Biopharmaceutical CMO And CRO Market

Market Overview

The global biopharmaceutical CMO And CRO market size was valued at USD 28.70 billion in 2021 and is predicted to reach USD 51.36 billion by 2030, increasing at a CAGR of 6.68% from 2022 to 2030.

The CMO and CRO of the biopharmaceutical business are essential to the success of the industry. The biopharmaceutical industry has a direct impact on the CMO and CRO. Growing consumer demand for biopharmaceutical treatments has fuelled the biopharmaceutical industry's explosive rise. Globally, the biopharmaceutical business is expanding at a rapid pace and now comprises over 20% of the entire pharmaceutical industry.

A contract manufacturing organization (CMO) is a business that contracts with other pharmaceutical businesses to provide full-service drug production for the development of new drugs. Research services are provided on a contract basis by contract research organizations (CROs) to the pharmaceutical, biotechnology, and medical device industries. This includes biopharmaceutical development, biological assay design and commercialization, preclinical testing, and clinical trials.

COVID-19 led to an enormous increase in the number of cases in 2020. In order to keep up with the competition, leading players in the biopharmaceutical business have been boosting their investments to boost output and efficiency. Biopharmaceutical companies are currently outsourcing resource- and capital-intensive phases, as well as the entire biomanufacturing chain in some cases, resulting in a growing need for contract services.

The pharmaceutical industry's supply chain has been severely disrupted by the COVID-19 epidemic. However, because supply chain delays help biopharmaceutical CMOs and CROs, they have positively responded to the outbreak. CMOs and CROs in the Western Hemisphere would benefit the most in the event of a pandemic.

Market Dynamics

Market Drivers

• Demand For Biopharmaceutical CMO And CRO Services to Rising Due to Strong Biologics Pipeline

As pharmaceutical and biotechnology firms spend more money on contracted development and production services provided by outside vendors, this industry will expand. During the forecast period, it is expected that the market for biopharmaceutical contract manufacturing organizations will expand by double digits, with smaller CMOs anticipating faster growth than bigger CMOs. The high growth rate is mostly attributable to the expanding number of biologics pipelines that are scheduled to be released over the projection period. A growing pipeline of biopharmaceuticals will significantly increase the demand for outsourcing services.

As an illustration, the U.S. Food and Drug Administration (U.S.FDA) approved 64 novel molecular entities and biologics in 2018. The pace of mergers and acquisitions in the biopharmaceutical CMO & CRO industry is also expected to increase, which will contribute to the rise in revenue.

• The New Bioprocessing Technologies and Single-Use Systems Integration

There has been a noteworthy number of consolidations in the biopharmaceutical industry in recent years. With these mergers, the biopharmaceutical contract manufacturing and service sectors hope to grow their operations and remain competitive.

It has been expected that new therapies, new bioprocessing techniques, and a major shift in the bio/pharmaceutical business related to goods will put more pressure on contract bio producers. As a result of these considerations, alternative business models are being increasingly adopted in order to meet the needs of their various stakeholders and customers. In light of these considerations, the biopharmaceutical CMO and CRO market is expected to grow at a high rate in the near future.

The biopharmaceutical CMO and CRO market is expected to benefit from the usage of single-use systems in their production facilities, which will increase manufacturing capacity. During the projected period, this is expected to open up new opportunities for growth in the global market. 

Market Restraints

• Market Growth Is Impeded by High Initial Investments and Limited Outsourcing

In comparison to the 5% to 10% profit margins in the pharmaceutical CMO market for biopharmaceuticals, the CMO market for biopharmaceuticals has a profit margin of above 30%. Investments in manufacturing facilities and new equipment to increase biomanufacturing at a faster pace are the main factors limiting the market's growth to a certain degree. The market's expansion is further hampered by the restricted use of outsourcing by well-established biopharmaceutical companies. Additionally, contract negotiations between CMOs and consumers have been noted to be difficult because of the legal landscape and the intricacy of the service itself. Negotiations between clients and CMOs are thorny because of issues like intellectual property rights and warranties as well as cost and timeframes.

Market Opportunites

• Initiatives To Develop Innovative Growth Opportunities

Innovative growth opportunities are being implemented by the major players in the biopharmaceutical CMO and CRO markets. One of the most important ways to promote market growth is to expand R&D activity and investment in R&D. Other growth tactics include regional expansions, new product development, collaboration with other players in the industry as well as the extension of the distribution network and mergers & acquisitions to acquire a competitive advantage in the global market.

Commercial production of the COVID-19 vaccine will be shared over the course of a ten-year partnership between Lonza and Moderna. In the first half of 2020, some delays in clinical trials were made up for by these developments. The contract manufacturing organization industry is predicted to reveal substantial growth opportunities throughout the foreseeable future. In light of the tightening squeeze on biopharmaceutical companies' short-term revenues and profit margins caused by declining R&D productivity and rising development costs, This, in turn, has offered attractive opportunities for the CMOs & CROs to speed their business operations.

Regional Analysis

The global biopharmaceutical CMO And CRO market are segmented by geography into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

In 2021, the revenue share held by North America was the highest, at about 35 percent of total revenue. This can be ascribed to the fact that there are many local providers of services in the vicinity of the area. CMOs are responsible for the production of a sizeable percentage of the approved products sold in the United States. The emergence of a number of small and mid-sized biopharmaceutical enterprises (SMEs) that lack the resources and money to construct facilities that are well-equipped with resources is problematic. Because of this, CMOs and SMEs in the United States have become more dependent on one another, which has led to the United States market is the most dominant globally.

During the time covered by the forecast, it is anticipated that the Asia Pacific would expand at a substantial compound annual growth rate. The cost-associated benefits, such as lower labor prices and operating costs across the area, are the primary cause for the rise in outsourcing in Asian nations. This is the primary reason for the rise in outsourcing in Asian countries. It is projected that India will demonstrate tremendous development as a result of the enormous amount of large molecule manufacturing that occurs in this country. The absence of global regulatory uniformity for the clearance of biosimilar products is a crucial factor that has pushed the Indian market forward. There were fifty biosimilars that were accepted for use in India in 2016, while only twenty-four of those were accepted in Europe, and only five were accepted in the United States.

Segmental Analysis

The global biopharmaceutical CMO And CRO market share are divided into different segments according to the Source, Service, Product, and Region (Geography).

By Source, the global biopharmaceutical CMO And CRO market are segmented into Mammalian and Non-mammalian. Due to a dearth of internal knowledge within the sector, the mammalian category held the biggest market share in 2021, accounting for more than 50 percent of the total. This can be explained by their capacity to add post-translational changes to complex protein therapies that are analogous to those found in humans. In addition, the sector has reaped significant benefits as a direct result of the development of innovative and improved expression systems, as well as improved process monitoring services, cell line handling equipment, automated screening techniques, and disposable devices.

These advancements have led to the production of biologics using mammalian cells being more productive and efficient as a result. Cell lines derived from organisms other than mammals, such as those derived from microorganisms, are acknowledged as being capable of functioning as factories. In order to detect distinct microorganisms and investigate their potential, cutting-edge procedures are currently being put into action. This is expected to, in turn, contribute to the portion of the biopharmaceutical manufacturing market that focuses on non-mammalian organisms.

By Service, the global biopharmaceutical CMO And CRO market are segmented into Contract Manufacturing and Contract Research. Due to the growing trend of biopharmaceutical companies outsourcing their research efforts, the contract research category is anticipated to display the highest CAGR of 7.49 percent over the course of the projection year. The industry is home to a sizeable number of contract manufacturing organizations (CMOs) and opportunistic CMOs, all of which are active participants in the business of supplying biopharma companies with a comprehensive range of services, such as cell cultivation and fill/finish operations. In addition, customers are spending a significant amount of money to have the manufacturing component of their product development cycle outsourced.

Because of these considerations, this particular segment now accounts for the biggest share overall. On the other hand, contract research organizations (CROs) are working hard to make the most of the prospective opportunities in the business. It is anticipated that new market entrants as well as smaller-scale players who are primarily focused on the development of biopharmaceuticals will choose contract research services for their discovery programs of new candidates, thereby contributing to the expansion of the segment. This will cause the segment to grow.

By Product, the global biopharmaceutical CMO And CRO market are segmented into Biologics and Biosimilars. The biologics sector was the dominant player in the market in 2021, with a revenue share that was more than 80 percent of the total. This growth can be attributed to the high specificity of biologics, the complex manufacturing steps involved, as well as a higher success rate when compared to other drug molecules. CMOs have been able to efficiently address the growing demand for biologics production services thanks to the implementation of technologies such as bioreactors designed for one-time use only, continuous purification processing, disposable plastic containers, and real-time quality analysis.

In addition, a number of pharmaceutical companies are making investments in the development of biosimilars with the goal of outperforming earlier in-class innovator medications in terms of safety, effectiveness, disposition, or cost. Because of this, the level of competition among innovator manufacturers has increased, which is likely to be beneficial to CMOs in the long run.

By Region or Geography, the global biopharmaceutical CMO And CRO market are segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. In 2021, North America had a revenue share of about 35%. In part, this is due to a number of service providers operating in the area. As a result of reduced labor and operating expenses in the region, outsourcing has become increasingly popular in Asian countries. India is expected to make great progress because of the country's massive output of big molecules.

Recent Developments

• May 2022 - Germany's Boehringer Ingelheim (BI) has announced that it has acquired approval from the Central Drugs Standard Control Organization (CDSCO) to market its medicine Jardiance (empagliflozin) in India, for the whole spectrum of heart failure disorders regardless of ejection fraction.
• January 2022 - An agreement to acquire a cell treatment manufacturing facility from Atara Biotherapeutics, Inc. for USD 100 million has been announced by Fujifilm Corporation. Clinical and commercial cell treatments, such as allogeneic T-cells and CAR T immunotherapies, can be produced in this facility, which is conveniently located in Thousand Oaks, California.