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 the process.
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.
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 potentials.
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.
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 forecast.
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.
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:
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 markets.
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 industry.
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