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OBR

The Oncology Pipeline: Maturing, Competitive, and Growing?


By Steven J. Gavel

The oncology R&D arms race is in full swing, and with the invest- Let’s take a look at the nature of the oncology pipeline
ment comes unparalleled risk. IMS offers a look at the trends in the and its outlook…
oncology pipeline, the saturated market segments, and how the block-
buster model is changing. Global Oncology Sales Driven by Innovation
In North America and the EU, approximately 70% of all
The IMS Global Oncology Forecast estimates that sales of anti-cancer agents are of therapeutic agents intro-
between now and 2012, the oncology market will grow at a duced in the past 10 years, driven largely by innovations
compound annual rate of 12% to 15% to reach $75 to $80 derived from biotechnology. Over 30% of sales are from
billion in global sales—nearly double the forecasted growth launches in the past 5 years (Fig. 1). These innovations
rate of the overall pharmaceutical market. In 2008, the have improved quality of life, delayed disease progression,
class will contribute 17% of the industry’s sales growth. But and helped prolong survival for patients battling different
the 5-year trend will be toward slower growth, and compa- types of cancer—including breast, colon, lymphoma, leu-
nies with products currently in the late-stage pipeline will kemia, and kidney.
be entering the oncology market at a much more challeng-
ing time.
100
Crowding in the market is a relatively new phenom-
enon, and it is changing the economics of the business. 31
80
% MARKET SHARE US$

Regulators and technology assessors are raising the bar for


60
approval. With the leverage that comes from having treat- 37
ment choices and the pressure that comes from escalating 40 69%
total costs, payers are seeking to control utilization and 20
32
price. Furthermore, physicians are becoming more selec-
tive in their therapy decisions. As the return on investment 0
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
ratio changes, it is not unreasonable to suggest that over ‘03-’07 ‘98-’02 <=1997
the next 5 years, the late-stage pipeline may be marked by
significant failures. At the very least, many companies may Figure 1. Historic Oncology Sales by Launch Year
need to reset their expectations for upcoming launches. Source: IMS Health, MIDAS, Dec 2007

Targeted Therapies Entering the Market 1998–2008

1998 1999 2000 2001 2002 2003

14 ONCOLOGY BUSINESS REVIEW • ONCBIZ.COM • SEPTEMBER 2008


Competitive Intensity Is Increasing Currently, there are 790 oncologics in Phase 2 devel-
Since the introduction of Herceptin® in 1998, manufac- opment (131 of those are for follow-on indications of
turers have been flocking to oncology, creating an R&D marketed products); 160 in Phase 3 (57 of those being fol-
arms race. Several large pharmaceutical companies (some low-on indications); and 32 in preregistration (25 of which
of which have little or no prior experience in cancer thera- are follow-on indications). Thus, the true scale of the late-
peutics) have committed more than 20% of their late-stage stage pipeline is much more driven by the “trailing edge”
pipeline projects to oncology molecules. Currently, just 10 of existing products than it is by the “building wave” in
manufacturers account for 75% of global oncology sales Phase 1 and 2 (Fig. 2).
(defined as anti-cancer therapeutic drugs), but the market
will become less concentrated as a plethora of new players
make their entrance. 900
790
800
Obviously, with this level of investment comes substan- 700
tial risk. Manufacturers are finding that R&D costs are 600

NO. R&D PROJECTS


rising and that commercial promotion into crowded tumor 500
659
markets requires heavier resources. These factors are com- 400
bining to diminish the return on investment in cancer 300
therapy, suggesting that companies need to take a hard 200 160
50
look at their investment strategies. 100
131
103
7
0 57 43
Follow-on Indications Take the Lead Phase II Phase III Pre-registration/registered

Nearly 2,000 individual molecules for the treatment of Follow-on indications of marketed products All others
cancer are under development—a measure of the indus-
try’s determination and ongoing commitment to finding Figure 2. Oncology Pipeline: Breakdown by Indication
new and innovative treatments for cancer. Even if only Source: IMS Health, MIDAS, Dec 2007
one-third of these indications are ultimately approved,
treatment options will be enormously expanded for many
tumor types over the next 10 to 20 years.
Blockbuster Model in Jeopardy
The days of high, unmet need across all tumor types and
Many of the molecules in late-stage development are settings are gone. Currently, products to treat high-inci-
being evaluated not just for one indication, but for a dence tumors dominate the Phase 3 and Pre-Registration
range of potential cancer indications. Added to this, is pipeline—with more than 20 molecules in late-stage
the ongoing research into follow-on indications for prod- development for breast and pancreatic cancers, and more
ucts that are already approved and available for other than 10 for non-Hodgkin’s lymphoma, prostate cancer,
tumor types—investigations that include more than 230 and malignant melanoma. Other cancers that still offer
potential new indications for molecules already available significant potential include advanced lung cancer, gastro-
to physicians. intestinal cancers, and esophageal cancer.

DENOSUMAB
(Amgen)

RECENTIN
(AZ)

Etc…

2004 2005 2006 2007 2008 2009

SEPTEMBER 2008 • ONCBIZ.COM • ONCOLOGY BUSINESS REVIEW 15


The Oncology Pipeline: Maturing, Competitive, and Growing?

In terms of indication sequencing, companies are pur- The challenges to succeeding with this strategy are
suing a strategy of introducing new molecules in a niche bound to mount. As products expand beyond their ini-
market and then seeking label extensions for use in other,
07148 OBR print ad:Layout 1 2/19/08 11:36 AM Page 1
tial niche indication, they will have to prove the value
higher-incidence tumor types in succession. Indeed, half that they deliver for the money, since payers will have
of the 790 projects currently in Phase 2 are intended for the means to compare and prioritize treatment options.
niche cancer HOW CAN YOUR ONCOLOGY DRUG
indications. CLEAR
Already in the US, uptake on new products is slowing.
TODAY’S MARKET HURDLES? Physicians and payers are requiring evidence of drug effi-
cacy, and a positive cost vs. benefit ratio before making
THE BEST WAY TO KNOW. the move to adopt newer therapies in areas where treat-
NSCLC
breast cancer ments already exist.
ovarian cancer
IMS’ analyses illustrate that new products are grow-
non-Hodgkin lymphoma
colorectal cancer ing only incrementally until additional indications are
renal cancer approved 3 to 6 years down the road—a phenomenon that
pancreatic cancer jeopardizes the traditional “blockbuster model.” This is
AML not to suggest that new products entering niche markets
prostate cancer
head and neck cancer
cannot be successful—only that they will likely achieve
gastric cancer incremental, rather than explosive, growth. In this envi-
CML ronment, success will favor larger companies that can
CLL afford multiple parallel trials to avoid having to enter
melanoma
markets one at a time.
glioma
small cell lung cancer
cervical cancer
Conclusion
glioblastoma Clearly, the now-crowded oncology market is maturing.
biliary tract cancer In the most prevalent tumor areas, patients, providers and
bladder cancer payers have treatment choices, and in some, available
ASK IMS. cancer
treatments have even saturated the diseased population
We have a point of view. Informed by worldwide experience that spans major and niche cancers,
myeloma
including traditional therapies and new technologies.We can help you build indication
lung cancer
in major
strategiesmarkets. This phenomenon has profound impli-
to fully maximize the value of your oncology products — across the lifecycle. Conduct health
soft tissue
economic and outcomes studies to ensure reimbursement and market access. Create product for manufacturers who have naturally pinned high
sarcoma cations
positioning
lymphoma supported by promotional and sales programs that drive market uptake. hopes on at least a percentage of the 2,000 individual mol-
myelodysplastic syndromeinformation… analytics… and consulting expertise to master the market. Our global information sources
Only IMS has the
ecules they are developing to treat cancer. SJG
capture the
facts. Our analytical tools extract their meaning. And our 1,400 business consultants deliver solutions that are based on evidence and
hepatocellular carcinoma
forged by experience.

To learn more, ALL call us today at 610.397.7122, or visit


www.imshealth.com/ask
leukemia
endocrine cancer Steven J. Gavel is Director of IMS’ Oncology Fran-
brain tumor chise, where he leads commercial activities re-
hematological cancer lated to this major therapy area. Gavel has more
©2008 IMS Health Incorporated or its affiliates. All Rights Reserved.
skin cancer
than 20 years experience with ethical, generic and medical device products
0 2 4 6 8 10 12 14 in the oncology market. He can be reached at sgavel@us.imshealth.com
PRODUCT INDICATIONS
or at 610-834-5029.

Registered Pre-registration Phase III

Figure 3. Near-Term Pipeline by Tumor Type


Source: IMS R&D Focus Dec 2007 Oncology products

16 ONCOLOGY BUSINESS REVIEW • ONCBIZ.COM • SEPTEMBER 2008

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