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

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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

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Market report scope

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.