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Report ID: HC0003
Pages: 156
Base Year: 2023
Format: PDF
Historical Date: 2019-2022
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.
Scope of the Report
** In – depth qualitative analysis will be provided in the final report subject to market
Primary and Secondary Research
In order to understand the market in detail we conduct primary and secondary research. We collect as much information as we can from the market experts through primary research. We contact the experts from both demand and supply side and conduct interviews to understand the actual market scenario. In secondary research, we study and gather the data from various secondary sources such as company annual reports, press releases, whitepapers, paid databases, journals, and many other online sources. With the help of the primary interviews, we validate the data collected from secondary sources and get a deep understanding on the subject matter. Post this our team uses statistical tools to analyses the data to arrive at a conclusion and draft it in presentable manner.
Market Size Estimations
Understanding and presenting the data collected is a crucial task. Market sizing is a critical part of the data analysis and this task is performed by using Top-down and bottom-up approaches. In this process, we place different data points, market information and industry trends at a suitable space. This placement helps us presume the estimated & forecast values for coming few years. We use several mathematical and statistical models to estimate the market sizes of different countries and segments. Each of this is further added up to outline the total market. These approaches are individually done on regional/country and segment level.
Data Triangulation
As we arrive at the total market sizes, the market is again broken down into segments and subsegments. This process is called as data triangulation and is implementable wherever applicable. This step not only helps us conclude the overall market engineering process, but also gives an assurance on accuracy of the data generated. The data is triangulated based on studying the market trends, various growth factors, and aspects of both demand and supply side.