly, Janssen, Merck Sharp & Dohme Corp. (MSD), a subsidiary of Merck & Co., Inc. and Pfizer. All are united under the Association of the American Pharmaceutical Manufacturers in Bulgaria (AmPharMA) and are also members of the Research-Based Pharmaceutical Manufacturers Association (ARPhaRm) representing 24 international drugs companies.

 

Source: NHIF; Fitch Solutions

 

Pharmacies & Drug Stores

An ageing population provides pharmacy operators with a growing number of loyal customers and a stable demand. The market is also one of the most consolidated among retail sub-sectors in Bulgaria. Currently, there are some 3500 registered pharmacies operating in Bulgaria. The leading retail chain, Apteka Mareshki, has more than 300 drug stores, and there are three more chains with more than 45 pharmacies, including the only foreign brand, DM Pharma. With Bulgaria’s population in mind, there is more room for the market to grow. With several large players already in place, consolidation is likely to follow, as some of the pharmacy chains are big enough to acquire smaller, regional competitors in the medium to long term.

Bulgaria-based distributor of pharmaceuticals Sopharma Trading (part of Sofia-based Sopharma - Bulgaria’s second-largest drug maker and one of the country’s oldest companies, T/O in 2020 USD 665 million) entered the retail market in mid-2017 and has been expanding rapidly ever since. The company has expanded in 20 cities running 80 pharmacies under the Sopharmacy brand.

Online sale of OTCs and nutrition products is on the rise recording annual growth of some 15-20 percent hence the increase in online pharmacies and specialized shops. 

Medical Devices

Bulgaria represents one of the smallest medical device markets in the EU, which will register a mid-single-digit local currency compound annual growth rate (CAGR) over the 2018-2024 period. The market is largely reliant upon imports which are primarily sourced from other EU member states and the US. Market growth will be dependent upon increasing healthcare funding and the success of efforts to develop the private sector. 

 

Source: Fitch Solution Estimate, National Statistics Institute

Key opportunities:

•              National Children’s Hospital Project worth USD 45.2 million – opportunities for U.S. medical devices suppliers to participate in the project which shall have 400 beds and operating facilities. The company that was awarded the contract has one year to prepare and submit its plan for development. The project is expected to take three and a half years to complete.

•              Active implantable devices

•              Anaesthetic and respiratory devices

•              In vitro diagnostic devices

•              Ophtalmic and optical devices

•              Diagnostic and therapeutic radiation devices

•              Hospital equipment

•              Laboratory equipment

•              X-ray machines

•              Software and hardware

E-health & Innovation

There is a strong U.S. presence in Bulgaria of key enterprises providing healthcare solutions for the med-tech industry. The U.S. market share is between 30-40 percent and increasing. Excellent mobile and internet networks are available in the country with high penetration rates, which makes the market very friendly and open to innovation and digital technologies. Intense competition exists, mainly from German and Chinese providers competing on price and delivery. The National Health Insurance Fund (NHIF) administers the resources collected from the mandatory health insurance contributions. Bulgaria’s e-health sector reform strategy encourages modernization and upgrades in a wide range of areas including the demand for telemedicine and introduction of a national health care portal.   Overall, Bulgaria is expected to receive around 350 million USD from the European Resilience and Recovery fund for different projects in the healthcare sphere that would improve access to healthcare, connectivity and bolster prevention of fatal casualties in critical time periods.

Focusing on e-Health, m-Health, telemedicine and big data is outlined in the National e-Health Strategy 2014-2020. Currently the project for the National Health Information System is underway with several tenders announced for various systems with major opportunities for US companies in the following:

•              ERP/EHR/PHR/E-prescriptions management solutions;

•              Telemedicine & m-Health;

•              Pharmacy automation, software and services;

•              Picture archiving and communication system (PACS);

•              Big data and cloud solutions.

R&D and Clinical Trials

Bulgaria ranks top 20 in the world in clinical trials performed and the Bulgarian market is valued at USD 330 Million. Bulgaria offers great potential for Contract Research Organizations (CRO) and all major providers are present in market. U.S. enterprises enjoy a market share estimated at 50 percent and continue to support operations in Bulgaria. Main competitors are German, Swiss and French CROs. There is an active Bulgarian Association of Clinical Research (BACR) with some 135 members that is advocating for high standard in conducting clinical trials and adherence to the requirements of the Bulgarian and international standards.

http://bacr-bg.com/en/About-the-Association

Dietary Supplements & Sports Nutrition

Dietary food supplements is one of the bestselling segments with a steady growth in the last years. The sub sector recorded 14.5 percent growth reaching USD 239 million. Dietary supplements have enjoyed increased popularity over the last five years and represent more than half of overall value sales in vitamins and dietary supplements, with a 55 percent share. The increased popularity of such products is mainly due to the fact that they are seen as natural, harmless and a healthy substitute for synthetic traditional remedies which have the potential for side-effects. The most popular dietary supplements category is probiotic supplements and this category represents a 25 percent share of overall sales of dietary supplements.

Medical Tourism

In recent years Bulgaria developed a network of private cosmetics surgery and dental clinics which are at very affordable price and at world-class medical service. Coupled with the tradition of balneology, spa tourism, modern facilities and rehabilitations centers and the highly qualified healthcare staff makes Bulgaria a top choice for European and world visitors. Major opportunities include treatment of infertility, plastic surgery, dental care, hip replacement, surgery and laser eye surgery.   The cost of medical or cosmetic services in relation to the quality provided is a strong incentive for the further development of this specific type of tourism, including direct foreign investments.

Trade Events

Bulmedica/Buldental

Resources

• Ministry of Healthcare 
• National Health Insurance Fund 
• Association of Research-based Pharmaceutical Manufacturers in Bulgaria (http://www.arpharm.org/)

U.S. Commercial Service Sofia Contact Information

Name: Milko Minev  

Position: Commercial Specialist

Email: milko.minev@trade.gov

Phone: +359-2-937-5145