Title: Secondary market research, Competitor and Customer market segment

analysis for DECOY-7 Project

Prepared For: Niall Barron

Prepared By: Padraig Doolan

Date: July 31st 2015

Contents:

Executive Summary

1.0 Global Biologics/Biopharmaceuticals market

2.0 Geographic market analysis

3.0 US Biopharmaceuticals market

4.0 Rate of product approvals

5.0 Product Types that dominate or are growing

5.1 mAbs

5.2 Therapeutic proteins

5.3 Vaccines

6.0 Chinese Hamster Ovary (CHO)-based expression system as a manufacturing platform:

7.0 mAbs will be the biggest growth area in biopharmaceuticals

8.0 RNA interference (RNAi): Market Value and Growth Trends

9.0 miRNA research tools and miRNA Service Providers: Market Value and Growth Trends

10.0 Putting a value on DECOY-7 miRNA-based modulation of CHO-produced biopharmaceuticals

11.0 Drivers for and Value of Contract Research in Biopharma

11.1 CRO Definition:

12.0 SWOT Analysis

13.0 References

Executive Summary:

The global market for biologics and bioengineered protein drugs totals sales in the hundreds

of billions of dollars and continues to grow at medium-high single-digit rates in all markets.

The USA is the leader in the bioengineered protein drug market, followed by the Emerging

markets (of China, India, the Pacific Rim and Russia), followed by the European market.

The rate of biopharmaceutical approvals in the United States and European Union has

remained relatively steady, while mAbs and insulins are the future growth products.

As Insulins are predominantly produced in microbial systems, DCU will focus efforts on

recruiting mAb-producing customers as a priority.

CHO is the dominant mammalian production platform for the production of

biopharmaceuticals

The value of the miRNA service market to the production of mAbs in CHO is currently

estimated to be worth at least $21.8 million and is expected to increase to $35.1 million by

2018 at a CAGR of 10.0%

1.0 Global Biologics/Biopharmaceuticals market

The global biologics market totalled $200.6 billion in 2013 and is expected to grow to nearly $234

billion in 2014 and to $386.7 billion by the end of 2019 (Figure 1), at compound annual growth rate

(CAGR) of 10.6%[1].

Figure 1. Global Biologics Market forecast (2012-2019) ($ millions) [1]

The global market for bioengineered protein drugs was valued at $151.9 billion in 2013, increasing to

about $157 billion in 2014[2,3]. Another study[4] estimated the total cumulative sales value of

biopharmaceuticals at $140 billion in 2013, with cumulative sales over the most recent survey period

for which statistics are available (2010–2013 inclusive) reaching just short of half a trillion dollars.

The market is further expected to grow to about $222.7 billion in 2019, at a compound annual

growth rate (CAGR) of 7.2% from 2014 through 2019[2,3].

2.0 Geographic market analysis:

Currently, the USA represents the largest segment of the global biologics market, at 39.2%[1].

However, this has decreased from 41.2% in 2011 and is expected to continue to decrease to 37.8%

by 2019; largely the result of more product development and launches in the developing countries

during that period[1]. The UK market has remained relatively constant (at 24%), while the emerging

markets of China, India, the Pacific Rim and Russia have increased steadily to a 22.5% market share

in 2015 and it is projected that his segment will continue to show growth of 8.2% through the 2013-

2019 forecast period[1]. The rest of the world (ROW) accounts for approximately 14.3% of the global

biologics market[1].

The USA is the leader in the bioengineered protein drug market, registering $68 billion in 2013 and is

expected to be at $111 billion by 2019, a CAGR of 9.1%[2,3]. Emerging markets secured about $47.5

billion in 2013 and that figure is expected to grow at a CAGR of 4% to reach over $56 billion by 2019,

while the European market had sales of about $36.5 billion in 2013 and is anticipated to reach nearly

$55.4 billion by 2019 at 7.4% CAGR (Figure 2) [2,3].

Figure 2. Global Market for bioengineered protein drugs (2012-2019) ($ millions) [3]

3.0 US Biopharmaceuticals market

In 2012, the US biotech sector grew at a high double-digit rate, driven by rapid uptake of several

recently launched monoclonal antibodies (mAbs) and diabetes products[5]. Total sales of biologics in

the United States during that period reached ~$63.6 billion, an 18.2% increase over 2011 sales, more

than 7-fold higher than sales in the pharmaceutical sector overall, which experienced growth of only

2.5% in 2012[5]. During 2012–2013, overall US sales of biologics grew by 18.2%, which was sharply

higher than the low- to mid-single-digit growth rate of the past 4–5 years[5]. Growth in 2014 was

driven by the success of many recently launched products, stabilization of sales of products with past

safety woes (e.g., ESAs) and continued growth of existing products[5].

4.0 Rate of product approvals

The number of approved biopharmaceuticals marketed in the United States and/or EU now stands

at 212[4]. During the period of 2010-2014, over a quarter (26%) of all genuinely new drug approvals

in the United States were biopharmaceuticals, which is in line with the value reported in previous

surveys (21–24%)[4]. Over the period of 2010-2014, the rate of biopharmaceutical approvals in the

United States and European Union has remained relatively steady compared with previous time

periods, with the approval of 54 biopharmaceutical (recombinant biologic) products (17 mAbs, 9

hormones, 8 blood-related proteins, 6 enzymes, 4 vaccines, 4 fusion proteins, 4 granulocyte-colony

stimulating factors , 1 interferon and 1 gene therapy-based product)[4]. 32 (59%) of these new

products were genuinely new to the market (containing 30 new active ingredients), while the

remaining products represent biosimilars, me-too products and products previously approved

elsewhere[4].

5.0 Product Types that dominate or are growing: mAbs, Hormones Fusion Proteins, Therapeutic

Enzymes and Recombinant Vaccines

5.1 mAbs: mAbs dominate approvals overall since the end of the 1990s and between 2010-2014

they represented almost 27% of all approvals[4]. Monoclonal Antibodies (mAbs) comprised 38.6% of

the 2013 market, worth nearly $77.4 billion and this segment is expected to increase to nearly

$153.2 billion by 2019, a CAGR of 12.1%, the fastest predicted rate rise within the total biologics

market[1]. US sales of mAbs were approximately $24.6 billion in 2012, an increase of 18.3% over 2011

figures (see Figure 3[5]).

5.2 Therapeutic proteins: Therapeutic proteins (broken down[5] into 7 sub-categories; hormones,

growth factors, fusion proteins, cytokines, therapeutic enzymes, blood factors and anti-coagulants)

accounted for 47.2% of the 2013 market ($94.6 billion) and are expected to increase to nearly

$168.3 billion by 2019, a CAGR of 8.2%[1]. Hormones were clearly the 2nd-highest-selling class of

biologics in the US in 2012, with growth factors, fusion proteins and cytokines the next “big-three”

products maintaining a substantial market share (Figure 3[5]). Of these three, fusion proteins (35.3%)

and cytokines (14.5%) demonstrated a strong upswing in growth during 2012 (Figure 3[5]).

Despite comprising the largest segment of the therapeutic proteins output, majority of hormones

(with some exceptions) are not produced in mammalian cells and thus lie outside the application

scope of the DECOY-7 technology.

Figure 3: Top nine categories of biologic drugs in terms of US sales in 2012. The pie chart shows US

sales of these drug categories. The table shows the growth rates of the categories between 2011 and

2012. The red boxes indicate the major categories showing the fastest growth rate during that

period (Figure 2 from [5]).

Therapeutic enzymes, blood factors and anti-coagulants accounted for a much smaller share of the

US biologics market, although the therapeutic enzymes market segment experienced a strong

upswing in growth rate (34.3%) during 2012 (Figure 3[5]). The period of 2010-2014 has also

witnessed an absence of approvals (and thus drop-off in approval rates) for a range of traditional

product classes; for example, no recombinant thrombolytic agent, anticoagulant, interleukin or

erythropoietin has been approved since 2010, likely reflective of market saturation relative to

demand in the case of these products[4].

One stark outcome from this analysis is that the success story of sales growth for most of these drug

classes are largely dependent on a small number of “blockbuster” drugs; for example, just four

products make up 80% of all hormone sales[5], while the ten best-selling biopharmaceuticals taken

together (generating sales of $69.8 billion in 2013), represented 50% of total biopharmaceutical drug

product revenues that year[4]. This trend has been consistent over the recent history of the industry;

for example, comparing both 2004 and 2014, the top ten selling products comprised nearly half of all

biopharmaceutical sales and four of the top ten products in 2004 have remained on the top ten list

for 2014 (Enbrel, Remicade, Rituxan/Mabthera, and Neulasta/Neupogen)[6].

To highlight this, Table 1 shows the estimated number of biopharmaceutical products currently sold

in the US market, divided into the nine categories of biologic drugs[5], illustrating the comparatively

much smaller number of clear market leaders (and thus, drivers of sales growth) in each category.

Biologic Class No. Market Leaders Total No. of Products

MAbs 10 40

Hormones 13 Not estimated

Growth Factors 5 Not estimated

Fusion Proteins 3 10

Cytokines 4 Not estimated

Therapeutic Enzymes 6 Not estimated

Blood Factors 3 7

Recombinant Vaccines 4 Not estimated

Anti-coagulants Not estimated Not estimated

Total 212[4]

Table 1: Estimated number of biopharmaceutical products sold in the US market and number of market leaders for each category

5.3 Vaccines: Vaccines make up the third and final segment of the biologics market and while the

size of this market segment is substantial (worth $33.8 billion in 2014) and growing (at a rate of 14%

CAGR and expected to reach $65.2 billion by 2019)[1], the majority of vaccines are not produced in

mammalian cells and thus lie outside the application scope of the DECOY-7 technology. Figures for

recombinant vaccines[5] make up a much smaller proportion ($1.1 billion in 2012) of the overall

figure for vaccine sales and this market segment similarly experienced a strong upswing in growth

rate (32.1%) during 2012 (Figure 3[5]).

6.0 Chinese Hamster Ovary (CHO)-based expression system as a manufacturing platform:

CHO is the dominant mammalian production platform for the production of biopharmaceuticals.

Figure 4[4] compares mammalian versus nonmammalian-based expression systems for the

biopharmaceutical production and shows cumulative product approvals (1982–2014) and product

approvals for the period 2010–2014, demonstrating that CHO is responsible for 35.5% of cumulative

product approvals and easily dwarfs the application and success of competing mammalian

expression systems[4].

Figure 4. Expression systems used to manufacture biopharmaceutical products (Figure 5b from [5]).

The data set is expressed as a percentage of total biopharmaceutical product approvals for the

period in question.

Quantitatively, microbial production still predominates; in 2010, total biopharmaceutical

manufacturing activity equated to some 26.4 metric tonnes (26,400 kg) of pure protein (active

pharmaceutical ingredients) of which 68% (17.9 metric tonnes) were derived from microbial

systems, with the remaining 32% (8.5 metric tonnes) derived from mammalian systems[4]. However,

there has been a steady increase in the prominence of mammalian over nonmammalian-based

expression systems used for the production of approved products; from a 1:2 Mammalian: Non-

mammalian ratio prior to 1989 to a 3:2 ratio for the period 2010-2014[4].

7.0 mAbs will be the biggest growth area in biopharmaceuticals

Additionally, there are substantial product type differences between the platforms, with (for

example) Insulins constituting the bulk of product produced in microbial systems, whereas mAbs

(together with their more desirable configuration, specificity and high-growth-potential) constituting

the vast bulk of product produced in mammalian systems[4].

For example, given drug discovery timelines and irrespective of technological innovations in the

pipeline, it seems likely that approvals over the next few years will continue to be dominated by

mAb-based products, with demand projected to reach some 13.4 metric tonnes by 2016, almost

double the 2010 value[4]. mAbs are six of the top ten product sales in 2013, while the ongoing

breadth and depth of research and innovation within the antibody engineering field ensures that

mAb-based products will remain the most prominent class of biopharmaceuticals for the future[4].

Additionally, IMS Health projections suggest that biologic-based products will continue to gradually

increase in terms of overall pharmaceutical market share (~18% in 2012 to ~20% in 2017), with

growth dominated by mAbs and insulins[4].

Finally, a comparison of global biopharma sales between 2004 and 2014 demonstrated that antibody

products dominate the development pipeline (Figure 5[6].), with over 80% of the nearly 400 products

in late stage development (Phase 2 through BLA/MAA/NDA application) being antibody-related

products, only 10% of which are produced in microbial systems[6].

Figure 5: Biopharmaceutical Market Comparison 2004/2014. The plot compares global sales of

Recombinant therapeutic products and mAbs produced in mammalian and microbial expression

systems between 2004 and 2014 (Figure 1 from [6]).

8.0 RNA interference (RNAi): Market Value and Growth Trends

Academic and pharmaceutical interest in proteomics and genomics research is considered to be the

most important factor affecting growth in the Life Science Tools and Reagents market[7]. The global

market for life science tools and reagents (into which miRNAs would be typically classified) reached

$47.8 billion in 2012[7]. This figure is expected to increase to $51.3 billion in 2013 and $77.6 billion in

2018, with a projected five-year compound annual growth rate (CAGR) of 8.6%[7].

The RNA research market grew from $2 billion in 2011 to $2.1 billion in 2012[7]. Revenues in this

market are driven by innovations in miRNA research and this market will continue to grow at a CAGR

of 3.3% from 2013 to 2018, to reach almost $2.2 billion in 2013[7].

The RNA interference market grew from $922.9 million in 2011 to $962.6 million in 2012 and will

continue to grow at a CAGR of 3.9% to generate revenue of $1.2 billion by 2018 (Figure 6[7]).

Figure 6. Global revenues of tools used in the RNA Research/Interference market (2011-2018)

The North American RNA interference market generated $399.9 million in 2013 and will generate

approximate revenue of $487.8 million by 2018, growing at 4.1% CAGR[7]. The European and

emerging markets generated revenues of $292.7 million and $303.8 million, respectively, in 2013

and are expected to generate $352.8 million and $363.4 million, respectively, by 2018, growing at

respective CAGRs of 3.8% and 3.6% (see Figure 7[7].).

Figure 7. Global revenues of the RNA Interference market by region (2011-2018)

9.0 miRNA research tools and miRNA Service Providers: Market Value and Growth Trends

miRNA-based strategies offer many advantages over conventional gene therapy-based processes for

modulating cell line phenotypes. The most desirable quality of miRNA as process-modulating agents

is their potential to regulate multiple genes, often in with a common network or biochemical

pathway.

The global market for microRNA (miRNA) research tools, services, diagnostics and drug discovery

was valued at $478.8 million in 2013[8]. This market is expected to reach $572 million in 2014 and

over $1 billion in 2019, at a compound annual growth rate (CAGR) of 12.6% for the period of 2014 to

2019[8].

The global miRNA service market was valued at $40.7 million in 2013, $46.4 million in 2014 and is

expected to grow to $74.6 million by 2019, a CAGR of 10.0% (see Figure 8[8]).

Figure 8. Global market for miRNA research tools, services, diagnostics and drug discovery (2013-

2019)

10.0 Putting a value on DECOY-7 miRNA-based modulation of CHO-produced biopharmaceuticals

Putting an accurate value on the application of the DECOY-7 technology faces several challenges; (i)

the application of the technology is currently limited to the CHO expression system, (ii) while we

have accurate values for each of the biopharmaceutical sub-classes, the value of biopharmaceuticals

produced exclusively in CHO has not been independently estimated and (iii) the usage or value of

competing technologies has not been independently estimated.

To address this and to deliver an estimate of the commercial value of our technology, we have

utilised relevant value assessments for closely-related markets. For example, we have focused on

using only 2013 financial figures (2013 was chosen as a common year of reference) highlighted in

this report and have limited the estimates to production of mAbs only for simplicity (as the bulk of

mAbs are produced in CHO and also given the prevalence & high growth potential for this product

segment).

Combining these figures (as will be explained below), we estimate that the value of the DECOY-7

technology for mAb production in its currently-envisaged application format (miRNA-based

modulation of the CHO-based manufacturing platform) was worth nearly $21.8 million in 2013 and is

expected to grow at a CAGR of 10.0% to a value of $35.1 million in 2013 by 2019.

Derivation of value of DECOY-7 (and the associated application of miRNA research tools to CHO-

based production of mAbs):

1. $51.3 billion: 2013 value of global market for life science tools and reagents[7]

2. $478.8 million: 2013 value of global market for microRNA (miRNA) research tools,

services, diagnostics and drug discovery[8]

3. Therefore, in 2013, miRNA research tools represented <1% (0.93%) of the life science

tools market

4. $40.7 million: 2013 value of global miRNA service market, with an expected CAGR of

10.0% to grow to $74.6 million by 2019[8]

5. Therefore, in 2013, the miRNA service market represented 8.5% of the miRNA research

tools market, or <0.08% (0.93% x 8.5%) of the life science tools market

6. $77.4 billion: 2013 value of the global Monoclonal Antibodies (mAb) market; expected

to increase with a CAGR of 12.1% to nearly $153.2 billion by 2019[1]

7. 35.5%: Percentage of new biopharmaceutical product approvals produced in CHO,

expressed as a percentage of total biopharmaceutical product approvals[4]

8. Therefore, the 2013 value of the CHO-produced global Monoclonal Antibodies (mAb)

market is $27.5 billion

9. If we assume the 2013 values of the Life Sciences Tools market and CHO-produced

global mAbs market are equivalent; the value of the miRNA service market to the

production of mAbs in CHO is $21.8 million ($27.5 billion x 0.079%)

10. Assuming a lower CAGR of 10.0% (estimated for global miRNA service market[8], instead

of the 12.1% for global mAbs[1]), this market should increase to $35.1 million by 2018

11.0 Drivers for and Value of Contract Research in Biopharma

In recent years, while global pharmaceutical sales have increased, pharmaceutical manufacturers

have experienced a considerable drop in profit margins, with increasing price and cost pressures,

regulatory changes and patent expiries leading to shrinking margins[9]. Over the past 10 years,

research and developments costs have risen by more than 80% but the number of new products has

dropped considerably[9]. To reduce production costs, increase the speed-to-market, reduce risk and

increase profit margins, pharmaceutical companies are looking toward new business models,

accomplished through contract manufacturing, research and packaging[9].

North America is the largest market for pharmaceutical/biopharmaceutical research, conducting

more than three-quarters of the world’s research and development and holding the IP rights for

most of the world’s new drug products[9]. Contract research revenues generated from North America

were $14.1 billion in 2012 and are expected to reach about $23.2 billion by 2018, growing at a CAGR

of 8.4% (see Figure 9[9]).

Europe is the second-leading market for contract research in biopharma, worth an estimated $10.7

billion in 2012 and expected to reach $17.9 billion by 2018, after increasing at five-year CAGR of

8.7%[9]. An increasing aging population and emphasis on biopharmaceutical development are the

major growth drivers of contract research in North America and Europe (see Figure 9[9]).

The Asian emerging markets for contract research are flourishing, with an estimated value of $8.5

billion in 2012 and expected to reach $18.8 billion by 2018, growing at a CAGR of 14.4% [9]. Low

R&D and labour costs are some of the reasons manufacturers are outsourcing to CROs in these

markets (see Figure 9[9]).

Figure 9. Global market for contract research by region (2011-2018) ($ Billions) (Figure 19[9])

Overall, North America is the leading market with a 42.3% share; Europe had a 32.1% share of the

contract research market in 2012, while emerging markets accounted for about 25.5% in 2012[9].

The global market for contract research services was classified[9] into Clinical, Drug Discovery,

Analytical and “Others” segments. Given its highly-specific nature, the DECOY-7 technology would

not be considered to fall into the first three categories and can be considered to be classified into

this “Others” segment of contract research disciplines. The “others” segment includes services

offered by the CRO in support of the discovery, clinical and analytical research, such as medical

writing, regulatory document processing and various strategic advisory services.

North America is again the largest market for “Other” pharmaceutical/biopharmaceutical research,

with an estimated value of $2.0 billion in 2012 and expected value of $2.9 billion in 2018 (CAGR of

5.6%; see Figure 10[9]). Europe is in second place (estimated value of $1.6 billion in 2012 and

expected value of $1.8 billion in 2018 (CAGR of 1.7%)), followed by the Asian Emerging markets

(estimated value of $1.2 billion in 2012 and expected value of $1.9 billion in 2018 (CAGR of 7.8%;

see Figure 10[9]).

Figure 10. Global market for “Other” contract research services by region (2011-2018) ($ Millions)

(Figure 24[9]).

11.1 CRO Definition: A Contract Research Organisation (CRO) (or Clinical Research Organisation)

is an Organisation that offers various aspects of the clinical research process to a pharmaceutical,

medical device or biotechnology company. Contract research organisations employ various clinical

research associates, biostatisticians, medical writers, project managers and similar clinical research

professionals to support the clinical trial process on behalf of their pharmaceutical, biotechnology or

medical device company sponsors. A clinical research organisation may assume responsibility for

reviewing and validating the clinical trial data collected by a clinical investigator during a clinical trial.

The DA defines a CRO as “a person (i.e. a legal person, may be a corporation) that assumes, as an

independent contractor with the sponsor, one or more of the obligations of a sponsor (e.g. design of

a protocol, selection or monitoring of investigations, evaluation of reports and preparation of

materials to be submitted to the FDA”)

12.0 SWOT Analysis:

From an analysis of sales volume, pricing, indication expansions, competition within biologics and

from small-molecule drugs, safety issues and promising new candidates carried out by Aggarwal,

(2014), the following SWOT (Strengths, Weaknesses, Opportunities, Threats) Analysis for the U.S.

biopharma industry has been compiled:

Strengths:

Billion-dollar sales on individual products

Double-/Triple-digit growth in certain market sectors (e.g. MAbs, Fusion proteins)

Rapid uptake of new products (especially MAbs; some reaching blockbuster status in <2years)

Expansion into new indications for existing products dramatically increase the number of available patients

Seriousness of diseases targeted by biologics makes it harder for payers (individuals, healthcare providers, governments) not to cover these drugs

Small markets can still be highly profitable (e.g. Therapeutic Enzymes: 100s-1000 patients)

Product complexity in certain segments (e.g. MAbs) leading to lower competition

Weaknesses:

High development costs ($1-$2 Billion)

Long product delivery times (several years)

High level of regulation/legislation restrictions

Restrictions on marketing directly to patients

Industry success largely dependent on MAbs and Hormones

Within biologic classes, industry largely dependent on a small number of “blockbuster” drugs (i.e. just four products make up 80% of all hormone sales)

Price sustainability

Manufacturing challenges (e.g. particularly for Therapeutic Enzymes)

Market saturation in some segments (e.g. for Blood Products)

Intense competition in certain segments (e.g. small-molecule Growth Factors (CSFs/ESAs))

Opportunities:

New product launches

Expansion into new indications for existing products

Introduction of layers of Biosimilars legislation (i.e. to combat competition from Biosimilars)

Government initiatives (e.g. roll-out of Affordable Care Act (ACA)) leading to expanded patient numbers

Rising prevalence of key diseases (e.g. Diabetes)

High “unmet need” for certain diseases

Improved product efficacy (e.g. serum half-life for hormone products)

Improved product delivery/formulations (e.g. oral/pen dispensation, subcutaneous injection formulation) leading to improved patient compliance

New clinical guidelines (e.g. reduced incidence of delivery for rt-PA) leading to improved patient compliance

Price increases

Stabilisation of sales for some mega-blockbuster products that previously suffered setbacks (e.g. ESAs)

Resolution of certain manufacturing problems

FDA “Fast-tracking” process leading to shortened product development time and reduced costs (note: not indicated by Aggarwal, 2014)

Threats:

Biosimilars (apart from Cytokines (for now!)) and Biobetters

Reimbursement issues (has affected sales of ESAs particularly badly)

New competitors, particularly via the expansion into new indications for existing products

Clinical trial failures or demonstration of adverse side effects leading to FDA “decline to approve” or “black box” warnings

Sales decline in certain market segments (e.g. Growth Factors (ESAs particularly), Blood Products)

Pricing “backlash/pushback” from clinicians, media and public (e.g. BMS’s Yervoy - $30k/injection) leading to low uptake for some drugs (e.g. Provenge, Zaltrap)

Ongoing trials for new/next-generation product versions (especially for Blood Products)

Concerns over safety (especially for Recombinant Vaccines)

Political posturing/scaremongering in response to safety concerns impacting patient uptake (especially for Recombinant Vaccines)

Aggressive marketing tactics (e.g. by Merck) leading to increased political scrutiny

Market withdrawals (e.g. for Xigris (Anticoagulant) following failed study endpoints)

13.0 References:

[1] Biologic Therapeutic Drugs: Technologies and Global Markets, January 2015, BCC Research BIO079C, http://www.bccresearch.com/market-research/biotechnology/biologic-therapeutic-drugs-technologies-markets-report-bio079c.html [2] Global Markets for Bioengineered Protein Drugs, August 2014, BCC Research BIO009F, http://www.bccresearch.com/market-research/biotechnology/bioengineered-protein-drugs-report-bio009f.html [3] 2014 Biotechnology Research Review, January 2015, BCC Research BIO069F, http://www.bccresearch.com/market-research/biotechnology/2014-biotechnology-research-review-report-bio069f.html [4] Walsh, G. Biopharmaceutical benchmarks 2014. Nat Biotechnol. 2014 Oct;32(10):992-1000. doi: 10.1038/nbt.3040. [5] Aggarwal, 2014: What’s fueling the biotech engine—2012 to 2013. Nat Biotechnol. 2014 Jan;32(1):32-9. doi: 10.1038/nbt.2794. [6] (2015) Big, bigger, but will they be the biggest? The past, present and future of MAbs in the market place. BPTC. Published Jun 15, 2015 http://www.bioprocessblog.com/archives/743 [7] Life Science Tools and Reagents: Global Markets, January 2015 BCC Research BIO083B http://www.bccresearch.com/market-research/biotechnology/life-science-tools-reagents-bio083b.html [8] MicroRNA Research Tools, Diagnostics and Therapeutics: Global Markets, September 2014, BCC Research BIO115B, http://www.bccresearch.com/market-research/biotechnology/microRNA-research-tools-diagnostics-therapeutics-report-bio115b.html [9] Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging - Focus on Contract Research, August 2013, BCC Research PHM156A, http://www.bccresearch.com/market-research/pharmaceuticals/contract-pharmaceutical-research-phm156a.html