세계의 생물학적 안전성 시험 제품 및 서비스 시장 보고서(2025년)
Biological Safety Testing Products And Services Global Market Report 2025
상품코드 : 1825632
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

생물학적 안전성 시험 제품 및 서비스 시장 규모는 향후 몇 년간 급성장할 것으로 예측됩니다. 2029년 연평균 성장률(CAGR)은 13.2%를 나타낼 것으로 예측되고 100억 4,000만 달러로 성장할 전망입니다. 예측 기간 동안의 성장은 건강 문제 치료 시 안전성과 효과적인 평가의 중요성 증가, 신약 및 치료제 개발 확대, 세포·유전자 치료 개발에 대한 관심 증대, 바이오의약품 분야 투자 증가, 바이오의약품 안전성 촉진 정책을 강화하는 정부 주도 등에 기인할 수 있습니다. 예측 기간의 주요 동향에는 기술적 발전, 생물학적 부하 시험에 대한 수요 증가, 바이오의약품 및 생물학적 제제에 대한 투자 증가, 규제 준수에 따른 채택 촉진, 주요 기업 간 인수합병 등이 포함됩니다.

향후 5년간 13.2% 성장이라는 예측치는 이전 전망치 대비 0.1% 소폭 하락한 수치입니다. 이 하락은 주로 미국과 타국 간 관세 영향 때문입니다. 관세 장벽은 독일과 스위스에서 공급원인 엔도톡신 검출 키트 및 무균성 시험 서비스의 비용을 증가시켜 미국 내 의약품 안전성을 저해할 것으로 예상됩니다. 이는 제품 출시 지연과 품질 관리 비용 증가로 이어질 것입니다. 또한 상호 관세 부과와 무역 긴장 및 제한 강화로 인한 전 세계 경제 및 무역에 대한 부정적 영향으로 그 효과가 더욱 광범위하게 나타날 것입니다.

향후 유전자 치료에 대한 수요 증가가 생물학적 안전성 시험 제품 및 서비스 시장을 촉진할 것으로 예상됩니다. 유전자 치료는 결함 유전자를 대체, 개질된 또는 보충하여 질병을 치료하거나 예방하는 의학적 접근법입니다. 유전자 변이에 대한 투자 및 연구 향상과 뒷받침되는 규제 환경은 혁신을 더욱 촉진하고 유전자 치료의 용도를 넓힙니다. 유전자 치료 분야의 생물학적 안전성 시험 제품 및 서비스는 바이러스 벡터와 유전 물질이 오염 물질로부터 자유롭고 사용하기에 안전함을 보장합니다.예를 들어, 2024년 1월 미국을 거점으로 하는 비영리의 의학·과학 단체인 미국 유전자·세포 치료 학회(American Society of Gene &Cell Therapy)가 발표한 문서에 따르면 2023년 4분기에 3상 임상시험 중 유전자 치료제의 수가 10% 증가했으며, 2022년 3분기 이후 분기 기준으로 처음으로 이런 유형 증가가 나타났습니다고 보고되었습니다. 따라서 유전자 치료에 대한 수요 증가가 생물학적 안전성 시험 제품 및 서비스 시장을 촉진하고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁과 관세, 그리고 코로나 및 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별 및 국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도와 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문, 전략

제36장 부록

HBR
영문 목차

영문목차

Biological safety testing products and services encompass the equipment and methods used to verify that biological products are safe and free from harmful contaminants, ensuring their safety and efficacy for medical use. The primary goal is to detect and prevent contamination by bacteria, viruses, fungi, and other pathogens.

The main products and services in biological safety testing include reagents and kits, instruments, and services. Reagents and kits consist of various chemicals, enzymes, antibodies, and other materials used to identify and measure contaminants, pathogens, or impurities in biological products. Testing types include endotoxin tests, sterility tests, cell line authentication and characterization tests, bioburden tests, adventitious agent detection tests, residual host contamination detection tests, and others, which are applied to vaccines and therapeutics, blood and blood-based products, gene therapy, tissue and tissue-based products, and stem cells.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.

The biological safety testing products and services market research report is one of a series of new reports from The Business Research Company that provides biological safety testing products and services market statistics, including biological safety testing products and services industry global market size, regional shares, competitors with a biological safety testing products and services market share, detailed biological safety testing products and services market segments, market trends and opportunities, and any further data you may need to thrive in the biological safety testing products and services industry. This biological safety testing products and services market research report delivers a complete perspective on everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The biological safety testing products and services market size has grown rapidly in recent years. It will grow from $5.4 billion in 2024 to $6.12 billion in 2025 at a compound annual growth rate (CAGR) of 13.3%. The growth in the historic period can be attributed to the prevalence of target diseases, rising production of next-generation biologics, growing demand for biologics, rise in adoption of testing tools, growth in the pharmaceutical and biotechnology industries, and rising emphasis on regulatory compliance.

The biological safety testing products and services market size is expected to see rapid growth in the next few years. It will grow to $10.04 billion in 2029 at a compound annual growth rate (CAGR) of 13.2%. The growth in the forecast period can be attributed to rising importance of evaluating their safety and effectiveness in treating health problems, increasing development of new therapeutics and treatments, rising interest in developing cell and gene therapies, rising investments in the biopharmaceutical space, and rising government initiatives to promote biopharmaceutical safety. Major trends in the forecast period include technological advancements, increasing demand for bioburden testing, rising investments in biopharmaceuticals and biologics, regulatory compliance driving adoption, and mergers and acquisitions among key players.

The forecast of 13.2% growth over the next five years reflects a slight reduction of 0.1% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. Tariff barriers are expected to hamper U.S. drug safety by increasing the cost of endotoxin detection kits and sterility testing services sourced from Germany and Switzerland, thereby delaying product releases and elevating quality control expenditures. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The increasing demand for gene therapies is expected to drive the growth of the biological safety testing products and services market in the future. Gene therapy is a medical approach that uses genes to treat or prevent diseases by replacing, modifying, or supplementing defective genes. Enhanced investment and research into gene mutations, along with supportive regulatory environments, further stimulate innovation and broaden the applications of gene therapies. Biological safety testing products and services in gene therapy ensure that viral vectors and genetic materials are free from contaminants and safe for use. For example, in January 2024, according to the document published by the American Society of Gene & Cell Therapy, a US-based non-profit medical and scientific organization, reported a 10% increase in the number of gene therapies in Phase III clinical trials during the fourth quarter of 2023, marking the first quarterly increase of this type since the third quarter of 2022. Thus, the rising demand for gene therapies is driving the market for biological safety testing products and services.

Leading companies in the biological safety testing products and services market are advancing rapid animal-free bacterial endotoxin testing to improve patient safety and accelerate drug development. This innovative approach aims to shorten testing time and increase reliability without using animal-based products. For example, in January 2024, Charles River Laboratories International, a US-based pharmaceutical and biotechnology company, launched the Endosafe Trillium cartridge. This product uses recombinant technology to detect and quantify endotoxins without relying on animal-derived materials. It is the first rapid animal-free bacterial endotoxin test that offers a quicker turnaround time and eliminates the need for animal-derived reagents, thereby promoting sustainability and ethical testing practices. The Endosafe Trillium cartridge provides rapid, accurate results while reducing dependence on traditional Limulus amebocyte lysate (LAL) sourced from horseshoe crabs.

In September 2023, Technical Safety Services, a US-based biotechnology company, acquired Controlled Environment Management LLC for an undisclosed amount. This acquisition is intended to boost TSS's support for pharmaceutical, biotechnology, and healthcare clients by broadening its geographic reach and service offerings. Controlled Environment Management LLC, a US-based company, provides crucial services for biological safety testing, including testing, validation, certification, and calibration of controlled environments.

Major companies operating in the biological safety testing products and services market are Merck KGaA, Thermo Fisher Scientific Inc., Quest Diagnostics Incorporated, SGS Societe Generale de Surveillance SA, Eurofins Scientific, Agilent Technologies Inc., Lonza Group AG, WuXi AppTec Co. Ltd., Charles River Laboratories Inc., BioMerieux SA, Almac Group, Samsung Biologics Co. Ltd., Maravai LifeSciences Holdings Inc., Genscript Biotech Corp, Wako Pure Chemical Industries Ltd., Associates of Cape Cod Inc., InvivoGen S.A.S., Microcoat Biotechnologie GmbH, BSL BIOSERVICE Scientific Laboratories Munich GmbH, Redberry, PathoQuest

North America was the largest region in the biological safety testing products and services market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the biological safety testing products and services market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the biological safety testing products and services market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The biological safety testing product and services market consists of revenues earned by entities by providing services such as viral clearance studies, environmental monitoring, toxicology testing, and batch release testing. The market value includes the value of related goods sold by the service provider or included within the service offering. The biological safety testing market also includes sales of polymerase chain reaction (PCR) machines, biosafety cabinets, autoclaves, and centrifuges. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Biological Safety Testing Products And Services Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on biological safety testing products and services market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for biological safety testing products and services ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The biological safety testing products and services market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Biological Safety Testing Products And Services Market Characteristics

3. Biological Safety Testing Products And Services Market Trends And Strategies

4. Biological Safety Testing Products And Services Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Biological Safety Testing Products And Services Growth Analysis And Strategic Analysis Framework

6. Biological Safety Testing Products And Services Market Segmentation

7. Biological Safety Testing Products And Services Market Regional And Country Analysis

8. Asia-Pacific Biological Safety Testing Products And Services Market

9. China Biological Safety Testing Products And Services Market

10. India Biological Safety Testing Products And Services Market

11. Japan Biological Safety Testing Products And Services Market

12. Australia Biological Safety Testing Products And Services Market

13. Indonesia Biological Safety Testing Products And Services Market

14. South Korea Biological Safety Testing Products And Services Market

15. Western Europe Biological Safety Testing Products And Services Market

16. UK Biological Safety Testing Products And Services Market

17. Germany Biological Safety Testing Products And Services Market

18. France Biological Safety Testing Products And Services Market

19. Italy Biological Safety Testing Products And Services Market

20. Spain Biological Safety Testing Products And Services Market

21. Eastern Europe Biological Safety Testing Products And Services Market

22. Russia Biological Safety Testing Products And Services Market

23. North America Biological Safety Testing Products And Services Market

24. USA Biological Safety Testing Products And Services Market

25. Canada Biological Safety Testing Products And Services Market

26. South America Biological Safety Testing Products And Services Market

27. Brazil Biological Safety Testing Products And Services Market

28. Middle East Biological Safety Testing Products And Services Market

29. Africa Biological Safety Testing Products And Services Market

30. Biological Safety Testing Products And Services Market Competitive Landscape And Company Profiles

31. Biological Safety Testing Products And Services Market Other Major And Innovative Companies

32. Global Biological Safety Testing Products And Services Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Biological Safety Testing Products And Services Market

34. Recent Developments In The Biological Safety Testing Products And Services Market

35. Biological Safety Testing Products And Services Market High Potential Countries, Segments and Strategies

36. Appendix

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