Types of Pharmaceutical Companies Serving The Pharmaceutical Industry

2. What are the different types of
Organizations make up the
Pharmaceutical Industry?

3. Pharmaceutical Sectors: Multinationals
Develop and manufacture new chemical entities (NCE’s) for the
Pharmaceutical market.
Multinational Companies
Multinational companies are set apart from others in that they typically
meet the following:
1. Global purchasing unit
2. Multiple R&D and manufacturing sites (global)
The ten largest pharmaceutical companies in the world account for more
than a third of the industry's total market share according to the World
Health Organization.

4. Pharmaceutical Sectors: Multinationals
Multinational Companies
Abbott
Astellas
Astra Zeneca
Boerhinger Ingelheim
Bristol Myers Squibb
Eli Lilly
Johnson & Johnson
GSK
Merck
Novartis
Pfizer
Hoffman LaRoche
Sanofi-Aventis

5. Pharmaceutical Sectors: Branded Pharma Companies:
Branded Pharmaceutical Companies
Branded Pharmaceutical Company:
A company whose principle business activity is developing,
manufacturing and selling chemical or biological products for
human use that are licensed by the United States Food and
Drug Administration or a similar regulatory agency of a foreign
government for the treatment of human disease conditions and
illness.

6. Pharmaceutical Sectors: Branded Pharma Companies:
Branded Pharmaceutical Companies
Branded Pharma Companies develop “New Drug Entities
(NCE’s)“for the pharmaceutical market and are typically
responsible for handling the drug from discovery, through
clinical trials, and commercial launch.
These companies execute both the research and initial
manufacture of the drug.
They differ from multinational companies in size,
Geographical locations, and volume of business (smaller).

7. Takeda
Allergan
Amylin
Genentech
Orion Pharmaceuticals
Endo Pharmaceuticals
Biovail
Amgen
KV Pharmaceuticals
Dong-A Pharmaceuticals
Branded Pharmaceutical Companies
Pharmaceutical Sectors: Branded Pharma Companies:

8. Pharmaceutical Sectors: CMO’s:
Contract Manufacturing Organizations
(aka “CMO’s”)
• CMO’s manufacture drug substance (APIs) and/or final
dosage forms (ie; tablets, capsules, vials) for branded,
multi-national, and other pharma segments.
• These companies typically do not have R&D or develop
their own products.

9. Pharmaceutical Sectors: CMO’s:
Contract Manufacturing Organizations
(aka “CMO’s”)
Large pharmaceutical companies increasingly turn to contract
manufacturing organizations (CMOs) to help achieve efficiencies
in cost, capacity and time-to-market, or to obtain a specific
Expertise not available “in-house.”
Contract Pharmaceutical Manufacturing, Research, and Packaging
(PHM043B), the world market for global pharmaceutical contract
manufacturing and contract research organizations (CRO) was worth
some $126.1 billion in 2014, a figure that is expected to increase to
$185.4 in 2015, a compounded annual growth rate (CAGR) of 8.0%.

10. Pharmaceutical Sectors: CMO’s:
Contract Manufacturing Organizations
(aka “CMO’s”)
Albany Molecular Research, Inc.
Alkermes
Alza Corp. (J&J Company)
Atrix Laboratories (QLT)
Cangene
Carbogen Laboratories Ag
Cedarburg Pharmaceuticals, Ltd.
Chembridge Corp.
Girindus
Hovione Sa
Icos Corp.
Lonza Group
Ranbaxy Research Labs
Schwarz Pharma

11. Pharmaceutical Sectors: CRO’s:
Contract Research Organizations
(aka “CRO’s”)
A Contract Research Organization (CRO), also known as a
"clinical research organization," is an organization that offers clients
a wide range of pharmaceutical research services.
In the Code of Federal Regulations, the U.S. Food and Drug
Administration regulations state that a CRO is "a person [which may be
a corporation] that assumes, as an independent contractor with the
sponsor, one or more of the obligations of a sponsor, e.g., design of a
protocol, selection or monitoring of investigations, evaluation of reports,
and preparation of materials to be submitted to the Food and Drug
Administration." [21 CFR 312.3(b)]

12. Reasons for outsourcing to contract
research organizations
•Reduces the time required to develop and bring a new drug to market
•Sponsor can convert the fixed costs of maintaining the personnel,
expertise and facilities like data management necessary for clinical trial
management into variable costs.
•Non-availability of services in-house
•Knowledge of regulatory affairs in a particular country of interest
•Increased complexity of clinical trials
•Increased amount of data required from clinical trials
•Multinational and multi-center nature of current clinical trials
•Large requirement of patient populations
•Regionalized diseases
Pharmaceutical Sectors: CRO’s:

13. Pharmaceutical Sectors: CRO’s:
Contract Research Organizations
(aka “CRO’s”)
CRO market size and growth
• Global industry analysts estimated that pharmaceutical and
biotechnology companies spent approximately $57 billion on R & D in
2014, out of which an estimated $14 billion was used for the outsourcing
services offered by the CRO industry.
• This figure is expected to increase further with the broadening of the spectrum
of services outsourced to cover the entire value chain.
•As the outsourced services to China and India move up the value chain to cover
phase 1/2 trials, the total contracts value may go up to $20 billion by 2015.

14. Pharmaceutical Sectors: CRO’s:
Contract Research Organizations
(aka “CRO’s”)
• Covance Inc.
• Cato Research
• Quintiles Transnational Corp.
• SFBC International
• MDS Pharma Services
• ACORN CRO Services
• Ferro Pfanstiehl Laboratories
• Acumen
• Indigo Biosciences
• CCS Associates
• Ciron Biopharma Research
• Exodon Neuroscience Research
• Synteract, Inc./
• Symbion Research International

16. Thank You!