INTRODUCTION Characterised by increased utility in chronic diseases and capital intensive manufacturing, the global biopharmaceutical market is expanding robustly. As the demand for biologics is increasing continuously, manufacturers are on the lookout for novel strategies that will help them attain maximum returns on investment.Derived from biological elements, biologic medications have transformed the treatment paradigm of life threatening, debilitating diseases. However, such drugs come at staggering prices in the market. Hence, cheaper biological products have become an economic and healthcare requisite.
Amongst the impending patent cliffs, shrinking drug pipelines and increasing pressure to reduce treatment costs, biosimilars are poised to capture an unprecedented position in the biopharmaceutical industry. Supported by numerous factors including the recent progression in the regulatory landscape, the biosimilars market is witnessing an increased extent of adoption and heightened investment and deal making activity.
Biosimilars have currently attained a small portion of their anticipated future potential. The real commercial prospects lie in the two leading innovator biologics markets, the US and Europe, which account for a major proportion of the global spending on biologics. Europe, with the introduction of regulatory guidance in 2005 and the first biosimilar authorisation in 2006, is well ahead of the US. Till date, there are 16 marketed biosimilar products in Europe. However, in the recent years, the US has witnessed tremendous progression in terms of the advances in the regulatory landscape.
The involvement of generic manufacturers and R&D based pharmaceutical and biotechnology companies has led to the emergence of a diversified competitive marketplace. Realizing the huge commercial prospects, several innovator biotech companies are actively engaged in the development of biosimilars. In addition, this segment has become lucrative for other companies such as Fujifilm and Samsung. The contribution by such players does ensure a fresh inflow of money to fund development programs.
Overall, with the learning curve for biosimilars still evolving, the market offers huge growth opportunities along with demanding requirements in terms of clinical development, manufacturing and marketing authorisation. Driven by an extensive pipeline, contribution of numerous pharmaceutical players and the huge market opportunity likely to unfold in the US and EU, the biosimilars industry is poised to witness an unrivalled market uptake.
SCOPE OF THE REPORT The ‘Global Biosimilars Market, 2015 - 2025’ report provides an extensive study of the rapidly growing biosimilars market. With the blockbuster biologics losing patent protection and biotechnology industry striving to minimize costs, biosimilars are being viewed as viable substitutes to the highly expensive biological medications. The study presents an in-depth review of the developments in established markets and emerging regions, with respect to the market landscape, global and local players, regulatory scenario and emerging opportunities. It provides a detailed analysis of the worldwide pipeline of biosimilars on key parameters such as product categories, indications, biosimilar targets and status of development.
The study presents a comprehensive view of key product classes into which biosimilars can be categorized; these include monoclonal antibodies (mAbs), insulin, interferons, G-CSF/ GM-CSF, erythropoietins and others. We have highlighted some of the important aspects specific to these product categories including regulatory guidelines, development challenges, marketed / pipeline biosimilars, sales data (where available) and information on patent expiry of the reference products.
The report assesses some of the key drivers that have governed the evolution of biosimilars market over the past several years along with an elaborate discussion on the future trends that will shape the market in the coming years. One of the focus areas of this study is to estimate size of the future opportunity in the biosimilars market over the next decade, segmented on the basis of geographical clusters and product categories.
The study also provides information on some of the most recent activities in this market; amongst others, these include growing collaborations, investment activity and technological advancements. In addition to some of the well-known benefits and a promising outlook, the study also highlights considerable challenges currently prevalent in the market. Examples of such challenges include manufacturing complexities, heterogeneous regulatory framework, and associated safety and efficacy issues. Nevertheless, these challenges are paving the way for new strategies and technological improvements, which will indeed be advantageous in the long run.
The report provides market forecasts for the time period 2020 and 2025. The research, analysis and insights presented in this report is backed by a deep understanding of key insights gathered both from secondary and primary research.
RESEARCH METHODOLOGY Most of the data presented in this report has been gathered by secondary research. We have also conducted interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will shape up across different regions and drug segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include - Annual reports - Investor presentations - SEC filings - Industry databases - News releases from company websites - Government policy documents - Other analysts’ opinion reports
While the focus has been on forecasting the market over the coming nine years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
CHAPTER OUTLINES Chapter 2 provides an executive summary of the insights captured in our research. The summary offers a high level view on where the biosimilars market is headed in the mid-long term.
Chapter 3 provides a general overview on biosimilars, along with their comparison with generic and innovator products. We have also explained the manufacturing and marketing specifications of biosimilars along with information on other aspects such as naming and prescription. The chapter also presents a discussion around the time and cost of biosimilars, clinical trial designs and highlights quality considerations and safety and immunogenicity concerns.
Chapter 4 discusses the trends, regulatory landscape, historical evolution, current market scenario and key players in the three developed markets of the US, Europe and Japan.
Chapter 5 focuses on the evolution of biosimilars in the emerging markets providing information on regulatory framework, current landscape and leading players. The emerging regions we have considered in our analysis include China, India, Brazil, Korea, Mexico and Argentina.
Chapter 6 provides a detailed analysis of the worldwide pipeline of biosimilars. An in-depth review including distribution of the biosimilar products by product category, indication, biosimilar targets, status of development, geography and developers has been covered.
Chapter 7 highlights the key growth drivers and restraints to the biosimilars market. Some of the primary market drivers include growing healthcare expenses and impending patent expiries of the blockbuster biologic drugs.
Chapter 8 focuses on mAb biosimilars with respect to the regulatory developments, challenges and profiles of key target reference products and their biosimilar portfolio. Each profile provides an overview on the drug, background and history of development, indications and dosage forms, sales data, patent status and list of marketed and clinical/preclinical development pipeline of biosimilars.
Chapter 9 provides information on insulin biosimilars in terms of target patient population, global insulin market, regulatory guidelines and profiles of key target reference products and their biosimilar portfolio.
Chapter 10 provides details on interferon biosimilars covering the challenges, regulatory guidelines and profiles of key target reference products and their biosimilar portfolio.
Chapter 11 covers the other important biosimilar product classes; these include G-CSF/GM-CSF, erythropoietins and somatropins, providing information on key target reference products and their biosimilar portfolio.
Chapter 12 analyses recent developments in the biosimilars field. It contains information about partnerships that have taken place in the past few years and a section on the investment activities and technological trends which have recently shaped the market.
Chapter 13 focuses on outsourcing of biosimilars, a major growth opportunity for contract manufacturers. The chapter provides an overview of CMOs which are actively engaged in the biosimilars market and the upcoming opportunities which are likely to generate significant interest in the wider contract manufacturing market.
Chapter 14 presents the detailed forecast for the biosimilars market for the time period 2020 and 2025, segmented by geographic clusters and product categories.
Chapter 15 summarises the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.
Chapter 16 is a collection of transcripts of interviews conducted during the course of this study.
Chapter 17 is an appendix which provides tabulated data and numbers for all the figures provided in the report.
Chapter 18 is an appendix which provides a list of companies and organisations mentioned in the report.
EXAMPLE HIGHLIGHTS 1. The market is driven by the presence of a growing pipeline; during our research, we identified over 600 biosimilar products across various product categories covering mAbs, insulin, interferons amongst others. 2. Specifically, mAb biosimilars being developed for multiple diseases form a sizeable proportion of the preclinical/clinical development pipeline. In our pipeline, we reviewed around 200 mAb biosimilars. Neupogen, Enbrel and Humira, owing to their staggering revenues, are examples of some of the most popular target reference products. 3. The emerging pharmaceutical markets of Asia, Latin America and Eastern Europe, with benefits such as lower labour costs, access to regional / domestic markets and, most importantly, relaxed regulatory requirements serve as attractive destinations for biosimilars research and commercialisation. This geographical cluster currently dominates the market with respect to the number of approved products. 4. In order to exploit the advantages of combined resources and use licensed assets, stakeholders have announced numerous collaborations in the recent past. During our research, we identified around 70 partnerships which have taken place in the biosimilar market over the last few years. 5. Looking at the ongoing focus, the market is well positioned to achieve a robust growth in the coming decade as the number of patent expiries grows and the legal and regulatory squabbles are sorted out; based on a very comprehensive analysis, we have projected the market to be worth USD 32 billion worldwide by 2025. 6. Although emerging markets have been on a fast track in the recent past, the desired market uptake in the US and Europe will drive the market to attain its peak potential.
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