Biopharmaceutical Analytical Testing Services Market size is set to grow by USD 4.67 billion from 2024-2028, Increase in demand for mAbs boost the market, Technavio

NEW YORK, May 27, 2024 /PRNewswire/ -- The global biopharmaceutical analytical testing services market size is estimated to grow by USD 4.67 billion from 2024-2028, according to Technavio. The market is estimated to grow at a CAGR of  14.68%  during the forecast period. 

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Market Driver

Monoclonal antibodies (mAbs) are essential proteins developed to bind to specific antigens in the body. They are widely used to treat diseases like cancer, often in combination with radiotherapy or drugs for targeted therapy. The global market for mAbs is growing due to their use in immunotherapy and personalized medicine, which tailors treatments for specific populations. Increased R&D for diseases like Ebola and rheumatoid arthritis boosts demand. Quality control tests ensure the effectiveness of mAbs, driving the need for biopharmaceutical analytical testing services. Consequently, the rising demand for mAbs is expanding the biopharmaceutical testing market.

Market Challenges

• The development of new drug formulations is facing challenges due to complex molecules and chemical conjugates. Patient-specific cancer vaccines and other advanced treatments require novel test methods, leading to potential regulatory data discrepancies and increased approval times of 5-10 years.
  
  
• Innovations in molecular biology and combinatorial chemistry have produced drug candidates with poor solubility, complicating analysis and impacting bioavailability. Approximately 80-85% of pipeline molecules exhibit low solubility, necessitating higher doses and causing more side effects. Until industry guidelines for handling these new compounds are released, market growth may be hindered by these analytical and regulatory challenges.

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Segment Overview 

1. Service 
• 1.1 Bioanalytical
• 1.2 Method development and validation
• 1.3 Stability testing
• 1.4 Others
2. End-user 
• 2.1 Pharma and biotech companies
• 2.2 CROs
3. Geography 
• 3.1 North America
• 3.2 APAC
• 3.3 Europe
• 3.4 South America
• 3.5 Middle East and Africa

1.1 Bioanalytical-  The bioanalytical segment has shown notable growth, valued at USD 0.85 billion in 2017 and continuing to rise through 2021. This growth is driven by the increased use of biosimilars for medical conditions like diabetes and cancer. Contract research organizations, pharmaceutical companies, and bioanalytical labs are expanding services and investing in new laboratories. The outsourcing of R&D activities by pharmaceutical companies to focus on core areas is another key factor. Additionally, new product development and innovation are expected to boost demand, further driving market growth during the forecast period.

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Research Analysis

The Biopharmaceutical Analytical Testing Services Market is experiencing notable growth driven by the need for rigorous drug purity and safety assessments. Key services include bioanalytical testing, stability testing, and GMP lot release. Focus areas cover biologics, monoclonal drugs, and biosimilars, ensuring compliance with ICH guidelines.

Outsourcing analytical services to specialized laboratories enhances efficiency for biotech companies and supports the drug development pipeline. Critical tests for immunogenicity, pharmacokinetics, and biological potency ensure patient safety and product quality. This market also addresses the rising demand for tailored medicine, improving treatment outcomes for chronic and infectious diseases.

Market Research Overview

The Biopharmaceutical Analytical Testing Services Market is growing due to the rising demand for quality control in drug discovery and biotherapeutics. Services include drug release testing, impurity analysis, and examination of drug targets and metabolites in biological fluids like blood, plasma, serum, urine, and saliva. Ensuring the safety and efficacy of pharmaceuticals and therapeutics is critical, as poor-quality medicines can impact patient health. Comprehensive testing of tissue extracts and pharmaceutical components is essential. Funding systems support R&D efforts in this field, ensuring robust testing procedures to maintain high standards in biopharmaceuticals.

Table of Contents:

1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation

• Service
• Bioanalytical
• Method Development And Validation
• Stability Testing
• Others
• End-user
• Pharma And Biotech Companies
• CROs
• Geography
• North America
• APAC
• Europe
• South America
• Middle East And Africa

7 Customer Landscape
8 Geographic Landscape
9 Drivers, Challenges, and Trends
10 Company Landscape
11 Company Analysis
12 Appendix

About Technavio

Technavio is a leading global technology research and advisory company. Their research and analysis focuses on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions.

With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

Contacts

Technavio Research
Jesse Maida
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Email: [email protected]
Website: www.technavio.com/

SOURCE Technavio