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Chapter 4 GLOBAL MARKET FOR NANOPARTICLES IN LIFE SCIENCE NANOPARTICLES IN BIOTECHNOLOGY, DRUG DEVELOPMENT AND DRUG DELIVERY BIO113B August 2014 Jackson Highsmith Project Analyst ISBN: 1-56965-904-4 BCC Research 49 Walnut Park, Building 2 bcc Research Wellesley, MA 02481 USA or (toll-free within the USA), www.bccresearch.com EFTA01113381 810113B - Nanoparticles in Biotechnology, Drug Development and Drug Delivery CHAPTER 4 GLOBAL MARKET FOR NANOPARTICLES IN LIFE SCIENCE The global market for nanoparticles applied to the life sciences was over $24.9 billion in 2013. That was a 15.9% CAGR from 2012, for which revenues were nearly $21.6 billion. The projected revenues for 2014 are $29.6 billion, at a CAGR of 18.5% over the 2013 level. It is projected that revenue will increase in the five-year period from 2014 to 2019 to $79.8 billion at a CAGR of 22.0%. While the percentage increase shows a decreasing trend over time, the overall value of this industry is strong, exhibiting double-digit increases in each period. TABLE 10 GLOBAL MARKET FOR NANOPARTICLES IN BIOTECHNOLOGY AND PHARMACEUTICALS, THROUGH 2019 (S MILLIONS) CAGR% Application 2012 2013 2014 2019 2014-2019 Drug delivery systems 11,346 13,388 15,798 44,503 23.0 Drug development and formulation 9,345 10,563 12,571 32,266 20.7 Diagnostic imaging, diagnostic testing* 466 550 649 1,621 20.1 Biotechnology applications 412 486 587 1,448 19.8 Total 21,569 24,987 29,605 79,838 22.0 *Revenues in this category do not include the cost of imaging instruments or fees paid to physicians or hospitals for imaging and analysis. Source: BCC Research. The total market for biomedical-related nanoparticles will grow by 22.0% CAGR from 2014 to 2019. This will increase 2012 revenues from nearly $21.6 billion to $79.8 billion in 2019, a CAGR of 20.6%. The largest part of this will come from the drug system delivery segment. New nanoparticles will be developed, nanocrystal production methods will be improved and newly discovered drugs will be incorporated into these systems. In addition, many older drugs (especially anticancer drugs) that were too difficult to use because of toxicity or solubility problems will not be brought into the market as nanoparticle systems improve or eliminate these problems. GLOBAL MARKET FOR NANOPARTICLES IN BIOTECHNOLOGY Biotechnology applications of nanoparticles are primarily in diagnostic assay development, identification and testing of new tags to add to nanoparticles, refining the method for producing nanoparticles to develop more selective systems, and basic investigation of metabolic and other processes going on within the normal and the diseased cells. Revenues for 2012 for this area were $412 million, with much of that coming from NIH Copyright o BCC Research, Wellesley MA USA, Website: www.bccresearch.com 25 EFTA01113382 810113B - Nanoparticles in Biotechnology, Drug Development and Drug Delivery grants and other types of research funding. Many grants have been given to universities and medical facilities for the development of specific probes. There is also a large amount of internal R&D spending that has occurred internally within major pharmaceutical companies. The value of this spending is mainly confidential. For that reason, this type of revenue is not included in the biotechnology applications figures used in this report. TABLE 11 GLOBAL REVENUES BIOTECHNOLOGY APPLICATIONS OF NANOPARTICLES, THROUGH 2019 (S MILLIONS) CAGR% Field 2012 2013 2014 2019 2014-2019 Biotechnology applications 412 486 587 1,448 19.8 Total 412 486 587 1,448 19.8 Source: BCC Research. Revenues for this segment of the nanoparticles industry are forecast to increase to $1.4 billion by 2019 for a CAGR of 19.8% over 2014 value. Basic biochemistry and biotechnology research and development will: (1) improve our knowledge of the multiplicities of biological processes that are at work in the normal cell and in diseased cell systems, (2) provide identification and testing of new biomarkers, cell receptors and regulators (activators/inhibitors), (3) improve functionality of RNA species, and (4) fuel the investigation into new drugs, biomedical testing and devices. GLOBAL MARKET FOR NANOPARTICLES IN DRUG DEVELOPMENT Nanoparticles are finding increased use in screening candidate drugs under development. This screening provides data on the efficacy and selectivity of a drug for the target disease for which it is intended. It allows determination of the minimum effective dose to achieve the required medical outcome and indicates minimum levels of toxicity for the drug candidate. These studies are done in animal model systems and in selected human trials. The successful candidate drugs then move on to full clinical trials in humans. Nanoparticle probes that also enable the drug developer to visualize the results of treatment can eliminate drugs that might fail when put into full-blown clinical trials. Failure of a candidate drug at that level represents a large loss of time and money to the developing company. Drug formulation is also a critical step along the pathway from drug discovery to commercialization. Nanoparticle drug delivery systems allow smaller doses of a drug to be required for clinical trials and eventual production. For many drugs, the task of finding the right formulation to allow the drug to be delivered to the cell target in the proper amount requires many tries at getting the right mix of drug, fillers, additives and other components required for a stable preparation. This is particularly true for encapsulated drug preparations that are to designate long-acting (LA) or sustained-release (SR) drugs. Copyright o BCC Research, Wellesley MA USA, Website: www.bccresearch.com 26 EFTA01113383 810113B - Nanoparticles in Biotechnology, Drug Development and Drug Delivery TABLE 12 GLOBAL MARKET FOR NANOPARTICLES IN DRUG DEVELOPMENT AND FORMULATION, THROUGH 2019 (S MILLIONS) CAGR% Field 2012 2013 2014 2019 2014-2019 Drug development and formulation 9,345 10,563 12,571 32,266 20.7 Total 9,345 10,563 12,571 32,266 20.7 Source: BCC Research. The 2014 market for drug development and formulation nanoparticles was nearly $12.6 billion. This was a CAGR of 19.0% from 2013 when revenues were almost $10.6 billion. Revenues are forecast to increase to almost $32.3 billion by the end of 2019, a 20.7% rate of growth over 2014. Revenues in this area are high in 2013 and 2014 because many of the older, less effective drugs that were abandoned years ago have been the subject of reformulation efforts. These drugs have the potential to get FDA approval as a new chemical entity (NCE) based on an innovative way to deliver an existing approved drug. While projections are strong for the five year period (2014 to 2019), they may be diminish in the period as legacy drugs complete reformulation and additional drugs are not developed. The percent increase in revenue for the forecast period is also projected to decrease due to the application of knowledge gained in nanoparticle drug formulation during the preceding 10 years. This knowledge should enable more rapid formulation of new drugs, thus reducing the overall cost for this step in the drug development timeline. GLOBAL MARKET FOR NANOPARTICLES IN DRUG DELIVERY SYSTEMS The most promising area for nanoparticle application in the life sciences is in the area of drug delivery systems. The ability to deliver a potentially smaller dose of a drug specifically to the target organ or, in the case of cancer, to specific cells will revolutionize the practice of medicine. Furthermore, if the nanoparticles can be tagged with components from individual patients' cells and then put back into the patient's body, this will eliminate the problems of immunological rejection of the nanoparticles and go a long way toward advancing the concept of individualized treatment. In general, there is a great deal of interest in the medical community toward these types of approaches. Copyright C. KC Research, Wellesley MA USA, Website: www.bccresearch.com 27 EFTA01113384 810113B - Nanoparticles in Biotechnology, Drug Development and Drug Delivery TABLE 13 GLOBAL REVENUES FROM NANOPARTICLES IN DRUG DELIVERY SYSTEMS, THROUGH 2019 (S MILLIONS) CAGR% Field 2012 2013 2014 2019 2014-2019 Drug delivery systems 11,346 13,388 15,798 44,503 23.0 Total 11,346 13,388 15,798 44,503 23.0 Source: BCC Research. The revenue from nanoparticle-derived drug delivery systems is forecast to show double-digit growth through the projected five-year period of 2014 to 2019. During this period, drugs currently in pharmaceutical company pipelines will gain FDA approval and enter the market, adding to the potential revenue for this area. Drugs that go off patent during this period may have generic equivalent drugs that use nanoparticle delivery systems enter the market. Additional growth will occur from sales of these drugs and delivery systems in other countries around the world. Growth from 2012 to 2013 was 18.0%, and from 2013 to 2014 (projected) will also be 18%. Projected growth from almost $15.8 billion in 2014 to $44.5 billion in 2019 will be at a CAGR of 23.0%. It should be noted that nanoparticles for drug development (almost $32.3 billion) and drug delivery systems ($44.5 billion) account for 96% of the life sciences nanoparticle applications revenue ($79.8 billion). GLOBAL MARKET FOR NANOPARTICLES IN DIAGNOSTIC IMAGING The diagnostic imaging area will continue to expand in its revenue base for nanoparticle-based imaging probes. Revenues will continue to increase in the double-digits for the period 2012 to 2019. This is in part due to the advancement being made in tags for nanoprobes and nanosensors. It is also due to the increased utilization of this technology as more physicians begin to see the merits of using nanoparticle probes in their imaging work. The CAGR for the increase in revenue from 2012 to 2019 is 19.5%. This was slightly higher than the increase realized in the one year period 2013 to 2014 (18.0%). For the five-year forecast period from 2014 to 2019, the revenues will increase by about 20.1%. From there on, this area will remain relatively flat unless some unexpected new development occurs to advance this technology further. Copyright o BCC Research, Wellesley MA USA, Website: www.bccresearch.com 28 EFTA01113385 810113B - Nanoparticles in Biotechnology, Drug Development and Drug Delivery TABLE 14 GLOBAL REVENUES FROM NANOPARTICLES IN DIAGNOSTIC IMAGING SYSTEMS, THROUGH 2019 (S MILLIONS) CAGR% Field 2012 2013 2014 2019 2014-2019 Diagnostic imaging, diagnostic testing* 466 550 649 1,621 20.1 Total 466 550 649 1,621 20.1 *Revenues in this category do not include the cost of imaging instruments or fees paid to physicians or hospitals for imaging and analysis. Source: BCC Research. A part of the increase in imaging revenues will come from countries like India, China, Russia, Japan and the Pacific Rim, where improving healthcare and awareness is leading to better treatment facilities. These countries will develop their own diagnostic imaging departments and utilize the nanoparticle-probe imaging agents in their practices. GLOBAL DISTRIBUTION OF NANOBIOTECHNOLOGY AND NANOMEDICINE COMPANIES Nanobiotechnology and nanomedicine companies are starting up in many countries around the world. In the United Kingdom, there are 20 companies; Canada has 19, and the U.S. has at least 34. The U.S. figure does not include much of the nanoparticle drug working going on in major pharmaceutical companies unless they have a specific subsidiary (usually through acquisition) in this area. The table below shows the countries with the highest number of companies. There are no listed companies in Mexico or South America. Russia has no (reported) companies in this area. TABLE 15 GLOBAL DISTRIBUTION OF NANOBIOTECHNOLOGY AND NANOMEDICINE COMPANIES Country Number of Companies Company Names Alchemia Anteo Diagnostics Biometic CeramiSphere EnGene Living Cell Technologies pSivida Australia 9 Starpharma Copyright o BCC Research, Wellesley MA USA, Website: www.bccresearch.com 29 EFTA01113386 81O113B - Nanoparticles in Biotechnology, Drug Development and Drug Delivery Belgium 1 Alnyx Axela Biophage Pharma DiagnoCure Epocal Innovative Bioceramix Labopharm Nicoya Lifesciences NanoMed QLT Sopratek Pharma Tekmira Pharmaceuticals Canada 10 Zymeworks China 2 NanoTech Med, NOD Pharmaceutical AC Serendip Across Barriers Aquonova Biomers Biontex Capsulation Endotherme Life Sciences Molecules Febit Aynbio Genocxx Graffinity Pharma Germany 15 Xantes Bioanalytics Singapore 1 Curiox Biosystems Dabur Pharma India 2 Meda Biotech Biosensia Cellix Deerac Fluidics Ireland 4 Elan Micronit Netherlands 2 Nanosens Arrayon Atheris Laboratories Debiopharm Group Debiotech Molecular Machines & Industries Nano Bridging Molecules Switzerland 7 Tecan Copyright o BCC Research, Wellesley MA USA, Website: www.bccresearch.com 30 EFTA01113387 810113B - Nanoparticles in Biotechnology, Drug Development and Drug Delivery Dongbu HiTek Ecopro Finetex EnE InkTec LG Chem Park Systems Seron Technologies South Korea 8 TTM Attana Camurus Cline Scientific Genovis Nanoxis Oasmia S :lc- 7 Spago Imaging Advancell Bionostra Endor Nanotechnologies Ingeniatrics Technologies Izasa Spain 6 Nanoimmunotech Source: BCC Research, NanoWerk database Copyright Co KC Research, Wellesley MA USA, Website: www.bccresearch.com 31 EFTA01113388