Bioprocess Analyzers Market – By Product, By Analysis Type, By Application, By End-use – Global Forecast, 2024 – 2032

Bioprocess Analyzers Market Size

The global bioprocess analyzers market size was valued at around USD 2 billion in 2023 and is estimated to grow at 11.5% CAGR from 2024 to 2032. Bioprocess analyzers are specialized instruments designed to monitor and analyze various parameters involved in bioprocesses, which utilize living cells or their components, such as enzymes or organelles, to produce desired products. These analyzers are critical for optimizing, controlling, and ensuring the quality and efficiency of biotechnological processes, particularly in the production of biopharmaceuticals, biofuels, and other bioproducts.
 

The rising demand for biopharmaceutical products is a key driver of market growth. With a growing global population and an increasing prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders, the need for advanced biopharmaceutical treatments is intensifying. For example, noncommunicable diseases account for 41 million deaths annually, significantly impacting low- and middle-income countries. This has resulted in a greater emphasis on developing biologics, vaccines, and therapeutic products. Consequently, the role of bioprocess analyzers in monitoring and optimizing complex manufacturing processes becomes essential in ensuring high-quality biopharmaceutical production.
 

Moreover, advancements in biotechnology have led to significant innovations in bioprocessing, further driving the demand for advanced and automated bioprocess analyzers. The rising demand for biosimilars, due to their cost-effectiveness compared to biologics, also boosts the market. Government initiatives and funding are further contributing to advancements in this technology, underscoring the importance of bioprocess analyzers in the biopharmaceutical industry.
 

Bioprocess Analyzers Market Trends

The increasing demand for biosimilars, driven by their cost-effectiveness compared to expensive biologics, is significantly contributing to the growth of the market. The production of biosimilars, used in the treatment of diseases like cancer, rheumatoid arthritis, and diabetes, requires advanced bioprocessing technologies for consistent and efficient production.
 

• Biosimilars are highly similar to approved reference biologics, requiring rigorous manufacturing processes to ensure quality and efficacy. This necessitates the use of advanced bioprocess analyzers to monitor and control production parameters, ensuring compliance with stringent regulatory standards.
   
• Regulatory agencies like the FDA and EMA have stringent requirements for biosimilar approval, increasing the demand for bioprocess analyzers that provide accurate and reliable data on product quality.
   
• For example, data from the National Institutes of Health (NIH) reveals that in 2021, the EMA approved 55 biosimilars out of 65 marketing authorization applications. Similarly, the FDA approved 26 biosimilars, with 11 currently available on the U.S. market. This high rate of approval highlights the critical need for precise and reliable analytical tools in the development and production of biosimilars.
   
• Furthermore, the approaching patent expiries of many blockbuster biologics offer opportunities for the development of biosimilars. As the industry seeks to rapidly and efficiently produce these alternatives, the demand for advanced bioprocess analyzers has increased. These tools are essential for ensuring that biosimilars meet the high-quality standards required for successful market entry.
   

Bioprocess Analyzers Market Analysis

Based on product, the market is segmented into instruments and consumables & accessories. The consumables & accessories segment dominated the market with the largest revenue of USD 1.1 billion in 2023 and is expected to grow at a lucrative CAGR of 11% over the forecast period.
 

• Automation and continuous bioprocessing are driving demand for analyzer-compatible consumables. Key components include disposable sensors, sample tubes, and filters for real-time monitoring, enhancing process efficiency.
   
• For instance, Thermo Fisher Scientific’s Nalgene Sample Tubes are specifically designed for automated sampling systems, offering high-throughput compatibility and reducing manual intervention, thus further boosting the efficiency of continuous processes.
   
• Further, with the evolution of bioprocessing technologies and the increasing complexity of biologics production, there is also a growing demand for advanced consumables, including specialized membranes for chromatography and high-performance analytical reagents.
   
• These ongoing advancements and the rising complexity of biologics production are key factors fuelling the demand for bioprocess analyzer consumables and accessories.
   

Based on analysis type, the bioprocess analyzers market is segmented into substrate analysis, metabolite analysis, and concentration detection. The concentration detection segment dominated the market with the largest revenue of USD 1.1 billion in 2023 and is expected to grow at a lucrative CAGR of 11.6% over the forecast period.
 

• Biologics production, including monoclonal antibodies and vaccines, requires precise measurements of proteins, metabolites, pH levels, dissolved oxygen concentration, and cell densities. This necessity increases demand for accurate concentration detection analyzers, which are crucial for optimizing yield, ensuring product consistency, and meeting regulatory standards.
   
• The adoption of continuous and real-time bioprocessing enhances the need for these analyzers. Real-time concentration detection enables rapid data acquisition, allowing for timely adjustments during production to maintain optimal conditions.
   
• Additionally, the growing trend towards personalized medicine and the development of complex biologics necessitate highly specific concentration measurements. These measurements are crucial for tailoring treatments to individual patients, adding to the demand for precise analyzers.
   
• Therefore, these factors are expected to augment segmental growth.
   

Based on application, the bioprocess analyzers market is segmented into antibiotics, recombinant proteins, biosimilars, and other applications. The antibiotics segment held a significant revenue share of 30.8% in 2023 and is expected to grow at a CAGR of 10.2% over the forecast period.
 

• Antibiotic production relies on complex microbial fermentation, which is sensitive to environmental conditions. These conditions affect the microbe’s growth and produce antibiotics. Bioprocess analyzers use sensors and probes to monitor these conditions closely. This allows for quick adjustments to maintain optimal conditions, ensuring high-quality products.
   
• Efficiency in antibiotic production further relies on maintaining optimal fermentation conditions, such as balanced oxygen levels, precise nutrient feed, and controlled temperature. Advanced bioprocess analyzers automate these adjustments, reducing the need for manual intervention and maximizing production yields.
   
• Further, contamination risks, a major concern in antibiotic production, can lead to reduced yields or even batch failure. Bioprocess analyzers help mitigate these risks by enabling sterile sampling and real-time analysis, allowing early detection of any deviations that could compromise the process.
   
• Moreover, tools such as automated samplers and spectrophotometers enable quick analysis of critical parameters, allowing for faster and more efficient antibiotic production. These tools facilitate prompt and accurate adjustments, improving overall productivity and resource utilization during fermentation, thereby driving market growth.
   

Based on end-use, the bioprocess analyzers market is segmented into biopharmaceutical companies, CROs & CMOs, research & academic institutes, and other end-users. The biopharmaceutical companies segment dominated the market with the largest revenue of USD 904.4 million in 2023 and is expected to grow at a lucrative CAGR of 11.3% over the forecast period.
 

• The growing complexity of biologics and personalized medicines is driving biopharmaceutical companies to adopt advanced bioprocess analyzers to enhance production efficiency, improve product quality, and ensure regulatory compliance.
   
• To stay competitive, these companies must maximize productivity and control costs, which bioprocess analyzers facilitate by offering continuous optimization of fermentation and cell culture processes through detailed insights into cellular metabolism and nutrient consumption.
   
• Further, the growing demand for personalized medicines and complex biologics means biopharmaceutical companies must innovate and scale efficiently. Bioprocess analyzers offer scalable solutions that support both small-scale R&D and full-scale manufacturing, ensuring a smooth transition while maintaining quality and efficiency.
   
• The drive for rapid development and scale-up of new therapies further emphasizes the need for analyzers that support faster and more reliable process optimization, such as high-throughput screening systems and continuous bioprocessing technologies.
   

The North America bioprocess analyzers market is forecasted to reach USD 2 billion by 2032. The U.S. dominated the North American market with the largest revenue of USD 712.7 million in 2023.
 

• The rising prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders is driving demand for biologics and personalized medicines, which in turn boosts the need for bioprocess analyzers. These tools are crucial for enhancing production efficiency, ensuring product quality, and maintaining regulatory compliance in the development of new therapies.
   
• For instance, according to the Global Cancer Observatory, approximately 89.1% of cancer cases in 2022 were reported in the U.S., while Canada accounted for about 10.9% of these incidences.
   
• Moreover, the growing demand for advanced therapies, personalized medicine, and biologics in North America fuels the need for precise and efficient bioprocessing solutions. The focus on improving healthcare outcomes and addressing complex medical conditions drives the adoption of sophisticated bioprocess analyzers.
   
• The expansion of biomanufacturing capabilities in North America, driven by the need to scale up production of biologics and advanced therapies, further emphasizes the demand for high-performance bioprocess analyzers.
   

The bioprocess analyzers market in the UK is expected to experience significant and promising growth from 2024 to 2032.
 

• The Medicines and Healthcare products Regulatory Agency (MHRA) and other regulatory bodies provide clear guidelines for the approval of biopharmaceutical products, creating a stable environment for manufacturers.
   
• The UK's highly skilled workforce in science and engineering, supported by continuous professional development and diverse expertise in fields such as biochemistry and data science, fosters innovation and collaboration between academia and industry, positioning the country as a leader in the market.
   

Japan's bioprocess analyzers market is anticipated to witness lucrative growth between 2024 and 2032.
 

• Japan's regulatory framework is primarily governed by the Ministry of Health, Labour, and Welfare (MHLW) and executed through the PMDA. The approval process mandates manufacturers to strictly adhere to Good Manufacturing Practice (GMP) guidelines, ensuring both safety and efficacy.
   
• The Japanese government actively bolsters its biologics industry, modernizing the regulatory approval process for biosimilars. This move is anticipated to boost the demand for bioprocess analyzers. Japan's biosimilar regulations, established in March 2009, closely mirror those of the European Union (EU), prioritizing safety, efficacy, and quality.
   

The bioprocess analyzers market in Saudi Arabia is expected to experience significant and promising growth from 2024 to 2032.
 

• The growing focus on biotechnology and pharmaceutical industries in Saudi Arabia is driving demand for advanced bioprocess analyzers. Governments are investing in research and development facilities and biotechnology hubs to boost local production capabilities and innovation.
   
• For instance, initiatives such as Saudi Arabia's Vision 2030 and the UAE's National Innovation Strategy are designed to boost local industries, including biotechnology and pharmaceuticals, creating a favorable environment for the adoption of bioprocess analyzers.
   
• These efforts are expected to lead to an increased adoption of bioprocess analyzers as pharmaceutical and biotechnology firms seek to enhance their research, production efficiency, and regulatory compliance.
   

Bioprocess Analyzers Market Share

The market is highly competitive, featuring a mix of major global players and smaller to medium-sized companies vying for market share. A key aspect of market strategy involves the continuous introduction of innovations, such as advanced sensing technologies and integrated automation solutions. Notably, prominent industry players exert considerable influence in this dynamic landscape, often driving advancements through substantial investments in research and development.
 

Additionally, strategic alliances, acquisitions, and mergers play crucial roles in strengthening market positions and expanding global footprints amidst evolving regulatory landscapes, while a focus on sustainability and efficiency in bioprocessing further shapes the competitive landscape.
 

Bioprocess Analyzers Market Companies

Some of the eminent market participants operating in the Bioprocess Analyzers industry include:

• 4BioCell GmbH & Co. KG
• Agilent Technologies, Inc.
• Danaher Corporation
• Endress+Hauser Group Services AG
• Eppendorf AG
• F. Hoffmann-La Roche Ltd.
• Nova Biomedical
• Randox Laboratories Ltd.
• Sartorius AG
• Solida Biotech GmBH
• SYSBIOTECH GmbH
• Thermo Fisher Scientific Inc.
• Xylem Inc.
   

Bioprocess Analyzers Industry News:

• In January 2023, Nova Biomedical launched the BioProfile FAST CDV, a high-throughput, fully automated analyzer for viable cell density and viability, capable of delivering results in under 70 seconds with just a 100µL sample volume. This release marked a significant advancement in the field of cell analysis, providing laboratories with faster and more efficient options for viable cell testing.
   
• In May 2023, Cytiva, a subsidiary of Danaher Corporation, merged with Pall Corporation's life sciences division, expanding Cytiva's bioprocessing portfolio. The merger integrated Pall's biotech brands such as Allegro, Supor, and Pegasus with Cytiva's existing offerings like ÄKTA and Xcellerex. This move strengthened Danaher's leadership in life sciences by broadening its bioprocessing capabilities and accelerating therapeutic development.
   

The bioprocess analyzers market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments:

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Market, By Product

• Instruments
• Consumables & accessories

Market, By Analysis Type

• Substrate analysis
• Metabolite analysis
• Concentration detection

Market, By Application

• Antibiotics
• Recombinant proteins
• Biosimilars
• Other applications

Market, By End-use

• Biopharmaceutical companies
• CROs & CMOs
• Research & academic institutes
• Other end-users

The above information is provided for the following regions and countries:

• North America
  • US.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific 
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America 
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa 
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa