Irish pharmaceutical sector overview

Darragh McCarthy 16.05.2012

Ireland is a location of choice for the majority of the world’s top pharmaceutical companies.  Since the birth of the sector in 1959 when Leo Laboratories set up a manufacturing operation in South Dublin, the pharmaceutical sector has grown continuously and remains one of the most dynamic industries in Ireland.  

  • 1959 – Leo Laboratories set up Ireland’s first manufacturing operation 
  • 1960’s – Manufacturing begins to grow in Ireland, with a focus on Active Pharmaceutical Ingredients (API)
  • 1990’s – Shift towards high value secondary manufacturing OSD/Vaccines among others
  • 2000’s – Ireland established as location of choice for biopharmaceutical operations with set up of the world’s largest bioprocessing facility by Wyeth in Grange Castle 
  • Today – Ireland is the world’s largest net exporter of pharmaceutical products. 50% of all of Ireland’s manufactured exports are pharmaceutical products. 
 
Primary and secondary manufacturing  
 
API
Since the inception of the pharmaceutical industry in Ireland, primary manufacturing has formed the backbone of the sector. Initially, pharmaceutical operations in Ireland were predominantly focussed on the production of API’s for export and downstream processing into finished healthcare products – tablets/capsules etc.
 
Munster and the greater Dublin area continue to be the areas of choice for API operations. The high population densities and excellent infrastructure, (including the availability of water, transport links and technical service providers) available in these areas satisfies the highly demanding requirements of drug substance manufacturing. 
 
Key players in the API market in Ireland include Pfizer, GSK, Roche, UCB Schwarz, Bristol Myers Squibb, Astellas.
 
Finished Product
As the pharmaceutical sector in Ireland has matured, a notable shift from primary manufacturing to high-value finished products, including Parenterals and Oral Solid Dose. A large number of sites also carry out multi-product manufacturing operations, with primary and secondary products made in single facilities.
 
Major finished product manufacturer’s areas are Gilead Teva, GSK, Mylan, Pfizer, Helsinn Birex and Forest Laboratories. 
 
Virtual Pharmaceutical Manufacturing
Recent years have seen a strong increase in the number of companies engaging in “Virtual Manufacturing” – pharmaceutical companies producing their products their products through the engagement of other, established manufacturing organisations. 
 
This method of pharmaceutical production relies on relationship management between suppliers and contract manufacturers and a core complement of experienced staff, including supply chain specialists, a competent QA/Compliance/QP team with expertise in documentation review, compliance and batch release.
 
Virtual manufacturing represents a highly profitable and effective business model, with little capital expense and high margin.
 
Notable examples of this type of business include Lawrence Lads (BMS), Shire and Aspen Pharmacare, Jazz Pharma. 
Darragh McCarthy's picture
Associate Director
dmccarthy@morganmckinley.ie