Hello!
Konichiwa!

Trends and Opportunities in Pharma/Biotech
Protein Expression Market
Research Report
Shailesh Maingi
Kineticos Life Sciences
May 16, 2008
Shailesh Maingi
Kineticos Life Sciences
July 6, 2009

Before we get started…

Why are we here?

The Approach…
Our Approach…

The Punch Line

Global Healthcare is a great market

Pharma is struggling

Biotech is surging…

Outsourcing
is growing
rapidly…

The competition is strong…

Rare opportunity

Aging population is driving demand…

U.S. Population & Population Age
65+ in Thousands
YEAR TOTAL AGE 65+ %65+
1900 75,994 3,099 4.1
1930 122,755 6,705 5.5
1960 180,671 16,675 9.2
1995 263,434 33,649 12.8
2030 349,993 70,175 20.1
(U.S. Census Bureau, 1994)

Population Projections

Aging Population
• 65+ is fastest growing
– 75% growth (2010-2030)
• By 2050, 85+: 18.2 to 31.1 million
Grocki (2004). Journal of Gerontological Nursing.

Most Frequently Occuring Chronic
Conditions
• arthritis
• hypertension
• hearing impairment
• heart disease
• cataracts
• orthopedic impairment
• sinusitis
• diabetes

Daily Activity Assistance
50%
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%
65-69 70-74 75-79 80-84 85+

Reflections on the
pharma industry…
Background

Global pharma market is large
$54B
57% of prescriptions
$62B
North America: 50% of spend
($44B) $353B
Higher approval rates
100% = $513 B

With Good Growth…

R&D spend is increasing- 6% CAGR

Where does it go?
10,000 NMEs to 1
approved product
Regulatory pressures
Large clinical trials
10%

New drug approvals are declining

R&D cost/drug are increasing

Pipeline is promising (67% in virtual/emerging companies)
Database Integrity Pioneer Market/Customer requirements
Clinical phase Database Database
Pre-clinical 13465 8495
Phase 1 1891 1170
development
Excellence in service &
Innovative culture
Speed,
Economy of scale, High-level
Phase 2 2288 1301
Phase 3 793 386
Process stability,
Low-cost
Pre-registration 130 118
cGMP
(NDA)
Registered (IND) 73 57

Big Emerging
Pharma/Bio Pharma/Bio
97% of all assets 67% of pipeline

NDA approval times declined from 1992 to 2001
Framing the
Issues
Source: Reichert, Janice M. “Trends in Development and Approval Times for New Therapeutics in the United
States,” Nature Reviews: Drug Discovery, Sept. 2003, Vol. 2.

Drug Withdrawals…data does not match perception

Glucophage
Zithromax
Augmentin Neupogen
Imigran
Zestrill Biaxin
Rocephin
Neurontin
Prinivil
Levaquin Novolin Oxycontin
Inotril
Diflucan
Celexa
Lovenox Zoloft Pravachol
Claritin Effexor
Advair
Flovent
Losec Epogen Prevacid Melavotin
Plavix Fosamax
Paxil
Zocor Norvasc Risperdal
Cipro Procrit
Based on 2001 sales

Generics share of U.S. prescriptions increasing
Generic Share of Market
60% 57%
51%
50% 47%
43%
40%
40%
33%
30% 27%
19%
20%
10%
0%
1984 1987 1990 1993 1996 1999 2002 2005

Pharma consolidation and concentration
1988 2003
Merck 3.9% Pfizer 12.3%
Glaxo 2.9% Glaxo 9.0%
Ciba 2.8% J&J 6.6%
Hoechst 2.5% Merck 6.6%
AHP 2.2% AZ 5.6%
Bayer 2.2% BMS 4.6%
J&J 2.2% Novartis 4.1%
SB 2.1% Wyeth 3.8%
Pfizer 2.1% Lilly 3.5%
Sandoz 2.0% SP 3.2%

The growth of Biotech…

What is biotechnology?
The use of living
organisms to make
industrial, agricultural
or medical products
by means of
recombinant DNA,
cell fusion and other
cellular and
biomolecular
processes.

Evolving Opportunity
Growing mammalian cell
expression with
Modern bioprocessing increasingly complex
market develops with targets. Processing
primary focus on demand exceeds global
microbial methods capacity
1980 1990 1997 2000 2005 2010
FDA Modernization Act
simplifies bioprocess CMO market remains
transfers and creates fragmented and
CMO opportunity. BLA undeveloped despite over
replaces PLA and ELA 650 biologics in
requirement. development

1990’s
5% of new drug
approvals were
biologics Accelerating Demand
for Biologics
2006
36% of new drug
approvals were
biologics

Accelerating Demand
for Biologics

Shift to Monoclonal Antibodies (MABs)
PreClinical - Mostly MABs
Clinical Trials - Shift to MABs
Marketed Products - Mostly NonMABs

Therapeutic areas for MABs

- 67% of active pipeline
Emergence of Biotechnology - Lower attrition rate – more successful
to market (21% to 11%)
- In-licensed drugs will equal self
discovered in 2010
13
15
3
3 38
3 28
7 5
58 22
10
9
3
20
5
5
8
Size and Density of US Based PharMa
Size and Density of Top 250 Biotech Co

Personalized Medicine (Biomarkers)
Personalized Medicine