Market Overview

The global biopharmaceuticals contract manufacturing market was valued at USD 18.89 Billion in 2023 and is expected to reach a value of USD 30.32 Billion by 2032, at a CAGR of 5.9% over the forecast period (2024–2032).

These factors have all helped the global biopharmaceutical contract manufacturing market to grow enormously over the last few years, primarily due to the increasing demand for biologics and increases in research in biopharmaceuticals along with the outsourcing of manufacturing activities by pharmaceutical as well as biotechnology firms. Therapeutic proteins, monoclonal antibodies, and vaccines are some of the biopharmaceuticals; this segment of pharmaceuticals is rapidly growing because their high specificity in targeting complex illnesses. The drug development process for biopharmaceuticals is more difficult and demands more resources as compared to traditional small molecule drugs, which is one of the reasons why many companies are outsourcing more and more to obtain assistance with these problems. This trend has led to the growth of the contract manufacturing sector, which offers customized services for the production of biopharmaceutical pharmaceuticals.

CMOs have emerged as critical partners to biopharma manufacturers in the developmental process, due to their ability to handle everything from early-stage development to large-scale commercial manufacturing. The decision to outsource depends on several variables; among them is cost-effectiveness, whether the facilities are equipped with state-of-the-art technology, and whether the capacity lies to focus on core skills such as marketing and medication development. Partnering with a CMO offers alternative small biotech companies less costly capital expenditures in the building of their own production facilities. Larger pharm companies benefit also because they can handle fluctuating demand, increase capacity to produce, and accelerate the timelines before innovative treatments reach the market.

One of the primary reasons why contract manufacturing is booming is the increasing complexity of biologics. Such medicines are manufactured using methods like advanced purification techniques and cell culture systems, recombinant DNA technologies, among others, which require sophisticated infrastructures and deep technical know-how. Biopharmaceutical-focused CMOs have made huge investments in cutting-edge manufacturing platforms like continuous manufacturing procedures and single-use technologies, all enhancing the flexibility and efficiency of production. These innovations guarantee that strict regulatory criteria are followed in various markets and help reduce the cost of items offered.

A large and increasing number of biologics in the pipeline have been propelling the growth of this market. Many therapeutic areas, including immunology, oncology, and rare diseases, are still in development for biopharmaceuticals. The size and complexity of production of novel treatments make it increasingly impossible for biopharma companies to refrain from utilizing CMOs. Biosimilars, or lower-priced versions of biologics, are also an emerging trend that is helping the biopharmaceutical contract manufacturing business since many of the patents of the most popular biologics have run out or are close to running out. The development of biosimilars demands more extensive manufacturing skills and further increases the need for specialized contract manufacturing services.

Key Findings:

As Per International Federation of Pharmaceutical Manufacturers & Associations:

• On average, researchers identify one promising compound among 5,000–10,000 screened. Researchers then extensively test the compound to ensure its efficacy and safety, a process that can take 10 to 15 years for both a medicine and a vaccine.
• In 2020, 53 new medicines were launched, while currently more than 9,000 compounds are at different stages of development globally.
• In 2021, the number of drugs in development for particular disease areas were:
  • Cancer: 3,148
  • Immunology: 1,677
  • Neurology: 1,668
  • Infectious diseases: 1,488
• The research-based biopharmaceutical industry is estimated to have spent USD 198 billion globally on biopharmaceutical R&D in 2020.

Market Dynamics - Market Drivers

Increasing Biologics Manufacturing Outsourcing Trend Among Biopharmaceutical Companies

• Increase in the use of biologics in medicine has brought about manufacturing outsourcing at a really impressive rate. Contract biologics manufacturers are equipped with the needed skills and resources to meet strict quality requirements and ensure the efficacy of these complex drugs. These contract manufacturers have extensive knowledge of downstream processes, cell culture, protein chemistry, and the effects of process factors on yield and protein structure when scaling up from the lab to the GMP scale. Biopharmaceutical businesses want to collaborate with CDMOs as a very effective means of accelerating the development and manufacturing process because of their tremendous experience in the realm of biologics, chemical manufacturing control, and commercial manufacture. Also, the major biopharmaceutical companies outsource clinical and commercial bio manufacturing to reduce the cost and risk associated with internal development and manufacture. It, therefore leads to an upsurge in biopharmaceutical contract manufacturing industry.

Market Opportunity

Growing Curiosity About Cell and Gene Therapies

• Gene and cell therapies can potentially treat diseases that will not be treated by biologics and small molecule drugs due to their high specificity. The high therapeutic promise of these medications has caused many pharmaceutical companies to focus on the development and launch of these drugs. This has increased the demand for the development and manufacturing of cell and gene therapies. At present, more than 20 cell and gene therapies have received approval from the US FDA since April 2022. Advances in the number of candidates for cell and gene treatment, now passing through several phases of clinical development, and their complex manufacturing procedures, have made institutions offering manufacturing services in greater demand. This will, in turn, create more opportunities for the contract production of these medications.

Market Restraining Factors

Intellectual Property Rights Issues

• Intellectual property protection is the most crucial component of contract manufacturing. The innovator business must give the manufacturer all the information about its patented invention in order for the contract manufacturer to produce the medicine. There is a chance that someone will copy the materials, use the information improperly, and run afoul of the law. Routine manufacturing task outsourcing has emerged as a possible trend for the business recently. For example, pharmaceutical companies are outsourcing this process because it requires expertise and resources to develop complex biologics in a way that meets the demands of each patient. Sustaining the current trend in the biopharmaceutical contract manufacturing market and safeguarding intellectual property protection depend heavily on pharmaceutical companies and contract manufacturing organisations (CMOs) keeping a sincere relationship.

Segmentation Analysis

The market scope is segmented because of by Source, by Service, by Product, By Therapeutic Area.

By Source

Based on the Source of the market is segmented into Mammalian, Non-mammalian.

In the non-mammalian sources, the mammalian cell culture segment leads the worldwide biopharmaceutical contract manufacturing industry. These cells were largely responsible for this leadership since they can synthesize complex proteins that are similar to the biological structure of human beings. This has made them suitable for biologics production such as hormones and monoclonal antibodies. For the production of the majority of these biologics, mammalian cells such as Chinese hamster ovary (CHO) cells are used. They provide the necessary post-translational modifications, such as glycosylation required by many biologic drugs to be safe, effective, and therapeutically functional.

Of greater significance in bio manufacturing is the use of mammalian systems, since monoclonal antibodies continue to remain one of the main growth drivers for the biopharmaceutical industry. Dependence on Mammalian Cell Lines Although these antibodies are used for treating major diseases like cancer and autoimmune disorders, their precise structure and function rely strictly on mammalian cell lines.

Moreover, mammalian-based production is now more productive and economical with developments in mammalian cell culture technologies such as the creation of high-yield, scalable procedures and enhancements in bioreactor design. Due to their efficiency, familiarity with the regulations, and expanding pipeline of biologic pharmaceuticals, mammalian systems now constitute the ideal choice for biopharmaceutical manufacture and therefore ensure their monopoly over non-mammalian sources in the market.

By Service

Based on the Service of the market is segmented into Process Development, Downstream, Upstream, Fill & Finish Operations, Analytical & QC studies, Packaging.

Historically, services offered by the downstream processing segment dominate the biopharmaceutical contract manufacturing market. The commodity produced in upstream manufacturing is eventually refined and purified downstream for meeting the stringent regulatory requirements and release of a pure and safe final product. This step of the process is critical to the production of biopharmaceuticals because biologic drugs, particularly therapeutic proteins and monoclonal antibodies, must be subjected to sophisticated purification steps that eliminate impurities, cell debris, and other contaminants that might compromise the ultimate safety and efficacy of the product.

The downstream processing shows superiority by the complexity of biologics, which require extremely precise purification methods such as chromatography, ultrafiltration, and centrifugation. These technologies have turned downstream processing into an integral part of the production workflow that has to be performed to ensure consistency and quality in the final product desired. Moreover, there is an increasing demand for biologics and biosimilars, which require efficient and scalable downstream processes since purification steps can heavily influence overall production schedules and prices.

More importantly, the trend towards continuous bio manufacturing and single-use technologies has made downstream services much more critical. These innovations enable large-scale production without compromising quality, making downstream processing a significant focus area for CMOs. It also reduces contamination risks and enhances the efficiency of purification. The product quality ensured by its critical importance has cemented the leadership position of downstream processing in the industry.

Regional Snapshots

By region, Insights into the markets in North America, Europe, Asia-Pacific, Latin America and MEA are provided by the study. The region, North America, has been the stronghold of this biopharmaceutical contract manufacturing market due to various important factors. Some of the globe's biggest pharmaceutical and biotechnology companies can be found in this region, along with an established network of CMOs having advanced capabilities. Due to the presence of major players such as Lonza, Catalent, and Samsung Biologics, along with heavy investments in R&D, North America has maintained its dominance. The region has a strong regulatory framework, talented human resources, and significant government incentives towards biopharmaceutical innovation and especially in the U.S. Furthermore, the demand for biologics, including monoclonal antibodies and vaccines, is seen to be very high. This drives the need for outsourced manufacturing services in this region to make its market strength.

The Asia-Pacific region is the projected site of the highest growth rate in terms of biopharmaceutical contract manufacturing. This has been driven largely by investment in building biopharmaceutical infrastructure, an expansion of the number of CMOs, and increasing capabilities in biologic production in countries such as China, India, and South Korea. The rapid growth of the Asia-Pacific market is also influenced by various cost advantages, favourable regulatory reforms, and an expanding patient base for biologic therapies. The rising number of clinical trials and drug development activities are adding to the focus on innovation in the region, further boosting demand for contract manufacturing services-positioning it as the fastest-growing market in the foreseeable future.

Key Findings:

As Per International Federation of Pharmaceutical Manufacturers & Associations:

• All industrial sectors, the biopharmaceutical industry has consistently invested the most in R&D, even in times of economic turmoil and financial crisis. The research-based biopharmaceutical industry is estimated to have spent USD 198 billion globally on biopharmaceutical R&D in 2020.

List of Companies Profiled:

• Boehringer Ingelheim GmbH
• Lonza
• Inno Biologics Sdn Bhd
• Rentschler Biotechnologie GmbH
• JRS PHARMA
• AGC Biologics
• ProBioGen
• FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
• Toyobo Co. Ltd.
• Samsung BioLogics
• Thermo Fisher Scientific, Inc.
• Binex Co., Ltd.
• WuXi Biologics
• AbbVie, Inc.
• Novartis AG
• ADMA Biologics, Inc.
• Catalent, Inc
• Cambrex Corporation
• Pfizer Inc.
• Siegfried Holding AG

Key Industry Developments

In March 2024, Lonza announced the signing of an agreement with F. Hoffmann-La Roche Ltd (Roche) for the acquisition of Roche’s large scale biologics manufacturing site in Vacaville, U.S.

In October 2023, Vaxcyte, Inc., an U.S. based company engaged in the R&D initiatives of innovative vaccines, announced the expansion of their collaboration with Lonza for the global commercial manufacturing of their broad-spectrum pneumococcal conjugate vaccines (PCVs).

In July 2023, Samsung Biologics secured two high-value deals totalling USD 1,115.7 (£ 897.0) million with Pfizer, including the CDMO's largest single contract signing to date.

In April 2023, Fujifilm Diosynth Biotechnologies acquired 41 acres of land nearby to its existing biomanufacturing campus in North Carolina. This land can bring more capacity for manufacturing and development of biologics.

In February 2023, Lotte Biologics announced an investment of USD 3.00 billion to construct three biomanufacturing plants in Korea.

In January 2023, Samsung Biologics' contract development and manufacturing organization (CDMO) participated in the J.P. Morgan Healthcare Conference held in San Francisco, California. During the conference, the company presented its 2024 business plans and strategy.

In January 2023, Lotte Biologics acquired a commercial-scale biomanufacturing facility in New York from Bristol-Myers Squibb to enter the CDMO market.

In February 2022, Samsung Biologics received six CMO leadership awards across all performance categories, including capabilities, compatibility, expertise, reliability, quality, and service.

Report Coverage

The report will cover the qualitative and quantitative data on the global Biopharmaceuticals Contract Manufacturing Market. The qualitative data includes latest trends, market players analysis, market drivers, market opportunity, and many others. Also, the report quantitative data includes market size for every region, country, and segments according to your requirements. We can also provide customize report in every industry vertical.

Report Scope and Segmentations:

Regional Analysis

North America accounted for the highest xx% market share in terms of revenue in the Biopharmaceuticals Contract Manufacturing market and is expected to expand at a CAGR of xx% during the forecast period. This growth can be attributed to the growing adoption of Biopharmaceuticals Contract Manufacturing. The market in APAC is expected to witness significant growth and is expected to register a CAGR of xx% over upcoming years, because of the presence of key Biopharmaceuticals Contract Manufacturing companies in economies such as Japan and China.

The objective of the report is to present comprehensive analysis of Global Biopharmaceuticals Contract Manufacturing Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language.

Biopharmaceuticals Contract Manufacturing Market Report is also available for below Regions and Country Please Ask for that

North America

• U.S
• Canada

Europe

• Switzerland
• Belgium
• Germany
• France
• U.K
• Italy
• Spain
• Sweden
• Netherland
• Turkey
• Rest of Europe

Asia-Pacific

• India
• Australia
• Philippines
• Singapore
• South Korea
• Japan
• China
• Malaysia
• Thailand
• Indonesia
• Rest Of APAC

Latin America

• Mexico
• Argentina
• Peru
• Colombia
• Brazil
• Rest of South America

Middle East and Africa

• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest Of MEA

Points Covered in the Report

• The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.
• The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 5 years data history and forecast.
• The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail.
• Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements.
• The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Key Questions

• How much the global Biopharmaceuticals Contract Manufacturing Market valued?
• Which region has the largest share in 2024 for the global Biopharmaceuticals Contract Manufacturing Market?
• What are the driving factors for the market?
• Which is the leading segment in the global market?
• What are the major players in the market?

Research Scope of the Market

• Historic year: 2019-2022
• Base year: 2023
• Forecast: 2024 to 2032
• Representation of Market revenue in USD Million