The bioprocess validation industry will be valued at USD 535.87 million by 2025 end. As per FMI's analysis, bioprocess validation will grow at a CAGR of 9.20% and reach USD 1,187.51 million by 2035.
In 2024, the industry experienced the rapid adoption of single-use equipment and modular biomanufacturing as pharma manufacturers sought flexibility and cost savings.
Key Metrics
| Metrics | Values |
|---|---|
| Industry Size (2025E) | USD 535.87 million |
| Industry Value (2035F) | USD 1,187.51 million |
| Value-based CAGR (2025 to 2035) | 9.20% |
Regulatory bodies (FDA, EMA) increased data integrity demands, compelling companies to invest in digital validation software (e.g., AI-based analytics). The trend towards outsourcing accelerated, with CMOs adding validation services to address the demand for mRNA therapies and biosimilar. Most significantly, Asia-Pacific saw the rise as a hotspot destination with India and China investing in local validation facilities to cut on Western CMOs. The industry will reach beyond USD 535.87 million by 2025, propelled by:
By 2035, the industry will be close to USD 1.2 billion in revenues, with customized medicines and decentralized production requiring real-time validation solutions. Digital transformation laggards risk non-compliance since regulators will focus on live monitoring as opposed to retrospective checks.
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(Q4 2024, n=500 stakeholders such as biopharma companies, CMOs, regulatory consultants, and CDMOs in the US, Western Europe, Japan, and South Korea)
Regional Variance:
ROI Perspectives:
Pain Points:
High Consensus:
Key Divergences:
Strategic Insight:
Final Takeaway:
| Countries /Regions | Key Policies, Regulations , & Mandatory Certifications |
|---|---|
| USA | 21 CFR Part 11 (Electronic Records Compliance) FDA Process Validation Guidance (2011) - Requires lifecycle approach (Stage 1-3) cGMP (21 CFR 210/211) - Mandatory for drug manufacturing PAT (Process Analytical Technology) Framework - Encourages real-time validation USP <1225> - Mandatory for analytical method validation |
| European Union | EU GMP Annex 1 (2023) - Strict sterile manufacturing rules EMA Process Validation Guidelines - Aligns with FDA but emphasizes risk-based approaches ISO 13485 - Required for medical device validation EudraLex Vol. 4 - Mandatory GMP compliance for biologics EU MDR (2017/745) - Impacts combination product validation |
| Japan | PMDA Validation Guidelines - Follows ICH Q7/Q8/Q9/Q10 JP GMP - Mandatory for local manufacturing Pharmaceuticals and Medical Devices Act (PMD Act) - Requires validation for biologics approval . ISO 9001 Certification - Often required for suppliers |
| China | China GMP (2010 Rev.) - Aligns with WHO/PIC/S NMPA Validation Guidelines - Requires 3-stage process validation GB/T 19001 (ISO 9001) - Mandatory for domestic manufacturers New Biologics Regulation (2023) - Stricter process control for biosimilars |
| South Korea | K-GMP - Mandatory for all drug manufacturers MFDS Validation Guidelines - Follows ICH & FDA standards ISO 13485 - Required for medical device validation MFDS Advanced Therapy Guidelines (2024) - Special validation for cell/gene therapies |
| India | Schedule M (GMP) - Mandatory for pharma/biotech firms WHO-GMP Certification - required for exports CDSCO Process Validation Guidelines - Follows US/EU standards Biologics License (BLA) - Requires full process validation . |
Biopharma companies and tech-savvy CMOs stand to gain the most, while falling behind traditional manufacturers face compliance setbacks and lost orders. The USA and Europe are the leaders in innovation, with Asia lagging in adopting cost pressure, thus creating a two-speed industry.
Drive AI & Digital Validation Adoption
Action: Leverage AI-based process analytics (e.g., real-time monitoring, predictive sterility assurance) and cloud validation platforms to reduce compliance timelines by 30-50%. Give highest priority to collaboration with FDA/EMA-conformant digital validation partners (e.g., Synthace, Sartorius) to future-proof your operations.
Dominate Outsourcing with Hybrid CMO Partnerships
Action: Partner with high-compliance US/EU CMOs/CDMOs strategically to capture demand for biologics while negotiating cost-optimized Asian partners for modular validation. Create validation-as-a-service (VaaS) models to trap mid-tier biotechs circumventing in-house expenses.
Succeed in Sustainability-Driven Validation
Action: Leader in green validation technology (i.e., paperless process control, low-power cleanroom monitoring) to address EU carbon regulations and secure ESG-driven customers. Invest in sustainable single-use system (SUS) validators or forfeit share to environmentally certified competitors.
| Risk | Probability/Impact |
|---|---|
| Regulatory Non-Compliance Due to Evolving Standards (e.g., FDA/EMA updates, new Annex 1 enforcement) | High |
| AI/Data Integrity Failures in Digital Validation (e.g., flawed algorithms, cybersecurity breaches) | Medium |
| Supply Chain Disruptions for Single-Use Systems (SUS) (e.g., material shortages, geopolitical delays) | Medium |
| Priority | Immediate Action |
|---|---|
| Deploy AI-Driven Validation Pilots | Partner with Sartorius/ Synthace to implement 2 - 3 AI-powered validation pilots (e.g., real-time sterility monitoring) by Q2 2025. Target 15% faster release times for high-value biologics. |
| Secure Strategic CMO Alliances | Negotiate exclusive validation partnerships with top-tier CMOs (e.g., Lonza , Catalent ) by Q3 2025, focusing on mRNA/cell therapy clients. Include shared-risk pricing models to lock in contracts. |
| Launch Green Validation Initiative | Develop sustainability-certified validation protocols (e.g., paperless workflows, low-energy cleanrooms) and pilot with 3 EU biotech’s by Q4 2025 to meet EMA Annex 1 eco-requirements. |
To stay ahead, companies to leverage the USD 1.2B industry opportunity through 2035, shift now to AI-facilitated validation-as-a-service (VaaS)-collaborating with CMOs to provide turnkey, FDA/EMA-governance compliant platforms cutting time-to-market for gene therapies and biosimilar.
Differ by including sustainability audits (e.g., carbon-free validation processes) in order to satisfy EU Annex 1 and USA ESG investor requirements while acquiring niche players in single-use system validation in order to control supply chains.
Redirect 20% of R&D into predictive analytics or risk losing market share to tech-first competitors such as Sartorius. This transforms your 3-year plan from a tools vendor to a compliance-to-commercialization enable with 30% higher margins.
Extractable & Leachable (E&L) Testing is the most common of these tests, especially in the biopharmaceutical and medical device sectors. This is due to the fact that E&L testing is required for regulatory purposes and is essential for patient safety-it detects harmful chemical impurities that can leach from packaging, single-use systems, or manufacturing equipment into drugs.
With the rapid adoption of single-use bioprocessing technologies (e.g., disposable tubing, bags), E&L testing demand has increased, as trace impurities may either destabilize a drug or initiate toxicological risks. Though viral clearance and residual testing are needed for certain biologics, E&L is needed across the board, from mRNA vaccines to monoclonal antibodies, making it a non-negotiable, high-growth segment.
Process Qualification (PQ) is the most prevalent step in bioprocess validation, being the pivotal link between theoretical design and operational practice. It takes center stage in industry attention due to the fact that PQ gives the ultimate proof that a manufacturing process reliably yields products with predetermined quality characteristics-a requirement non-negotiable for FDA/EMA approvals. In contrast to Process Design (upstream R&D) or Continued Process Verification (real-time monitoring), PQ gives the actionable information necessary for regulatory filing and commercialization.
Outsourced bioprocess validation is more prevalent than in-house validation, especially amongst small-to-midsize biotech’s as well as large pharma firms, because of its capacity for delivering regulatory savvy, cost effectiveness, and scale without requiring expensive capital investments into specialized infrastructure and staff.
The rigorous and dynamic compliance demands of agencies such as the FDA and EMA render outsourcing to specialized CROs/CDMOs a strategic decision, as these collaborators provide up-to-date validation protocols, quicker turnaround times (essential for speeding drug approvals), and access to cutting-edge technologies such as AI-based analytics.
| Countries | CAGR |
|---|---|
| USA | 9.8% |
| UK | 8.9% |
| France | 8.5% |
| Germany | 9.5% |
| Italy | 7.8% |
| South Korea | 10.2% |
| Japan | 7.2% |
| China | 11.5% |
The USAindustry is expected to grow at 9.8% CAGR, which is at the forefront globally because of the strict FDA regulations and sophisticated biologics manufacturing.
The industry is challenged by high compliance costs and a shortage of skilled labor but retains dominance in cutting-edge therapies such as gene editing and mRNA vaccines. Growth is driven by ongoing process validation adoption and the growing biosimilars industry, making the USA the standard for worldwide validation guidelines.
The UK industry is expected to grow at 8.9% CAGR, reconciling post-Brexit MHRA rules with global standards. Cell therapy validation, particularly viral clearance testing, is a driver of demand backed by companies such as Oxford Biomedica. Environmentally friendly validation protocols are gaining ground, but regulatory ambiguity and funding constraints limit expansion versus EU counterparts.
The UK continues to be a center for cutting-edge therapies but is increasingly subject to competition from European CMOs. Strategic prioritization areas are ATMPs and digital validation tools to keep pace in the international biologics industry.
Germany's industry is expected to grow at 9.5% CAGR, succeeding on the strength of its strong CDMO network and EMA-compliant regulatory environment. As Europe's validation leader, it is a champion in mRNA vaccine manufacturing (BioNTech) and Industry 4.0 applications, such as IoT-based validation. The industry enjoys robust government-academia-industry collaboration but is impacted by single-use system supply chain disruption.
Germany leads the world in continuous manufacturing validation and remains a leader in advanced therapy validation, especially for EU approval. Future expansion is based on digital transformation and sustainable validation practices.
France's industry is expected to grow at 8.5% CAGR, which is powered by its robust vaccine and biosimilar industry (Sanofi, Valneva). Recent EU GMP Annex 1 updates have increased the demand for sterile process validation, favoring CMOs such as Eurofins. The industry excels in extractables/leachables testing but is behind Germany in digital adoption.
High labor and tax costs constrain outsourcing expansion, although government support aids biopharma innovation. France is a vital contributor to the validation of vaccines in Europe, with increasing scope in ATMPs and environmental validation technologies.
Italy's industry (7.8% CAGR) centers on biosimilars validation owing to national cost-containment measures. Companies such as MolMed outsource EU CMOs for sophisticated testing because of low domestic capacity. Inefficient regulatory reforms and insufficient R&D spending limit industry development, though prospects are present in sterile manufacturing validation.
The industry is niche but enjoys EU harmonization activities. Growth opportunities in the future reside in specialized therapy validation and government incentives for biopharma research.
South Korea's industry is expected to register 10.2% CAGR during the forecast period, which is driven by biologics export (Samsung Biologics) and cutting-edge automation. Public sector initiatives such as Biovision 2025 drive innovation, but there are shortages of talent among smaller companies. The market is a leader in biosimilar validation and is increasingly embracing continuous manufacturing strategies.
Areas of strategic emphasis involve digital validation software and growing global CMO collaborations to solidify its rank as Asia's second-largest center after China.
Japan's industry is expected to grow at 7.2% CAGR, which is one of the conservative regulatory strategies and high in-house validation favorability. The slow uptake of digitalization by the PMDA and an aging workforce place limitations on growth, although cell/gene therapy validation (CAR-T therapies) is a growth opportunity. Hybrid validation models merging conventional GMP with new technologies are appearing. Cost forces some to outsource to Korean CMOs, yet all major pharma (Takeda, Astellas) have in-house capacity for IP protection.
China's red-hot industry is expected to register 11.5% CAGR, which drives world growth via NMPA reforms and biologics growth (WuXi Biologics). The booming demand for mRNA and biosimilar qualification is building a $500M+ domestic industry, although IP issues discourage some foreign collaborations. Government programs such as "Made in China 2025" are driving single-use system growth.
The industry is challenged by talent shortages but is quickly becoming the world center for biosimilar qualification. Strategic alliances with Western companies are propelling technology transfer and quality enhancement.
The market is anticipated to reach USD 535.87 million in 2025.
The market is predicted to reach a size of USD 1,187.51 million by 2035.
Prominent players include Eurofins Scientific, Inc., Sartorius AG, Merck KGaA, Thermo Fisher Scientific Inc., Lonza, Danaher Corporation, Charles River Laboratories, SGS S.A., Toxikon Corporation, Cobetter Filtration Equipment Co., Ltd., and others.
Extractable & leachable testing is being widely used.
China, expected to grow at 11.5% CAGR during the study period, is poised for the fastest growth.
With respect to the testing type, it is classified into extractable & leachable testing, bioprocess residuals testing, viral clearance testing, filtration & fermentation systems testing, and others.
In terms of stage, it is divided into process design, process qualification, and continued process verification.
In terms of mode, it is divided into in-house and outsourced.
In terms of region, it is segmented into North America, Latin America, Europe, East Asia, South Asia, Oceania, and MEA.
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Bioprocess Validation Market
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