TABLE OF CONTENTS 1. INTRODUCTION 1.1 STUDY DELIVERABLES 1.2 MARKET DEFINITION 1.3 STUDY ASSUMPTIONS 2. RESEARCH METHODOLOGY 2.

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2 TABLE OF CONTENTS 1. INTRODUCTION 1.1 STUDY DELIVERABLES 1.2 MARKET DEFINITION 1.3 STUDY ASSUMPTIONS 2. RESEARCH METHODOLOGY 2.1 INTRODUCTION 2.2 METHOD OF ANALYSIS 2.3 STUDY PHASES 2.4 SECONDARY RESEARCH 2.5 DISCUSSION GUIDE 2.6 ECONOMETRIC MODELLING 2.7 EXPERT VALIDATION 2.8 STUDY TIMELINE 3. EXECUTIVE SUMMARY 4. KEY INFERENCES 5. MARKET OVERVIEW AND INDUSTRY TRENDS 5.1 CURRENT MARKET SCENARIO 5.2 THE UNANSWERED KEY QUESTIONS 5.3 PORTER'S FIVE FORCES ANALYSIS BARGAINING POWER OF SUPPLIERS BARGAINING POWER OF CONSUMERS THREAT OF NEW ENTRANT THREAT OF SUBSTITUTE PRODUCTS AND SERVICES COMPETITIVE RIVALRY WITHIN THE INDUSTRY

3 6. DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES ANALYSIS 6.1 MARKET DRIVERS SEVERAL BLOCKBUSTER BIOPHARMACEUTICALS GOING OFF-PATENT IN THE NEXT 5-10 YEARS PROMOTION OF BIOSIMILARS BY EASE IN GOVERNMENT POLICIES MARKET STILL IN THE EARLY STAGE, WITH HIGH GROWTH POTENTIAL INCREASING DEMAND FOR BIOSIMILAR DRUGS DUE TO THEIR COST- EFFECTIVENESS 6.2 MARKET RESTRAINTS CONCERNS REGARDING SUBSTITUTABILITY AND INTERCHANGEABILITY REGULATORY UNCERTAINTY PRODUCTION COMPLEXITY 6.3 KEY CHALLENGES COMPETITION FROM BIOBETTERS, COMBINED WITH CONSUMER BRAND CONSCIOUSNESS INTERCHANGEABILITY 6.4 CURRENT OPPORTUNITIES IN THE MARKET LOCAL PARTNERSHIPS IN EMERGING MARKETS 7. GLOBAL BIOSIMILAR MARKET-BY PRODUCT CLASS 7.1 MONOCLONAL ANTIBODIES ADALIMUMAB INFLIXIMAB RITUXIMAB TRASTUZUMAB BEVACIZUMAB

4 7.1.6 OTHERS 7.2 RECOMBINANT HORMONES INSULIN HUMAN GROWTH HORMONE FOLLICLE-STIMULATING HORMONE OTHERS 7.3 RECOMBINANT GROWTH FACTOR GRANULOCYTE COLONY-STIMULATING FACTOR ERYTHROPOIETIN OTHERS 7.4 IMMUNOMODULATORS INTERLEUKINS CYTOKINES IMMUNOMODULATORY IMIDE DRUGS (IMIDS) OTHER IMMUNOMODULATORS 7.5 ANTI-INFLAMMATORY AGENTS TNF INHIBITORS OTHER ANTI-INFLAMMATORY AGENTS 8. GLOBAL BIOSIMILAR MARKET SEGMENTATION - BY GEOGRAPHY 8.1 NORTH AMERICA UNITED STATES CANADA MEXICO 8.2 EUROPE UNITED KINGDOM

5 8.2.2 GERMANY FRANCE ITALY SPAIN REST OF EUROPE 8.3 ASIA-PACIFIC CHINA JAPAN INDIA AUSTRALIA SOUTH KOREA REST OF APAC 8.4 MIDDLE EAST & AFRICA (MEA) GCC SOUTH AFRICA REST OF MEA 8.5 SOUTH AMERICA BRAZIL ARGENTINA REST OF SOUTH AMERICA 9. COMPETITIVE LANDSCAPE 9.1 MERGERS AND ACQUISITIONS ANALYSIS 9.2 AGREEMENTS, COLLABORATIONS, AND PARTNERSHIPS 9.3 NEW PRODUCT LAUNCHES 10. COMPANY PROFILES

6 10.1 APOTEX INC BIOCON 10.3 CELLTRION 10.4 ELI LILLY AND COMPANY 10.5 TORRENT PHARMACEUTICALS 10.6 HOSPIRA 10.7 LG LIFE SCIENCES LIMITED 10.8 MYLAN 10.9 INTAS PHARMACEUTICALS LTD NOVARTIS/SANDOZ TEVA PHARMACEUTICALS ZYDUS CADILA HEALTHCARE STADA ARZNEIMITTEL DR. REDDY S LABORATORIES INC SAMSUNG BIOEPIS 11. OUTLOOK OF THE MARKET

7 1. INTRODUCTION 1.2 MARKET DEFINITION Biosimilars refer to a similar, but not identical copy of the original product, with parallel properties to a product that has already been licensed. Biosimilars can be made only when the patent for the original product expires. This report analyzes and discusses the global biosimilar market. The global biosimilar market has been segmented based on the product class into monoclonal antibodies (adalimumab, infliximab, rituximab, trastuzumab, bevacizumab, and others), recombinant hormones (insulin, human growth hormone, and follicle stimulating hormone), recombinant growth factors (granulocyte colony stimulating factor, erythropoietin, and others), immunomodulators (interleukins, cytokines, immunomodulatory imide drugs, and others), antiinflammatory agents (TNF inhibitors and others), in accordance with primary research interviews with the Oncologist, Care Hospitals. Further, based on geography, the market studied has been categorized into North America, Europe, Asia-Pacific, Middle East & Africa, and South America. The North American segment includes Canada, the United States, and Mexico. The European segment includes the United Kingdom, Germany, France, Italy, Spain, and rest of Europe. The Asia-Pacific segment includes Australia, New Zealand, China, India, Japan, South Korea, and rest of Asia-Pacific. The Middle East & African segment includes Gulf Cooperation Council (GCC), South Africa, and rest of Middle East & Africa. The South American segment includes Brazil, Argentina, and rest of South America. A holistic study of the market has been carried out, by incorporating various factors, extending from country-specific demographic conditions and business cycles, to market-specific microeconomic influences, needed to analyze the future trends of this market. The research uncovers many paradigm shifts in the studied market, in terms of regional competitive advantage and dynamics, primarily with respect to the services.

8 2. RESEARCH METHODOLOGY INTRODUCTION For this study, we have adopted a highly structured, two-stage process. These are: (a) size estimation of the review period, and (b) the market engineering for the forecast period of the global-, country-, and segment-level data, which leads to the data generation process (DGP) for the variables studied. The size estimations are carried out through multiple bottom-up and topdown approaches. The bottom-up approach includes examining historical revenues of key players, studying the size of the applications, value- and supply-chain analysis and end-user demand analysis. These are then cross-validated against secondary and primary sources. The topdown approach is an incisive research process, where the global market sizing is carried out through secondary research, which is then validated by primary industry experts. In this report, for analyzing future trends during the forecast period of the market studied, we have incorporated rigorous statistical and econometric methods. These are tallied against secondary and primary sources, corroborated by our in-house experts, who thoroughly make use of our extensive data intelligence repository. The market is studied holistically, from both the demand- and supply-side perspectives. The dual perspective helps to analyze both end-user and producer behavior patterns during the review period, which may affect future price,

9 demand and consumption trends. As the study demands analysis of the long-term nature of the market, identification of factors influencing the market is based on the fundamentality of the market studied. Through secondary and primary source-based research, endogenous and exogenous factors are identified and, through data extraction, transformed into quantitative data. STUDY PHASES SECONDARY RESEARCH The first phase of the research process is to conduct extensive secondary research, which includes the identification of intelligence related to the market studied, from our data repository. Secondary data is compiled from various databases, such as industry bodies, associations, journals, company annual reports, white papers, research publications by recognized industry experts, paid data sources, and other published literature. Data regarding the business plans and strategies of the companies are derived from recent annual/investor reports of key industry players, which are then used for qualitative comparison and analysis. Financial data on these companies are sourced primarily from industry association & stock exchange filings, which helps us to maintain a benchmark standard. DISCUSSION GUIDE The next phase is to prepare an exhaustive discussion guide. The primary purpose of this phase is to extract qualitative information with respect to the market, from key industry leaders. The

10 collated information works as a supplement to the quantitative analysis. The discussion guide helps in identifying major segments, such as, market factors, like drivers, restraints and challenges; key economic factors; interaction between major market players; supply-side and value-chain structure; bottom-up and/or topdown nature of the market, the competitive landscape, recent long- and short-term strategic developments and the market shares of key players. The guide helps in deciding the scope and deliverables of the study, in terms of the requirement of the market. ECONOMETRIC MODELLING The next phase involves market engineering, which includes analyses of collected data, market breakdown and forecast. Macro- and micro-economic indicators, which are exogenous and endogenous in nature respectively, are identified through causal and correlation analyses, which are further analyzed against the study variables to derive statistical inferences on the market studied. A structural forecast model is developed in the process, and the most statistically reliable model is considered for forecasting. Methods, such as, the Markov chain and Monte Carlo simulation, are used to estimate the dynamics between the subsegments. Data points thus obtained are verified by the process of data triangulation. The latter allows us to validate the numbers and arrive at close estimates. After data validation, the analysts write the report. Analysts garner insights from the data and forecasts, and conceptualize the entire business ecosystem.

11 EXPERT VALIDATION The final phase, before analysts begin writing the report, is the expert validation. At this state, crossvalidation through market experts and/or key personnel from the industry/market concerned is carried out, the estimated and projected values arrived at through data triangulation. These key personnel may be senior researchers, directors, CFOs, or CEOs. The cross-validated estimates are finally approved by the in-house experts of Mordor Intelligence. 6. DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES ANALYSIS 6.1 MARKET DRIVERS SEVERAL BLOCKBUSTER BIOPHARMACEUTICALS GOING OFF-PATENT IN THE NEXT 5-10 YEARS The patent for blockbuster drugs (that have been the top-selling drugs for many years) has either expired or is expected to expire in the coming years. The expiration of patents opens up opportunities for biosimilars to enter the market and increase industry competition. Hence, biosimilars are expected to make up an increasing share of the biologics market. A study reported that about 32 drugs lost patent protection at the time of the passage of Hatch-Waxman Amendments. Pfizer lost patent protection for Zoloft (antidepressant) and Celebrex (NSAID), Merck for Zocor (cholesterol drug), Teva for Copaxone (immunomodulator), AstraZeneca for Nexium (GERD), Bristol-Myers Squibb for Pravachol (cholesterol drug), etc. Table: Major Biological Patent Expiries: Europe Product/Molecule Patent Expiry Herceptin 2014 Avastin 2019 Remicade 2014

12 Rituxan/Mabthera 2013 Humira 2018 Enbrel 2015 Lantus 2015 Orencia 2017 Table: Major Biological Patent Expiries: United States Product/ Molecule Patent Expiry Rituxan 2016 Humira 2016 Erbitux 2018 Remicade 2018 Avastin 2019 Herceptin 2019 Lantus 2015 Levemir 2017 Enbrel 2028* Orencia 2019 *The patent on Enbrel was set to expire in 2012; however, a second patent has been issued in the United States, which grants exclusivity for 16 years. Owing to the biological patent expiration, innovator companies (Amgen, Pfizer, Merck, Boehringer Ingelheim, etc.) and generics manufacturers (Cipla, Dr. Reddy s, Mylan, Sandoz, Teva, etc.) are devoting resources to biosimilars and many contract research organizations (CROs)

13 (Biocon, Parexel, Quintiles, etc.) are offering services, which are specifically tailored toward biosimilars. Some of the aforementioned drugs have therapeutic applications in diseases, such as cancer, diabetes, cardiovascular diseases, and others. As disease incidences are increasing globally (more rapidly in low- and middle-income countries), the demand for similar drugs (biosimilar drugs) is expected to increase. This demand is expected to drive the market for biosimilar drugs. Biosimilars are drawing the market's attention as a result of patent cliff, which is expected to place nearly 36% of the biologic drug market at risk. 6.2 MARKET RESTRAINTS CONCERNS REGARDING SUBSTITUTABILITY AND INTERCHANGEABILITY An interchangeable product is one that would be expected to produce the same clinical results in any given patient and the biological product may be substituted for the reference product, without the intervention of the prescriber. Interchangeability is considered a major benefit for biosimilar development, as section 351(I) of the Public Health Service Act allows for interchangeable biosimilars to be substituted for their reference product at the pharmacy level. Among few differences in the regulatory approach of EMA and FDA, the most important difference is regarding the designation of interchangeability. EMA s approach does not include any designation of interchangeability, while FDA plans to create a level of approval for an interchangeable biosimilar. FDA requires licensed biosimilars and interchangeable biological products to meet the agency s rigorous standards of safety and efficacy. The post marketing data collected from products first licensed and marketed as biosimilars are not sufficient to demonstrate interchangeability. This data may be helpful to determine the data that is necessary to support interchangeability; however, the data itself is not enough. This means that even the already-approved biosimilar products may be able to obtain interchangeable

14 status, if sponsors provide switching study data. The data and information needed to support a demonstration of interchangeability can be influenced by factors, like product complexity and product-specific immunogenicity risk. Such complexity in substitutability and interchangeability is challenging the biosimilar market s growth. 7. GLOBAL BIOSIMILAR MARKET-BY PRODUCT CLASS 7.1 MONOCLONAL ANTIBODIES ADALIMUMAB Adalimumab (originator drug: Humira) is an anti-tnf drug. TNF (tumor necrosis factor) is produced in excess in certain conditions, such as rheumatoid arthritis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. This biosimilar causes inflammation, pain, and damage to the bones and joints. Adlimumab blocks the action of TNF, reduces inflammation, and provides relief from the disease condition. Humira is approved by US FDA for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, Psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and chronic plaque psoriasis. Amjevita, Amgen s version of Humira is the first adalimumab biosimilar to be approved by US FDA in September Two European versions, named Amgevita and Solymbic, were recommended in the European Union (EU) in January Amgevita and Solymbic are the first adalimumab biosimilars recommended for approval in the EU. In the EU, Amgevita is prescribed for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, and uveitis. Solymbic is intended to treat similar inflammatory disease conditions. Other than Amgen, companies, such as Boehringer Ingelheim, Merck,

15 Samsung Bioepis and Sandoz are also expected to enter the market shortly. The adalimumab biosimilar is also marketed in India, by Zydus and Torrent Pharmaceuticals. 8. GLOBAL BIOSIMILAR MARKET SEGMENTATION - BY GEOGRAPHY Global Biosimilar Market, (in USD million) Value CAGR % Market Value 1,586.7 XX XX XX XX XX The global biosimilar market was valued at USD XX million in 2017, and is expected to reach USD XX million in 2018 and USD XX million by 2023, recording a CAGR of XX % during the forecast period Biosimilar Market: Revenue in USD million, by Geography, Region CAGR % North America XX XX XX XX XX Europe XX XX XX XX XX XX Asia-Pacific XX XX XX XX XX XX Middle East & Africa XX XX XX XX XX XX South America XX XX XX XX XX 27.7% Total XX XX XX XX XX XX In 2017, North America accounted for the highest value of USD XX million, and is expected to reach USD XX million by 2023, recording a CAGR of XX % during the forecast period. The North American segment is poised to record the fastest growth, followed by Asia-Pacific and Europe.

16 Biosimilar Market: Revenue in USD million, by Product Class, Product Class CAGR % Monoclonal Antibodies XX XX XX XX XX XX Recombinant Hormones XX XX XX XX XX 39.1% Recombinant Growth Factors XX XX XX XX XX XX Immunomodulators XX XX XX XX XX Anti-inflammatory Agents XX XX XX XX XX XX Total XX XX XX XX XX XX By product class, the monoclonal antibodies (MAb) segment of the market studied accounted for the highest value 1 of USD XX million in 2017, and is expected to record a CAGR of XX % over the forecast period, to reach USD XX million by Biosimilar Market: Revenue in USD million, Monoclonal Antibodies, by Region, Region CAGR % North America XX XX XX XX XX XX Europe XX XX XX XX XX XX Asia-Pacific XX XX XX XX XX Middle East & Africa XX XX XX XX XX XX 1 Source: Oncologist from Care Hospitals, Hyderabad, India

17 South America XX XX XX XX XX 27.9% Total XX XX XX XX XX XX The North American monoclonal antibodies segment of the market studied was valued at USD XX million in 2017, and is poised to record the highest CAGR of XX % during the forecast period. Biosimilar Market: Revenue in USD million, Recombinant Hormones, by Region, Region CAGR % North America XX XX XX XX XX Europe XX XX XX XX XX XX Asia-Pacific XX XX XX XX XX XX Middle East & Africa XX XX XX XX XX XX South America XX XX XX XX XX 27.4% Total XX XX XX XX XX XX The recombinant hormones segment of the market studied was valued at USD XX million in 2017, and is expected to register a CAGR of XX% during the forecast period, to reach USD XX million by Biosimilar Market: Revenue in USD million, Recombinant Growth Factors, by Region, Region CAGR % North America XX XX XX XX XX XX Europe XX XX XX XX XX XX Asia-Pacific XX XX XX XX XX Middle East & Africa XX XX XX XX XX XX

18 South America XX XX XX XX XX XX Total XX XX XX XX XX XX Biosimilar Market: Revenue in USD million, Immunomodulators, by Region, Region CAGR % North America XX XX XX XX XX XX Europe XX XX XX XX XX XX Asia-Pacific XX XX XX XX XX XX Middle East & Africa XX XX XX XX XX XX South America XX XX XX XX XX XX Total XX XX XX XX XX XX Biosimilar Market: Revenue in USD million, Anti-inflammatory Agents, by Region, Region CAGR % North America XX XX XX XX XX XX Europe XX XX XX XX XX XX Asia-Pacific XX XX XX XX XX XX Middle East & 28.5 XX XX XX XX XX Africa South America XX XX XX XX XX XX Total XX XX XX XX XX XX

19 8.1 NORTH AMERICA Biosimilar Market: Revenue in USD million, by Region, Global, Year CAGR % Market Value XX XX XX XX XX The North American segment of the market studied was valued USD XX million in 2017, and is expected to reach USD XX million in 2018 and USD XX million by 2023, recording a CAGR of XX % during the forecast period Biosimilar Market: Revenue in USD million, by Region, North America, Country CAGR % United States XX XX XX XX XX XX Canada XX XX XX XX XX XX Mexico XX XX XX XX XX XX Total XX XX XX XX XX XX The US biosimilar segment of the market studied was valued at USD XX million in 2017, and is expected to reach USD XX million in 2018 and USD XX million by 2023, registering a CAGR of XX % during the forecast period Biosimilar Market: Revenue in USD million, By Product Class, North America, Product Class CAGR % Monoclonal Antibodies XX XX XX XX XX XX Recombinant Hormones XX XX XX XX XX XX Recombinant Growth Factors XX XX XX XX XX XX Immunomodulators XX XX XX XX XX XX Anti-inflammatory Agents XX XX XX XX XX XX

20 Biosimilar Market: Revenue in USD million, Monoclonal Antibodies, by Region, North America Country CAGR % United States XX XX XX XX XX Canada XX XX XX XX XX XX Mexico XX XX XX XX XX 23.3% Total XX XX XX XX XX XX Biosimilar Market: Revenue in USD million, Recombinant Hormones, by Region, North America Country CAGR % United States XX XX XX XX XX XX Canada XX XX XX XX XX XX Mexico XX XX XX XX XX XX Total XX XX XX XX XX XX Biosimilar Market: Revenue in USD million, Recombinant Growth Factors, by Region, North America Country CAGR % United States XX XX XX XX XX XX Canada XX XX XX XX XX XX Mexico XX XX XX XX XX XX Total XX XX XX XX XX XX Biosimilar Market: Revenue in USD million, Immunomodulators, by Region, North America

21 Country CAGR % United States XX XX XX XX XX XX Canada XX XX XX XX XX 40.1% Mexico XX XX 63.0 XX XX XX Total XX XX XX XX XX XX Biosimilar Market: Revenue in USD million, Anti Inflammatory Agents, by Region, North America Country CAGR % United States XX 31.8 XX XX XX XX Canada XX XX XX XX XX XX Mexico XX XX XX XX XX 20.2% Total XX XX XX XX XX XX UNITED STATES Currently, the United States is a very small market for biosimilars. However, the US market is anticipated to grow, as it is expected to be the largest contributor of biosimilars, and account for a major share in the global revenue, during the forecast period. This can be attributed to patent expiration of existing biologics. The United States has an approximate patent expiration limit of 15 years, for innovator drugs. The country has great opportunities for biosimilars, as biologics carry higher price. By 2020, the US market is estimated to become susceptible to biosimilar competition. The key products in the US market are - Remicade, Enbrel, Rituximab, Adalimumab, Infliximab, Etanercept, Darbepoetin Alpha, etc. As of January 2017, there are four biosimilars (Zarxio biosimilar to Neupogen, Inflectra for Remicade, Erelzi for Enbrel, and Amjevita for Humira) that have been approved. However, only two of the four approved biosimilars are

22 currently in the market. Sandoz was the first to obtain approval for a biosimilar (Zarxio) in the United States, as per the new FDA biosimilar regulatory pathway. M923, biosimilar HUMIRA (adalimumab), is under phase-iii trial, and is expected to be sold soon by Momenta. Many biosimilars are in the pipeline by Teva Inc., including TVB018 CT-P10 (Rituxan), and CTP6 (Herceptin). The company has received approval for tbo-filgrastim (XM02 filgrastim). Herceptin is expected to be marketed by Mylan, with FDA biosimilar approval. Pfizer has introduced Remicade biosimilar, with a 15% discount in the country. The key players in the US biosimilar product market are - Sandoz, Amgen, Teva Pharmaceutical Industries, Hospira, STADA Arzneimittel, and Mylan. As per a recent report, 41 biosimilars are under development, out of which, 23 biosimilars are ready to be released into market, and a large number (estimated to be 260) of biosimilars are in pipeline, are anticipated to be marketed soon. 10. COMPANY PROFILES NOVARTIS/SANDOZ Business Overview Novartis is leading global supplier of generic pharmaceuticals. Through a merger of Ciba-Geigy and Sandoz, Novartis was formed in 1996; it is headquartered in Basel, Switzerland. The company business is segmented into innovative patented medicines, generics and eye care devices across the globe. Sandoz holds number one position in sales of ophthalmic, transplantation medicines, biosimilars and of generic anti-infectives worldwide. In 2016, Sandoz acquires, from Pfizer, the rights for the production and commercialization of biosimilar infliximab. In production of certain significant therapeutic such as generic cardiovascular, injectables, gastrointestinal dermatology, respiratory, central nervous system, pain and metabolism Sandoz holds a leading position, globally.

23 Products & Services Products/Services Sandoz Erelzi Description Biosimilar of etanercept for the treatment of multiple inflammatory diseases. Erelzi was approved in the United States and it is indicated for rheumatoid arthritis (RA), active polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis ankylosing spondylitis (AS), and plaque psoriasis. Zarzio Sandoz Rixathon Omnitrope Binocrit First biosimilar to be approved in the United States. Zarzio is the biosimilar of Granulocyte Colony Stimulating Factor (G-CSF). A biosimilar of rituximab, indicated for the treatment of blood cancer and several immunological diseases. Omnitrope is a biosimilar of growth hormones. It is indicated to children who lack growth hormones. Binocrit is used for the treatment of symptomatic anemia. Financial Overview (in USD million) Revenue (+/-) % Change Total Revenue 9,895 10,144 (-)3 Biopharmaceuticals (-)2 Operating Income or Loss (-)7 Net Income (-)6 Analyst View Sandoz holds the highest market share in the biosimilar market. Sandoz, a Novartis division is expected to launch five biosimilars (LA-EP2006 (pegfilgrastim), HX575 (epoetinalfa), GP2013 (rituximab), GP2017 (adalimumab), GP1111 (infliximab)) of immunology biologic and oncology across the globe by Sandoz has a strong focus on biosimilars. The key products launched in the United States, include amphetamine salts extended release (Shire s Adderall XR ), linezolid

24 solution for infusion/injection (Pfizer s Zyvox ), mometasonefuroate (Merck & Co. Inc. s Nasonex nasal spray), and oxiconazole nitrate (Fougera soxistat ). Sandoz has a strong distribution channel and is the first company to get approval under the new regulatory pathway in the United States, in 2015, for biosimilar products. 11. WHY BUY THIS REPORT? Biosimilars is a similar, not identical, copy of the original product, having parallel properties to the product that has already been licensed. Biosimilars can be made only when the patent for the original product expires. This report analyzes and discusses the biosimilar market, globally based on product class and geography. A holistic study of the market has been carried out by incorporating various factors extending from country-specific demographic conditions and business cycles to market-specific microeconomic influences needed to analyze the future trends of the market. The research uncovers many paradigm shifts in the studied market, in terms of regional competitive advantage and dynamics, primarily with respect to the services. This report focuses on the market outlook for Biosimilars in the 18 markets across North America (Canada, Mexico, and US), Europe (France, Germany, Italy, Russia, Spain, and UK), Asia-Pacific (APAC: Australia, China, India, Japan and South Korea), South America (Argentina and Brazil), and the Middle East and Africa (GCC and South Africa). The analysis identifies the key drivers in the Biosimilars, discusses the competitive landscape, and provides future outlook for this market by geography. Key Questions Answered in This Report: What is the current and future Biosimilars market outlook in the developed and emerging markets? What trends are affecting the global market? Which are the key, high growth markets that Biosimilars manufacturers should expand into?

25 What are the challenges and complications that have hindered widespread adoption? With developing the next-generation of devices, what aspects of the technology are device manufacturers focused on optimizing? How will new entrants impact the Biosimilars market? Scope Overview of recent key industry events and analysis of their market impact. Annualized total market revenue, procedure trends, and market outlooks by segment and by region through Key topics covered include strategic competitor assessment, market characterization, identification of unmet needs, reimbursement considerations, evaluating market access in each region covered in the report, and implications of the emerging technologies in the market. Analysis of the current and future market competition in the global RKR market. Insightful review of industry drivers, barriers, and challenges. Reasons to buy Identify the unmet needs with the current generation of Biosimilars and understand how emerging technologies will meet these unmet needs. Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the Biosimilars market in the future. Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors.

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