several types of pharmaceutical companies serving the industry

Stuart Silverman – CEO & Founder

What are the different types of organizations that make up the Pharmaceutical Industry?

Pharmaceutical Sectors: Multinationals

Develop and manufacture new chemical entities (NCE’s) for thePharmaceutical market.

Multinational Companies

Multinational companies are set apart from others in that they typcially 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 Organisation. Here we look at who the current top ten companies are, and some of their leading products and therapies.

Pharmaceutical Sectors: Multinationals

Multinational CompaniesAbbottAstellasAstra ZenecaBoerhinger IngelheimBristol Myers SquibbEli LillyJohnson & JohnsonGSK

MerckNovartisPfizerHoffman LaRocheSanofi-AventisSchering PloughWyeth

Pharmaceutical Sectors: Branded Pharma Companies:

Branded Pharmaceutical Companies

•Branded Pharma Companies develop “New Drug Entities (NCE’s)”for the pharmaceutical market and are typcially responsible for handling the drug from discovery, through clinical trials, andcommercial launch.These companies execute both the research and initial manufacture ofthe drug.

•They differ from multinational companies in size, geographicallocations, and volume of business (smaller).



Branded Pharmaceutical Company: A company whoseprincipal 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.

TakedaAllerganAmylinGenentechKing PharmaceuticalsOrion Pharmaceuticals

Endo PharmaceuticalsBiovailAmgenOSI PharmaceuticalsKV PharmaceuticalsDong-A Pharmaceuticals



Pharmaceutical Sectors: CMO’s:

Contract Manufacturing Organizations (aka “CMO’s”)

• CMO’s manufacture drug products and/or final dosage forms (ie; tablets, capsules, vials) for branded, multi-national andvirtual pharma segments.

• These companies typically do not have R&D or develop their own products.



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 2006, a figure that is expected to increase to $185.4 in 2011, a compounded annual growth rate (CAGR) of 8.0%.



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 GroupRanbaxy Research Labs Schwarz Pharma

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)]

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


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 2005, 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 2010.


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

several types of pharmaceutical companies serving the industry

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