The global market for biosimilars reached $1.7 billion in 2010 and $2.5
billion in 2011. The market is expected to reach $3.6 billion by 2016, a
compound annual growth rate (CAGR) of 7.7%.
The market in the APAC region for biosimilars reached $605 million in 2010 and
$683 million in 2011. The market is expected to reach $1.1 billion by 2016, a
CAGR of 10.3%.
The market in the United States for biosimilars reached $507 million in 2010
and $1.1 billion in 2011. The market is expected to reach $1.3 billion by
2016, a CAGR of 4.1%.
Biosimilars are comparable versions of original biopharmaceuticals. Since
biologics are highly complex molecules, it is not possible to make identical
copies of them. Hence, these products are not technically biogenerics. The
differences of the biosimilar products from the reference biologic drug can be
attributed to various manufacturing details including differences in
expression systems, cell cultures, and many other bioprocessing conditions in
Since it is scientifically impossible to make identical copies of biologic
drugs, biologic drugs often enjoy an extended market exclusivity period.
However, the need to deal with rising healthcare costs has made it necessary
to develop regulatory guidelines to analyze and approve copies of biologic
drugs. The European Medicines Agency (EMA) has been the pioneer and the
leading regulatory agency to establish guidelines for the approval of
biosimilars. Several other regulatory agencies including the World Health
Organization (WHO) have followed the EMA guidelines to a great extent in
establishing their own guidelines.
The recent expiry of data protection or patents for the first group of
biopharmaceuticals has opened up the possibility of developing biological
products similar to these original products and to rely for licensing in part
on the extensive knowledge gained with the originator products. Although copy
versions of original biopharmaceuticals are already available in different
parts of the world, there are no consistent regulatory processes applied
worldwide for the market authorization of these products. The governments in
semi- and unregulated markets are slowly adopting regulatory policies for
improving the quality standards of these products. Unlike in the small
molecule generic drugs sector, the biosimilar market is expected to grow at a
relatively slow pace due to the safety concerns associated with them.
STUDY GOAL AND OBJECTIVES
Rising healthcare costs are driving the need for affordable yet effective
biologic drugs for the treatment of various therapeutic conditions. Even
though regulatory framework for the approval of biosimilars was in place in
Europe for over five years, the market penetration has been slow. The safety
concerns and the relatively lower cost advantages are the main restraints for
this sector in regulated markets. In semi- and unregulated markets, the
affordability is poor even for biologic drugs including biosimilars. However,
progress in the scientific understanding of biologic drugs and improvements in
the bioprocessing and analytical testing methodologies indicate high potential
for significant cost reduction in the development of biosimilars. This is
creating a situation that is challenging the market exclusivity being enjoyed
by biologic innovator brands even after losing their patent protection. Since
more blockbuster biologic drugs are losing patent protection, the interest in
the sector is increasing worldwide. Aspirant companies include even
multinational pharmaceutical and biotechnology companies as indicated by the
recent investment trends in the sector. Even multinationals in the
electronics industry are making strategic entry with huge investments. In
this context, it is interesting to analyze the market trends and future growth
This BCC report provides an in-depth look at the demand for biosimilar drugs
that have entered the market worldwide and forecasts the growth prospects for
these products. It also analyses the biosimilar pipeline worldwide and
includes their potential for getting approved and gaining significant market
shares during the forecast period. Important product classes are considered
separately while analyzing the market trends, and a bottoms-up approach is
adopted for estimating the market size. Semi- and unregulated markets are
also studied thoroughly and included in the report even though the products
developed and marketed in these markets are not considered comparable in
quality with the biosimilars marketed in regulated markets. Ignoring the
potential of these products while studying the market dynamics is a mistake
since key players in these markets are entering into tie-ups with partners
with experience in regulated markets. Moreover, years of market experience in
less regulated markets are likely to provide invaluable safety and efficacy
insights, which will be an added advantage for these products.
Since regulation is the main factor that is driving and restraining the
biosimilar market, regulatory framework in all the key markets is analyzed
thoroughly. This report also analyses the future regulatory trends in all the
key markets. Other aspects of the market analyzed in the report include
pricing trends, technology advancements and their effects in affordability of
biosimilars, key players in various regional markets and their capabilities,
and the rising investments and the financial environment of the sector.
INTENDED AUDIENCE OF THE STUDY
This study provides valuable perspective on the regulatory framework worldwide
that is playing a key role in shaping the biosimilar market. The scientific
improvements and their influence in shaping the market are also analyzed in
depth. Valuable insights on the investment trends and business models adopted
by different key players in various parts of the world are provided. Various
product classes that are getting attention from the biosimilar players and
their therapeutic areas are analyzed and their future market trends are
Business strategies adopted by different categories of industry players
including big pharmaceutical companies, biotech companies, start-up biotech
and technology platform companies have been analyzed. These detailed
analyses are targeted to help strategy developers and decision makers of
biotech and pharmaceutical companies as well as other stakeholders including
payers, venture capitalists, regulatory authorities, physicians and
pharmacies. This is especially suitable for legislators involved in
government policy development programs as well as law firms involved in IP
matters of the healthcare industry. Technology trend analysis gives an
overview of successful technologies, which is helpful for research managers in
charge of project identification and development.
MARKET DEFINITION, SCOPE AND FORMAT
The market definition is important to consider in this report. There are
several copies of biologic drugs sold for many years in semi- and unregulated
markets before the establishment of biosimilar guidelines by the European
Medicines Agency (EMA). The regulatory processes in these regions for the
approval of these products are considerably less stringent compared to that of
EMA. However, these companies are targeting regulated markets, and are
adopting various strategies to enter highly regulated markets such as Europe
and the U.S. Hence, the approach taken for this report is to include all the
products for which EMA has already published guidelines for market
authorization or for which guidelines are under development. The scope of
this report includes the product segments such as somatropin, erythropoietin,
Colony Stimulating Factors (CSFs), interferons, interleukins, insulin and
insulin analogues, follicle stimulating hormones (FSHs), monoclonal antibodies
(MAbs), and low molecular weight heparins (LMWH). It is often argued that
LMWH is not essentially a biosimilar product since it is derived from dead
tissues. However, considering the complexity of LMWH, EMA has developed
specific guidelines for LMWH; hence, this is included as one of the product
segment in this report. The global market size estimation includes the above
mentioned product segments.
Both EMA and World Health Organization (WHO) exclude vaccines from
consideration as biosimilars. The EMA guideline says: "Due to complexity and
the likelihood that they cannot be thoroughly characterized at the molecular
level, vaccines must be considered on a case-by-case basis." Besides
vaccines, plasma-derived products and their recombinant analogues are also
excluded from biosimilar guidelines by EMA due to their complex and variable
physicochemical, biological and functional characteristics. Therefore,
vaccines and blood products are not included as product segments in this
report. Other biologic drug segments excluded in the market estimation of
this report include streptokinase, hyaluronidase, etc., since biosimilar
guidelines neither exist at present nor under development by EMA.
This report contains:
- An overview of biosimilar product classes in various regions worldwide.
- Biosimilar products approved by EMA.
- A look at the biosimilar pipeline worldwide.
- Detailed analysis of the emerging regulatory framework in regulated
- Comparison of biosimilar guidelines in Europe, the U.S., Japan, Canada,
and the guidelines developed by WHO.
- Detailed analysis of the market and key players in Europe and
country-by-country analysis of key markets in Europe and the market forecasts
for the region for various product classes
- Detailed analysis of U.S. market regulation, key players and emerging
- Detailed analysis of the APAC market with analysis of key national markets
(including Australia, Singapore, Korea, India, China and Japan), local
players, investment trends and regulatory developments.
- Detailed analysis of the rest of world (ROW) market size, trends, country
analysis of promising markets (including Brazil, Russia, and Canada), regional
players, and emerging regulatory and market trends.
- Technology trends and patent analysis.
- Profiles of over 70 key players.
- Global and regional sales projections through 2016 for various product
classes and regions.
INFORMATION SOURCES AND METHODOLOGY
Both primary and secondary research methodologies were used in preparing this
study. The base year is 2011. The market size reflects the global revenues
of drugs within the product classes recognized as biosimilars by EMA.
Advanced pipeline products with high chances of entering the market during the
forecast period are considered for market forecasts. The sales represent
total revenues, which include the sales of these products in the respective
Market figures are based on revenues at the manufacturer level and are
projected at 2011 dollar values (i.e., inflation is not computed into the
projection figures). Forecasts are based on the projections of the
marketers, regulatory trends, patent expiry of innovator brands, strategies of
innovator companies, concerns of various stakeholders including physicians and
patients in each region, competitiveness of the market in terms of numbers of
biosimilar products in each category, and marketing strategies of key players.
The information and data to prepare this study were derived from regulatory
agencies, trade literature, patient support groups, annual reports of
companies and industry-related databases. The analysis presented is based on
an extensive survey of the biopharmaceutical industry as well as a detailed
examination of published literature and reports obtained from regulatory
authorities, medical research institutions, and national and world health
organizations. Key information from the literature was used to obtain expert
opinion and insights on commercial potential and market sizes from industry
professionals, academic researchers and government agency spokespersons.
Syamala Ariyanchira is actively involved in technology assessment, strategic
planning, competitor analysis, due diligence, and market analysis. She
combines her technical background with current business sector issues with
ease. Her clients include investment firms, government agencies, and chemical
and pharmaceutical companies. She holds a Ph.D. from Indian Institute of
Science, Bangalore, India, and has over sixteen years of experience in the