Title: Secondary market research, Competitor and Customer ... · 1.0 Global...
Transcript of Title: Secondary market research, Competitor and Customer ... · 1.0 Global...
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