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Overview
The Biopharma Buffer market size is forecast to reach USD 11.58 billion by 2032, after growing at a CAGR of 10.16% during 2024-2032. The surge in investments by numerous companies in drug discovery and development-related research and development has resulted in a notable expansion of the biopharma buffer industry. Pharmacies that deal with biopharmaceuticals are spending a significant amount of their funds on research and development to provide innovative drug formulations and treatment alternatives for various difficult diseases. Biopharma buffers are essential to the drug production process when it comes to the purification, stability, and transportation of biologic pharmaceuticals. High-quality buffers are therefore in greater demand due to the growing R&D pipeline of biologic therapies that target infectious diseases, cancer, and uncommon disorders. A consistent supply of buffers is also needed by the expanding trend of outsourcing manufacturing tasks to specialist contract manufacturing companies, which is fostering market expansion.
For instance, in April 2023, an agreement was made between Asahi Kasei Bioprocess America and GeminiBio to strategically collaborate on the advancement of inline buffer formulation (IBF) in the biopharmaceutical sector. A whole new level of efficiency and cost savings can be achieved throughout the biopharmaceutical manufacturing process by combining the system from Asahi Kasei Bioprocess with the pre-mixed concentrates from GeminiBio into a single package.
Report Coverage
The report “Biopharma Buffer Market– Forecast (2024-2032)”, by IndustryARC, covers an in-depth analysis of the following segments of the Biopharma Buffer market.
By Type: Pre-formulated Buffers, Customized Buffers, Concentrated Buffers, Others
By Application: Cell Culture, Purification, Formulation
By Component: Amino Acids, Acetic Acid, Phosphate, Histidine, Others
By Buffer Preparation: Liquid, Powder
By Material Form: Dry, Liquid
By End User: Pharmaceutical companies, Academic institutions, Hospitals, Others
By Geography: North America, South America, Europe, Asia-Pacific
Key Takeaways
• The liquid material form and Pre-formulated Buffers have seen marginal growth post covid. This likely refers to the increasing demand for liquid-based biopharma buffer products in response to the pandemic. Liquid materials are often preferred for their ease of use, storage, and transportation, making them a popular choice for biopharmaceutical companies looking for efficient solutions in a post-pandemic world. The growth of the liquid material form in the global biopharma buffer market post-COVID-19 impact analysis is likely to be driven by factors such as the expansion of biopharmaceutical production capacity, advancements in bioprocessing technologies, and a greater emphasis on research and development in the biopharmaceutical sector.
• The amino acid component type is anticipated to be a top looser segment. This segment saw a significant negative impact following the pandemic, possibly due to disruptions in supply chains, changes in consumer behavior, and shifts in healthcare priorities. Amino acids are essential building blocks for proteins and are crucial in biopharmaceutical processes, so any downturn in this segment could have implications for the overall industry.
• In the post-COVID-19 era, the global biopharma buffer market has seen significant shifts in various segments. One of the notable marginal loser segments is formulation application. With the impact of the pandemic and changes in market dynamics, companies focusing on formulation applications within the biopharma buffer market have faced challenges.
By Type - Segment Analysis
Pre-formulated buffers dominated the Biopharma Buffer market in 2024. The market for pre-formulated buffers in biopharma is driven by the increasing demand for biopharmaceutical products, rising investments in research and development, and the growing number of biopharmaceutical manufacturing facilities globally. For instance, A £277 million ($299.59 million) investment in the inaugural round of Life Sciences Innovative Manufacturing Fund (LSIMF) awards is anticipated to help four life sciences enterprises in the United Kingdom advance life sciences manufacturing projects. The market for pre-formulated buffers in biopharma is expected to witness significant growth in the coming years due to the increasing adoption of biopharmaceuticals, advancements in bioprocessing technologies, and the continuous development of new biopharmaceutical products. Additionally, the emphasis on quality control and regulatory compliance in biopharma manufacturing is driving the demand for high-quality pre-formulated buffers that can ensure consistent and reliable results in biopharmaceutical production.
By Application - Segment Analysis
Cell Culture dominated the Biopharma Buffer market in 2024. The 2022 report from the International Agency for Research on Cancer (IARC) indicates that there were approximately 20 million new cancer cases and 9.7 million cancer deaths globally in 2022. This trend is expected to escalate significantly, with projections suggesting around 35 million new cancer cases by 2050. This increase in cancer incidence, particularly in countries with low and medium Human Development Index (HDI) levels, underscores the urgent need for improved healthcare infrastructure and cost-effective cancer care. As cancer rates rise, there will be a greater demand for advanced medical technologies and treatments, including those involving cell culture technologies. Cell culture is integral to cancer research and treatment development, driving the need for specialized buffers used in these processes. The growing cancer burden will likely stimulate increased investment and innovation in the biopharma buffer market, as these buffers are critical for the successful cultivation and analysis of cancer cells.
By Component - Segment Analysis
Amino acids dominated the Biopharma Buffer market in 2024. Amino acids are biocompatible and mimic natural physiological conditions, which helps in reducing the risk of adverse reactions in pharmaceutical formulations. This makes them suitable for use in buffers where safety and compatibility are critical. Amino acids can stabilize biologics and other sensitive compounds during formulation and storage. Their ability to interact with proteins and other molecules helps maintain the integrity and activity of the active ingredients.
Amino acids generally have low toxicity profiles, which is essential for ensuring the safety of pharmaceutical products. This property makes them favorable for use in buffers that come into contact with biological systems. Amino acids can act as both buffering agents and stabilizers. Their versatility allows for the formulation of buffers with specific pH and stability requirements, which is important for various biopharmaceutical applications. This versatility and effectiveness as buffer substances make amino acids a key driver in the demand for biopharma buffers.
By Buffer Preparation – Segment Analysis
Liquid dominated the dominated the Biopharma Buffer market in 2024. The rapid development and adoption of advanced medical technologies require precise and reliable buffers for various biopharmaceutical applications. Liquid buffers are crucial in various stages of biopharmaceutical research and development, including clinical trials. They are commonly used in the preparation and stabilization of biological samples, in assays, and during the formulation of drugs. As of May 17, 2023, ClinicalTrials.gov lists a total of 452,604 registered clinical trials worldwide. Out of these, 64,838 trials are currently seeking participants. This marks a notable rise from the more than 365,000 trials recorded in early 2021, highlighting considerable growth in the clinical research field. The increase in registered studies can be attributed to several key factors, including progress in medical technology; a broader range of diseases being researched; the emergence of personalized medicine; and the urgent demand for new treatments and vaccines, particularly due to global health emergencies like the COVID-19 pandemic.
By Geography - Segment Analysis
North America dominated the dominated the Biopharma Buffer market in 2024. The North American biopharma buffer market size was valued at $1.92 billion in 2024 and is estimated to generate $3.94 billion by the end of 2032 growing at a CAGR of 9.4% from 2025 and 2032. North America, particularly the United States, is a global hub for biopharmaceutical manufacturing. The biopharma buffer market is anticipated to be driven by recent expansions in US manufacturing capacity for innovative medicines such as biologics, cell and gene therapies, and mRNA-based pharmaceuticals. For example, in April 2024, Amgen established a new AI-enabled biomanufacturing plant in New Albany, Ohio. In February 2024, AstraZeneca announced a $300 million investment in a new cell therapy facility in Rockville, Maryland, to launch its cell therapy platforms in the United States for cancer trials and potential commercial supply.
However, as the global demand for high-purity buffers and biochemicals grows in tandem with the biopharmaceutical and diagnostics markets, buffer manufacturers in this region are expected to face increasing challenges in securing a sustainable supply of the critical chemistries required for their processes and end products.
Drivers – Biopharma Buffer Market
• Growing Investments in The Biopharmaceutical Sector
A significant driving force behind the expansion of the biopharma buffer market is the growing investments made in the biopharmaceutical sector by both public and commercial entities. The development of manufacturing capabilities, R&D efforts, and buffer formulation innovation are all fueled by these investments. The market for biopharma buffers is crucial to the expansion of the biopharmaceutical sector as a whole because it is driven by the increasing efforts of research institutes and biopharmaceutical businesses to discover and create new medicines. As a result, there is a constant need for high-quality specialty buffers.
• Growing Demand for Biopharmaceuticals
The demand for biopharmaceuticals is being driven by the rising incidence of chronic diseases and the rising need for individualized treatment. Because biopharma buffers are a necessary part of the process of making biopharmaceuticals, this is in turn boosting the need for them. Because of aging populations, changing lifestyles, and environmental factors, chronic diseases like cancer, diabetes, cardiovascular disease, and autoimmune disorders are becoming more commonplace worldwide. Due to the complexity of these illnesses, sophisticated, tailored treatments are frequently needed; many of these treatments are biopharmaceuticals.
• Expanding Utilization of Single-Use Technologies
Due to their low cost and lower danger of contamination, single-use technologies are gaining traction in the biopharmaceutical sector. The need for biopharma buffers is being driven by the increasing use of single-use bioprocessing systems, which include biopharma buffers as a necessary component. The use of single-use technologies (SUTs) in the production of biopharmaceuticals lowers production costs, boosts the flexibility of the manufacturing line, and accelerates batch turnaround times during line changes. The creation of a safe and legally compliant product is also made easier by the closed manufacturing processes. Over the past decade, the field of biomanufacturing has seen substantial advancements.
Challenges – Biopharma Buffer Market
• Market Expansion is Hindered by Challenges Related to Regulatory Compliance
To ensure the safety and effectiveness of medications, the FDA and EMA are regulatory authorities that place stringent regulations on the formulation, quality, and manufacturing methods of buffers used in drug development. The introduction of additional buffer choices is delayed by the potential cost and time associated with meeting these requirements. This bureaucracy can impede market evolution and innovation by delaying the quick adoption of effective buffering strategies.
• High Costs are a Significant Restraint in the Biopharma Buffer Market
The market for biopharma buffers is restrained by high costs, which are especially high for highly specialized or purified buffers that need to be produced and acquired. These expenses result from the requirement for highly pure raw ingredients, sophisticated production techniques, and exacting quality assurance to satisfy regulatory requirements. As a result, the high cost of these buffers may prevent certain biopharmaceutical businesses from using them or from affording them, particularly those with smaller budgets. This financial strain could result in a decrease in the use of premium buffers, which would affect the market's general expansion and innovation.
Market Landscape
Technology launches, acquisitions, and R&D activities are key strategies adopted by players in the Biopharma Buffer market. In 2024, the Biopharma Buffer market share has been consolidated by the major players accounting for 64% of the share. Major players in the Biopharma Buffer market are Thermo Fisher Scientific Inc., Merck KGaA., Becton, Dickinson and Company (BD), GE Healthcare among others.
Developments:
- January 10, 2024: Thermo Fisher Scientific introduced a new line of high-purity biological buffers designed to enhance the stability and efficacy of biopharmaceutical formulations. These buffers are tailored for critical applications in protein purification and cell culture processes.
- March 5, 2024: Merck KGaA launched an innovative buffer delivery system aimed at improving the efficiency and accuracy of buffer preparation in biopharmaceutical manufacturing. This system is expected to streamline workflows and reduce preparation time.
- July 19, 2023: Lonza expanded its buffer manufacturing capabilities by opening a new facility dedicated to producing high-quality buffers for the biopharma industry, addressing the increasing market demand.
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