The
generic
sterile injectable are FDA approved biologics that are used
for the treatment of many diseases and disorders in the vast arena of
the healthcare industry. The generic sterile injectable are very
inexpensive as compared to that of their branded counterparts of
these drugs and performs equally well. Thus, these Injectables are
heavily in demand all the time and are used in majority of hospitals
and clinics across the globe. However, due to the stringent FDA
regulations for the production of these injectable, the rigorous
demand satisfaction of these injectable has always been a constant
challenge for the key players in the global generic sterile
injectable market.
Market
Dynamics
The
growing incidence and prevalence of chronic as well as infectious
diseases and musculoskeletal disorders is a key factor fueling growth
of the global generic sterile injectable market. About 53% of the
disease burden is contributed by non- communicable diseases in India
according to the National Health System Resource Centre (NHSRC) in
2016, which accounts up to 37 million deaths in India annually. As
per the Chronic Disease Prevention and Health Promotion by the
Centers for Disease Control and prevention (CDC), 117 million people
in the U.S., suffered from one or more chronic diseases and two of
these chronic diseases, heart diseases and cancer jointly accounted
nearly 48% of all the deaths. Apart from prevalence of chronic
diseases, several other factors that are responsible to fuel the
growth of generic sterile injectable market includes rise in
prevalence of infectious diseases such as malaria and tuberculosis
and its cost effective treatments in emerging economies as well as
the musculoskeletal disorders such as osteoarthritis, rheumatoid
arthritis and osteoporosis are also responsible for accelerating
demand for generic sterile injectable. Product portfolio expansion
and development of new products that can be used in the treatment of
these diseases, are some of the other factors augmenting growth of
the global generic sterile injectable market. However, the complex
regulatory guidelines by FDA for production procedures and stringent
regulations for ANDA filings are impeding growth of the global
generic sterile injectable market.
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Rapid
increase in the prevalence of chronic diseases globally drives the
global generic sterile injectable market
The
growing prevalence of chronic diseases and rapidly increasing ageing
population that are highly susceptible to chronic diseases are the
important factors effecting positively showing significant growth in
generic sterile injectable market in North America. Growing number of
chronic disorders such as cancer and diabetes as well as the
consequent rise in demand for newer generic injectable across various
countries in Europe would further fuel growth of the market in the
region. However, stringent regulations by U.S. FDA such as,
monitoring of the flexible intravenous (IV) solution bags from
exposure to rough surfaces during labelling and packaging for any
microscopic punctures or holes on the surface of the bag in order to
avoid the microscopic defects that may lead to microbial
contamination.
Key
players indulged in strategic implementation of various policies for
the product portfolio expansion of the generic sterile injectable
•
In 2016, Baxter acquired Claris’ Injectables, a 15 years old global
generic injectable pharmaceutical company for the production of
injectable medicines such as anesthesia and analgesics,
anti-infective, renal, and critical care medications
•
Baxter has also recently signed an agreement with Dorizoe, an India
based life sciences company manufacturing generic sterile injectable.
The duo is expected to develop more than 20 generic injectable
products including oncolytic and cardiovascular medicines.
•
According to FiercePharma, Fresenius Kabi is expected to show a
revenue booster in the forecast years due to a major investment of
US$ 250 million to turn a U.S. site for expanding the capabilities of
the production of generic injectable and sterile injectable.
•
Pfizer marked its leading share in the generic sterile injectable
market through its collaboration with Hospira in 2015.
Other
landmark acquisitions for the boost of generic sterile injectable
market consists Hikma acquiring the assets of the Bedford
Laboratories and Sun Pharma’s acquisition of Pharmalucence in 2014
that resulted in benchmarking sales of generic sterile injectable.
Market
Taxonomy
This
report segments the global generic sterile injectable market on the
basis of drug type, therapeutic application, distribution channel,
and geography. On the basis of drug type, the generic sterile
injectable market is segmented into Monoclonal antibodies, cytokines,
insulin, peptide hormones, vaccines, immunoglobulins, blood factors,
peptide antibiotics and others. On the basis of therapeutic
application, the generic sterile injectable market is segmented into
cancer, diabetes, cardiovascular diseases, central nervous system,
infectious disorders, musculoskeletal and others. On the basis of
end-user, the generic sterile injectable market is segmented into
hospital, drug stores, pharmacies and online pharmacies. For
comprehensive understanding of market dynamics, the global generic
sterile injectable market is analyzed across key geographical regions
namely North America, Europe, Asia Pacific, Latin America, Africa,
and Middle East. Each of these regions is analyzed on basis of market
findings across major countries in these regions for a macro-level
understanding of the market.
Detailed
Segmentation:
Global
Generic Sterile Injectable Market, By Drug Type:
•
Monoclonal Antibodies
•
Cytokines
•
Insulin
•
Peptide Hormones
•
Vaccines
•
Immunoglobulins
•
Blood Factors
•
Peptide Antibiotics
•
Others
Global
Generic Sterile Injectable Market, By Therapeutic Application:
•
Cancer
•
Diabetes
•
Cardiovascular Diseases
•
Central Nervous System
•
Infectious Disorders
•
Musculoskeletal
•
Others
Global
Generic Sterile Injectable Market, By Distribution Channel:
•
Hospitals
•
Drug Stores
•
Pharmacies
•
Online Pharmacies
Global
Generic Sterile Injectable Market, By Geography:
•
North America
•
Europe
•
Asia-Pacific
•
Latin America
•
Middle East
•
Africa
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