Gemcitabine HCl: A Novel Anti-Cancer Drug
The global healthcare space has made phenomenal strides over the years, and cultural shifts, policy adjustments, and cost of care have contributed to a more patient-empowered shift in care delivery systems. As cancer is becoming one of the most expensive diseases to treat, the implementation of clinical pathways in oncology is gaining its very own eminence, which serves as an important tool in reducing variability in care delivery, improving outcomes, and controlling costs.
As several chemotherapy compounds have demonstrated activity against human malignancies, and fillings for Abbreviated New Drug Application (ANDA) have increased, the gemcitabine HCl market necessitates a thorough understanding and unbiased analysis. Transparency Market Research (TMR), in its new research study, brings to fore compelling insights and dynamic analysis to help its readers gain an in-depth understanding of the gemcitabine HCl market behavior in 2019 and beyond.
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Evolution and Future Prospects
The use of gemcitabine HCl has come a long way since it was studied in clinical trials during the early 1990s and approved for medical use in 1995. In view of its low-toxicity profile, gemcitabine HCl became an ideal candidate for the treatment of the ailing and elderly population suffering from advanced non-small cell lung cancer (NSCLC). The worldwide sales of gemcitabine HCL closed in on US$ 500 million in 2018, and companies with a strong position in the market have gained the first-mover advantage. However, leading gemcitabine HCL market players are also put to test, as the significant rise in the demand for generic drugs has compelled the U.S. and European Union to update the import policies and legal cGMP requirements for API manufactures.
Generic Gemcitabine HCl Remains the Preferred Choice
The sales of generic cancer drugs are gaining strength in price-sensitive countries such as China, India, and Brazil, as the huge gap between the number of new cancer cases and cancer survivors initiates a surge in the acceptance of generic gemcitabine HCl. The year 2010 remains important in the context of generic versions of gemcitabine HCl; following the loss of exclusivity and patent expiry of 'Gemzar', a blockbuster branded gemcitabine drug of Eli Lily and Company, leading players are focusing on R&D investments and activities for these variants of cancer drugs. In addition, product innovation and strategies are highly influenced by the ease of developing generic formulations of gemcitabine HCl as compared to branded formulations; they are more rapid and exempted from the requirement to conduct clinical trials and toxicity studies. Therefore, leading market players are entering into manufacturing of generic drugs with cost-effective alternatives to branded products.
Innovations have also been forthcoming for combining the generic gemcitabine HCl with other compounds to enhance the treatment of several forms of cancer. Studies have found that, gemcitabine, in combination with nab-paclitaxe, results in prolonging the survival of patients suffering from metastatic pancreatic cancer.
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Multimodal Approach to Lead the Gemcitabine HCl Market
Bolster the Sales Force with Multi-Channel Engagement
As competition in the gemcitabine HCl market intensifies, a strong product profile no longer suffices for building a distinctive brand persona. With the shift in purchasing power and reduced access to healthcare professionals (HCPs), pharmaceutical companies are being challenged to differentiate while adapting to the new rules of the market. The emergence of new digital channels brought significant changes among the leading gemcitabine market players in terms of maintaining HCP contact and increasing overall reach.
Investments in R&D Activities to Focus on Innovative Combined Products
R&D strategies in the gemcitabine HCl market, in the past few years, have been primarily focused on the improvement of treatment delivery and combination therapy. Sensing the unmet needs in the space and poor efficacy of the current treatments, key manufacturers have been prompted to explore and bring improved versions of branded gemcitabine agents into the market. These factors played an important role in Sun Pharma’s decision to launch ready-to-infuse INFUGEM (gemcitabine in sodium chloride injection) in 2019, the first chemotherapy product that comes in a premixed, ready-to-infuse formulation. This strategic move by Sun Pharma is highly likely to influence other stakeholders to invest in the R&D of combination therapy.
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Focus on Lucrative Markets Such as India and China
Sensing the heavy investment scenario in the healthcare sector in developing countries such as India, China, and Singapore, key manufactures are targeting the expansion of their presence in these regions. India- and China-based companies also have a strong presence in the global gemcitabine HCl market, with a large number of gemcitabine API manufacturers in India investing to comply with U.S. FDA regulations, and file DMF applications.
The Competitive Landscape
The gemcitabine HCl market shows a high level of consolidation, with Eli Lily and Company, Teva Pharmaceuticals Industries Ltd., and Sun Pharmaceutical Industries Ltd. operating at the top of the market space.
Considering the nature of the product, maximization of drug potential and their commercialization continue to be influencing factors, and to stay competitive, many of these leading players are collaborating with important stakeholders in order to understand the challenges in developing effective gemcitabine HCl with minimum side effects. For instance, in 2018, Eli Liliy and Company collaborated with ARMO Biosciences Inc. to bolster Eli Liliy’s oncology program through the addition of ARMO's lead product candidate, pegilodecakin.
Strategic mergers and acquisitions to strengthen the therapeutic business and licensing agreements also remain a focus area of key manufacturers. In addition, as the importance of new product approval and commercialization intensifies, many players are entering into strategic partnerships and distribution agreements. It is highly likely that, companies such as Pfizer, Inc., Dr. Reddy’s Laboratories Ltd., and Mylan N.V. will continue to emphasize on business partnerships to stay ahead of their competitors.
As developing countries are investing in healthcare infrastructure to improve the quality of services and expand access, manufacturers will need to strengthen their marketing capabilities in these regions. With new updates and increasing stringency in regulatory standards, new collaborative models between pharmaceutical companies and research institutes will accelerate the development of new drugs and their approval processes.
Considering the poor efficacy of the current treatments for pancreatic cancer, the authors of this study feel that, along with price pressure and increased competition, key manufactures will need to dedicate their efforts toward developing cost-effective, reliable, and high-quality versions of gemcitabine HCl.
Global Gemcitabine HCl Market: Overview
- Global gemcitabine HCl market size in 2018 – over US$ 500 Mn. The global gemcitabine HCl market is anticipated to grow at CAGR of nearly 7% during the forecast period.
- The global gemcitabine HCl market report provides elaborative information and data analysis of the market with regards to segments based on application, type, end user, and geographical region.
- The gemcitabine HCl market report provides detailed qualitative analysis with market forecast along with drivers, restrains and opportunities in the market. Additionally, the gemcitabine HCl market report also provides company profiles and competition matrix, which gives a brief idea about the business overview and competitive landscape of the gemcitabine HCl market.
- The global gemcitabine HCl market report gives an idea about the market attractiveness of the industry in terms of particular segments and regions. It also gives provide quantitative and qualitative analysis on the market share of key players and competitive strategies adopted by them, by taking into account year-on year growth and market size.
- Year on year growth rate of each segment of the global gemcitabine HCl market has been studied and analyzed after complete analysis of the demographics, patent expiry of branded drugs, past trends, regulatory trends, future trends, drug development lifecycle, etc. These key elements will help old as well as new players in the gemcitabine HCl market take strategic decisions in order reinforce their positions and multiply their share in the global gemcitabine HCl market.
Global Gemcitabine HCl Market: Key Segments
- Based on type, the global gemcitabine HCl market has been segmented into branded and generic. In terms of application, the gemcitabine HCl market has been classified into pancreatic cancer, breast cancer, ovarian cancer, non-small-cell lung carcinoma (NSCLC), and others. Based on end user, the gemcitabine HCl market has been categorized into hospitals, cancer centers, and others.
- By type, the global gemcitabine HCl market is expected to be dominated by generic drug manufactures, due to the patent expiry of branded drugs as well as increase in the demand for low-cost, efficient, and quality products. In terms of application, the global gemcitabine HCl market is predicted to be led by the pancreatic cancer segment, due to an increase in the number of pancreatic patients, as well as gemcitabine being considered as the 1st line of drug for the treatment of patients. By end user, the hospitals segment is expected to be a prominent segment in the global gemcitabine HCl market in the coming years.
Global Gemcitabine HCl Market: Regional Outlook
- By geographical region, the global gemcitabine HCl market is divided into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Each region is further sub-divided into their respective countries.
- The gemcitabine HCl market size and forecast of these regions/sub-regions/countries have been provided for the duration of 2019 to 2027. The CAGRs of the respective segments are also provided for the period of 2019 2027; here, 2018 has been considered as the base year.
- North America, Europe, and Asia Pacific are predicted to have substantial shares as far as regional markets are concerned, in the global gemcitabine HCl market.
- North America, Europe, and Asia Pacific are among the prominent markets, due to the patent expiry of Eli Lily’s branded drug Gemzar.
- Asia Pacific and North America are large markets for gemcitabine HCl, owing to the favourable regulatory scenario for large molecule injectables (biosimilars), high demand for cost-effective generic formulations over branded ones, and government support to increase the utilization of generic injectable products, in these regions. A large number of manufacturers from emerging countries are targeting North America and Asia Pacific for launching generic injectable formulations, owing to injectable drug shortages being observed in these regions during the last decade. Patent expiry, increase in demand, and cost effectiveness are the key factors that are expected to drive the global gemcitabine HCl market.
- Well-funded generic drug manufacturers are expected to exploit the growth outlook of the global gemcitabine HCl market. For example, gemcitabine API manufacturers in Asian countries such as India and China, who comply with U.S. FDA regulations, have been investing heavily in the generic drug sector. They have been filing Drug Master File (DMF) applications. Drug Master File (DMF) is a document that provides detailed information about the drug’s manufacturing facility, and the methods and processes used in the manufacturing, packaging, processing, and storage of drugs for humans. This scenario is expected to drive the global gemcitabine HCl market in the coming years.
Companies Mentioned in the Report
- The gemcitabine HCl market report provides a complete analysis of the major players currently operating in the market. Additionally, the gemcitabine HCl market report also provides a brief analysis of the product portfolio, company overview, business strategies, and recent developments of the players.
- Some of the companies profiled in the gemcitabine HCl market report are Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Accord-UK Ltd., Pfizer, Inc., Mylan N.V., Sun Pharmaceutical Industries Ltd., Fresenius Kabi AG, Dr. Reddy’s Laboratories Ltd., and Ingenus Pharmaceuticals.
Gemcitabine HCl Market: Report Description
A recent report published by Transparency Market Research analyzes the impact of past and present landscape on the future of the global gemcitabine HCl market. The study offers detailed information on the latest trends and opportunities for key stakeholders in the gemcitabine HCl market during the period of 2019-2027.
The report helps readers gauge the various dynamics of the gemcitabine HCl market, and provides actionable insights that can arm key stakeholders in the gemcitabine HCl market with the necessary information to take critical and well-informed decisions. TMR’s study also provides a key indicator analysis to define the growth prospects of the gemcitabine HCl market, and future estimates regarding the development of the gemcitabine HCl market in terms of value and volume.
The report provides exclusive data on the sales of gemcitabine HCl and the potential increase across different geographical regions. The study also includes thorough analysis of the existing competitive landscape, and offers detailed insights on product innovation and business development strategies adopted by key players in the gemcitabine HCl market.
Key Questions Answered in the Gemcitabine HCl Market Report
The report details a qualitative and quantitative breakdown of the gemcitabine HCl market, based on thorough research about the macro- and micro-economic aspects influencing the growth of the gemcitabine HCl market. Comprehensive information featured in the report can provide answers to various questions for industry participants, in order to enhance their decision-making processes. Some of these questions include:
- How is the regulatory scenario in developed countries impacting the gemcitabine HCl market?
- What are the potential threats faced by key stakeholders in the gemcitabine HCl market?
- How will the historical prospects of the gemcitabine HCl market influence changes in the future?
- What are the imperative strategies adopted by leading players to strengthen their position in the gemcitabine HCl market?
- How will DMF fillings by India- and China-based companies influence the expansion of the gemcitabine HCl market?
- What are the R&D strategies used by key manufactures to receive approval of their products?
- What are the upcoming commercial prospects in the gemcitabine HCl market?
Gemcitabine HCl Market: Research Methodology
The research methodology followed by TMR’s analysts to obtain detailed information and estimate the overall size of the gemcitabine HCl market involves conducting thorough research. Industry-based information acquired through secondary resources are verified by conducting interviews with relevant stakeholders, which helped the analysts deliver extensive insights on how the gemcitabine HCl market will grow and expand during the course of the forecast period.
Around 34% of primary research for the development of the emcitabine HCl market report involved interviewing industry experts such as CEOs, presidents, directors, chairmen, vice presidents, and chief medical officers. Nearly 66% of primary respondents involved generic or branded medicine providers, scientists, physicians, oncology surgeons, healthcare professionals, surgeons, medical assistants, and assistant medical directors, along with product and brands managers of companies operating in the sales of gemcitabine HCl.
For secondary research, analysts have referred to company websites, white papers, annual reports, and financial report to confirm the accuracy of the future trends and opportunities of the gemcitabine HCl market. Other secondary resources include the Organization for Economic Co-operation and Development, Pubmed, Department of Health and Human Services, National Center for Health Statistics U.S., National Institute for Health and Clinical Excellence, and Association for Accessible Medicines.
Gemcitabine HCl Market: Segmentation
TMR’s report classifies the information into four broader categories – type, application, end user, and region. It include extensive assessment of the dynamics and evolving trends associated with each segment, and how they impact the overall growth of the gemcitabine HCl market.
The gemcitabine HCl market report covers all-inclusive information on the segment-wise trends and developments in the gemcitabine HCl market. Specific information includes y-o-y growth analysis, market value share comparison, pricing analysis, supply chain assessment, and attractiveness analysis on the basis of type, end user, and application across each key region
Non-small-cell-lung Carcinoma (NSCLC)
Middle East & Africa