프로세스 분석 기술(PAT) 시장 규모는 2024년에 121억 3,000만 달러로 평가되며, 2024-2031년에 CAGR 10.1%로 성장하며, 2031년에는 177억 4,000만 달러에 달할 것으로 예측됩니다.
제약 분야에서 공정 분석 기술 시스템의 채택을 촉진하는 주요 요인은 공정 분석 화학(공정 분석기)의 혁신과 대량의 데이터를 수집하고 해석할 수 있는 능력입니다. 이 조사 보고서는 세계의 프로세스 분석 기술(PAT) 시장을 종합적으로 평가했습니다. 주요 부문, 동향, 시장 성장 촉진요인, 억제요인, 경쟁 구도 시장에서 중요한 역할을 하는 요인 등을 종합적으로 분석합니다.
세계 공정 분석 기술(PAT) 시장의 정의
FDA는 PAT를 주요 품질 매개변수(CPP)와 원료 및 가공 재료의 성능 특성 관찰을 통해 의약품 제조 공정을 구축, 평가, 관리하기 위한 시스템이라고 설명하고 있습니다. 이 방법은 주로 중요한 품질 매개 변수를 식별하여 프로세스를 이해하고, 적절하고 신속하게 모니터링하고, 과도한 공정을 줄이고, 균일성을 높이고, 불합격품을 최소화하고, 검사 효과를 개선하는 데 중점을 둡니다. 이 시스템은 실시간 정보를 활용하여 공정의 변동성과 제조 능력을 줄이기 위해 실시간 정보를 활용하여 지속적인 공정 제조 개선을 촉진하고 지원하는 것으로, 운영과 관련된 많은 공정을 모두 완벽하게 이해해야 합니다.
PAT는 위험을 고려한 체계적인 방법으로 의약품의 개발, 제조, 품질관리를 지원하는 최첨단 툴을 폭넓게 제공합니다. 이러한 툴은 지식 관리를 위한 툴, 프로세스 및 엔드포인트 모니터링 및 제어를 위한 툴, 다변량 데이터 분석 모니터링 및 제어를 위한 툴, 최신 프로세스 분석기, 프로세스 분석 화학을 위한 툴 등으로 구분할 수 있습니다. 프로세스 분석 화학을 위한 툴 등입니다. 시스템내 이 기술은 프로세스 개발 및 위험 감소 전략을 이해하고 지속적인 개선과 지식 공유를 달성하기 위해 데이터를 수집하는 효과적이고 효율적인 방법을 제공할 수 있습니다.
세계 공정 분석 기술(PAT) 시장 개요
제약 분야에서 공정 분석 기술 시스템의 채택을 촉진하는 주요 요인은 공정 분석 화학(공정 분석기)의 혁신과 대량의 데이터를 수집하고 해석할 수 있는 능력입니다. PAT의 기본적인 장점은 유통 전에 품질이 평가되는 것이 아니라, 제품에 내장되어 있다는 점입니다. 배치 불량을 줄이고, 제조 사이클 시간을 단축하고, 자동화를 촉진합니다. 공정 분석 기술(PAT) 시장의 확대는 제약 및 바이오 제약 산업에서 연구개발(R&D)에 지출되는 비용 증가에 의존하고 있습니다. 지난 수십년간 제약회사들은 연구개발에 대한 투자를 대폭 늘려왔습니다.
소규모 제약사가 공정 분석 기술을 도입하지 못하는 가장 큰 요인 중 하나는 실무 경험이 풍부하고 기능 및 제어 시스템을 이해하는 자격을 갖춘 기술 전문가/운영자가 필요하다는 점입니다. 또한 모든 공정 분석 기술 제품 및 서비스는 일반 기업 직원이 서비스 요구 사항을 적절히 처리하기 위해 지원이 필요하므로 지속적인 기술 지원이 필요합니다. 공정 분석 기술 시장은 의약품 및 약품 생산에 대한 정부 규제 강화로 인해 큰 수혜를 받을 수 있습니다. 예를 들어 USFDA는 2011년 1월 인간 및 동물용 의약품 및 생물제제 제조에 대한 공정 검증 권고안을 발표하여 제조 문제의 주요 원인이 신속하게 해결될 수 있도록 수정함으로써 기업이 일상적으로 공정 수명주기를 강화할 필요성을 강조했습니다. 강조했습니다.
Process Analytical Technology (PAT) Market size was valued at USD 12.13 Billion in 2024 and is projected to reach USD 17.74 Billion by 2031, growing at a CAGR of 10.1% from 2024 to 2031.
The primary factors boosting the adoption of process analytical technology systems in the pharmaceutical sector are innovations in process analytical chemistry (process analyzers) and its capacity to capture & interpret large volumes of data. The Global Process Analytical Technology (PAT) Market report provides a holistic evaluation of the market. The report offers a comprehensive analysis of key segments, trends, drivers, restraints, competitive landscape, and factors that are playing a substantial role in the market. substantial role in the market.
Global Process Analytical Technology (PAT) Market Definition
The FDA describes PAT as a system for creating, evaluating, and managing pharmaceutical manufacturing processes through the observation of key quality parameters (CPP) and performance characteristics of raw and processed materials. This method primarily focuses on understanding the processes by identifying the critical quality parameters, monitoring them appropriately and promptly, and providing improved efficacy in testing while reducing over-processing, boosting uniformity, and minimizing rejects. This mechanism facilitates and supports continuous process manufacturing improvement by utilizing real-time information to reduce process variance and manufacturing capability and calls for a complete understanding of all the many processes involved in the operation.
PAT offers a wide variety of cutting-edge tools to help develop, manufacture, and quality control medicines in a risk-aware, systematic way. Using its structure, these tools can be divided into the following categories: Tools for knowledge management, tools for monitoring and controlling processes and endpoints, tools for monitoring and controlling multivariate data analysis, and tools for modern process analyzers or process analytical chemistry. This technology within the system can provide effective and efficient ways to collect data to understand process development and risk-reduction strategies and achieve continuous improvement and knowledge sharing.
Global Process Analytical Technology (PAT) Market Overview
The primary factors boosting the adoption of process analytical technology systems in the pharmaceutical sector are innovations in process analytical chemistry (process analyzers) and its capacity to capture & interpret large volumes of data. The fundamental benefit of PAT is that quality is integrated into the product rather than being assessed before distribution. It aids in reducing batch rejection, shortening manufacturing cycle times, and boosting automation. The expansion of the Process Analytical Technology (PAT) Market relies on the amount of money spent on research and development (R&D) in the pharmaceutical and biopharmaceutical industries due to the high operating and capital expenditures. Over the past few decades, pharmaceutical companies have dramatically boosted their investment in research and development.
One major factor preventing some small pharma companies from implementing process analytical technology is the need for qualified technical experts/operators with thorough working experience and comprehension of functionality and control systems. Additionally, since regular company employees need help to adequately handle the servicing requirements, all process analytical technology products and services require ongoing technical support. The market for process analytical technologies may benefit significantly from increased government regulations regarding the production of pharmaceuticals and drugs. For instance, the USFDA released Process Validation recommendations for the production of human and animal pharmaceutical and biological products in January 2011, which underlined the requirement for businesses to routinely reinforce the process lifecycle by making modifications to ensure the main causes of manufacturing problems are rapidly resolved.
The Global Process Analytical Technology (PAT) Market is Segmented on the basis of Products and Services, Measurement, End User, Technique, and Geography.
Products
Services
Based on Products and Services, the market is segmented into Products and Services. Products accounted for the largest market share and are projected to grow at a CAGR of 9.68% during the forecast period. Process Analytical Technology (PAT) has been gaining importance in the biotech community because of its potential to provide continuous real-time quality assurance resulting in improved operational control and compliance. With the rising evolution in biopharmaceutical manufacturing, there is increasing use of PAT as it applies to the processes that produce biotech products and therapeutic products.
On-line
In-line
At-line
Off-line
Based on Measurement, the market is segmented into On-line, In-line, At-line, Off-line. On-line accounted for the largest market share and is projected to grow at the highest CAGR of 10.61% during the forecast period. Integrating online measurement and modeling of critical quality attributes with automated feedback control of the process parameters impacting these attributes should reduce product variability. On-line, the sample is diverted from the main process analyzed and may be returned.
Pharmaceutical Manufacturers
Biopharmaceutical Manufacturers
Contract Research and Manufacturing Organizations
Others
Based on End User, the market is segmented into Pharmaceutical Manufacturers, Biopharmaceutical Manufacturers, Contract Research and Manufacturing Organizations, and Others. Pharmaceutical Manufacturers accounted for the largest market share and are projected to grow at a CAGR of 9.78% during the forecast period. Process analytical technologies (PAT) play an important role in the process development and scale-up of asymmetric syntheses of chiral molecules including active pharmaceutical ingredients in the pharmaceutical industry.
Spectroscopy
Chromatography
Particle Size Analysis
Capillary Electrophoresis
Others
Based on Technique, the market is segmented into Spectroscopy, Chromatography, Particle Size Analysis, Capillary Electrophoresis, and Others. Spectroscopy accounted for the largest market share and is projected to grow at the highest CAGR of 10.96% during the forecast period. Spectroscopy is referred to as the study using precise color bands as generalized from visible light of the electromagnetic spectrum for describing experimental spectroscopic methods.
North America
Europe
Asia Pacific
Latin America
Middle East and Africa
Based on regional analysis, the Global Process Analytical Technology (PAT) Market is classified into On the basis of regional analysis, the market is bifurcated into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. North America accounted for the largest market share and is projected to grow at a CAGR of 9.46% during the forecast period. The North American region is emerged as one of the prominent contributors to the global Process Analytical Technology (PAT) Market.
Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players.