Biopharmaceuticals Manufacturing Consumables Testing Market Size, Share & Trends Analysis Report By Service (Laboratory, Custom), By Raw Material (Formulation Excipients, API), By Region, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The global biopharmaceuticals manufacturing consumables testing market size was valued at USD 572.0 million in 2023 and is projected to grow at a CAGR of 12.3% from 2024 to 2030. 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.

The rising technological advancements in analytical techniques have provided vendors with improved capabilities to test cell lines, proteins, raw materials, and other consumables used in the manufacturing of large molecules. The development in medical instrumentation is fostering the growth of the biopharmaceuticals manufacturing consumables testing market. The increasing adoption of automation and digitization for testing procedures and to ensure minimal human errors has also contributed to the market growth.

Service Insights

The compendial & multi-compendial laboratory-testing segment accounted for the largest market share of 48.7% in 2023. This is attributed to the presence of numerous providers offering services in compliance with various compendia. The 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.

The custom testing/customer proprietary testing segment is projected to grow at the fastest CAGR of 13.4% over the forecast period. 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

The Active Pharmaceutical Ingredients (API) segment dominated the market in 2023. APIs are often mixed with excipients, also known as additives, to enhance the absorption, stability, and solution of the drugs. The use of API provides therapeutic advantages, drug products includes several elements such as coatings to aid in delivery, patient adherence, and stability. According to PhRMA Org, the U.S. manufactured 53% of the USD 85.6 billion worth of APIs used in medicines consumed in 2021. The collaboration between API and drug consumables helps effectively to meet healthcare demands and improve patient results.

The compendial methods (USP / EP / JP) based vendor qualification program support segment is expected to register the fastest CAGR during the forecast period. Compendial methods are often optimized and validated, ensuring the most accurate and précised result. It involves using set standards in pharmacopeia to evaluate raw materials. The utilization of USP standards allows hospitals to work with assurance and minimal chances of inaccurate outcomes.

Regional Insights

North America biopharmaceuticals manufacturing consumables testing market dominated the market in 2023 owing to the presence of a substantial number of biopharmaceutical manufacturing facilities in the region. The continuous development in research and development industry is driving the demand for testing of consumables, and making the region a global hub for biopharmaceutical manufacturing industry.

U.S. Biopharmaceuticals Manufacturing Consumables Testing Market Trends

The U.S. biopharmaceuticals manufacturing consumables testing market dominated the North America market with a share of 83.1% in 2023 due to the development of advanced analytical equipment and methods, which leads to improvement in precise assessment of goods and testing capacities.

Europe Biopharmaceuticals Manufacturing Consumables Testing Market Trends

The Europe biopharmaceuticals manufacturing consumables testing market identified as a lucrative region in 2023 due to the strong establishment of biopharmaceutical sector including leading global pharmaceutical companies such as AstraZeneca, Novartis, and others.

The UK biopharmaceuticals manufacturing consumables testing market is expected to grow rapidly in the coming years. Increased focus on product quality and patient safety has resulted in thorough examination of the manufacturing process, including consumables. This emphasizes the importance of comprehensive testing to reduce risks. Various pharmaceutical companies are outsourcing consumable testing to specialized labs, which is propelling the market expansion.

Asia Pacific Biopharmaceuticals Manufacturing Consumables Testing Market Trends

Asia Pacific is witnessing a surge in biopharmaceutical manufacturing, driven by growing patient population, rising prevalence of chronic diseases, and rising R&D investments. The region provides a strong edge in terms of labor competitiveness when compared to other countries

Key Biopharmaceuticals Manufacturing Consumables Testing Company Insights

Some key companies in biopharmaceuticals manufacturing consumables testing market include Alcami Corporation, Merck KGaA, Catalent, Inc, Charles River Laboratories., and others. These service providers have formed strategic partnerships with various well-known biopharmaceutical companies worldwide. The companies are putting in concentrated effort to comply with evolving regulatory needs and satisfy increasing demand.

• Alcami Corporation provides pharmaceutical development and manufacturing services to small and mid-size pharmaceutical and biotechnology companies globally. The main services provided by the company involve API development and manufacturing, clinical and commercial finished dosage form manufacturing, solid-state chemistry development, packaging and stability services, formulation development, and commercial finished dosage form manufacturing, packaging and stability services, as well as analytical development and testing services.

Biopharmaceuticals Manufacturing Consumables Testing Market Report Scope

Global Biopharmaceuticals Manufacturing Consumables Testing Market Report 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 2018 to 2030. For this study, Grand View Research has segmented the global biopharmaceuticals manufacturing consumables testing market report based on service, raw material, and region.

• Service Outlook (Revenue, USD Million, 2018 - 2030)

  • Laboratory Testing

  • Custom Testing / Customer Proprietary Testing

  • Compendial & Multi Compendial Laboratory Testing

• Raw Material Outlook (Revenue, USD Million, 2018 - 2030)

  • Formulation Excipients

  • Active Pharmaceutical Ingredients (API)

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

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • KSA

    • UAE

    • South Africa

    • Kuwait