Buffer Preparation Market: Focus on Buffer Manufacturing Systems and Service Providers - Distribution by Scale of Operation (Preclinical / Clinical and Commercial) and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2035

Buffer Preparation Market Overview

The global buffer preparation systems market is anticipated to grow at a CAGR of around 10%, till 2035. Buffers are aqueous solutions used to control pH in drug manufacturing process and are a vital component in maintaining the stability of both biologics and small molecules during production and in their final form. Moreover, buffers are used in multiple upstream and downstream bioprocesses for various applications, including maintaining the stable pH of culture, enhancing yield of desired products, maintaining defined purification conditions and stabilizing the final product while maintaining its functional characteristics. However, conventional buffer manufacturing is a complex process that requires large floor space and trained labor. In addition, conventional buffer production is a time consuming, multistep process that contributes to high production costs as well as batch-to-batch variations in the final products. In fact, as per a report by BioPharma, preparation of a 2,000 L buffer is expected to take more than 35 hours.

To overcome the challenges associated with conventional buffer preparation / buffer manufacturing processes, pharmaceutical players are either installing novel buffer preparation systems in their manufacturing facilities or outsourcing buffer manufacturing needs to third party service providers. In recent years, the use of buffer manufacturing / buffer management systems has witnessed rapid adoption trends. This can be attributed to the fact that these systems occupy less floor space and are integrated with advanced technologies for maintaining physiological conditions of buffers during the downstream processes. It is worth mentioning that novel buffer preparation systems can manufacture 2,000 L buffer within 40-50 minutes. In fact, as per a report by Pall Corporation, the use of buffer management systems can result in a 50% reduction in labor costs and a 12% decrease in buffer manufacturing costs. Additionally, outsourcing the complex process of buffer manufacturing is expected to result in an annual savings of USD 90,000 and a 75% reduction in buffer preparation time. Driven by the growing demand for buffers and challenges associated with buffer manufacturing, the buffer preparation systems market is anticipated to witness steady growth in the coming decade.

Key Market Insights

The Buffer Manufacturing Market: Focus on Buffer Manufacturing Systems and Service Providers - Distribution by Scale of Operation (Preclinical / Clinical and Commercial) and Key Geographical Regions (North America, Europe, Asia and Rest of the World): Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape, market size and future opportunities for the players engaged in the development of buffer management systems and providing buffer manufacturing services. The report answers many key questions related to this industry.

Need for Novel Buffer Preparation Systems

Buffer manufacturing has been one of the most crucial processes in the biopharmaceutical industry with wide range of applications. However, buffer production is an expensive, lengthy and labor-intensive process that requires significant floor space and specialized equipment. Additionally, buffer storage during the large scale production of biopharmaceuticals can be a challenge as buffer storage requires a large floor space at a time when emerging product classes are driving the need for multi-use, multi-scale manufacturing. 

In order to address the aforementioned challenges associated with buffer preparation and buffer storage, several players have developed novel buffer preparation systems / in-line conditioning systems which enable simultaneous preparation of buffer from raw materials and their use in upstream and downstream applications. Integrated with automated technology platforms and sensors, such systems have allowed precise and controlled production of buffers in timebound manner. It is worth highlighting that the use of novel buffer preparation systems / inline buffer conditioning systems has already demonstrated promising results in buffer manufacturing, in terms of process automation, time reduction and buffer quality. For instance, NIIMBL-BioPhorum Buffer Stock Blending Skid claims to manufacture 4,000 L of buffer in two hours, compared to the six to eight hours needed for traditional buffer manufacturing process.

Buffer Manufacturing Systems Market Landscape

Presently, close to 45 buffer preparation / manufacturing systems are available in the market for buffer production. Such buffer preparation systems can automate buffer production process across different scales of operations. It is worth highlighting that the novel buffer manufacturing systems are integrated with a wide range of features, including conductivity sensors, pressure sensors, temperature sensors, pH sensors and filters. Notably, a large number of buffer manufacturing systems have been developed to operate in an automated mode, reducing the risk of errors prone to human interface. In addition, over 20% of the buffer manufacturing systems offer preparation of both diluted and conditioned buffers, offering flexibility to users. In November 2021, California based Agilitech launched their automated single-use inline dilution system that offers dilution of concentrated buffer solutions and their delivery for downstream processes at the point of use and time of use.

Need for Outsourcing Buffer Manufacturing Services to Contract Manufacturers

Given the technical and operational challenges associated with the production of buffers, innovators in the biopharmaceutical industry are increasingly relying on the contract service providers for their buffer manufacturing needs. The buffer preparation service provider landscape consists of close to 45 players, featuring a mix of start-ups and experienced large players, that claim to provide services for buffer preparation across different scales of operations. Notably, majority of the players established post-2000 are headquartered in North America, primarily in the US. It is worth highlighting that more than 45% of the service providers offer at least three services in this domain, such as fill / finish and packaging, formulation development and manufacturing services for buffers.

Partnership and Collaboration Trends in Buffer Preparation Market

Stakeholders in the buffer manufacturing industry have forged several deals in order to enhance their product portfolios and augment the reach of their proprietary buffer manufacturing systems. It is worth highlighting that over 40% of these partnerships have been inked since 2021. Majority of such deals are focused on acquisitions, followed by distribution agreements and strategic alliances. In May 2023, GeminiBio signed an agreement with Asahi Kasei Bioprocess America to improve biomanufacturing process by using latter’s inline buffer management system, MOTIV.

Key Drivers for the Buffer Preparation Systems Market

The growing demand for biological buffers is one of the key drivers for the buffer manufacturing systems market. In addition, the need for automated buffer preparation systems is expected to drive the buffer manufacturing market size during the forecast period.

Market Size of Buffer Manufacturing / Buffer Preparation Systems 

Driven by the growing demand for buffers and challenges associated with buffer preparation and buffer storage, the buffer manufacturing systems market is anticipated to grow at a CAGR of ~10% in the forecast period. It is worth highlighting that more than 65% of the current market share is captured by players based in North America and Europe.

Key Companies in the Buffer Manufacturing Market

Examples of the key players in this industry (the complete list of players is available in the full report) include Asahi Kasei, Avantor, Canvax, Cytiva, Lonza, Merck, Pall Corporation, Thermo Fisher Scientific and Uniogen.

Scope of the Report

The report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry, across different regions. Amongst other elements, the report includes:

• An executive summary of the insights captured during our research, offering a high-level view on the current state of the buffer preparation systems market and its likely evolution in the mid-to-long term.
• A general overview of buffer manufacturing, along with information on conventional and novel methods of buffer manufacturing. In addition, the chapter highlights the challenges associated with buffer manufacturing, advantages of outsourcing buffer manufacturing and key considerations while selecting an outsourcing partner. Further, it concludes with a discussion on future perspectives in this market.
• A detailed assessment of the overall market landscape of buffer preparation / manufacturing systems, based on several relevant parameters, such as type of system (whole unit and buffer tank), mode of operation (automatic and manual), scale of operation (preclinical, clinical and commercial), vessel fabrication material(s) (stainless steel, polymer and others), system mobility option (mobile and stationary), feature(s) of buffer manufacturing system (conductivity sensor, pH sensor, temperature sensor, pressure sensor, filter and others), integrated technique(s) (chromatography, filtration and others), buffer manufacturing process (batch and continuous), type of buffer form(s) (conditioned buffers and diluted buffers) and bioprocessing method (downstream and upstream). In addition, it provides an in-depth analysis of the buffer manufacturing system providers, based on their year of establishment, company size, location of headquarters and most active players (in terms of number of buffer manufacturing systems offered).
• A comprehensive product competitiveness analysis of buffer manufacturing systems, based on developer power (in terms of number of years of experience of a company) and product competitiveness (in terms of type of system, mode of operation, scale of operation, vessel fabrication material(s), system mobility option, feature(s) of buffer manufacturing system, integrated technique(s), buffer manufacturing process, buffer form(s), bioprocessing method, availability of GMP manufacturing and single use components).
• Elaborate profiles of key players (shortlisted based on proprietary criterion) engaged in the development of buffer preparation systems, including a brief overview of the company, details related to product portfolio, recent developments and an informed future outlook. 
• A detailed assessment of the overall market landscape of buffer manufacturing service providers, based on several relevant parameters, such as year of establishment, company size, location of headquarters, location of facilities, scale of operation (pre-clinical, clinical and ready-to-use buffers), buffer(s) manufactured (acetate buffers, amino acid buffers, borate buffer, carbonate / bicarbonate buffers, citrate buffers, potassium buffers, phosphate buffers, sodium buffers and other buffers), buffer formulation (liquid and powder), buffer packaging format (bags, bioprocess containers, bottles, polymer drums, and other types of packaging), compatible biologic(s) (antibody, cell therapy, enzyme, nucleic acid, peptide / protein, vaccine and other types of compatible biologics), application area(s) (drug development, drug manufacturing, purification, research and other application area), type of service (fill / finish and packaging, formulation development, manufacturing, process development, scale-up and other types of services) and most active players (in terms of number of facilities and number of services).
• A comprehensive company competitiveness analysis of buffer manufacturing service providers based in North America, Europe and Asia, based on supplier power (in terms of number of years of experience of a company) and company competitiveness (in terms of number of facilities, location of facilities, scale of operation, type of buffer(s) provided, buffer(s) manufactured, buffer formulation, buffer packaging format, compatible biologic(s), application area(s), type of service and availability of GMP manufacturing).
• Elaborate profiles of key companies (shortlisted based on proprietary criterion) providing buffer manufacturing services including a brief overview of the company, key executives, company portfolio, recent developments and an informed future outlook. 
• A detailed analysis of partnerships inked between stakeholders engaged in this industry, since 2017, based on several relevant parameters, such as year of partnership, type of partnership (acquisitions, commercialization agreements, development agreements, distribution agreements, manufacturing agreements, product development agreements, product distribution agreements, product integration and distribution agreements, product / technology installation agreements, research and development agreements, service agreements, strategic alliances, and others, type of partner, company size, most active players (in terms of the number of partnerships signed) and regional distribution of partnership activity in this domain.

One of the key objectives of this research report was to estimate the current opportunity, market size and the future growth potential of the buffer manufacturing market during the forecast period. We have provided an informed estimate on the likely evolution of the market in mid-to-long term for the period, 2023-2035. Our year-wise projections of the current and future opportunity have further been segmented based on relevant parameters, such as scale of operation (preclinical / clinical and commercial), and key geographical regions (North America, Europe, Asia and Rest of the World). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios of the industry’s evolution.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What are buffer preparation systems? 

Answer: A buffer preparation system prepares buffers to be used in various stages of recovery operations. The buffer prep system contains equipment used for large scale and small scale buffer preparation.

Question 2: What is in line dilution?

Answer: Inline dilution is an added capability to chromatography systems that brings multiple process streams together to dilute or blend a solution at the point of use. Buffer and process solutions are mixed with water to meet the targeted final buffer composition.

Question 3: What is the need for novel buffer preparation systems? 

Answer: Buffer management / manufacturing is a complex process that requires extensive cost, floor space, trained labor and is prone to human errors. To overcome these challenges, novel buffer preparation systems have been developed that offer several advantages, including automation of buffer manufacturing process, shortened manufacturing timeless, requirement of less floor space and production of high quality buffers. 

Question 4: How many players have developed / are currently engaged in the development of buffer preparation systems?

Answer: Presently, close to 30 companies are engaged in the development and distribution of proprietary buffer preparation systems worldwide. Some of the established players engaged in this industry include Asahi Kasei, Avantor, Cytiva, Genentech, Merck, Pall Corporation, Parker Hannifin, Sartorius and Thermo Fisher Scientific. 

Question 5: What types of partnerships are most common in the field of buffer preparation systems?

Answer: Acquisitions are the most common types of partnerships inked by stakeholders that are engaged in the development and distribution of proprietary buffer preparation systems, followed by strategic alliances and distribution agreements.

Question 6: How many players provide services related to buffer manufacturing?

Answer: Presently, more than 40 players located across the globe claim to provide services related to buffer manufacturing to pharmaceutical companies, research institutions and other end users.

Question 7: What is the likely growth rate (CAGR) of buffer preparation systems market?

Answer: The buffer manufacturing systems market is expected to grow at a CAGR of ~10% during the forecast period.

Question 8: Which region has the highest market share in the buffer manufacturing market?

Answer: Currently, North America is expected to capture the maximum share of the buffer manufacturing systems market. Further, Asia is likely to grow at a considerable pace during the forecast period.