Downstream Processing in Biopharmaceuticals · stages of downstream processing, such as the removal...

Downstream Processing in Biopharmaceuticals Adoption of Disposable Technology at Improved Economies of Scale to Optimize Production Efficiency and Cost-effectiveness

GBI Research Report Guidance

GBIHC215MR / Published NOV 2012

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

GBI Research Report Guidance

The report provides an analysis of the various manufacturing techniques, emerging technologies, and key stakeholders in the biopharmaceutical industry. It also explains the role of downstream processing along with the different challenges and unmet needs identified in the biopharmaceutical industry. The report provides information on reagent market and reagent suppliers of downstream processing.

The report starts with an executive summary highlighting the key points of the biopharmaceutical Contract Manufacturing Organization (CMO) market, the downstream processing market, and the reagent market.

Chapter three briefly describes biopharmaceuticals, their manufacturing, downstream processing, and upstream processing.

Chapter four focuses on the role of downstream processing in the biopharmaceutical industry, and analyzes and compares the various manufacturing processes, and gives the key stakeholders in the manufacturing sector. It also provides information on the reagents used, reagent suppliers, equipment suppliers, and reagent market.

Chapter five covers the global CMO market, CMO market for biopharmaceuticals, and the CMO market for downstream processing.

Chapter six focuses on the challenges and unmet needs in the market, and covers all the major issues related to downstream processing and their desired stage in the future.

Chapter seven focuses on emerging technologies and covers all major technological developments in downstream processing, especially focusing on single-use technologies.

Chapter eight focuses on industry analysis, and covers key drivers and restraints, the impact of environmental factors, and the market dynamics of the downstream process.

Chapter nine covers all the key players in the downstream equipment market, reagent market, and CMO industry across the globe.


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

Downstream Processing in Biopharmaceuticals: - Executive Summary

Downstream Processing in Biopharmaceuticals - Executive Summary

Global Contract Manufacturing Organizations Market is Set to Grow Steadily due to the Increased Outsourcing of Pharmaceutical Production for Western Pharmaceutical Manufacturers to Asian Countries

Initially, the concept of providing total biopharmaceutical solutions was present only within the US and certain European countries. Over the past couple of years, countries such as India, Korea and China have started adopting the same business model. Due to vast differences in production and labor costs, manufacturers are shifting their focus to Asian Contract Manufacturing Organizations (CMOs). The overall cost of drug manufacturing in India is up to XX% cheaper than in Western countries. Cost savings at this scale present an excellent opportunity for Western pharmaceutical manufacturers to outsource to Asian CMOs. Apart from this, CMOs are also applying a strategy of integration. Over the past couple of years, CMOs have been integrating their service portfolios to offer complete solutions to pharmaceutical manufacturers. Through these kinds of relationships, both the CMOs and the pharmaceutical manufacturers can pursue large-scale business opportunities using each other’s facilities.

GBI Research suggests that the global CMO market is set to grow steadily due to the increased outsourcing of pharmaceutical production for Western pharmaceutical manufacturers to Asian countries. The global CMO market was valued at $XX billion in 2011. This market grew at around XX% over 2008, when the market was approximately $XX billion. The major factor driving this market is the increase in the sourcing of biopharmaceutical and generic manufacturing. The market revenues are forecast to reach an approximate value of $XX billion by 2018, growing at a CAGR of XX% from 2011.

Downstream Processing, Global, Contract Manufacturing Organizations, Biopharmaceutical Market, Revenue ($bn), 2008–2018

2008 2011 2018

Rev

enue

($bn

)

CAGR (2008–2011) : XX%

CAGR (2011–2018) : XX%

Source: GBI Research

Cost savings present an excellent opportunity for Western pharmaceutical manufacturers to outsource to Asian CMOs


Page 5 © GBI Research. This is a licensed product and is not to be photocopied

Table of Contents

1 Table of Contents

1 Table of Contents................................................................................................................................. 5 1.1 List of Tables............................................................................................................................. 7 1.2 List of Figures............................................................................................................................ 8

2 Downstream Processing in Biopharmaceuticals - Introduction............................................................... 9 3 Downstream Processing in Biopharmaceuticals - Market Overview ......................................................10

3.1 Overview of Biopharmaceuticals ..............................................................................................10 3.1.1 Cytokines .........................................................................................................................10 3.1.2 Enzymes...........................................................................................................................10 3.1.3 Hormones ........................................................................................................................10 3.1.4 Clotting Factors................................................................................................................10 3.1.5 Vaccines ..........................................................................................................................11 3.1.6 Monoclonal Antibodies.....................................................................................................11 3.1.7 Cell Therapies...................................................................................................................11 3.1.8 Antisense Drugs ...............................................................................................................11 3.1.9 Peptide Therapeutics........................................................................................................11

3.2 Overview of Downstream Processing in Biopharmaceuticals .....................................................12 3.2.1 A Typical Downstream Processing Operation ....................................................................13 3.2.2 Major Check Points during Downstream Processing ..........................................................14

4 Downstream Processing in Biopharmaceuticals - Role of Downstream Processing in the Biopharmaceutical Industry.................................................................................................................15

4.1 Major Reagents, Reagent Suppliers and Reagents Market related to Downstream Process .......18 4.1.1 Major Reagents ...............................................................................................................18 4.1.2 Reagent Suppliers ............................................................................................................19 4.1.3 Reagent Market...............................................................................................................21

4.2 Major Equipment Suppliers......................................................................................................22 5 Downstream Processing in Biopharmaceuticals - Downstream Processing Market for CMOs.................24

5.1 Global CMO Market Overview..................................................................................................24 5.2 CMO Biopharmaceuticals Market Characterization...................................................................24 5.3 CMO Market Size for Downstream Processing ..........................................................................26

6 Downstream Processing in Biopharmaceuticals - Challenges and Unmet Needs in Downstream Bioprocess ..........................................................................................................................................28

6.1 Challenges ...............................................................................................................................28 6.1.1 Chromatographic Capture ................................................................................................28 6.1.2 Reducing the Purification Steps.........................................................................................28 6.1.3 Titer Increment/Capacity Bottleneck.................................................................................29 6.1.4 Virus Clearances...............................................................................................................29 6.1.5 Scaling –Up......................................................................................................................29

6.2 Unmet Needs...........................................................................................................................29 6.2.1 Unmet Medical Needs ......................................................................................................29 6.2.2 Realistic Achievement of Economies of Scale.....................................................................29 6.2.3 Technological Development of Disposables at Large Scale.................................................29 6.2.4 Reagent Costs and their Effectiveness...............................................................................30

7 Downstream Processing in Biopharmaceuticals - Emerging Technologies and their Implications ...........31 7.1 Single Use Technology/Disposable Technology .........................................................................32

7.1.1 Advantages......................................................................................................................32 7.1.2 Disadvantages .................................................................................................................32

7.2 Multi-column Chromatography ................................................................................................32 7.2.1 Advantages......................................................................................................................32 7.2.2 Disadvantages .................................................................................................................33

7.3 Tangential Flow Filtration.........................................................................................................33



Table of Contents

7.3.1 Advantages......................................................................................................................33 7.3.2 Disadvantages .................................................................................................................33

8 Downstream Processing in Biopharmaceuticals - Industry Analysis.......................................................34 8.1 Key Drivers and Restraints........................................................................................................34

8.1.1 Key Drivers of Downstream Processing Market .................................................................34 8.1.2 Key Restraints of Downstream Processing Market.............................................................35

8.2 Porter’s Five Forces Model for Industry Analysis .......................................................................36 8.3 Major Events and their Impact – Analysis .................................................................................38

9 Downstream Processing in Biopharmaceuticals - Competitive Landscape .............................................39 9.1 Market Dynamics of Downstream Processing and Impact .........................................................39

9.1.1 Market Structure..............................................................................................................39 9.2 Key Equipment Players.............................................................................................................40

9.2.1 Pall Corporation ...............................................................................................................40 9.2.2 Millipore..........................................................................................................................42 9.2.3 Sartorius Stedim Biotech S.A.............................................................................................44

9.3 Key Reagent Players.................................................................................................................46 9.3.1 Life Technologies..............................................................................................................46 9.3.2 Sigma Aldrich...................................................................................................................48

9.4 Key CMO Players......................................................................................................................50 9.4.1 Lonza...............................................................................................................................50 9.4.2 Boehringer Ingelheim.......................................................................................................52 9.4.3 Diosynth Biotechnology....................................................................................................54

10 Downstream Processing in Biopharmaceuticals - Appendix ..................................................................56 10.1 Market Definitions...................................................................................................................56 10.2 Abbreviations ..........................................................................................................................56 10.3 Bibliography ............................................................................................................................57 10.4 Research Methodology ............................................................................................................58

10.4.1 Coverage .........................................................................................................................58 10.4.2 Secondary Research .........................................................................................................58 10.4.3 Primary Research .............................................................................................................59 10.4.4 Expert Panel Validation ....................................................................................................59

10.5 Contact Us...............................................................................................................................59 10.6 Disclaimer................................................................................................................................59



Table of Contents

1.1 List of Tables

Table 1: Downstream Processing, Global, Cost Breakups of Upstream and Downstream Processing, 2011...............................................................................................................................................17

Table 2: Downstream Processing, Global, Reagent Suppliers, 2011........................................................20 Table 3: Downstream Processing, Global, Total Reagent Market for Downstream Processing, Revenue

($m), 2009–2011.....................................................................................................................22 Table 4: Downstream Processing, Global, Total Reagent Market for Downstream Processing, Revenue

Forecast ($m), 2011–2018.......................................................................................................22 Table 5: Downstream Processing, Global, Equipment Suppliers, 2011....................................................23 Table 6: Downstream Processing, Global, CMO Biopharmaceutical Market, Revenue ($bn), 2008–2011.25 Table 7: Downstream Processing, Global, CMO Biopharmaceutical Market, Revenue Forecast ($bn),

2011–2018 .............................................................................................................................25 Table 8: Downstream Processing, Global, Downstream Processing Market for CMOs, Revenue ($bn),

2009–2011 .............................................................................................................................27 Table 9: Downstream Processing, Global, Downstream Processing Market for CMOs, Revenue ($bn),

2011–2018 .............................................................................................................................27 Table 10: Downstream Processing, Key Equipment Players, Pall Corporation, Major M&A Deals, 2009–

2012.......................................................................................................................................41 Table 11: Downstream Processing, Key Equipment Players, EMD Millipore, Major M&A Deals, 2009–2010

...............................................................................................................................................43 Table 12: Downstream Processing, Key Equipment Players, Sartorius Stedim Biotech S.A, Major M&A

Deals, 2008.............................................................................................................................45 Table 13: Downstream Processing, Key Reagent Players, Life Technologies, Major M&A Deals, 2009–2011

...............................................................................................................................................47 Table 14: Downstream Processing, Key Reagent Players, Sigma-Aldrich, Major M&A Deals, 2009–2012...49 Table 15: Downstream Processing, Key CMO Players, Lonza, Major M&A Deals, 2009–2010....................51 Table 16: Downstream Processing, Key CMO Players, Boehringer Ingelhiem, Major M&A Deals, 2009–2011

...............................................................................................................................................53 Table 17: Downstream Processing, Key CMO Players, Diosynth Biotechnology, Major M&A Deals, 2009–

2011.......................................................................................................................................55



Table of Contents

1.2 List of Figures

Figure 1: Downstream Processing, Global, Biopharmaceutical Types, 2011.............................................10 Figure 2: Downstream Processing, Global, Overview of General Drug Development Process, 2011..........12 Figure 3: Downstream Processing, Global, Process Steps, 2011 ..............................................................13 Figure 4: Downstream Processing, Global, Changing Distribution of Cost along with Yield Increment, 2011

...............................................................................................................................................15 Figure 5: Downstream Processing, Global, Yield Percentage vs Number of Purification Steps, 2011.........16 Figure 6: Downstream Processing, Global, Cost Breakups of Upstream and Downstream Processing, 2011

...............................................................................................................................................17 Figure 7: Downstream Processing, Global, Total Reagent Market for Downstream Processing, Revenue

($m), 2009–2018.....................................................................................................................21 Figure 8: Downstream Processing, Global, CMO Biopharmaceutical Market, Revenue ($bn), 2008–2018.25 Figure 9: Downstream Processing, Global, Downstream Processing Market for CMOs, Revenue ($bn),

2009–2018 .............................................................................................................................26 Figure 10: Downstream Processing, Global, Challenges, 2011...................................................................28 Figure 11: Downstream Processing, Global, Emerging Technologies and their Likely Adaptation, 2011......31 Figure 12: Downstream Processing, Global, Industry Analysis, Key Drivers and Restraints, 2011................35 Figure 13: Downstream Processing, Global, Industry Analysis, Porter’s Five Forces Model, 2011 ...............36 Figure 14: Downstream Processing, Global, Industry Analysis, Major Market Events and their Impact, 2011

...............................................................................................................................................38 Figure 15: Downstream Processing, Global, Industry Analysis, Market Dynamics, 2011.............................39 Figure 16: Downstream Processing, Key Equipment Players, Business Overview, Pall Corporation, 2011 ...40 Figure 17: Downstream Processing, Key Equipment Players, Business Overview, EMD Millipore, 2011......42 Figure 18: Downstream Processing, Key Equipment Players, Business Overview, Sartorius Stedim Biotech

S.A, 2011 ................................................................................................................................44 Figure 19: Downstream Processing, Key Reagent Players, Business Overview, Life Technologies, 2011......46 Figure 20: Downstream Processing, Key Reagent Players, Business Overview, Sigma-Aldrich, 2011...........48 Figure 21: Downstream Processing, Key CMO Players, Business Overview, Lonza, 2011 ............................50 Figure 22: Downstream Processing, Key CMO Players, Business Overview, Boehringer Ingelheim, 2011....52 Figure 23: Downstream Processing, Key CMO Players, Business Overview, Diosynth Biotechnology, 2011.54



Downstream Processing in Biopharmaceuticals - Introduction

2 Downstream Processing in Biopharmaceuticals - Introduction

Downstream processing applies to the process of recovery and purification of biosynthetic products, recycling the components and treating product waste after biological fermentation. There are various stages of downstream processing, such as the removal of insolubles; isolation, purification, and polishing of the product.

Downstream processing has a major role in biopharmaceutical manufacturing industry. It accounts for more than XX% of the total manufacturing cost. However, the cost of production may vary as per the titer yield (protein production level).



Downstream Processing in Biopharmaceuticals - Role of Downstream Processing in the Biopharmaceutical Industry

4 Downstream Processing in Biopharmaceuticals - Role of Downstream Processing in the Biopharmaceutical Industry

Downstream processing plays a major role in overall drug production, accounting for XX% of the total manufacturing cost. Though the cost may vary according to the titer yield, developers are concerned with devising ways to cut down their increasing costs.

Increasing the protein production level, commonly known as titer, is the prime focus in downstream processing and can be achieved in a cell-culture bioreactor. The increasing titers in cell culture have recently changed the focus of process development efforts toward improving the economics of product recovery and purification processes.

Figure 4: Downstream Processing, Global, Changing Distribution of Cost along with Yield Increment, 2011

3g/liter

1g/liter

0.1g/liter

Tite

r yei

ld in

g/li

ter

Upstream cost percentage Downstream cost percentage

Source: GBI Research; Vermasvuori , 2009

g/liter: grams per liter

According to research conducted by Sommerfeld and Strube (2005), if titer yield is increased from XXg/XX (gram per liter) to XXg/XX, drastic changes can be observed in the cost ratio of upstream and downstream processing.

With the development of new technologies, the overall cost remains low, but downstream processing costs are still much higher than upstream costs.

Additionally, if the increase in annual output is accompanied by titer increases, then the changes in the cost ratio of upstream and downstream processing are likely to become even more prominent. On a small scale, fixed costs tend to dominate and any changes in raw materials will have a minimal impact. However, as the scale increases, the role of raw materials becomes more critical. It is therefore important to look at the distribution of the costs.



Downstream Processing in Biopharmaceuticals - Role of Downstream Processing in the Biopharmaceutical Industry

The figure and table below give the cost breakups of upstream and downstream processing:

Figure 6: Downstream Processing, Global, Cost Breakups of Upstream and Downstream Processing, 2011

Upstream processing for100 mg

Upstream processing for3,000 mg

Downstream Processing for100 mg

Downstream Processing for3,000 mg

Cos

t in

$

Materials Equipments Labor

Upstream costs have not increased much due to almost unaffected labor costs

Downstream costs have increased substantially due to high costs for labor and materials for production

Source: GBI Research; Suzanne, 2009

Table 1: Downstream Processing, Global, Cost Breakups of Upstream and Downstream Processing, 2011

Upstream Processing

for 100mg Upstream Processing

for 3,000mg Downstream

Processing for 100mg Downstream Processing

for 3,000mg

Materials

Equipment

Labor

Source: GBI Research; Suzanne, 2009l

It shows that the cost of downstream processing has increased substantially due to high labor costs and the material cost of purification. However, a slight change in labor cost does not affect the upstream production cost (Suzanne, 2009)



Downstream Processing in Biopharmaceuticals Appendix

10 Downstream Processing in Biopharmaceuticals - Appendix

10.1 Market Definitions

Biologics: Products derived from living sources, such as humans, animals, bacteria, and viruses such as vaccines, immune globulin, and anti-toxins.

Downstream Bioprocess: When the cell mass from the upstream processing segment are processed to meet purity and quality requirements, this process is referred to as downstream processing.

Transgene: When a foreign gene and control sequence is introduced in a genetic structure in order to make some modification, it is called a transgene.

Capacity Bottleneck: A bottleneck is a phenomenon where the performance or capacity of an entire system is limited by a single or limited number of components or resources.

10.2 Abbreviations

AEX: Anion Exchange Chromatography

ATPS: Aqueous Two Phase Systems

BPVs: Bioprocess Vessels

CAGR: Compound Annual Growth Rate

CFF: Cross Flow Filtration

CHO: Chinese Hamster Ovary

CIP: Cleaning-In-Place

CMOs: Contract Manufacturing Organizations

CS: Cell Systems

DNA: Deoxyribonucleic Acid

DSP: Downstream Processing

EBA: Expanded-Bed Adsorption

FT: Flow Through

GS: Genetic Systems

HCP: Host Cell Proteins

HIC: Hydrophobic Interaction Chromatography

MBS: Molecular Biology Systems

MCC: Multi-Column Chromatography

MF: Microfiltration

mRNA: Messenger Ribonucleic Acid

PEG: Polyethylene Glycol

PES: Polyethersulfone

RNA: Ribonucleic Acid

SEC: US Securities and Exchanges Commission

SEZ: Special Economic Zone

SIAL: Sigma-Aldrich Corporation

SIP: Steam-In-Place

SMB: Simulated Moving Bed Chromatography




TFF: Tangential Flow Filtration

UF: Ultrafiltration

UF/DF: Ultrafiltration/diafiltration

WFI: Water for Injection

10.3 Bibliography

Bengio S and Sievers D (2012). Chromatographic Purification in Downstream Processing. BioProcess International.

Boehringer Ingelheim GmbH (2011). Annual Report. Available from: http://annualreport.boehringer-ingelheim.com/uploads/media/BoehringerIngelheim_Annual_Report_2011_complete.pdf

Carta G and Jungbauer A (2010). Protein Chromatography: Process Development and Scale-Up.

Diosynth Biotechnology (2011). Annual Report. Available from: http://www.diosynthbiotechnology.com/modules/mastop_publish/files/files_46532e5906899.pdf

Dutta R (2008). Fundamentals of Biochemical Engineering. Available from: http://xa.yimg.com/kq/groups/23466667/1698543276/name/fulltext_10.pdf

EMD Millipore (2011). Annual Report. Available from: http://www.merckgroup.com/company.merck.de/en/images/Merck_Annual_Report_2011_EN_tcm1612_87112.pdf?Version= [Accessed May, 2012].

Life Technologies Corporation (2011). Annual Report. Available from: http://www.lifetechnologies.com/content/dam/LifeTech/Documents/PDFs/about-us/annual-review/AR_2011Final.pdf

Lonza Group Ltd. (2011). Annual Report. Available from: http://www.lonza.com/~/media/Assets/about-lonza/Investor%20Relations/Investor%20Relations%20Misc%20Assets/Financial%20Reports/2011_FY_E_final.ashx [Accessed May, 2012].

Marc B, et al. (2009). Single-Use, Continuous-Countercurrent, Multicolumn Chromatography. BioProcess International.

Markus L, et al. (2011). Disposable Downstream Processing for Clinical Manufacturing. BioProcess International. Available from:http://www.bioprocessintl.com/journal/supplements/2011/May/Disposable-Downstream-Processing-for-Clinical-Manufacturing-315201 [Accessed February, 2012].

Millipore Technical Publications (2012). Increasing Purity on ProSep-vA Affinity Chromatography Media using an Intermediate Wash Step. Available from: http://www.millipore.com/techpublications/tech1/tb1026en00 [Accessed 8 February, 2012]

Pall Corporation (2011). Annual Report. Available from: http://investors.pall.com/phoenix.zhtml?c=110318&p=irol-reportsannual [Accessed 17 May, 2012].

Pall Corporation (2012). Tangential Flow Filtration Introduction. Available from: http://www.pall.com/main/Biopharmaceuticals/Tangential-Flow-Filtration-Introduction-51907.page [Accessed February, 2012].

Russell J (2012). Reducing Uncertainty Surrounding Biosimilar Production. Genetic Engineering and Biotechnology News. Available from: http://www.genengnews.com/keywordsandtools/print/1/27094/ [Accessed May, 2012]

Sartorius Stedim Biotech S.A. (2011). Annual Report. Available from: http://www.sartorius.com/fileadmin/media/global/company/ir/ir_reference_document_2011_sartorius_stedim_biotech.pdf

Science Daily (2012). Biopharmaceutical. Available from: http://www.sciencedaily.com/articles/b/biopharmaceutical.htm [Accessed 20 February, 2012]




Sigma-Aldrich Corporation (2011). Annual Report. Available from: http://www.sigmaaldrich.com/etc/medialib/corporate/annual-report/2011/2011ar-pdf-annual-report.Par.0001.File.dat/Sigma_Aldrich_2011AnnualReport.pdf

Sommerfeld and Strube (2005). Challenges in biotechnology production—generic processes and process optimization for monoclonal antibodies. Available from: http://www.aseanbiotechnology.info/Abstract/21022478.pdf

Suzanne S (2009). Economic Drivers and Trade-Offs in Antibody Purification Processes. BioPharm International. Available from: http://www.biopharminternational.com/biopharm/article/articleDetail.jsp?id=633295&sk=&date=&pageID=2 [Accessed 7 February, 2012].

Thermo Scientific (2012). Mem-PER Eukaryotic Membrane Protein Extraction Kit. Available from: http://www.piercenet.com/browse.cfm?fldID=06010422 [Accessed 24 February, 2012].

Vermasvuori R (2009). Production Of Recombinant Proteins And Monoclonal Antibodies –Techno-Economical Evaluation Of The Production Methods. Available from: http://lib.tkk.fi/Lic/2009/urn100121.pdf

10.4 Research Methodology

GBI Research’s dedicated research and analysis teams consist of experienced professionals with a pedigree in marketing, market research, consulting backgrounds in the medical devices 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. The following research methodology is followed for all databases and reports.

10.4.1 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.

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

The coverage is further streamlined and strengthened with additional inputs from GBI Research’s expert panel (see below).

10.4.2 Secondary Research

Secondary research was carried out on internal and external sources being to obtain qualitative and quantitative information relating to each market.

The secondary research sources that are referred to in this report include but are not limited to:

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

Industry trade journals, scientific journals and other technical literature

Relevant patent and regulatory databases

National government documents, statistical databases and market reports

News articles, press releases and webcasts specific to the companies operating in the market




10.4.3 Primary Research

GBI Research conducts hundreds of primary interviews each 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 the market size, market trends, growth trends, competitive landscape, and future outlook

Helps in validating and strengthening the secondary research findings; and

Further develops the analysis team’s expertise and market understanding

Primary research involves email correspondence, and telephone interviews as well as 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, marketing/product managers, market intelligence managers and national sales managers;

Hospital stores, laboratories, pharmacies, distributors and paramedics;

Outside experts: investment bankers, valuation experts, research analysts specializing in specific medical equipment markets; and

Key Opinion Leaders (KOLs): physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of pharmaceutical drugs.

10.4.4 Expert Panel Validation

GBI Research uses a panel of experts to cross-verify its databases and forecasts.

GBI Research’s expert panel comprises marketing managers, product specialists, international sales managers from medical device companies, academics from research universities, KOLs from hospitals, consultants from venture capital funds and distributors/suppliers of medical equipment and supplies.

Historic data and forecasts are relayed to GBI Research’s Expert Panel for feedback and adjusted in accordance with their feedback.

10.6 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.

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