바이오의약품 수요 증가, 만성질환 유병률 증가, 일회용 기술 채택 확대 등의 요인으로 인해 다운스트림 처리 시장은 향후 몇 년 동안 크게 성장할 것으로 예상되며, Verified Market Research의 애널리스트에 따르면 다운스트림 처리 시장 은 2024년 299억 3,000만 달러에서 1,001억 8,000만 달러에 달할 것으로 예상됩니다.
기업들은 효율성과 확장성을 향상시키기 위해 지속적으로 기술 혁신을 수행하고 있으며, 이는 시장의 역동성과 경쟁력을 확보하기 위한 노력의 일환입니다. 이로 인해 2024년부터 2031년까지 연평균 16.30%의 CAGR로 시장이 성장할 것으로 예상됩니다.
다운스트림 프로세싱 시장 정의/개요
다운스트림 프로세싱은 생물학적 제품이 생산된 후 수행되는 중요한 공정을 말합니다. 이는 처음 발견된 복잡한 혼합물에서 원하는 제품을 분리하고 정제하는 것입니다. 이 혼합물은 종종 발효액이라고 불리며, 세포, 불필요한 단백질, 영양소, 기타 세포 생성물 등을 포함할 수 있습니다.
다운스트림 프로세싱은 생물학적 공급원으로부터 가치 있는 제품을 얻는 데 중요한 역할을 합니다. 인슐린이나 백신과 같은 바이오의약품의 정제, 식품 제조와 같은 산업 공정에 필요한 효소 분리, 식물이나 미생물에서 약효가 있는 천연물 추출 등에 사용됩니다. 요컨대, 세포와 생물체에서 원시 출력을 추출하여 우리가 건강과 다양한 산업적 용도에 의존하는 순수하고 기능적인 제품으로 변환하는 것입니다.
생물체 또는 그 세포 과정에서 유래한 의약품의 일종인 바이오의약품에 대한 수요 증가는 다운스트림 프로세싱의 주요 촉진제입니다. 바이오의약품은 높은 표적 특이성, 적은 부작용, 복잡한 질병을 치료할 수 있는 능력 등 기존 의약품이 갖지 못한 몇 가지 장점을 가지고 있습니다. 이 때문에 인슐린, 암 치료용 단클론항체, 유전자 치료제 등 바이오의약품의 개발 및 생산이 급증하고 있습니다. 이에 따라 이러한 복잡한 분자를 정제하고 분리하기 위한 효율적이고 확장 가능한 다운스트림 처리 기술에 대한 수요가 크게 증가하고 있습니다.
또한 암, 당뇨병, 자가면역질환과 같은 만성질환의 증가는 전 세계 의료시스템에 큰 부담을 주고 있습니다. 이러한 만성질환은 장기적인 치료가 필요한 경우가 많은데, 바이오의약품은 이러한 질병과의 싸움에서 귀중한 무기가 될 수 있음이 입증되고 있습니다. 예를 들어, 바이오의약품은 혈당 조절을 통해 당뇨병 관리에 도움을 주거나, 기존 항암제보다 더 정확하게 암세포를 표적화하여 환자의 부작용을 최소화할 수 있습니다. 세계 인구의 고령화와 만성질환 발생률이 지속적으로 증가함에 따라 효과적인 바이오의약품 치료에 대한 수요는 그에 비례하여 증가하여 다운스트림 프로세싱 시장을 발전시킬 것으로 보입니다.
다운스트림 프로세싱은 매우 비용이 많이 드는 시도가 될 수 있습니다. 특히 크로마토그래피 시스템이나 한외여과 장치에는 많은 비용이 소요됩니다. 또한, 크로마토그래피용 수지, 필터 등의 소모품도 비용 증가로 이어집니다. 또한, 다운스트림 프로세싱 장비의 작동 및 유지보수, 공정 효율을 확보하기 위해서는 숙련된 인력이 필수적입니다. 전문성이 요구되기 때문에 유자격자 확보가 어렵고, 그 급여는 생산 비용에 큰 영향을 미칩니다.
또한, 다운스트림 프로세싱은 본질적으로 복잡하며, 정제되는 특정 제품에 맞게 조정된 수많은 공정을 포함합니다. 높은 수율을 달성하고 엄격한 순도 요건을 충족하기 위해서는 각 공정을 신중하게 최적화해야 합니다. 이 최적화 과정은 시간이 오래 걸리며, 크로마토그래피, 여과, 단백질 생화학 등의 분야에 대한 전문 지식이 필요합니다. 다운스트림 프로세싱의 복잡성은 중소기업이나 바이오의약품 제조에 처음 진입하는 기업에게 큰 도전이 될 수 있습니다. 효율적인 정제 공정을 개발 및 도입할 수 있는 전문 지식과 자원을 사내에 보유하고 있지 않은 경우, 시장에서 효과적으로 경쟁하는 데 어려움을 겪을 수 있습니다.
The downstream processing market is expected to grow significantly in the coming years, driven by factors such as the increasing demand for biopharmaceuticals, the rising prevalence of chronic diseases, and the growing adoption of single-use technologies. According to the analyst from Verified Market Research, the downstream processing market is estimated to reach a valuation of 100.18 USD Billion over the forecast subjugating around 29.93 USD Billion valued in 2024.
Companies are continually innovating to improve efficiency and scalability, ensuring the market's dynamic and competitiveness. It enables the market to grow at aCAGR of 16.30% from 2024 to 2031.
Downstream Processing Market: Definition/ Overview
Downstream processing refers to the crucial steps taken after a biological product has been produced, typically through fermentation or cell culture. It's all about isolating and purifying the desired product from the complex mixture it's initially found in. This mixture, often called fermentation broth, can contain cells, unwanted proteins, nutrients, and other cellular byproducts.
Downstream processing plays a critical role in obtaining valuable products from biological sources. It's used to purify biopharmaceuticals like insulin and vaccines, isolate enzymes needed for industrial processes like food production, and extract natural products with medicinal properties from plants and microorganisms. In essence, it takes the raw output from cells or organisms and transforms it into the pure and functional products we rely on for health and various industrial applications.
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The rising demand for biopharmaceuticals, a category of drugs that are derived from living organisms or their cellular processes, is a major driver for downstream processing. Biopharmaceuticals offer several advantages over traditional medications, including higher target specificity, fewer side effects, and the ability to treat complex diseases. This has led to a surge in the development and production of biopharmaceuticals, such as insulin, monoclonal antibodies for cancer treatment, and gene therapies. As a result, the demand for efficient and scalable downstream processing techniques to purify and isolate these complex molecules has grown significantly.
Furthermore, the increasing prevalence of chronic diseases like cancer, diabetes, and autoimmune disorders places a significant burden on healthcare systems worldwide. These chronic conditions often require long-term treatment, and biopharmaceuticals are proving to be a valuable weapon in this fight. For instance, biopharmaceuticals can help manage diabetes by regulating blood sugar levels or target cancer cells more precisely than traditional chemotherapy drugs, minimizing side effects for patients. As the global population ages and the incidence of chronic diseases continues to rise, the demand for effective biopharmaceutical treatments will correspondingly increase, propelling the downstream processing market forward.
Downstream processing can be a very expensive endeavor. The cost of equipment can be significant, especially for chromatography systems and ultrafiltration units. Consumables, such as chromatography resins and filters, also add to the bottom line. Furthermore, skilled labor is essential for operating and maintaining downstream processing equipment and ensuring process efficiency. The specialization required can make it challenging to find qualified personnel, and their salaries can contribute significantly to production costs.
Furthermore, Downstream processing is inherently complex, involving a multitude of steps tailored to the specific product being purified. Each step needs to be carefully optimized to achieve high yields and meet stringent purity requirements. This optimization process can be time-consuming and requires specialized expertise in areas like chromatography, filtration, and protein biochemistry. The complexity of downstream processing can pose significant challenges for smaller companies or those venturing into biopharmaceutical production for the first time. They may lack the in-house expertise or resources to develop and implement efficient purification processes, hindering their ability to compete effectively in the market.
According to VMR analysis, the biopharmaceutical companies segment is estimated to hold the largest market share during the forecast period. Biopharmaceutical companies are the primary producers of drugs, vaccines, and other biopharmaceuticals. They require robust downstream processing capabilities to handle large-scale production volumes and ensure consistent product quality. Academic labs and research institutes typically work with smaller quantities for research purposes and may not require such extensive downstream processing infrastructure.
Furthermore, Biopharmaceutical companies are constantly striving to improve downstream processing efficiency and scalability. This is crucial for keeping production costs down and meeting growing market demands. Contract Manufacturing Organizations (CMOs), while offering downstream processing services, cater to a wider range of clients with varying needs. Biopharmaceutical companies often have the resources to invest in advanced, scalable downstream processing technologies, giving them an edge.
The large-scale downstream processing segment is estimated to dominate the Downstream Processing market during the forecast period driven by the surge in demand for biopharmaceuticals, particularly for established drugs and therapies, which necessitates large-scale production to meet market needs. Large-scale downstream processing allows biopharmaceutical companies to achieve higher production volumes efficiently.
Furthermore, Large-scale operations benefit from economies of scale in several ways. Bulk purchasing of raw materials and consumables for downstream processing can lead to lower costs per unit. Additionally, large-scale facilities can potentially streamline processes and optimize resource utilization, further enhancing efficiency. For example, a large-scale facility might implement automated equipment and continuous processing techniques, which can reduce labor costs and improve throughput compared to smaller-scale batch processing. large facilities can leverage their buying power to negotiate better deals with suppliers of chromatography resins, filters, and other essential materials.
According to VMR analysts, North America is estimated to dominate the Downstream Processing market during the forecast period. North America boasts a well-established and strong pharmaceutical and biopharmaceutical industry. This translates to a high demand for downstream processing capabilities to support the production of various biopharmaceuticals.
North America has a well-developed healthcare infrastructure with stringent regulatory frameworks for biopharmaceutical production. This focus on quality necessitates advanced downstream processing methods to ensure product safety and efficacy.
Furthermore, Governments in North America, recognizing the potential of biopharmaceuticals to improve public health and drive economic growth, often provide significant funding and support for research and development in biopharmaceutical technologies. This financial backing fuels innovation in downstream processing techniques, encouraging the development of more efficient, scalable, and cost-effective methods for purifying biopharmaceuticals. Additionally, government grants and tax incentives can stimulate private sector investment in R&D, further accelerating advancements in downstream processing technologies. This strong focus on research fosters a collaborative environment where universities, research institutions, and biopharmaceutical companies can work together to develop next-generation downstream processing solutions.
The Asia Pacific region is estimated to exhibit the highest growth within the Downstream Processing Market during the forecast period. The Asia-Pacific region is home to a vast and growing patient population. This, coupled with a rising middle class with more disposable income for healthcare, creates a significant market for biopharmaceuticals. This translates to a need for expanded downstream processing facilities to meet the anticipated demand. Additionally, As economies in the region flourish, governments are investing heavily in healthcare infrastructure and biopharmaceutical research. This surge in activity creates a strong demand for downstream processing capabilities to support large-scale biopharmaceutical production.
Furthermore, There's a growing emphasis on research and development (R&D) in the Asia-Pacific biopharmaceutical sector. This focus on innovation fosters collaboration between universities, research institutions, and biopharmaceutical companies. This collaborative environment can accelerate advancements in downstream processing technologies, leading to the development of more efficient, scalable, and cost-effective purification methods. Additionally, Regulatory frameworks for biopharmaceutical production in the Asia-Pacific region are becoming more streamlined and harmonized. This can ease the process for companies looking to establish downstream processing facilities in the region.
The downstream processing market is a competitive landscape characterized by a dynamic interplay between established industry leaders and emerging companies with innovative technologies. Well-entrenched players leverage their vast experience, extensive product portfolios, and global reach to maintain a strong market presence.
Some of the prominent players operating in the Downstream Processing Market include:
Lonza Group
Thermo Fisher Scientific Inc.
Danaher Corporation (Pall Corporation)
Sartorius Stedim Biotech S.A.
Merck KGaA (Merck Millipore)
Eppendorf AG
GE Healthcare
Bio-Rad Laboratories, Inc.
Boehringer Ingelheim
In December 2024, Lonza Group partnered with a leading biotechnology company to develop and manufacture a novel gene therapy for a rare genetic disorder. Lonza's expertise in downstream processing will be crucial in purifying and isolating the large quantities of viral vectors needed for this gene therapy treatment. This collaboration highlights the growing importance of downstream processing in bringing innovative biopharmaceutical therapies to patients
In 2024, Thermo Fisher Scientific launched a new chromatography resin specifically designed for high-throughput protein purification. This innovative resin boasts a unique ligand chemistry that offers superior binding capacity and faster purification times for a wide range of protein targets. This can significantly improve the efficiency of downstream processing workflows, especially for biopharmaceutical companies working on large-scale production of protein-based drugs or therapeutics. The new resin is also designed to be compatible with high-flow chromatography systems, further accelerating protein purification processes.
In 2024, Danaher Corporation (Pall Corporation) introduced a new generation of single-use filters for improved performance and scalability in downstream processing.