U.S. Biotechnology Market Size to Increase USD 1.79 Trillion by 2033

According to Nova One Advisor, the U.S. Biotechnology market size was estimated at USD 552.49 billion in 2023 and it is projected to increase USD 1,794.11 billion by 2033 with a CAGR of 12.5 % from 2024 to 2033.

Government support plays a major role in propelling market growth, focusing on modernizing regulatory frameworks, enhancing approval processes and reimbursement policies, and standardizing clinical studies. The National Science Foundation (NSF) and Synthetic Biology Engineering Research Center (SynBERC) are responsible for conducting regular evaluations of synthetic biology. Biotechnology applications are experiencing a surge in market revenue thanks to the growth of personalized medicine and the development of orphan drug formulations. This has resulted in the emergence of many new and innovative biotech firms, contributing to the industry’s expansion.

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Key Takeaways:

• DNA sequencing dominated this market and held the highest revenue market share of 18% in 2023
• The others’ segment is anticipated to grow at the fastest CAGR of 28.1% during the forecast period.
• The health segment dominated the market and accounted for the largest revenue market share of 44.13% in 2023.
• Bioinformatics is expected to witness the fastest growth, with a CAGR of 17.2% during the forecast period.

The U.S. accounted for over 35.6% of the global biotechnology market 2023. The increasing demand for agricultural products like wheat, rice, and beans, driven by population growth, highlights the importance of biotechnology-based solutions. Scientists focus on advanced agricultural technologies through extensive research and development (R&D) to address challenges such as pest attacks, limited land availability, and water scarcity. Moreover, investments in agriculture R&D, exemplified by companies like Loopworm and initiatives like the USD 101 million investment by Unilever and others in regenerative agriculture, propel market growth. Supportive government guidelines, particularly in synthetic biology, and the decreasing costs of DNA sequencing are also significant drivers of the biotechnology market’s expansion.

The market has seen a positive influence from the COVID-19 pandemic, as it has spurred an increase in opportunities and advancements in developing and producing vaccines for the virus. Moreover, the success of mRNA vaccines and expedited approval processes have resulted in a spike in vaccine-related revenues, demonstrated by a collective revenue of approximately USD 31 billion in 2021 from vaccines by Moderna, Pfizer/BioNTech, and Johnson & Johnson. In addition, the growing demand for biotechnology tools in agricultural applications, such as micro-propagation, molecular breeding, tissue culturing, traditional plant breeding, and the creation of genetically modified crops, among others, has further propelled the market’s growth.

In addition, an increasing tendency is observed toward accepting genetically modified crops and seeds that can endure insect-resistant herbicides. This trend is playing a significant role in the expansion of the market. A robust clinical trial pipeline and funding availability in tissue engineering and regeneration technologies further fuel the market growth. Moreover, the increasing need for effective clinical interventions to address chronic conditions like cancer, diabetes, age-related macular degeneration, and various forms of arthritis is expected to propel market growth. Leading companies are actively exploring and advancing pipeline products targeting conditions such as diabetes, neurological disorders including Parkinson’s and Alzheimer’s diseases, different types of cancers, and cardiovascular ailments. Notably, data from clinicaltrials.gov in January 2021 revealed 126 agents undergoing clinical trials for Alzheimer’s disease treatment, with 28 treatments in phase III trials.

Fermentation technology is on the rise in the life sciences and healthcare industries, positively impacting market expansion. The development of simplified and vortex bioreactors and other improvements to traditional bioreactors has driven advancements in fermentation technology and increased its popularity. Additionally, vortex bioreactors have been upgraded for more efficient wastewater treatment. These advancements in fermentation technology are expected to fuel market growth.

In recent years, there has been a noticeable increase in the use of biotechnological methods such as stem cell technology, DNA fingerprinting, and genetic engineering. The growth in the market for stem cell technologies can be attributed to advancements in stem cell therapeutics, rising demand for biologics, and an increased emphasis on creating personalized medicines. DNA fingerprinting is becoming more prevalent in forensic science, and it’s also being used to investigate familial relationships in animal populations and measure inbreeding levels. In a similar vein, the use of genetic engineering and cloning techniques is expanding in animal breeding and the production of complex biological substances.

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The Top 5 Biotechnology Trends for 2024

• Gene Editing:

This technique in biotechnology inserts, removes, changes, or replaces specific pieces of a person’s existing DNA. To treat diseases, scientists are exploring ways to edit pieces of DNA at precise spots along the gene. The goal of gene editing is to change the existing gene and correct mutations where they occur. CRISPR is the most common type of editing.

With this innovation, scientists can now modify genes or replace faulty genes with healthy ones to potentially treat, cure, or prevent a disease or medical condition.

• Precision Medicine:

The approach to precision medicine allows researchers and doctors alike to predict more accurate treatment and preventive strategies for a particular disease, usually in groups of people.

The goal of this trend is to reduce the risk of human complications in the healthcare industry. Professionals in the field of science are holding on to the promise of precision medicine as it expands in the future.

• Biomanufacturing:

This trend relies on naturally occurring processes and reactions to produce outputs such as chemicals, material, etc. that are normally produced through a synthetic process. The most common biological process of biomanufacturing is fermentation.

The goal of this application in biomanufacturing is to search for ways to boost sustainability, reduce energy consumption, and increase innovation and productivity. This trend is truly poised to continue advancing.

• Synthetic Biology:

The principle of this trend is to engineer new biological systems or re-design existing ones for useful purposes. It involves manipulation of biological compounds which are then integrated into cells which are chosen to provide suitable experimental strategy.

Although there are hurdles to overcome in this trend, its potential still outweighs the challenges. It is capable of delivering new solutions to agriculture, global healthcare, manufacturing, and many more.

• Bioprintin:

The relatively new technology is an additive manufacturing process like 3D printing. The only difference is that bioprinters print with cells or biomaterials to create organ-like structures that is beneficial to the healthcare industry. The grandiose potential of this trend benefits several industries including drug discovery, regenerative and personalized medicine.

As more researchers gauge the latest bioprinting technology, the developments will surely breakthrough in the coming years.

What are the risks and limitations of U.S. Biotechnology?

• Regulatory Challenges: The regulatory environment for biotechnology in the U.S. can be complex and stringent. Obtaining approvals for new biotech products or processes can be time-consuming and costly. Additionally, changes in regulations or unexpected regulatory hurdles can pose challenges for biotech companies.
• Ethical Concerns: Biotechnology raises ethical questions, particularly regarding issues such as genetic engineering, cloning, and the use of biotechnological tools in areas like agriculture and medicine. These concerns can lead to public debate, regulatory restrictions, and reputational risks for companies involved.
• Intellectual Property Issues: Intellectual property (IP) rights are crucial in biotechnology due to the significant investment in research and development. However, patent disputes and challenges can arise, hindering innovation and leading to legal battles that can be costly and time-consuming.
• Health and Safety Risks: The development and use of biotechnological products, such as genetically modified organisms (GMOs) or gene therapies, may pose health and safety risks if not adequately tested or regulated. Ensuring the safety of biotech products for consumers and the environment is paramount but can be challenging.
• Environmental Impact: Biotechnology can have both positive and negative environmental impacts. While some biotech applications, like biofuels or bioremediation, offer potential environmental benefits, others, such as genetically modified crops, may raise concerns about biodiversity, ecosystem health, and unintended consequences.
• Market Uncertainty: The biotechnology industry is characterized by rapid technological advancements and evolving market dynamics. Companies face uncertainty regarding market demand, competition, and the adoption of new biotech products or therapies, which can affect investment decisions and business viability.
• Public Perception and Acceptance: Public perception of biotechnology can influence its acceptance and adoption. Negative perceptions or misinformation about biotech products or processes may lead to public resistance, regulatory scrutiny, or consumer boycotts, impacting market access and profitability.

Technology Insights

DNA sequencing dominated this market and held the highest revenue market share of 18% in 2023, which can be attributed to declining sequencing costs and rising penetration of advanced DNA sequencing techniques. This technology is key in creating personalized cancer treatments by pinpointing mutations. Widely embraced in research, DNA sequencing efficiently compares large DNA segments across species. Advancements in sequencing systems are enhancing speed and cost-effectiveness, offering substantial potential in healthcare applications. Government support, exemplified by grants like the USD 10.7 million NIH award in May 2021 for Alzheimer’s disease research, is fueling the expansion of sequencing for disease insights.

The others’ segment is anticipated to grow at the fastest CAGR of 28.1% during the forecast period. This segment includes fermentation in food and environmental applications, driven by the rising use of microorganisms in the food industry and to address environmental challenges like climate change. Intechopen highlighted in February 2023 that employing microorganisms in food processing can boost efficiency, save time and energy, and establish a more consistent processing system commercially. With the modern lifestyle’s demands, there is a growing reliance on processed foods, leading to an increased demand for such products. Fermentation in food processing leverages microorganisms’ growth and metabolic activity to stabilize and transform food materials by converting organic acids or carbon dioxide and carbohydrates to alcohols under anaerobic conditions using bacteria, yeasts, or a combination of them. This is anticipated to fuel market growth.

Application Insights

The health segment dominated the market and accounted for the largest revenue market share of 44.13% in 2023. The use of biotechnology in healthcare is transforming the industry. Innovations in genomics, molecular biology, cellular and tissue engineering, bio-imaging, new drug discovery, and delivery methods offer promising possibilities for enhancing diagnostic capabilities and broadening treatment options. The segment’s growth is expected to be driven by an increasing disease burden, the rising availability of agri-biotech and bio-services, and technological advancements in the bio-industrial sector. Furthermore, significant progress in Artificial Intelligence (AI), machine learning (ML), and big data is also fueling the segment’s growth and boosting its adoption food and beverage industries.

Bioinformatics is expected to witness the fastest growth, with a CAGR of 17.2% during the forecast period. The bioinformatics industry has seen rapid global expansion, driven by various fields like physics, mathematics, and pharmaceuticals, and the emergence of new biotechnology fields like proteomics and genomics. The surge in data from increased biotechnology R&D has broadened bioinformatics’ scope. It’s now widely used for bioresource conservation & management, biology prospecting, product & process evaluation, and managing complex data for national programs. Cloud computing has become integral to bioinformatics, providing scalable computing & storage, data sharing, and on-demand resource access. The rise of biomedical cloud platforms catering to specific research community needs is a notable trend, expected to boost bioinformatics tool adoption in life sciences.

Recent Developments

• In October 2023, Amgen announced that it had completed its acquisition of Horizon Therapeutics plc. Horizon Therapeutics is a biopharmaceutical company focused on developing and commercializing therapies for rare genetic and autoimmune diseases.
• In October 2023, Gilead Science’s subsidiary, Kite and Epicrispr Biotechnologies, announced a research collaboration and licensing agreement to utilize Epic Bio’s gene regulation platform in developing advanced cancer cell therapies.
• In September 2023, Biogen announced that the U.S. Food and Drug Administration (FDA) had approved CONFIDENCE (tocilizumab-above) in its intravenous form, representing a biosimilar monoclonal antibody concerning ACTEMRA.

Key U.S. Biotechnology Company Insights

The biotechnology sector is witnessing a trend where companies form alliances through various strategic initiatives such as business collaborations, partnerships, and development agreements. The primary motivation behind these initiatives is the collective development of innovative therapeutics for improved results and cost reduction. The market’s growth is largely due to the launch of new and innovative products, contracts, acquisitions, technological advancements, and wide-ranging applicability. For instance, in January 2021, Sartorius Stedim Biotech acquired the chromatography process equipment division of Novasep. This division’s chromatography products portfolio includes resin-based batch systems and advanced chromatography systems for various applications, including oligonucleotides, small molecules, insulin, and peptides.

Key U.S. Biotechnology Companies:

• AstraZeneca
• Gilead Sciences, Inc.
• Bristol-Myers Squibb
• Sanofi
• Biogen
• Abbott Laboratories
• Pfizer, Inc.
• Amgen Inc.
• Novo Nordisk A/S
• Merck KGaA
• Johnson & Johnson Services, Inc.
• Novartis AG
• F. Hoffmann-La Roche Ltd.
• Lonza

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Biotechnology market.

By Technology

• Nanobiotechnology
• Tissue Engineering and Regeneration
• DNA Sequencing
• Cell-based Assays
• Fermentation
• PCR Technology
• Chromatography
• Others

By Application

• Health
• Food & Agriculture
• Natural Resources & Environment
• Industrial Processing
• Bioinformatics
• Others

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