The global process analytical technology market (PAT) is expected to grow from USD 2.59 billion in 2020 to USD 7.19 billion by 2027, at a CAGR of 13.6% during the forecast period 2020-2027. Rising R&D expenditure by drug manufacturers and investments by government in emerging economies on implementation of process analytical technology, growing adherence to the quality by design (QbD) principles, and rising focus on increasing quality and manufacturing process efficiency are some of the key factors driving the demand in process analytical technology market. Technological advancements in the analytical devices industry have led to a greater adoption and implementation of process analytical technology in pharmaceutical as well as biopharmaceutical industry. The factors that hinder the growth of the market include, high cost of implementation and lack of skilled professionals.
The trend of outsourcing the manufacturing of pharma products to pure contract manufacturing organisations (CMOs) has been witnessed significantly in process analytical technology market in the recent past, due to the various advantages these CMOs offer such as low cost of production, low capital investment, desired quality production, time saving, and flexibility to divert resources to focus on other areas, such as marketing.
Outsourcing also allows for easier compliance with different regulations of various regulatory bodies. The USFDA has begun an aggressive inspection schedule over the past few years, and external contractors are now under the spotlight. For instance, in July 2017, Pfizer Inc. partnered with Catalent Pharma Solutions for the production of Advil Liqui-Gels Minis (ibuprofen), Pfizer Inc.’s over-the-counter (OTC) pain relief product, following a 20-year collaboration on the development and production of Advil Liqui-Gels. The trend of outsourcing the manufacturing to contact manufacturing organization is expected to continue in the process analytical technology market during the forecast period.
Due to the high capital investment as well as operational costs, the growth of process analytical technology market is dependent on the research and development (R&D) expenditure in the pharmaceutical industry. The R&D expenditure by pharmaceutical companies has increased significantly over the past few decades.
According to Research America, investment in medical and health R&D in the U.S. increased by 13.3% from 2013 to 2015. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), its member companies invested an estimated $58.8 billion in R&D in 2015, an increase of 10.3% from 2014.
Also, according to the Organization for Economic Co-operation and Development (OECD), the R&D spending in emerging economies such as BRICS nations have increased considerably in recent past. Furthermore, in January 2011, the USFDA released a Process Validation guidance that noted the need for companies to continually improve the process lifecycle by making adaptations, to assure root causes of manufacturing problems are quickly corrected. With such regulations imposed by the USFDA and other regulatory authorities, adherence to QbD principles is increasing among pharma and biopharma companies during manufacturing process. This, in turn, is driving the growth of process analytical technology market.
Key players profiled in this market are Bruker Corporation (U.S.), and PerkinElmer, Inc. (U.S.), Thermo Fisher Scientific, Inc. (U.S.), Agilent Technologies, Inc. (U.S.), and Danaher Corporation (U.S.).
The global market for process analytical technology is divided regionally into North America, Latin America, Eastern Europe, Western Europe, Asia Pacific excluding Japan, Japan, and Middle East and Africa. Among these regions, the North America region dominates the market of process analytical technology demand because of the highest presence of pharmaceutical industry followed by Europe. APEJ and Japan are expected to grow at the highest CAGR in the forecast period because of the rapid industrialization and government regulations in the development of pharmaceuticals manufacturing. On the other hand, MEA is expected to show moderate growth rate for process analytical technology demand.
The trend of outsourcing the manufacturing of pharma products to pure contract manufacturing organisations (CMOs) has been witnessed significantly in process analytical technology market in the recent past, due to the various advantages these CMOs offer such as low cost of production, low capital investment, desired quality production, time saving, and flexibility to divert resources to focus on other areas, such as marketing.
Outsourcing also allows for easier compliance with different regulations of various regulatory bodies. The USFDA has begun an aggressive inspection schedule over the past few years, and external contractors are now under the spotlight. For instance, in July 2017, Pfizer Inc. partnered with Catalent Pharma Solutions for the production of Advil Liqui-Gels Minis (ibuprofen), Pfizer Inc.’s over-the-counter (OTC) pain relief product, following a 20-year collaboration on the development and production of Advil Liqui-Gels. The trend of outsourcing the manufacturing to contact manufacturing organization is expected to continue in the process analytical technology market during the forecast period.
Due to the high capital investment as well as operational costs, the growth of process analytical technology market is dependent on the research and development (R&D) expenditure in the pharmaceutical industry. The R&D expenditure by pharmaceutical companies has increased significantly over the past few decades.
According to Research America, investment in medical and health R&D in the U.S. increased by 13.3% from 2013 to 2015. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), its member companies invested an estimated $58.8 billion in R&D in 2015, an increase of 10.3% from 2014.
Also, according to the Organization for Economic Co-operation and Development (OECD), the R&D spending in emerging economies such as BRICS nations have increased considerably in recent past. Furthermore, in January 2011, the USFDA released a Process Validation guidance that noted the need for companies to continually improve the process lifecycle by making adaptations, to assure root causes of manufacturing problems are quickly corrected. With such regulations imposed by the USFDA and other regulatory authorities, adherence to QbD principles is increasing among pharma and biopharma companies during manufacturing process. This, in turn, is driving the growth of process analytical technology market.
Key players profiled in this market are Bruker Corporation (U.S.), and PerkinElmer, Inc. (U.S.), Thermo Fisher Scientific, Inc. (U.S.), Agilent Technologies, Inc. (U.S.), and Danaher Corporation (U.S.).
The global market for process analytical technology is divided regionally into North America, Latin America, Eastern Europe, Western Europe, Asia Pacific excluding Japan, Japan, and Middle East and Africa. Among these regions, the North America region dominates the market of process analytical technology demand because of the highest presence of pharmaceutical industry followed by Europe. APEJ and Japan are expected to grow at the highest CAGR in the forecast period because of the rapid industrialization and government regulations in the development of pharmaceuticals manufacturing. On the other hand, MEA is expected to show moderate growth rate for process analytical technology demand.
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