Global Biologics CDMO Market

MARKET SCOPE:

The global biologics CDMO market is projected to grow significantly, registering a CAGR of 11.4% during the forecast period (2024 – 2032).

Biologics CDMO stands for biologics contract development and manufacturing organization. A contract development and manufacturing organization (CDMO) specializing in biologics offers pharmaceutical companies comprehensive services for the development and manufacturing of biological medicinal products. Such CDMOs may either exclusively focus on the development and manufacturing of biologics or extend their services to encompass small-molecule drugs as well. These biologics CDMOs frequently form partnerships with pharmaceutical companies aiming to introduce new biological or medical products, commonly referred to as biopharmaceuticals or biologics. Certain biologic CDMOs specialize in addressing specific bottlenecks in the development process, while full-service biologics CDMO companies have the capability to oversee various stages of drug development and manufacturing.

MARKET OVERVIEW:

Driver: Access to new technologies and higher speed of execution realized by CDMOs is propelling the market growth.

The imperative to decrease the supply chains and enhance lead-time efficiency is compelling companies to implement various measures to meet demand, with contract manufacturing emerging as a key facilitator in streamlining the execution process. Contract manufacturing is often complemented by contract packaging, especially for certain pharmaceutical drugs. Consequently, pharmaceutical companies are actively seeking vendors that offer integrated services encompassing contract manufacturing, contract packaging, and quality testing. Additionally, third-party logistics providers like DHL are expanding their service capabilities to include contract packaging services.

Contract Development and Manufacturing Organizations (CDMOs) are gaining substantial market traction by leveraging advanced technology and specialized expertise. Staying abreast of the latest technological trends is particularly crucial for niche CDMOs that specialize in a specific compound or dosage form. Biopharmaceutical CDMOs stand out in this competitive landscape, demonstrating a higher likelihood of success. They exhibit a willingness to embrace cutting-edge technology and invest the necessary time and capital to cultivate differentiated capabilities. The most effective CDMOs are agile and quick to scale up their capacity while remaining flexible. As the prevalence of infectious diseases rises and the demand for novel therapies increases, pharmaceutical and biotech companies, which require substantial capital investments for advanced technologies, are forging collaborations with CDMOs. This collaborative approach is a significant driver for the market expansion.

Opportunities: Lack of in-house capacity among emerging drug development companies is anticipated to pave the way for market growth in the upcoming years.

Capacity limitations persist as a challenge within the pharmaceutical industry, with nearly 6 out of 10 pharmaceutical manufacturers encountering minor constraints at various manufacturing stages. The complexity inherent in biopharmaceutical production, surpassing that of traditional pharmaceuticals, contributes to a global shortage of production capacity. Consequently, prices remain elevated, and applications often find limitations in low-volume and high-need areas. However, in comparison to biotherapeutic developers, Contract Manufacturing Organizations (CMOs) appear to be less impacted by significant constraint issues.

CMOs have experienced a surge in capacity utilization rates due to escalating demand, driven by heightened production levels and strategic measures implemented by CMOs to balance supply and demand. Unlike product developers, CMOs express fewer concerns about overall capacity constraints since clients engage them specifically for tasks within their delivery capacities, without expecting responsibilities extending beyond manufacturing capabilities. Therefore, the challenge faced by biopharmaceutical companies in meeting demanding turnaround times and the escalating need for higher capacities create opportunities for the continued growth of Contract Development and Manufacturing Organizations (CDMOs) in the current market scenario.

COVID IMPACT:

The COVID-19 pandemic has demonstrated the viability of vaccine manufacturing and outsourcing as a sustainable revenue stream for companies within the market. With the anticipation of introducing booster vaccines following the initial COVID-19 vaccine rollout, there is an expected creation of a favorable landscape for growth for Contract Development and Manufacturing Organization (CDMO) vendors.

The analysts have indicated that the biologics Contract Development and Manufacturing Organization (CDMO) industry has been and will remain influenced by the ongoing impact of COVID-19, with sustained demand projected for vaccines and therapeutic antibodies over the coming years. Moreover, the pandemic has underscored vulnerabilities in the supply chain, particularly the worldwide dependence on China and India for the production of active pharmaceutical ingredients (APIs) and generics. This realization is anticipated to prompt diversification in the supply chain, with countries increasingly adopting domestic manufacturing and supply strategies. In turn, this presents an opportunity for CDMOs to capitalize on the evolving landscape and play a key role in supporting diversified and resilient supply chains.

SEGMENTATION ANALYSIS:

The drug substance is anticipated to grow significantly during the forecast period.

The surge in biologics approvals, particularly by the FDA, along with robust clinical pipelines and reduced failure rates of biologic drugs, plays a significant role in driving the demand for drug substances. The growth of the biologics market concurrently fuels the evolution of associated processes, many of which are outsourced to Contract Development and Manufacturing Organizations (CDMOs) by smaller and mid-sized pharmaceutical companies. Outsourced biologic development activities encompass a range of tasks, from assay development and toxicology studies to the establishment of master cell banks.

REGIONAL ANALYSIS:

The North American region is set to witness significant growth during the forecast period.

The North America region holds as a pivotal market in the biologics Contract Development and Manufacturing Organization (CDMO) industry, primarily due to the presence of two major economies, the United States and Canada. The United States, housing one of the world's major pharmaceutical industries, commands a substantial share of the market revenue. The region, as per Results Healthcare, holds approximately 37% of the CDMO market share, with anticipated mid-single-digit percentage growth in the coming years.

Several factors contribute to the high demand for clinical trials in the United States, including the prevalence of chronic diseases, an aging population, and an increased focus on evidence-based practice. The landscape of clinical trials has seen a shift from academic medical centers to community-based practices and global sites in various countries.

The region is further buoyed by the strong presence of Contract Research Organizations (CROs), including QVIA Holdings Inc., Pharmaceutical Product Development LLC, PRA Health Sciences Inc., and Laboratory Corporation of America Holdings. Companies like Biovectra are actively engaged in providing contract development and manufacturing capacity for intermediates and active pharmaceutical ingredients (APIs) at four cGMP facilities in North America. Additionally, Chinese CDMO BioVectra's recent 10-year lease deal for a clinical manufacturing facility in the United States contributes to the growth of the biologics CDMO market.

Emergent BioSolutions has played a significant role by securing various CDMO deals with COVID-19 vaccine developers such as Vaxart, Novavax, J&J, and AstraZeneca. The company's expertise in commercializing anti-infectious disease vaccines, along with its pandemic-ready manufacturing network, played a crucial role in winning these deals. The Bayview drug substance facility in Baltimore, Maryland, designed and built-in collaboration with the U.S. government, serves as a strategic asset for pandemic response, featuring single-use bioreactor systems of up to 4,000 L in the newly established Center for Innovation in Advanced Development and Manufacturing (CIADM).

COMPETITIVE ANALYSIS

The global biologics CDMO market is reasonably competitive with mergers, acquisitions, and product launches. See some of the major key players in the market.

Euroapi

• In May 2022, Euroapi, a Contract Development and Manufacturing Organization (CDMO) with a specialization in small-molecule active pharmaceutical ingredients (APIs), commenced trading on the Euronext Paris stock exchange in May 2022. Sanofi, recognizing the potential and capabilities of Euroapi, is strengthening its collaboration by establishing a long-term customer relationship with the CDMO. As a testament to this commitment, Sanofi has agreed to acquire a minority stake of approximately 30% in Euroapi, subject to a two-year lock-up period. This strategic move signifies the confidence and support Sanofi places in Euroapi's role in the pharmaceutical manufacturing landscape.

Samsung Biologics

• In January 2022, Samsung Biologics has entered into an agreement with Biogen to purchase Biogen's 50% stake in Samsung Bioepis, a joint venture established by the two entities, for a sum of up to USD 2.3 billion. The full acquisition of Biogen's stake by Samsung Biologics is expected to enhance Samsung Bioepis' capabilities in biosimilar development and bolster its prospects for future performance in the domain of new drug development

Rentschler Biopharma SE

Emergent BioSolutions Inc.

JRS PHARMA LP

Boehringer Ingelheim International GmbH

WuXi Biologics (Cayman) Inc.

Samsung Biologics Co. Ltd.

Lonza Group Ltd.

FUJIFILM Diosynth Biotechnologies U.S.A. Inc.

Binex Co. Ltd.

Novartis AG

AbbVie Inc.

Thermo Fisher Scientific Inc.

Scope of the Report

By Product Type

Drug Product

Drug Substance

By Cell Line Type

Microbial

Mammalian

Viral Vector & Other Modalities

By Service Type

Clinical

Commercial

By Region

North America (the United States & Canada)

Europe (Germany, UK, France, Spain, Italy, and the Rest of Europe)

Asia Pacific (China, Japan, India, and Rest of Asia Pacific)

Rest of the World (the Middle East & Africa, Latin America, and Rest of The World)

Keys reasons to purchasing this report

It provides a technological development map over time to understand the industry’s growth rate and indicates how the biologics CDMO market is evolving.

The report offers a dynamic method to various factors that drive or restrain the growth of the market and specifies which biologics CDMO submarket will be the main driver of the overall market from 2024 to 2032.

It renders a definite analysis of changing competitive dynamics and stipulates the leading players and what are their prospects over the forecast period.

It builds a nine-year estimate based on how the market is predicted to grow and shows what will market shares of the global region change by 2032 and which country will lead the market in 2032.