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Cambrex webinar: A History of the API & Intermediates Contract Manufacturing Industry (1975 – 2015). November 2016. 1

The manufacturing of active pharmaceutical ingredients (APIs) is a complex, specialized activity,

requiring the expert intertwining of chemistry and engineering. Historically, this was performed

by large pharmaceutical companies, who saw value in taking the drug seamlessly from drug

discovery to large-scale manufacture and keeping the whole process under one roof. In parallel to

this, contract manufacturing organizations (CMOs) arose to support production when additional

capacity was needed or specialized chemistry required.

This webinar aims to present an expert review of the last 40 years of the CMO industry for small

molecules. In addition to in-depth analysis by Cambrex, performed over the period 1975-2015, a

series of primary research interviews with industry experts was undertaken. In total, the views of

10 industry veterans, each of whom had no less than 25 years’ experience in the CMO industry,

have been presented.

This webinar aims to present the audience with an historic overview of how contract

manufacturing has evolved since the early days of being a niche, opportunistic industry, with just

a few suppliers where most manufacturing was still routinely performed in-house within large

pharmaceutical plants, to one that blossomed into a $50-60bn enterprise, where outsourced

pharmaceutical manufacturing has now become the rule rather than the exception.

After looking back over the last 40 years, Cambrex will then offer a forward-looking opinion

on what to expect for the CMO industry in the coming 5 years from 2016 through to 2020. The

webinar will then culminate in an unveiling of the new Cambrex brand – with a focus on Active

Ingredients | Dynamic People – and how the organization is well positioned to become the leading

CMO in small molecule manufacturing by 2020.

Amanda Flanagan Associate Director, QC

A History of the API & Intermediates Contract Manufacturing Industry (1975 – 2015)

A Cambrex webinar overview

http://www.cambrex.com

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This webinar will:

• Learn about the last 40 years of the API manufacturing industry with respect to small molecules.

• Understand the opinion of industry experts as they give valuable insights into their own

experiences during 1975-2015

• Explore how the industry has evolved to the booming business it is today and the outlook for the

CMO market over the next 5 years (2016-2020).

• Gain an opportunity to see the unveiling of the new Cambrex brand and learn about its ambition

to become the leading small molecule API manufacturer

Current estimates for the size of the overall API manufacturing market, including both the captive and contract

sectors, are around $50-60 billion per year. There have been a large number of articles and editorials in recent

years covering developments in the small molecule industry, as well as a renewed sense of excitement in API

manufacturing. As a result, this seemed an appropriate time to look back at how the contract manufacturing industry

has evolved over the last 40 years to the large and growing market that operates today.

Contract manufacturing organizations (CMOs) are often asked two questions: when did API manufacturing start

and how did it evolve? Books, documents or reports that serve to give a comprehensive answer to these questions

are difficult to find and Cambrex felt it was an opportunity to author its own. Part of this rationale was philanthropic

but the other part was a fact finding mission as, with many industries, it is possible to learn a lot about the future by

considering the successes and mistakes from the past.

Contributors

Dr. Matthew Moorcroft VP of Global Marketing, Cambrex

Matt is the Vice President of Global Marketing and Communications for Cambrex. Prior

to joining Cambrex, he worked for Lonza and held a number of roles including Head of

Global Marketing, VP Generics and Biosimilars, and Head of Strategy, Pharmaceuticals

and Biologics. After gaining experience in the custom development and manufacturing

business, he developed models for biosimilars and generic drug products. He has 15

years of commercial and scientific experience in the pharmaceutical, biotechnology and

chemical industry covering both innovative and generic medicines. Matt graduated with a

Ph.D. in Chemistry from the University of Oxford.

Alex Maw Director, Marketing and Communications, Cambrex

Alex is the Director of Marketing and Communications for Cambrex with responsibility

for corporate marketing and brand strategy. Prior to joining Cambrex, she held group

marketing and communications responsibilities for Consort Medical plc and its divisions:

Aesica and Bespak and held a range of marketing roles at Aesica prior to the acquisition

of the company by Consort Medical. She has specific experience in driving brand strategy

and growth in the pharmaceutical contract services sector.

Alex graduated with a BA (Hons) in Marketing Management from Newcastle Business

School, Northumbria University and has a Professional Postgraduate Diploma in Marketing

from the Chartered Institute of Marketing. Alex also holds Chartered Marketer status.

Cambrex webinar: A History of the API & Intermediates Contract Manufacturing Industry (1975 – 2015). November 2016.


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When did the industry start and how has it evolved?

To start this study, Cambrex built a simple model of supply and demand for the API market. The first phase was to

start from existing data. Reviewing the past ten years was relatively simple, but looking for comparable information

over the past 40 years was more difficult due to the absence of data points. However, after a concerted effort a

pertinent collection of data was assembled. Whilst raw data would get this work underway, Cambrex was extremely

cognizant of the fact that to really understand this complex industry, it was ultimately going to be vital to speak with

experts who had been there and seen enough over the past 40 years from first-hand experience.

The industry experts

The experts Cambrex spoke to were hand selected due to their extensive experience in the API industry, with an

average of 30 years’ experience each. These included five experts from CMO or supplier organizations and five

outsourcing/procurement experts from pharmaceutical companies to give a balanced blend of experience.


The CMO and supplier experts:

Simon Edwards, VP, Global Sales & Marketing, Cambrex (27 years’ experience)

Previous companies: Lonza, Great Lakes

Roles held: Sales/BD, Head of BU, Chemicals,

Biologics and Biosimilars

Paolo Russolo, President, Cambrex (45 years’ experience)

Previous companies: Profarmaco

Roles held: Chemical Engineering, Finance, Sales/BD,

Managing Director

Carl Johansson, Global Director, Proprietary Products, Cambrex (34 years’ experience)

Previous companies: Dow Chemicals

Roles held: Sales/BD, Product Management,

Procurement, General Manager

Dr. Jan Ramakers, Consultant, FCCG (35 years’ experience)

Previous companies: DSM, Deutsche Bank, Wood

Mackenzie

Roles held: Business Research, M&A, Due Diligence

Jim Miller, President, PharmSource (37 years’ experience)

Previous companies: St. Anthony Publishing, Williams

and Wilkins, Boston Consulting Group

Roles held: Corporate Development, Consultant

The outsourcing/procurement and pharma company experts:

Ken Kent, VP, Chemical Development & Manufacturing, Gilead (28 years’ experience)

Previous companies: Gilead

Roles held: R&D, Process Development, Manufacturing

Peter Lyford, Commodity Director, GSK (26 years’ experience)

Previous companies: GSK

Roles held: Procurement, R&D to Commercial

Manufacture

Dix Weaver, Consultant, Weavchem LLC (30 years’ experience)

Previous companies: Eli Lilly, Evonik, DCAT (president)

Roles held: Sourcing, Procurement, Supply Chain

Consultant, Toxicology

Rob Miotke, Consultant, Advantage Pharma Solutions LLC (40 years’ experience)

Previous companies: Aerojet Fine Chemicals, Angus

Roles held: Sales/BD, Commercial Director, General

Manager, President

Steven Cray, Director, Supplier Relationship Management, Shire (34 yeas’ experience)

Previous companies: Graham Packaging, Thomas &

Betts, SPS Technologies, Price Waterhouse

Roles held: BD, Finance, Supply Chain, Procurement

In memoriam: Dr. Peter Pollak – sadly he passed away in August 2016. As one of the first champions of the contract

manufacturing industry, this study is dedicated to him in an effort to continue his narrative on the API industry.


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Results: 40 years of the CMO industry

Medicine consumption data

Figure 1 shows the consumption of small molecule drugs (in volume terms) over the past 40 years, outlining the

significant increase in consumption from 1975-76, due to the development of ‘blockbuster’ drugs, with examples

such as Tagamet® and Zantac®. A substantial proportion of the next era of growth was due to the effects of the

Hatch-Waxman Act and the introduction of generics into the USA, which boosted consumption as prices eroded and

patients had increased access to affordable medicine.

The following era of growth was spurred by the rise of BRIC countries (Brazil, Russia, India and China) as important

consumers of medicine. In the final period of growth, covering 1995-2015, consumption was positively affected by

continued patent expiry and the recent uptake in new drug approvals.

Figure 1

Drug approval data

To verify one view of demand against another, Cambrex’s analysis looked at the approval of small molecule new

chemical entities (NCEs) in the US over the same 40-year period. In the period between the 1970s and 1980s, new

product launches fluctuated between 10 and 30 launches per year; a sign that the industry was beginning to emerge

and that making medicines was a sustainable business model. This process really began to speed up during the race

to launch blockbusters heading into the 1990s, a period in which approvals steadily increased.

This growth peaked around 1996-97 but faced a notable decline due to a reduction of new small molecule drug

approvals in the early 2000s as the industry’s focus switched to other modalities such as recombinant proteins and

monoclonal antibodies. However, growth in the NCE sector reignited during the mid-2000s to 2015, with NCE drug

approvals rising once again, fueled in part due to a focus on orphan therapies and utilizing the recently introduced

expedited approval process in the US.

CMO competitor data

Turning the attention to the supply side of the supply/demand equation, figure 2 focuses on the entry of CMO

competitors.

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Resurgence from R&D due to Oncology, Targeted and Orphan Drugs

2012 Patent Cliff

Introduction and Growth of Pharmerging Countries

‘1st Wave’ Patent Expires and Entry of Generics

Growth of Blockbusters

Hatch-Waxman Act in full swing facilitating generic launches

Consumptiongrowing in Brazil,Russia, India and China (BRIC)

Novel mechanisms,new molecules,e.g. Proteinkinase inhibitors

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e.g. GSK’s Tagamet® (cimetidine) and Zantac® (ranitidine)

IMS Data

Data Interpolated from WHO

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Pharmaceuticals Consumption – Data



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As can be seen, major entrants to the market included companies such as Cambrex, DSM and Lonza in the early

years, followed in later years by Indian companies such as Ranbaxy and Piramal, and later still by Chinese CMOs such

as Porton and Desano.

Figure 3 shows the same data with the CMOs grouped by their geographic locations and provides a more useful

overview of the evolution of the market. In the nascent period between the 1940s to the 1960s, mainly big pharma

manufacturing sites operating through captive manufacturing are visible. In the 1960s and 1970s, we see the first

entry of the early and pioneering CMOs into the industry and the phrase CMO becomes a familiar concept. While

some of these were CMOs from Europe and the US, many were actually based in the UK.

Figure 3

DSM1960

Cambrex 1963

TAPI1971

BASF1977

OmniChem1978

Piramal1989

ZhejiangHisun1990

Hetero2000

ShanghaiDesano2008

Siegfried1964

Lonza1973

EvonikSAFC1979

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SourceCambrex Newport

First Entrance of API Manufacturers

CMO Entrants – Data

Figure 2


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Early CMO pioneers (UK and EU/US) entering market at risk

Entry of Indian and Chinese CMOs

Gold rush / Later US/EU CMO entrants enticed by success of early CMOs and prosperity of pharma market

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CMO Entrants – Data

Entrance of API Manufacturers –by region

SourceCambrex Newport


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During the period 1980 to 2000, there was a continued influx of CMOs from the US and Europe and the majority

of these companies comprised of generic API manufacturers following the enactment of the Hatch-Waxman Act.

Finally, in the period 2000-2010, as the industry continued to prove a lucrative venture and entice new entrants, the

market saw the entry of Indian and Chinese CMOs.

Results: the four stages of the industry

When the components of the supply and demand model were assembled, Cambrex identified four distinct periods

which stood out as pivotal moments which helped to explain the birth and establishment of the CMO industry. These

formed the basis of the interviews with the panel of experts highlighted earlier.

Stage 1: the early years (pre-1980)

For simplicity, figure 4 shows a combination of the previous graphs of API consumption, NCE approvals and CMO

entrants in an attempt to highlight our four stages of the industry.

Figure 4

The early period up to 1980 is characterized by the growing API consumption due to the introduction of early

blockbusters, as well as the first flurry of NCE approvals from the FDA. This coincides with the entry of a few

pioneering CMOs who saw an opportunity in the market. Many of these companies exposed themselves to great

risk in terms of investing in a business that was seen to be very speculative at the time. Their entrance was due to

the lack of manufacturing capacity in big pharma due to the unexpected successes of early blockbusters, which

far exceeded initial forecasts and ultimately exposed the conservatism in their carefully laid out capacity planning

models. Consequently, pharmaceutical companies began to use chemical technology experts and CMOs to help with

this capacity shortfall.


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The first CMOs were essentially technology specialists, particularly in hazardous chemistries which big pharma

were either unable or unwilling to carry out themselves. At this stage, most manufacturing contracts were either

for single steps in the chemical synthesis or for pharmaceutical intermediates other than APIs, the latter being

still manufactured in-house by the pharmaceutical companies. GSK was one example of an early adopter of

outsourcing, particularly due to the company’s involvement in some of the early blockbusters, which had completely

outperformed expectations.

Due to the high or growing NCE rate and the presence of ‘me-too’ blockbusters, there was growing competition

between pharmaceutical companies that were involved in a foot race to launch as many new drugs as possible. Many

of these products were based on high dosages and were large volume products, which further exacerbated the

shortfall in in-house capacity during this period.

Stage 2: the growth years (1980-1996)

The next period of the industry occurs during 1980 to 1996, defined as the ‘growth years’. By this time, the

blockbuster model was in full swing and manufacturing capacity was being built by both big pharma and CMOs to

accommodate the new drug approvals. The industry was booming, fueled by large R&D budgets in big pharma and

the introduction of new technologies such as biotechnology, high-throughput screening (HTS) and combinatorial

chemistry. This led to many predicting higher and higher approvals of NCEs with some CEOs engaging in a ‘race-to-

the-top’, outbidding their rivals in their claims of ever-bulging pipelines and forecasts of unprecedented new drug

approvals.

Figure 5

The lack of capacity in big pharma (despite its investment and efforts to redress this) resulted in a surge of

entrants into the CMO space. Such was the lure of this ‘new’ industry, it also captured the attention of the large

commodity chemical companies who began to repurpose their existing capacity to accommodate pharmaceutical

API production. At the same time, legacy CMOs were not satisfied with manufacturing intermediates in single-step

processes and began to capture more business from pharmaceutical companies; working on longer, multi-step

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processes from basic building blocks to advanced intermediates and even to APIs. This led to a number of visionary

CMOs investing bravely and spending millions of dollars on new, multi-product facilities.

Some of the study survey experts commented that, while large profits made the sector extremely lucrative for new

entrants, not everyone was appropriately set up to benefit. Some of the commodity chemical companies found it

difficult to adjust to the increased demands of the pharmaceutical industry and found that manufacturing APIs and

intermediates was a ‘whole new ball game’ to working in the more established chemical industry sector they were

familiar with.

CMOs moving from the manufacture of single-step intermediates to the multi-step synthesis of APIs would build a

business case justified on the concept of serving multiple customers with their technology or their capacity. One

survey expert noted that during this period there were some adventurous and pioneering CMOs that were investing

heavily and taking a leap of faith in the building of new multi-purpose facilities.

Aside from the inflated expectations from pharmaceutical companies and their senior management on the seemingly

unstoppable number of new drug launches, this hysteria was also infectious amongst banks and analysts, with many

predicting high double-digit growth rates for the market. This resulted in an increasingly bullish outlook and big

pharma began making strategic supplier agreements with their CMOs – promising to mutually share in this success,

fill all their capacity and take them to some sort of ‘Promised Land’.

Stage 3: the competitive years (1996-2010)

The period from 1996 to 2010 was termed the ‘competitive years’ in the evolution of the contract manufacturing

industry. From the demand side, a major factor influencing the sector was the patents on several blockbusters began

to expire which would lead to generic competition and the inevitable downward pressure on drug prices. While this

resulted in a period of instability for pharmaceutical innovators, and the wave of cost-cutting measures that unfolded,

the effect of generics was to drive consumption upwards as more patients had access to affordable medicine. This

growth was in addition to the boost in consumption caused by the rapid economic development of the emerging

BRIC countries further bolstering demand.

Figure 6

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This period was also one of declining NCE approvals. Mergers and acquisitions at big pharma meant there was a

rationalization of companies’ combined portfolios, as well as a growing interest in alternative molecule types, moving

away from small molecules to biologics.

On the supply side, the rapid growth seen in the previous period of the ‘growth years’ was now moving to India and

China, which apparently caught western-based CMOs off guard. At this time, pressure on big pharma to reduce their

costs effectively incentivized their sourcing teams to take (calculated) gambles and begin to risk quality for a lower

price. This resulted in an almost inevitable and regrettable period of a ‘race-to-the-bottom’ on API prices, of which

suppliers from low-cost countries such as India and China-based CMOs were the ultimate beneficiaries.

This was a time when western CMOs first began to recall losing proposals or contracts to Indian or Chinese

competitors and the threat from low-cost CMOs became suddenly very real. Coinciding with this, a shift from

custom synthesis to toll manufacturing meant that using CMOs for their skills in a specialist technology or

developing a process was no longer required. CMOs were beginning to be seen as undifferentiated suppliers from

the pharmaceutical companies’ point of view, with the inevitability that the lowest-bidding CMO would be routinely

awarded the business.

One of the survey experts commented that western CMOs were not prepared for this shift and were repeatedly

asked not to get involved in generic products when working with their innovator pharmaceutical customers. It was

therefore unexpected when pharmaceutical companies started to do business with Indian generic firms for their

CMO needs.

Other experts remarked on the move to toll manufacturing, producing APIs using the customers’ process rather than

developing their own manufacturing route, which meant that differentiation was solely down to price. Some CMOs

found it difficult to compete with low-cost suppliers, which had the advantage of being able to produce generic APIs

and the formulated drug product; which added a base load of capacity utilization, combined with lower labor costs

and lower expectations on return on capital. Although the race-to-the-bottom on price was a compromise on quality,

if it led to a 20 to 30 per cent reduction in CMO pricing, the allure was too great for big pharma which was in full

cost-cutting mode.

Another expert discussed their cynicism around all the rhetoric talk around partnerships or win-win alliances and

exclusive relationships when it became clear that pharmaceutical companies would be quick to bring in new low-cost

CMO suppliers. Interestingly, on the other hand, mid-sized and small pharmaceutical companies actually tended to

stay away from this strategy. They had concerns about quality, were reluctant to work with CMOs based in Asia, and

were more likely to continue to work with their local western suppliers.

Stage 4: the resurgent years (2010-2015)

The fourth and final segment in the history of contract manufacturing history is the period from 2010 to 2015, or the

‘resurgent years’. Again, by comparing the supply and demand curves we can see a steady increase in consumption

and a tightening of the supplier base. (figure 7)

While consumption continues to increase, Cambrex recently reported its research findings that the industry is

experiencing a shift towards lower commercial drug volumes, no longer measured in 100s of MT as seen in the mid-

1990s, but now in the region of 1-10MT seen today.

Additionally, on the demand side, NCE approvals have started to rise once more. Largely fueled by the

pharmaceutical sector’s focus on oncology and targeted medicine, in addition to orphan indications.

From the supply perspective, there has been a notable decrease in the number of new entrants into the CMO market.

When combined with continued divestment or closure of mature API plants by the larger pharmaceutical companies,

this has manifested in the current period of high demand for manufacturing services from US- and EU-based CMOs

with the right capacity.

One survey expert commented that since there had been a concerted effort to move back to western CMOs – it

would be hard for any CMO not to be enjoying a good time in the industry. Another expert was quick to point out

that labor costs in China, compared to those in other countries, have continued to rise and have started to make low-

cost CMOs no longer as attractive as they once were.

There was also a rebuke that during the previous ‘race-to-the-bottom’, sourcing teams were going through the

process of trying to unpick some of these agreements. There was also a suggestion that western CMOs, in particular,

have been quick to react to new trends through the use of more advanced market intelligence. They are looking at

the market from a “what’s next?” perspective and are being more forward-thinking in their outlook.



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Figure 7

It is also important to monitor the customer base dynamics; smaller pharmaceutical and biotech companies are

actually occupying a bigger share of the pharmaceutical market and the development pipeline with their products.

These products frequently, but not always, have lower volume requirements than classical drugs because of their

higher potency and highly targeted therapy.

Today, the market continues to be heavily fragmented, with no single CMO holding more than 1 to 3 per cent share of

the market. One survey expert remarked that trying to find a good quality CMO is actually difficult at the moment,

as they are all busy and their capacity is full. There was also an observation that some CMOs have accumulated a

lot of debt in the past five years, which now needs to be serviced or paid off, and this should serve as a warning to a

prospective customer in terms of cash flow or the threat of long-term financial security of a CMO.

Another observation was that mid-size pharmaceutical companies, which typically lack internal manufacturing

assets, mitigate the risk of a CMO capacity shortfall by carrying more inventory in the case of a supply chain issue.

Other experts noted the lack of sophisticated forecasting tools and processes and how this led to both under

capacity and over capacity during the 1980s, 1990s and 2000s. Even though launch projections have vastly

improved in recent years, flexibility is seen as a vital offering from a CMO in order to handle changing customer

requirements or to react to new forecasts.

2016-2020: what’s next for the industry?

The interesting question from the study is to really find an answer to “what’s next?”. Contract manufacturing has to

learn as much from its rich history as possible in order to best prepare itself for the future.

From the demand side, the research identifies the trend towards increasing consumption. According to the Cambrex

data, drug consumption continues to increase driven by more patients taking more medicine, more often.

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The contract manufacturing space will continue to be dynamic and CMOs will continue to evolve. There will still

be shake-ups and M&A activity but technology, customer focus and market intelligence will remain important and

contribute to the continuing success of the sector. One expert warned that despite the renewed optimism in the

sector, pharmaceutical companies could start building captive capacity once more, should CMOs stop investing in

technology and infrastructure to meet their needs. They believe CMOs need to keep their technology edge, and

in some way come full circle back to 1975 and be able to offer a specialism to differentiate themselves from the

‘capacity for hire’ business models of their competitors. One expert warned of the real risk that big pharma could still

use CMOs as a “cheap date”, meaning the pharmaceutical company will use the CMO when it needs a supplier but

drop them just as quickly if additional material or capacity is not needed.

Another interesting finding from the interviews was that chemistry is becoming more complex. One expert

suggested that gone are the days of the ‘easy four-step chemistry’ and there is a move to more complex and longer

syntheses. NCE approval rates are currently the highest for some time, and experts expect that they are likely to

remain steady. There was one remark about the difficulties in making forecasts and their need for CMOs to be more

flexible given the wide variation typically seen in eventual upsides and downsides.

2016-2020: how should CMOs prepare for the future?

Cambrex posed the question, “what do CMOs have to do to keep a leadership position in the future?” and found four

key areas to consider – new technology, new customer focus, new data and new markets.

New technology

CMOs should continue to look at trends and invest in the next ‘big thing’ in order to be able to offer this to their

customers in the future. The survey experts commented that innovation is important and that the best CMOs are

those that have adapted and moved with the industry. While everyone considered it important to be considered an

expert, one respondent offered caution that against the idea of being “everything to everybody”, because in reality,

most CMOs that attempt this fail. CMOs should think carefully before they become too broad; for example, providing

both biologics and small molecule API manufacturing services.

New customer focus

CMOs need to work with customers who require their CMO to be as successful as they are to ensure longevity and

a mutually beneficial relationship. The relative size of the contract manufacturer is also an important consideration

in reaching new customers, and having sufficient size and scale afford the CMO the opportunity to work with

equivalently sized customers. The caveat to this being that the CMO should resist the urge to become too large that

it succumbs to the pitfalls of inflexibility and bureaucracy, and loses the mantle of “being easy to do business with”.

One expert noted that CMOs must be able to handle the dichotomy of working with both “juggernauts and

gymnasts”. They need to be able to handle pharmaceutical customers of varying sizes and cultures without adopting

a one-size-fits-all approach. There was a widespread consensus among the interviewed experts that CMOs still have

a long way to go in this area and they need to be more flexible and easy to work with, with the ultimate goal of being

easy to buy from.

New data

There was a clear view from the experts that investing in market intelligence and being able to spot trends was

a vital tool in a CMO’s armory in order to support key decision making. Understanding which chemistries, which

technologies, what capacity to build, etc. were all important strategic questions. One expert remarked that there

was an “arms race” within CMOs trying to get access to more and more market data and build market and business

intelligence functions in order to process all this information and stay ahead of the competition. Compared to the

early years, the pace of change is now so great in the CMO industry that contract manufacturers need to continually

be looking ahead.

New markets

There has always been a drive to find new markets and new customers, but one new trend that was unearthed

during the study was the growing tendency to get involved in earlier parts of the supply chain, and not just focus on



the final API. CMOs can potentially participate in moving upstream to offer manufacturing intermediates and early

chemical steps; which has the advantage of offering supply chain security to the customer and also giving the CMO

access to the opportunity to add a base load of capacity.

Another expert noted that while a CMO can move backwards into its value chain, there is also the strategic option

to move forward, for example, into formulation development. Many larger CMOs have taken this opportunity and

adopted a ‘one-stop-shop’ or ‘end-to-end’ supplier approach. This particular topic divided some opinion amongst

our interview panel, with some experts suggesting this was a synergistic offering to bolt on to the CMO; while others

were less enthusiastic and questioned whether there was additional value in having both the API and the drug

product contract manufacturing under one roof.

12

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