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Home > Pharmaceuticals >  COVID-19 >  COVID-19: Contract Pharmaceutical Development and Manufacturing Relationships

COVID-19: Contract Pharmaceutical Development and Manufacturing Relationships

This report examines contract manufacturing agreements for vaccines and therapies targeting COVID-19. It reports that there are more than 1,000 vaccines and therapies in development for COVID-19, and 36 vaccines and therapies approved (or granted emergency use authorization) for COVID-19 (as of report publication). At the beginning of the pandemic, slightly more than half of these agreements were for vaccines; this proportion has risen and continues to rise, as several vaccines have proven their safety and efficacy, received approval, and are being ordered in billions of doses by numerous governments.

COVID-19 therapy development has been less successful, although there are several efficacious therapies on the market. There is still an unmet need in this area, as vaccine distribution takes time, vaccine efficacy is not 100%, and certain parts of the population will not receive a vaccine or will not have a strong immune response. Many of the promising clinical-stage therapies and marketed therapies are monoclonal antibodies (often repurposed from development in other indications). Their manufacture requires CDMOs with specialized biologic capabilities.

What are the market dynamics and trends in the contract manufacturing of COVID-19 therapeutics and vaccines?

Marketed vaccines and therapies: 36 vaccines and therapies are approved or otherwise authorized for emergency use. For vaccines especially, the shift to commercial-scale volumes necessitates new and larger contract manufacturing agreements.

Pipeline vaccines and therapies: More than 1,000 vaccines and therapies are still in development for COVID-19. Some, now in late-stage development, will be approved, but most will undergo attrition.

Vaccine contracts increase: The ratio of vaccine: therapy manufacturing contracts has increased over time as several successful vaccines reach the market. Many CDMOs are involved in the commercial scale-up effort for hundreds of billions of doses. This high volume can make manufacturing slots scarce at some CDMOs.

The US wins contracts: US facilities are the clear winner by the number of contract manufacturing agreements. India and Germany are in second and third places.

Complex active pharmaceutical ingredients (API): Contract manufacturing agreements are most commonly for API – Biologics (Protein and Peptide). API is an early production step; many products will not progress far enough in clinical trials to require a final dose from the manufacturer. Protein and Peptide are popular molecule types because of the preponderance of vaccines and monoclonal antibodies in the COVID-19 pipeline. The top vaccines require either viral vectors or mRNA—both novel technology. All these molecules require contract manufacturing organizations with specialist facilities for this relatively complex manufacturing.

What are the COVID-19 therapies and vaccines that are marketed worldwide?

There are 36 therapies and vaccines marketed worldwide through full regulatory approvals or through emergency use authorizations. In developed pharma markets, mRNA and vector vaccines dominate over other vaccine types. These are novel molecule types and require special manufacturing expertise.

With multiple vaccines having shown impressive efficacy, notably for reductions in the need for hospitalization and mortality, the window for utility for COVID-19 therapies may be rapidly contracting (see COVID-19 Pharma Executive Briefing, July 27, 2021). However, this may be offset by increased illness caused by the predicted rise of vaccine-resistant variants and shortages of vaccines in certain countries, such as India. Pfizer CEO Albert Bourla told Fox News on August 24 that it is “likely” that a variant of SARS‑CoV‑2 will “one day” emerge that is resistant to Pfizer’s current vaccine; at that time, the company plans to develop a tweaked vaccine within three months.

What is the value chain of contract manufacturing industry?

The contract manufacturing industry’s value chain is simplified into three main segments, beginning with API, which is the active component of a vaccine or therapy. API manufacturing is followed by dose form manufacturing, when active and inactive ingredients are combined to produce the final dose form, such as a tablet or an injectable. The final step is the packaging: primary packaging is the placing of a dose form into the container that makes actual physical contact with the drug, e.g., a vial or prefilled syringe for an injectable. Secondary packaging is the placing of a primary package into an outer container, for example, putting a vial into a cardboard box.

As illustrated by the value chain, API is the starting step and can have big implications on which dosage forms or packaging are used later in the process. For instance, a high number of contract service agreements being made for biologic API manufacture (Section 0) has major implications for injectable dose form manufacturing and packaging.

Contract manufacturing agreements for COVID-19 vaccines and therapies, by manufacturing facility

Contract manufacturing agreements for COVID-19 vaccines and therapies, by manufacturing facility

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Who are the top CDMOs with contract manufacturing agreements for COVID-19 vaccines and therapies?

The leaders include the CDMOs Catalent and Lonza, and the pharma sponsor companies AstraZeneca, Johnson & Johnson, and Pfizer.

CDMOs with contract manufacturing agreements for COVID-19 vaccines and therapies

CDMOs with contract manufacturing agreements for COVID-19 vaccines and therapies

To know more about key players, download a free report sample

Market report scope

CDMOs

Catalent and Lonza, AstraZeneca, Johnson & Johnson, and Pfizer

Scope

This report is the companion to Contract Manufacturing Service Agreements – Rising Manufacturing Opportunities Driven by Pharmaceutical Pipeline Expansion (July 2020). IT covers contract manufacturing agreements for COVID-19 vaccines and drugs worldwide, across a range of different services and manufacturing scales. It covers clinical and commercial contracts. As COVID-19 pharmaceuticals are being ordered in billions of doses by numerous governments, the number of contract service agreements secured serves as an indicator of a CMO’s performance. This report is critical for establishing an understanding of the overall CMO industry as it responds to the challenges and opportunities of the pandemic.

This 52-page report gives an important expert quantitative analysis of the contract manufacturing industry’s response to the COVID-19 pandemic. Findings are based on the industry’s most comprehensive databases of the CMO industry (GlobalData’s Databases of Contract Service Providers, Drugs, and Deals). This analysis is primarily driven by the Deals Database, which is continuously updated and reveals manufacturing relationships for Pharma products and the types of services offered. The 23 figures and 6 tables throughout the report illustrate major points and trends.

  • Overview of contract manufacturing agreements worldwide for COVID-19 pharmaceuticals and the levels of outsourcing associated with different services and drug type
  • Detailed view of CDMO performance by contract manufacturing agreement and an assessment of their manufacturing scale
  • Manufacturing agreements are assessed by different molecule types, service type, dose form, facility geography, sponsor company types, and CDMO types.

Reasons to Buy

This report is required reading for

  • CMO executives who must have deep understanding of the COVID-19 vaccine and drug landscape both pipeline and marketed to make strategic planning and investment decisions.
  • Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management.
  • Investors that need a deeper understanding of the market to identify and value potential investment targets.

Companies Mentioned

ABF Pharmaceutical Services GmbH

Abzena Ltd

Adienne Pharma & Biotech SA

Advanced BioScience Laboratories Inc

Advent Srl

AGC Biologics Inc

Ajinomoto Bio-Pharma Services

Akron Biotechnology LLC

Aldevron LLC

Allergopharma GmbH & Co KG

Almac Group Ltd

Amgen Inc

Apeptico Forschung und Entwicklung GmbH

Aragen Bioscience Inc

Aspen Pharmacare Holdings Ltd

AstraZeneca UK Ltd

Attwill Medical Solutions

Avid Bioservices Inc

Avra Laboratories Pvt Ltd

Bachem Holding AG

Bajaj Healthcare Ltd

Batavia Biosciences BV

Bausch Health Companies Inc

Baxter Biopharma Solutions

Bayer AG

BDR Pharmaceuticals Internationals Pvt Ltd

Beijing Institute of Biological Products

Beijing Minhai Biotechnology Co Ltd

Bharat Biotech Ltd

Binnopharm JSC

Biocad

BioCell Corp Ltd

BioCentriq

Biocon Ltd

BioConvergence LLC

Biofabri SL

Biogen Inc

Biological E Ltd

BioNTech SE

Biotechpharma UAB

Bryllan LLC

Cadila Healthcare Ltd

Cambrex Corp

Cascade Chemistry

Catalent Inc

Celltrion Inc

Celonic AG

Cenexi SAS

Centaur Biopharmaceutical Services Inc

Chime Biologics Ltd

CinnaGen Ilac San ve Tic AS

Cipla Ltd

Clover Biopharmaceuticals

CMIC Holdings Co Ltd

Cobra Biologics Ltd

CSL Behring Australia Pty Ltd

Curia Inc

Daiichi Sankyo Biotech Co Ltd

Dalton Pharma Services

Delpharm SAS

Dr. Reddy’s Laboratories Ltd

Drugmex SAPI de CV

Dyadic International Inc

Eli Lilly and Co

Emergent BioSolutions Inc

Esteve Huayi Pharmaceutical Co Ltd

EUSA Pharma

Exelead Inc

Exothera SA

Fareva SA

Flamma SpA

Fujifilm Corp

GALENpharma GmbH

Gamaleya Federal Research Center of Epidemiology and Microbiology

GC Pharma

Genentech USA Inc

Generium

Genscript Biotech Corp

Gilead Sciences Inc

Gland Pharma Ltd

GlaxoSmithKline Inc

Goodwin Biotechnology Inc

Grand River Aseptic Manufacturing Inc

Haffkine Bio-Pharmaceutical Corp Ltd

Hainan Visum Pharmaceutical Co Ltd

Halix BV

Hankook Korus Pharm Co Ltd

Hester Biosciences Ltd

Hetero Drugs Ltd

Hikma Pharmaceuticals Plc

Hoffmann-La Roche Ltd

Hualan Biological Engineering Inc

Humanigen

iBio Inc

IDT Biologika GmbH

Indian Immunologicals Ltd

Institute of Medical Biology Chinese Academy of Medical Sciences

Institute of Virology Vaccines and Sera Torlak

Insud Pharma

IriSys LLC

ISU ABXIS Co Ltd

Janssen Biotech Inc

JCR Pharmaceuticals Co Ltd

Jubilant HollisterStier LLC

Jubilant Pharmova Ltd

Julphar Saudi Arabia LLC

Kaneka Corp

Kaneka Eurogentec SA

Kern Pharma SL

KM Biologics Co Ltd

Laboratorio Reig Jofre SA

Laboratorios de Biologicos y Reactivos de Mexico SA de CV

Laboratorios Farmaceuticos Rovi SA

Laboratorios Richmond SACIF

LakePharma Inc

LFB Biomanufacturing

List Biological Laboratories Inc

Lonza Group Ltd

Mabxience Holding SL

Mankind Pharma Ltd

Medicago

Merck

Merck & Co Inc

Mibe GmbH Arzneimittel

MilliporeSigma

Mithra Pharmaceuticals SA

Moderna Inc

Morepen Laboratories Ltd

National Resilience Inc

National Resilience Inc (including subsidiaries Ology Bioservices Inc, Therapure Biopharma Inc)

Nephron Pharmaceuticals Corp

NeuroRx

Nipro Pharma Corp

Northern RNA Inc

Novartis AG

Novartis Farma SpA

Novasep Holding SAS

Novavax

Oakwood Laboratories LLC

Oxford BioMedica Plc

Panacea Biotec Ltd

Par Sterile Products LLC

Patheon NV (Thermo Fisher Scientific)

PCI Pharma Services

Pfizer Inc

PharmaMar

Pharmaniaga Berhad

Pharmasyntez

Pharmstandard

Polymun Scientific Immunbiologische Forschung GmbH

PolyPeptide Group AG

Polyvac

PT Bio Farma

Quotient Sciences Ltd

Recipharm AB

RedHill Biopharma

Regeneron Pharmaceuticals Inc

Rentschler Biopharma SE

Rhein-Minapharm Biogenetics SAE

Richter-Helm BioLogics GmbH & Co KG

Ridgeback

R-Pharm

Saidal

Samsung Biologics Co Ltd

Sanofi

Saptagir Laboratories Pvt Ltd

Sciarra Laboratories Inc

Serum Institute of India Pvt Ltd

SGS Life Science Services

Shenzhen Yuanxing Gene Technology Co Ltd

Shilpa Medicare Ltd

Siegfried Holding AG

Sinovac Biotech Ltd

SK Bioscience Co Ltd

Sorrento Therapeutics Inc

Sothema

Sovereign Pharma Pvt Ltd

Spera Nexus Inc

Spera Pharma Inc

STC Biologics Inc

Stelis Biopharma Pvt Ltd

Sterling Pharma Solutions Ltd

Strides Pharma Science Ltd

Summit Biosciences Inc

Supriya Lifescience Ltd

Symbiosis Pharmaceutical Services Ltd

Synairgen

Sypharma Pty Ltd

The Biovac Institute

The State Research Center of Virology and Biotechnology VECTOR

TopRidge Pharma Ltd

Turk Ilac ve Serum Sanayi AS

Uniao Quimica Farmaceutica Nacional SA

Unigen Co Ltd

UPM Pharmaceuticals Inc

Vabiotech

Vacsera

Valneva

Vaxart

Vectura Group Plc

Vetter Pharma-Fertigung GmbH & Co KG

VGXI Inc

Vibalogics GmbH

Vigene Biosciences Inc

Virchow Biotech Pvt Ltd

Wacker Chemie AG

Waisman Biomanufacturing

WuXi Biologics

Zydus Healthcare Ltd

Table of Contents

1 Executive Summary

2 Players

3 Trends

4 Industry Analysis

5 Value Chain: Contract Manufacturing Service Agreements

6 Appendix

7 Companies

8 About the Authors

List of Tables

Table 1: Top Trends in COVID-19 Contract Manufacturing

Table 2: Promising Pipeline Therapies

Table 3: Promising Pipeline Vaccines

Table 4: Marketed Therapies and Vaccines

Table 5: Further Reading

Table 6: CDMOs with COVID-19 Contract Manufacturing Agreements

List of Figures

Figure 1: Leaders and Disruptors: Top Players in Outsourcing COVID-19 Vaccine/Therapeutic Manufacturing

Figure 2: Pipeline Therapies in Development for COVID-19

Figure 3: Pipeline Vaccines in Development for COVID-19

Figure 4: Clinical Trials of COVID-19 Therapies and Vaccines

Figure 5: The Contract Manufacturing Value Chain

Figure 6: COVID-19 Vaccine and Therapy Contract Manufacturing Agreements

Figure 7: Contract Manufacturing Agreements for COVID-19 Vaccines and Therapies – Manufacturing Facility Geography

Figure 8: Contract Manufacturing Agreements for COVID-19 Vaccines and Therapies – Manufacturing Facility Country

Figure 9: Contract Manufacturing Agreements for COVID-19 Vaccines – Manufacturing Facility Geography

Figure 10: Contract Manufacturing Agreements for COVID-19 Therapies – Manufacturing Facility Geography

Figure 11: COVID-19 Contract Manufacturing Agreements by Molecule Type

Figure 12: Contract Manufacturing Agreements by Service Type

Figure 13: Contract Manufacturing Agreements by Dosage Form

Figure 14: Outsourcing by API/Dose/Packaging

Figure 15: Count of Services Per Contract

Figure 16: Contract Manufacturing Agreements – Scale of Services

Figure 17: Top CDMOs by COVID-19 Contract Service Agreements

Figure 18: CDMOs with COVID-19 Contract Manufacturing Agreements – by Market Cap

Figure 19: Market Cap Bands of CDMOs (Therapies vs. Vaccines)

Figure 20: Contract Manufacturing Agreements by Top Products/Sponsors

Figure 21: Vaccine Contract Volume, Gamaleya and AstraZeneca

Figure 22: Vaccine API Contract Manufacturing Facilities, Worldwide

Figure 23: Vaccine API Contract Manufacturing Facilities, US

Frequently Asked Questions

Johnson & Johnson, AstraZeneca Plc, Gilead Sciences Inc., Eli Lily Co., and Regeneron Pharmaceuticals Inc. are the top bio/pharma companies in outsourcing COVID-19 vaccine/therapeutic manufacturing.

Catalent, Lonza, Curia, Thermo Fisher, Samsung Biologics Co Ltd, Wuxi Biologics/STA, and AGC Biologics Inc are the top contract manufacturing organizations in outsourcing COVID-19 vaccine/therapeutic manufacturing.

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