PharmSource - Contract Dose Manufacturing Industry by the Numbers: Composition, Size, Market Share and Outlook - 2018 Edition

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The motivation for pharma companies outsourcing their manufacturing is often to do with lacking expertise, equipment, or cost reduction (especially for small to mid-sized CMOs) in development of their product’s API or dose. For clinical dose manufacturing, there is a high risk associated with the pipeline drug product and as such using a CMO for this mitigates risk for pharma companies that may otherwise have to invest in equipment and facilities. This report, the 2018 version in this annual series, characterizes the contract dose manufacturing industry along a number of quantitative dimensions, including number and type of participants, market size, market shares of the top CMOs and profitability. We also assess the outlook for the industry. This report is an improvement over previous reports because it utilizes GlobalData’s Intelligence Center Drug database to provide deeper analysis of the industry.

Most commercial dose companies have solid dose manufacturing facilities, as new products become molecularly complex issues arise such as those surrounding bioavailability and formulation (delivery technologies are becoming increasingly important) for products that are often have poor solubility or are highly potent (Hickman et al. 2018). As batches are becoming smaller due to an increasing use of orphan drugs and drugs for patient sub populations such as pediatrics, the ability for flexible and small-scale is becoming particularly desirable. These two trends will affect consolidation trends for CMOs as certain technologies are increasingly sought after and will also affect dose related revenue growth as many CMOs will not have the capabilities to provide the desired service for a changing drug products in a decreasing patient population. PharmSource predicts that dose related CMO revenues will grow more slowly than for their API counterparts. Many dose CMOs will have to improve their formulation and drug delivery technologies to compete for clients with products that are often have poor solubility or are highly potent

Key Questions Answered

- What is the geographic reach of Dose CMOs?

- What are the 2017 revenues generated by Contract dose manufacturing industry?

- What are the components of revenue change for Contract Dose Manufacturers?

- What is the breakdown of 2017 revenues by different dosage forms?

- What are the characteristics of the largest dose CMOs?

- How did the revenue growth of Contract Dose manufacturers in 2017 compare to Contract API manufacturers?

- What proportion of approved NDAs have had their Dose manufacture outsourced between 2008-2017?

- What is the outlook for the dose CMO industry?

- What Dose CMO M&A deals occurred in 2017?

Key Benefits

- To describe and evaluate the dose market, segmented by type of growth and dosage form contributions

- To describe and assess the M&A environment for Dose CMOs

- To assess the outlook for buyers and sellers of contract manufacturing services for commercial dose, including the supply/demand balance

Scope

Overview of dose contract revenue market size, the components of growth and dosage form specific revenues for CMOs providing pharmaceutical finished dosage form for supply to the highly regulated markets of the US, Canada, EU and Japan.

Detailed view of dose CMO M&A deals and services gained for commercial dose manufacturing, established from the PharmSource Contract Service Providers database.

Assessment of dose CMO industry size and structure.

Characterising types of dosage form manufacture provided by the leading dose CMOs.

Reasons to buy

This 47-page report gives an important expert quantitative analysis on the contract dose manufacturing industry. Findings are based on the industry’s most comprehensive database of the dose CMO industry (PharmSource’s Database of Contract Service Providers and Financial Database) this analysis is driven by a proprietary model of the dose manufacturing industry, which is continuously updated and refined. The 8 tables and 10 figures throughout the report illustrate major points and trends. This report is required reading for -

- CMO executives and strategic decision-makers: improves understanding of the dose CMO industry and a critical input for strategic planning efforts.

- Sourcing and procurement executives in bio/pharmaceutical companies: improving understanding of crucial components of the supply base that will provide insights for supplier selection and management.

- Private equity investors: they can deeper understanding of the dose CMO market and important insight for identifying potential investment targets.

Companies mentioned

3M Drug Delivery Systems

Abbvie

ABC Farmaceutici

Abiogen

Accupac

Acino Holding AG

ACS Dobfar

Adare Pharmaceuticals

Aenova (Swiss Caps/Dragenopharm)

Aesica

Akiyama Jyozai

Alcami

Alfa ...

3M Drug Delivery Systems

Abbvie

ABC Farmaceutici

Abiogen

Accupac

Acino Holding AG

ACS Dobfar

Adare Pharmaceuticals

Aenova (Swiss Caps/Dragenopharm)

Aesica

Akiyama Jyozai

Alcami

Alfa Wasserman

Almac

Alpex Pharma

Althea Technologies Inc.

Amatsi

American Regent/Luitpold Pharmaceuticals

AMRI

AMW GmbH

Anfarm

Apotek Produktion & Laboratorier (APL)

Applied Laboratories

ARx LLC

Asept Pak

Aseptic Technologies

Aspen Bad Oldesloe

Athlone Laboratories Ltd

Avara

Ayanda

Baccinex

BAG Healthcare

Bankyo Pharmaceuticals

Bausch & Lomb

Baxter

Bell-More

Beltapharm

Bepharbel

Company  Name

Berlin-Chemie AG

Best Formulations

BI Bioexcellence

BioConnection B. V.

Biofabri

Biofarm Italia

Biofilm

Bioluz

Biopharma

BioTechnique

Bluepharma

BMP Bulk Medicines & Pharmaceuticals Production GmbH

BOLDER Arzneimittel GmbH

Boots Contract Manufacturing

Bruschettini S.r.l.

BSP Pharmaceuticals

Bushu Pharmaceuticals

Capsula Operculata GmbH

Catalent

Cenexi

Chanelle Medical

Chartwell

Citra Pharma Manufacturing

CMIC

Coating Place

Cobra Biologics

Colep

Conforma

Cook Pharmica

Corden Pharma

Corium

Cosmo Pharmaceuticals

CPL

Curida

Custom Pharmaceuticals

Cyndea Pharma

Daito

Debiopharm Research & Manufacturing SA

Dechra (Dales)

Delpharm

Demo SA

Doppel

DPT

Dr. R. Pfleger

Dr. Reddy's

Ei (formerly Harmony Labs)

Emergent Biopharma

Encap Drug delivery

E-Pharma Trento

Europhartech

Ever Pharma GmbH

Exela Pharma Sciences

Famar

FAREVA Holdings

Farmalabor (Grupo medinfar)

Farmasierra SA

Ferrer Internacional

Fertin Pharma

Fine Foods NTM Spa

Fresenius Kabi

Frontida

Fulton Medicinali

G&W Laboratories, Inc.

Gap Pharma

Gedeon Richter

Gemini Pharmaceuticals

Generis

GI Pharma

GL Pharma

Glatt Pharmaceutical Services

Glaxosmithkline

GP-Pharm

Grand River Aseptic Manufacturing

Grifols

Groupe Panpharma

Grunenthal

Grupo Azevedos

Guardian Drug Company

Halo Pharmaceutical

Hanford Pharmaceuticals

Hasco Lek

HBM Pharma

Helsinn

Hermes Arzneimittel GmbH

Holopack

Horizon Pharmaceuticals

Iberfar

Injectalia

Italfarmaco

ITC farma

Jubilant HollisterStier

Kemwell

Kern Pharma

Klocke Group (inc. IDT)

Kokando

Labiana

Laboratoire AJC

Laboratoire Elaiapharm

Laboratoires Chemineau

Laboratoires Galéniques Vernin (LGV)

Laboratoires Gilbert

Laboratoires Lavoiser Chaix

Laboratoires Macors/Opodex

Laboratoria Smeets

Laboratoria Wolfs

Laboratorio Farmaceutico CT

Laboratorios Basi

Laboratorios Ern

Lacer SA

Lachifarma

Lamp San Prospero SPA

Laphal Industrie

Legacy Pharmaceuticals

Lichtenheldt

Lifecore Biomedical LLC

Lindopharm

Lisapharma

LNK International

Lomapharm - Rudolf Lohmann GmbH

Losan Pharma

LSNE

LTS Lohmann Therapie-Systeme GmbH

Marine Ingredients

Maropack AG

Mayne Pharma

MEDA Manufacturing

Medicofarma SA

Medinsa

Meditop

Medreich

Mikart

MIPHARM

Miwana AB

MonoSol Rx

Nagase Medicals

Nephron Pharmaceuticals Corporation

Nexgen Pharma

NextPharma

Nipro Pharma

Nitto Medic

Nordmark Arzneimittel GmbH & Co. KG

Nova Laboratories

Oakwood Laboratories

OFI

Oncomed Manufacturing a.s

Oncotec

Orion Pharma

Orofino Pharmaceuticals Group

Osmopharm SA

Patheon (part of Thermo Fisher)

Pegasus Labs

Perrigo/Wrafton

Pfizer CentreOne

Pharma Developpement

Pharma Stulln GmbH

Pharma Tech Industries

Pharmapack

Pharmascience

Pharmasol/Pharmaserve

Pharmatis

Pierre Fabre

Pierrel

PII

Pillar5 Pharma

Piramal Pharma Solutions

PL Developments

Plastikon Industries

PMRS

Polfarmex S.A.

Polpharma

Prasfarma S.A.

PrimaPharma, Inc.

Procaps

Procemsa

Purna Pharma

Pyramid Laboratories

QPharma

Qualiphar NV

Rafarm

Rechon Life Science

Recipharm

Recro Pharma

Reig Jofre

Rentschler

Rompharm

Ropack

Rottendorf

Rovi Contract Manufacturing

R-Pharm

RubiePharm Arzneimittel GmbH

Salutas Pharma

Samsung Biologics

Sandoz

Saneca Pharmaceuticals

Sanico NV.

Sanochemia

Sanofi

Sciarra Laboratories

Servier

Siegfried/AMP/Hameln

Sigma-Tau PharmaSource, Inc.

Siit

Sintetica

Sirton

SM Farmaceutici

SMB

Solupharm

Sose Pharma

Sovereign Pharmaceuticals

Stason

Statens Serum Institut

Sterling Pharmaceutical Services

Sterop Laboratories

Surepharm

Symbiosis Pharmaceutical Services

Synerlab

Tapemark

Tedor Pharma

Tesa Labtec GmbH

The Ritedose Corp

Thepenier Pharma Industrie S.A.

Toa Pharmaceuticals Co. Ltd

Toll Pharma

Tower Laboratories, Ltd

Trillium Health Care Products Inc.

Uniafarm

Unicep

Unimedic Group

Unither

Unolab

Ursapharm

Valpharma

Vetter

Vianex SA

Vifor Pharma

Vioser S.A.

Vistin Pharma AS

Wagener & Co. GmbH

WellSpring Pharma Services

Wiewelhove

Wockhardt CM

Xellia Pharmaceuticals

Zhejiang Huahai Pharmaceutical Co., Ltd

Table of Contents

1 Executive Summary 1

2 Industry Size and Structure 3

Definition of the Dose CMO Universe 3

Industry Demographics 3

3 Major Developments Affecting Industry ...

1 Executive Summary 1

2 Industry Size and Structure 3

Definition of the Dose CMO Universe 3

Industry Demographics 3

3 Major Developments Affecting Industry Structure 8

4 Industry Size and Growth 12

Dose Manufacturing 12

5 CMO Market Shares 17

Characteristics of the Largest CMOs 18

6 Analyzing Recent Dose CMO Industry Performance 21

The Outlook for the Dose CMO Industry 27

7 Appendix 30

Methodology for Market Size & Growth Estimates 30

CMO Classifications 31

Industry Cost of Goods 33

Bibliography 41

Primary Research - Key Opinion Leaders Interviewed for this Report 42

About the Authors 42

List of tables

Table 1: Summary of CMO Facility Acquisition Activity, 2012-2017 8

Table 2: CMO Acquisitions of Bio/Pharmaceutical Company Facilities, 2017 9

Table 3: CMO Acquisitions ...

Table 1: Summary of CMO Facility Acquisition Activity, 2012-2017 8

Table 2: CMO Acquisitions of Bio/Pharmaceutical Company Facilities, 2017 9

Table 3: CMO Acquisitions of Bio/Pharmaceutical Companies, 2017 9

Table 4: CMO Acquisitions of Other CMOs, 2017 10

Table 5: Private Equity Investments in the Dose CMO Industry, 2012-2017 10

Table 6: Percentage of Commercial Dose CMOs thatOffer Clinical Dose Manufacture, by Revenue Tier 15

Table 7: Revenue Composition and Strategic Orientation of Leading CMOs, 2017 19

Table 8: Geographical Reach of Dose CMO Universe 33

List of figures

Figure 1: Geographic Reach of the Dose CMO Universe, 2017 5

Figure 2: Dose CMOs by Revenue, 2017 7

Figure 3: Dose CMO Market Size ...

Figure 1: Geographic Reach of the Dose CMO Universe, 2017 5

Figure 2: Dose CMOs by Revenue, 2017 7

Figure 3: Dose CMO Market Size, 2009-2017 12

Figure 4: Components of Growth for Dose CMOs, 2016-2017 14

Figure 5: Dose CMO Dosage Form Segments in 2017 ($B) 16

Figure 6: Dose CMO Industry Market Share by Company Size, 2017 17

Figure 7: Bio/Pharma Services Sector Performance 21

Figure 8: Organic Revenue Growth for Public CMOs 23

Figure 9: Breakdown of NMEs & Outsourced NMEs Approved for Global Bio/Pharma Companies, 2008-2017 24

Figure 10: Breakdown of US Orphan Drug Approvals, 2008-2017 26

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