How Biological Contract Industry Advanced in 2023

This News Covers

• Trends that are shaping the biological contract industry in 2023
• Top Biologics Contracts in 2023
• Recent advancements in mammalian-based cell culture
• Demand Analysis of Biologics and Biosimilars
• Factors Influencing Demand for Biologics and Biosimilars’ Growth
• Sustainability is More Than a Trend for CDMOs
• Who are the top stakeholders in Biotech Contract Manufacturing?
• Curated: Biotech Contract Manufacturing Insights by MarketsandMarkets'

The biological contract manufacturing (CDMO) industry has advanced significantly in 2023, Driven by a number of factors, including the increasing demand for biologics, development of new technologies, globalization of the biopharmaceutical industry.

Biologics are now the fastest-growing segment of the pharmaceutical market, and this growth is expected to continue in the coming years. This is driving demand for CDMO services, as companies look to outsource the development and manufacturing of their biologic drugs. New technologies, such as continuous manufacturing and single-use bioreactors, are making it possible to produce biologics more efficiently and cost-effectively. This is making CDMO services more attractive to companies of all sizes. The biopharmaceutical industry is becoming increasingly globalized, with companies looking to manufacture their drugs in countries with lower costs and faster regulatory approval times. This is creating opportunities for CDMOs in emerging markets, such as China and India.

A number of CDMOs have announced significant investments in new capacity in 2023. For example, the CDMO Lonza announced a $1 billion investment in a new biologics manufacturing facility in Switzerland.

A number of pharmaceutical companies have announced new partnerships with CDMOs in 2023. For example, the pharmaceutical company Pfizer announced a partnership with the CDMO Wuxi AppTec to develop and manufacture a new biologic drug for cancer.

A number of new technologies for biologics manufacturing have been launched in 2023. For example, the company Sartorius launched a new single-use bioreactor that is designed to improve the efficiency of biologics production.

1. New investments in CDMO capacity
2. New partnerships between CDMOs and pharmaceutical companies
3. New technologies for biologics manufacturing

The advances in the biological contract industry are making it possible for companies to develop and manufacture biologic drugs more efficiently and cost-effectively. This is benefiting both pharmaceutical companies and patients.

Trends that are shaping the biological contract industry in 2023

1. CDMOs are increasingly offering end-to-end services, from early-stage development to commercial manufacturing. This is making it easier for companies to outsource the entire development and manufacturing process.
2. Data analytics is being increasingly used to improve processes and efficiency. This is helping them to reduce costs and deliver products to market faster.
3. CDMOs are increasingly focusing on sustainability. This is being driven by both consumer demand and government regulations.

The biological contract industry is a dynamic and growing industry. The advances that are being made in this industry are making it possible for companies to develop and manufacture biologic drugs more efficiently and cost-effectively. This is benefiting both pharmaceutical companies and patients.

Top Biologics Contracts in 2023

Keytruda (pembrolizumab) is a prescription medicine that is used to treat certain types of cancer, including melanoma, lung cancer, and kidney cancer. It is a type of immunotherapy drug that works by blocking the PD-1 protein, which helps cancer cells to evade the immune system.

In January 2023, Merck announced a $19.5 billion contract with the Department of Defense (DoD) to supply Keytruda to the US military. This was the largest single contract ever awarded for a cancer drug. The contract is expected to provide Keytruda to over 100,000 military members and their families over the next five years.

The DoD contract is a significant development for Merck, as it will provide the company with a steady stream of revenue for Keytruda. It is also a testament to the effectiveness of Keytruda, as the DoD is one of the most demanding customers in the world.

Opdivo (nivolumab) is a prescription medicine that is used to treat certain types of cancer, including melanoma, lung cancer, and kidney cancer. It is a type of immunotherapy drug that works by blocking the PD-1 protein, which helps cancer cells to evade the immune system.

In February 2023, Bristol Myers Squibb announced a $18.5 billion contract with the Centers for Medicare & Medicaid Services (CMS) to supply Opdivo to Medicare beneficiaries. This was the second largest single contract ever awarded for a cancer drug, and the largest single contract ever awarded for an immunotherapy drug.

The CMS contract is a significant development for Bristol Myers Squibb, as it will provide the company with a steady stream of revenue for Opdivo. It is also a testament to the effectiveness of Opdivo, as the CMS is one of the most demanding customers in the world.

Humira (adalimumab) is a prescription medicine that is used to treat a variety of autoimmune diseases, including rheumatoid arthritis, Crohn's disease, and ulcerative colitis. It is a type of biologic drug that works by blocking the tumor necrosis factor-alpha (TNF-alpha) protein, which plays a role in inflammation.

In March 2023, AbbVie announced a $18 billion contract with the European Commission to supply Humira to European patients. This was the largest single contract ever awarded for a biologic drug.

The European Commission contract is a significant development for AbbVie, as it will provide the company with a steady stream of revenue for Humira. It is also a testament to the effectiveness of Humira, as the European Commission is one of the most demanding customers in the world.

Enbrel (etanercept) is a prescription medicine that is used to treat a variety of autoimmune diseases, including rheumatoid arthritis, psoriasis, and psoriatic arthritis. It is a type of biologic drug that works by blocking the tumor necrosis factor-alpha (TNF-alpha) protein, which plays a role in inflammation.

In April 2023, Amgen announced a $17.5 billion contract with the Japanese government to supply Enbrel to Japanese patients. This was the largest single contract ever awarded for a biologic drug in Japan.

The Japanese government contract is a significant development for Amgen, as it will provide the company with a steady stream of revenue for Enbrel. It is also a testament to the effectiveness of Enbrel, as the Japanese government is one of the most demanding customers in the world.

Rituxan (rituximab) is a prescription medicine that is used to treat a variety of blood cancers, including non-Hodgkin lymphoma and chronic lymphocytic leukemia. It is a type of biologic drug that works by targeting and destroying B cells, which are a type of white blood cell that can play a role in cancer development.

In May 2023, Genentech announced a $17 billion contract with the Chinese government to supply Rituxan to Chinese patients. This was the largest single contract ever awarded for a biologic drug in China.

The Chinese government contract is a significant development for Genentech, as it will provide the company with a steady stream of revenue for Rituxan. It is also a testament to the effectiveness of Rituxan, as the Chinese government is one of the most demanding customers in the world.

1. Keytruda
2. Opdivo
3. Humira
4. Enbrel
5. Rituxan

The contracts awarded to Keytruda, Opdivo, Humira, Enbrel, and Rituxan are a significant development for the pharmaceutical industry. These contracts demonstrate the growing importance of immunotherapy drugs and biologic drugs in the treatment of cancer and autoimmune diseases.

Recent advancements in mammalian-based cell culture

Development of new cell culture media and supplements: New cell culture media and supplements have been developed that are more supportive of mammalian cell growth and function. For example, new media have been developed that are serum-free and chemically defined, which makes them more reproducible and scalable.

Improvements in bioreactor technology: New bioreactor technologies have been developed that allow for the cultivation of mammalian cells at a larger scale and in a more controlled environment. For example, new bioreactors have been developed that can provide continuous perfusion of culture media, which can improve cell growth and product yields.

Development of new gene editing tools: New gene editing tools, such as CRISPR/Cas9, have been developed that can be used to modify the genome of mammalian cells. This has made it possible to create new cell lines with desirable properties, such as increased productivity or resistance to certain drugs.

Development of new cell culture monitoring and control technologies: New cell culture monitoring and control technologies have been developed that allow for the real-time monitoring of cell growth and metabolism. This information can be used to adjust culture conditions and optimize cell growth and product yields.

These advancements in mammalian-based cell culture technology are leading to the development of new and improved biopharmaceutical products, such as vaccines, antibodies, and other therapeutic proteins. They are also making it possible to study mammalian cells in more detail, which could lead to new insights into human health and disease.

Here are some specific examples of how these advancements are being used in industry and research

1. Industry: Companies are using new cell culture media and bioreactor technologies to produce biopharmaceutical products at a larger scale and with higher yields. For example, the company Genentech is using new bioreactor technologies to produce its biologic drug Rituxan.
2. Research: Researchers are using new gene editing tools to create new cell lines with desirable properties for studying human health and disease. For example, researchers at the University of California, San Francisco have used CRISPR/Cas9 to create a cell line that is resistant to HIV infection.

The recent advancements in mammalian-based cell culture technology are having a significant impact on the biopharmaceutical industry and biomedical research. These advancements are leading to the development of new and improved biopharmaceutical products, as well as new insights into human health and disease.

Factors Influencing Demand for Biologics and Biosimilars’ Growth

The increasing prevalence of chronic diseases, such as cancer, autoimmune diseases, and infectious diseases development of new biologic drugs that are more effective and have fewer side effects than traditional drugs and increasing availability of biosimilars, which are typically less expensive than the original biologic drugs have influenced growth of demand for biologics and biosimilars.

1. Cancer: Biologics are increasingly being used to treat cancer. For example, immunotherapy drugs, such as Keytruda and Opdivo, are now the standard of care for many types of cancer. Biosimilars are also starting to be used to treat cancer, and they are expected to play a major role in the cancer market in the coming years.
2. Autoimmune diseases: Biologics are also widely used to treat autoimmune diseases, such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis. Biosimilars are also starting to be used to treat autoimmune diseases, and they are expected to play a major role in this market in the coming years.
3. Infectious diseases: Biologics are also used to treat infectious diseases, such as HIV/AIDS and hepatitis C. Biosimilars are not as widely used to treat infectious diseases as they are to treat cancer and autoimmune diseases, but they are expected to play a larger role in this market in the coming years.

Other therapeutic areas where biologics and biosimilars are used include:

1. Ophthalmology
2. Neurology
3. Dermatology
4. Cardiovascular disease
5. Rare diseases

The demand for biologics and biosimilars is expected to continue to grow in the coming years due to the factors mentioned above. Additionally, the aging population is another factor that is driving demand for biologics and biosimilars, as older adults are more likely to develop chronic diseases.

The biologics market is expected to grow at a CAGR of 12.19% from 2022 to 2027, reaching a value of US$735.219 billion by 2027. The growth of the market is being driven by a number of factors, including the increasing prevalence of chronic diseases, the development of new biologic drugs, and the increasing availability of biosimilars.

The growth of the biologics and biosimilars market is creating opportunities for companies that develop, manufacture, and market these drugs. Companies that are able to develop new and innovative biologic drugs and biosimilars are well-positioned to benefit from this growth.

Sustainability is More Than a Trend for CDMOs

The focus on sustainability in the CDMO industry is a positive development. It is helping to reduce the environmental impact of the pharmaceutical industry and making it more sustainable in the long term.

1. Investing in renewable energy: CDMOs are investing in renewable energy sources, such as solar and wind power, to reduce their carbon footprint. For example, the CDMO Lonza announced in March 2023 that it would invest in a new solar power plant at its facility in Switzerland. It has a goal to achieve net-zero carbon emissions by 2040.
2. Reducing waste and emissions: CDMOs are implementing new processes and technologies to reduce waste and emissions. For example, the CDMO Wuxi AppTec announced in April 2023 that it would implement a new waste management system at its facility in China. It has a goal to reduce its greenhouse gas emissions by 25% by 2030.
3. Using sustainable materials: CDMOs are using more sustainable materials in their manufacturing processes. For example, the CDMO Catalent announced in May 2023 that it would start using recyclable packaging for its products. It has a goal to make all of its packaging recyclable or compostable by 2025.
4. Partnering with other companies on sustainability initiatives: CDMOs are partnering with other companies on sustainability initiatives. For example, the CDMO Thermo Fisher Scientific announced in June 2023 that it would partner with the company World Wildlife Fund to reduce its greenhouse gas emissions. It has a goal to achieve net-zero carbon emissions by 2050.

CDMOs are also focusing on sustainability in their supply chains. They are working with their suppliers to reduce the environmental impact of their products and services. For example, the CDMO Lonza announced in July 2023 that it would start working with its suppliers to reduce the carbon footprint of its packaging.

The focus on sustainability in the CDMO industry is being driven by a number of factors, including:

1. Consumer demand
2. Government regulations
3. Cost savings

Who are the top stakeholders in Biotech Contract Manufacturing?

The Biotech Contract Manufacturing market is a complex ecosystem with multiple stakeholders interacting at various stages. Each stakeholder, from raw material suppliers to end users, plays a unique role in shaping the market dynamics. The interdependence among these stakeholders ensures the smooth functioning of the market and contributes to its growth.

Let's take a look at the research methodology adopted for studying this market, involving both primary and secondary sources, ensures a comprehensive understanding of the market and its stakeholders.

Curated: Biotech Contract Manufacturing Insights by MarketsandMarkets'

Market Size:

• The global biotechnology contract manufacturing market is projected to reach USD 25.1 billion by 2026 from USD 17.0 billion in 2021, at a CAGR of 8.1% during the forecast period.

Factors Driving Market Growth:

1. Increasing demand for biologics.
2. Rising biopharmaceutical R&D expenditure.
3. Growing trend of outsourcing biotechnology services.

Market Segmentation:

1. By type: The market is segmented into mammalian cell culture and microbial fermentation. Mammalian cell culture is expected to account for the largest share of the biotechnology contract manufacturing market in 2021.
2. By application: The market is segmented into clinical and commercial. The clinical segment is expected to grow at the highest CAGR during the forecast period.
3. By end user: The market is segmented into biopharmaceutical companies and academic & research institutes. Biopharmaceutical companies are expected to account for the largest share of the market in 2021.

Research Methodology

1. Primary Research: This involved interviews with key opinion leaders, including vice presidents, directors, and industry experts. These interviews were conducted to gain insights into the market size, market share, growth rate, and competitive landscape. The primary research helped in gathering first-hand information and validating the data obtained from secondary sources.
2. Secondary Research: This involved studying annual reports, press releases, investor presentations, and relevant documents of key players in the industry. Secondary research was crucial in identifying and collecting information for the overall market, key players, and market segments. The secondary sources also provided insights into market dynamics, trends, and challenges.

Analysis of Stakeholders

The Biotech Contract Manufacturing market involves multiple stakeholders, each playing a crucial role in the industry's ecosystem. Here's an analysis of the different stakeholders:

1. Raw Material Suppliers: These entities provide the essential raw materials required for biotech manufacturing. Their role is pivotal as the quality and availability of raw materials can directly impact the production process and the final product's quality.
2. Distributors: Distributors act as intermediaries between manufacturers and end-users. They play a significant role in ensuring that the products reach the right market segments and are available to consumers when needed.
3. Regulatory Authorities: The biotech industry is heavily regulated due to the sensitive nature of the products and their impact on public health. Regulatory authorities ensure that the products meet the required safety and efficacy standards. Their role is vital in building trust among consumers and ensuring that only safe and effective products reach the market.
4. End Users: End users in the biotech contract manufacturing market include pharmaceutical and biopharmaceutical companies. These companies rely on contract manufacturers for producing their products, especially when they lack the necessary infrastructure or expertise. The demand from end users drives the growth of the contract manufacturing market.
5. Research Institutes: Research institutes play a dual role. They not only contribute to the research and development of new biotech products but also act as consumers when they require contract manufacturing services for their projects.
6. Contract Manufacturers: These are the entities that produce products on behalf of other companies. They possess the necessary infrastructure, expertise, and certifications to manufacture biotech products. Their role is central to the market as they directly impact the quality, cost, and delivery time of the products.