tries, through management of demand like
PROBLEM STATEMENT/ INTRODUCTION
• Use of alternates
• Refining the test procedures
• Replace the traditional models with new research models
Recommendation: Procurement of animal models must
move from transactional to strategic engagements, as it
brings in cost savings with assured supply of animal models.
Further, management of the demand through adoption of
newer technologies, refinement of the process, reduces the
animals required. This also helps in fail early fail cheap op-
tions that reduce the overall cost of development of drugs.
Animal research has been a rite of passage for developing
new drugs to treat humans. The practice has an established
history from 3BC. Today, animal based testing is carried
out by a variety of industries, ranging from research labs in
Pharmaceutical, cosmetics to chemical and agrochemical
testing. Animal models preferred for research are rodents,
dogs, cats, primates. The regulatory authorities like FDA,
EMA, and REACH mandate the drugs/chemicals that are
intended for human use, must be tested on animals. These
tests are aimed largely at understanding the toxicity, immunogenicity and efficacy of the drugs, chemicals or cosmetics
upon administration on animals.
However, animal models cannot predict toxicology completely in human beings. This can be attributed to the variance of concordance of the two species (humans and animals), in genome, age, dosage patterns, immune response, etc.
Recent recall of Omontys (erythropoietic agent) due to
severe anaphylactic reactions serves a tragic example of lack
of predictability of animal testing. Fialuridine (nucleoside analogue) trial by NIH and TGN1412 (immunomodulary drug) trial
by Tegenero Therapeutics present strong cases, wherein toxic
reactions in humans were not identified during animal testing.
Despite the mandate, regulatory authorities agree that
animal testing can predict about 40-45% toxicities that might
occur in humans.
Procurement of animal models in recent past has not ushered in significant cost efficiencies from supply market. The
suppliers through mergers and acquisitions have achieved
considerable market share across different geographies in
specialized capabilities as well as capacities. This in turn led
to market consolidation, wherein, the top 5 service providers
have garnered 80% of the market. Hence, they dictate the
price, leaving buyers with very little power for negotiation
Introduction: The research model and services (RMS) is the most crucial segment of preclinical trials, as it helps in determining the safety and efficacy of a new drug. The market for RMS is consolidated with the top
5 service providers having ~80% of the market. The market
is entirely driven by the regulatory mandate for animal testing, thus, service providers like Charles River Laboratories,
Taconic Farms, Harlan, Marshall, dictate the price of
research models in all geographies.
Main: The procurement of RMS has not brought in cost
savings in the recent past, as the supplier power is very high
and the services virtually irreplaceable.
This whitepaper is targeted to address the looming issues
faced by category managers for research animals in pharmaceutical, cosmetics, agrochemical as well as chemical indus-
■ By Meenakshi L, Senior Research Analyst, and C. Vivek, Senior Domain Lead
A new look at procurement of animal models
■ 64 MARCH 2014 | PHARMACEUTICAL PROCESSING
■ PHARMPRO. COM
■ PROCUREMEN T
3D tissues – Benefits versus Limitations
Lesser false positives for false negatives
and more closer to the in vivo models
Expensive; validation of assays is difficult
as source of tissue brings in variability
Difficult to handle, require expertise
1st and 2nd tier assays are commercially
High throughput screening possible only
for low complexity models
Figure1: Alternatives to animal testing, cost savings, and adoption rates.
Type of Alternate
Stem Cell Research
for Large Pharma
Source: Interactions with industry experts