Vaccine Contract Manufacturing Market

Market Overview

The global vaccine contract manufacturing market size was valued at USD 2.45 billion in 2022. It is estimated to reach USD 7.04 billion by 2031, growing at a CAGR of 12.45% during the forecast period (2023–2031). The increasing demand for greater vaccine production has resulted in contract manufacturers gaining a larger share and higher demand in the vaccine contract industry.

Vaccines play a major role in the prevention and eradication of several life-threatening infectious diseases across the world. The rise in the demand for treating such diseases, along with R&D related to new vaccine discovery and a surge in vaccination awareness among people, are the major factors boosting the vaccine contract manufacturing market growth. Vaccines include several varieties such as live-attenuated, inactivated, sub-unit, recombinant, toxoid, and many others.

This market includes various outsourcing services, including development, analytical, upstream and downstream processing, quality control, supply chain, etc. Contract manufacturing of vaccines is provided at commercial, clinical, and preclinical scales. Biopharmaceutical companies continuously outsource their vaccines to meet the clinical demand during epidemics and pandemics.

Market Dynamics

Global Vaccine Contract Manufacturing Market Drivers

Manufacturers' Focus on Scaling-Up Vaccine Production

One of the most effective and affordable defenses against potentially fatal infectious diseases is vaccination. The WHO estimates that vaccinations save up to 3 million lives annually. Even though vaccines have been produced for many years, technology for developing them has recently undergone substantial advancements, and novel vaccination modalities are rising. The COVID-19 pandemic also brought attention to the necessity for inventive and quick manufacturing processes to meet vaccine demand.

Most manufacturers are likely to emerge as major players contributing to the higher growth of the market. For instance, Novavax started production of its vaccine in its recently purchased production site in Bohumil, Czech Republic. In Neuville-sur-Saône's advanced production facility and Marcy-l'Etoile's brand-new vaccine research facility, Sanofi is investing more than USD 610 million. Such tactics will aid in the global mass manufacture of vaccines. Hence, the growing need for larger vaccine production has benefitted contract manufacturers to increase their share and demand in the vaccine contract market.

Growing Collaboration Between Vaccine Developers and Contract Manufacturers

Advancements in therapeutic and preventative vaccines have renewed the interest in contract manufacturing. Infectious diseases are the primary focus for vaccine contract manufacturers. The high global demand for influenza during its short-term efficacy and annual administration has significantly aided the outsourced vaccine market. Approximately 52% of vaccine contract manufacturers are actively involved in the cancer field to create sophisticated vaccines. Similarly, the efficiency of the Human Papillomavirus (HPV) vaccine and the expansion of the target audience to include both males and females has secured the HPV vaccine's future and made it a strong candidate for outsourced production. Time to market is a considerable issue, especially when there is a surge in the need for vaccines, such as flu during bird flu and swine flu outbreaks.

Furthermore, larger companies with late-stage products and early-stage vaccine candidates of smaller biotech companies mostly rely on contract manufacturing by CMOs. Small companies lacking manufacturing capabilities have no choice but to rely on external suppliers, and larger companies require additional resources to produce a billion doses. In both these cases, contract manufacturers are helping companies to meet their various requirements to scale up their production, especially for their pipeline COVID-19 vaccines. Hence, growing agreements between vaccine developers and contract manufacturers boost market growth.

Global Vaccine Contract Manufacturing Market Restraint

Dearth of Storage Infrastructure and Limitations Associated with Supply Chain

The development of vaccines to prevent various infectious diseases has been one of the most significant healthcare accomplishments in the last century. Vaccines should be handled according to the recommended specifications. Failure to stick to such vaccine handling and storage conditions may render them useless. Some studies reported improper vaccine storage leading to the administration of sub-potent vaccines, which may have been associated with outbreaks of vaccine-preventable diseases in several developing countries.

The loss of vaccinations is attributed to inadequate cold chain conditions, including infrastructure, power outages, and poor maintenance. According to research, several developing nations waste about USD 4 million and USD 6 million of pentavalent and pneumococcus vaccines, respectively. Delayed and inadequate handling are the main causes of loss of vaccine potency. All the above factors impede the market growth.

Global Vaccine Contract Manufacturing Market Opportunities

Cost-Effective and Time-Saving Services of Contract Manufacturers

Contract manufacturing services are a strategy for companies ranging from big pharma players to small specialty entities. Major factors driving the demand for contract manufacturers include continuous cost-cutting efforts, decreased time to market, growing specialty firms that lack in-house manufacturing facilities, and increased outsourcing. In recent years, pricing pressures have driven contract manufacturers to form operations in developing markets. As a result of offshoring, many companies have established their facilities in China, South Korea, India, Malaysia, and Singapore. Moreover, investments continue to surge into Asia, with several foreign CMOs expanding their operations, especially in China. Due to price competitiveness, outsourcing manufacturing to low-cost Asian countries in larger volumes has become a significant choice.

Additionally, the main reasons for an OEM to outsource work to a CMO are consistently better speed to market, cost savings, and enhanced quality. The nature of outsourcing has changed as vaccine production has been kept in-house for quality and regulatory compliance. CMOs offering vaccine manufacturing gained high productivity, which is relatable to enhanced time to market and affordability, as reducing manufacturing costs can positively impact product price, which leads to market growth.

Regional Analysis

Based on region, the global vaccine contract manufacturing market share is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global vaccine contract manufacturing market shareholder and is anticipated to exhibit a CAGR of 12.81% during the forecast period. The US is the major revenue contributor in North America mainly due to an increase in the demand for vaccines, reflecting the growth in awareness of vaccinations and their benefits against infectious diseases. This led to the development of regular vaccination programs and new immunizations. Moreover, North America has widespread vaccine manufacturers and an increasing number of biopharmaceutical companies. All these factors collectively elevated the growth of North America in the vaccine contract manufacturing market.

Europe is estimated to exhibit a CAGR of 12.77% over the forecast period. The increase in vaccine contract manufacturing in Europe can be attributed to several significant causes, such as the aging population, the prevalence of bacterial and viral diseases, the growing need for immunizations, and the rapid expansion of the biopharma and biotech sectors. The vaccine outsourcing sector is being driven by increased investments resulting from the strong emphasis of government entities on research and development (R&D) in various European areas.

Asia-Pacific is expected to grow rapidly in the vaccine contract manufacturing market throughout the forecast period. This is mainly due to the involvement of contract manufacturers in the development of vaccines, which is growing at a constant pace. The region is expected to emerge as the fastest-growing region for developing and manufacturing vaccines. The top revenue-generating countries in this region are China, India, Japan, South Korea, and Australia. India is expected to have the most significant growth because of the need for immunizations to control the spread of contagious illnesses, such as hepatitis B, tuberculosis, Haemophilus influenzae type B, and other ailments.

In Latin America, economic globalization has increased the movement of people and goods with changes in occupational health and environmental hazards constantly transferring health risks. For instance, an epidemiologic transition with a gradual increase in the rate of infectious diseases is observed. The dominant diseases in Latin America are expected to exceed the US and other developed countries in the next 25 years. The potential for the spread of newly-discovered or re-emerging infectious diseases.

Segmental Analysis

The global vaccine contract manufacturing market is segmented by scale of operation, vaccine type, and service.

Based on the scale of operation, the global vaccine contract manufacturing market is bifurcated into commercial, clinical, and preclinical. 

The clinical segment dominates the global market and is projected to exhibit a CAGR of 13.28% over the forecast period. Vaccines must be produced in large batches during the clinical phase and at a lower cost per dose for broad and effective production. Production of sufficient doses of vaccines safely and with efficacy is becoming a challenge. Vaccine production involves tightly controlled conditions that are difficult to maintain during the scale-up from a research lab to global production. Moreover, there is added time pressure to scale vaccine production faster. Contract manufacturers partnered with bioprocessing companies to provide required vaccine doses in various clinical trial phases.

Based on the vaccine type, the global vaccine contract manufacturing market is divided into sub-attenuated vaccines, live-attenuated vaccines, inactivated vaccines, RNA vaccines, and others. 

The sub-attenuated vaccine segment is the largest revenue contributor to the market and is expected to exhibit a CAGR of 11.76% throughout the forecast period. Sub-unit vaccines have been developed for a number of diseases, such as hepatitis, influenza, pertussis, pneumococcal disease, meningococcal disease, and human papillomavirus (HPV). National and international organizations have mandated the vaccination program to enable more people to get vaccinated in response to rising infectious illnesses causing epidemics and pandemics due to declining immunization coverage in many places. The anticipated surge in vaccine production will likely benefit CMOs' expertise in vaccine manufacturing services.

Based on service, the global vaccine contract manufacturing market is divided into fill/finish, analytical and QC studies, cell/virus banking, and others. 

The fill/finish segment owns the largest market share and is expected to exhibit a CAGR of 12.78% throughout the forecast period. Fill or finish services are the most critical and specialized aspect of manufacturing biologicals. It is typically the last step of the injectable drug manufacturing process. Fill or finish providers can offer specialized services in areas such as types of primary packaging containers (ampoules, cartridges, syringes, and vials), various biologics, and scale of operations (preclinical, clinical, and commercial). Their services include formulation, fill, packaging and labeling, lyophilization, and other services for the final production of the drug product. Fill/finish services are frequently expensive in manufacturing and are subject to strict regulation by regulatory bodies. Vaccine producers working to overcome these obstacles rely on CMOs to outsource their goods quickly and affordably.

Recent Developments

• July 2023- Sanofi, a prominent pharmaceutical company, announced that they are targeting the Middle East after AstraZeneca and National Resilience have already made progress in the United Arab Emirates.