Biosimilars Market, 2018-2026 - Industry Applications,Market Share, Segmentation, Company Share: Coherent Market Insights
Biosimilars
are biopharmaceutical drug having active components, which are
similar to one that has previously been licensed. They are identical
copies of the original products and can be manufactured only when the
patent for the original innovator product expires. Biologics or
biosimilars are sensitive to changes in manufacturing process due to
the higher molecular complexity.
Biosimilars are
generally derived from living cells of plants, animals, yeast,
bacteria and viruses, through genetic engineering processes including
controlled gene expression and recombinant DNA technology. In 2010,
the Food and Drug Administration (FDA) approved biosimilars as a part
of Patient Protection and Affordable Care Act. The approval process
is based on thorough demonstration of similarity and comparability
with existing approved product.
Patent expiry of
drugs and increasing government initiatives for biosimilars to drive
growth of the biosimilars market
Increasing demand
for cost-effective drugs, increasing number of geriatric population,
high healthcare expenditure, increasing government support and
initiatives to develop and promote biosimilars, strategic
collaborations to enhance productivity and clinical trial for
development of biosimilars are major factors driving growth of the
market. According to the American Health and Drug Benefits in 2013,
an estimated sale of biosimilars was more than US$ 1 billion
annually. For instance, global sales of biosimilars was projected to
reach US$ 7.19 billion for Remicade (infliximab) and US$ 5.98 billion
for Avastin (bevacizumab), owing to high adoption of biosimilar drugs
by doctors and patients. Furthermore, expiry and termination of
pharmaceuticals drugs such as Humira, Enbrel and Remicade is
providing significant opportunity for new players to enter the
market.
Biosimilars
Market Taxonomy
The global
biosimilars market is segmented on the basis of product type,
manufacturing type, application, end user, and geography.
On the basis of
product type, the global biosimilars market is segmented into:
Monoclonal
Antibodies
Recombinant
Hormones
Anti-Inflammatory Agents
Recombinant
Growth Stimulators
Immunomodulators
On the basis of
by manufacturing type, the global biosimilars market is segmented
into:
In-house
Manufacturing
Contract
Manufacturing Organizations
On the basis of
application, the global biosimilars market is segmented into:
Chronic &
Autoimmune Diseases
Oncology
Blood Disorders
Growth Hormone
Deficiency Diseases
Infectious
Diseases
Others
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Availability of
biosimilar drugs at cost effective rate is expected to boost growth
of biosimilars market in Asia Pacific
Regional
segmentation of the biosimilars market by Coherent Market Insights
comprises North America, Europe, Asia Pacific, Latin America, Middle
East, and Africa. The first biosimilar, Sandoz’s Zarxio was
approved by FDA in 2015 for sale in North America. According to the
American Society of Health-System Pharmacists survey in 2013, around
99% of 214 surveyed pharmacy directors reported shortage of at least
one oncologic drug with distribution of biosimilars. Also,
biosimilars market in North America region is expected to gain
significant traction, owing to increasing prevalence of cancer,
autoimmune diseases, kidney failures, and growth hormone deficiency.
Biosimilar drugs provide cost effective treatment options for various
diseases such as diabetes, rheumatoid arthritis and cancer, thus
providing opportunities for growth of market in China and India.
Furthermore, biosimilars market in Asia Pacific region is expected to
witness higher growth, availability of cost effective biosimilars,
high adoption rate, and consistent guidelines issued by regulatory
bodies.
Key players
operating in the biosimilars market include Sandoz International
GmbH, Apotex, Biocon, Zydus Cadila Healthcare, Celltrion, Pfizer,
Hexal, Accord Healthcare, Harvest Moon Pharmaceuticals, Eli Lilly,
and Teva Pharmaceuticals. Leading manufacturers are focusing on
outsourcing the production of biosimilar drugs with strategic
collaborations to replace existing drugs. For instance, in August
2016, the FDA approved Sandoz for the biosimilar Erelzi for treatment
of multiple inflammatory diseases such as rheumatoid arthritis,
plaque psoriasis, ankylosing spondylitis and juvenile idiopathic
arthritis.
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