Bioanalytical Testing Services Market Forecasts to 2030 – Global Analysis By Type (Cell-Based Assays, Virology Testing, Method Development Optimization, Serology, Immunogenicity, Biomarker Testing, Pharmacokinetics Testing, Bioavailability Testing, Bioeq

Bioanalytical Testing Services Market Forecasts to 2030 – Global Analysis By Type (Cell-Based Assays, Virology Testing, Method Development Optimization, Serology, Immunogenicity, Biomarker Testing, Pharmacokinetics Testing, Bioavailability Testing, Bioequivalence Testing, Pharmacodynamics Testing and Other Types), Molecule (Small Molecule and Large Molecule), Workflow, Therapeutic, End User and By Geography

According to Stratistics MRC, the Global Bioanalytical Testing Services Market is accounted for $5207.3 million in 2023 and is expected to reach $116.38 million by 2030 growing at a CAGR of 12.2% during the forecast period. Bioanalytical testing is the term for the analytical process used to examine biological and biotechnological products. In the production of biotechnology and pharmaceuticals, analytical procedures are essential. Drug discovery, development, and commercialization all involve the use of bio analytical evaluation. The bio analytical testing services sector is a subset of the larger life sciences and healthcare sectors that focuses on the examination and testing of biological samples, such as tissues, blood, urine, and other bodily fluids, in order to gather important data for regulatory compliance, clinical diagnosis, and research. It is crucial to many industries, including biotechnology, medicines, environmental monitoring, food safety, and clinical research.

According to a report from the Indian Pharmaceutical Alliance (IPA), the Indian pharmaceutical industry was growing at a rate of 7–8% and is estimated to register USD 80–90 billion in annual revenue by 2030.

Market Dynamics

Driver

Rising adoption of the quality by design approach

Pharmaceutical companies are increasingly using the Quality-by-Design (QbD) concept, which has been widely embraced by regulatory bodies like the EMA and US FDA, to improve the quality of their products, the robustness of their manufacturing processes, and the productivity of their factories. With the release of ICH Q8 (R2) (pharmaceutical development), ICH Q9 (quality risk management), and ICH Q10 (pharmaceutical quality system), the QbD method in the pharmaceutical business has evolved throughout time. In the upcoming years, it is anticipated that the growing acceptance and use of the QbD approach among pharmaceutical and biopharmaceutical operations around the world will significantly contribute to the expansion of the global market.

Restraint

High operational costs

The market for bio analytical testing services is significantly constrained by high operational costs. These costs are required in order to hire highly skilled employees, maintain cutting-edge analytical equipment, and implement strict quality control procedures. The pricey equipment needed for bio analysis is frequently expensive to buy and keep up. Furthermore, high labour expenses are a result of the demand for specialised talent in sectors like chemistry, biology, and data processing. Smaller companies in particular may find it challenging to scale their businesses and make a profit from offering bio analytical testing services, and they may need to make continual investments to stay competitive and comply with industry standards and laws.

Opportunity

Emergence of advanced and versatile platforms

The emergence of sophisticated and flexible platforms that improve innovative methods has had an impact on the growth of bio analytical testing services. The discipline of bio analysis has advanced recently since new approaches in the sector are capable of handling any issues that can arise. These elements are anticipated to boost the industry's overall growth for bio analytical testing services. Prominent markets are implementing cutting-edge technologies, like dry blood spot technology, to measure pharmacokinetics because it has more benefits than other traditional methods. The dry blood spot method has a number of important advantages, including the need for a small processing sample, easy sample storage, reduced biohazard concerns, the lack of post-collection processing, and many more. Therefore, the presence of advanced technologies is simplifying the quantification process and thereby expected to increase the bio analytical testing services market growth during the forecast period.

Threat

Client dependence

The market for bio analytical testing services faces a serious challenge from client dependence. Services companies may be financially vulnerable if they rely excessively on a select group of important customers. However, a significant revenue shortfall could come from a key client shifting to another provider or reducing their testing requirements. It is crucial to reducing this danger to diversify the client base and retain solid client relationships through outstanding customer service and value-added services. By diversifying their clientele, businesses can reduce their exposure to the potential loss of a single customer and assure steadier, sustainable growth in the competitive bio analytical testing market.

Covid-19 Impact

The spread of COVID-19 has reduced the output of the industrial sectors, and as a result of its significant impact on several worldwide operations, there has been a rise in demand for effective vaccines, treatments, and other medical services. As a result, the market for bio analytical testing services saw an increase in demand during the epidemic. Healthcare providers relied on point of care services and screening techniques for early viral diagnosis in people. Additionally, the businesses have introduced cutting-edge methodologies and technology that have reduced processing time. The essential techniques include automated sample preparation, ultra-performance liquid chromatography, mass spectrometry, and others. Such advanced technologies as robotics and barcode systems have proved efficient during the pandemic.

The sample preparation segment is expected to be the largest during the forecast period

The sample preparation segment is estimated to hold the largest share. An essential step in the analysis process is sample preparation, which is an emerging area in the bio analytical testing services market. Before being tested or analysed, biological samples must be carefully and methodically prepared. Moreover, techniques for sample preparation include sample extraction, purification, concentration, and occasionally alteration. This component is essential for improving the sensitivity, specificity, and accuracy of analytical techniques and allowing the detection and quantification of small amounts of target compounds.

The virology testing segment is expected to have the highest CAGR during the forecast period

The virology testing segment is anticipated to have lucrative growth during the forecast period. The analysis and detection of viruses in biological samples is the primary focus of the virology testing component of the market. It is essential to clinical research, pharmaceutical development, and public health. The need for virology testing services has grown due to the persistent hazards posed by new viral illnesses and pandemics. This section is crucial for the management and prevention of infectious diseases because it uses a variety of techniques to diagnose and examine viral infections, including PCR, serology, and next-generation sequencing.

Region with largest share

North America commanded the largest market share during the extrapolated period due to the facilities available across the region and increasing investment for the R&D from US pharmaceutical titans. Additionally, pharmaceuticals are working very hard to create new medicines and they have developed over 1100 oncology treatments that are in various phases of clinical development. The business for bio analytical testing services is expanding across North America because of the presence of major market players like Pfizer.

Region with highest CAGR

Asia Pacific is expected to witness profitable growth over the projection period. A rise in investments made by organisations offering bio analytical testing services in the region, an increase in the number of companies adopting these services, and corporate and regulatory reforms are other factors driving the market in Asia Pacific. Small enterprises in China and India that are focused on building biologics pipelines, as well as an increase in the pace of adoption of cutting-edge technologies, like single-use technologies, by businesses that provide bio analytical testing services, have boosted the market.

Key players in the market

Some of the key players in the Bioanalytical Testing Services Market include Syneos Health, Intertek Group, Med pace, PPD, Inc., Euro fins Scientific, Laboratory Corporation of America, Pace Analytical Services, ICON plc, PRA Health Sciences , Charles River Laboratories International, Inc., WuXi App Tec, SGS SA Toxikon, Inc., IQVIA, Pharmaceutical Product Development, Frontage Labs, Covance Inc., Alta sciences, BioAgilytix Labs, Vipragen Biosciences and Bio needs India Private Limited.

Key Developments

In June 2023, ICON plc, one of the world leaders in CRO and healthcare intelligence, announced the release of its new ICON Digital Platform. The platform facilitates seamless integration of ICON site, patient, site, and sponsor services along with harmonized and customizable data delivery.

In June 2023, Syneos Health, one of the leading companies in biopharmaceutical solutions, announced a patient-centric partnership with uMotif, a clinical trial solutions organization. The collaboration is aimed at aiding the acceleration of clinical trials and introducing new therapies to patients via an end-to-end and more effective digital platform. This platform comprises robust Electronic Patient-reported Outcomes (ePRO) and Electronic Clinical Outcome Assessment (eCOA) capabilities

In May 2023, IQVIA a significant provider of advanced analytics, clinical research services, and technology solutions in the world, announced a strategic partnership RED, to battle against AIDS and the injustices that permit pandemics to thrive. This partnership supports laboratory system strengthening.

Types Covered
• Cell-Based Assays
• Virology Testing
• Method Development Optimization
• Serology, Immunogenicity
• Biomarker Testing
• Pharmacokinetics Testing
• Bioavailability Testing
• Bioequivalence Testing
• Pharmacodynamics Testing
• Other Types

Molecules Covered
• Small Molecule
• Large Molecule
• Other Molecules

Workflows Covered
• Sample Preparation
• Sample Analysis
• Other Workflows

Therapeutics Covered
• Hematology
• Neurology
• Metabolic Disorders
• Oncology
• Immunology
• Orthopedics
• Other Therapeutics

End Users Covered
• Pharma & Biotechnology Companies
• Contract Research Organizations
• Other End Users

Regions Covered
• North America
US
Canada
Mexico
• Europe
Germany
UK
Italy
France
Spain
Rest of Europe
• Asia Pacific
Japan
China
India
Australia
New Zealand
South Korea
Rest of Asia Pacific
• South America
Argentina
Brazil
Chile
Rest of South America
• Middle East & Africa
Saudi Arabia
UAE
Qatar
South Africa
Rest of Middle East & Africa

What our report offers
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements