1M.J. Rathbone and A. McDowell (eds.), Long Acting Animal Health Drug Products: Fundamentals and Applications, Advances in Delivery Science and Technology, DOI 10.1007/978-1-4614-4439-8_1, © Controlled Release Society 2013

Abstract This chapter provides an outlook for future projections of growth in the livestock industry and the likely resultant demands of the animal health products market.

It describes the animal health industries landscape that, in recent years, has been dominated by acquisitions and mergers. Mergers have allowed the newly formed companies to expand their portfolios into new areas of prospective growth which include the biotech area. The chapter concludes that such changes have been facili-tated by collaborations or licensing agreements with small companies holding pat-ent protected technologies for niche markets. Indeed, the opportunity for partnerships and alliances has become the core of a new business strategy for big pharma.

1.1 Introduction

1.1.1 Livestock Industry

Livestock systems occupy about 30% of the planet’s land surface and this sector accounts for 40% of agricultural GDP. The livestock sector is increasingly orga-nized in supply chains that employ about 1.4 billion people globally and livestock products provide one-third of humanity’s protein intake [ 1 ] .

Chapter 1 Animal Health Markets and Opportunities: Farmed Animal Landscape

Shobhan Sabnis and Michael J. Rathbone

S. Sabnis (*) Global Manufacturing Services, P fi zer Animal Health , Greater New York City Area , USA e-mail: shoban.sabnis@p fi zer.com

M. J. Rathbone Division of Pharmacy , International Medical University , Kuala Lumpur , Malaysia

Any views or opinions presented in this document are solely those of the author and do not neces-sarily represent those of the company

2 S. Sabnis and M.J. Rathbone

As countries have become more af fl uent and the world’s population has contin-ued to rise, the demand for meat and other livestock products has grown substan-tially. Figure 1.1 shows the top meat producing country by species [ 2 ] .

According to FAO, global meat production is projected to more than double from 229 million tons in 2000 to 465 million tons in 2050, while milk output is set to climb from 580 to 1,043 million tons to meet the demands of the growing popula-tion. While the growth in consumption in the developed countries is expected to be steady, the major increase is expected in the countries that have or will experience rapid economic growth. A comparison of per capita meat and dairy consumption by geographical regions is shown in Figs. 1.2 and 1.3 , respectively.

Fig. 1.1 Top producers of meat by species in 2009 (data from FAOSTAT http://faostat.fao.org/site/339/default.aspx )

0

20

40

60

80

100

1965 1998 2030

Con

sum

ptio

n (k

g/ye

ar)

Industrialized countries

Latin America

East Asia

Developing countries

Near East and North Africa

Sub-Saharan Africa

South Asia

Fig. 1.2 Per capita meat consumption by regions from 1965 to 2030

31 Animal Health Markets and Opportunities: Farmed Animal Landscape

The increase in meat and dairy requirement will be met through direct and indi-rect pathways. Direct pathways include a higher number of food producing animals per capita, increased weight of meat/carcass, and increased productivity for milk and dairy products. The indirect pathways include a better supply chain for meat prod-ucts and reduced waste pre and post end user purchase. This increase in demand is also likely to bring about signi fi cant changes to the meat production business mod-els. More industrialized and intensive production systems are likely to be the future of livestock industry in many of the countries. Figure 1.4 shows the factors that would be responsible for the shift in global meat production business models [ 1, 3 ] .

1.1.2 Animal Health Products Market

The overall increase in meat and dairy consumption will continue to be mirrored by a growth in animal health products market. The world animal health market

0

50

100

150

200

250

1965 1998 2030

Con

sum

ptio

n (k

g/ye

ar) Industrialized countries

Latin America

Near East and North Africa

South Asia

Developing countries

Sub-Saharan Africa

East Asia

Fig. 1.3 Per capita milk consumption by regions from 1965 to 2030

Increase in foodanimals in confinement/decrease in animals in

natural habitat

Reduced water availabilitycausing an increase in the amount

of energy spent to get water

Increase in urbanization causingimprovements in supply chain

Better quality of crops, improvedproductivity causing decrease in

cost of nutrition

Better feed additives

Better diagnostics

Better preventive careand vaccines

Better disease control

Increase in demand formeat

Increased pressure tomanage cost

Fig. 1.4 Factors that will trigger the global growth of commercial livestock production in the future

4 S. Sabnis and M.J. Rathbone

was about 17.5 billion US dollars in 2005. It has grown to about 19.2 billion in the year 2010 [ 4 ] and if this trend continues, then the world market will surpass 30 billion by 2020.

The animal health market is composed of approximately 60% livestock and 40% companion animal by sales. The livestock market can be further divided by species. In 2008, the share by major species is shown in Fig. 1.5 .

The veterinary market for livestock can also be classi fi ed in three product groups. They are vaccines or biologicals (25%), pharmaceuticals or small molecules (63%), and feed additives (12%) with market share in parentheses [ 4– 6 ] . Livestock medicine is becoming increasingly herd based and preventive in approach—a consequence of a shift to mass production business models in the developed and developing countries [ 7 ] . This trend is likely to increase the share of biologicals in the future as compared to small molecule pharmaceuticals.

1.2 Animal Health Industries Landscape

The last few years have seen signi fi cant consolidation within the animal health industry with acquisitions and mergers. Many of the acquisitions allowed the acquirers to expand into new areas of prospective growth, e.g., aquaculture, genomics, diagnostics, specialty devices, etc. The largest 20 companies based on revenues in 2010 are shown in Fig. 1.6 (data collected from yearly revenue state-ments where available). Figure 1.6 shows the percent change from previous year on the Y2 axis .

Most of the animal health companies posted positive revenue change from 2009, which was a dif fi cult year for the industry where global economy contracted sharply. Many of these companies have continued to invest heavily in R&D. The Animal Health Institute (AHI, 1325GSt NW # 700 Washington, DC) reports that animal health R&D investment has been 0.6–0.7 billion USD/year for last 5 years, which is only one-fortieth the human health R&D budget on average. There are only a few modi fi ed release animal health dosages forms in the market when a comparison is made with human health pharmaceuticals. Fewer than 25 NADA submissions are

Cattle45%

Pigs27%

Poultry19%

sheep8%

other1%

Fig. 1.5 Livestock market by species—2008

51 Animal Health Markets and Opportunities: Farmed Animal Landscape

classi fi ed as modi fi ed or sustained release. There were 94 NADA submissions (not counting supplementals) made in past 5 years. Out of these, 51 submissions were for farmed animals. However, very few of these were modi fi ed release dosage forms. Modi fi ed release animal health products registered from 2007 to 2011 for farmed animals are given in Table 1.1 (prepared from data available on USFDA and EPA databases).

Financial factors, which include limited budgets assigned to conduct veterinary R&D, the cost competitive amount that can be charged for the fi nished product, and the expensive time-consuming product registration process may be some of the factors for this trend [ 8 ] . However, there may be a shift in this trend in the coming decades.

1.3 Research Collaborations

According to OECD, comparisons of key indicators across countries suggest a posi-tive relationship between measures of research collaboration and scienti fi c impact. Worldwide, the 50 universities with the highest impact, measured by normalized citations to academic publications across all disciplines, are concentrated in a handful of countries. Overall, 40 of the top 50 universities are located in the United States, and the rest in Europe. A more diverse picture emerges on a subject-by-subject basis.

-20

-10

0

10

20

30

40

50

60

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

Pfiz

er A

nim

al H

ealth

Inte

rvet

/Sch

erin

g-P

loug

h

Mer

ial

Bay

er

Ela

nco

Ani

mal

Hea

lth

Boe

hrin

ger

Nov

artis

Ani

mal

Hea

lth

Idex

x La

bora

torie

s

Virb

ac

Cev

a S

ante

Ani

mal

e

Uni

ted

Pet

Gro

up

Dec

hra

Vet

oqui

nol

Alp

harm

a

Bal

chem

Ani

mal

Hea

lth

Neo

gen

Aba

xis

Inc.

Nov

ozym

es F

eed

Enz

ymes

Hes

ka

EC

O A

nim

al H

ealth

% C

han

ge

Mill

ion

s (U

SD

)

2010 Revenue*

Change from 2009* (%)

Fig. 1.6 Comparison of yearly revenue of top 20 animal health companies

Tabl

e 1.

1 M

odi fi

ed r

elea

se a

nim

al h

ealth

pro

duct

s re

gist

ered

fro

m 2

007

to 2

011

for

farm

ed a

nim

als

Reg

ulat

ed b

y C

VM

T

rade

nam

e A

ppro

val n

umbe

r A

ppro

val

date

A

ctiv

e in

gred

ient

s C

ompa

ny

Spec

ies

Dos

age

form

R

oute

of

adm

inis

trat

ion

Indi

catio

n

Rev

alor

® X

S N

AD

A 1

41-2

69

2007

T

renb

olon

e ac

etat

e an

d es

trad

iol

Inte

rvet

/Mer

ck

Ani

mal

Hea

lth

Cat

tle (

stee

rs)

Solid

dos

e im

plan

t SC

W

eigh

t gai

n

Lon

gran

ge™

N

AD

A 1

41-3

27

2011

E

prin

omec

tin

Mer

ial

Cat

tle (

past

ure)

In

ject

able

sol

utio

n SC

B

RD

E

xced

e®

Ster

ile S

uspe

nsio

n a N

AD

A 1

41-2

09

2008

C

eftio

fur

crys

talli

ne

free

aci

d

UpJ

ohn/

P fi ze

r C

attle

and

ho

rses

St

erile

oil

susp

ensi

on

for

inje

ctio

n

SC

BR

D

EA

ZI-

BR

EE

D

CID

R S

heep

Ins

ert

NA

DA

141

-302

20

09

Prog

este

rone

U

pJoh

n/P fi

zer

Shee

p (e

wes

) So

lid m

atri

x in

sert

In

trav

agin

al

Indu

ctio

n of

es

trus

in e

wes

D

YN

AM

AX

C

ontr

olle

d R

elea

se

Cap

sule

s (A

ustr

alia

)

APV

MA

:640

99/5

0025

20

10

Aba

mec

tin,

albe

ndaz

ole,

co

balt,

sel

eniu

m

Mer

ial

Shee

p (a

dult)

So

lid d

ose

tabl

ets

in a

gas

troi

ntes

tinal

re

tent

ive

devi

ce

Ora

l an

thel

min

tic

Reg

ulat

ed b

y E

PA

XP

820

EPA

Reg

no.

3903

9-17

20

09

Aba

mec

tin a

nd

pipe

rony

l but

oxid

e Y

-Tex

Cor

p C

attle

So

lid m

atri

x E

ar ta

g C

ontr

ol o

f ho

rn

fl ies

and

tick

s E

LIM

INA

TO

R®

E

AR

TA

GS

(for

C

anad

a)

NA

C N

o.: 1

2341

562

2006

/07

Cyp

erm

ethr

in a

nd

diaz

inon

V

étoq

uino

l C

anad

a In

c.

Cat

tle

Solid

mat

rix

Ear

tag

Con

trol

of

horn

fl i

es a

nd

face

fl ie

s

a EX

CE

DE

(C

eftio

fur

Cry

stal

line

Free

Aci

d): A

New

Sus

tain

ed-R

elea

se I

njec

tabl

e A

ntib

iotic

for

Hor

ses,

P fi z

er T

echn

ical

Bul

letin

, 201

0

71 Animal Health Markets and Opportunities: Farmed Animal Landscape

There is evidence that some universities in Asia are emerging as leading research institutions. Many of the leading fi rms in knowledge-intensive industries have emerged in a limited number of regions in the world. The production of scienti fi c knowledge is shifting from individuals to groups, from single to multiple institu-tions, and from a national to an international scope.

1.4 Patent Landscape

If intellectual property applications are seen as a marker for R&D activity, then the top fi ve animal health companies have made approximately 120 patent applications with the USPTO in last 5 years. This represents only 2–3% of the total worldwide patent applications related to animal health or veterinary topics in those years. Most of the patent applications have been made by smaller entities. Figure 1.7 shows the trend in animal health related patent applications over the last 5 years. Although a major portion of the animal health patent applications had a farmed animal focus, the modi fi ed/sustained release category constituted only about 2–4% of the total animal health applications.

The presence of young fi rms among patent applicants underlines the inventive dynamics of fi rms early in their development and their desire to develop new activi-ties and products—crucial to their survival and relative growth. During the period 2007–2009, fi rms less than 5 years old fi ling at least one patent application

Year2006 2007 2008 2009 2010 2011 2012

Num

ber

of p

aten

t ap

plic

atio

ns

−50

0

50

100

150

200800

900

1000

1100

1200

1300

Total veterinary patent applications Patent applications with live stock focus Patent applications with modified release focus Top 5 companies' vet focus patent applications

Fig. 1.7 Trend in animal health related patent applications over the last 5 years

8 S. Sabnis and M.J. Rathbone

Table 1.2 Niche controlled release technology fi rms

Institute Technology Intellectual property

Iowa State University Research Foundation Inc.

Single dose controlled release vaccine formulations using polyanhydride microspheres

[ 12 ]

OctoPlus N.V., Zernikedreef 12 2333 CL Leiden, The Netherlands

OctoDex™ drug and vaccine delivery systems for controlled release of therapeutic proteins and particulate systems and containing dextran hydroxyethyl methacrylate as the polymeric building block

OctoDex company factsheet

Langer Lab, 77 Massachusetts Ave, Cambridge, MA

Development of controlled release systems that can be magnetically, ultrasonically, or enzymatically triggered to increase release rates

[ 13– 15 ]

MedinCell S.A., Cap Alpha, Avenue de l’Europe 34830 Clapiers France

MedinGel™ in vivo hydrogel forming system constituted of a mono-dispersed tridimensional of hydrophilic network (PEG) linked with hydrophobic microdomains (PLA) for delivering small molecules, peptides, and proteins

Medincell™ Introductory brochure http://www.medincell.com/medingel/technology

Cytogel Pharma, LLC, 3 Thorndal Circle. Darien, CT

Injectable microspheres are obtained from double bond-functionalized polyhydric alcohol ester or from block copolymer of polyglycerol caprolactone maleate and methoxy poly(ethylene glycol)

[ 16, 17 ]

(continued)

represented on average 25% of all patenting fi rms, and generated 10% of patent applications [ 9 ] .

1.5 Controlled Release Initiatives for the Future

In today’s environment, it is not enough for fi rms to focus only on short-term tech-nology development based on existing core competencies; they must be able to place long-term technology bets, based on current trends, competition, and stake-holder value proposition [ 10 ] . The blockbuster strategy, which involved one drug for large markets, has been gradually observed to decline, leading to narrow product portfolios, a small number of genuinely innovative compounds, and proliferation of life cycle management opportunities. These opportunities will involve signi fi cant partnerships and alliances as well as other collaboration networks, including partici-pation of different industry service providers [ 11 ] . Resurgence of generic companies

91 Animal Health Markets and Opportunities: Farmed Animal Landscape

(continued)

Institute Technology Intellectual property

Starpharma, Baker IDI Building, 75 Commercial Road, Melbourne, VICTORIA 3004, AUSTRALIA

Macromolecular vehicles such as polylysine dendrimers for enhanced delivery of small molecule and biological drugs to control solubility, half-life, toxicity, and targeting

[ 18 ] , Starpharma drug delivery summary http://www.starpharma.com/assets/downloads/Starpharma-Drug-Delivery-Summaryv3.0.pdf

DURECT Corporation, 2 Results Way, Cupertino, CA 95014

SABER™ injectable controlled release system uses a high-viscosity base component, such as sucrose acetate isobutyrate and diffusible excipients. DURIN™ technology involves polymers and copolymers prepared from glycolide, DL-lactide, L-lactide, and □-caprolactone. These thermoplastic materials are stable when dry but degrade by simple hydrolysis of the polymer backbone aqueous environment

[ 19 ] , Durect’s SABER fact-sheet http://www.durect.com/pdf/SABER_Brochure_July2010.pdf ; [ 20 ] , Durect’s DURIN fact-sheet http://www.durect.com/pdf/DURIN_HRES.pdf

Catalent Pharma Solutions, 14 Schoolhouse Road, Somerset, NJ 08873

OSDrC® technology enables the design of single or multicore tablets, with a variety of core numbers, shapes, sizes, and placement within the tablet for better quality and release control

[ 21 ] , OSDrC®OPTIDOSE™ Drug Delivery Technology brochure http://www.catalent.com/index.php/offerings/OSDrC-R-OPTIDOSE-drug-delivery-technology/OSDrC-R-OPTIDOSE-Drug-Delivery-Technology

Flamel Technologies, 33, avenue du Dr. Georges Levy—Parc Club du Moulin à Vent, 69693 Vénissieux Cedex—France

Medusa® platform (pGluVE, or PGA A1) is based on a hydrophilic biodegradable polyglutamate chain grafted with hydrophobic Vitamin E. The polymer self assembles in aqueous medium to form a stable solution of nano-sized hydrogels comprising multiple polymer chains and 95% water

[ 22 ] , Medusa® drug delivery platform description http://www. fl amel.com/wp-content/uploads/2011/11/Flamel-Technologies-Medusa-Drug-Delivery-Platform.pdf

PolyPid Ltd., 13 Hamazmera Street, Ness-Ziona 74047, Israel

BonyPid TM is a biodegradable bone void fi ller that is micro-coated with a PolyPid biodegradable formula-tion. Its advantage is its ability to treat an infection effectively by controlling the release of the active drug, for 3–4 weeks to successfully eradicate the bacteria that may cause infections

[ 23 ]

Table 1.2 (continued)

10 S. Sabnis and M.J. Rathbone

and pro fi t erosion of the small molecule product, advances in the biopharmaceuti-cals research, and increased trend toward prevention rather than treatment will fur-ther give opportunities to niche controlled release technology companies to collaborate and expand the animal health product portfolios. Some such niche con-trolled release technology fi rms are listed in Table 1.2 .

1.6 Niche Company Considerations

Today, more than ever, the current status of the animal health industry is driving niche companies to develop innovative technologies with the goal for selling them to big pharma. However, such companies should realize that the scope for livestock animal product success is limited and that the competition is fi erce. Niche compa-nies develop technology platforms based on perceived technology needs or clinical needs. In-house expertise and/or market savvy determine which track a niche com-pany will pursue.

There is more than one way to crack an egg, and, in a competitive market, the best and most superior technology can be overlooked for one that ful fi lls the desired

Institute Technology Intellectual property

Nanomi B.V., Zutphenstraat 51, 7575 EJ Oldenzaal, The Netherlands

Microsieve™ emulsi fi cation technology is applied for the production of precisely de fi ned functional emulsions, and micro- and nanospheres with controlled release, diagnostics, molecular imaging applications. The heart of the microsieve™ technology is a silicon membrane that is fabricated by photolithographic techniques to achieve uniformity of pore size (CV ~ 5%) and shape in a highly reproducible way.

[ 24, 25 ]

Trilogic Pharma 331 Perimeter Parkway Ct, Montgomery, AL 36116

TRI-726 system consists of a combination of a triblock copolymer and a natural polysaccharide and is designed to take advantage of body temperature to undergo sol-to-gel transition. It can be a liquid (viscous or dilute), a semisolid (gel/paste), a spray, or a foam to suit the need. TRI-726 has the ability to erode over a period of several hours to several days. This feature allows for slow release of the incorporated drug over this period

[ 26 ]

Table 1.2 (continued)

111 Animal Health Markets and Opportunities: Farmed Animal Landscape

criteria. Those being: cost effectiveness, demonstrable rapid speed to market, robustness, functionality, reliability, and present a point of differentiation. The niche company should bear these criteria in mind, include them in their technology prod-uct brief, and build them into their product at every opportunity during the research phase. Big pharma will not invest their time and effort in a niche company’s tech-nology just because it is innovative and elegant as these latter features do not enhance sales in a market that is dominated by large numbers of products which promise small revenues.

In recent years, few new drug entities have appeared on the animal health market, numerous existing big blockbuster drugs have come off patent, and there are limited clinical conditions that livestock are treated for (since they are culled well before old age and its af fl ictions affect the animal). Because livestock have a market de fi ned and fl uctuating economic value, technologies must be cheap to manufacture as well as have demonstrable safety, ef fi cacy, and which can be manufactured to a high quality.

In the animal health arena, the opportunities for a niche company to sell or license a technology to big pharma are considerably smaller compared to their human coun-terparts. To be successful, niche companies need to spend time and effort identify-ing the next growth segments of the market, identifying the right product candidates to demonstrate feasibility of the technology, and set the goal of being fi rst in line to present their solution to big pharma.

A fi nal consideration is the fi nancial conditions of the deal. All the economic fac-tors discussed in this chapter mean that niche companies need to be realistic when negotiating deals with big pharma. Expectations must be in line with eventual sales revenue and related to the magnitude of risk to turn the technology into a product at the time of negotiation.

Niche companies need to be cognizant of the amount of time and fi nancial invest-ment that is required to assure their technologies are suf fi ciently along the track to attract big pharma’s interest. A great idea is not enough. Indeed, in vivo demonstra-tion of technology feasibility may also not be suf fi cient to attract attention. The right time to pitch the technology to big pharma is always dif fi cult to determine and should be made on a case-by-case basis. In general, the further along the registration path the technology is, the lower the fi nancial and success/failure risk there is, and the more likely big pharma will be interested in viewing a niche company’s offer-ings. The bottom line is that niche companies should not underestimate just how far they need to take their good idea along the track towards registration before interest by big pharma is forthcoming. This may mean larger and bigger-than-expected investments by the niche company in time, effort, and money to get the technology to that stage. However, the further along the registration track, the greater the fi nancial returns can be negotiated.

A niche company will need to use compounds in their technologies to demonstrate its potential as a delivery platform. Often, when the technology portfolio is presented to big pharma, this results in the delivery system being perceived as being for the treatment of the condition for which the drug treats. In addition, as pointed out earlier, normally a technology will need to be close to registration to attract big pharma’s

12 S. Sabnis and M.J. Rathbone

interest in it (as a marketable product) as this minimizes risk to big pharma. The end result of this need is that the technology loses its identity (as a technology platform) and big pharma cannot see beyond the offering as a product for the delivery of the particular drug that was used to demonstrate the technologies feasibility or fl exibility.

Big pharma interested in a technology offering will be willing to negotiate col-laborative development deals; licensing of the technology either for clinical condi-tions, drug types, or market regions; or outright purchase of the technology. Big pharma will be looking for some form of protection of the technology. Therefore, patenting the technology or having some in-house know-how is an important edge. Deals involving cost of manufacture and supply of pivotal batches can be negotiated, as well as upfront, milestone, and fi nal payments, with their mag-nitude dependent upon the nearness to market registration and fi nancial and suc-cess/failure risk considerations.

1.7 Future Directions and Outlook

The biopharmaceuticals area is maturing into mainstream pharmaceutical area. Most of the major animal health companies have implemented biopharma R&D programs. In fact, four of the ten largest human health drugs were monoclonal anti-bodies and together grossed over 20 billion in 2010. One animal health product has received approval for treatment of canine leukemia (containing CL/mAb 231) [ 27 ] . Many of the animal health companies have established active programs and collaborations for developing mAbs and expect to bring product offerings to market within the next few years. Application of modi fi ed release technologies for deliver-ing mAbs would be a valuable proposition because of the propensity for highly speci fi c or targeted therapy for a narrow subpopulation. However, mAbs are already being used in many of the diagnostic kits in the animal health industry and this trend is expected to grow in the next decades. In fact, Osborne [ 28 ] projects that 80% of all new pharmaceutical products by 2030 would be based on biotechnology. Although such advances may be projected based on trends, this area is still in development in the animal health arena.

Pathways for regulatory approvals need to be clearly de fi ned for new technolo-gies, whether USDA or CVM will act as the regulatory body for such products, or whether a combination of both agencies would be required for the products mar-keted in the US.

1.7.1 Potential for Niche Companies

The second major challenge for biotech products to enter animal health mainstream is the economics of developing such differentiated products for smaller, targeted subpopulation [ 29 ] . There needs to be a value added bene fi t to make the investment worthwhile. And this makes a case for small niche companies that would provide

131 Animal Health Markets and Opportunities: Farmed Animal Landscape

specialized, patent protected technologies to big pharmas as collaborations or licensing deals.

1.8 Concluding Remarks

The animal health market is complex and challenged by limited budgets assigned to conduct veterinary R&D, the cost competitive amount that can be charged for the fi nished product, and the expensive time-consuming product registration process. The last few years have seen signi fi cant consolidation within the animal health industry with acquisitions and mergers. Future growth of the livestock industry to meet human demand for food supply presents the opportunity for pharmaceutical intervention to assure high production rates through improved animal health, pro-duction, and reproduction. Over the past 50 years, existing small molecules have resulted in relatively few controlled release products appearing on the animal health market (compared to the controlled release products that service the human market). Today the biopharmaceuticals area is maturing into mainstream pharmaceutical area. Major big pharma are hesitant to conduct in-house R&D product development due to the high cost and risks associated with developing such differentiated prod-ucts for smaller, targeted markets. This offers the opportunity for small companies to develop niche products and provide such specialized, patent protected technolo-gies to big pharmas as collaborations or licensing deals.

References

1. Thornton PK (2010) Livestock production: recent trends, future prospects. Phil Trans R Soc B 365:2853–2867

2. Food and Agriculture Organization of the United Nations’ statistical database (FAOStat) (Sept 2011). http://faostat.fao.org/site/339/default.aspx

3. Godfray HCJ, Crute IR, Haddad L, Lawrence D, Muir JF, Nisbett N, Pretty J, Robinson S, Toulmin C, Whiteley R (2010) The future of the global system. Phil Trans R Soc B 365:2769–2777

4. Evans T (2009) Global animal health industry and trends, a US perspective. AVDA Congress: Thriving in Dynamic Times, St. Petersburg, FL

5. Foster TP, Abraham SS (in press) Veterinary dosage forms. In: Swarbrick J (ed) Encyclopedia of pharmaceutical science and technology, 4th edn. Informa Healthcare, London

6. Vetnosis Limited (2009) Veterinary report. Edinburgh, United Kingdom 7. Perry BD, Grace D, Sones K (2011) Current drivers and future directions of global livestock

disease dynamics. Proc Natl Acad Sci USA 108:1–7 8. Rathbone M, Brayden D (2009) Controlled release drug delivery in farmed animals: commer-

cial challenges and academic opportunities. Curr Drug Deliv 6:383–390 9. OECD Science, Technology and Industry Scoreboard 2011 10. Brunner CS (Jun 2004) Challenges and opportunities in emerging drug delivery technologies,

PG report. Emerging Drug Delivery Technologies, # 0403 11. Vancauwengerghe CE (2011) The reshaping of pharmaceutical industry landscape: partner-

ships and alliances are the core of new business strategy. Drug Dev Deliv 11:8–15

14 S. Sabnis and M.J. Rathbone

12. Kipper M (2010) Controlled-release immunogenic formulations to modulate immune response. US patent 7,858,093B1

13. Sheppard NF, Santini JT, Cima MJ, Langer RS, Ausiello D (2008) Method for wirelessly monitoring implanted medical device. US patent application US2008/0221555A1

14. Sheppard NF, Santini JT, Cima MJ, Langer RS, Ausiello D (2007) Microchip reservoir devices using wireless transmission of power and data. US patent 7,226,442B2

15. Polat BE, Hart D, Langer RS, Blankschtein D (2011) Ultrasound-mediated transdermal drug delivery: mechanisms, scope, and emerging trends. J Control Release 152:330–348

16. Wu D, Chu CC, Carozza J (2011) Injectable microspheres. US patent 8,034,383 17. Wu D, Chu CC, Carozza J (2008) Hydrogel compositions comprising serum albumins for vac-

cines. US patent application 20080226725A1 18. Krippner GY, Williams C, Kelly B, Henderson S, Wu Z, Razzino P (2010) Targeted polylysine

dendrimer therapeutic agent. US patent application 20100292148A1 19. Verity N (2011) Controlled-release anesthetic delivery systems, US patent application

20110009451 20. Chen G, Kleiner L, Houston P, Nathan A, Rosenblatt J (2007) Implantable caprolactone-based

polyester elastomeric depot compositions and uses thereof. US patent application 20070184084A1

21. Ozeki Y, Izumi K, Watanabe Y, Okamoto H, Danjo K (2005) Advanced dry-coated tablets as a solid coating technology-1. Pharm Tech Jpn 21:1407–1413

22. Chan Y, Meyrueix R, Kravtzoff R, Nicolas F, Lundstrom K (2007) Review on Medusa®: a polymer-based sustained release technology for protein and peptide drugs. Expert Opin Drug Deliv 4:441–451

23. Emanuel N, Neuman M, Barak S (2010) Sustained-release drug carrier composition. World patent application WO2010007623

24. Wissink J, Van Rijn C, Nijdam W, Goeting C, Heskamp I, Veldhuis G (2005) Device for gen-erating microspheres from a fl uid, method of injecting at least one fi rst fl uid into a second fl uid, and an injection plate. World patent application 2005115599 A1

25. Veldhuis G, Gironès M, Bingham D (2009) Monodisperse microspheres for parenteral drug delivery. Drug Deliv Technol 9:24–31

26. Alur H, Harwick J, Mondal P, Johnston T (2009) Self solidifying bioerodible barrier implant. World patent application 2009073658 A1

27. Antineoplastic agents (2010) In: Kahn CM (ed) Merck veterinary manual, 10th edn. Merck Sharp & Dohme Corporation, New Jersey

28. Oborne M (2010) The bioeconomy to 2030: designing a policy agenda. OECD Observer, 278 29. Reviere J (2007) The future of veterinary therapeutics: a glimpse towards 2030. Vet J

174:463–471