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Outsourcing in Pharma
BY- HARISHANKAR SAHU
MBA PM07
DEFINITION
Key Drivers
Types
Advantages
Disadvantages
Conclusion
Outsourcing Value
DEFINITION of 'Outsourcing'
• Outsourcing - the current mantra of pharmaceutical
industry .
• A practice used by different companies to reduce
costs by transferring portions of work to outside
suppliers.
• Outsourced activities can be in various fields’ right
from the drug discovery till manufacturing of the
products.
• Outsourcing process is basically contract based.
Key Drivers of Outsourcing
• Focus on core strengths.
• Reduced operational cost.
• minimize ownership cost.
• Decrease time to market.
• Enhance service portfolio, etc.
Type of Outsourcing…
• Outsourcing in pharmaceuticals is broadly
divided into
Research & development outsourcing.
Clinical trials outsourcing.
manufacturing outsourcing.
Packaging outsourcing.
Sales & Marketing outsourcing.
Research & development outsourcing
• Area covered-
– All development process.
– Development of production process.
– Development of drug delivery system.
– Development of standard technologies.
 Example
 Divi’s Laboratories offers services like development of
process design for new drug candidates as well as
impurity profile studies, process validation to MNC’s like
Pfizer etc.
 Nicholas Piramal outsourcing for Siegfried of switzerlands
for development of P’ceutical products.
Clinical trials outsourcing
• Clinical trial outsourcing services involves obtaining clinical
study data of molecules in the pre launch stage.
• Outsourcing of clinical trials is done by CRO’s – CONTRACT
RESEARCH ORGANISATION
• A CRO is an organization that provides support to
the pharmaceutical industries in the form of research
services outsourced on a contract basis.
• They conduct whole phases of clinical trials as well as single
phase also like pre-clinical study, phase III study.
Clinical trials outsourcing
• Examples
– Biocon’s , Clinigene division conduct clinical trails for Vithal
Mallaya Foundation, for Cuban firm-
 testing of monoclonal antibodies for head and neck cancer.
 And Testing for novo Nordisk, glcoxylated haemoglobin in
diabetes patients.
– Suven, offers services like in-vitro testing , pharmaco-kinetics
and even toxicology studies upto preclinical development. In
therapeutic category like antidepressant, anti AIDS, anti-
cholestrol and anti-hypertension, it serves the clients like
Hoechst, Du Pont, Degussa and Abbott.
manufacturing outsourcing
• Manufacturing outsourcing involves the supply of active
pharmaceutical raw materials, API ingredients, formulation as well
as intermediates.
• Outsourcing in manufacturing process is basically contract based.
• In India majority of the companies are looking towards the
outsourcing process.
• Recently the bulk drug contract manufacturing contributes to 77%
and API manufacturing contributes 55% of total contract
manufacturing .
• world market for contract pharma manufacturing will reach
$79.24bn in 2019. It will rise from $54.54bn in 2013. (According to
Pharma outlook report).
manufacturing outsourcing
• Examples
– Glaxo India is producing ranitidine bulk for Glaxo Wellcome.
– Ranbaxy outsourcing Cefachlor manufacturing for Eli Lilly.
– Lupine outsourcing D2 amino butanol for Cynamid.
– Kopran Research Laboratories Ltd. Outsourcoing for Synpac
laboratories for supply of Penicillin-G bulk.
 Other outsoucing manufacturing company-
• Kremoint Pharma Pvt.Ltd
• Mackur Lab Pvt Ltd
• Parnax Lab Ltd
• Maxheal manufacturing Pvt.Ltd etc
Indian company CRAMS partner CRAMS products
Lupin Labs
DMS (United States)
Fujisawa (Japan)
Apotex (Canada)
API for Cephalosporins
Cefixime
Cefuroxime, Axetil, Lisinopril
Nicholas Piramal
Allegran (United States)
Advanced Medical Optics (United
States)
Pfizer (United States)
Bulk drugs and formulations
Eye products
APIs & formulations for veterinary
products
Wockhardt Ivax (United States) Anti-ulcer
Dishman Pharma
GSK (United Kingdom)
AstraZeneca (Sweden)
Merck (Germany)
Intermediates and APIs
Nexium
Losartan
Source: Assocham, Frost & Sullivan analysis
Contract Research and Manufacturing Services Deals
25%
15%
20%
55%
15% 15%
0%
10%
20%
30%
40%
50%
60%
Discovery API
development
Dodage
development
APImanufacturing Dosage
manufacturing
Packaging
Extent of Outsourcing in Each Area of the Value Chain 2013
ExtentofOutsourcing
Outsourced Core Functions
Outsourcing Value
Source : www.frost.com
• Late life-cycle outsourcing – API manufacturing represents the highest share
 Drug discovery, development activities and dosage manufacturing – potential future areas
Advantages of Outsourcing
• Outsourcing reduce the overall costs by 30% to 35%.
• Its Faster and cheaper.
• Reduces drug development cost.
• Reduces problems faced during the regulatory processes
around the world.
• Improve manufacturing efficiencies.
• Reduce excess production capacity by divesting facilities.
• Minimize investments in capital-intensive facilities.
• Improve net earnings and cash flow.
• Divert resources to focus on other competencies like
marketing .
Disadvantages of Outsourcing
 Managerial control loss.
 Vendor relationship management risk.
 Internal talent loss.
Conclusion
It’s a great challenge to successfully manage the
outsourcing relationship and generate value.
But Outsourcing solves the problems for the pharma
companies and allows them to exploit the potential of
new drug discovery technologies.
Reference
• http://www.investopedia.com/terms/o/outsourcing.asp#ixzz3kOhX
n0Q5 .
• http://www.businesswire.com/news/home/20150130005621/en/R
esearch-Markets-2015-Trends-Global-Clinical-
Development#.VcjeC_mqqkp
• https://www.kpmg.com/Ca/en/IssuesAndInsights/ArticlesPublicatio
ns/Documents/Outsourcing-pharmaceutical-industry.
HARISHANKAR SAHU
MBA PM07

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Outsourcing in pharma

  • 1. Outsourcing in Pharma BY- HARISHANKAR SAHU MBA PM07
  • 3. DEFINITION of 'Outsourcing' • Outsourcing - the current mantra of pharmaceutical industry . • A practice used by different companies to reduce costs by transferring portions of work to outside suppliers. • Outsourced activities can be in various fields’ right from the drug discovery till manufacturing of the products. • Outsourcing process is basically contract based.
  • 4. Key Drivers of Outsourcing • Focus on core strengths. • Reduced operational cost. • minimize ownership cost. • Decrease time to market. • Enhance service portfolio, etc.
  • 5. Type of Outsourcing… • Outsourcing in pharmaceuticals is broadly divided into Research & development outsourcing. Clinical trials outsourcing. manufacturing outsourcing. Packaging outsourcing. Sales & Marketing outsourcing.
  • 6. Research & development outsourcing • Area covered- – All development process. – Development of production process. – Development of drug delivery system. – Development of standard technologies.  Example  Divi’s Laboratories offers services like development of process design for new drug candidates as well as impurity profile studies, process validation to MNC’s like Pfizer etc.  Nicholas Piramal outsourcing for Siegfried of switzerlands for development of P’ceutical products.
  • 7. Clinical trials outsourcing • Clinical trial outsourcing services involves obtaining clinical study data of molecules in the pre launch stage. • Outsourcing of clinical trials is done by CRO’s – CONTRACT RESEARCH ORGANISATION • A CRO is an organization that provides support to the pharmaceutical industries in the form of research services outsourced on a contract basis. • They conduct whole phases of clinical trials as well as single phase also like pre-clinical study, phase III study.
  • 8. Clinical trials outsourcing • Examples – Biocon’s , Clinigene division conduct clinical trails for Vithal Mallaya Foundation, for Cuban firm-  testing of monoclonal antibodies for head and neck cancer.  And Testing for novo Nordisk, glcoxylated haemoglobin in diabetes patients. – Suven, offers services like in-vitro testing , pharmaco-kinetics and even toxicology studies upto preclinical development. In therapeutic category like antidepressant, anti AIDS, anti- cholestrol and anti-hypertension, it serves the clients like Hoechst, Du Pont, Degussa and Abbott.
  • 9. manufacturing outsourcing • Manufacturing outsourcing involves the supply of active pharmaceutical raw materials, API ingredients, formulation as well as intermediates. • Outsourcing in manufacturing process is basically contract based. • In India majority of the companies are looking towards the outsourcing process. • Recently the bulk drug contract manufacturing contributes to 77% and API manufacturing contributes 55% of total contract manufacturing . • world market for contract pharma manufacturing will reach $79.24bn in 2019. It will rise from $54.54bn in 2013. (According to Pharma outlook report).
  • 10. manufacturing outsourcing • Examples – Glaxo India is producing ranitidine bulk for Glaxo Wellcome. – Ranbaxy outsourcing Cefachlor manufacturing for Eli Lilly. – Lupine outsourcing D2 amino butanol for Cynamid. – Kopran Research Laboratories Ltd. Outsourcoing for Synpac laboratories for supply of Penicillin-G bulk.  Other outsoucing manufacturing company- • Kremoint Pharma Pvt.Ltd • Mackur Lab Pvt Ltd • Parnax Lab Ltd • Maxheal manufacturing Pvt.Ltd etc
  • 11. Indian company CRAMS partner CRAMS products Lupin Labs DMS (United States) Fujisawa (Japan) Apotex (Canada) API for Cephalosporins Cefixime Cefuroxime, Axetil, Lisinopril Nicholas Piramal Allegran (United States) Advanced Medical Optics (United States) Pfizer (United States) Bulk drugs and formulations Eye products APIs & formulations for veterinary products Wockhardt Ivax (United States) Anti-ulcer Dishman Pharma GSK (United Kingdom) AstraZeneca (Sweden) Merck (Germany) Intermediates and APIs Nexium Losartan Source: Assocham, Frost & Sullivan analysis Contract Research and Manufacturing Services Deals
  • 12. 25% 15% 20% 55% 15% 15% 0% 10% 20% 30% 40% 50% 60% Discovery API development Dodage development APImanufacturing Dosage manufacturing Packaging Extent of Outsourcing in Each Area of the Value Chain 2013 ExtentofOutsourcing Outsourced Core Functions Outsourcing Value Source : www.frost.com • Late life-cycle outsourcing – API manufacturing represents the highest share  Drug discovery, development activities and dosage manufacturing – potential future areas
  • 13. Advantages of Outsourcing • Outsourcing reduce the overall costs by 30% to 35%. • Its Faster and cheaper. • Reduces drug development cost. • Reduces problems faced during the regulatory processes around the world. • Improve manufacturing efficiencies. • Reduce excess production capacity by divesting facilities. • Minimize investments in capital-intensive facilities. • Improve net earnings and cash flow. • Divert resources to focus on other competencies like marketing .
  • 14. Disadvantages of Outsourcing  Managerial control loss.  Vendor relationship management risk.  Internal talent loss.
  • 15. Conclusion It’s a great challenge to successfully manage the outsourcing relationship and generate value. But Outsourcing solves the problems for the pharma companies and allows them to exploit the potential of new drug discovery technologies.
  • 16. Reference • http://www.investopedia.com/terms/o/outsourcing.asp#ixzz3kOhX n0Q5 . • http://www.businesswire.com/news/home/20150130005621/en/R esearch-Markets-2015-Trends-Global-Clinical- Development#.VcjeC_mqqkp • https://www.kpmg.com/Ca/en/IssuesAndInsights/ArticlesPublicatio ns/Documents/Outsourcing-pharmaceutical-industry.
  • 17.