Abstract
This report will provide industry planners, commercial developers and the
investment community with a thorough review of the operating landscape for
generic injectables over the next 5 years. The report is packed with primary
source information and market forecasts, and takes a balanced view of the
players and products that will shape this high value market sector.
A number of high value drugs due to come off patent in the USA and Europe over
the next few years are injectable.
These include drugs to treat cancer, venous thrombosis, gastrointestinal
disorders and hospital acquired infections. Alongside these and falling in the
same therapeutic categories are drugs that have come off patent in the USA
since 2004 and have attracted generic competition, such as cancer therapies
carboplatin and paclitaxel.
Generic companies are also beginning to take an interest in some of the older
high value biopharmaceuticals, including erythropoietin, filgrastim,
recombinant insulin, somatropin and interferon. If regulatory hurdles can be
overcome, the potential rewards for generic companies in biosimilar products
are huge. While the first approval of a biosimilar product has yet to happen
in either the US or the EU, the new EMEA guidelines can be seen as a step in
the right direction.
The traditional view of generic drugs is that they offer a cheap alternative
to their branded equivalents. Cost has been an important factor in their
development, particularly for oral drugs that are relatively cheap to produce
and can be introduced to that market at a fraction of the price of the
original drug. Generic companies are, however, beginning to look for higher
profit margins and injectable drugs potentially offer such opportunities.
Combined sales of the non-biological injectables included in this study will
be in the region of US$16.5 billion in 2005, of which around US$5.5 billion
will lose patent protection in the USA by 2010. The proprietary
biopharmaceuticals that we believe are most likely to become available as
generics once the legal hurdles to registration have been overcome, currently
have combined sales in the region of US$25.4 billion.
Cancer
Cancer is a leading cause of morbidity and mortality in the developed world
and is increasing in the developing world. In Western Europe, 24.9% of all
deaths are attributed to cancer. In the Americas, around 18.4% of registered
deaths are due to cancer; in the USA the proportion is 22.8% (2002). In 2005,
around 1.4 million people in the USA will be diagnosed with cancer and 570,280
will die from the disease. Of these, 16.9% will be diagnosed with prostate
cancer, 15.5% with breast cancer, 12.6% with cancer of the bronchus and lung,
and 10.6% with colorectal cancer.
The available treatment options for cancer may vary according to the cancer
site, disease progression, age and health of the patient. Treatment may
include surgery, radiotherapy, chemotherapy and/or hormone therapy. Current
therapy regimes typically include a combination of off-patent and patented
drugs, a number of which are injectable.
Generic companies currently active in the anti-cancer injectables market
include American Pharmaceutical Partners (APP), Baxter Healthcare, Bedford
Laboratories, Eon Labs (Sandoz), Mayne Pharma, Pharmachemie (Teva),
Pliva-Lachema, Sicor (Teva), Spectrum Pharmaceuticals and SuperGen. A number
of the older reference drugs are no longer marketed by the originator
companies, although generics remain available.
Among the most recently available generics are carboplatin, paclitaxel and
leuprolide. Carboplatin became fully open to generic competition in the US in
October 2004, since when the FDA has approved 13 ANDAs.
Questions, Questions
Which company has the most comprehensive portfolio of FDA approved anti-cancer
injectables? What will the market value of docetaxel (Taxotere --
sanofi-aventis) be in 2010? In which country does Pliva market its generic
version of sanofi-aventis Eloxatin (oxaliplatin)? What effect will changes in
Medicare payments have on leuprolide sales over the next few years?
Cardiovascular Disorders
Thrombosis
Venous thrombosis is the third most common cardiovascular disorder in the US,
affecting almost two million people each year. Of these, around 60,000 will
develop a pulmonary embolism, which will prove fatal in 8-10% of cases.
Low molecular weight heparins (LMWH) are commonly used in the treatment of
deep vein thrombosis, pulmonary embolism and unstable coronary artery disease,
and the prevention of venous thrombo-embolism.
The most commonly prescribed LMWH in the US and major European markets is
sanofi-aventis Lovenox/Clexane (enoxaparin), with sales of over US$2.3 billion
in 2004, of which US$1.4 billion were in the US.
There have already been a number of ANDA applications for generic enoxaparin,
including from Amphastar and Teva in 2003, which have been the subject of
patent infringement litigation. More recently, Novopharm (Teva) and Momenta
Pharmaceuticals have submitted ANDAs for generic enoxaparin.
Between 2000 and 2004, the number of prescriptions dispensed for parenteral
anticoagulants in England increased from around 27,600 to 72,800. The majority
of these were LMWHs; around 64,600 prescriptions of LMWH were dispensed in
England in 2004 at a net ingredient cost (NIC) of around £6.5 million (US$12.0
million). During this period, enoxaparin has taken market share from other
LMWHs.
Global sales of enoxaparin in 2004 amounted to 1,904 million euros (US$2,368
million). Outstanding issues relating to patent protection may mean the
entrance of generic enoxaparin in the US is delayed until 2012.
Questions, Questions
What percentage of LMWH prescriptions in England were for enoxaparin in 2004?
Which company has a marketing agreement with Amphastar relating to its
proposed generic enoxaparin? What factors are likely to affect the future
market for enoxaparin?
Gastrointestinal
In any year, up to 40% of the adult population in the UK suffer from
dysfunction of the upper gastrointestinal tract. Of these, gastro-oesophageal
reflux disease (GORD) accounts for 15-20%, gastric and duodenal ulcers account
for 15-25% and stomach cancer for 2%. The remainder of causes are classified
as non-ulcer dyspepsia. According to the National Institute for Health and
Clinical Excellence (NICE), the most clinically and cost effective treatment
for severe GORD is offered by proton pump inhibitors (PPIs). In milder cases,
NICE guidance states that PPIs remain the most clinically effective treatment,
but may not be cost effective.
The world market for PPIs is around US$21 billion, of which the US accounts
for around 60%. Branded PPIs currently available in the US and Europe include
AstraZenecas Losec/Prilosec (omeprazole) and Nexium (esomeprazole), TAP
Pharmaceuticals Prevacid (lansoprazole), Wyeths Protonix (pantoprazole) and
Eisais Pariet/Aciphex (rabeprazole sodium). Of these, esomeprazole,
lansoprazole and pantoprazole are available in IV formulations.
The market for injectable PPIs is relatively small in comparison with oral
formulations. Injectable PPIs are used mainly in hospitals for patients who
are unable to take oral forms.
Also included in this section of the report is GSKs anti-emetic blockbuster,
Zofran (ondansetron), which was originally available only in injectable form
but has also been available in oral forms since 1999. A number of companies
have received tentative approval from the US FDA for generic ondansetron,
including the injectable form.
Questions, Questions
What is the annual growth rate of the US hospital market for PPIs? What
percentage of the US hospital market for acid suppressants is supplied by
injectable H2 agonists? Which companies have received tentative US FDA ANDA
approval for generic ondansetron injection? Which drug currently in trials may
influence the market for ondansetron from 2007?
Anti Infectives
Cephalosporins and other anti-infectives
The global anti-infectives market is valued at around US$30 billion. The
global cephalosporins market is worth around US$9.7 billion annually. While
the bulk of the market is oral cephalosporins, around 27% is sterile
(injectable) cephalosporins, equivalent to US$2.6 billion.
There are a number of generic injectable cephalosporins already on the market.
Between March 2000 and August 2005, there were 19 ANDA approvals for generic
injectable cephalosporin APIs and formulations: cefotaxime (five), cefazolin
(four), cefuroxime (two) and ceftriaxone (eight).
The most recent to come off patent in the US was Rocephine (ceftriaxone
sodium) in July 2005. Sales of Roches world leading injectable antibiotic
exceeded US$1 billion in 2003 and 2004. Lupin was first to achieve FDA ANDA
approval for its generic version of ceftriaxone, followed by Sandoz, Orchid
and Baxter.
The basic patent for Maxipime (cefepime hydrochloride) will expire in March
2007, although there are two other patents on this drug which run until
February 2008. Nonetheless, Orchid has already unveiled plans to launch
generic cefepime onto the US market.
In addition to cephalosporins, the report looks at other antibiotics,
piperacillin sodium, fluconazole and levofloxacin.
Questions, Questions What will the market value be for ceftriaxone
sodium (Roche, Rocephine) be in 2010? Why are prices of injectable fluconazole
unlikely to fall? What are the prospects for Indian manufacturers Lupin and
Orchid in the valuable US cephalosporin market? What issues may influence
generic manufacturers when cefepime hydrochloride (BMS, Maxipime) loses patent
protection in 2007?
Biopharmaceuticals Biological drugs account for 10-15% of the world
pharmaceutical market. In the USA, the biopharmaceuticals market is valued at
around US$30 billion. The biologicals sector is outperforming the
pharmaceutical industry as a whole, growing at double the pace in some cases.
Huge regulatory, scientific and legal problems surround the concept of
biogenerics. Research-based manufacturers continue to argue that it is
impossible to prove equivalence with a branded biologic drug. This is not a
widely held view outside the branded industry, but satisfying regulators in
Western markets remains a daunting prospect. Manufacturers estimated filing
dates have so far proved to be over-optimistic.
Company Information Generic substitution by health payers has continued
apace and, allied with a generally low commercialisation of new drugs, this
has spurred the market to double digit growth.
However, much of that growth has been in mainstream drugs with tablet/capsule
administration, and oversupply in some areas has led to low margins for
generic companies.
The injectable generic business is bucking this trend. Relatively few
companies produce injectables but a favourable cocktail of high prices, good
yields and new market opportunities is likely to make the sector more
attractive to a wider range of companies.
Companies analysed in this report:
- American Pharmaceutical Partners
- Amphastar
- Apotex
- Baxter Healthcare
- Bedford Laboratories
- Hospira
- Mayne Pharma
- Orchid
- Paddock Laboratories
- Sandoz
- Spectrum
- Pharmachemie (Teva)
- Sicor (Teva)
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