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Given its global position as the leading type of lung cancer and now also the leading cause of death (having recently overtaken heart disease), NSCLC is invariably an important therapeutic area. However, the number of approved therapies has recently increased, with patent expirations also nearing for some products. As a result, improved therapeutic efficacy and applicability to patient subgroups will play a particularly crucial role in terms of successful product placement in an increasingly price-conscious market. Collaboration with public health authorities and indication extensions of existing treatments will inevitably be sought as new market placement opportunities.
NSCLC comprises the vast majority of all lung cancer cases, a testament to its importance as a therapeutic and commercial target.
The estimated value of the global NSCLC market is US$3bn, with a 2010-2015 forecast compound annual growth rate (CAGR) of around 10%. ^ok to use 2010-2015, rather than 2009-2015?^
The fragmented marketplace is characterised by high unmet need and poor overall survival rates (usually below 12 months, partly due to late diagnosis) of NSCLC patients, with those factors continuing to drive interest in the development of new - increasingly improved and personalised - therapies.
Key developments over the past 12 months include recommendations that Eli Lilly's Alimta (pemetrexed for injection)'s and Roche's Tarceva (erlotinib)'s indications be extended to maintenance therapy for NSCLC, which will also extend their potential patient reach.
The coming years will pose new regulatory, as well as clinical and patent expiration issues, as fund-holders become more selective about approvals, both on the basis of - including comparable - cost and safety.
In fact, head-to-head studies measuring therapeutic efficacy and cost-effectiveness of competing treatments will be increasingly used to determine reimbursement pathways for both new and existing products.
Products offering superior clinical efficacy and tolerance will be in an advantageous position regarding their less effective competitors, although the price and overall treatment cost will remain important considerations.
Nevertheless, a number of competing therapies can actually be used to treat the same NSCLC patient through different stages of the disease, depending on factors such as tolerability, the need for for first- or second-line treatment and price, which should result in few outright 'losers' in the marketplace.
Medical advances in molecular biology and related fields are providing opportunities for the development of treatments for particular subgroups of patients, which are likely to be increasingly explored by drugmakers.
In particular, NSCLC vaccines, which would be used to treat rather than to prevent the condition, have the potential to become the new gold standard for NSCLC treatment, especially given their - as currently reported - limited side effects.
NSCLC Market Overview
Non Small Cell Lung Cancer (NSCLC)
NSCLC is a term used to denote a group of lung cancers characterised by similar cancer cell structures, which grow and spread more quickly than those of small cell lung cancer. The three main types are squamous cell carcinoma (usually affecting the centre of the lung, near bronchus, and representing around a third of all NSCLC cases), adenocarcinoma (affecting outer lung areas, and accounting for around 30% of NSCLC cases), and large cell carcinoma (can occur anywhere in the lung and spread faster than the other two types).
Most common causes of NSCLS include smoking, radiation, air and water pollution and working in professions that frequently require contact with asbestos and similar chemicals. Symptoms of NSCLC vary, but can include chest pain, weight loss, fatigue and persistent cough, although early-stage cancers often do not have any symptoms.
According to figures published by the American Cancer Society and other leading global expert groups on the subject, NSCLS accounts for between 80 and 90% of lung cancer cases reported globally, thus affecting up to 1.5mn people. Lung cancer itself is the leading cause of cancer deaths worldwide (estimated at around 30% of the total), both in men and women, ahead of the number of deaths from - combined - breast, colon and prostate cancers.
Treatment varies on the stage of the particular NSCLC and can include surgery, chemotherapy (accounting for around two-thirds - but fast falling in importance - of all treatments), and radiation and laser therapy. A number of modern pharmaceuticals - including biologics - are also used in combination with other types of therapies. In the United States (US) alone, each year around 100,000 patients undergo drug therapies for advanced NSCLC.
We calculate the current value of the global NSCLC market to be in the region of US$3bn. Placing the figure into perspective, in 2009, IMS Health reported that the total sales of oncology drugs reached US$55bn. In the previous year, the same source shows that code L (antineoplastic and immunomodulating agents, which includes oncology treatments) of the Anatomical Therapeutic Chemical classification were worth US$74bn. Given that most existing cancer therapies are currently used for more than one type of cancer, it is difficult to correctly calculate sales achieved for each individual indication. Nevertheless, given the astronomical annual cost of modern cancer drugs - of upwards of US$50,000 per patient - it is clear that the NSCLC market holds much commercial potential.
Table: Value of the Global NSCLC Market
Annual Growth Rate
Source: ^Global Insight - that's correct, no?^ estimates and calculations
Industry experts suggest a variety of NSCLC annual growth rates going forward, with a consensus seemingly being in the range of some 11-14% through to 2015. We also suggest an upward trajectory of growth, but based on a lower 2010-2015 compound annual growth rate (CAGR), which we calculate will barely touch double digit figures. The key reasons behind this calculation include patent expirations, pipeline failures, and the fact that the public fund-holders have tightened their belts, especially in the aftermath of the global economic crisis, and are now making more cautious and restrictive reimbursement decisions.
Graph: Annual Development of the Global NSCLC Market Values
Source: ^Global Insight - that's correct, no?^ estimates and calculations
In fact, market development will be shaped by a combination of factors. On the positive note, growth will be boosted by a strong pipeline of new products (including those offering better therapeutic efficacy and safety profiles) and the increase in the number of NSCLC cases (both relative and absolute, due to better detection rates and population growth, respectively). An increase in patients' awareness of new treatments and their trust in modern therapies will also drive the uptake of new NSCLC products.
On the other hand, funding restrictions - given the high cost of modern treatments, most patients inevitably rely on state reimbursement - patent expirations and the lack of irrefutable proof of the superiority of some products over their competitors will continue to hamper value development of the NSCLC market. An additional issue is that of negative press surrounding the pharmaceutical companies' financial involvement in the clinical trials that provide data in support of their own products, which has already made regulatory authorities more cautious.
Key Approved Therapies
Although mostly based on the combination of chemotherapy agents, such as taxanes and antimetabolites, standard treatment options for NSCLC tended to vary between countries. For example, in the US, the standard initial therapy was based on the combination of carboplatin and paclitaxel. In Europe, chemotherapy regimens based on combinations of vinorelbine, gemcitabine, docetaxel and pemetrexed, with cisplatin rather than carboplatin, were more frequently used, similarly to treatment choices available in Japan and elsewhere in Asia.
Table: Key Pharmaceuticals Used for the Treatment of NSCLC
Points of interest
Alimta (pemetrexed)/Eli Lilly
Available as first-line in the European Union (EU) and the US, in combination with cisplatin, but never for patients with squamous disease. On the other hand, highly effective in non-squamus patients (who are often non-squamous), which provides therapeutic advantage over competitors. Recently recommended as maintenance therapy. Cheaper than Avastin.
Avastin (bevacizumab)/Roche (Chugai)
First-line tyrosine kinase inhibitor (TKI), used in combination with chemotherapy for the majority of non-squamous NSCLC. Not approved as second-line. In November 2009 approved for NSCLC treatment in Japan (NSCLC approvals in the US and Europe gained in 2006 and 2007, respectively). Also approved for other indications, including colorectal cancer. Better tolerated than Alimta.
Erbitux (cetuximab)/ Merck Serono (Bristol-Myers Squibb)
18-week treatment costs in the region of US$80,000 per patient, used in combination with platinum-based chemotherapy. Facing generic competition. Recently rejected in Europe as the treatment of EGFR-expressing, advanced or metastatic NSCLC in combination with platinum-based chemotherapy.
Gemzar (gemcitabine)/Eli Lilly
First-line therapy facing generic competition imminently, although a reprieve possible. Approved for treatment of other types of solid tumours.
First-line oral EGFR TKI. However, one of the clinical trials testing Iressa against placebo (the Iressa Survival Evaluation in Lung Cancer (ISEL) trial) found no significant median survival differences; similar findings from the gefitinib versus docetaxel in the second-line setting resulted in Iressa no longer being available in the US to new cancer patients. In 2009, Iressa launched in the EU, at a cost of around EUR3,500 (US$5,000) for a one-month course, which is mostly subsidised by state and/or health insurance authorities. UK's authorities recently determined that Iressa be compared with against platinum-based chemotherapy in combination with Lilly's Gemzar, docetaxel, paclitaxel, or vinorelbine; Alimta in combination with platinum-based therapy; and best supportive care.
Tarceva (erlotinib)/Genentech/OSI (Roche)
Also an EGFR TKI (second-line oral therapy for all types of NSCLC), with clinical trials indicating its therapeutic efficacy and improved survival rates in second- as well as third-line settings. Recently recommended in Europe as maintenance therapy, but only for a particular patient subgroup. Relatively few major side effects. Not effective in the K-ras patient population.
First-line therapy for all types of NSCLC, on which patent protection due to expire soon. Also one of leading breast cancer therapies.
Advances in molecular biologics and genetics over the past decades have lead to the detection of overexpression of the epidermal growth factor receptor (EGFR), among other anomalies, in NSCLC patients. It appears that around 10% of NSCLC cases are caused by EGFR mutations. Mutation of the ras family of oncogenes is also responsible for the development of NSCLC, with K-ras, N-ras and H-ras patients likely to respond differently to the same treatment. Around 30% of adenocarcinoma patients have some kind of ras mutations, which have - interestingly - to date not been detected in non-smokers. In line with such information, targeted and personalised therapies are expected to play an increasing role in the NSCLC market over the coming decade.
Graph: Type of NSCLC in Global Patients
Source: ^Global Insight?^ estimates, Hammer Stock Blog ^(found something similar on http://www.hammerstockblog.com/the-winner-of-asco-2009/, presume it's ok to quote?^
In fact, biologics specifically designed to address EGFR disturbances as well as oncogenes' amplification or inactivation have become the forefront of NSCLC treatment, as they allow for a more targeted approach on a cellular basis. These new chemotherapy agents - including Eli Lilly's Gemzar (gemcitabine) and Alimta (pemetrexed) - are now considered as the standard of care, in combination with cisplatin and carboplatin. They can also be used on top of or instead of Sanofi-Aventis' Taxotere (docetaxel) and paclitaxel (BMS's Taxol, patent expired). However, their high cost (of both production and use) - in addition to considerable negative side effects - has hampered their higher uptake.
The above issues need to be addressed with some urgency, as the number of expanded indications of existing NSCLC products has been recommended in recent months. Nevertheless, NSCLC drugs are increasingly being used to target specific patient subgroups, based on factors such as race, gender, type of genetic mutations and the stage of cancer spread, which should provide some room for manoeuvring. On the other hand, other existing oncology products (such as Bayer Schering/Onyx's Nexavar) used for other types of cancer are increasingly being explored as potential NSCLC therapies, which will increase competition.
The race is heating up in the face of patent expirations looming large over Sanofi-Aventis' Taxotere (docetaxel), Eli Lilly's Gemzar (gemcitabine) and Bristol-Myers Squibb's Paraplatin (carboplatin), all due to lose their protection before 2012.[Rough estimate of combines sales of these drugs pre-patent expiry] On a positive note for patent-holders, in April 2010, Eli Lilly's compound patent on Gemzar was upheld by a District Court in the US, with its validity now in effect until 15 November 2010. Moreover, the company is appealing the previous ruling that prevents it from enforcing a separate 'method-of-use' patent. If successful, Eli Lilly could protect its product until 7 May 2013.
In the meantime, NSCLC drug manufacturers continue demonstrating the therapeutic efficacy of their products in a bid to extend their commercial applicability and thus value. A recent SATURN trial, for example, showed that Roche's Tarceva (erlotinib) met a secondary endpoint of extending overall patient survival when administered immediately after chemotherapy, rather than following tumour regrowth. The uptake of Tarceva remains conditional, due to its sizeable price tag, despite the fact that it seems to be particularly effective in prolonging survival of some 10% of NSCLC patients that suffer from a mutated form of EGFR. On a very positive note, in March 2010, Tarceva received European Medicines Agency (EMEA)'s recommendation as a first-line maintenance treatment in advanced or metastatic NSCLC, which means that the product can be used in patients whose disease has stabilised after four cycles of treatment with first-line therapy.
The above decision will provide some respite to the drug's manufacturer, Roche, as the US regulatory authority, the Food and Drug Administration (FDA), refused to recommend Tarceva as first-line maintenance therapy for advanced NSCLC.However, , the FDA has recently allowed a three-month extension for the final review, following the filing of new data by Roche-owned OSI Pharma and Genentech.
First-Line, Second-Line, Maintenance Therapies
First-line treatment refers to the original therapy used to medicate patients. If a disease re-occurs, a second-line option is used, with around half of patients progressing to this stage (due to factors such as tolerability of side effects). Less than half of second-line patients receive third-line therapies, indicating the importance of market placement from a commercial point of view. Physicians usually change their products of choice from first- to second- and again to third-line treatment, which also limits commercial opportunities for drugmakers.
Maintenance therapy is a new type of treatment referring to drugs administered to patients straight after chemotherapy, without waiting for the condition to re-occur. In regard to NSCLC, maintenance therapy has been validated in clinical trials, which has likely softened regulatory authorities' stance on the use of such expensive products. However, only around half of all first-line patients are eligible for maintenance therapy, as they must record disease stabilisation or certain clinical responses.
The NSCLC market landscape is mostly served by a handful of players, although none of them seem to be in a position of dominance. This situation has largely arisen from the fact that none of the existing products can claim to be the perfect treatment for NSCLC - neither in terms of therapeutic efficacy nor from the funding point of view. Additionally, depending on the stages of NSCLC in particular patients, more than one product can be used during the treatment cycle.
Nevertheless, among the ten or so leading participants in the field, Roche (with Tarceva and Avastin) and Eli Lilly (with Gemzar and Alimta) have emerged as the strongest players. Other participants include AstraZeneca (with Iressa), Sanofi-Aventis (with Taxotere) and Bristol-Myers Squibb (with Ertibux). Most leading global drugmakers - including Pfizer - are also interested in the NSCLC field, given the potential returns, although smaller companies, such as Abraxis BioScience, have been making more of a mark in the pipeline arena.
Graph: NSCLC Market Value by Company (2010)
Source: ^Global Insight^ estimates
Outside developed markets, there are a few other treatment options for NSCLC. For example, Simcere - China's leading domestic drugmaker - appears confident that its oncology agent Endu/Endostar (recombinant human endostatin injection) will be included in the country's national health insurance reimbursement listing. The company recently reported positive Phase IV post-marketing trial results for its product, which inhibits the growth of cancer by starving it of oxygen and other nutrients, in combination with standard chemotherapy regimens. Endu also does not appear to result in significant increases of the side effects caused by chemotherapy, which should provide it with a significant marketing advantage. Endu has been registered in China as an NSCLC treatment since 2005 - under the class I, innovative category.
Key Pipeline Therapies
The pipeline for NSCLC drugs is considerable, with candidate products targeting different phases of the condition, using different methods of action (for example, ArQule's ARQ 197 targets c-Met inhibitor - in combination with Tarceva - which recently completed Phase II trials) and administration, and offering improved formulations of existing products. The fragmented marketplace and the largely unmet need for effective NSCLC therapies - given the disparate requirements of different patient subgroups - provide plentiful opportunities to newcomers with successful offerings.
According to various sources and estimates, the NSCLC clinical trials pipeline currently numbers over 100 products, thus representing one of the most dynamic cancer research areas. Global pharmaceutical majors are also increasingly partnering smaller biotech firms, licensing out their early-state product candidates. We suggest that five new agents may reach the market by 2015, including at least one vaccine, although they will inevitably remain used in combination with existing products and possibly only by small patient subgroups.
In fact, many of the pipeline candidates are first-in-class products, which means that their uptake is initially likely to be cautious - especially if they carry a premium price - until larger post-launch efficacy and safety studies have proven their worth. Nevertheless, therapeutic shortcomings of the existing therapies clearly make the NSCLC market landscape a promising commercial target, with the current market leaders likely to struggle to maintain their shares, unless they also improve their product offering.
Current Pipeline Leaders
Bayer Schering/Onyx's Nexavar (sorafenib) was recently entered into a new Phase III trial. The candidate is being tested on non-squamous NSCLC patients who have failed to respond to at least two, if not three, previous attempts at treatment with different therapies. The product is already avaialble in major markets as the treatment for renal cell carcinoma and hepatocellular carcinoma. Nexavar is also being developed separately as a potential treatment for breast, ovarian, and colorectal cancer.
French biotech Transgene has been given US approval to commence Phase III clinical trials on TG4010, which is being studied as a treatment for advanced NSCLC in patients with a normal level of activated Natural Killer (NK) cells before treatment. Phase IIb trial results revealed improved survival rate of patients treated with TG4010, with all other parameters tested also showing increased clinical benefit for NK subgroup of patients. The French company is looking for investors, who would provide further research funding.
Cell Therapeutics is currently undertaking Phase III trials of a new formulation of paclitaxel, in partnership with Novartis. Its Opaxio candidate, however, had already suffered a set-back, with discouraging results preventing a New Drug Application (NDA) filing. On a positive note, the company is now targeting specific patient subgroups (women suffering from ovarian cancer and NSCLC) with its candidate, which may prove more fruitful.
In April 2010, ArQule released Phase II trial results for ARQ 197, when used in combination with Roche's Tarceva. In patients with advanced, refractory NSCLC, progression-free survival (PFS) in the ARQ 197 plus erlotinib trial was longer than in the erlotinib plus placebo trial, although the difference does not appear to be statistically significant. On the other hand, statistical significance for PFS was achieved for the pre-defined sub-group of patients with non-squamous histology. Clearly, molecular and genetic advances are increasing the potential for better targeting of patient subgroups, which will also require better diagnostic tools and thus lead to further commercial opportunities.
Other candidates touted for success include Amgen's EGFR-targeting pantitumumab, which has a favourable toxicity profile and is targeting first-line setting, and Abraxis BioScience's Abraxane, which represents an improved formulation of paclitaxel (as Opaxio). In March 2010, Abraxane (as first-line treatment) was reported to have met its Phase III primary endpoint, when in comparison to Taxol (both in combination with carboplatin). The developer is planning to submit a supplementary NDA (sNDA) application for the first-line indication during 2011. Abraxane, which uses a proprietary albumin-based nab platform, is already marketed as a solvent-free chemotherapy for metastatic breast cancer.
In the meantime, Human Genome Sciences was making headway with its first-line therapy mapatumumab (HGS-ETR1), although the March 2010 publication of Phase II results showed little improvement in combination with paclitaxel and carboplatin. Otherwise, Spectrum/GPC and BMS are in the race with second-line therapy satraplatin (Phase III) and epothilone analogue BMS-310705 (Phase II), respectively.
Most recently, clinical work commenced on vaccines against NSCLC, although no such products are yet close to commercialisation. In contrast to standard vaccines used against infectious diseases, NSCLC vaccine candidates would not be used to prevent the cancer, but rather to treat it. Specifically, vaccines would be used to boost the body's immune system so that patients themselves can effectively fight their cancers.
Clearly, the commercial potential of vaccines would be substantial, as they would significantly reduce the need for lengthy hospitalisations and drug regimens, although they must prove their clinical efficacy without a doubt. Early clinical trials seem to suggest that side effects of NSCLC vaccines are limited, which would make them extremely suitable to those patients who are intolerant of other systemic therapies.
To date, the most promising vaccine candidates include Merck KGaA's Stimuvax (targeting inoperable advanced NSCLC), which is in competition to be first-to-market with rival companies such as Transgene, Dendreon Corp and Antigenics. Stimuvax is expected to be launched as early as 2012, and could change the commercial landscape, provided the drug proves itself therapeutically and gains the trust of both professional and patient communities.
However, further human testing of Stimuvax (based on the active ingredient LBLP25) was suspended in March 2010, after a patient participating in a Phase II arm of the multiple myeloma trial (in combination with cyclophosphamide, unlike in other studies) contracted encephalitis. Merck KGaA, which is co-developing the vaccine in collaboration with Oncothyreon, had already commenced Phase III trials in the field of NSCLC. Originally, Phase II NSCLC data showed only mild side effects (nausea and injection site reactions), which such a safety profile could have potentially provide a major advantage for the vaccine's commercialisation.
Pipeline Candidate Failures
Despite considerable promise and funds ploughed into research and development of new therapies, clearly not all candidates can be brought to commercialisation. In October 2009, AstraZeneca admitted defeat and withdrew its US and EU regulatory filing for Zactima (vandetanib), which was indicated for the treatment of advanced NSCLC. The decision was made following the assessment of clinical data that showed no improved overall survival in patients using Zactima in combination with chemotherapy. The development represents a major drawback for the company with a flagging pipeline. However, AstraZeneca, which had touted Zactima as a treatment for a number of cancers in addition to NSCLC, is still planning to finalise Phase III studies in order to provide a more comprehensive overview of the drug's clinical effectiveness.
Around the same time, BMS, which partnered the candidate's developer Celltech, pulled the plug on the development of an NSCLC selective matrix metalloproteinase inhibitor (BMS-275291). The product, which was studied in combination with Taxol (paclitaxel) and Paraplatin (carboplatin), did not show enough promise to meet its required efficacy endpoint.
Another major surprise was the recent failure of Pfizer's figitumumab (CP-751,871) as a Phase III treatment for patients with previously treated non-adenocarcinoma NSCLC. The candidate was being studied in combination with erlotinib as a second- or third-line treatment, but showed no statistically significant improvement in the overall survival endpoint when compared to erlotinib alone. Although Pfizer is committed to studying figitumumab for other indications as well as to finding the right patient population to study the compound, the company is now losing ground to competitors with more advanced NSCLC clinical programmes.
Nevertheless, in H209, Pfizer advanced its investigational compound (PF-02341066) into Phase III clinical study for the treatment of advanced NSCLC with anaplastic lymphoma kinases (ALK) fusion gene and progression on a platinum-based chemotherapy. The candidate, will be tested in the late-stage study compared with pemetrexed or docetaxel for PFS as the primary endpoint. The company's NSCLC oncology pipeline also includes early-stage clinical trials for axitinib (AG-13736) - in combination with paclitaxel/carboplatin or gemcitabine/cisplatin (discontinued after Phase III for pancreatic cancer indication) - and pan-HER inhibitor (PF-00299804, which is currently in Phase II trials).
Other NSCLC candidates that have recently failed include ASA404 (DMXAA) from Antisoma, which in March 2010 discontinued Phase III development of the investigational lung cancer compound. The drug, which was being developed in collaboration with Swiss pharma major Novartis, reportedly showed no or little survival benefits. Similarly to Pfizer's case, the scrapping of this late-stage programme will represent a major set-back in the new product race to reach the NSCLC market, as well as a major financial burden. Antisoma and Novartis had previously planned to file for regulatory approval by 2011.
Pricing and Reimbursement Issues
Clinical and cost-effectiveness data have become increasingly important as a determinant of the scope of reimbursement decisions, especially regarding expensive NSCLC drugs, which can often only prolong life marginally rather than cure the condition. In August 2009, the UK's healthcare guidelines and guidance organisation, the National Institute for Health and Clinical Excellence (NICE), recommended Eli Lilly's Alimta (pemetrexed) as first-line maintenance NSCLC treatment, with the positive final appraisal in April 2010 moving the product closer to reimbursement listing.
The documents show that the cost per National Health Service (NHS) patient would amount to £12,076, based on £800 (US$1,219.6) for a 500-mg vial excluding value-added tax (VAT) calculations. The approval recommendation is based on the so-called end of life criteria, under which NICE can take into account the benefit of treatments that can extend life in patients with short life expectancy or in cases when the drug is licensed for indications affecting very few patients with incurable diseases. The JMDB trial showed that Alimta has lower incidences of febrile neutropaenia and alopecia, as well as lead to shorter infusion times and fewer hospital visits, than Gemzar, also manufactured by Eli Lilly.
Also in 2009, the EU's regulatory authority EMEA rejected Merck Serono's application for its product Erbitux to be used - in combination with platinum-based chemotherapy - in the treatment of EGFR-expressing, advanced or metastatic NSCLC. The decision was based on the judgement that the drug's progression-free survival (PFS) benefits do not outweigh its risk of side-effects, although it is not clear which studies were used for assessment. Merck Serono's sales of Erbitux - which is indicated for colorectal, head and neck tumours - achieved a 15% year-on-year (y-o-y) increase, with sales reaching EUR332mn (US$473.2mn) in H109. In the US, the drug is marketed by BMS and ImClone.
More recently, a study - published in the Journal of Oncology Practice in early 2010 - found that evidence-based care can save as much as 35% of the annual NSCLC treatment costs. The study, conducted by US Oncology and health insurer Aetna, is reportedly the first project that empirically measured the cost-effectiveness of evidence-based treatment guidelines for cancer treatments. Clearly, as many advanced nations are increasingly using evidence-based medicine for treatments in the public sector, proving cost-effectiveness and therapeutic efficiency of their products has become a necessary task for drugmakers.
Outlook and Implications
Drugmakers competing in the NSCLS field are dealing with an increased number of challenges posed not only by therapeutic considerations, but also by changes in pricing and reimbursement policies of major users/funders of their products. Consequently, the importance of differentiating their medicines from competitors - be it on efficacy or on price or on a combination of these- is a must for their successful placement on the market.
The richness of the clinical pipeline programme in the field of NSCLC is a testament to the companies' commitment to this therapeutic field. Medical and genetic advances are increasing the number of potential therapeutic targets, which also providing developers with better-defined patient subgroups. In the coming years, this trend of working towards more 'personalised' therapies will increase, leading to the rising number of biologics being used in the NSCLC field, at the expense of chemotherapy.
In terms of the NSCLC marketplace, the fact that a single patient can be treated with a number of competing therapies during the continuum of care will mean that each company and each product can theoretically carve a niche for themselves. Much will, however, depend on their therapeutic applicability to particular subsets of patients. On a positive note, a related commercial opportunity in this area is the development of appropriate diagnostic tools for the purpose of determining suitable target audiences.
The extension of some existing NSCLC products' indications to maintenance therapies for the condition is also a significant victory for their drugmakers, especially as leading first-line therapies are facing both generic competition and the launch of new first-line medicines. However, clearly, safety and cost considerations - now more frequently determined on the basis of head-to-head competitor comparisons - will retain their importance. Companies will need to prove substantial improvements in PFS and survival rates in order to justify reimbursement placement of their costly therapies, which will inevitably require tricky pricing negotiations with public health authorities and purse-holders.