GBICH0071MR Active Pharmaceutical Ingredients sample · Active Pharmaceutical Ingredients (API) Market in the Americas to 2017 Shift Towards Generics and Biosimilars as South and

Active Pharmaceutical Ingredients (API) Market in the Americas to 2017 Shift Towards Generics and Biosimilars as South and Central America Emerges as a Key Growth Region

GBI Research Report Guidance

GBICH0071MR / Published AUG 2012 Page 2

© GBI Research. This is a licensed product and is not to be photocopied

GBI Research Report Guidance

The coverage in this report is as follows:

Chapter three contains a description of the Contract Manufacturing Organization (CMO) trends in the Americas, the importance of CMOs and the growth drivers for CMOs in the API manufacturing industry.

Chapter four contains an API market overview and revenue forecast for the Americas. The chapter includes an API classification based on synthesis routes, a description of the API industry in the Americas, and its respective drivers and restraints. This section also details a classification of synthetic and biotech API by customer base and their revenue analysis by country.

Chapter five contains an API market overview and revenue forecast for North America. The chapter covers classification of APIs by customer base and an in-depth analysis of revenue trends and shares, including analysis by therapeutic category and product type. This section also provides revenue share analysis by therapeutic application.

Chapter six contains an API market overview and revenue forecast for the US. The chapter covers classification of API by customer base and an in-depth analysis of revenue trends and shares, including analysis by therapeutic category and product type.

Chapter seven contains an API market overview and revenue forecast for Canada. The chapter covers classification of API by customer base and an in-depth analysis of revenue trends and shares, including analysis by therapeutic category and product type.

Chapter eight contains an API market overview and revenue forecast for the South and Central America (SCA). The chapter covers classification of API by customer base and an in-depth analysis of revenue trends and shares, including analysis by therapeutic category and product type. This section also provides revenue share analysis by therapeutic application.

Chapter nine contains the appendix of the report, illustrating the methodology, research process and important definitions included in the report.

GBICH0071MR / Published AUG 2012

Page 3 © GBI Research. This is a licensed product and is not to be photocopied

Executive Summary

Executive Summary

The Americas’ API Market Revenue is Expected to Reach $XX Billion in 2017 at a CAGR of XX%

The Active Pharmaceutical Ingredients (API) market in the Americas accounted for revenues of $XX billion in 2005, and grew at a Compound Annual Growth Rate (CAGR) of XX% to $XX billion in 2011. The market is expected to grow at a CAGR of XX% to reach $XX billion by 2017. As the North American pharmaceutical market recovers from the impacts of economic downturn, API market revenues are expected to witness steady growth.

The faster growing markets of South and Central America (SCA) will provide a greater contribution to the overall growth of the API market in the Americas. Brazil in particular is witnessing very strong growth in pharmaceuticals and API market revenues, and is expected to overtake Mexico in the coming years. Meanwhile, the expected increase in biotech API revenues in the Americas is expected to continue to support revenue growth through to 2017.

The following figure shows revenues in the API market in the Americas from 2005 to 2017.

The Americas’ API Market, Revenue Analysis, ($m), 2005–2017

XX

XX

XX

2005 2011 2017

Year

Rev

enue

($m

)

CAGR XX%

CAGR XX%

Source: GBI Pharmaceutical Database (accessed on: July 2, 2012); Pharm Tech CPA 2009; GPHA 2011a.

Biosimilars are another category of generics, also referred to as generic biotech API or Follow-On Biologics (FOB). APIs derived from biotechnology provide high-growth market potential but are expensive to develop and manufacture. Approvals for biosimilars are expected to increase through to 2017 due to patent expiries during the forecast period.

Therefore, their associated development costs are significantly higher than small molecule generic APIs. The cost of production is also higher when compared to generics. According to GBI Research estimates, biosimilar APIs will enjoy a healthy CAGR of XX% to 2017. This significant increase in the biosimilar market is likely to boost overall API revenues in the Americas during the forecast period.

The Americas’ API market accounted for around XX% of the global API market revenue of $XX billion in 2011. North America’s API revenue accounted for XX% of the overall API revenue share in this region in 2011. The North American API market was primarily dominated by the US with revenue of $XX billion which accounted for XX% of the overall North American API revenue in 2011.

The Americas’ API market accounted for around XX% of the global API market revenue of $XX billion in 2011. The US was the market leaders



Table of Contents

1 Table of Contents

1 Table of Contents................................................................................................................................. 6 1.1 List of Tables............................................................................................................................. 9 1.2 List of Figures...........................................................................................................................10

2 Introduction........................................................................................................................................11 3 Contract Manufacturing Organizations in the Americas’ API Manufacturing .........................................12

3.1 Introduction ............................................................................................................................12 3.1.1 Steps Involved in Outsourcing API Manufacturing to Contract Manufacturing Organizations

........................................................................................................................................12 3.1.2 The US Contract Manufacturing Organization Market .......................................................12

4 The Americas’ Active Pharmaceutical Ingredients Market ....................................................................14 4.1 Market Overview.....................................................................................................................14

4.1.1 API Classification Based on Synthesis Routes.....................................................................14 4.1.2 Classification Dependent on Customer Base......................................................................15

4.2 Industry Structure....................................................................................................................15 4.3 Pricing and reimbursement in Americas ...................................................................................16 4.4 The US Healthcare System - Introduction..................................................................................16

4.4.1 Health Insurance..............................................................................................................16 4.5 Brazil Healthcare System - Introduction....................................................................................17

4.5.1 Public Insurance...............................................................................................................17 4.5.2 Private Insurance .............................................................................................................17

4.6 The Americas’ API Market Drivers ............................................................................................17 4.6.1 Upcoming Patent Expiries are Expected to Alter the API Market Dynamics in the Americas 17 4.6.2 Increasing Uptake of Biologics across Different Therapeutic Areas and Government

Initiatives for Biomedical Research to Boost the API Revenues ...........................................17 4.6.3 Mergers and Acquisitions have Increased Significantly in the American Pharmaceutical

Industry ...........................................................................................................................18 4.6.4 Growth in the Pharmaceutical Industry and Increasing Elderly Population are Driving the

Growth of the Americas’ API Market.................................................................................18 4.7 The Americas’ API Market Restraints........................................................................................18

4.7.1 Economic Downturn has Restricted Investment in the Pharmaceutical Industry..................18 4.7.2 Lack of Cheap Labor, High Costs and Saturation of the Market are Likely to Hinder New Drug

Development in the Region...............................................................................................18 4.7.3 Regulatory Changes Lead to Delays in the Launch of New Drugs........................................18 4.7.4 Patent Expiries and Increased Consumption of Generics Threatens API Revenue Growth ....18 4.7.5 Huge Deficits Provoke Cuts in Healthcare Reimbursement .................................................19

4.8 API Total Revenue Analysis in the Americas ..............................................................................20 4.8.1 The Americas’ Revenue Share by Product Types ................................................................22 4.8.2 The Americas’ Synthetic API Total Synthetic Revenue Analysis (2005–2017) .......................23 4.8.3 The Americas’ Synthetic API Market Revenue Share Analysis by Customer Base in 2011 .....28 4.8.4 The Americas’ Synthetic API Revenue Trend Analysis 2005–2017 .......................................29

4.9 The Americas’ Biotech API Market Analysis...............................................................................31 4.9.1 The Americas’ Biotech API Revenue Analysis 2005–2017 ...................................................31

4.10 The Americas’ Biotech API Market Revenue Analysis by Customer Base ....................................35 4.10.1 The Americas’ Biotech API Market Revenue Share Analysis by Customer Base....................35 4.10.2 Patent Expiry of Leading Biologics in the Americas ............................................................36 4.10.3 The Americas’ Biotech API Revenue Trend Analysis 2005–2017..........................................37

5 North American Active Pharmaceutical Ingredients Market .................................................................39 5.1 North American API Market Overview......................................................................................39 5.2 North American API Market Drivers..........................................................................................39

5.2.1 Continuous Growth in the Pharmaceutical Industry Sustains the API Market’s Growth in North America .................................................................................................................39



Table of Contents

5.2.2 Generic Sector Spurs the Growth of the North American API Market..................................39 5.2.3 Increasing Focus on Biological Drugs Helps the API Market’s Revenue Growth ...................39

5.3 North American API Market Restraints .....................................................................................39 5.3.1 Recent Economic Slowdown has Restricted the Growth of the Pharmaceutical Industry......39 5.3.2 High Cost of New Drug Development Hampers Innovation ................................................39 5.3.3 Patent Expiries of Blockbuster Molecules will Contain the Growth of the API Market in North

America ...........................................................................................................................40 5.4 North American Total API Revenue Analysis based on Synthesis Routes 2005–2017 ..................41 5.5 North American API Revenue Share Analysis by Product Types 2005–2017 ...............................43 5.6 North American API Revenue Analysis Dependent on Customer Base........................................44

5.6.1 North American Synthetic API Revenue Analysis by Customer Base, 2005–2017 .................44 5.6.2 North American Synthetic API Market Revenue Share Analysis by Customer Base, 2005–

2017 ................................................................................................................................46 5.6.3 North American Biotech API Revenue Analysis by Customer Base, 2005–2017....................47 5.6.4 North American Biotech API Revenue Share Analysis by Customer Base, 2005–2017 ..........49

5.7 North American API Revenue Share Analysis by Therapeutic Applications .................................50 6 The US Active Pharmaceutical Ingredients Market ...............................................................................52

6.1 The US API Market Overview....................................................................................................52 6.2 The US Total API Revenue Analysis Based on Synthesis Routes 2005–2017................................52 6.3 The US API Revenue Share Analysis by Product Types 2005–2017 .............................................55 6.4 The US API Revenue Analysis Dependent on Customer Base .....................................................56

6.4.1 The US Synthetic API Revenue Analysis by Customer Base, 2005–2017...............................56 6.4.2 The US Synthetic API Market Revenue Share Analysis by Customer Base, 2005–2017 .........58 6.4.3 The US Biotech API Revenue Analysis by Customer Base, 2005–2017 .................................59 6.4.4 The US Biotech API Revenue Share Analysis by Customer Base, 2005–2017........................61

7 Canadian Active Pharmaceutical Ingredients Market............................................................................62 7.1 Canadian API Market Overview ................................................................................................62 7.2 Canadian Total API Revenue Analysis based on Synthesis Routes 2005–2017 ............................62 7.3 Canadian API Revenue Share Analysis by Product Types 2005–2017..........................................64 7.4 Canadian API Revenue Analysis Dependent on Customer Base..................................................65

7.4.1 Canadian Synthetic API Revenue Analysis by Customer Base, 2005–2017...........................65 7.4.2 Canadian Synthetic API Market Revenue Share Analysis by Customer Base, 2005–2017 .....67 7.4.3 Canadian Biotech API Revenue Analysis by Customer Base, 2005–2017 .............................68 7.4.4 Canadian Biotech API Revenue Share Analysis by Customer Base, 2005–2017....................70

8 South and Central America Active Pharmaceutical Ingredients Market.................................................71 8.1 South and Central American API Market Overview ...................................................................71 8.2 South and Central America API Market Drivers .........................................................................71

8.2.1 Government Initiatives and Growing Investments in the Pharmaceutical Industry Gives a Boost to API Market Growth.............................................................................................71

8.2.2 Improvement in Regulatory Environment..........................................................................71 8.2.3 Increasing Number of Clinical Trials Leading to Market Growth .........................................71 8.2.4 Ageing Population and Increasing Prevalence of Lifestyle Diseases Fuel Market Growth.....71

8.3 South and Central American API Market Restraints...................................................................72 8.3.1 Import Dependence for APIs Restricts Market Growth .......................................................72 8.3.2 Delay in Regulatory Processes Hinders the Industry Growth...............................................72

8.4 South and Central American Total API Revenue Analysis based on Synthesis Routes 2005–201772 8.5 South and Central American API Revenue Share Analysis by Product Types 2005–2017 .............74 8.6 South and Central American API Revenue Analysis Dependent on Customer Base .....................75

8.6.1 South and Central American Synthetic API Revenue Analysis by Customer Base, 2005–2017........................................................................................................................................75

8.6.2 South and Central American Synthetic API Market Revenue Share Analysis by Customer Base, 2005–2017..............................................................................................................77



Table of Contents

8.6.3 South and Central American Biotech API Revenue Analysis by Customer Base, 2005–2017 .78 8.6.4 South and Central American Biotech API Revenue Share Analysis by Customer Base, 2005–

2017 ................................................................................................................................80 8.7 South and Central American API Revenue Share Analysis by Therapeutic Applications...............81

9 Appendix ............................................................................................................................................83 9.1 Abbreviations ..........................................................................................................................83 9.2 Market Definitions...................................................................................................................83 9.3 References ..............................................................................................................................83 9.4 Methodology...........................................................................................................................84

9.4.1 Coverage .........................................................................................................................84 9.4.2 Secondary Research .........................................................................................................84 9.4.3 Primary Research .............................................................................................................85 9.4.4 Expert Panel Validation ....................................................................................................85

9.5 Contact Us...............................................................................................................................85 9.6 Disclaimer................................................................................................................................85



Table of Contents

1.1 List of Tables

Table 1: CMO Market, the US, Revenue Analysis ($bn), 2005–2017.......................................................13 Table 2: API, the Americas, Total Revenue Analysis, $m, 2005–2017 .....................................................21 Table 3: API, the Americas, Revenue Share by Product Types, (%) 2011.................................................22 Table 4: Synthetic API, the Americas, Revenue Analysis, $bn, 2005–2017..............................................25 Table 5: Synthetic API, the Americas, Revenue Share Analysis by Region, (%) 2011................................26 Table 6: Synthetic API, the Americas, Revenue Share Trend, %, 2005–2017...........................................27 Table 7: Synthetic API, the Americas, Revenue Share by Customer Base, (%), 2011................................28 Table 8: Synthetic API, the Americas, Revenue Analysis by Customer Base, $m, 2005–2017...................30 Table 9: Biotech API, the Americas, Revenue Analysis, ($m), 2005–2017 ...............................................32 Table 10: Biotech API, the Americas, Revenue Share by Region, %, 2011.................................................33 Table 11: Biotech API, the Americas, Revenue Share Trend, %, 2005–2017..............................................34 Table 12: The Americas’ Biotech API Market, Revenue Share Analysis by Sectors Based on Customer Base,

2011.......................................................................................................................................35 Table 13: Biotech API, the Americas, Key Patent Expiry of Leading Biologics, 2003–2017 .........................36 Table 14: Biotech API, the Americas, Revenue Analysis by Customer Base, $m, 2005–2017 .....................38 Table 15: API Market, North America, Major Drugs to Lose Patent Protection, 2012 and 2016................40 Table 16: API, North America, Revenue Analysis by Product Types, $m, 2005–2017.................................42 Table 17: API, North America, Revenue Share by Product Type, %, 2005–2017........................................43 Table 18: Synthetic API, North America, Revenue Analysis by Customer Base, $m, 2005–2017 ................45 Table 19: Synthetic API, North America, Revenue Share by Customer Base, %, 2005–2017 ......................46 Table 20: Biotech API, North America, Revenue Analysis by Customer Base, $m, 2005–2017...................48 Table 21: Biotech API, North America, Revenue Share by Customer Base, %, 2005–2017.........................49 Table 22: API, North America, Revenue Split by Therapeutic Applications, %, 2011–2017 ........................51 Table 23: API, the US, Revenue Analysis by Product Types, $m, 2005–2017.............................................54 Table 24: API, the US, Revenue Share by Product Type, %, 2005–2017 ....................................................55 Table 25: Synthetic API, the US, Revenue Analysis by Customer Base, $m, 2005–2017.............................57 Table 26: Synthetic API, the US, Revenue Share by Customer Base, %, 2005–2017...................................58 Table 27: Biotech API, the US, Revenue Analysis by Customer Base, $m, 2005–2017 ...............................60 Table 28: Biotech API, the US, Revenue Share by Customer Base, %, 2005–2017 .....................................61 Table 29: API, Canada, Revenue Analysis by Product Types, $m, 2005–2017............................................63 Table 30: API, Canada, Revenue Share by Product Type, %, 2005–2017...................................................64 Table 31: Synthetic API, Canada, Revenue Analysis by Customer Base, $m, 2005–2017 ...........................66 Table 32: Synthetic API, Canada, Revenue Share by Customer Base, %, 2005–2017 .................................67 Table 33: Biotech API, Canada, Revenue Analysis by Customer Base, $m, 2005–2017 ..............................69 Table 34: Biotech API, Canada, Revenue Share by Customer Base, %, 2005–2017....................................70 Table 35: API, South and Central America, Revenue Analysis by Product Types, $m, 2005–2017 ..............73 Table 36: API, South and Central America, Revenue Share by Product Type, %, 2005–2017 .....................74 Table 37: Synthetic API, South and Central America, Revenue Analysis by Customer Base, $m, 2005–2017

...............................................................................................................................................76 Table 38: Synthetic API, South and Central America, Revenue Share by Customer Base, %, 2005–2017....77 Table 39: Biotech API, South and Central America, Revenue Analysis by Customer Base, $m, 2005–2017.79 Table 40: Biotech API, South and Central America, Revenue Share by Customer Base, %, 2005–2017 ......80 Table 41: API, South and Central America, Revenue Split by Therapeutic Applications, %, 2011–2017......82



Table of Contents

1.2 List of Figures

Figure 1: CMO Market, the US, Revenue Analysis ($bn), 2005–2017.......................................................13 Figure 2: The Americas’ API Market, Product Types................................................................................14 Figure 3: API, the Americas, Value Chain, 2011.......................................................................................15 Figure 4: API, the Americas, Total Revenue Analysis, $m, 2005–2017 .....................................................20 Figure 5: API, the Americas, Revenue Share by Product Types, (%), 2011................................................22 Figure 6: Synthetic API, the Americas, Revenue Analysis, ($m), 2005–2017.............................................24 Figure 7: Synthetic API, the Americas, Revenue Share Analysis, (%), 2011...............................................26 Figure 8: Synthetic API, the Americas, Revenue Share Trend Analysis by Region, (%), 2005–2017............27 Figure 9: Synthetic API, the Americas, Revenue Share by Customer Base, (%), 2011................................28 Figure 10: Synthetic API, the Americas, Revenue Trend by Product Types, ($m), 2011...............................29 Figure 11: Biotech API, the Americas, Revenue Analysis,($m), 2005–2017 ................................................31 Figure 12: Biotech API, the Americas, Revenue Share, (%), 2011...............................................................33 Figure 13: Biotech API, the Americas, Revenue Share Trend, (%), 2005–2017 ...........................................34 Figure 14: Biotech API, the Americas, Revenue Share Analysis by Customer Base, (%), 2011 .....................35 Figure 15: Biotech API, the Americas, Revenue Trend Analysis by Customer Base, ($m) Types, 2005–201737 Figure 16: API, North America, Revenue Analysis by Product Types, ($m), 2005–2017 ..............................41 Figure 17: API, North America, Revenue Share by Product Type, (%), 2005–2017......................................43 Figure 18: Synthetic API, North America, Revenue Analysis by Customer Base, ($m), 2005–2017..............44 Figure 19: Synthetic API, North America, Revenue Share by Customer Base, (%), 2005–2017....................46 Figure 20: Biotech API, North America, Revenue Analysis by Customer Base, ($m), 2005–2017.................47 Figure 21: Biotech API, North America, Revenue Share by Customer Base, (%), 2005–2017.......................49 Figure 22: API, North America, Revenue Split by Therapeutic Applications, (%), 2011–2017......................50 Figure 23: API, the US, Revenue Analysis by Product Types, ($m), 2005–2017...........................................53 Figure 24: API, the US, Revenue Share by Product Type, (%), 2005–2017..................................................55 Figure 25: Synthetic API, the US, Revenue Analysis by Customer Base, ($m), 2005–2017 ..........................56 Figure 26: Synthetic API, the US, Revenue Share by Customer Base, (%), 2005–2017 ................................58 Figure 27: Biotech API, The US, Revenue Analysis by Customer Base, ($m), 2005–2017 ............................59 Figure 28: Biotech API, The US, Revenue Share by Customer Base, (%), 2005–2017 ..................................61 Figure 29: API, Canada, Revenue Analysis by Product Types, ($m), 2005–2017 .........................................62 Figure 30: API, Canada, Revenue Share by Product Type, (%), 2005–2017.................................................64 Figure 31: Synthetic API, Canada, Revenue Analysis by Customer Base, ($m), 2005–2017 .........................65 Figure 32: Synthetic API, Canada, Revenue Share by Customer Base, (%), 2005–2017...............................67 Figure 33: Biotech API, Canada, Revenue Analysis by Customer Base, ($m), 2005–2017............................68 Figure 34: Biotech API, Canada, Revenue Share by Customer Base, (%), 2005–2017..................................70 Figure 35: API, South and Central America, Revenue Analysis by Product Types, ($m), 2005–2017............72 Figure 36: API, South and Central America, Revenue Share by Product Type, (%), 2005–2017 ...................74 Figure 37: Synthetic API, South and Central America, Revenue Analysis by Customer Base, ($m), 2005–2017

...............................................................................................................................................75 Figure 38: Synthetic API, South and Central America, Revenue Share by Customer Base, (%), 2005–2017 .77 Figure 39: Biotech API, South and Central America, Revenue Analysis by Customer Base, ($m), 2005–2017

...............................................................................................................................................78 Figure 40: Biotech API, South and Central America, Revenue Share by Customer Base, (%), 2005–2017 ....80 Figure 41: API, South and Central America, Revenue Split by Therapeutic Applications, (%), 2011–2017 ...81



Introduction

2 Introduction

Active Pharmaceutical Ingredients (APIs) are any substance or mixture of substances used as an active ingredient in the manufacture of a drug or medicinal product. This active ingredient is responsible for the therapeutic effect of the drug, and the efficacy of a drug entirely depends upon the concentration and composition of the API.

APIs are used during a number of stages of pharmaceutical development, such as stability sample testing, general analytical testing and method development. They are also used as Good Manufacturing Practice (GMP) APIs in clinical trials, and as source materials for manufacturing marketed drugs. In this report, both the merchant and captive API markets are considered.



The Americas’ Active Pharmaceutical Ingredients Market

4.8 API Total Revenue Analysis in the Americas

The API market revenues in the Americas were $XX billion in 2005. Both the API and pharmaceutical markets in the region have grown consistently over the past decade. However, growth rates were low in 2008 and 2009 due to the impact of the economic slowdown on the healthcare industry. The Americas’ API market generated a total revenue of $XX billion in 2011, recording a growth rate of XX% from 2005 to 2011. Developments in the biotech API sectors combined with moderate growth in synthetic APIs are likely to drive the Americas to $XX billion by 2017 with a CAGR of XX% over the forecast period.

The following figure shows the past revenues and revenue forecasts of the Americas’ API market from 2005 to 2017.

Figure 4: API, the Americas, Total Revenue Analysis, $m, 2005–2017

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

Year

Rev

enue

($m

)

Gro

wth

Rat

e (%

)

Revenue ($m) Growth Rate (%)

Source: GBI Pharmaceutical Database (accessed on: June 8, 2012); GPHA 2011a; PTSM 2011; GPHA 2011b; ePT 2009; Pharm Tech CPA 2009.

Healthy growth in biotech API sectors combined with moderate growth in synthetic APIs are likely to drive the Americas to $XX billion by 2017 with a CAGR of XX% over the forecast period




The following table provides information on the past revenues and revenue forecasts of the Americas’ API market from 2000 to 2017.

Table 2: API, the Americas, Total Revenue Analysis, $m, 2005–2017

Year Revenue ($m)

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

CAGR (2005–2011)

CAGR (2011–2017)





4.8.1 The Americas’ Revenue Share by Product Types

In 2011 the synthetic API market held a revenue share of XX%, while biotech API held a revenue share of XX%. However, the biotech API market is set to post a higher growth rate of XX% in the forecast period to reach $XX billion.

The following figure shows the revenue share analysis of the Americas’ API market by product types in 2011.

Figure 5: API, the Americas, Revenue Share by Product Types, (%), 2011

Synthetic API

Biotech API


The following table provides information on the revenue share analysis of the Americas’ API market by product types in 2011.

Table 3: API, the Americas, Revenue Share by Product Types, (%) 2011

Product Type Revenue Share (%)

Synthetic API

Biotech API

Total

Source: GBI Pharmaceutical Data Base (accessed on: June 8, 2012); GPHA 2011a; PTSM 2011; GPHA 2011b; ePT 2009; Pharm Tech CPA 2009.



Appendix

9 Appendix

9.1 Abbreviations

ACA: Affordable Care Act

API: Active Pharmaceutical Ingredients

CAGR: Compound Annual Growth Rate

CMO: Contract Manufacturing Organizations

CPA: Chemical Pharmaceutical Generic Association

CNS: Central Nervous System

CVS: Cardiovascular System

ENT: Ear, Nose and Throat

FDA: Food and Drug Administration

FOB: Follow-On Biologics

GTI: Gastrointestinal Tract

GMP: Good Manufacturing Practice

NIH: National Institute of Health

R&D: Research and Development

SCA: South and Central America

S-CHIP: The State Children’s Health Insurance Program

VA: Veteran’s Administration

9.2 Market Definitions

The Americas refers to North America and South and Central America. North America we defined as the US and Canada. South and Central America we considered as single entity (we considered Mexico and Brazil and Argentina market dynamics while forecasting the revenue values of South and Central America).

9.3 References

Canada generics (CPGA) 2011 SCRIP; Available from http://www.canadiangenerics.ca/en/resources/market_trends.asp (accessed on: June 6, 2012).

Generic Pharmaceutical Association (GPHA) 2011a SCRIP; Available from http://www.gphaonline.org/about-gpha/about-generics/case/generics-providing-savings-americans (accessed on: June 6, 2012).

Pharm Tech CPA 2009 SCRIP; Available from: http://www.pharmtech.com/pharmtech/Article/Promising-Outlook-for-Biotech-APIs/ArticleStandard/Article/detail/570627 (accessed on: July 1, 2012).

Pharmaceutical Technology Sourcing and Management (PTSM) 2011 SCRIP; Available from http://www.pharmtech.com/pharmtech/Most+Viewed+Articles/Global-Pharma-Market-Expected-to-Reach-1-Trillion/ArticleStandard/Article/detail/724871 (accessed on: June 16, 2012).

Shifting Fortunes in API Market (API Growth) 2009 SCRIP; Available from Growthhttp://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=615825 (accessed on: June 26, 2012).

US Generics Approval (GPHA) 2011b SCRIP; Available from: http://www.gphaonline.org/about-gpha/about-generics/case/recent-approvals (accessed on: June 6, 2012).



Appendix

US Biopharmaceutical market (phrma) 2011 SCRIP; Available from http://www.phrma.org/sites/default/files/84/battelle-phrmabiopharmaceuticalsimpacts-usandstatesummary.pdf (accessed on: July 6, 2012).

US Patents (USPTO) 2011 SCRIP; Available from http://www.uspto.gov/patents/resources/terms/156.jsp (accessed on: July 6, 2012).

The Electronic Newsletter of Pharmaceutical (ePT 2009) SCRIP; Available from Technologyhttp://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=637179 (accessed on: June 26, 2012).

9.4 Methodology

GBI Research’s dedicated research and analysis teams consists of experienced professionals with marketing, market research and consulting backgrounds in the petrochemical industry and advanced statistical expertise.

GBI Research adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and the Strategic and Competitive Intelligence Professionals (www.scip.org).

All GBI Research databases are continuously updated and revised.

9.4.1 Coverage

The objective of updating GBI Research’s coverage is to ensure that it represents the most up to date vision of the industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company, association and competitor sources.

Company coverage is based on three key factors: market capitalization, revenues and media attention/innovation/market potential. This can be further supported by the following:

An exhaustive search of 56 member exchanges is conducted and companies are prioritized on the basis of their market capitalization.

The estimated revenues of all major companies, including private and governmental, are gathered and used to prioritize coverage.

Companies which are making the news, or which are of particular interest due to their innovative approach, are prioritized.

GBI Research aims to cover all major news events and deals in the petrochemical industry, updated on a daily basis.

9.4.2 Secondary Research

The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and US Securities and Exchanges Commission (SEC) filings.

Industry trade journals and other literature.

Internal and external proprietary databases.

National government documents, statistical databases and market reports.

News articles, press releases and web-casts specific to the companies operating in the market.



Appendix

9.4.3 Primary Research

GBI Research conducts hundreds of primary interviews a year with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions:

It provides first-hand information on market size, market trends, growth trends, competitive landscape, and future outlooks for markets and sectors

It helps in validating and strengthening secondary research findings

It further develops the analysis team’s expertise and market understanding

Primary research involves email interactions, telephone interviews and face-to-face interviews for each market, category, segment and sub-segment across geographies

The participants who typically take part in such a process include, but are not limited to:

Industry participants: CEOs, VPs, business development managers, market intelligence managers and national sales managers,

Outside experts: investment bankers, valuation experts, research analysts and key opinion leaders specializing in petrochemicals markets.

9.4.4 Expert Panel Validation

GBI Research uses a panel of experts to cross-verify research and forecast methodologies and drive its analytical content.

The GBI Research expert panel comprises marketing managers, product specialists, international sales managers from petrochemical companies; academics and geologists from research universities, consultants from venture capital funds and distributors/suppliers of petro chemicals goods and services.

9.6 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GBI Research.

GBICH0071MR Active Pharmaceutical Ingredients sample · Active Pharmaceutical Ingredients (API) Market in the Americas to 2017 Shift Towards Generics and Biosimilars as South and

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