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Investor perspective on the CMO

Industry

EXTERNAL SUPPLY FORUM

Discussion document | Oct 6, 2017

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Any use of this material without specific permission of McKinsey & Company Last Modified 08-03-2018 09:43 Romance Standard Time
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Investor observations on the CMO industry
1. CMO industry is highly strategic for healthcare, supporting >50% of top 50 global
drugs by revenue, in the biotech segment even 90%

Last Modified 08-03-2018 09:43 Romance Standard Time


Industry 2. However we see a very fragmented market, with top 20% players accounting for only
structure one quarter of global revenue
3. Significant deal activity exists, however does not really contribute to a tangible
increase in consolidation

4. CMOs with weak track record record to utilize sites. Idle capacity is a major
challenge for the industry, ~30% of plants could cover global demand
Operational 5. CMO not achieving structurally higher operational performance than pharmacos,
performance unit cost is not a differentiator, potential impact from complexity and constraints to
optimize
6. Quality controls are often less robust than internal sites, leading to higher risk

7. Revenue is steadily growing with especially FDF players clearly outgrowing the

Printed
industry. Outlook positive with increasing divergence of regions and technologies
8. EBIT margins are slightly growing, however clearly different by technology. 30%+ of
industry players with razor-thin margin
Financial
9. Industry evaluation (EV/ EBITDA multiple) is significant increasing, indicating that
performance
CMOs are moving up the value chain from execution to innovation/ development
and outlook
10. This includes a shift in the industry risk profile, with CMO players significantly
stepping up CAPEX and M&A
11. The industry will see growing differentiation of CMO value propositions, e.g. with
technology specialists and commodity champions as possible success profiles
McKinsey & Company 2
Investor observations on the CMO industry
1. CMO industry is highly strategic for healthcare, supporting >50% of top 50 global
drugs by revenue, in the biotech segment even 90%

Last Modified 08-03-2018 09:43 Romance Standard Time


Industry 2. However we see a very fragmented market, with top 20% players accounting for only
structure one quarter of global revenue
3. Significant deal activity exists, however does not really contribute to a tangible
increase in consolidation

4. CMOs with weak track record record to utilize sites. Idle capacity is a major
challenge for the industry, ~30% of plants could cover global demand
Operational 5. CMO not achieving structurally higher operational performance than pharmacos,
performance unit cost is not a differentiator, potential impact from complexity and constraints to
optimize
6. Quality controls are often less robust than internal sites, leading to higher risk

7. Revenue is steadily growing with especially FDF players clearly outgrowing the

Printed
industry. Outlook positive with increasing divergence of regions and technologies
8. EBIT margins are slightly growing, however clearly different by technology. 30%+ of
industry players with razor-thin margin
Financial
9. Industry evaluation (EV/ EBITDA multiple) is significant increasing, indicating that
performance
CMOs are moving up the value chain from execution to innovation/ development
and outlook
10. This includes a shift in the industry risk profile, with CMO players significantly
stepping up CAPEX and M&A
11. The industry will see growing differentiation of CMO value propositions, e.g. with
technology specialists and commodity champions as possible success profiles
McKinsey & Company 3
1 Highly strategic industry for patients – 60% of drugs depend on CMOs in
at least 2 steps of the value chain In-house In-house + outsourced
Outsourced Partner/licensor + outsourced

Last Modified 08-03-2018 09:43 Romance Standard Time


Routes Technologi- Annual sales WW – API Dose Packaging
Product Company of admin. cal category sales 2022, USD million strategy strategy strategy
Humira Injection Biotechnology 16,078
Harvoni Oral Conventional 9,081
Rituxan Injection Biotechnology 7,410
Revlimid Oral Conventional 6,974
Avastin Injection Biotechnology 6,885
Herceptin Injection Biotechnology 6,884
Lantus Injection Biotechnology 6,322
Remicade Injection Biotechnology 6,184
Enbrel Injection Biotechnology 5,965
Prevnar 13 Injection Biotechnology 5,718

Printed
Lyrica Oral Conventional 4,966
Advair Inhalation Conventional 4,720
Neulasta Injection Biotechnology 4,648
Copaxone Injection Conventional 4,223
Sovaldi Oral Conventional 4,001
Tecfidera Oral Conventional 3,968
Januvia Oral Conventional 3,908
Opvido Injection Biotechnology 3,774
Truvada Oral Conventional 3,566
Crestor Oral Conventional 3,401
SOURCE: Evaluate Pharma, PharmSource McKinsey & Company 4
1 Clear strategy difference – Big Pharma is less likely to involve CMOs in
their top products than “Challenger” PharmaCos

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Top 50 drugs manufacturing strategy analysis
Percent 100% inhouse CMO partially involved 100% outsourced

39 drugs 11 drugs
100% 0%

56%
91%

44%

0% 9%

Printed
Big Pharma "Challenger"/Biotech
▪ Amgen ▪ Merck ▪ AbbVie ▪ Regeneron
▪ AZ ▪ Novartis ▪ Gilead ▪ Alexion
▪ Bayer ▪ Novo Nordisk ▪ Celgene ▪ Astellas
▪ BI ▪ Pfizer ▪ Biogen
▪ Lilly ▪ Roche
▪ GSK ▪ Sanofi
▪ J&J ▪ Teva
SOURCE: Evaluate Pharma, PharmSource Strategic Advantage, Press and Web search McKinsey & Company 5
Pharma/chemicals company providing
2 CDMO market is still highly fragmented, with top 20 CDMO services (estimated sales
from CDMO business shown)

CDMOs accounting for ~27% of the overall market ….

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Pharma contract manufacturing market breakdown Top 20 players by sales
Sales, global, 2015/16 USDbn
Teva Fareva Boehringer Ingelheim Teva 2.0
Patheon Zhejiang Hisun Siegfried Patheon 1.9
Catalent Aurobindo Pfizer CentreOne
Catalent 1.8 ▪ Pharma CDMO
Lonza 1.6 market is highly
Lonza Aenova Others1 fragmented
Fareva 1.4
Zhejiang Hisun 1.4 – Over 500 players
in total
3% 3% Aurobindo 1.4
3% Aenova 1.2 – Top 5 players
2% account for <15%
2% Boehringer Ingelheim 0.8
of the market
2% 2% Siegfried 0.7
2% – Top 20 players
Pfizer CentreOne 0.7
1% 1% account for ~27%
1% Divis Laboratories 0.6
▪ Given the current

Printed
Vetter 0.5
industry structure and
Nipro 0.5 degree of
Famar 0.5 fragmentation,
consolidation is
Almac 0.5
expected to continue,
Delpharm 0.4 albeit at a slow pace
AbbVie 0.4
79%
Baxter BioPharma 0.4
Dr. Reddy’s 0.3
Samsung Biologics 0.3

1 Others include ~500 CMOs with <1% market share


SOURCE: Frost & Sullivan “Global Pharma CMO Market”, 2013 & 2016; VisionGain “Leading Pharmaceutical Contract Manufacturing Organizations”,
2014, RNCOS API forecast 2017, Annual Reports, McKinsey analysis McKinsey & Company 6
2 … a market much more fragmented than the pharma and
med device industry

Last Modified 08-03-2018 09:43 Romance Standard Time


Market share of Top 20 Players by industry segment
Percent Top 20 Other

100% = ~$72bn ~$122bn ~$390bn ~$900bn

27%
34%

56% 60%

Printed
73%
66%

44% 40%

Pharma CMO OTC Medical Device Pharma

SOURCE: Frost & Sullivan “Global Pharma CMO Market”, 2013 & 2016; VisionGain “Leading Pharmaceutical Contract Manufacturing Organizations”, 2014,
RNCOS API forecast 2017, Annual Reports, Evaluate Pharma, Evaluate MedTech, Nicholas Hall, McKinsey analysis McKinsey & Company 7
2 For comparison, in Electronic Manufacturing Services, top 10 players
account for 65% market

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Top 10 electronic contract manufacturing companies and their market shares, 2014
Company Revenue, USDbn Market share

139 31.9%

31 7.0%

25 5.7%

20 4.5%

16 3.7%

15 3.5%

Printed
14 3.2%

7 1.6%

6 1.4%

6 1.3%

Others 158 36.2%

World Total 436,510

SOURCE: Manufacturing Market Insider, July 2015 McKinsey & Company 8


3 We can see capacity consolidation and increase deals, NOT EXHAUSTIVE

but majority are technology access deals

Last Modified 08-03-2018 09:43 Romance Standard Time


Deal reason
Deal value Technology Regional
Buyer Target Deal type USDmn capabilities presence Scale Comment
Catalent acquiring Cook to
Acquisition 950 strengthen their Biologics
acapabilities and capacity

Acquisition 300

Deal is part of diversification


Acquisition 287
strategy
Patheon acquiring Banner
Acquisition 255
especially for Capsule technologies
Patheon acquiring Irix especially for
Acquisition 162
“difficult-to-make”-API capabilities

Printed
Acquisition 160

Acquisition 130

Siegfried acquiring Hameln


Acquisition 100
especially for narcotics capabilities

Acquisition 30

Patheon acquiring Agere especially


Acquisition
for complex solubility expertise

SOURCE: Windhover, PharmaDeals, PharmSource Strategic Advantage, Press and Web search McKinsey & Company 9
3 Despite a total of ~80 M&A transactions per year, Other

the CMO market stays very fragmented Top 20

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…leading to some consolidation, but market
~80 transactions per year in CDMO market…
stays very fragmented
CDMO M&A and transaction deals Pharma CMO market share of Top 20 Players by
Number of Deals year, Per year

95

79 77
69 2011 80% 20%
58
55

Printed
2016 73% 27%

2011 12 13 14 15 2016

SOURCE: Frost & Sullivan “Global Pharma CMO Market”, 2013 & 2016; VisionGain “Leading Pharmaceutical Contract Manufacturing Organizations”, 2014,
RNCOS API forecast 2017, Annual Reports, PharmaSource Strategic Advantage, McKinsey analysis McKinsey & Company 10
3 Private Equity owns 29 FDF/DP CMOs (~10%) and we see 2-5 PE based
investment deals p.a. in this industry

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Private equity investment activity in the FDF/DP CMO space
Number of Deals
▪ 29 FDF/
5 DPCMOs are
Private Equity
4 owned (based
on 282 CMOs in
2016)
3 3
▪ PE ownership
2 share of 10% is
slightly higher
than ~7% in
1

Printed
broader
Healthcare
sector
2011 12 13 14 15 2016 ▪ >25% of CMOs
with revenue
over $100m are
owned by PE

SOURCE: PharmSource Strategic Advantage Database of Contract Service Providers, Capital IQ McKinsey & Company 11
Investor observations on the CMO industry
1. CMO industry is highly strategic for healthcare, supporting >50% of top 50 global
drugs by revenue, in the biotech segment even 90%

Last Modified 08-03-2018 09:43 Romance Standard Time


Industry 2. However we see a very fragmented market, with top 20% players accounting for only
structure one quarter of global revenue
3. Significant deal activity exists, however does not really contribute to a tangible
increase in consolidation

4. CMOs face challenges to utilize their sites – and idle capacity is a major
challenge for the industry, with ~30% of plants could potentially cover global demand
5. CMOs do not always achieve structurally higher operational performance than
Operational
pharma companies, and their unit cost is not always a differentiator – which could be
performance
driven by complexity and constraints to optimize
6. CMO quality systems burdened with significantly higher complexity, leading to
higher risk than internal sites

7. Revenue is steadily growing with especially FDF players clearly outgrowing the

Printed
industry. Outlook positive with increasing divergence of regions and technologies
8. EBIT margins are slightly growing, however clearly different by technology. 30%+ of
industry players with razor-thin margin
Financial
9. Industry evaluation (EV/ EBITDA multiple) is significant increasing, indicating that
performance
CMOs are moving up the value chain from execution to innovation/ development
and outlook
10. This includes a shift in the industry risk profile, with CMO players significantly
stepping up CAPEX and M&A
11. The industry will see growing differentiation of CMO value propositions, e.g. with
technology specialists and commodity champions as possible success profiles
McKinsey & Company 12
4 Capacity utilization is a major challenge in the industry, Secure future SOLIDS

Uncertain future
~30% of plants is able to cover global demand
UNIT COST, USD CENT PER PU Q3 Q2 Q1

Last Modified 08-03-2018 09:43 Romance Standard Time


Utilization [%]
xx
xx
xx
xx xx
xx

CMO sites Pharma sites1

Printed
Capacity needed to cover
the global demand 1

Capacity per plant


1 Production runs at 52 weeks x 5 days x 3 shifts utilization and 60% OEE

SOURCE: McKinsey POBOS McKinsey & Company 13


SOLIDS

5 CMOs are now always achieving higher operational performance than


Pharma site, and their unit cost is behind industry (limited sample)
UNIT COST, USD CENT PER PU

Last Modified 08-03-2018 09:43 Romance Standard Time


Top Quartile = xx CMO Top Quartile = xx CMO sites Q3 Q2 Q1
Median = xx CMO Median = xx Sample

OEE based on max


speed [%]
xx

xx xx
xx xx
xx

Printed
CMO sites Pharma sites1

xx xx

xx xx
xx
xx

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SOURCE:
AND McKinsey POBOS
PROPRIETARY McKinsey & Company 14
by agreement between Participant and McKinsey.
SOLIDS

5 Are CMOs partly kept behind by complexity and


restrictions to optimize?

Last Modified 08-03-2018 09:43 Romance Standard Time


Number of different SDUs per formulation line [#] However, CMOs are also not always in
position to optimize their sites to an extent
xx xx possible for Pharma companies
xx
xx ▪ Savings pass through: depending on
xx the contractual set up, savings will be
xx passed through to Pharma companies,
reducing the incentive for the CMOs
▪ Lack of scale: all but the largest
CMO sites Pharma sites1 contract manufacturers often lack
sufficient scale to gain sufficient
leverage in negotiations to an extent
Number of SKUs per packaging line [#]
many pharma players are able to
▪ Customer-led materials and process

Printed
xx specifications: flexibility for CMOs to
xx optimize their processes is often
limited due to strict guidelines and
xx specifications from Pharma companies
xx
xx xx ▪ Capabilities: being smaller in size – it
often is challenging to attract the right
talent to run optimization
CMO sites Pharma sites1
1 Pharma with exclusion of CMO sites

SOURCE: McKinsey POBOS McKinsey & Company 15


Investor observations on the CMO industry
1. CMO industry is highly strategic for healthcare, supporting >50% of top 50 global
drugs by revenue, in the biotech segment even 90%

Last Modified 08-03-2018 09:43 Romance Standard Time


Industry 2. However we see a very fragmented market, with top 20% players accounting for only
structure one quarter of global revenue
3. Significant deal activity exists, however does not really contribute to a tangible
increase in consolidation

4. CMOs with weak track record record to utilize sites. Idle capacity is a major
challenge for the industry, ~30% of plants could cover global demand
Operational 5. CMO not achieving structurally higher operational performance than pharmacos,
performance unit cost is not a differentiator, potential impact from complexity and constraints to
optimize
6. Quality controls are often less robust than internal sites, leading to higher risk

7. Revenue is steadily growing with especially FDF players are outgrowing the pharma

Printed
industry. Outlook positive with increasing divergence of regions and technologies
8. EBIT margins are slightly growing, however clearly different by technology. 30%+ of
industry players with razor-thin margin
Financial
9. Industry evaluation (EV/ EBITDA multiple) is significant increasing, indicating that
performance
CMOs are moving up the value chain from execution to innovation/ development
and outlook
10. This includes a shift in the industry risk profile, with CMO players significantly
stepping up CAPEX and M&A
11. The industry will see growing differentiation of CMO value propositions, e.g. with
technology specialists and commodity champions as possible success profiles
McKinsey & Company 16
7 CMOs with continuous revenue growth, especially FDF dominated
players more than double of pharma industry growth
Indexed revenue growth of top publicly noted CDMOs (2012 = 100)

Last Modified 08-03-2018 09:43 Romance Standard Time


CAGR
2012-16, %
150
CDMOs (mainly 13%
FDF,partly API)1

API players2 3%
100

Printed
50

0
2012 13 14 15 2016

1 1 e.g., Patheon, Catalent, Nipro, Recipharm, ACS, others


2 e.g., Lonza, Hisun, Siegfried, Divis, Aesica, others
SOURCE: Capital IQ McKinsey & Company 17
MARKET OVERVIEW

7 FDF CDMO market is expected to continue to outgrow the pharma ESTIMATES


market, however growth will be unevenly distributed across regions …

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USDbn Share of absolute
Forecast growth, 2015-25 CAGR 2015-25

45
~8% p.a. 42 14%
39
36
33
30 ROW
28
26 4% APAC 7%
24
22 27%
20
18 40%

28%
7%

Printed
North Europe
America

201415 16 17 18 19 20 21 22 23 24 2025 9%
The global contract manufacturing
market of FDF expected to grow at
8% p.a. – faster than that of overall
prescription pharma market (5% p.a.)
1 Regional breakdown based on country of CDMO origination
SOURCE: Global Industry Analyst, expert interviews, McKinsey McKinsey & Company 18
MARKET OVERVIEW

7 … and technologies, with increasing trends towards technology ESTIMATES

specialization, and injectables and sterile liquids being key growth drivers

Last Modified 08-03-2018 09:43 Romance Standard Time


Global pharma contract manufacturing1, CAGR # of
breakdown by technology, FDF 2010-15 2015-25 players2 Key drivers
Injectables Sterile - Liquids Non-Sterile - Liquids Solids ▪ Increased focus on
& Semi-solids & Semi-solids specialized technologies
(e.g. cytotoxics,
lyophilized injectables)
Injectables 19%
24% ▪ Reformulation of existing
Sterile
products (e.g. in
haematology)
8% 45% 11% 13% ~150-200
9%
▪ Continued growth of
Liquids biopharma
& Semi-
solids 22%
18%
▪ Lower R&D investment
compared to other
8% 8% 8% technologies
~200-300 ▪ Higher growth expected
12% 2% 1% in steriles (e.g. nasal,

Printed
Non-
sterile ophthalmics)

Solids 51% 49%


6% 4% ~250-350 ▪ Growing Gx market, esp.
in LCC, spurred by LOE
35% wave in recent years and
healthcare reforms
▪ Cost pressure, need for
manufacturing efficiency
and scale
2010 2015 2025
Actual Forecast

1 Incl. originator drugs, generics, biopharmaceuticals, and vaccines 2 Number of CDMOs producing one of more products within a technology segment
SOURCE: Frost & Sullivan, Global Industry Analyst, McKinsey McKinsey & Company 19
8 EBIT margins are slightly improving, however clearly different by
segment; 30% of players with razor-thin margin

Last Modified 08-03-2018 09:43 Romance Standard Time


Example players
EBIT in % of revenue EBIT in % of revenue 2016
16
Celltrion 37%
15
Lonza 14%
14
API players2
Aesica 13%
13
12 Siegfried 6%
CDMOs
11 Hisun 2%
(mainly FDF,
10 partly API)1

Printed
Catalent 13%
9
Patheon 12%
8
ACS 11%
1
Recipharm 9%
0
Nipro 7%
2012 13 14 15 2016
1 e.g., Patheon, Catalent, Nipro, Recipharm, ACS, others
2 e.g., Lonza, Hisun, Siegfried, Divis, Aesica, others
SOURCE: Capital IQ McKinsey & Company 20
9 EV/EBITDA multiple is significantly increasing …
Enterprise value multiple; times

Last Modified 08-03-2018 09:43 Romance Standard Time


5 year back 3 year back 1 year back Latest
As on Sep 2012 As on Sep 2014 As on Sep 2016 As on 28 Sep 2017
Zhejiang Hisun 24 17 28 28
Zhejiang Huahai 21 28 38 34
Divi’s Laboratories 18 20 22 14
Shandong Xinhua 12 13 14 16
Siegfried 11 13 13 16
Nipro 10 10 9 9
Lonza 9 13 15 22
Catalent n/a 14 14 19
Aurobindo 8 11 16 12

Printed
Daito 5 6 6 6
Recipharm n/a 11 15 14
Celltrion n/a n/a n/a n/a
Samsung Biologics n/a n/a n/a n/a

Median 11 13 15 16

Note: All data ending Sep 28, 2017; n/a represents “not applicable”
SOURCE: S&P Capital IQ McKinsey & Company 21
9 Successful CDMOs use development services as a growth EXPERT ESTIMATES

engine for their revenues by securing the pipeline and ensuring


better pricing

Last Modified 08-03-2018 09:43 Romance Standard Time


Share of revenues from internally developed
products, % CDMO often use their
40-70% development services
to:

▪ Fuel Growth:
20-40% secure a pipeline of
internally developed
products, and
5-10%

Printed
Improve margins:
establish
Commodity Regular Innovators
development
services as a key
differentiator and an
enabler for
improved pricing

SOURCE: Expert interviews, market research, press publications McKinsey & Company 22
9 Many CDMOs have high and growing share of revenue coming from
development services

Last Modified 08-03-2018 09:43 Romance Standard Time


Manufacturing and others Development services xx% Development revenues CAGR, %

Revenue and revenue share from development services, % (EURmn)

29% 10% n/a

1,900 500 1,900

75%
84% 87%

Printed
25% (475)
16% (80) 13% (240)

SOURCE: Factiva, Hoover’s, web search, company reports McKinsey & Company 23
10 Major CMOs have increased their CAPEX investments in recent years

CMO Capex spend development

Last Modified 08-03-2018 09:43 Romance Standard Time


CAPEX as percent or revenues 2012 2016

11%
10%
9% 9%
8%
7% 7%
6% 6%

Printed
3%

SOURCE: Capital IQ, PharmSource, Press and Web search McKinsey & Company 24
10 In the past years, multiple CDMOs have leveraged partnerships and
M&As as a way to increase development capabilities

Last Modified 08-03-2018 09:43 Romance Standard Time


Examples of M&A activity in Pharmaceutical Contract Manufacturing Industry trends & implications

EV and ▪ Healthy M&A activity in


Acquirer Target Year multiple1 Description Pharma outsourcing
industry, with ~ one third of
2014 n/a ▪ Micron Technologie’s particle size all transactions in CDMO
engineering capabilities enhances Catalent’s and development sector
solutions for early stage drug development
processes
▪ Increase in M&A activity
amongst CMOs as they
2014 n/a ▪ Acquisition of SMARTag™ technology attempt to transform
platform, that offers a new toolkit to develop themselves into CDMOs
optimized ADCs and bioconjugates ▪ Valuations in past years
2016 n/a ▪ Extensive early-phase drug development remain at a premium with a
capabilities from discovery to clinic to extend median disclosed EBITDA
Catalent’s development portfolio multiple of 13.2x

2016 n/a ▪ Acquisition expands Catalent’s global OTC


▪ Main driver of M&A activity
is the enhancement of
and prescription pharmaceutical softgel

Printed
capabilities in develop-
development capabilities
ment, formulation and
2015 60 USDm, ▪ Expansion of analytical service capabilities analytical testing
2.2x/10.0x and drug development services to include ▪ Especially when aiming to
sterile injectable formulation development build up specialized
2016 21 USDm ▪ Access to increased development capabilities, such as
operations both in scale and breadth of biologics, or innovative
capabilities technologies (e.g. softgel)
acquisitions are a favorable
2016 25 USDm, ▪ Capabilities in developing, manufacturing option for CDMOs
1.5x/12.5x and scaling up small molecule APIs for
clinical phase projects

1 Enterprise value, Revenue multiple/ EBITDA multiple


SOURCE: Capstone, Capital IQ, Contract Pharma, Company websites, press search McKinsey & Company 25
11 The industry will see growing differentiation of CDMO NON EXHAUSTIVE

value propositions

Last Modified 08-03-2018 09:43 Romance Standard Time


Technology specialists Differentiating factors
▪ Strong capability in specialized technologies
▪ Providing low-volume or irregular services, which larger pharma
companies may not want to have in-house
How to get there?
▪ Acquire under-utilized sites from the large players, and boost the
utilization with additional clients
▪ Enter joint development partnerships with few major pharmacos

Integrated Differentiating factors Commodity Differentiating factors


players ▪ End-to-end value chain coverage champions ▪ Large volume of operations, allowing
▪ Broad range of offerings, allowing full for economy of scale
lifecycle coverage (e.g. research, ▪ Low-cost-country location with e.g.
testing, launch) competitive labor and raw materials
How to get there? How to get there?
▪ Understand from clients key priority ▪ Move part of the operations to LCC
▪ Improve utilization at existing

Printed
technologies or offerings to develop
▪ Bring it as part of strategic partnership facilities
discussions, and build commitments ▪ Operational excellence and cost
▪ Secure investments required, and reduction programs in the sites
start development

Market access players Differentiating factors


▪ Operating in the markets with strict requirements for local manufacturing
How to get there?
▪ Build or acquire manufacturing facilities in markets with strong localization requirements
▪ Invest in market registration or authorization expertize

SOURCE: McKinsey, expert interviews McKinsey & Company 26

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