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

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 a CAGR 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.

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.

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 as market 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.

The following different terminologies of biosimilars are considered while estimating the market size:

Biosimilars 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.

This research report categorizes the market into the following segments:

Global Biosimilars Market, by Product:
Recombinant Non-glycosylated Proteins
Insulin
Human Growth Hormone
Granulocyte Colony-stimulating Factor (G-CSF)
Interferons
Recombinant Glycosylated Proteins
Erythropoietin
Monoclonal Antibodies
Follitropin
Recombinant Peptides
Glucagon
Calcitonin

Global Biosimilars Market, by Service:
Contract Manufacturing Organizations (CMO)
Contract Research Organizations(CRO)
Others (Bioinformatics and Sales & Marketing Services)

Global Biosimilars Market, by Application:
Oncology
Blood Disorders
Chronic & Autoimmune Diseases
Growth Hormone Deficiency
Infectious Diseases
Others

Global Biosimilars Market, by Geography:
North America
U.S.
Canada
Europe
U.K.
Germany
France
Italy
Spain
Rest of Europe (RoE)
Asia-Pacific
China
Japan
South Korea
India
Rest of Asia-Pacific(RoAP)
Rest of World
Latin America
Africa
Middle East

The global market is segmented on the basis of products, applications, and services. By product, the global biosimilars market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The recombinant non-glycosylated proteins market is further classified into insulin, granulocyte colony-stimulating factor (G-CSF), interferon, and human growth hormone; whereas the recombinant glycosylated proteins market is further broken down into erythropoietin, monoclonal antibodies, and follitropin. Glucagon and calcitonin are considered under the recombinant peptides segment. The recombinant glycosylated proteins segment is the largest segment with a share of 40% of the global market in 2013. Of all the products, monoclonal antibodies will be the fastest-growing segment at an estimated CAGR of 41.9% from 2013 to 2018. Following this, insulin will be the second-fastest growing market from 2013 to 2018.The growth is attributed to the rise in incidences of diabetes; the ongoing patent expiration of biologic drugs such as Lantus, Humalog, and Novorapid; and the cost effectiveness of biosimilars of insulin.

By application, the market is segmented into oncology, blood disorders, growth hormonal deficiency, chronic and autoimmune disorders, and others (female infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, and chronic kidney failure). Oncology is the largest and fastest-growing segment of the global biosimilars market. This is attributed to the increasing prevalence of oncology along with the rise in aging population and the changing lifestyles. The global market will be worth $2.0 billion by 2018, growing at a CAGR of 20.1% during the forecast period (2013 to 2018). The major factors driving the growth of the market are the launch of new biosimilars (monoclonal antibodies, filgrastim, and follitropin); ongoing clinical research on potential pipeline products; patent expirations of various biologics such as Neupogen, Humira, and Lantus; and the increasing demand for first-wave biosimilar products such as somatropin, filgrastim, and erythropoietin.

The global market is highly consolidated with the top three players, namely, Sandoz (Germany), Hospira (U.S.), and Teva (Israel) occupying 90% of the market share. Other key players include Dr. Reddy’s Laboratories (India), Biocon Ltd. (India), Mylan (U.S.), Biopartners (Switzerland), Amgen (U.S.), and Intas Biopharmaceutical Ltd. (India).

Table Of Contents

1 INTRODUCTION 26

1.1 OBJECTIVES OF THE STUDY 26
1.2 REPORT DESCRIPTION 26
1.3 MARKETS COVERED 28
1.4 STAKEHOLDERS 30
1.5 MARKET SCOPE 30
1.6 RESEARCH METHODOLOGY 31
1.6.1 MARKET SIZE ESTIMATION AND DATA TRIANGULATION 32
1.6.2 MARKET SHARE 35
1.6.3 KEY DATA POINTS FROM SECONDARY SOURCES 35
1.6.4 KEY DATA POINTS FROM PRIMARY SOURCES 35
1.6.5 ASSUMPTIONS 37

2 EXECUTIVE SUMMARY 38

3 PREMIUM INSIGHTS 42

3.1 BIOSIMILAR MARKET VS. BIOLOGIC MARKET 42
3.2 GLOBAL BIOSIMILAR MARKET 43
3.2.1 MARKET DYNAMICS 44
3.2.2 PRODUCT MARKET 45
3.2.3 APPLICATION MARKET 46
3.3 GEOGRAPHIC ANALYSIS, BY COUNTRY 47
3.4 MARKET SHARE ANALYSIS 48

4 MARKET OVERVIEW 49

4.1 INTRODUCTION 50
4.2 EVOLUTION 53
4.3 MARKET SEGMENTATION 55
4.4 MARKET DYNAMICS 57
4.4.1 DRIVERS 57
4.4.1.1 Growing Pressure to cut Healthcare Expenditure, an Impetus to the Demand of Biosimilars 57
4.4.1.2 Off-patent Biologic Products to Boost the Biosimilars Market 58
4.4.1.3 Rise in aging Population Triggers the Incidences of Chronic Disorders and thus Boosts the Biosimilars Market 59
4.4.1.4 Growing Demand for Biosimilar Drugs due to Their Cost Effectiveness 60
4.4.1.5 Rising Incidences of Various Diseases to Boost the Biosimilars Market 61
4.4.1.6 Strategic Collaborations Lead to Increased Productivity and Clinical Trial Activities for Biosimilars 62
4.4.1.7 Government Support and Initiatives Propel the Biosimilars Market 64
4.4.2 RESTRAINTS 65
4.4.2.1 High Manufacturing Complexities and Costs, a Significant Entry Barrier for Companies 65
4.4.2.2 Stringent Regulatory Requirements in Countries to Adversely Affect Investments in Biosimilars 66
4.4.2.3 Innovative Strategies by Biologic Drug Manufacturers to Restrict Entry into the Biosimilars Market 66
4.4.3 OPPORTUNITIES 67
4.4.3.1 Emerging Countries 67
4.4.3.2 Untapped Indications 68
4.4.4 CHALLENGES 69
4.4.4.1 Requirement of Complex Infrastructure for Manufacturing as well as Extensive Clinical Trials for Obtaining Approval 69
4.4.4.2 Bulk Production to Meet Market Demand is a Challenge for Smaller Manufacturers 69
4.5 WINNING IMPERATIVES 70
4.5.1 PARTNERSHIPS and AGREEMENTS TO GAIN COMPETITIVE ADVANTAGE 70
4.5.2 SANDOZ’S IN-HOUSE CAPABILITIES MADE IT THE GLOBAL LEADER 71
4.6 BURNING ISSUES 72
4.6.1 OPPORTUNITIES FOR NEW ENTRANTS IN THE BIOSIMILARS MARKET 72
4.6.2 PRODUCT WITHDRAWALS PROVIDE SIGNIFICANT OPPORTUNITIES FOR NEW ENTRANTS 73
4.6.3 TERMINATION OF JOINT VENTURES ALLOWS COMPANIES TO FOCUS ON CORE COMPETENCIES 73
4.6.4 DISCONTINUATION OF PATENT BY ROCHE PROVIDES OPPORTUNITIES TO OTHER PLAYERS 74
4.7 BIOSIMILARS PIPELINE ANALYSIS 75
4.7.1 ABOUT 50 BIOSIMILARS OF MONOCLONAL ANTIBODY IN THE PIPELINE 75

5 INDUSTRY ANALYSIS 82

5.1 INTRODUCTION 83
5.2 RESEARCH and DEVELOPMENT INVESTMENT ANALYSIS 84
5.3 INDUSTRY TREND ANALYSIS 86
5.3.1 FORTHCOMING PATENT EXPIRATIONS 86
5.3.2 MANUFACTURING AGREEMENT 86
5.4 PORTER’S FIVE FORCES ANALYSIS 87
5.4.1 THREAT OF NEW ENTRANTS 88
5.4.2 THREAT OF SUBSTITUTES 88
5.4.3 COMPETITOR RIVALRY 89
5.4.4 BARGAINING POWER OF SUPPLIERS 89
5.4.5 BARGAINING POWER OF BUYERS 89

6 GLOBAL BIOSIMILARS MARKET, BY PRODUCT 90

6.1 INTRODUCTION 91
6.1.1 BIOSIMILARS DEMAND TO GROW OWING TO HIGH EFFICACIES and LOW PRICES 92
6.2 RECOMBINANT NON-GLYCOSYLATED PROTEINS 96
6.2.1 INSULIN BIOSIMILAR WILL DRIVE THE RECOMBINANT NON-GLYCOSYLATED PROTEINS SEGMENT 96
6.2.2 INSULIN 98
6.2.2.1 Insulin Glargine, Lispro, and Aspart will go off-patent in 2014 99
6.2.3 RECOMBINANT HUMAN GROWTH HORMONE (RHGH) 101
6.2.4 GRANULOCYTE COLONY-STIMULATING FACTOR (FILGRASTIM) 103
6.2.4.1 Strong Biosimilar Pipeline to Boost the Filgrastim Market 104
6.2.5 INTERFERONS 106
6.2.5.1 Biosimilar of Interferon available only in Asia-Pacific and RoW Regions due to Less Stringent Regulatory Pathway 106
6.3 RECOMBINANT GLYCOSYLATED PROTEINS 108
6.3.1 ERYTHROPOIETIN (EPO) 111
6.3.1.1 Cost Effectiveness of EPO Biosimilars, One of the Major Driving Factors 112
6.3.2 MONOCLONAL ANTIBODIES (MAB) 113
6.3.2.1 Monoclonal Antibodies Market, a Lucrative Opportunity for Companies 113
6.3.3 FOLLITROPIN 115
6.3.3.1 New Biosimilar of Follitropin ‘Ovaleap’ Received Marketing Authorization in Europe in 2014 116
6.4 RECOMBINANT PEPTIDES 117
6.4.1 GLUCAGON 118
6.4.1.1 Glucagen, the First FOP approved in U.S. 118
6.4.2 CALCITONIN 119
6.4.2.1 U.S. FDA does not Support Miacalcin as a Treatment for Osteoporosis 120

7 GLOBAL BIOSIMILAR MARKET, BY APPLICATION 122

7.1 INTRODUCTION 123
7.2 ONCOLOGY 124
7.2.1 GROWING COST BURDEN OF CANCER WILL STIMULATE THE DEMAND FOR MABS and FILGRASTIM 125
7.3 BLOOD DISORDERS 127
7.3.1 RISE IN INCIDENCES OF ANEMIA, LEUKEMIA, MYELOMA and LYMPHOMA WILL ENHANCE THE NEED FOR BIOSIMILARS 127
7.4 CHRONIC AND AUTOIMMUNE DISEASES 130
7.4.1 MONOCLONAL ANTIBODIES TO BOOST THE APPLICATION OF BIOSIMILARS IN AUTOIMMUNE DISEASES 130
7.5 GROWTH HORMONE DEFICIENCY 133
7.5.1 ABOUT 10,000 NEW PATIENTS ARE DIAGNOSED ANNUALLY WITH GROWTH HORMONAL DISORDERS 133
7.6 INFECTIOUS DISEASES 135
7.6.1 GROWING CASES OF HEPATITIS, A BOOST FOR THE INTERFERON BIOSIMILAR MARKET 135
7.7 OTHERS (FEMALE INFERTILITY, HYPOGLYCAEMIA, MYOCARDIAL INFARCTION, POSTMENOPAUSAL OSTEOPOROSIS and CHRONIC KIDNEY FAILURE) 137

8 GLOBAL BIOSIMILARS SERVICE MARKET 138

8.1 INTRODUCTION 139
8.1.1 RandD AND MANUFACTURING ISSUES PROVIDE SIGNIFICANT OPPORTUNITIES TO CRO and CMO 139
8.2 CONTRACT MANUFACTURING ORGANIZATIONS 143
8.2.1 CMO PROVIDE CONSIDERABLE OPPORTUNITIES TO COMPANIES PLANNING TO ENTER BIOSIMILARS MARKET 143
8.3 CONTRACT RESEARCH ORGANIZATIONS 145
8.3.1 LACK OF EXPERTISE WITH THE BIOSIMILAR PLAYERS, A PROSPECT FOR CRO 145
8.4 OTHERS (NON-CLINICAL and BIOINFORMATICS) 147

9 GEOGRAPHIC ANALYSIS 148

9.1 INTRODUCTION 149
9.1.1 EUROPE DOMINATES THE GLOBAL BIOSIMILAR MARKET DUE TO ITS WELL DEFINED REGULATORY GUIDELINES 150
9.2 NORTH AMERICA 153
9.2.1 RISE IN PRESSURE TO CUT HEALTHCARE COST and A LEADING BIOLOGIC MARKET WILL INCREASE THE DEMAND FOR LOW PRICED BIOSIMILARS 153
9.2.2 REGULATORY OUTLOOK 156
9.2.2.1 U.S. 156
9.2.2.2 Canada 157
9.2.3 MARKET ANALYSIS 158
9.2.3.1 U.S. 158
9.2.3.1.1 Financial support by U.S. government to FDA for review of biosimilars will add significant growth to biosimilar industry 158
9.2.3.2 Canada 159
9.3 EUROPE 165
9.3.1 EUROPE IS THE PIONEER FOR THE DEVELOPMENT OF BIOSIMILARS 165
9.3.2 REGULATORY OUTLOOK 169
9.3.3 MARKET ANALYSIS 170
9.3.3.1 U.K. 170
9.3.3.1.1 Well-developed generics market and growing pressure to decrease drug prices to drive the biosimilars market 171
9.3.3.2 Germany 172
9.3.3.2.1 Reference pricing system of Germany leads to faster adoption of biosimilars 172
9.3.3.3 France 173
9.3.3.3.1 Biosimilars not considered as generic drugs and are excluded from the French substitution list 173
9.3.3.4 Spain 174
9.3.3.4.1 Effect of recession on branded drugs will shift the market towards biosimilar drugs 174
9.3.3.5 Italy 174
9.3.3.5.1 Adoption of biosimilars low compared to branded versions 174
9.3.3.6 Rest of Europe (RoE) 175
9.3.3.6.1 Substitution status varies in different countries 175
9.3.3.6.2 Reference pricing system of Denmark will proliferate the biosimilar market 176
9.4 ASIA-PACIFIC 185
9.4.1 APAC, A BLUE-EYED MARKET FOR INVESTORS IN BIOSIMILARS OWING TO LESS STRINGENT REGULATORY PATHWAY 185
9.4.2 GROWING MEDICAL TOURISM and LOW MANUFACTURING COST WILL PROPEL THE BIOSIMILAR MARKET 187
9.4.3 REGULATORY OUTLOOK 190
9.4.3.1 China 190
9.4.3.2 India 190
9.4.3.3 Japan 191
9.4.3.4 South Korea 191
9.4.4 MARKET ANALYSIS 192
9.4.4.1 China 192
9.4.4.1.1 Lack of government regulation and low IP protection for biologic compounds will drive the biosimilar market 192
9.4.4.2 India 193
9.4.4.2.1 Semi-regulatory environment for approving similar biologic drugs propels the biosimilar market 194
9.4.4.3 Japan 195
9.4.4.4 South Korea 196
9.4.4.4.1 Government support and strong biosimilar pipeline, an impetus to the biosimilar market 196
9.4.4.5 Rest of Asia-Pacific (RoAP) 197
9.4.4.5.1 Australia and Malaysia to aggressively promote the adoption of biosimilars 197
9.5 REST OF THE WORLD (ROW) 206
9.5.1 LATAM PROVIDES HIGH GROWTH OPPORTUNITIES FOR BIOSIMILAR PLAYERS 206
9.5.2 REGULATORY OUTLOOK 208
9.5.2.1 Brazil 208
9.5.2.2 Mexico 208
9.5.2.3 Argentina 208
9.5.2.4 Saudi Arabia 209
9.5.3 MARKET ANALYSIS 209
9.5.3.1 Latin America 209
9.5.3.1.1 Strong economic condition and government support will strengthen the biosimilar industry in Brazil 210
9.5.3.2 Africa 210
9.5.3.3 Middle East 211

10 COMPETITIVE LANDSCAPE 218

10.1 INTRODUCTION 218
10.1.1 AGREEMENTS and PARTNERSHIPS WAS THE KEY STRATEGY ADOPTED BY BIOSIMILAR PLAYERS 218
10.2 MARKET SHARE ANALYSIS 219
10.3 AGREEMENTS, JOINT VENTURES, PARTNERSHIPS, and COLLABORATIONS 221
10.4 ACQUISITIONS 227
10.5 NEW PRODUCT LAUNCHES 230
10.6 OTHERS (REGULATORY APPROVALS) 233

11 COMPANY PROFILES 238
(Overview, Financials, Products and Services, Strategy, and Developments)*

11.1 ACTAVIS, INC. 238
11.2 AMGEN, INC. 243
11.3 BIOCON LTD. 249
11.4 CELLTRION, INC. 253
11.5 CIPLA LTD. 257
11.6 DR. REDDY’S LABORATORIES LTD. 260
11.7 EMCURE PHARMACEUTICALS LTD. 265
11.8 HOSPIRA, INC. 268
11.9 LG LIFE SCIENCES LTD. 274
11.10 MERCK KGAA 277
11.11 MYLAN, INC. 282
11.12 RANBAXY LABORATORIES LTD. 286
11.13 ROCHE HOLDING LTD. 290
11.14 SANDOZ INTERNATIONAL GMBH
(DIVISION OF NOVARTIS INTERNATIONAL AG) 296
11.15 STADA ARZNEIMITTEL AG 302
11.16 SYNTHON 306
11.17 TEVA PHARMACEUTICAL INDUSTRIES LTD. 309
11.18 WOCKHARDT LTD. 316
*Details on Financials, Product and Services, Strategy, and Developments might not be captured in case of unlisted companies.

LIST OF TABLES

TABLE 1 REGION-SPECIFIC TERMINOLOGY OF BIOSIMILARS 52
TABLE 2 KEY ATTRACTIVE BIOLOGICS UNDER THREAT OF PATENT EXPIRY,
2012 - 2018 59
TABLE 3 KEY ALLIANCES OF THE BIOSIMILARS INDUSTRY 63
TABLE 4 GLOBAL BIOSIMILARS MARKET, BY PRODUCT, 2011 - 2018 ($MILLION) 95
TABLE 5 GLOBAL BIOSIMILARS MARKET: RECOMBINANT NON-GLYCOSYLATED PROTEINS, BY PRODUCT, 2011 - 2018 ($MILLION) 98
TABLE 6 BIOLOGIC INSULIN GOING OFF-PATENT, 2010 - 2015 100
TABLE 7 BIOSIMILARS MARKET: INSULIN, BY GEOGRAPHY,
2011 - 2018 ($MILLION) 101
TABLE 8 BIOSIMILARS MARKET: RECOMBINANT HUMAN GROWTH HORMONE,
BY GEOGRAPHY, 2011 - 2018 ($MILLION) 103
TABLE 9 BIOSIMILARS MARKET: GRANULOCYTE COLONY-STIMULATING FACTOR, BY GEOGRAPHY, 2011 - 2018 ($MILLION) 105
TABLE 10 BIOSIMILARS MARKET: INTERFERON, BY GEOGRAPHY,
2011 - 2018 ($MILLION) 107
TABLE 11 GLOBAL BIOSIMILARS MARKET: RECOMBINANT GLYCOSYLATED PROTEINS, BY PRODUCT, 2011 - 2018 ($MILLION) 110
TABLE 12 BIOSIMILARS MARKET: ERYTHROPOIETIN, BY GEOGRAPHY,
2011 - 2018 ($MILLION) 112
TABLE 13 BIOLOGIC RECOMBINANT MONOCLONAL ANTIBODIES GOING
OFF-PATENT, 2010 - 2019 114
TABLE 14 BIOSIMILARS MARKET: MONOCLONAL ANTIBODIES, BY GEOGRAPHY, 2011 - 2018 ($MILLION) 115
TABLE 15 BIOSIMILARS MARKET: FOLLITROPIN, BY GEOGRAPHY,
2011 - 2018 ($MILLION) 116
TABLE 16 GLOBAL BIOSIMILARS MARKET: RECOMBINANT PEPTIDES,
BY PRODUCT,2011 - 2018 ($MILLION) 118
TABLE 17 BIOSIMILARS MARKET: GLUCAGON, BY GEOGRAPHY,
2011 - 2018 ($MILLION) 119
TABLE 18 BIOSIMILARS MARKET: CALCITONIN, BY GEOGRAPHY,
2011 - 2018 ($MILLION) 120
TABLE 19 GLOBAL BIOSIMILAR MARKET, BY APPLICATION,
2011 - 2018 ($MILLION) 123
TABLE 20 BIOSIMILAR DRUGS USED TO TREAT CANCER 125
TABLE 21 ONCOLOGY BIOSIMILARS MARKET, BY GEOGRAPHY,
2011 - 2018 ($MILLION) 126
TABLE 22 BIOSIMILAR DRUGS USED TO TREAT BLOOD DISORDERS 128
TABLE 23 BLOOD DISORDERS BIOSIMILARS MARKET, BY GEOGRAPHY,
2011 - 2018 ($MILLION) 129
TABLE 24 BIOSIMILAR DRUGS USED TO TREAT CHRONIC AND AUTOIMMUNE DISORDER 131
TABLE 25 CHRONIC AND AUTOIMMUNE DISORDERS BIOSIMILARS MARKET,
BY GEOGRAPHY, 2011 - 2018 ($MILLION) 132
TABLE 26 GROWTH HORMONAL DISORDER BIOSIMILARS MARKET,
BY GEOGRAPHY, 2011 - 2018 ($MILLION) 134
TABLE 27 BIOSIMILAR DRUGS USED TO TREAT INFECTIOUS DISEASES 136
TABLE 28 INFECTIOUS DISEASES BIOSIMILARS MARKET, BY GEOGRAPHY,
2011 - 2018 ($MILLION) 136
TABLE 29 BIOSIMILAR DRUGS USED TO TREAT VARIOUS OTHER DISEASES 137
TABLE 30 BIOSIMILARS MANUFACTURING STRATEGIES OF LEADING PLAYERS 140
TABLE 31 JOINT VENTURES OF CMOS and PHARMACEUTICAL COMPANIES FOR BIOSIMILARS 144
TABLE 32 JOINT VENTURES OF CROS and PHARMACEUTICAL COMPANIES FOR BIOSIMILARS 146
TABLE 33 GLOBAL BIOSIMILARS MARKET, BY GEOGRAPHY,
2011 - 2018 ($MILLION) 152
TABLE 34 BIOSIMILAR DRUGS IN NORTH AMERICA 155
TABLE 35 BIOLOGIC DRUGS GOING OFF-PATENT IN THE U.S., 2012 - 2018 155
TABLE 36 REGULATORY STATUS IN NORTH AMERICA 157
TABLE 37 NORTH AMERICA: BIOSIMILARS MARKET, BY PRODUCT,
2011 - 2018 ($MILLION) 159
TABLE 38 NORTH AMERICA: RECOMBINANT NON-GLYCOSYLATED PROTEIN MARKET, BY PRODUCT, 2011 - 2018 ($MILLION) 160
TABLE 39 NORTH AMERICA: RECOMBINANT PEPTIDES MARKET, BY PRODUCT, 2011 - 2018 ($MILLION) 161
TABLE 40 NORTH AMERICA: BIOSIMILARS MARKET, BY APPLICATION,
2011 - 2018 ($MILLION) 162
TABLE 41 NORTH AMERICA: BIOSIMILARS MARKET, BY COUNTRY,
2011 - 2018 ($MILLION) 163
TABLE 42 NORTH AMERICA:RECOMBINANT NON-GLYCOSYLATED MARKET,
BY COUNTRY, 2011 - 2018 ($MILLION) 164
TABLE 43 NORTH AMERICA: RECOMBINANT PEPTIDES MARKET, BY COUNTRY, 2011 - 2018 ($MILLION) 164
TABLE 44 BIOSIMILAR DRUGS IN THE EUROPEAN MARKET 167
TABLE 45 BIOLOGIC DRUGS GOING OFF-PATENT, 2013 - 2018 168
TABLE 46 SUBSTITUTION STATUS IN EUROPEAN COUTRIES 170
TABLE 47 EUROPE: BIOSIMILAR MARKETS, BY PRODUCT,
2011 - 2018 ($MILLION) 176
TABLE 48 EUROPE: RECOMBINANT NON-GLYCOSYLATED PROTEIN MARKET,
BY PRODUCT, 2011 - 2018 ($MILLION) 177
TABLE 49 EUROPE: RECOMBINANT GLYCOSYLATED PROTEIN MARKET,
BY PRODUCT, 2011 - 2018 ($MILLION) 178
TABLE 50 EUROPE: RECOMBINANT PEPTIDES MARKET, BY PRODUCT,
2011 - 2018 ($MILLION) 179
TABLE 51 EUROPE: BIOSIMILARS MARKET, BY APPLICATION,
2011 - 2018 ($MILLION) 180
TABLE 52 EUROPE: BIOSIMILARS MARKET, BY COUNTRY,
2011 - 2018 ($MILLION) 181
TABLE 53 EUROPE: RECOMBINANT NON-GLYCOSYLATED MARKET, BY COUNTRY, 2011 - 2018 ($MILLION) 182
TABLE 54 EUROPE: RECOMBINANT GLYCOSYLATED MARKET, BY COUNTRY,
2011 - 2018 ($MILLION) 183
TABLE 55 EUROPE: RECOMBINANT PEPTIDES MARKET, BY COUNTRY,
2011 - 2018 ($MILLION) 184
TABLE 56 SIMILAR BIOLOGIC DRUGS IN ASIA-PACIFIC REGION 188
TABLE 57 STATUS OF REGULATORY PATHWAY IN ASIA-PACIFIC REGION 191
TABLE 58 APAC: BIOSIMILARS MARKET, BY PRODUCT, 2011 - 2018 ($MILLION) 198
TABLE 59 APAC: RECOMBINANT NON-GLYCOSYLATED PROTEIN MARKET,
BY PRODUCT, 2011 - 2018 ($MILLION) 199
TABLE 60 APAC: RECOMBINANT GLYCOSYLATED PROTEIN MARKET, BY PRODUCT, 2011 - 2018 ($MILLION) 200
TABLE 61 APAC: RECOMBINANT PEPTIDES MARKET, BY PRODUCT,
2011 - 2018 ($MILLION) 200
TABLE 62 APAC: BIOSIMILARS MARKET, BY APPLICATION,
2011 - 2018 ($MILLION) 201
TABLE 63 APAC:BIOSIMILARS MARKET, BY COUNTRY, 2011 - 2018 ($MILLION) 202
TABLE 64 APAC: RECOMBINANT NON-GLYCOSYLATED MARKET, BY COUNTRY, 2011 - 2018 ($MILLION) 203
TABLE 65 APAC: RECOMBINANT GLYCOSYLATED MARKET, BY COUNTRY,
2011 - 2018 ($MILLION) 204
TABLE 66 APAC: RECOMBINANT PEPTIDE MARKET, BY COUNTRY,
2011 - 2018 ($MILLION) 205
TABLE 67 BIOSIMILAR DRUGS IN ROW 207
TABLE 68 REGULATORY STATUS IN THE ROW BIOSIMILARS MARKET 209
TABLE 69 ROW: BIOSIMILARS MARKET, BY PRODUCT, 2011 - 2018 ($MILLION) 211
TABLE 70 ROW: RECOMBINANT NON-GLYCOSYLATED PROTEIN MARKET,
BY PRODUCT, 2011 - 2018 ($MILLION) 212
TABLE 71 ROW: RECOMBINANT GLYCOSYLATED PROTEIN MARKET, BY PRODUCT, 2011 - 2018 ($MILLION) 213
TABLE 72 ROW: RECOMBINANT PEPTIDES MARKET, BY PRODUCT,
2011 - 2018 ($MILLION) 213
TABLE 73 ROW: BIOSIMILARS MARKET, BY APPLICATION,
2011 - 2018 ($MILLION) 214
TABLE 74 ROW:BIOSIMILARS MARKET, BY REGION, 2011 - 2018 ($MILLION) 215
TABLE 75 ROW: RECOMBINANT NON-GLYCOSYLATED MARKET, BY REGION,
2011 - 2018 ($MILLION) 216
TABLE 76 ROW: RECOMBINANT GLYCOSYLATED MARKET, BY REGION,
2011 - 2018 ($MILLION) 216
TABLE 77 ROW: RECOMBINANT PEPTIDE MARKET, BY REGION,
2011 - 2018 ($MILLION) 217
TABLE 78 ACQUISITIONS, 2011 - 2013 228
TABLE 79 NEW PRODUCT LAUNCHES, BY COMPANY, 2011 - 2013 232
TABLE 80 REGULATORY APPROVALS, BY COMPANY, 2011 - 2013 233

LIST OF FIGURES

FIGURE 1 MARKET ESTIMATION and DATA TRIANGLUATION FOR BIOSIMILARS MARKET 33
FIGURE 2 MARKET FORECASTING MODEL 34
FIGURE 3 GLOBAL BIOSIMILARS MARKET REVENUE, 2013 - 2018 ($MILLION) 39
FIGURE 4 GLOBAL BIOSIMILARS MARKET, BY GEOGRAPHY,
2013 - 2018 ($MILLION) 40
FIGURE 5 COMPARISON OF BIOSIMILARS and. BIOLOGICS MARKETS,
GEOGRAPHIC SHARE, 2013 42
FIGURE 6 GLOBAL BIOSIMILAR MARKET, REVENUE and GROWTH RATE,
2013 - 2018 43
FIGURE 7 GLOBAL BIOSIMILARS MARKET DYNAMICS 44
FIGURE 8 GLOBAL BIOSIMILAR MARKET, BY PRODUCT, 2013 - 2018 45
FIGURE 9 GLOBAL BIOSIMILAR MARKET, BY APPLICATION, 2013 - 2018 46
FIGURE 10 BIOSIMILAR MARKET: GEOGRAPHIC ANALYSIS, 2013 ($MILLION) 47
FIGURE 11 MARKET SHARE ANALYSIS, BY KEY PLAYERS, 2013 48
FIGURE 12 EVOLUTION OF THE BIOSIMILARS MARKET, 2005 - 2013 54
FIGURE 13 GLOBAL BIOSIMILARS MARKET SEGMENTATION 56
FIGURE 14 BIOSIMILARS UNDER PIPELINE, BY PLAYER 76
FIGURE 15 NUMBER OF BIOSIMILAR MONOCLONAL ANTIBODIES IN THE PIPELINE, BY COMPANY 77
FIGURE 16 BIOSIMILARS IN PRECLINICAL STAGE 78
FIGURE 17 BIOSIMILARS IN PHASE I CLINICAL TRIAL 79
FIGURE 18 BIOSIMILARS IN PHASE II CLINICAL TRIAL 80
FIGURE 19 BIOSIMILARS IN PHASE III CLINICAL TRIAL 81
FIGURE 20 GLOBAL BIOSIMILARS MARKET: RESEARCH and DEVELOPMENT ANALYSIS 85
FIGURE 21 GLOBAL BIOSIMILARS MARKET: PORTER’S FIVE FORCES ANALYSIS 87
FIGURE 22 GLOBAL BIOSIMILARS MARKET: OPPORTUNITY MATRIX,
BY PRODUCT, 2013 93
FIGURE 23 GLOBAL BIOSIMILARS MARKET, BY PRODUCT, 2011 - 2018 ($MILLION) 94
FIGURE 24 GLOBAL BIOSIMILARS MARKET: RECOMBINANT NON-GLYCOSYLATED PROTEIN BIOSIMILARS, BY PRODUCT, 2011 - 2018 ($MILLION) 97
FIGURE 25 GLOBAL BIOSIMILARS MARKET: RECOMBINANT GLYCOSYLATED PROTEINS, BY PRODUCT, 2011 - 2018 ($MILLION) 109
FIGURE 26 GLOBAL BIOSIMILARS MARKET: RECOMBINANT PEPTIDES,
BY PRODUCT,2011 - 2018 ($MILLION) 117
FIGURE 27 GLOBAL BIOSIMILAR SERVICES MARKET SHARE, 2013 VS. 2018 142
FIGURE 28 OPPORTUNITY MATRIX: BIOSIMILARS MARKET, BY COUNTRY, 2013 151
FIGURE 29 KEY GROWTH STRATEGIES, 2010 - 2013 218
FIGURE 30 GLOBAL BIOSIMILARS MARKET SHARE ANALYSIS,
BY KEY PLAYER, 2013 220
FIGURE 31 AGREEMENTS, JOINT VENTURES, PARTNERSHIPS, and COLLABORATIONS, BY COMPANY, 2010 - 2013 222
FIGURE 32 AGREEMENTS, JOINT VENTURES, PARTNERSHIPS, and COLLABORATIONS, 2010 - 2013 223
FIGURE 33 ACQUISITIONS, BY COMPANY, 2011 - 2013 228
FIGURE 34 NEW PRODUCT LAUNCHES, 2011 - 2013 231
FIGURE 35 APPROVALS, 2011 - 2013 233
FIGURE 36 ACTAVIS: TOTAL REVENUE ($BILLION) and OPERATING MARGIN (%), 2010 - 2012 239
FIGURE 37 ACTAVIS: BUSINESS REVENUE MIX, 2012 239
FIGURE 38 ACTAVIS: MARKET STRATEGY, 2011 - 2013 241
FIGURE 39 AMGEN, INC.: TOTAL REVENUE ($BILLION), 2010 - 2012 244
FIGURE 40 AMGEN, INC.: GEOGRAPHIC REVENUE MIX, 2012 244
FIGURE 41 AMGEN, INC.: MARKET STRATEGY, 2011 - 2013 246
FIGURE 42 BIOCON LTD.: TOTAL REVENUE ($MILLION) and OPERATING MARGIN (%), 2011 - 2013 250
FIGURE 43 CELLTRION, INC.: TOTAL REVENUE ($MILLION) and OPERATING MARGIN (%), 2010 - 2012 254
FIGURE 44 CELLTRION, INC.: MARKET STRATEGY, 2011 - 2013 255
FIGURE 45 CIPLA LTD.: TOTAL REVENUE ($BILLION), 2011 - 2013 258
FIGURE 46 CIPLA LTD.: GEOGRAPHIC REVENUE MIX, 2012 258
FIGURE 47 DR.REDDY’S LABORATORIES LTD.: TOTAL REVENUE ($BILLION) andOPERATING MARGIN (%), 2011 - 2013 261
FIGURE 48 DR.REDDY’S LABORATORIES LTD.: BUSINESS REVENUE MIX, 2013 262
FIGURE 49 DR.REDDY’S LABORATORIES LTD.: GEOGRAPHIC REVENUE MIX, 2013 262
FIGURE 50 DR. REDDY’S LABORATORIES LTD.: MARKET STRATEGY, 2011 - 2013 264
FIGURE 51 HOSPIRA, INC.: TOTAL REVENUE ($MILLION) and OPERATING MARGIN (%), 2010 - 2012 269
FIGURE 52 HOSPIRA, INC.: SEGMENT REVENUE MIX, 2012 270
FIGURE 53 HOSPIRA, INC.: GEOGRAPHY REVENUE MIX, 2012 270
FIGURE 54 HOSPIRA, INC. MARKET STRATEGY, 2011 - 2013 272
FIGURE 55 LG LIFE SCIENCES: TOTAL REVENUE ($MILLION) and OPERATING MARGIN (%), 2010 - 2012 275
FIGURE 56 MERCK: TOTAL REVENUE ($BILLION) andOPERATING MARGIN (%),
2010 - 2012 278
FIGURE 57 MERCK: BUSINESS REVENUE MIX, 2012 278
FIGURE 58 MERCK: GEOGRAPHIC REVENUE MIX, 2012 279
FIGURE 59 MYLAN, INC.: TOTAL REVENUE ($BILLION) and OPERATING MARGIN (%), 2010 - 2012 283
FIGURE 60 MYLAN INC.: BUSINESS REVENUE MIX, 2012 283
FIGURE 61 MYLAN INC.: GEOGRAPHIC REVENUE MIX, 2012 284
FIGURE 62 MYLAN, INC.: MARKET STRATEGY, 2011 - 2013 285
FIGURE 63 RANBAXY LABORATORIES LTD.: TOTAL REVENUE ($BILLION) and OPERATING MARGIN (%), 2010 - 2012 287
FIGURE 64 RANBAXY LABORATORIES LTD.: GEOGRAPHIC REVENUE MIX, 2011 288
FIGURE 65 RANBAXY, MARKET STRATEGY, 2007 - 2013 289
FIGURE 66 ROCHE: TOTAL REVENUE ($BILLION) and OPERATING MARGIN (%),
2010 - 2012 291
FIGURE 67 ROCHE: BUSINESS REVENUE MIX, 2012 291
FIGURE 68 ROCHE: GEOGRAPHIC REVENUE MIX, 2012 292
FIGURE 69 SANDOZ INTERNATIONAL: TOTAL REVENUE ($MILLION) and OPERATING MARGIN (%), 2010 - 2012 297
FIGURE 70 SANDOZ INTERNATIONAL: SEGMENT REVENUE MIX, 2012 298
FIGURE 71 SANDOZ INTERNATIONAL: GEOGRAPHY REVENUE MIX, 2012 298
FIGURE 72 STADA: TOTAL REVENUE ($BILLION) and OPERATING MARGIN (%),
2010 - 2012 303
FIGURE 73 STADA: BUSINESS REVENUE MIX, 2012 303
FIGURE 74 STADA: GEOGRAPHIC REVENUE MIX, 2012 304
FIGURE 75 TEVA PHARMACEUTICAL INDUSTRIES LTD.: TOTAL REVENUE ($MILLION) and OPERATING MARGIN (%), 2010-2012 310
FIGURE 76 TEVA PHARMACEUTICAL INDUSTRIES LTD.: SEGMENT REVENUE MIX, 2012 311
FIGURE 77 TEVA PHARMACEUTICAL INDUSTRIES LTD.: GEOGRAPHIC REVENUE MIX, 2012 311
FIGURE 78 TEVA PHARMACEUTICAL INDUSTRIES LTD.: MARKET STRATEGY,
2011 - 2013 313
FIGURE 79 WOCKHARDT: TOTAL REVENUE ($BILLION) and OPERATING MARGIN (%), 2011 - 2013 317
FIGURE 80 WOCKHARDT: GEOGRAPHIC REVENUE MIX, 2013 318

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