Bio-Process Technology

Global Bio-Process Technology Market to Reach US$68.5 Billion by 2030

The global market for Bio-Process Technology estimated at US$34.7 Billion in the year 2024, is expected to reach US$68.5 Billion by 2030, growing at a CAGR of 12.0% over the analysis period 2024-2030. Biologics Safety Testing, one of the segments analyzed in the report, is expected to record a 11.7% CAGR and reach US$17.8 Billion by the end of the analysis period. Growth in the Cell Culture segment is estimated at 13.6% CAGR over the analysis period.

The U.S. Market is Estimated at US$9.4 Billion While China is Forecast to Grow at 16.1% CAGR

The Bio-Process Technology market in the U.S. is estimated at US$9.4 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$14.3 Billion by the year 2030 trailing a CAGR of 16.1% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 8.8% and 10.6% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 9.5% CAGR.

Global Bio-Process Technology Market – Key Trends & Drivers Summarized

Why Is Bio-Process Technology Central to the Manufacturing of Biologics, Advanced Therapies, and Next-Generation Biopharmaceuticals?
Bio-process technology forms the operational core of biopharmaceutical manufacturing, enabling the production of complex biologics—including monoclonal antibodies, recombinant proteins, vaccines, and cell and gene therapies—under tightly controlled, reproducible, and scalable conditions. It encompasses upstream (cell line development, fermentation, bioreactor culture) and downstream (filtration, chromatography, purification) processes that convert living cell systems into high-purity, therapeutically active products. As biologics continue to dominate new drug pipelines, bio-process technology has become a strategic enabler of therapeutic efficacy, compliance, and commercial scalability.

Unlike small-molecule production, biologics manufacturing is inherently variable, requiring sophisticated bioprocess controls, high-grade raw materials, and stringent environmental monitoring. The ability to maintain cell viability, ensure consistent expression yields, and preserve product quality across batches is paramount. Bio-process platforms are increasingly being tailored to specific therapy types, such as perfusion systems for continuous manufacturing, viral vector platforms for gene therapy, or closed-system bioreactors for CAR-T cell production—each with distinct performance and compliance demands.

As the industry shifts toward high-mix, low-volume production of personalized therapies, bio-process technology is adapting to enable smaller batch sizes, faster changeovers, and modular facility design. The convergence of bioprocess engineering, digital controls, and real-time analytics is allowing for greater process intensification and precision manufacturing, positioning bio-process technology as a linchpin of future-ready biologics infrastructure.

How Are Process Intensification, Digital Integration, and Single-Use Systems Reshaping Bio-Process Technology Platforms?
Process intensification is emerging as a key driver, with manufacturers adopting high-cell-density culture systems, perfusion bioreactors, and continuous downstream purification to reduce footprint, increase yield, and lower cost per gram. These strategies are being used to accelerate production timelines for critical biologics—including pandemic-response vaccines and rare disease therapies—without compromising quality or regulatory adherence. Continuous manufacturing is also enabling real-time process adjustments and shorter development cycles, a major advantage for time-sensitive clinical pipelines.

The integration of digital tools—such as PAT (Process Analytical Technology), model-based control systems, and AI-driven analytics—is transforming how bioprocesses are designed, monitored, and optimized. Digital twins, cloud-based batch records, and predictive maintenance platforms are supporting closed-loop feedback systems that enable early detection of process deviations and facilitate proactive decision-making. These tools are also strengthening regulatory documentation, reducing batch failures, and improving tech transfer outcomes across sites and CDMO partnerships.

Single-use bioprocessing systems continue to gain traction, particularly in upstream operations, due to their flexibility, reduced cleaning validation burden, and improved contamination control. Pre-sterilized disposable bioreactors, tubing sets, and filtration cartridges support rapid scale-up and scale-down operations, making them ideal for multi-product facilities and clinical manufacturing. As cost, sustainability, and waste management remain concerns, suppliers are advancing recyclable and hybrid single-use solutions to maintain the value proposition across both commercial and developmental settings.

Which Therapeutic Areas, Regional Ecosystems, and Manufacturing Models Are Accelerating the Evolution of Bio-Process Technology?
Monoclonal antibodies, biosimilars, vaccines, and emerging modalities such as RNA-based therapies and viral vector-based gene treatments are the primary application areas driving investment in bio-process technology. The complexity of these products demands tailored bioprocess configurations that ensure stability, potency, and batch-to-batch consistency across both clinical and commercial supply chains. With many of these therapies targeting immunological, oncological, and infectious disease indications, the demand for rapid, adaptive, and compliant manufacturing solutions continues to intensify.

North America and Western Europe remain the epicenters of innovation and investment, led by large-scale biomanufacturers, academic centers of excellence, and CDMOs offering high-spec infrastructure. Asia-Pacific—particularly China, India, and South Korea—is rapidly scaling capacity through government-backed biotech initiatives and localization strategies for biologics manufacturing. These regions are investing in modular GMP facilities, regional tech transfer centers, and integrated supply networks to strengthen bio-process technology access and sovereignty.

Hybrid manufacturing models combining in-house infrastructure with outsourced CDMO capacity are becoming standard, especially for companies managing multiple biologics pipelines. Flexible capacity deployment, end-to-end process development services, and co-investment in manufacturing innovation are reshaping the traditional make-or-buy calculus. As drug developers seek to derisk production and accelerate market entry, bio-process technology providers with scalable platforms, regulatory expertise, and global deployment capabilities are emerging as preferred strategic partners.

What Are the Factors Driving Growth in the Bio-Process Technology Market?
The bio-process technology market is expanding as demand for biologics, cell-based therapies, and precision biomanufacturing accelerates globally. Process scalability, flexibility, and quality assurance are now critical differentiators in bringing novel therapeutics to market faster, safer, and more cost-effectively.

Key growth drivers include the rise of continuous and intensified bioprocessing, widespread adoption of single-use systems, integration of digital monitoring and AI-driven process controls, and increasing global biomanufacturing capacity. Innovation in platform technologies and modular infrastructure is further amplifying commercial readiness across diversified therapeutic pipelines.

As biopharma companies race to deliver complex therapies under compressed timelines and heightened regulatory scrutiny, could bio-process technology become the foundational architecture for a new era of biologics manufacturing—where agility, precision, and resilience define global competitiveness?

SCOPE OF STUDY:

The report analyzes the Bio-Process Technology market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Product Type (Biologics Safety Testing, Cell Culture, Cell Expansion, Cell Line Development, Flow Cytometry, Tangential Flow Filtration, Flow Cytometry); Application (Antibiotics, Biosimilars, Recombinant Proteins, Other Applications); End-Use (Biopharmaceutical Companies, Contract Manufacturing Organizations, Academic Research Institute, Other End-Uses)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 32 Featured) -

• Advanced Instruments, LLC
• Becton, Dickinson and Company (BD)
• Bio-Rad Laboratories, Inc.
• Corning Incorporated
• Danaher Corporation
• Eppendorf AG
• GE Healthcare
• Genedata AG
• Lonza Group AG
• Merck KGaA
• MilliporeSigma (Merck Group)
• Nova Biomedical
• Pall Corporation
• Repligen Corporation
• Sartorius AG
• Siemens Healthineers AG
• Stämm Biotech
• Thermo Fisher Scientific Inc.
• Univercells SA
• ZETA GmbH

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

To our valued clients, we say, we have your back. We will present a simplified market reassessment by incorporating these changes!

APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

USA
CHINA
MEXICO
CANADA
EU
JAPAN
INDIA
176 OTHER COUNTRIES.

Leading Economists - Our knowledge base tracks 14,949 economists including a select group of most influential Chief Economists of nations, think tanks, trade and industry bodies, big enterprises, and domain experts who are sharing views on the fallout of this unprecedented paradigm shift in the global econometric landscape. Most of our 16,491+ reports have incorporated this two-stage release schedule based on milestones.

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