Market Overview

The global biopharmaceuticals manufacturing consumables testing market size was valued at USD 554.36 Million in 2023 and is projected to grow at a CAGR of 11.9% from 2024 to 2032.

The global biopharmaceuticals manufacturing consumables testing market serves as a cardinal point for guaranteeing the safety, efficacy, and quality of biopharmaceutical products. Biopharmaceuticals, or such products as vaccines, monoclonal antibodies, and gene therapies, are revolutionizing healthcare, and this calls for the more stringent testing of consumables used in their manufacture. Consumables are a great deal, including filters, membranes, reagents, and single-use systems, which are integral to biopharmaceutical production, thus calling for strict quality control to provide regulation and avoid contamination risks. Testing consumables is therefore important to maintain consistency and reliability throughout the bio manufacturing pipeline-from upstream processing to final product packaging.

The biopharmaceutical industry has experienced rapid growth over the years due to technological improvements in biotechnology and personalized medicine, as well as the increasing use of biologics. With such growth, newer, advanced testing methods must be developed to ensure that production consumables meet increasingly stringent regulatory requirements for biopharmaceutical products. To ensure the safety of biopharmaceutical products, agencies, including the European Medicines Agency (EMA) and the U.S. Among these requirements are stringent criteria for quality control and testing procedures by the Food and Drug Administration (FDA). Testing consumables ensures that materials used in production do not contain impurities or compromise the quality of the end product.

Technological developments in consumables testing, which now include automation, high-throughput screening, and real-time monitoring, have further expanded the market. Cutting-edge technologies are increasingly adopted by manufacturers as a way of improving efficiency, preventing human error, and keeping pace with the latest developments in regulatory standards. In addition, the move towards single-use technologies in biopharmaceutical manufacturing has increased the need for strong testing solutions that can evaluate the performance, integrity, and sterility of disposable systems.

Market Dynamics - Market Drivers

Rising Demand for Biopharmaceuticals

• The rising demand for biologics, including monoclonal antibodies, vaccines, and gene therapies, is primarily fuelling the market for consumables testing in the biopharmaceuticals manufacturing process. With the elevated consumption of these new therapeutic treatments by healthcare facilities worldwide to treat chronic diseases, the pressure on good quality production has grown manifold. This, in turn, has intensified the attention toward stringent testing of consumables with respect to adherence to high standards of regulations to prevent tampering and contamination.

Stringent Regulatory Requirements

• The regulatory agencies like the FDA and EMA have put highly stringent regulations for the biopharmaceutical products to focus on their safety and effectiveness. The regulatory agencies strictly mandate proper quality control and testing procedures for consumables used in bio manufacturing processes. Biopharmaceutical companies, focusing on compliance with the dynamic changing regulations, are highly demanding market expansion in the consumables testing solutions.

Market Opportunities

Technological Advancements in Testing

• The growing breakthroughs in testing technologies bring substantial scope for the biopharmaceuticals manufacturing consumables testing market. Improved accuracy, faster results, and reduced human intervention through automation, high-throughput screening, and real-time monitoring systems leave a pathway to devise an efficient testing process. Organizations which embrace such advanced technologies hold an enhanced stake in ensuring the quality of consumables and, by progression, biopharmaceutical products themselves.

Growth in Single-use Technologies

• Single-use technologies are on the rise in biopharmaceutical manufacturing. Single use systems, including disposable bioreactors and filters, are gaining preference because of their cost-effectiveness and flexibility. These, however, need comprehensive testing for sterility, integrity, and performance. This trend is expected to support the growth prospects for robust consumables testing with the increasing adoption of single-use solutions by biopharmaceutical manufacturers.

Market Restraining Factors

High Costs of Testing

• The key restraint in the biopharmaceuticals manufacturing consumables testing market is the cost incurred in the process of testing. Highly advanced testing technologies coupled with high regulatory requirements lead to a substantial investment on consumables testing. Biopharmaceutical companies being small and medium-sized suffer from such cost burdens and therefore hinder the growth in certain regions.

Complexity of Biopharmaceutical Manufacturing Processes

• The complexity of the biopharmaceutical manufacturing processes with sensitive biologics makes testing consumables difficult. Only specialized skills and equipment can ensure the consistency and quality of consumables used in the various stages of production. The complexity of testing processes along with validation will be a restraint towards the adoption of new testing solutions in the industry.

Segmentation Analysis

The market scope is segmented because of by Product Type, by Testing Type, by Application, by End-user.

By Product Type

Based on the Product Type of the market is segmented into Reagents and Kits, Laboratory Equipment, Filters and Membranes, Single-use Systems, Other Consumables.

The Reagents and Kits segment accounts for the majority share in the market of consumables testing for biopharmaceuticals manufacturing. This is because they are regarded as necessary reagents that must be used in a significant number of testing procedures required in biopharmaceutical production to ensure quality. Those reagents and kits are mandatory for microbial tests, sterility tests, endotoxin detection, and other necessary assays for the assurance of safety and efficacy in the biopharmaceutical products. Thus, the need for special reagents does not decline but increases further because testing needs to be performed at various stages of production from raw material to final product validation.

Addition of versatility and necessity of reagents and kits across the platforms for various testing, including advanced technologies such as PCR, ELISA, and chromatography, further propel them to their market leadership. In addition, as biopharmaceuticals production scales up with the rising demand for biologics, such as monoclonal antibodies and gene therapies, the need to use reagents and kits for accurate and reliable testing becomes really crucial.

In addition, increasing biopharmaceuticals and therapies launch continuously necessitate continuous innovations in testing reagents, which in turn fuels their steady demand. The recurring nature of consumables such as kits and reagents also provides market participants with assured revenue making sure they do not lose a stronghold on the market for biopharmaceuticals manufacturing consumables testing.

By Testing Type

Based on the Testing Type of the market is segmented into Microbial Testing, Endotoxin Testing, Bio-burden Testing, Sterility Testing, Other Quality Control Tests.

Sterility testing has dominated the global market for testing consumables used in the production of biopharmaceuticals among the testing type categories. This is primarily because it is essential to ensure that biopharmaceutical products are free of any infectious microorganisms that may compromise product safety, especially in injectable biologics such as monoclonal antibodies and vaccines. Regulatory agencies such as the FDA and EMA require sterility testing as a necessity. Otherwise, there may be some contamination within the products that could seriously endanger patient safety.

Sterility is particularly critical in biopharmaceuticals since these products are usually manufactured in aseptic environments, and hence, sensitive to any breach of sterility from microbial contamination. In the event that a breach in sterility occurs in the manufacturing process, it will lead to product recalls, legal liabilities, and damage to the reputation of the manufacturer. Furthermore, sterility testing is applied across various stages of the production process, from raw material handling to the final packaging of the product.

Additionally, increases in single use systems and disposable bioprocessing technologies for the production of biopharmaceuticals create a greater need for sterility testing since single use systems, particularly, must be validated to prove they do not bring in contaminants. Specifically, sharp attentions on safety together with strict regulatory compliance have made it impossible to exclude sterility testing from the manufacturing process for drugs and biological medicinal products, thus enjoying continual supremacy in the industry.

Regional Snapshots

By region, Insights into the markets in North America, Europe, Asia-Pacific, Latin America and MEA are provided by the study. North America has dominated the global biopharmaceuticals manufacturing consumables testing market. This is primarily due to the fact that the region is currently led by a long-established biopharmaceutical industry, a strong healthcare infrastructure, and further investments in research and development. Most of the renowned biopharmaceutical companies are based in the United States, which collectively hold a large share in the world's biologics production. Moreover, strict regulatory requirements of such agencies as FDA force North American biopharmaceutical manufacturers to follow rigid quality control and testing standards. Such demand for the quality of testing consumables has led to a significant increase in products applied for sterility, microbial, and endotoxin testing, which are seen to be in significant demand in this region.

Asia-Pacific is expected to be the fastest-growing region in the biopharmaceuticals manufacturing consumables testing market. This growth can be ascribed to increased investment being made in the capabilities to manufacture biopharmaceuticals across countries like China, India, and South Korea. These governments are also offering supportive policies to encourage the expansion of the biotechnology and pharmaceutical industries. In the Asia-Pacific region, growth in advanced consumables testing needs is on the rise due to the expansion of contract manufacturing organizations and increased demand for biologics. Lower manufacturing costs in the region, as well as a growing emphasis on global regulatory standards compliance, are proving to be key drivers for market growth, making the region high-potential for future expansion.

List of Companies Profiled

• BioSpectra
• Catalent, Inc
• Merck KGaA
• Eurofins Scientific
• Alcami Corporation
• Agilent Technologies, Inc.
• Charles River Laboratories.
• Pace Analytical Services, LLC
• Nelson Laboratories, LLC (Gibraltar Laboratories)
• Element Materials Technology (Avomeen Analytical Services)

Key Industry Developments

In July 2024, Agilent Technologies Inc. announced it has signed a definitive agreement to acquire BIOVECTRA, a leading specialized contract development and manufacturing organization, for $925 million.

In May 2024, Merck, a leading science and technology company, has signed a definitive agreement to acquire life science company Mirus Bio for US$ 600 million (around € 550 million). Based in Madison, Wisconsin, USA, Mirus Bio is a specialist in the development and commercialization of transfection reagents. Transfection reagents, such as Mirus Bio's TransIT-VirusGEN®, are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for cell and gene therapies.

In February 2024, Catalent, Inc., a leader in enabling the development and supply of better treatments for patients worldwide, and Novo Holdings, a holding and investment company that is responsible for managing the assets and wealth of the Novo Nordisk Foundation, announced that they have entered into a merger agreement under which Novo Holdings will acquire Catalent in an all-cash transaction that values Catalent at $16.5 billion on an enterprise value basis.

In January 2024, Alcami Corporation (“Alcami”), a leading contract development and manufacturing organization (CDMO), announced it has completed the acquisition of Pacific Pharmaceutical Services, Inc. (“PPS”), a preferred provider of cGMP pharma storage and services.

In October 2023, Eurofins Scientific, a global leader in bio-pharmaceutical products testing, and one of the world leaders in genomic services, announces that it has signed an exclusive agreement with Ekkio Capital to acquire the Amatsigroup for a price of approximately EUR 130m plus some residual debt at closing. The contemplated transaction is expected to be completed over the next few months, subject to customary closing conditions including employees' representatives' information and consultation.

Report Coverage

The report will cover the qualitative and quantitative data on the global Biopharmaceuticals Manufacturing Consumables Testing Market. The qualitative data includes latest trends, market players’ analysis, market drivers, market opportunity, and many others. Also, the report quantitative data includes market size for every region, country, and segments according to your requirements. We can also provide customize report in every industry vertical.

Report Scope and Segmentations

Regional Analysis

North America accounted for the highest xx% market share in terms of revenue in the Biopharmaceuticals Manufacturing Consumables Testing market and is expected to expand at a CAGR of xx% during the forecast period. This growth can be attributed to the growing adoption of Biopharmaceuticals Manufacturing Consumables Testing. The market in APAC is expected to witness significant growth and is expected to register a CAGR of xx% over upcoming years, because of the presence of key Biopharmaceuticals Manufacturing Consumables Testing companies in economies such as Japan and China.

The objective of the report is to present comprehensive analysis of Global Biopharmaceuticals Manufacturing Consumables Testing Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language.

Biopharmaceuticals Manufacturing Consumables Testing Market Report is also available for below Regions and Country Please Ask for that

North America

• U.S
• Canada

Europe

• Switzerland
• Belgium
• Germany
• France
• U.K
• Italy
• Spain
• Sweden
• Netherland
• Turkey
• Rest of Europe

Asia-Pacific

• India
• Australia
• Philippines
• Singapore
• South Korea
• Japan
• China
• Malaysia
• Thailand
• Indonesia
• Rest Of APAC

Latin America

• Mexico
• Argentina
• Peru
• Colombia
• Brazil
• Rest of South America

Middle East and Africa

• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest Of MEA

Points Covered in the Report

• The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.
• The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 5 years data history and forecast.
• The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail.
• Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements.
• The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Key Questions

• How much the global Biopharmaceuticals Manufacturing Consumables Testing Market valued?
• Which region has the largest share in 2024 for the global Biopharmaceuticals Manufacturing Consumables Testing Market?
• What are the driving factors for the market?
• Which is the leading segment in the global market?
• What are the major players in the market?

Research Scope of the Market

• Historic year: 2019-2022
• Base year: 2023
• Forecast: 2024 to 2032
• Representation of Market revenue in USD Millio

Biopharmaceuticals Manufacturing Consumables Testing Market Trends: Market key trends which include Increased Competition and Continuous Innovations Trends: