Guatemala Pharma Market

Guatemala

Guatemala ranks as the largest, most populous country and economy in Central America. Guatemala’s population is roughly equally divided between urban and rural areas with low-and-middle income population. The country is known for its active volcanoes, its pristine rain forests with a rich biodiversity, and ancient Mayan sites. Guatemala has two seasons; wet May-October) and dry November-May)

Coffee is the single most important product, accounted for about 30 % of total export earnings.

GDP per Capita: USD 4,807

GDP Growth: 3.1%

Total Population

With 15Mn Guatemala is the most populated country in Central America

Currency

Guatemalan Quetza

1000 Guatemalan Quetza equivalent to USD 129.45

Capital

Guatemala City

Main Cities

1.   Guatemala City (Ciudad de Guatemala)

2.   Mixco

3.   Villa Nueva

4.   Petapa

5.   San Juan Sacatepéquez

6.   Quetzaltenango

7.   Antigua Guatemala

8.   Puerto Barrios

9.   Escuintla

International Borders

Guatemala located in south of Mexico that borders the Pacific Ocean and has a short coastline on the Gulf of Honduras in the Caribbean Sea. It is also bordered by Belize, El Salvador and Honduras.

Main Ports

§ Puerto Quetzal – Nelwy constructed Port

§ Puerto Santo Tomas de Castilla – Main Port

§ Puerto Barrios – Oldest Port.

Disease Profile

·       CVD

·       Cancer

·       Respiratory disease

·       Diarrhea

·       Ischemic heart disease

·       Cirrhosis

·       Diabetes

·       HIV/AIDS

·       Stroke

Pharma market

Guatemala is one of the largest Pharma market in the region of Central America. Market value is USD 1.1 Bn with CAGR of 8.1% and expected to reach USD 1.5 Bn by 2021. Its percapita spending is around USD 62. The enormous consumption of medicines is mainly unregulated as most pharmaceuticals are sold without medical prescription.

Approximately 70% of the USD 800 Mn is imported medicines with Mexico serving as the leading source of imports. Major generic dependent market sold as branded generics thus it provides a good opportunity for Indian Pharma companies to enter into Guatemala which is looking for affordable medicine.

Official reports claims that 64% of all drug purchases are made in the private sector, and the vast majority of private health spending is out-of-pocket.

Spending on medicines consumed is around 28% of total health expenditure and equivalent to 1.8% of GDP.

Medical Devices 

The US is the biggest supplier followed of Germany, Japan and China. USA is the largest trading partner of Guatemala with 40% share.

Registration Time

For Medical Devices – 2 to 3 weeks

Pharma Products – 6 to 8 months time it takes DRCPFA to perform registration.

FDA

Ministerio de Salud Pública y Asistencia Social

www.mspas.gob.gt

Registration Validity

5 years

Marketing Authorization Holder

A company/manufacturer or trader can be a MA holder provided they appoint a legal representative in the country by giving them POA. Also, one can appoint multiple distributors for single product.

Registration of pharmaceutical products (medicines)

MOH Fees – USD 15

MOH analysis – USD 300

Working Standard (300mg) is required for Guatemala with a shelf life not less than 18 months at the time of submitting the CTD dossier.

Samples for registration can be submitted in English with explanation letter. 

More than 17,000+ estimated number of products registered in Guatemala.  

All foreign language documents have to be legally translated into Spanish.     

Pharma Imports

Due to Covid 19, pharmaceutical companies are facing shortages of raw materials, mainly those imported from the U.S., Europe and China. Further, pharmaceutical industry kept alive with maintain their operations at an average of 70%.

Although, Panama is not a manufacturing hub but still it is one of the major suppliers of Pharma products to Guatemala along with El-Salvador and US.

India export to Guatemala in 2017 is USD 27.5Mn which is expected to reach USD 40Mn by 2020.

Many production plants from Guatemala moved to Mexico where they get the maximum benefit of Free Trade zone (North American Free Trade Agreement). Guatemala permits waiving import taxes on AIDS drugs where import & customs duty on Pharma products is around 5.8%

Pharma Distributors / Pharma Companies

There are approx 70 domestic and 2 MNC authorized to manufacture medicines within the country. A few pharmaceutical chains do exist in Guatemala which market “similares” (non-bioequivalent copy drugs). Its tax incentives could be a best destination for medicinal products’ and medical devices’ investments.  

Thousands of Wholesalers/ Distributors but with no clear set of market leaders.

1.   Akums Drugs & Pharmaceuticals Ltd – Italpharma

2.   Unosource Pharma Limited - Comercializadora De Productos Farmacológicos/Imcorsa/ Medicamentos Avanzados, Sociedad Anónima/ Soluciones Médicas De C.A/ Droguería Colón/ Droguería Médica Internacional/ Bodega Farmacéutica, S.A. 

3.   Akums Drugs & Pharmaceuticals Ltd – Italpharma

4.   Sandoz – Farmalogsa /Amicelco/ DASA/ Bodega Farmacéutica, S.A.

5.   Cachet Pharmaceuticals Pvt. Ltd. – Qadira / Futura/ Difper

6.   Ranbaxy Laboratories Limited – Amicelco

7.   Lupin Limited - Droguería Y Farmacia Lanquetin

8.   Aurobindo Pharma Limited - Cdi, S.A./ Corporación Umed/ Imcorsa/     Comercializadora De Productos Farmacológicos/ Medicamentos Avanzados, Sociedad Anónima/ Soluciones Médicas De C.A./Bawell Pharma/ Jogral Farmacéutica/ Bodega Farmacéutica, S.A/  

9.   Aurochem Laboratories Pvt. Ltd - Cresco Cygnus/ Futura/ VMG Healthcare Products/ Coface Guatemala/ Wensur

10. AstraZeneca - J.I.Cohen, S.A/ Centro Distribuidor, Sociedad Anónima/ Agencias J. I. Cohen

11. Advanced Remedies Pvt Ltd. - Genova Lab

12. Bharat Biotech International Limited- Comercializadora De Productos Farmacológicos/Imcorsa/Amicelco/ Zomapharma/ Intercare/ Fertimed/ Dynapro/

13. Biocon Limited – Amicelco/ Mundifarma/ VMG Healthcare Products/ Coface Guatemala/ Wensur/ Bayco/ Medicin Farmacéutica/ Lafrancol Guatemala/

14. Mylan Pharmaceuticals Pvt Ltd - Aviv Farmacéutica

15. Brawn Laboratories Limited – Farmacentro/ Farcen, S.A/ Italpharma/ Qadira

16. Cadila Pharmaceuticals Ltda – Locress

17. Cipla Ltd – Difasa

18. Ciron Drugs & Pharmaceuticals Ltd. – Promegal

19. Emcure Pharmaceuticals Limited – Amicelco/ Comercializadora De Productos/Farmacológicos/ Imcorsa

20. Elder Pharmaceuticals Ltda – Italpharma

*Captured only few companies and their respective distributors.

Maximum selling price of Pharmaceutical products:

§ Dextrose 5% – USD 1.80 per 1000ml

§ Dexamethosone 4mg/ml (Amp) – USD 2.57 per amp

§ Ceftriaxone 1g – USD 5.56 per vial

§ Azithromycin 200mg - USD 23.62 per 15ml

§ Amoxicillin 500mg – USD 12.84 per 10x10

§ ORS 7.1g sachet – USD 0.19 per sachet

 Public Healthcares & Biggest Tender Body:

Guatemalan Social Security Institute (IGSS) is the biggest player for health services in Guatemala. IGSS a semi-autonomous institution. It covers 17% of the population in the country. The institute delivers services through a network of 123 medical units, including 23 hospitals.

Two public institutions, MSPAS and the Guatemalan Social Security Institute (IGSS), represent an estimated 17% and 18% of total health financing, respectively. There is strategic alliances between MSPAS, IGSS, and the Armed Forces health system (Sanidad Militar).

The Ministry of Health network is a publically funded group of primary, secondary and tertiary healthcare centers that render services to approximately 70% of the population in Guatemala.

Guatemala’s health system is disproportionately financed by private health expenditures, especially out-of-pocket spending. Government spending on pharmaceuticals represented only 36% of the total expenditures

Thanks & Regards,

Dr. Palak Gupta

+91 9971140354

[email protected]