1) The biotech drug market continued steady expansion in 2005, though no new blockbuster drugs were launched. 2) Certain biologic therapies saw over 50% growth, and biologics make up nearly half of drug candidates in development and one in ten FDA filings. 3) Cancer research still dominates biotech drug development areas, followed by AIDS and other infectious diseases, though drug delivery also receives significant attention.

1. D ATA PA G E
Biotech drug market steadily expands
Stacy Lawrence
Unlike last year’s billion dollar approvals, Avastin (bevacizumab) and market). Certain biotech therapies are among the fastest growing drug
Erbitux (cetuximab), no biotech blockbusters were launched in 2005 market segments (mAbs sales grew by 52% in 2005); five of the 20
and none appear to be on the horizon. Almost half of the biologics best-selling drugs are large molecules. Biotech increasingly dominates
license applications pending at the US Food and Drug Administration the pipeline (44% of all discovery stage candidates) and has a growing
© 2005 Nature Publishing Group http://www.nature.com/naturebiotechnology
(FDA) are for supplementary indications (for drugs already on the share of drug applications (about one in ten of filings).
Investigational biotech drugs by area Top 10 biotech drugs by global sales
2004 sales Percent Annual 2004
Cancer continues to dominate, closely followed by AIDS and other Products (company) ($ millions) change growtha market share
infectious diseases. Drug delivery research gets considerable attention.
Erypo/Procrit $3,989 -4.2% 23.0% 9.0%
(Johnson & Johnson)
Cardiovascular 54
Diabetes 56 Epogen (Amgen) $2,897 -3.8% 14.1% 6.5%
Hepatitis B 63
Diagnostic 69 Enbrel (Amgen/Wyeth) $2,578 58.8% 42.1% 5.8%
Immune system 69
Aranesp (Amgen) $2,569 77.9% *** 5.8%
Influenza 72
Colon cancer a 72 Remicade (Johnson & $2,506 19.8% 130.8% 5.6%
Leukemia 77 Johnson/Schering-Plough)
Lung cancer 80
Mabthera/Rituxan (Roche) $2,192 24.4% 62.7% 4.9%
Breast cancer a 94
Hepatitis C 101 Neulasta (Amgen) $1,873 52.1% *** 4.2%
Prostate cancer a 104
Vaccines 110 Avonex (Biogen Idec) $1,383 16.4% 18.1% 3.1%
Gene therapy 118
Neupogen (Amgen/Roche) $1,344 -6.8% 2.5% 3.0%
Melanoma a 120
Drug delivery 157 Lantus (Aventis) $1,014 80.9% *** 2.3%
Infectious diseases 271
Total top 10 $22,346 20.7% 31.3% 50.4%
AIDS 313
Cancer 608 Global biotech market $44,353 17.0% 21.6% 100.0%
0 200 400 600 aCompound annual growth 1999-2003. Source:IMS Health
Number of biologic candidates
aCancer subtype broken out from total cancer. Source: BioPharm Insight
Potential blockbusters in the pipeline
Generic Annual sales
Biotech drug applications Company name Type Indication ($ millions)a
Of the pending/expected biologic license applications (BLAs), almost one- Amylin/Lilly Exenatideb Peptide Type II diabetes $1000+
third are for supplementary indications; unlike 2004, none of the new Onyx/Bayer Sorafenib Small molecule Kidney cancer $500-1000
applications is for projected blockbusters. CV Therapeutics Ranolazine Small molecule Chronic angina $400-500
MGI/Supergen Decitabine Small molecule Myelodysplastic $300-500
16 6 3
syndrome
Number of applications
8 11 Supplemental
14
New Cephalon Modafenil Small molecule Pediatric attention $300-500
12
2 deficit/hyperactivity
10
6 disorder
8
6 Celgene Lenalidomide Small molecule MDS and myeloma $300-500
4 Cephalon Naltrexone Small molecule Alcoholism $300-500
2
NPS Preos Recombinant Osteoporosis $300-500
0
Current pending 2005 BLAs 2006 BLAs hormone
BLAs expected expected aPeak annual sales potential ($millions). bAlready approved in April 2005. Source: SG Cowen
Application category
Data as of October 2005, based on FDA BLA applications. Source:SG Cowen
Biotech drug candidates by phase
Public biotech sales and R&D More than 2,500 large molecules in discovery represents 40% of all
drug candidates.
Biotech sales continue to grow in the double digits, but research spending
has leveled off.
Biotech drugs as percentage
3,000 44% 50%
Number of biotech drugs
2,584 Number of
39%
45%
of all drug candidates
$33.3 153 large molecule
2,500 drugs
$35.0 $19.8 Sales 40%
30%
$28.4 ($ billions) 24 35%
2,000 26% 27% Percent of total
$30.0 $24.3
$17.9
907 594 23% 22% 30% candidates that
$21.4 $20.5 R&D expense 615 19% 41 are large molecule
$25.0 1,500 25%
$ (billions)
($billions) 243
$19.3 $15.7
$16.1 $14.2 11%
20%
$20.0 $14.5 $10.7 1,000
$13.0
65 15%
$10.6
$15.0 $10.8 $9.0
500
10%
$9.3 $7.9
$7.7 5%
$7.7
$10.0 $7.0
0 0%
$5.0
al
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Based on public company data. Source: Ernst & Young Source: Biopharm Insight
1466 VOLUME 23 NUMBER 12 DECEMBER 2005 NATURE BIOTECHNOLOGY