Alderley Analytical: Bioanalytical Testing Innovation
Who They Are
Nestled in the inspirational calm of the Cheshire countryside is a courageous team of professionals building a clinical bioanalytical testing business. Alderley Analytical Ltd, recently founded in 2014, is poised to enter into a highly demanded but sophisticated clinical testing space for the pharmaceutical sector. Alderley Analytical has a high potential to develop an innovative approach to bioanalysis. Being a smaller company, Alderley Analytical has greater flexibility than its larger competitors to try different materials and methods. This means that the latest breakthrough in testing design may quickly place Alderley Analytical at the forefront of the bioanalysis market and perceived by customers as leaders in testing innovation.
Alderley Analytical has ready access to available laboratory infrastructure at the Alderley Park Biohub. This is a powerful asset for an exponential growth and expansion plan at nominal investment. Another valuable asset it has is its cohesive, hardworking and knowledgeable management team with over 20 years of operational and commercial experience in the field. Together, they demonstrate an aptitude for adopting new ideas, a readiness to face challenges and a passion to grow the business.
Alderley Analytical intends to pioneer the use of mass spectrometry (MS) in place of more traditional methods of clinical analysis. If successful, the MS method is capable of increasing testing volume and capacity, leading to a reduction in study leadtime and unit cost. Leveraging on the strengths of mass spectrometry, the company’s long-term objective is to develop, validate, offer and push for the regulatory acceptance of more tests based on this methodology. Together with the application of lean principles, Alderley Analytical is poised to offer far quicker turnaround times, improved productivity and increased efficiency compared with other competitors in this field.
Bioanalysis or the identification and quantification of biological and chemical entities are an integral part of pharmaceutical drug discovery. It occurs throughout the entire drug development life cycle from the research stage to the regulatory approval stage. There is a real need for small and large molecule analysis of pharmaceutical drug entities. The greatest growth in the bioanalytical market is in the area of large molecule analysis.Focusing primarily on bioanalytical services will enable Alderley Analytical to provide and expand a large specialist service offering. This is highly important in its branding strategy to be the de facto expert in this area and to position itself as the de jure laboratory to seek for bioanalytical advice. The number of potential contracts, starting at an average of 10 projects with gross revenue of £530,000 in 2015, is likely to reach an average of 145 projects with gross revenue of £9.3 million in 2019. Although Alderley Analytical now specialises in bioanalytical services tailored for the pharmaceutical industry, they have already started to develop other high-demand test services. One such service is the human dermal penetration test, which has been recently introduced by international regulatory watchdogs as a requirement for skin-contact cosmetic products.
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The Contract Research Organisation market is valued at USD$25 billion in 2011 globally and growing rapidly at a rate of 9% annually. Global revenues are expected to reach USD$38 billion in 2015. Laboratory services account for 20% of this industry with bioanalytical services accounting for 10% of the clinical test market grossing up to USD$282 million. Bioanalytical test services tend to concentrate in markets focused in drug development in the pharmaceutical sector such as the United States and the European Union. As drug development efforts increase in the pharmaceutical sector, the demand for bioanalytical services are expected to increase. This demand growth is additionally boosted as sub-contracting strategies become more popular, especially for laboratory services. With more widespread interest in medical and pharmaceutical research, especially in Asia, this demand will be driven by the need to comply with regulatory mandates and will draw an international interest or need for bioanalytical services.
Alderley Analytical Ltd, BioHub at Alderley Park, Alderley Edge, Cheshire, SK10 4TG, United Kingdom.