Market Scope
Market Research Future (MRFR) expects the biosimilars
market to thrive at a rate of 7.5% from 2020 to 2027 (analysis period).
Major Drivers and Impediments
Overall healthcare costs are rising owing
to the high-priced pharmaceutical drugs, particularly biologics. Government
bodies worldwide are concentrating on lower-priced drug synthesis. The United
States spends the most on healthcare and is therefore, working on cutting down
on the same. Likewise, price regulations in India and Japan for reducing the health
budget have bolstered the demand for cost containment. This scenario has thrown
light on the requirement for new affordable and effective therapeutics, which
can be favorable for the biosimilars industry in subsequent years.
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Popular biological drugs are edging towards
patent cliff and this can mean substantial profits for the global market. Cost
effectiveness of biosimilars, especially compared to the patented biologics and
successful outcomes during clinical trials should also benefit the global
market. The expanding pharmaceutical sector focused on developing biosimilar
drugs can be another key growth booster in the near future.
Market
Segmentation
Biosimilars industry can be considered with
respect to product, applications, and end users.
The products based on which the market has
been split into are recombinant glycosylated proteins, recombinant peptides,
and recombinant non-glycosylated proteins. Recombinant non-glycosylated
proteins are the biggest segment in the global market, thanks to the soaring
cases of chronic disorders ranging from growth hormone deficiency to diabetes. As
a result, recombinant non-glycosylated proteins are therapeutically used as
they are readily available and are cost-effective.
Application-wise, the biosimilars market caters
to chronic diseases, oncology, blood disorders, autoimmune diseases, infectious
diseases, growth hormone deficiency, and more. Blood disorders have emerged as
the top segment, as a result of the rising burden of the condition worldwide
and the increased use of biosimilars by virtue of their low cost and the
overall reduction in the treatment cost.
Major end users
in the global market are hospitals and clinics as well as research institutes.
Hospital and clinics are healthcare settings where treatment options and
skilled professionals are easily available, and therefore, have emerged as the
leading segment in the global industry.
Regional Status
Europe, MEA or Middle East & Africa
along with the Americas, APAC or Asia Pacific are the primary markets for
biosimilars.
Europe has taken the lead in the global
market, as the region houses a vast elderly pool, with close to one fifth of
the overall EU population aged more than 65 years. This has given way to
several lifestyle-related disorders such as oncology, autoimmune diseases, diabetes,
to name a few. Presumably, the scenario has raised the demand for biosimilars
and can mean higher market growth over the next few years. In addition to this,
numerous blockbuster biologics are on track to lose patent in the coming years,
which should present lucrative opportunities to the biosimilar manufacturers.
The North American market displays a bright
outlook and can emerge quite lucrative in the coming years, in view of the surging
burden of chronic ailments in Canada and the United States. The rising spending
on research activities by the healthcare agencies also fuels the market
expansion in the region. Favorable reimbursement landscape in the region,
especially in the US, encourages healthy competition as it results in lower incentives
for the players to compete based on price.
The APAC market is slated to witness considerable
growth, with China, South Korea and India offering a host of lucrative
opportunities for drug development as well as commercialization. These are generics-driven
countries and are known for frequently launching new and advanced manufacturing
platforms, which has brought down the costs associated with biosimilar
production. In the coming few years, majority of the patent expiries is touted
to be in biosimilars, which is deemed as a profitable aspect by leading
manufacturers and can translate into substantial market growth.
Eminent Vendors
Top manufacturers of biosimilars in the
global industry include Stada Arzneimittel AG (Germany), Teva Pharmaceuticals
(Israel), Biocon (India), Pfizer (US), Sandoz International (Germany), Eli Lily
& Company (US), Actavis, Inc. (US), Dr. Reddy’s Laboratories (India), Cipla
Ltd (India), Amgen, Inc. (US), Samsung Biologics (South Korea), Hospira
Inc.(US), Mylan, Inc.(US), Celltrion (South Korea), to mention a few.
Latest Developments
March 2021
European Medicines Agency has given the
green light to Kixelle, a biosimilar developed by Biocon Biologics Ltd., touted
to be the fourth ever biosimilar insulin and the second fast-acting insulin
analogue biosimilar to be introduced in the EU. Kixelle is a fast-acting biosimilar
insulin analog that helps treat diabetes mellitus in adolescents, children and adults.
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