Active Pharmaceutical Ingredients
Global Market - Forecast To 2020
The global active
pharmaceutical ingredient market is expected to reach approximately $175
billion by 2020, growing at a CAGR of around 6% during forecast period. Active
pharmaceutical ingredient is any substance or mixture of substances used in a
finished pharmaceutical product with pharmacological activity used for
diagnosis, cure, mitigation, treatment and prevention of diseases. Very less
number of finished pharmaceutical product manufacturers has their own API
manufacturing unit and nobody can make all required APIs in-house. It is
basically not easy for API manufacturers in developing countries to ensure a
product with quality at a reasonable price. API manufacturing involves
conversion of raw materials into API and mixing API and excipients for final
formulations. These formulations in the form of tablets, capsules or solutions are
packaged and then marketed.
Patent expiration of major
drugs that increased generic drug sales, government initiatives, increasing
aged population and regional penetration, local manufacturer expansion and high
uptake of biologics are some of the factors that are driving the market growth.
Whereas financial crisis, stringent regulatory policies, less investment in
pharmaceutical industry and fragmented market are the factors that are
hindering API market growth.
The global API market is
segmented based on synthesis, customer base, business type and therapeutic
applications. Depending on synthesis the market is classified into synthetic
chemical API, biotech API and HPAPI (Highly Potent Active Pharmaceutical
Ingredient). Biotech API is further segmented into mammalian cell culture,
monoclonal antibodies, recombinant proteins, vaccines, insulin analog, growth
hormones and interferons. Mammalian cell culture accounted for the largest share
in 2013, while monoclonal antibody segment is the fastest growing segment by
2020. Despite low production yields, high manufacturing cost and highly
unstable cell culturing method mammalian culture is the largest due to
post-translational mechanism present in living cells. Monoclonal antibodies are
growing at a faster pace due to demand for biotech APIs and increasing venture
capital investments that drives the market.
By-customer base the API
market is segmented into synthetic chemicals API, biotech API and HPAPI.
Synthetic chemical API is further classified into branded/innovative and
generic/non-branded API. Branded API accounted for the largest share whereas,
generic is the fastest growing segment. Biotech API is further divided into
biologics and biosimilars where biologics accounted for the largest share.
Depending on business type
the API market is segmented into captive and merchant. Captive market accounted
for the largest revenue in 2013. Based on the therapeutic applications the
global API market is categorized into eleven crucial application areas such as
anti-infectives, oncology, cardiovascular and hematopoietic system, central
nervous system, gastrointestinal disorder, respiratory system, hormonal-related
disorder, metabolic disorder, genito-urinary disorder, musculo-skeletal
disorder and others. Anti-infectives segment dominated the application market
with a largest in 2013 whereas oncology segment is the fastest growing segment
with a CAGR of approximately 8% by 2020. Patent expiration of major drugs,
increased incidence of various cancer diseases and aged population, high
government investments for cancer research and healthcare awareness are the
factors that drives the market whereas stringent regulations, failure of
crucial drugs in last stage of clinical trial, and economical crisis are the
factors that hampers the market growth.
Geographically API market
is segmented into North America, Asia-Pacific, Europe and Rest of the world
regions. North America dominated the global API market during the forecast
period. Asia Pacific region is the fastest growing with a CAGR of more than
7.5% by 2020 due to patent expirations of drugs, low operation costs, services
of Contract Manufacturing Organizations (CMO) and high investments in medical
research. Moreover the high cost of skilled labor and energy are the major
factors that forced European market to shift their base to countries such as
India and China.
Major players in the API
market include Teva Active Pharmaceutical Industries Limited (Israel), Ranbaxy
Laboratories (India), Dr. Reddy's Lab (India), Boehringer Ingelheim GmbH
(Germany), Lonza group (Switzerland), Lupin (India), Novartis (Switzerland),
Aurobindo pharma (India), and Albemarle Corporation (U.S.).
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