Biopharmaceuticals Manufacturing Consumables Testing Market Size, Share & Trends Analysis Report By Service (Compendial Testing, Laboratory Testing), By Raw Material Type (Excipients, API), And Segment Forecasts, 2018 - 2025

Report Overview

The global biopharmaceuticals manufacturing consumables testing market size to be valued at USD 709.92 million by 2025 and is expected to grow at a compound annual growth rate (CAGR) of 12.1% during the forecast period. Successful and efficient biopharmaceutical manufacturing is largely dependent on the purity and quality of consumables used during production. With growing issues pertaining to the quality of novel therapeutics such as poor solubility, increase in molecular sizes, and poor absorption properties, there is a rise in focus on exploring the various attributes of excipients and other raw materials.

Establishing identity, purity, and quality of raw/starting material is a crucial step in biopharmaceutical manufacturing. This is because any variation in excipient, additives, or API profile with respect to impurity, particle size, dissolution characteristics, and other factors can drastically influence the functioning and performance of the final product.

Quality standards have gradually evolved to support biologics production. Constant improvement in regulatory standards for biologic production also encompasses the use of proper raw materials and their qualification assessment. Regulations and guidance standards with respect to region-specific pharmacopeia have also accelerated raw material investigation to meet the requirements of biopharma manufacturers.

Characterization of raw materials by vendors in co-operation and collaboration with players in the pharma and biopharmaceutical industry helps address issues associated with the manufacturing process, thereby facilitating the rapid launch of the final product in the market. These issues include the quality-by-design and bioavailability of products. 

Perpetual introduction of new technologies and advancements in existing technologies for efficient large molecule production is one of the key drivers of this market. While some advancements are solely focused on biopharmaceutical production, the industry is also witnessing technological innovations to support thorough quality check based processing, right from raw materials to finished drugs.

Technological advancements in analytical technologies have provided vendors with improved capabilities to test proteins, raw materials, cell lines, and other consumables used during the production of large molecules. Advancements in portable Raman spectroscopy methods is one of the significant developments in this market. Agilent Technologies is one of the companies offering products based on the principle of Raman spectroscopy.

Biopharmaceuticals Manufacturing Consumables Testing Market Trends

The increased focus of pharmaceutical companies to expand the biopharmaceutical drug pipeline is driving the growth of the market. The continuous expansion in mutations of microbes and viruses along with the rise of distinct types of diseases has pushed the biopharmaceutical and industrial sector to join forces with each other to innovate and develop new bio drugs. Testing the drug components is an essential step to check and ensure the quality and purity of consumables and further for its approval, thereby promoting the market growth.

The development of biopharmaceutical consumables is a complex process that requires continuous monitoring and testing of their safety, purity, and efficacy by professionals for successful development and compliance with regulatory requirements. To proceed with their early-stage drug products through the development process, many biopharmaceutical companies rely on professional services. Moreover, the lack of skilled professionals required on the ground of testing equipment hampers the industry's growth. In addition, the deployment of testing equipment for raw materials is associated with high costs which arise as a challenge to the growth of the market.

However, biopharmaceutical drugs are increasingly being used in all branches of medicine due to effective clinical treatment modalities. They utilize for treating a broad range of diseases, including metabolic disorders and cancer thereby increasing the drug demand. This has thus provided lucrative opportunities for the growth of the market.

Service Insights

There are various services offered in the biopharma sector to ensure the purity and safety of consumables. Compendial and multi-compendial laboratory testing accounted for the largest share in 2017 owing to the presence of numerous providers offering services in compliance with various compendia. Presence of region-specific pharmacopeias compels companies to perform full-monograph testing, which has been observed to be expensive, contributing to the high revenue of this segment.

Custom testing/customer proprietary testing witnessed the lowest market penetration in 2017. This is due to the presence of relatively fewer services in this segment. However, changing customer requirements and the need for specific analysis for excipients are expected to lend this segment a much-needed boost in the coming years.

Raw Material Insights

By raw material, the biopharmaceuticals manufacturing consumables testing market is segmented into formulation excipients, Active Pharmaceutical Ingredients (API), and compendial methods (EP / JP / USP) based vendor qualification program support. API investigation services accounted for the largest revenue share in 2017 whereas compendial methods-based vendor qualification program support is anticipated to grow at a lucrative pace in the coming years. 

API assessment is a routine testing process in biopharma manufacturing. However, API characterization for biologic molecules is relatively more difficult and time-consuming as compared to synthetic APIs.

Rapid growth of the biopharma industry has made it necessary to keep pace with changing or improving regulatory requirements for analysis of raw materials required during biologics manufacturing. As a result, final product manufacturers seek vendor qualification program support to validate if services offered by the vendor comply with compendial monographs. This has driven the segment for compendial methods-based vendor qualification program support.

Regional Insights

North America dominated the market in 2017 with respect to revenue owing to the presence of a substantial number of biopharmaceutical manufacturing facilities in the U.S. Furthermore, effective regulations pertaining to biopharmaceutical production and approval in the country have contributed to the large share of North America in the global market.

Asian countries, with China and India at the forefront, are expected to emerge as lucrative sources of revenue in the coming years. This is due to improving the biopharmaceutical industry in the region as well as a shift in the attention of international companies toward the Asian market for outsourcing options.

Key Companies & Market Share Insights

Alcami Corporation; Merck KGaA; Eurofins Scientific; Agilent Technologies; Charles River; Catalent, Inc.; Avomeen Analytical Services; BioSpectra; and Pace Analytical Services, LLC are some service providers engaged in providing services for consumables testing in the biopharmaceutical industry. Other key participants include Gibraltar Laboratories; Pacific BioLabs; Toxikon, Inc.; Activation Laboratories Ltd.; MabPlex Inc.; SGS SA; Pharmetric Laboratory; Albany Molecular Research Inc.; Avance Biosciences; Triclinic Labs; Lonza; Boston Analytical; and STERIS.

These service providers are engaged in strategic alliances with several prominent biopharmaceutical companies across the globe. They are making focused attempts to meet changing regulatory requirements and fulfilling rising demand.

Recent Developments

• In March 2022, Alcami Corporation announced the addition of a 3,800 ft² Non-GMP Formulation Development Laboratory (FDL). The addition is to support customers with clinical and preclinical development programs.

• In February 2022, Agilent Technologies Inc. acquired advanced artificial intelligence (AI) technology developed by Virtual Control.

• In December 2021, Alcami Corporation completed the acquisition of Masy Systems Inc. a cGMP Biostorage and pharma support services provider company.

• In November 2021, Eurofins Scientific acquired Modern Testing Services (MTS) an independent consumer products quality assurance company.

Biopharmaceuticals Manufacturing Consumables Testing Market Report Scope

Global Biopharmaceuticals Manufacturing Consumables Testing Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global biopharmaceuticals manufacturing consumables testing market report on the basis of service, raw material type, and region:

• Service Outlook (Revenue, USD Million, 2014 - 2025)

  • Laboratory Testing

    • Chemical Analysis Testing

    • Enzyme Testing

    • Stability Testing

    • Sterility Testing

    • Others

  • Custom Testing / Customer Proprietary Testing

  • Compendial & Multi Compendial Laboratory Testing

• Raw Material Type Outlook (Revenue, USD Million, 2014 - 2025)

  • Formulation Excipients

  • Active Pharmaceutical Ingredients (API)

  • Compendial Methods (USP / EP / JP) Based Vendor Qualification Program Support

• Regional Outlook (Revenue, USD Million, 2014 - 2025)

  • North America

    • The U.S.

    • Canada

  • Europe

    • Germany

    • The U.K.

  • Asia Pacific

    • China

    • India

  • Latin America

    • Brazil

  • Middle East & Africa

    • South Africa