Here’s a handy guide to frequently requested data about the bio/pharma contract services industry.

How big is the market for…?

The market for overall bio/pharmaceutical outsourced development spending:

Market Size Source
2016: $26 billion
2019: $31 billion
Medpace
Presentation at Baird Global Healthcare Conference
September 2016

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The market for small and mid-sized bio/pharmaceutical outsourced development spending:

Market Size Source
2016: $8 billion
2019: $11 billion
Medpace
Presentation at Baird Global Healthcare Conference
September 2016

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The market for total global bio/pharmaceutical R&D spending:

Market Size Source
2016: $127 billion
2020: $148 billion
Icon plc
Presentation at JP Morgan Conference
January 2017
2015: $160 billion Catalent Pharma Solutions
Presentation at JP Morgan Conference
January 2016

Estimates can vary based on geographic scope and segments included (bio/pharma, animal health). Partnering dollars may be double-counted, once for giver and once for receiver.

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The market for absolute R&D growth from 2017-2020:

Market Growth Source
2-3% Icon plc
Presentation at JP Morgan Conference
January 2017

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The market for R&D outsourced clinical trials penetration:

Market Growth Source
40-50% Icon plc
Presentation at William Blair 35th Annual Growth Stock Conference
June 2015

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The market for R&D drug development spend:

Market Size Source
2015: $75.4 billion INC Research
Presentation at William Blair 36th Annual Growth Stock Conference
June 2016

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The market for R&D preclinical development:

Market Size Source
2015: $10.3 billion INC Research
Presentation at William Blair 36th Annual Growth Stock Conference
June 2016

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The market for R&D in-house clinical development:

Market Size Source
2015: $26.8 billion INC Research
Presentation at William Blair 36th Annual Growth Stock Conference
June 2016

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The market for R&D CRO clinical development:

Market Size Source
2015: $25.7 billion
2020: $36.7 billion
INC Research
Presentation at William Blair 36th Annual Growth Stock Conference
June 2016

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How much is the bio/pharmaceutical industry spending on investment for new plant and equipment?

Market Size Source
2013: $18.6 billion total capex
2014: $21.4 billion total capex represents an increase of 13%
Bio/Pharmaceutical Outsourcing Report
Pharma Industry Sees Increasing Capital Expenditures
May 2015

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How many NDA approvals have dose CMOs received in 2015?

Market Size Source
2015: 52 (43% of all NDA approvals) PharmSource Trend Report
“CMO Scorecard: Outsourcing of
NDA Approvals and CMO Performance”

March 2016

Data is for NDAs approved in 2015 for which the dose form is manufactured by a CMO.

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How many approved biosimilars are being manufactured by CMOs?

Market Size Source
2014: 2 biosimilars are using a CMO for the API, 6 are using a CMO for the dose form PharmSource Trend Report
“Catching a Wave: How much will CMOs benefit from biosimilars?”
January 2015

Data is for biosimilars approved in Europe through 2014.

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The market for clinical research – total spending:

Market Size Source
2017: $63 billion
2020: $72 billion
Icon plc
Presentation at JP Morgan Conference
January 2017
2015: $58 billion Catalent Pharma Solutions
Presentation at JP Morgan Conference
January 2016
2015: $54 billion Quintiles
Presentation at JP Morgan Conference
January 2016

Addressable market definition and perception will differ somewhat based on service offerings. Icon, Parexel, Quintiles closest to the market; Higher number may include investigator grants. Catalent focuses on clinical supplies piece, less familiar with clinical research segment.

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The market for clinical research – outsourced spending:

Market Size Source
2017: $30 billion (48% of total)
2020: $40 billion (55% of total)
Icon plc
Presentation at JP Morgan Conference
January 2017
2015: $29 billion (50% of total) Catalent Pharma Solutions
Presentation at JP Morgan Conference
January 2016
2015: $22 billion (41% of total) Quintiles
Presentation at JP Morgan Conference
January 2016
2014: $17.1 billion (46% of total)
2018: $21.8 billion (52% of total)
Parexel
Presentation at JP Morgan Conference
January 2015

Icon, Parexel, Quintiles closest to the market; Higher number may include investigator grants. Catalent probably includes clinical supplies piece, but others may not.

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The market for CMC development – total spending:

Market Size Source
2014: $22 billion Catalent Pharma Solutions
Presentation at JP Morgan Conference
January 2016

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The market for CMC development – outsourced spending:

Market Size Source
2014: $6.72 billion (30% of total) Catalent Pharma Solutions
Presentation at JP Morgan Conference
January 2016

Size suggests this includes API, formulation, CTM manufacture and clinical packaging

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The market for innovator API development and manufacturing – outsourced spending:

Market Size Source
2015: $13-15 billion Cambrex
Presentation at Jefferies 2016 Global Healthcare Conference
June 2016

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The market for generic APIs – total spending:

Market Size Source
2015: $11 billion Cambrex
Presentation at Jefferies 2016 Global Healthcare Conference
June 2016

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The market for API DEA schedule II:

Market Size Source
2015: $500-600 million Cambrex
Presentation at Jefferies 2016 Global Healthcare Conference
June 2016

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The market for discovery and preclinical development:

Market Size Source
2014: $15.8 billion
2016: $19.7 billion
AMRI
Presentation at JP Morgan Conference
January 2015

Includes discovery biology and chemistry, high throughput screening, safety and toxicology.

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How many drugs in preclinical to phase 3 development?

Source
March 2015: 10,900 Quintiles
Presentation at William Blair 35th Annual Growth Stock Conference
June 2015

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How many drugs in phase 1 to phase 3 development?

Source
March 2015: 4,700 Quintiles
Presentation at William Blair 35th Annual Growth Stock Conference
June 2015

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