The report
“Biosimilars Market Product [Recombinant
Non-Glycosylated Proteins (Insulin, Filgrastim, Somatropin), Glycosylated (Monoclonal
Antibodies, Erythropoietin), Peptides (Glucagon, Calcitonin)] & Application
(Oncology, Blood Disorders) – Global Forecast to 2018” by MarketsandMarkets is now
available at RnRMarketResearch.com. Contact sales@rnrmarketresearch.com with report name in subject line
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The global
is estimated to reach $2.0 billion by 2018 at a CAGR of more than 20% between
2013 and 2018.
The
biosimilar products market is segmented into recombinant non-glycosylated
proteins, recombinant glycosylated proteins, and recombinant peptides. The
recombinant non-glycosylated proteins market is further segmented as insulin,
granulocyte colony-stimulating factor (G-CSF), interferons, and human growth
hormone; whereas the recombinant glycosylated proteins market is further broken
down into erythropoietin, monoclonal antibodies, and follitropin. Calcitonin
and glucagon are considered in the recombinant peptides market. The recombinant
glycosylated proteins segment is expected to witness the highest growth due to
the increased demand for monoclonal antibodies in the treatment for cancer
(oncology), autoimmune disorders, blood disorders, and infectious diseases.
Oncology will be the fastest-growing segment and currently accounts for a 25%
market share in the global market in 2013. Following monoclonal antibodies,
biosimilars of insulin will be the fastest-growing products and are estimated
to grow at aCAGR of 35.6% from 2013 to 2018. The growth is attributed to the
rise in incidences of diabetes; ongoing patent expirations of biologic drugs
such as Lantus, Humalog, and Novorapid; and the cost effectiveness of the
biosimilars of insulin.
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Other notable driving factors for the global market include increasing
number of off-patented drugs, positive outcome in the ongoing clinical trials,
and rising demand for biosimilars in different therapeutic applications such as
rheumatoid arthritis and blood disorders.
Market dynamics analysis has identified that rising budgetary pressures
to reduce healthcare expenditures, increasing aging population, growing demand
for cost-effective alternatives, rising incidences of various diseases, and
conducive government initiatives are significant factors propelling the market
in the forecast period (2013 to 2018). On the other hand, stringent regulatory
environment, high manufacturing complexities and costs, and high-entry barriers
are considered to hinder the market growth.Additionally, the different
terminology and guidelines for biosimilars across regions will further burden
the biosimilars industry. Generic versions of biologic drugs approved under the
European Medical Agency (EMA) regulatory pathway and section 351K of the U.S.
FDA are considered as biosimilars. In the U.S., biosimilars are also known as
follow-on-proteins and have been approved under section 501(b), whereas in
Canada, biosimilars are called Substituent Entry Biologics (SEB).
Geographic analysis reveals that Europe is the largest contributor to
the global market. Asia-Pacific (China, India, and South Korea), North America
(U.S.), and Latin America (Brazil) are poised to grow at high double-digit
rates.
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The global market is highly consolidated with the top three players,
namely, Sandoz (Germany), Hospira (U.S.), and Teva (Israel) accounting for
approximately 90% of the market share. Other notable players in the market
include Dr. Reddy’s Laboratories (India), Biocon Ltd. (India), Mylan (U.S.),
Biopartners (Switzerland), Amgen (U.S.), and IntasBiopharmaceutical Ltd.
(India).
From an insight perspective, this research report focuses on the
qualitative data, market size, share, and growth of various segments and
sub-segments, competitive landscape, and company profiles. The qualitative data
covers various levels of industry analysis, such asmarket dynamics (drivers,
restraints, opportunities, and threats),value chain, biosimilar pipeline
analysis, porter’s five forces analysis, regulations, and reimbursement
challenges across geographies. The report also offers market shares, sizes, and
related growth of various segments of the industry. It also focuses on the
emerging and high-growth segments of biosimilars (monoclonal antibodies and
insulin), high-growth regions, countries, and the initiatives of their
respective governments.
The grey area, while estimating the market size, is the different
terminologies of biosimilars as well as different regulatory environments in
different regions. The different terminologies considered for this study are
Follow-on Proteins (U.S. and Japan), Subsequent Entry Biologics (Canada),
Biosimilars (Europe and Australia), and Similar Biologics (Asia excluding
Japan). North America and Europe have a stringent regulatory environment,
whereas in comparison, Asia and RoW have a less stringent regulatory
environment for approving biosimilars in the market.
The competitive landscape covers the growth strategies adopted by the
industry players in the last three years. The company profiles comprise of the
basic views on the key players in the biosimilars market and the product
portfolios, developments, and strategies adopted to maintain and increase their
market shares in the near future. The above-mentioned market research data,
current market size, and forecast of future trends will help the key players
and new entrants to make the necessary decisions regarding product offerings,
geographic focus, change in strategic approach, R&D investments for
innovations in products and technologies, and levels of output in order to
remain successful.
Scope of
the Report
The study covers the revenue market of recombinant glycosylated
proteins, recombinant non-glycosylated proteins, and recombinant peptides—the
three major drug classes of the market. The sales revenue of each biosimilar
drug was considered to estimate the global market. The market revenue for each
therapeutic area was calculated based on the type of drugs used to treat a
particular disease. The market share of the key players involved in
manufacturing and commercializing biosimilar products was considered to
estimate the market.
In North America, follow-on biologic products that were approved under
section 501(b) of the regulatory pathway are considered while estimating the
market size, while in Asia-Pacific, similar biologic products are considered to
estimate the market size.
The sales revenue of both biogenerics and biobetters are not in the
scope of this report. Biogenerics are the generic versions of biologic drugs
that might not be the exact copy of biologics but a few variations are
prevalent in these drugs with regards to efficiency, safety, and potency.
Biobetters, on the other hand, are improvised versions of biologic drugs and
are not similar or identical to biologic drugs in terms of efficacy, safety,
and quality.
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