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International Clinical Trials

Rising to the Challenge

 

Taking a bird’s eye view of the central laboratory business reveals a global marketplace under pressure to expand as the clinical trial sector grows in size and sophistication. Today, much of the clinical development of new drugs is outsourced by the pharmaceutical industry. This outsourcing is managed by hundreds of CROs worldwide, ranging from global industry leaders such as Covance and Quintiles, to small two-person niche companies. The proportion of work that is outsourced continues to grow at healthy doubledigit rates, and now stands at nearly 40 per cent. On the other hand, laboratory pathology analysis of blood, urine or other patient specimens is outsourced almost entirely, with a few parameters, usually biomarkers, being analysed in the pharmaceutical companies’ own laboratories.

The central laboratory business is by its very nature a global one, now that the pharmaceutical industry has stepped up its drug development to an international scale. Unlike CROs, the small pathology laboratory cannot compete with the large organisations, so the vast majority of business is concentrated in the hands of relatively few players – perhaps 25 – although local hospital laboratories contribute significantly to analysis in specific cases. If any regulatory submission for drug registration is involved, safety parameters may represent 50 or even 80 per cent of the clinical data. Such data are drawn from healthy volunteers in Phase 1 studies and from patients in Phase 2, while in Phase 3 several thousand patients’ data may be obtained. Once a drug has been cleared by regulatory authorities’ marketing, companies may voluntarily, or at the behest of authorities, run post-marketing studies, which may involve limited analysis of specimens from thousands of patients.

It is often not appreciated how important logistics are to the success of the clinical trial and the role of the clinical laboratory within it. Up to 40 per cent of the cost of safety analysis, and even 100 per cent of the difficulties lie in the transportation of specimens between the patient and the central laboratory. With the globalisation of the trials industry, global logistics companies will become increasingly important.

At one time much of the pharmaceutical industry carried out its own safety analysis in its own laboratories. This changed completely some time ago, and pathology was the first analytical discipline to be centralised. Now, both imaging and ECG measurement have also been centralised. As we all know, perhaps to our cost, development in the pharmaceutical industry is one of the most regulated sectors, and central laboratories have not been neglected. Such regulation and its associated quality assurance programmes are of vital importance to the success of the central laboratory concept.

The Global Marketplace

Providers for the central laboratory market can be divided into three types.

Firstly, there are local laboratories in hospitals, clinics, pharmacies and town centres; these also include specialised laboratories in academic hospitals. Some countries, such as France and Italy, may have several thousands of these small laboratories, with at least one in every town.

Secondly, there are large national or international laboratories that serve a variety of customers, including hospitals and clinics, GPs, general industrial premises and pharmaceutical clinical trials.

Lastly, there are custom laboratories set up to analyse specimens emanating from clinical trials only; these may be of various types including standalone laboratories, subsidiaries of the large corporations mentioned above or divisions of CROs. Some Phase 1 units have established their own laboratories to give high-speed turnover to the clinic, but do not offer these services to external customers (see below for a further breakdown of this sector).

The estimation of the size of the market for central laboratories is fraught with difficulty. Today, the drug development sector of the pharmaceutical outsourcing industry is valued at over $25 billion. It is fair to say that without CROs the industry would be unable to function as it does today. And as with CROs, part of the challenge of the estimation of size of the central laboratory market is that very few central laboratories are publicly quoted, and those few that are quoted are not ‘pure play’ central laboratories. Many of the privately owned central laboratories regard annual revenue fi gures as highly confidential.

We can divide central laboratories into the following categories:

  • Companies whose only business is central laboratories (A)
  • Companies where a major part of their business is central laboratories but carry out other analytical functions for the industry (B)
  • Companies whose business is centred mainly on central laboratories, but also carry out pathology for hospitals physicians and patients (C)
  • Companies whose major business function is clinical pathology for hospitals, physicians and patients, and for whom central laboratories are a minor part of the business (D)
  • Central laboratories that are part of CROs (E)
  • Other laboratories (F)

Figure 1 shows the number of laboratories in each of these classes. We can also break down the market by type of company, as shown in Figure 2.

Based upon figures provided by pharmaceutical companies themselves and via public media, we have tried to make an estimation of the global market size for central laboratory services. We estimate that approximately 18 per cent of total R&D expenditure is spent on trials requiring central laboratories. Central laboratory expenditure in a trial has been estimated at around 10 per cent. It is estimated that the biopharmaceutical industry invested around $128 billion in 2011. Hence, using this slightly crude methodology, we can calculate that R&D expenditure on central laboratories stands at $2.2 billion.

We can also estimate the total global market via the annual revenues of the central laboratories themselves, using revenue figures from all central laboratories of which we are aware (in many cases using estimates of their annual revenues). Using these estimates, we can calculate a global market of $2.2 billion. This figure is eight per cent of the total outsourced market of CROs.

Although Figures 1 and 2 show that there are a large number of central laboratories of various sorts, we estimate that some 25 companies make up over 85 per cent of the total market (see Table 1).

 

Challenges for the Future

It has been said that successful businesses constantly assess themselves and improve all dimensions of their business; metrics are the cornerstone of their assessment, and the foundation of any business improvement. Using this dictum, the Metrics Champion Consortium (MCC) was founded in 2006 in response to a perceived unmet need in standardised laboratory performance metrics. Today the MCC continues to maintain its mission and vision, and provides a safe harbour where member organisations (virtually all the top 25 laboratories and most R&D-based pharmaceutical companies) can continue to work collaboratively to develop and implement standardised performance metrics aimed at improving the efficiency and effectiveness of managing and tracking resources needed to successfully run clinical trials. For more information, see Guy A Mascaro’s article on page 46.

Personalised medicine will be a challenge for centralised laboratories in the future. In 2011 the Industry Pharmacogenomics Working Group issued a white paper on prospective retrospective biomarker analysis, and proposed a set of conditions for conducting such analysis, along with a decision tree for generating robust scientifi c data from samples collected in an already completed trial. This kind of dialogue will be increasingly important as the pharmaceutical industry moves away from general agents towards targeting therapies that are effective in much smaller patient populations. It is clear that biomarkers should be embedded in drug development processes as early as possible, and this is a role that the central laboratories should come to relish.

A further challenge for the central laboratory business will be to keep up with the medical and technological advances surrounding increasingly sophisticated macromolecules, and run tests which today are regarded as esoteric, as routine. This will put particular strain on laboratories that have been set up specifically to deal with clinical trials, as they do not normally posess, the wide palette of analyses that some more general reference laboratories have.

Near patient or point of care testing is a concept as old as the practice of medicine. To take a specimen from a patient and test it at the bedside or in a ward sideroom, to aid the physician in diagnosis and treatment, is something that has been attempted since antiquity. Until recently this took the form of very simple tests. But point of care testing is becoming increasingly sophisticated and not only aids faster diagnosis and treatment but also leverages the faster release of patients from expensive hospital beds. From a clinical trial point of view, point of care testing can offer a number of advantages; however, the centralisation of the localised generation of results and the integration of these results into an analytical database will be a challenge for the future. Similar challenges will be offered to the central laboratories in the collection of data from diverse sources and diverse technologies, exemplified by the use of the internet in remote diagnosis and monitoring of patients.

The industry, as noted above, is becoming increasingly global. This means that increasing numbers of trials and patients are located in less developed countries such as India, China and Brazil. The use of such countries has created regulatory hurdles concerning the transportation of samples outside the country of origin if the managers in that country decide that a truly central laboratory is to be used, with samples being analysed at a single location. Such difficulties have forced sponsors to consider the use of central laboratories that have in-country facilities, and to persuade other central laboratories to set up local laboratories or develop collaborative arrangements.

Conclusion

It is our view that the central laboratory business will continue to grow as clinical trials grow in size and sophistication. Whether this will lead to an increase in annual revenue, as the conflicting pressures from central laboratories clients increase, is more uncertain. It may also become even more centralised as the power of the large organisations increases. Laboratory techniques and IT in particular will also be involved, as will the analysis of biomarkers. One of the future challenges for this industry will be the tsunami of data generated in a trial. The processing of these data quickly and cost-effectively will be one of the major motifs for the future. However, the symbiotic relationship between sponsored clinical research and the central laboratories business will continue to be key to drug development, and will help to ensure that patients in trials are kept as safe as possible while ensuring that the drugs patients need are effective and safe.

As biological new medical entities increase we can expect that more sophisticated analytes will be determined, which will also increase the price of the analysis. We also expect the bioanalysis of patient samples to increase, leading to a convergence of the traditional central laboratory with the bioanalytical laboratory. Given this scenario, with trials becoming more sophisticated and analytes becoming less conventional, we can foresee that smaller players, particularly those without much in the way of general medical business, will be threatened by the major players. Threats of this kind have traditionally been met with consolidation of small players or their absorption by the market leaders. We would expect a similar response in the future along with mergers of some of the smaller companies and/or their acquisition by market leaders.


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Graham Hughes and Richard Barrett are co-editors of Central and Core Laboratories 2011, a 320-page report obtainable from Graham.

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Graham Hughes
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Richard Barrett
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