Global Biologics Contract Development and Manufacturing Organizations

Increased investments in the biosimilar segment, as well as the pooling of resources from pharmaceutical companies and CDMOs for their growth, are expected to offer lucrative opportunities for market expansion. Breach of IP rights and patents, on the other hand, may represent a market challenge.

Definition / Scope
Market Overview
Market Risks
Top Market Opportunities
Market Drivers
Market Restraints
Industry Challenges
Technology Trends
Pricing Trends
Regulatory Trends
Post COVID-19 Recovery
Market Size and Forecast
Market Outlook
Technology Roadmap
Competitive Landscape
Competitive Factors
Key Market Players
Strategic Conclusion
References
Appendix

Definition / Scope

A contract development and manufacturing company (CDMO) is a corporation that provides drug development and manufacturing services to the pharmaceutical sector. CDMOs and pharmaceutical corporations collaborate to outsource medication development and manufacture.

Some of the services offered by Biologics Contract Development and Manufacturing Organizations (CDMOs) include:

CDMO activities can broadly be divided into three fields: product development, manufacture of active pharmaceutical ingredients (API), and manufacture of finished dosage forms (FDF are all required from small-scale clinical batches to large-scale commercial production. As such, once a dedicated manufacturing line is established and validated at a CDMO.

Active Pharmaceutical Ingredients (API)

Originator products and generics account a roughly equal share of the commercial small molecule API industry. Although generic APIs often provide lower margins to manufacturers, this is frequently offset by the possibility to supply the same API to several customers.

Biologics

Despite the fact that small molecule commercial revenues now constitute for the majority of the CDMO business, biologics are the fastest growing sub-sector due to increased biologic approvals and the emerging biosimilar market (as increasing numbers of biologics reach patent expiry).

Finished Dosage Forms (FDF)

FDF has a smaller market share than API, with oral solids accounting for the majority of the market. Oral solids, on the other hand, are a more mature market with slower development than other FDFs such as liquids, semi-solids, and injectables.

The fastest-growing FDF segment is injectables. Manufacturing shortages of sterile injectables have resulted from increased demand for injectables (mainly due to the rise of biologics and oncolytic) paired with high technological hurdles to entry. The fastest-growing category include pre-filled syringes (PFS) and other more complicated injectable delivery devices (including auto-injectors).

Clinical

Despite the fact that clinical manufacturing accounts for a small percentage of the CDMO business (due to lower volumes), it is critical for securing customers and developing partnerships that will support commercial scale manufacturing.

Market Overview

The global biologics CDMO market was valued at USD 9.93 billion in 2020, and is predicted to grow at a CAGR of 10.87 % in the forecast period (2021 – 2026) to reach a Market Size of USD 18.63 billion by 2026.

During the COVID-19 pandemic, the CMO/CDMO service sector is particularly positioned to address some of the issues that drug developers are encountering. From medication development through clinical trials, supplies, manufacturing, and supply chain logistics, the pandemic has had a significant impact on the biopharma business. However, due to worldwide stockpiles of medicines and APIs, drug shortages caused by COVID-19 are projected to be limited in the immediate term. Due to their status as the world’s leading producers of active pharmaceutical ingredients (APIs) and generics, China and India have been hit the hardest by supply chain challenges.

Global economic growth, a growing and ageing population, and new product launches are propelling the pharmaceutical business forward at an exponential rate. Despite the fact that small molecules continue to dominate the market, large molecules such as biologics, biosimilars, and cell and gene therapies are predicted to increase at the highest rate during the projection period.

A substantial amount of the growth in the biologics market is due to cancer therapy. Despite the stronger growth forecast, small molecules outnumber biologics in terms of drug approvals. The US Food and Drug Administration’s Center for Drug Evaluation and Research, for example, approved 53 novel molecular entities (NMEs) in 2020, with 40 (75%) of these being tiny molecules. This continues a recent pattern in which small molecules account for roughly three-quarters of NME approvals. Small molecules accounted for 79 percent of NME approvals in 2019, compared to 71 percent in 2018, 74 percent in 2017, and 68 percent in 2016, when just 22 NMEs were approved.

Because biologic pharmaceuticals are high-value, high-margin goods, large firms are focused on supply security, quality assurance, IP protection of unique cell strains, and manufacturing method, which is posing a challenge to growth. Pfizer, for example, has kept large in-house manufacturing facilities, unlike several of its competitors in the pharmaceutical industry. It announced that it will produce BNT162b2 vaccine raw ingredients, mRNA active, and finished doses at its own facilities in Andover, Massachusetts, Kalamazoo, Michigan, and St. Louis. It will also target the European market from its Belgian location.

Despite the growing trend of keeping biologic API synthesis in-house, pharma companies are more comfortable and willing to outsource the secondary manufacturing and packaging phases of their biologics products. The dearth of available assets among CDMOs is another important element affecting the rise of biologics outsourcing to CDMOs. Due to increased investment from large CDMOs, this is projected to alter during the next five years. Fujifilm Corp., for example, is putting USD 928 million into Fujifilm Diosynth Biotechnologies, a CDMO that specializes in biologics and advanced therapeutics. This will increase the current drug substance manufacturing capacity of the Denmark facility, allowing it to extend its fill/finish capabilities and improve its assembly, labelling, and packaging services.

Further, Fujifilm Diosynth Biotechnologies also wants to establish and open a mammalian cell culture facility in the United States in 2025. The plant will include eight 20,000-liter stainless-steel bioreactor tanks for commercial medicinal material production when it opens. It will also include automated fill-finish and assembly services, as well as packing and labelling.

To extend and improve their biologic offerings, CDMOs are expected to create alliances and partnerships with pharmaceutical companies. For example, HJB, a biologics CDMO, and Ansun Biopharma signed a strategic agreement for CMC development and manufacture on Ansun Biopharma’s therapeutic biologics pipeline in August 2020.

Furthermore, for products that are technically complex to make, such as biologics, where tech transfer can be a lengthy and costly process, having a single supplier relationship helps lessen the risk of supply shortages. The CDMO should be able to sell additional services to the same customer as a result of the relationship, as well as lock in items at an earlier stage in their life cycle.

Market Risks

Some of the Major Risk Factors affecting the growth of the Global Biologics CDMO Market are

Growing market consolidation is a major risk for many CDMOs

Smaller CDMOs especially could be unable to compete on costs, technology or service range with the growing number of huge CDMOs that consistently expand their services and technological capabilities by acquiring other market participants. They also face the threat of being unable to compete for skilled employees. Qualified scientists and experienced project managers are in high demand for companies throughout the world, and CDMOs thus not only need to compete for talent with their immediate competitors but also with large, global pharmaceutical companies. Pharmaceutical companies are increasingly outsourcing low-volume formulations, like niche and orphan drugs, which involve high risks and low revenues.

High Level of Fragmentation

The current high level of fragmentation of the market implies that some CDMOs need to believe just one or more customers for an outsized a part of their revenues. This dependence is dangerous and creates tons of negotiating power for the customer to exercise downward pressure on prices. Even more price pressure comes within the sort of governmental healthcare cost containment efforts including increased regulation in many countries.

Top Market Opportunities

The Top Market Opportunities for Market Players in the Global Biologics CDMO Market include

Unprecedented growth in the therapy area of Oncology

Aside from the growing demand for selective targeted medicines, exceptional expansion in the oncology therapeutic field is fueling the HPAPI industry, with oncology accounting for over 60% of HPAPIs. With investments in both medication research and development, this industry continues to be a growing area of attention for practically all innovation firms. According to The IQVIA Institute’s Global Cancer Trends 2018, the global market for oncology therapy is predicted to reach $200 billion by 2022, growing at a rate of 10-13 percent per year over the next five years.

Oncology medicines tend to gain faster authorization due to the devastating nature of cancer and the rapid progression from the outset of sickness. Because of the special needs of oncology drug development and the necessity for quick programme progression, partnering with external CDMOs is the recommended route.

Rising number of mergers and acquisitions (M&As)

There have been an increasing number of mergers and acquisitions (M&As) in the CDMO industry in order to provide integrated services, boost speed, augment efficiencies, and expand worldwide networks. Private equity is increasingly playing a role in M&A in the sector, assisting smaller companies in achieving this goal. Others are looking to expand their reach or add advanced and specialized technologies that will allow them to provide unique solutions. Furthermore, the integrated strategy i.e., the conversion of contract manufacturers to CDMOs remains a driving force.

Shift towards value-added services using BioCDMOs

With the changing market landscape, BioCDMOs are adjusting their focus to providing value-added services to their pharma clients by establishing themselves as a one-stop shop. Through strategic agreements and partnerships, these organizations are adopting innovative manufacturing technologies such as single-use/disposable bioreactors, continuous, POD production, and so on, with the integration of IT-based solutions using the Industrial Internet of Things (IIoT). Mergers and acquisitions (M&As) are being used by larger players to acquire specific therapeutic and technical knowledge from smaller, specialized BioCDMOs. While the United States and Europe remain important markets, the outsourcing trend is steadily changing to Asia Pacific, with several new entrants offering low-cost drug development services.

Market Drivers

The Primary Factors driving the growth of the Global Biologics CDMO Market include

CDMOs provide cost-effective solutions

Pharmaceutical businesses are financially burdened by the conceptualization and development of drug formulas. Furthermore, obtaining the tools and technologies required for medication manufacture has a high initial and ongoing cost that is almost unaffordable for many small and mid-sized businesses. Finally, a late approval or rejection may result in financial losses. CDMOs offer integrated bioprocessing services, allowing for quick product releases. Furthermore, while these organizations have made significant expenditures in acquiring the necessary tools and technologies, pharma companies are not compelled to do so.

As a result, the spike in demand for outsourcing to CDMOs will ensure market growth, as CDMOs alleviate financial pressures and provide cost-effective solutions.

Massive investments from big bio-pharma

Biologics production has exploded in recent years, thanks to significant investments from both big biopharma and contract manufacturers. Small and large pharmaceutical businesses are increasingly outsourcing, which creates a promising opportunity for contract development and production companies (CDMOs). CDMOs are well positioned to bridge the gap between their clients and the patient as pharma turns its focus to more research and development and less in-house production. In today’s fast-paced environment, CDMOs are one of the most valuable assets to pharmaceutical and biologic firms. Pharmaceutical and biologic firms can free up internal resources to focus on internal capacity and improve process efficiencies by outsourcing manufacturing operations.

According to the 2019 PhRMA member annual survey, pharmaceutical businesses spend USD 79.6 billion in R&D. This investment in R&D propels biopharmaceutical businesses forward in their quest for novel treatments and cures. In 2018, 74 percent of all compounds in clinical trials are potentially first-in-class, which means they could constitute a new pharmacological class for treating a disease. Many therapeutic areas have significant percentages of prospective first-in-class clinical-phase research, including cancer (79%), neurology (74%), and diabetes (69%).

Surging demand for pharmaceutical products

The market for contract development manufacturing companies grew as demand for pharmaceutical products increased due to a rise in chronic diseases and the geriatric population. Pharmaceutical companies have been able to manufacture biologics and biosimilars more quickly due to the rise in chronic diseases and the ageing population, and most have contracted contract production and manufacturing organizations to handle and coordinate the company’s tasks, operations, and tests.

According to the World Health Organization, the prevalence of chronic diseases increased by 57% in 2020, and the world’s population of people aged 60 and more is expected to reach 2 billion by 2050. As a result, the market for contract development manufacturing organizations is expected to expand due to rising demand for pharmaceutical products.

Market Restraints

The Major Factors Restraining the growth of the Global Biologics CDMO Market include

Stringent Government Regulations

Government regulations governing the drug approval process may stifle the market for contract development manufacturing organizations. Several countries around the world are enforcing limits on pharmaceutical companies in order to protect the public from negative drug effects. The process of bringing new drugs to market is being slowed even more by these rules. For example, it takes at least ten years for a new drug to complete the process from conception to commercialization, with clinical trials taking six to seven years on average.

According to PhRMA data from 2020, the average chance of clinical success (the likelihood that a medicine in clinical trials would be approved) is estimated to be less than 12%. As a result, the market for contract development manufacturing organizations is expected to be hampered in the next years by rigorous government regulations.

Restrictions of global imports and exports

With new limits on foreign manufacture imposed as a result of the development of the current pandemic, the CDMO industry is at a loss as to how to deal with this stumbling block in their production. While most CDMO Industries have contracts abroad, it is becoming increasingly difficult for them to manage their businesses effectively.

Some countries like USA and UK have relaxed their regulations, recognizing that the pharmaceutical industry plays an important role in ensuring that pharmaceutical demands are satisfied. It is still insufficient, as many more people are still hampered.

Fewer contracts

Because demand is low, more pharmaceutical companies are focused on house manufacturing rather than outsourcing, therefore there are fewer contracts on the table in 2021. Outsourcing is typically done when there is a great demand, which will not be the case in 2021.

Despite the fact that the total number of drug approvals is increasing, large pharmaceutical companies’ R&D returns appear to be declining. Emerging biopharma companies with one or two drugs in development, for example, account for 18.3 percent of all drugs in active development, while the top ten pharma companies’ pipeline share has fallen from 13 percent in 2011 to 6.45 percent in early 2021. Virtual enterprises that outsource clinical development to de-risk R&D efforts have grown in popularity as R&D has transitioned to new biopharma.

The CDMO is growing at a snail’s rate, with fewer contracts, and will only experience an increase when demand for current losses rises. Of course, when the pandemic is finished and the economy begins to expand again, this is to be expected.

Industry Challenges

The Most Pressing Industry Challenges in the Global Biologics CDMO Market include

The requirement for CDMOs to provide excellent value in the supply chain is critical in today’s competitive marketplace. The need to streamline and accelerate the route to market for pharmaceuticals, as well as minimize the cost and complexity of development for pharmaceutical customers, makes addressing supply chain concerns particularly urgent. Because of the growing requirement to minimize working capital and free cash to support the development of new goods, these difficulties must be confronted head-on.

The scale-up challenge is also critical because pharma is under pressure to meet all of its production needs.

CDMOs are being pressed to show that they have a proven track record of implementing QbD, PAT, and continuous improvement. The desire to drastically reduce drug development time, optimize cost efficiency, reduce wastage during production, and identify strategies to execute drug development with less quantities of available high-value APIs is driving the continuous processing problem.

Technology Trends

Some of the key technology trends re-shaping the Global Biologics CDMO Market include

Growth in HPAPI and ADC markets

Recent technological advancements have resulted in the development of more effective and safer medicines. These advancements enable compounds to be more selective towards the target of interest, potentially reducing dosing frequencies while increasing patient compliance. The growing demand for potent, targeted therapies has fueled interest in highly potent NCEs. High potency active pharmaceutical ingredients (HPAPIs) are designed to achieve pharmacological activity with very small amounts of the active ingredient, while minimizing side effects and damage to the tissues surrounding the diseased area.

Rapid innovation in Antibody drug conjugates (ADCs) Development

Antibody drug Conjugates (ADCs) is one more section of designated treatments that has seen critical ventures in the course of the last decade. Three new ADCs were endorsed by the FDA in 2019, taking the absolute number of supported ADCs in the market to seven. In 2018, 22 new ADCs entered the center while roughly 13 entered the facility in 2019. The colossal capability of this portion is underlined by the way that there are in excess of 700 continuous clinical preliminaries that include ADCs. Given the intricacy of assembling, an expected 70-80 percent of ADC fabricating is moved to CDMOs that represent considerable authority in this class.

Pricing Trends

The Major Trends shaping the Pricing of the Biologics CDMO contracts include:

Dependance on Fewer Customers

CDMOs have to be compelled to rely on just one or more customers for an outsized a part of their revenues. This dependence is dangerous and creates tons of negotiating power for the customer to exercise downward pressure on prices. Even more price pressure comes within the sort of governmental healthcare cost containment efforts including increased regulation in many countries.

Stringent Regulation causing significant drop in Price

Most government bodies request a decrease in the price of pharmaceutical products because they believe the products are too expensive. As the pharmaceutical industry waits with bated breath, new laws to provide governments with better deals on pharmaceutical products may be implemented soon. The drop could have a direct impact on the CDMO industry, pushing it further adrift. Most CDMO firms are concerned about how low the prices will be and what this will mean for their industry.

Regulatory Trends

The Regulatory Trends of the Biologics CDMO Market in some of the Major economies across the globe are

Regulatory Trends in USA

The Generic Drug User Fee Act (GDUFA) is a bill that aims to improve public access to safe and effective generic pharmaceuticals while also lowering business costs.

The law only mandated user fees for companies submitting new medication applications until October 2012. (NDAs).

All enterprises that produce human generic medication products, as well as active components for human generic drug products, that are disseminated in U.S. commerce, are subject to FDA user fees as of October 1, 2012.

Because of the shortened review times, GDUFA fees will improve the Agency’s ability to fulfil important programme tasks while also lowering expenses.

Regulatory Trends in Europe

The European Union’s legal framework for human pharmaceuticals establishes guidelines to assure a high level of public health protection as well as the quality, safety, and efficacy of licensed medicines. It also fosters the smooth operation of the internal market through policies that encourage innovation. It is based on the premise that before a pharmaceutical product may be placed on the market, it must first obtain marketing authorization from the appropriate authorities.

Regulatory Trends in China

The People’s Republic of China’s Drug Administration Law (as revised in August 2019) is an important piece of legislation controlling drug administration in China. This law aims to improve health legislation by defining the terms “fake drugs” and “inferior drugs,” emphasizing the importance of “reliability regulation,” standardizing online drug sales, encouraging technological innovation, and defining legal liability and punishment through legislative amendments.

The Drug Administration Law is an example of responsive legislation, as it ensures citizens’ right to health. Under the Healthy China plan, the law prioritizes the review and approval of novel treatments for diseases such as rare diseases, supports domestic manufacturing and development of new therapeutics for rare diseases, and provides a clear legal basis for medications to treat uncommon diseases.

Post COVID-19 Recovery

The current COVID-19 outbreak has had an impact on the healthcare business. This pandemic has had a positive impact for the pharmaceutical contract development and manufacturing business. The outbreak has sparked a surge in pharmaceutical demand, spurring the development of corona-related vaccinations, antiviral vaccines, antibody treatment, and a variety of other pharmaceutical goods. To stay afloat, pharmaceutical companies have been urged to use contract development and manufacturing firms for pharmaceutical medication research and production.

Demand for CGMP drug ingredient and drug product manufacturing services has increased dramatically, particularly for CDMOs that can support a wide range of COVID vaccination technologies and, to a lesser extent, therapeutic monoclonal antibody products.

The majority of pharmaceutical corporations, contract research organizations, and research institutes are collaborating to turn research into useful pharmaceutical products. For example, Catalent Inc. (USA) and AstraZeneca PLC (UK) struck an agreement in August 2020 to increase manufacturing support for the University of Oxford’s adenovirus vector-based COVID-19 vaccine, AZD1222. Thermo Fisher Scientific Inc. (US) and Inovio Pharmaceuticals, Inc. (US) teamed in September 2020 to produce INOVIO’s DNA COVID-19 vaccine candidate INO-4800 and improve commercial production.

Market Size and Forecast

The global biologics CDMO market was valued at USD 9.93 billion in 2020, and is predicted to grow at a CAGR of 10.87 percent in the forecast period (2021-2026) to reach a Market Size of USD 18.63 billion by 2026

Product Development Services held the major Market Share

In the biologics contract development market, process development services had the highest revenue share of 70.3 percent in 2020. There are two types of biologics process development techniques: upstream process development and downstream process development. To cut costs and meet demand more efficiently, CMOs/CDMOs are implementing new technologies such as sophisticated expression systems, improved bioprocessing systems, and single-use technologies.

The Process Development Services generated revenues to the tune of US$ 6.98 Billion in 2020 and is projected to grow at a CAGR of 10.4% to reach a Market Size of US$ 12.64 Billion in 2026.

The majority of biologics manufacturing companies offer upstream process development services that are tailored to the clients’ business goals, available resources, regulatory constraints, and project timetable. Upstream process development for mammalian and microbial large-scale manufacturing services is provided by companies like AGC Biologics, Lakepharma, Inc., and Bionova Scientific.

Upstream Process Development accounts for 20% of the Market Share and accounted for US$ 1.99 Billion of the total revenue in terms of value and is expected to reach a Market Size of US$ 3.68 Billion in 2026.

Downstream processing is the purification and testing of the fermented medium containing the inoculum. Downstream process services include impurity isolation and identification, physicochemical characterization, pharmaceutical analysis, validating polishing, and packaging, among other quality checks. Packaging, labelling, and consultancy services are examples of additional product services.

Downstream processing generated revenue of US$ 993 Million in 2020 and is poised to reach a Market Value of US$ 1.89 Billion in 2027 growing at a CAGR of 11.3% in the forecast period (2021 – 2026).

Oncology dominates the Market based on Disease Indication

In 2020, oncology had the highest revenue share of 48.7% in the market for biologics contract development. The FDA approved 79 therapeutic mAbs in 2020 and they are currently on the market, with 30 of them being for cancer treatment. In 2020, biologics including GSK’s Dostarlimab were approved for the treatment of Endometrial cancer.

The Oncology segment is valued at US$ 4.83 Billion in 2020 and is projected to grow at a CAGR of 10.5% to reach a Market Size of US$ 8.79 Billion in 2026.

During the forecast period, the immunological disorder disease category is expected to have the highest CAGR of 13.2% in the biologics contract development market. Allergies, asthma, and autoimmune illnesses are among the disorders produced by immune system failure, and they impact from 7.6% to 9.4% of the world’s population.

The Immunological disorder disease segment is expected to generate revenue to the tune of US$ 2.38 Billion in 2020 and is poised to grow at a CAGR of 11.2% to attain a Market Size of US$ 4.52 Billion in 2026.

Microbial Cell Lines segment is the fastest growing based on Source

In the market for biologics contract development in 2020, the mammalian source category had the highest revenue share of 44.7 percent. During the projection period, the segment is expected to grow at a significant rate. This is due to the fact that employing mammalian cells for protein expression has the significant benefit of being able to synthesize mammalian proteins with all of the necessary post-translational modifications for a native structure. Mammalian cells, such as Chinese Hamster Ovary (CHO) cell lines, have long been favored, with CHO cells accounting for over 70.0 percent of all protein therapies created.

The Mammalian segment is valued at US$ 4.44 Billion in 2020 and is expected to grow at a CAGR of 10.7% to reach a Market Size of US$ 8.17 Billion in 2026.

Microbial cell lines are also frequently employed, with 48.0 percent of biologics licensed for manufacturing being produced in microbial systems such as E.coli and Saccharomyces cerevisiae. Microbial cell lines are mostly used by CDMOs to produce cytokines, hormones, enzymes, and some MABs. Insect, yeast, algal, and amphibian expression systems are also used to produce cell lines. Bacterial systems produce high amounts of protein in a short amount of time, whereas mammalian systems can produce proteins with human-like post-translational modifications.

The Microbial Cell Lines accounted for US$ 3.38 Billion in 2020 and is projected to grow at 12% to reach a valuation of US$ 6.67 Billion in 2026.

North America dominates the Biologics CDMO Market

North America dominated the biologics contract development market in 2020, accounting for 39.1 percent of total revenue. Over the forecast period, the region is expected to grow at a high rate. This is due to increased R&D investments as well as global players’ local presence and efforts to gain new patents. The increase in outsourcing operations and the number of clinical trials in the region are principally responsible for the growth of Contract Development Organizations (CDO). The National Cancer Institute (NCI) was awarded USD 70.0 million by the US government in 2018 to investigate genetic drivers in cancer and develop treatment strategies.

North America accounted for US$ 3.88 Billion of the total Market Revenue and is expected to grow at a CAGR of 10.2% to reach a Market Size of US$ 6.95 Billion in 2026.

Over the projected period, the market for biologics contract development in Asia Pacific is expected to grow at the fastest rate of 12.0%. This is due to regulatory organizations making different adjustments to improve clinical trial evaluation standards to meet global requirements, and many big businesses are investing in Asia Pacific. The Asia Pacific region has a large patient base and the opportunity for improved medical knowledge. In comparison to western countries, the expense of conducting a clinical trial is quite inexpensive here. The biologics contract development and manufacturing organization market in the region will benefit from the aforementioned factors.

Europe held a Market Share of 16% and is poised to grow at a CAGR of 10.4% to reach a Market Size of USD 2.88 Billion in 2026 from a Market Size of US$ 1.58 Billion in 2020.

Asia Pacific is valued at US$ 2.4 Billion in 2020 and is projected to grow at a CAGR of 12% to attain a Market value of US$ 5 Billion in 2026.

The Middle East & Africa registered a Market Share of 6% and is poised to grow at a CAGR of 10.2% to reach a Market Size of US$ 1.07 Billion in 2026 from a valuation of US$ 596 Million in 2020.

Latin America generated revenues to the tune of US$ 397 million in 2020 and is expected to grow at a CAGR of 10.3% to reach a Market Size of US$ 766.8 million in 2026.

Market Outlook

Rising demand for generics, increased investments in pharmaceutical R&D, and CDMO investments in innovative manufacturing technologies are all driving market expansion. In the future years, market growth is likely to be fueled by rising demand for biological therapies, a growing focus on specialty medications, growth in the nuclear medicine industry, and advancements in cell and gene therapies.

Due to the most effective therapeutic medication classes and garnering enormous investment for the biologics sector, the biologics segment will have a lucrative rise during the projection period. Because biologics have dominated human medicine development due to their long-lasting effects and capacity to precisely target the molecular origins of disease, demand for CDMOs is increasing, resulting in the segment’s growth.

By geography, Asia Pacific is going to have a lucrative growth during the forecast period due to the growing number of pharmaceutical companies in emerging economies such as India and China. Global corporations are choosing India in particular because of the country’s high manufacturing of biosimilars. Furthermore, the cheap cost of industrial operations and the availability of skilled personnel are important market drivers in this region.

Technology Roadmap

Gene therapies are exceedingly expensive at this point of development, but they hold the potential of becoming curative in a single step, lowering overall healthcare expenses. Many disorders could be treated thanks to recent advances in identifying disease-causing genes and the use of gene-editing tools for genetic modification. As a result, biopharmaceutical companies are concentrating on getting drugs to market quickly. Their efforts include building facilities and supply chains to meet growing patient demand around the world, lowering manufacturing costs, and improving the efficacy and potency of these innovative modalities and increasing safety to patients by reducing potential side effects of gene therapy products.

Implementing new, efficient, and resilient manufacturing and analytical technologies for the production of gene therapy products, as well as building a well-defined worldwide regulatory framework for process validation and batch release, are major components that solve these problems. Transient transfection of a complicated set of plasmids encoding the desired gene of interest (GOI) in HEK-293 or HEK-293T adherent cells or Sf9 insect cells is used in most modern viral vector production techniques. The desired viral vectors including the plasmids are expressed in the host cells, which must then be extracted and purified before being used either directly in a patient or via altering the patient’s cells. Formulation and fill/finish processes are extremely difficult for viral vector products, and there are substantial concerns with viral vector safety and potency studies and characterization.

Distribution Chain Analysis

The Distribution chain of the Global Biologics Contract Development and Manufacturing Organizations Market is as in the below image

Competitive Landscape

As leading competitors turn to inorganic expansion methods to deliver integrated solutions to customers, global biologics contract manufacturing demand will consolidate. Companies interested in meeting global biologics contract manufacturing demand are looking to increase their product reach and cement their position in the industry through acquisitions, collaborations, and partnerships with small and medium producers. Consolidation operations help a company’s plan move forward faster by increasing scale and depth in biologics contract manufacturing demand services.

Key Market Developments

In May 2021 – Samsung Biologics plans to feature an mRNA vaccine assembly line at its facility in Songdo, 30 kilometers southwest of Seoul, by the primary half 2022. messenger RNA (mRNA) vaccines are known for his or her safety and fast scalability in manufacturing, the corporate said during a statement, and are among the primary COVID-19 vaccines authorized to be used within the US.

In April 2021 – Gene Biotherapeutics partnered with Fujifilm Diosynth Biotechnologies to manufacture Generx [ad5fgf-4] phase 3 angiogenic gene therapy product candidate for refractory angina. Manufacturing operations are going to be conducted at FDB’s facilities in College Station, TX, where FDB will perform technology transfer and process development activities for Phase 3 clinical and commercial-scale GMP manufacturing of Generx.

Competitive Factors

The biologics contract manufacturing market’s manufacturers are concentrating on updating key features in response to technological breakthroughs while also lowering production costs. These factors contribute to the efficient production of pharmaceuticals and their economical distribution to the general public. As a result, these characteristics may provide the biologics contract manufacturing industry with remarkable growth prospects.

For Instance,

In March 2021 – WuXi Biologics has entered into an equity agreement with Pfizer China to accumulate its state-of-the-art biologics manufacturing facilities and its labor pool in Hangzhou, China. this may boost the commercial Drug Substance (DS) and Drug Product (DP) capacities for WuXi Biologics to deal with surging manufacturing demands.

In January 2021 – Boehringer Ingelheim entered into a strategic collaboration and licensing agreement with Enara Bio to research and develop novel targeted cancer immunotherapies, leveraging Enara Bio’s Dark Antigen discovery platform. The collaboration combines Boehringer Ingelheim’s approach to tackling cancer through pairing leading science with innovative immune-oncology platforms, like oncolytic viruses and cancer vaccines, with Enara Bio’s expertise in cancer antigen identification.

Key Market Players

Some of the Key Market Players in the Global Biologics Contract Development and Manufacturing Organizations Market include Thermo Fisher Scientific Inc. (US), Catalent, Inc. (US), Lonza Group Ltd. (Switzerland), Recipharm AB (Sweden), AbbVie Inc. (US), Aenova Group (Germany), Almac Group (UK), Siegfried Holding AG (Switzerland), and Ingelheim International GmbH (Germany).

Thermo Fisher Scientific Inc. is a company that creates, manufactures, and sells a wide range of products. Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Services are the company’s four segments. Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, and Unity Lab Services are some of the names under which it sells its goods and services. The Life Sciences Solutions division offers a variety of reagents, tools, and consumables for use in biological and medical research, as well as the development and manufacturing of new medications and vaccines.

Catalent, Inc. develops and manufactures drug delivery technologies, as well as biologics, protein, cell, and gene therapy biologics, and consumer health products. Softgel and Oral Technologies, Biologics, Oral and Specialty Delivery, and Clinical Supply Services are the company’s segments. The Softgel and Oral Technologies section is responsible for soft capsule formulation, development, and manufacturing, as well as large-scale production of oral solid dose forms. Oral and Specialty Delivery offers formulation development and production across a range of technologies, as well as integrated clinical development and commercial supply solutions. Manufacturing, packaging, distribution, and inventory management for pharmaceuticals and biologics in clinical trials are all part of the Clinical Supply Services division.

Lonza Group AG (Lonza) is a holding corporation established in Switzerland that provides products to the pharmaceutical, healthcare, and life science industries. Custom development and production of pharmaceuticals and drug delivery systems, as well as development of antimicrobial solutions for commercial purposes, are among the company’s services. Pharma & Biotech and Specialty Ingredients are the two segments in which the company operates. The Biologics, Small Molecule, Consumables, and Research Tools businesses are all part of the Pharma & Biotech division. The Specialty Ingredients segment focuses on anti-microbial applications within Consumer Health division, which covers hygiene, nutrition and private care products, also as preservatives, capsules and food supplements, among others, and Consumer & Resources Protection division, which incorporates coatings and composites, and agro ingredients.

Recipharm AB is one among the five largest pharmaceutical contract development and manufacturing organizations within the world, with production facilities in Sweden, France, Germany, Italy, Spain, Portugal, India and therefore the UK also as development sites in Sweden, Israel and therefore the USA. The Swedish-based company employs around 9,000 people and operates over 30 facilities. the corporate provides pharmaceutical companies round the world with end-to-end development and manufacturing services, including a good sort of dosage forms.

AbbVie Inc. (AbbVie) is a biopharmaceutical business that focuses on research. The company is involved in medicine and therapy research, development, manufacture, commercialization, and sales. Immunology products include Humira, Skyrizi, and Rinvoq; oncology medicines include Imbruvica and Venclexta; and oncology products include Imbruvica and Venclexta. Botox Cosmetic, Juvederm Collection, and other aesthetics goods; Neuroscience products such as Botox Therapeutic, Vraylar, Duopa and Duodopa, and Ubrelvy; Eye care products such as Lumigan, Alphagan, and Restasis.

Aenova Group, a German pharmaceutical company is owned by Apollo 8 GmbH, situated in Starnberg. Aenova manufactures medications and dietary supplements on a contract basis. The goods are made, packed, and delivered as tablets, hard capsules, and suppositories, as well as powder, ointment, and liquid preparations. In addition, the firm provides contract research and development, analysis, consulting, and distribution services.

Almac offers services which include research and development and production to other pharmaceutical companies such as Pfizer and GlaxoSmithKline. The company employs around 1500 people in Craigavon and has expanded into England, Scotland, and the United States, with a revenue of £167 million.

Siegfried Holding AG is a life sciences firm established in Switzerland that specializes in primary and secondary medication manufacturing. Drug substances and drug products are both produced by the company. Contract development and manufacturing of active pharmaceutical ingredients (APIs) and intermediates are part of the drug substance portfolio. Licensing, contract or co-development, and manufacture of oral solids and steriles are all part of the drug product range. Hypertension, benign prostate hyperplasia, depression, chronic myeloid leukaemia, glaucoma, asthma, schizophrenia and bipolar disorders, and diabetes are among the conditions for which the company’s treatments and chemicals are being developed. Production facilities are located in Switzerland, Germany, France, Malta, the United States, and China.

Boehringer Ingelheim is a private pharmaceutical company that is one of the worlds largest. With 146 affiliates and about 47,700 people, it is headquartered in Ingelheim and operates globally. The corporation is private and entirely owned by the Boehringer, Liebrecht, and von Baumbach families, unlike other large pharmaceutical companies that are publicly traded. Respiratory disorders, metabolism, immunology, cancer, and central nervous system diseases are among the company’s main areas of focus.

Strategic Conclusion

Global economic growth, a growing and ageing population, and new product launches are propelling the Global Biologics CDMO Market forward at an exponential rate. Despite the fact that small molecules continue to dominate the market, large molecules such as biologics, biosimilars, and cell and gene therapies are predicted to increase at the highest rate during the projection period.

Because biologic medications are high-value, high-margin products, top pharma companies’ proclivity to produce them in-house is posing a challenge to growth. Despite the growing trend of keeping biologic API synthesis in-house, pharma companies are more comfortable and willing to outsource the secondary manufacturing and packaging phases of their biologics products which is expected to poise well for the growth of the Global Biologics CDMO Market. Also, the increase in the number of Mergers & Acquisitions (M&As) among Market Players is expected to offer lucrative growth opportunities in the near future.

References

Appendix

CDMOs – Contract Development and Manufacturing Organizations
API – Active Pharmaceutical Ingredients
FDF – Finished Dosage Forms
PFS – Pre-Filled Syringes
NMEs – Novel Molecular Entities
M&As – Mergers and Acquisitions
IIoT – Industrial Internet of Things
WHO – World Health Organization
R&D – Research & Development
HPAPIs – High Potency Active Pharmaceutical Ingredients
ADCs – Antibody Drug Conjugates