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Pharma Landscape: Mapping the Research Focus

The pharmaceutical industry has witnessed many developments over the last decade. International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has predicted that the pharmaceutical industry will reach approximately USD 1,200 billion by 2016. Some recent emerging phenomena have been the rise of Antibody Drug Conjugates (ADCs), development of bolus injectors, ongoing rise of sustained release medical devices and the gradual emergence of 3D bioprinting. 

 

Roots Analysis has been at the forefront of these developments. We have been regularly tracking these developments as a part of our effort to provide comprehensive and insightful opinion of the leading trends and the likely future industry evolution. As a continuation of our efforts, we decided to put together an extensive list of research programs which are currently in progress by leading pharmaceutical firms worldwide. The intention of this exercise was to identify research areas which are backed up financially and where most of the research money is being spent. In addition, we also wanted to highlight the key winners based upon a high level analysis of the development pipelines of respective companies.

 

 

OBJECTIVE

 

This compendium of facts and figures analyses the present pharmaceutical research landscape from the following three perspectives:

  • Overall health of company specific research programs
  • Distribution by phases of development
  • Distribution by therapeutic areas

 

Our research covered the most sought after therapeutic areas such as cancer, cardiovascular & metabolic disorders, neurological disorders, immunological disorders as well as the lesser known areas such as blood disorders, virology and genetic disorders. The information that we captured for each pharmaceutical firm also included mechanism of action and specific indication areas. This data allowed us to present a ‘big picture’ on research programs of leading pharmaceutical firms covering strength of the research pipelines; this also allowed us to answer the basic queries around how many molecules are in advanced clinical trials and how many molecules have been filed for NDA (New Drug Application) and likely to be approved for marketing in near future.

 

We hope that sharing this analysis on the most recent and relevant facts & figures can add value for evidence-based policy making and future perspectives of investment in global health arena.

 

 

SCOPE AND METHODOLOGY

 

Data Gathering

For the purposes of this exercise, we restricted ourselves to the research programs of the top 75 pharmaceutical companies in the world (by sales). The main source of data was information presented in the research and development pipelines on the websites of respective companies. In total, we gathered data for 1,694 clinical trials. It is important to mention that we trusted the information presented on the company’s websites as the most accurate source of information and haven’t verified the information (or included additional information) from other publicly available databases (e.g. www.clinicaltrials.gov). The information which has been gathered is updated as of June 2014.

 

Analysis and Presentation

Once the raw dataset was ready, we analysed the overall research pipeline to identify a global snapshot of key focus areas. For the top 10 companies (ranked by number of clinical trials), we also zoomed in to provide additional details on their respective research programs. The details on these 10 companies are presented at the end of this whitepaper.

 

 

KEY TAKEAWAYS

 

Top 25 Pharmaceutical Companies by Global R&D Investment

Though the estimates vary, a quick search on Wikipedia lists around 175 pharma companies in the global market. Research and development is an integral part of any pharmaceutical company. R&D capabilities are regarded as a vital component of business strategy that provides a sustainable and long-term competitive advantage.

 

As a starting point, we identified the top 20 pharmaceutical companies on the basis of following three parameters (Table 1):

  1. By revenues
  2. By R&D investment
  3. By number of clinical trials in their research and development pipelines

 

As expected, 15 companies appear in the top 20 list of all the three parameters mentioned above.  These are Amgen, Astellas, AstraZeneca, Bayer, BMS, Daiichi Sankyo, GSK, Johnson & Johnson, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi and Takeda. In all of these companies, a significant proportion of the annual budget is spent on research. As a result, these companies have a number of molecules in advanced clinical stage of development.

 

TABLE 1 Pharmaceutical Companies: Global Rankings based on Revenue, R&D Investment and number of Molecules in Clinical Development

 

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Source: Roots Analysis

 

Roche and GSK have the most advanced research program

On the basis of total number of clinical trials for all the molecules in clinical development, we identified that Roche, with 108 clinical trials, leads the pack (Figure 1). This is, by far, the most elaborate program that any research company had as of June 2014. In 2013, Roche invested CHF 8.7 billion in R&D to produce valuable medicines and diagnostic tests that provide significant benefit to the medical community. A focus on targeted medicines and diagnostic tests has allowed Roche to expand its strong market position. The firm registered revenues worth CHF 36.3 billion in 2013; cancer medicines accounted for 62% of pharmaceutical sales.

 

It is important to highlight that the company has a very advanced development pipeline for Antibody Drug Conjugates (ADCs), one of the most important emerging area of therapeutics. The company, in collaboration with Seattle Genetics, has as many as 10 ADCs in Phase I, II, and III of development.

 

FIGURE 1 Leading Pharma Companies: Strength of Research Pipelines

 

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Source: Roots Analysis

 

 

Next in the line is GSK. The company claims to have accounted for 19% of the FDA new drug approvals during 2013. In addition, GSK’s pipeline has around 40 new molecular Entities (NMEs) in Phase II/III of clinical development. The firm boosts of a 13% internal rate of return on its R&D investments.

 

In 2013, GSK’s core R&D expenditure was GBP 3.4 billion. These targeted investments helped GSK achieve a global group turnover of GBP 26.5 billion during last year. Of  this,  GBP  17.9 billion was accounted for by the firm’s pharmaceutical division. Within pharma, the most important therapeutic area was respiratory, accounting for 42% of sales. This was followed by cardiovascular and urogenital, which registered 12.5% of sales. Figure 1 highlights the top 10 companies ranked by number of molecules in clinical development.

 

Molecules are well distributed in different phases of development

We looked at distribution of molecules in terms of their stage of clinical development. For simplicity, we reviewed the five categories, as listed below:

  • Filed
  • Phase 3
  • Phase 2
  • Phase 1
  • Others

 

The ‘Others’ category primarily includes molecules for which the phase of development hasn’t been revealed on the respective companies’ websites.

 

As evident from the Figure 2, Phase III, Phase II and Phase I account for 26%, 28% and 25% respectively of the total trails in the clinical pipeline for all therapeutic areas.

 

 

FIGURE 2 Global Pharma Research: Distribution of Number of Clinical Trials by Phases of DevelopmentOncology remains the most focused therapeutic area

 

                             All Therapeutic Areas                                                                     Oncology 

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Source: Roots Analysis

 
As evident from Figure 3, oncology is the primary therapeutic area which has garnered the focus of most of the companies. According to WHO, there are around 8.2 million instances of deaths from cancer annually. 25% of reported cases are breast cancers and lung cancers. It is estimated that in 2014, there will be 1.7 million new cancer cases and more than half a million deaths due to cancer in USA alone. The annual cancer cases are estimated to rise up to 22 million within the next two decades. Keeping these statistics in mind, pharmaceutical companies have earmarked a major proportion of their R&D investment on cancer related research.

 

Apart from Oncology, other prominent therapeutic areas include Neurology & Pain, Inflammatory & Immunological, Cardiovascular & Metabolic, and Respiratory & Related Disorders.  It is  important to mention that some molecules, for which therapeutic area has not been confirmed or not provided in company’s research pipelines, have been placed under the ‘Others’ category. 

 

Figure 2 makes these interpretations specific to oncology area. There are  533  clinical  trials related to oncology which are in progress (from about 75 companies studied for this paper). It is noteworthy that out of 533 clinical trials, 153 potential drug candidates are already in Phase III and 23 have been filed for NDA (New Drug Application). 

 

 

FIGURE 3 Global Pharma Research: Distribution of Number of Clinical Trials by Therapeutic Areas

 

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Source: Roots Analysis

 

 

CONCLUDING REMARKS

 

The biopharmaceutical industry is likely to continue its growth at a healthy pace. With advancements which have recently taken place, key stakeholders have invested significant amount of money in their respective research programs. Clearly, Oncology is the area where leading pharma companies have laid their prime focus; a major proportion of potential drug candidates from firms such as Roche and Pfizer fall in this area. As mentioned earlier, the rise of ADCs and other such molecules are likely to provide the necessary impetus in the mid-long term. Apart from the growing focus on oncology specific molecules, there have been a number of other developments in the industry. These include the emergence of new drug classes such as PCSK9 inhibitors (for treatment of cardiovascular heart diseases) and the emphasis being laid on innovative drug delivery devices such as bolus injectors. It is safe to conclude that, in the coming decade, a large number of new drug candidates are likely to be made commercially available to cater to some of the most pressing unmet needs in the industry.

 

In the subsequent pages of the actual whitepaper (which you will receive upon request), we have provided additional details on research pipelines of ten major pharma companies. For each specific company, we have looked at the distribution of molecules in clinical development by therapeutic areas and phases of development. In the tabulated Phase III molecules for each company, the same molecule may be undergoing trials for multiple indications.

 

 

 

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