Annual Report on Statistics of Production by Pharmaceutical Industry in 2013

Transcription

1 Annual Report on Statistics of Production by Pharmaceutical Industry in 2013 Health Policy Bureau, Ministry of Health, Labour and Welfare Section in charge: Statistics Section, Economic Affairs Division Tel: (Ex. 2532) (direct dialing)

2 Contents Overview of Research... 1 Overview of Results... 4 I Drugs Status of production of drugs Status of production by therapeutic category of drugs... 9 (1) Cardiovascular agents... 9 (2) Central nervous system agents... 9 (3) Other agents affecting metabolism (4) Digestive organ agents (5) Blood and body fluid agents (6) Dermatologic preparations (7) Biological preparations (8) Allergic agents (9) Sensory organ agents (10) Antibiotics (11) Extracorporeal diagnostic agents (12) Vitamins (13) Urogenital and anal organ agents (14) Hormones (15) Antineoplastics Status of production by drug form category, by classification according to use and by therapeutic category of drugs (1) Drug form category (2) Classification according to use (3) Therapeutic category The amount of production by region of drugs Composition of drugs by employee size and by production size (1) Composition by employee size (2) Composition by production size... 23

3 6. Status of import and export of drugs (1) Export II Sanitary materials Status of production of sanitary materials Status of production of sanitary materials by region III Medical devices Status of production of medical devices Status of production of medical devices by region Composition of medical devices by production size Status of import and export of medical devices (1) Export (2) Import IV Quasi-drugs Status of production of quasi-drugs Status of production of quasi-drugs by region (Statistics) shipment by therapeutic category of drugs and by classification according to use 46 shipment by main category of medical devices 48

4 Overview of Research 1. Purpose of research These research aims at clarifying the status of production, import etc. of drugs, quasi-drugs, sanitary materials and medical devices. 2. Scope of research Business establishments that market or manufacture drugs, quasi-drugs, and/or medical devices, which are authorized respectively to market and manufacture drugs, quasi-drugs, and/or medical devices, as per provisions of the Pharmaceutical Affairs Law*. Note that establishments that are categorized in the following business types are excluded from the scope of this research. (1) A manufacturer, or marketing authorization holder, of drugs that are produced by proprietors of pharmacies, using their own pharmacies equipment and/or apparatuses; (2) A marketing authorization holder of condoms and/or corrective lenses (excluding the import of packed products), which only market packed products, or such manufacturer which only undertakes packing of such products; and (3) A marketing authorization holder of absorbent cottons and/or gauzes, (excluding the import of packed products), which only market packed products, or such manufacturer which only undertakes packing of such products, as well as a marketing authorization holder, or manufacturer of sanitary treatment products (excluding products that only comprise absorbent cotton), which only market or manufacture large products. * The Pharmaceutical Affairs Law was revised on November 25, 2014, to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics. 3. Period of research From January 1 to December 31, Items of research Quantity, monetary amount etc. of production, import, shipment, export and inventory of drugs, quasi-drugs, sanitary materials and medical devices; also, employees (including temporary ones) at manufacturing plants that relate to drugs 5. Methods of research and reporting duties (1) Manufacturing plants The Ministry of Health, Labour and Welfare conducts research by way of prefectural governments, by online, and by FD and questionnaire sheets that are distributed to business establishments who are obliged to report. MHLW (Review and tabulate) Distribute FD / questionnaire sheets Submit Prefectures (Sort out and review) Distribute FD / questionnaire sheets Submit / online reporting Establishments that are obliged to report (Enter required information) 1

5 (2) Marketing authorization holder offices The Ministry of Health, Labour and Welfare conducts research, by online, and by FD and questionnaire sheets that are distributed to business establishments who are obliged to report. MHLW (Sort out, review and tabulate) Distribute FD / questionnaire sheets Submit / online reporting Establishments that are obliged to report (Enter required information) 6. Tabulation of results Tabulation of results was undertaken by the Health Policy Bureau, Ministry of Health, Labour and Welfare. 7. Precautions for use (1) Symbols - : a value that is below the smallest unit, or there is no available data 0 / 0.0: a value for mean, proportion etc. that does not correspond to 1 in the lowest digit of indication after rounding (2) Regions Hokkaido: Hokkaido Tohoku: Aomori, Iwate, Miyagi, Akita, Yamagata and Fukushima Kanto Etsusei: Ibaraki, Tochigi, Gunma, Saitama, Chiba, Tokyo, Kanagawa, Niigata, Yamanashi, Nagano and Shizuoka Tokai Hokuriku: Toyama, Ishikawa, Gifu, Aichi and Mie Kinki: Fukui, Shiga, Kyoto, Osaka, Hyogo, Nara and Wakayama Chugoku: Tottori, Shimane, Okayama, Hiroshima and Yamaguchi Shikoku: Tokushima, Kagawa, Ehime and Kochi Kyushu: Fukuoka, Saga, Nagasaki, Kumamoto, Oita, Miyazaki, Kagoshima, Okinawa (3) Terms production: Production quantity: The amount of production of final products (large products in the case of absorbent cottons and/or gauzes in sanitary materials) that are produced at a manufacturing plant during the period of research, which is given by multiplying production quantity by the selling price of the marketing authorization holder (including consumption tax). Production quantity of final products (large products in the case of absorbent cottons and/or gauzes in sanitary materials) that are produced at a manufacturing plant during the period of research; Conforming quantity is used as production quantity for products for national assay. 2

6 shipment: shipment during the period of research (including shipment by selling, as well as shipment to other manufacturing plants, business offices, warehouses in separate locations etc. within the same business entity), given by multiplying shipment quantity by the selling price of the marketing authorization holder (including consumption tax). The number of manufacturing plants / the number of marketing authorization holder offices: Number of manufacturing plants / marketing authorization holder offices, at which there were changes in production / import, shipment and/or month-end inventory of final products (large products in the case of absorbent cottons and/or gauzes in sanitary materials) during the period of research (monthly average) Prescription drugs: Drugs that are supplied to be used by physicians and/or dentists, or under the prescription or instruction of these Other drugs: Drugs other than prescription drugs OTC drugs: Of other drugs, drugs other than drugs for household delivery Drugs for household delivery: Of other drugs, drugs that are supplied to be used mainly as drugs for household delivery Import*: Refers to drugs that are produced mainly from imported drug materials (including raw powder, raw liquid, bulk products and preparation materials) Contract production: Manufacturing process of a final product that is contracted from a marketing authorization holder office of another company, whether the contracted process covers the whole or part of the manufacturing process of the relevant product; contracting of only packaging, labeling and/or storage processes is excluded from this research. Employees: Refers to employees who are regularly engaged in actual production / import, management or other activities pertaining to drugs, as of the end of a month of research; even executive officers and directors are included in regular employees, if they are engaged in specified tasks related to production / import of drugs (monthly average). Large products: Products that are made from raw cotton, raw fabric etc., and are ready to be packed after refining, drying etc.; With regards to absorbent cottons and gauzes in sanitary materials, reporting is required not for final products, but for large products before packing. 3

7 Overview of Results I Drugs The amount of production of final products of drugs in Japan in 2013 stood at 6, billion yen, while the amount of import from other countries was 3,077.3 billion yen. The combined amount was 9,971.3 billion yen. Domestic amount of shipment stood at 9,689.7 billion yen, while export to other countries was billion yen. 1. Status of production of drugs (1) The amount of production of final products of drugs in 2013 stood at 6,894.0 billion yen, down 82.7 billion yen (1.2%) from 6,976.7 billion yen in By classification according to use, the amount of production of prescription drugs stood at 6,194.0 billion yen, down 1.1%, while the amount of production of other drugs was billion yen, down 1.9%. With regards to the proportion, prescription drugs make up 89.8% of total, with the share of other drugs at 10.2%. Year-on-year changes over the past ten years were: down 0.8% in 2004, up 4.4% in 2005, up 0.7% in 2006, up 0.2% in 2007, up 2.6% in 2008, up 2.6% in 2008, up 3.0% in 2009, down 0.6% in 2010, up 3.1% in 2011, down 0.2% in 2012, and down 1.2% in (2) Trends in the amount of production of prescription drugs over the past ten years are indicated in Table 1. (3) The amount of production by main therapeutic category of drugs is indicated in Table 2 and other tables. The top ten categories make up 5,190.6 billion yen (75.3%). (4) The amount of production by sub therapeutic category of drugs, at or above 25.0 billion yen per year, is indicated in Table 3. 4

8 Table 1. Trends in the amount of production of drugs Year Amount Production Prescription drugs Other drugs OTC drugs Drugs for household delivery Yearon-year Proportion Amount Yearon-year Proportion Amount Yearon-year Proportion Amount Yearon-year Proportion Amount Yearon-year Proportion Mil. yen % % Mil. yen % % Mil. yen % % Mil. yen % % Mil. yen % % ,121, ,440, , , , ,390, ,741, , , , ,438, ,803, , , , ,452, ,828, , , , ,620, ,992, , , , ,819, ,174, , , , ,779, ,148, , , , ,987, ,344, , , , ,976, ,263, , , , ,894, ,193, , , , Note) Although the definitions of production and import were changed in 2005, the new definitions are applied to 2004 and before, because the comparison is conducted under the same conditions. 5

9 Table 2. production by main therapeutic category of drugs Ranking Main therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 6,894,014 6,976,712-82, Cardiovascular agents 1,255,017 1,297,037-42, Central nervous system agents 796, ,600-51, Other agents affecting metabolism 666, ,147 21, Digestive organ agents 532, ,354-39, Blood and body fluid agents 497, ,891-13, Dermatologic preparations 380, ,315-22, Biological preparations 327, ,174 21, Allergic agents 258, ,495 31, Sensory organ agents 242, ,043 10, Antibiotics 234, ,567-16, Extracorporeal diagnostic agents 220, ,348 10, Vitamins 178, ,128-6, Urogenital and anal organ agents 168, ,807-8, Hormones (including antihormones) 166, ,914 13, Antineoplastics 153, ,720-10, Nutrients, tonics 152, ,891 4, Traditional Chinese medicines 149, ,030 8, Respiratory organ agents 118, ,386-8, Chemotherapeutics 110, ,199 7, Intracorporeal diagnostic agents (excluding extracorporeal diagnostic agents) 64,118 52,490 11, Dialysis agents 50,338 51, Peripheral nervous system agents 33,919 35,743-1, Radioactive drugs 33,783 33, Other agents not mainly for therapeutic purpose 17,690 19,133-1, Public health agents 17,650 19,351-1, Others 67,534 63,738 3, (Note) The ranking in the main therapeutic category of drugs is based on the order of amounts of production in

10 Cardiovascular agents Central nervous system agents Other agents affecting metabolism Digestive organ agents Blood and body fluid agents Dermatologic preparations Biological preparation Allergic agents Sensory organ agents Antibiotics Figure 1. production by main therapeutic category of drugs Figure 2. Proportion of the amount of production by main therapeutic category of drugs Others 24.7% Cardiovascular agents 18.2% Antibiotics 3.4% Central nervous system agents 11.6% Sensory organ agents 3.5% Allergic agents 3.7% Biological preparations 4.8% Dermatologic preparations 5.5% Blood and body fluid agents 7.2% Digestive organ agents 7.7% Other agents affecting metabolism 9.7% 7

11 Rank ing Table 3. production by sub therapeutic category of drugs Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 6,894,014 6,976,712-82, Antihypertensives 623, ,617-4, Agents affecting metabolism, not elsewhere classified 414, ,987 17, Other blood and body fluid agents 318, ,872-17, Peptic ulcer agents 306, ,315-41, Analgesics, anti-itchings, astringents, anti-inflammatory agents 265, ,867-1, Other allergic agents 247, ,161 31, Vasodilators 213, ,305-13, Ophthalmic agents 207, ,318 7, Hyperlipidemia agents 206, ,602-29, Human blood preparations 203, ,447 12, Antipyretics and analgesics, anti-inflammatory agents 188, ,247 12, Other central nervous system agents 175, ,738-8, Psychotropics 167, ,462-30, Antidiabetic agents 154, ,903-1, Antibiotics acting mainly on gram-positive and gram-negative 152, ,989-6, bacteria 16 Other urogenital and anal organ agents 152, ,218-9, Traditional Chinese medicines 149, ,030 8, Biochemical testing reagents 109, , Anticoagulants 97,919 90,919 7, Serum-immunological testing reagents 83,959 76,738 7, Protein and amino acid preparations 83,877 80,461 3, Common cold drugs 82,237 82, Other cardiovascular agents 82,170 83,738-1, Other hormones (including antihormones) 81,652 82, Other digestive organ agents 80,309 81,816-1, Antiarrhythmic agents 73,764 69,710 4, Other antineoplastics 71,966 83,566-11, Blood substitutes 71,158 73,722-2, Hypnotics and sedatives, anxiolytics 71, ,850-30, Synthetic antibacterials 62,024 48,827 13, Vaccines 57,778 63,501-5, Antiparkinsonian agents 57,578 53,512 4, Vitamins A and D preparations 54,778 50,924 3, Multivitamin preparations (excluding Vitamins A and D 52,846 53, mixtures) Antibiotics acting mainly on gram-positive bacteria and 52,108 60,265-8, mycoplasma 36 Other nutrients, tonics 50,745 49,418 1, Antimetabolites 49,638 52,866-3, Antiepileptics 49,140 46,226 2, Vitamin B preparations (excluding Vitamin B1 preparations) 47,646 53,548-5, X-ray contrast media 47,344 40,709 6, Expectorants 41,250 46,738-5, Thyroid and para-thyroid hormone preparations 39,133 23,933 15, Metabolic disease preparations & combinations Expectorants 38,667 38, Kidney dialysis agents 34,959 35, Purgatives, clysters 34,745 36,010-1, Radioactive drugs 33,783 33, Antivirals 33,706 40,998-7, Other biological preparations 32,865 26,401 6, Mixed biological preparations 32,690 23,460 9, Antimicrobial agents 30,814 29,756 1, Gout preparations 29,146 27,015 2, Gastrointestinal agents and combinations 28,337 27, Antidiarrheals, intestinal regulators Bronchodilators 26,407 26, Diuretics 25,695 24,104 1, (Note) The ranking in the sub therapeutic category of drugs is based on the order of amounts of production in The amounts are over 25.0 billion yen. 8

12 2. Status of production by therapeutic category of drugs (1) Cardiovascular agents The amount of production of cardiovascular agents stood at 1,255.0 billion yen, which made up 18.2% of the amount of gross drug production, down 42.0 billion yen (3.2%) from the previous year. Breakdown is indicated in Table 4. The amount of production was the largest with antihypertensives, which makes up 49.6% of total, followed by vasodilators (17.0%), hyperlipidemia agents (16.5%), and other cardiovascular agents (6.5%). Table 4. production of cardiovascular agent Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 1,255,017 1,297,037-42, Cardiotonics 19,868 19, Antiarrhythmic agents 73,764 69,710 4, Diuretics 25,695 24,104 1, Antihypertensives 623, ,617-4, Capillary stabilizers Vasoconstrictors 10,107 9, Vasodilators 213, ,305-13, Hyperlipidemia agents 206, ,602-29, Other cardiovascular agents 82,170 83,738-1, (2) Central nervous system agents The amount of production of central nervous system agents stood at billion yen, which made up 11.6% of the amount of gross drug production, down billion yen (6.1%) from the previous year. Breakdown is indicated in Table 5. The amount of production was the largest with antipyretics and analgesics, anti-inflammatory agents, which made up 23.6% of total, followed by other central nervous system agents (22.0%), psychotropics (21.0%), common cold drugs (10.3%), hypnotics and sedatives, anxiolytics (8.9%),, and antiparkinsonian agents (7.2%). Table 5. production of central nervous system agents Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 796, ,600-51, General anesthetics 4,854 6,216-1, Hypnotics and sedatives, anxiolytics 71, ,850-30, Antiepileptics 49,140 46,226 2, Antipyretics and analgesics, anti-inflammatory agents 188, ,247 12, Stimulants Antiparkinsonian agents 57,578 53,512 4, Psychotropics 167, ,462-30, Common cold drugs 82,237 82, Other central nervous system agents 175, ,738-8,

13 (3) Other agents affecting metabolism The amount of production of other agents affecting metabolism stood at billion yen, which made up 9.7% of the amount of gross drug production, up 21.0 billion yen (3.3%) from the previous year. Breakdown is indicated in Table 6. The amount of production was the largest with agents affecting metabolism, not elsewhere classified, which made up 62.2% of total, followed by antidiabetic agents (23.2%), metabolic disease preparations & combinations (5.8%), and gout preparations (4.4%). Table 6. production of other agents affecting metabolism Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 666, ,147 21, Liver disease agents 5,692 4,519 1, Antidotes 13,939 11,818 2, Habitual intoxication agents Gout preparations 29,146 27,015 2, Enzyme preparations 9,559 9, Antidiabetic agents 154, ,903-1, Metabolic disease preparations & combinations 38,667 38, Agents affecting metabolism, not elsewhere classified 414, ,987 7, (4) Digestive organ agents The amount of production of digestive organ agents stood at billion yen, which made up 7.7% of the amount of gross drug production, down 39.8 billion yen (6.9%) from the previous year. Breakdown is indicated in Table 7. The amount of production was the largest with peptic ulcer agents, which made up 57.5% of total, followed by other digestive organ agents (15.1%), purgatives, clysters (6.5%), and gastrointestinal agents and combinations (5.3%). Table 7. production of digestive organ agents Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 532, ,354-39, Antidiarrheals, intestinal regulators 26,407 26, Peptic ulcer agents 306, ,315-41, Stomachics and digestives 11,345 12, Antacids 23,725 22, Purgatives, clysters 34,745 36,010-1, Cholagogues 21,546 18,028 3, Gastrointestinal agents and combinations 28,337 27, Other digestive organ agents 80,309 81,816-1,

14 (5) Blood and body fluid agents The amount of production of blood and body fluid agents stood at billion yen, which made up 7.2% of the amount of gross drug production, down 13.7 billion yen (2.7%) from the previous year. Breakdown is indicated in Table 8. The amount of production was the largest with other blood and body fluid agents, which made up 64.1% of total, followed by anticoagulants (19.7%), blood substitutes (14.3%), and hemostatics (1.9%). Table 8. production of blood and body fluid agents Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 497, ,891-13, Blood substitutes 71,158 73,722-2, Hemostatics 9,646 10, Anticoagulants 97,919 90,919 7, Other blood and body fluid agents 318, ,872-17, (6) Dermatologic preparations The amount of production of dermatologic preparations stood at billion yen, which made up 5.5% of the amount of gross drug production, down 22.1 billion yen (5.5%) from the previous year. Breakdown is indicated in Table 9. The amount of production was the largest with analgesics, anti-itchings, astringents, anti-inflammatory agents, which made up 69.9% of total, followed by antimicrobial agents (8.1%), other dermatologic preparations (5.3%), and antiparasitic dermatosis agents (4.7%). Table 9. production of dermatologic preparations Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 380, ,315-22, Antimicrobial agents 30,814 29,756 1, Skin protectants 1,756 1, Suppurative dermatosis agents 16,446 41,228-24, Analgesics, anti-itchings, astringents, anti-inflammatory agents 265, ,867-1, Antiparasitic dermatosis agents 17,872 16, Emollients (including caustics) 12,415 10,895 1, Hair remedies (hair growing agents, depilatories, hair dyes, hair tonics) 15,135 15, Bath preparations Other dermatologic preparations 9,984 19,

15 (7) Biological preparations The amount of production of biological preparations stood at billion yen, which made up 4.8% of the amount of gross drug production, up 21.5 billion yen (7.0%) from the previous year. Breakdown is indicated in Table 10. The amount of production was the largest with human blood preparations, which made up 62.1% of total, followed by vaccines (17.6%), other biological preparations and mixed biological preparations (10.0%). Table 10. production of biological preparations Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 327, ,174 21, Vaccines 57,778 63,501-5, Toxins, toxoids 826 1, Antitoxins, anti-leptospiral sera Human blood preparations 203, ,447 12, Biological test preparations Mixed biological preparations 32,690 23,460 9, Other biological preparations 32,865 26,401 6, (8) Allergic agents The amount of production of allergic agents stood at billion yen, which made up 3.7% of the amount of gross drug production, up 1.5 billion yen (13.9) from the previous year. Breakdown is indicated in Table 11 The amount of production was the largest with other allergic agents, which made up 95.9 of total, followed by antihistamines (2.1), and stimulation therapy agents (2.0) Table 11. production of allergic agents Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 258, ,495 31, Antihistamines 5,522 6, Stimulation therapy agents 5,134 4, Nonspecific immunogen preparations Other allergic agents 247, ,161 31,

16 (9) Sensory organ agents The amount of production of sensory organ agents stood at 242.1billion yen, which made up 3.5% of the amount of gross drug production, up 10.0 billion yen (4.3%) from the previous year. Breakdown is indicated in Table 12. The amount of production was the largest with ophthalmic agents, which made up 85.7% of total, followed by otic and nasal agents (9.9 %), and vertigo agents (4.4%) Table 12. production of sensory organ agents Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 242, ,043 10, Ophthalmic agents 207, ,318 7, Otic and nasal agents 24,071 21,210 2, Vertigo agents 10,616 10, Other sensory organ agents (10) Antibiotics The amount of production of antibiotics stood at billion yen, which made up 3.4% of the amount of gross drug production, down 16.8 billion yen (6.7%) from the previous year. Breakdown is indicated in Table 13. The amount of production was the largest with antibiotics acting mainly on gram-positive and gram-negative bacteria, which made up 65.1% of total, followed by antibiotics acting mainly on gram-positive bacteria and mycoplasma (22.2%), antibiotics acting mainly on mold (6.5%), and antibiotics acting mainly on gram-positive bacteria (3.1%). Table 13. production of antibiotics Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 234, ,567-16, Antibiotics acting mainly on gram-positive bacteria 7,185 7, Antibiotics acting mainly on gram-negative bacteria 2,638 2, Antibiotics acting mainly on gram-positive and gram-negative bacteria Antibiotics acting mainly on gram-positive bacteria and mycoplasma Antibiotics acting mainly on gram-positive bacteria, gram-negative bacteria, rickettsia and chlamydia 152, ,989-6, ,108 60,265-8, ,714 3, Antibiotics acting mainly on acid-fast bacteria 1,976 2, Antibiotics acting mainly on mold 15,241 16,838-1, Other antibiotics (including antibiotic combinations)

17 (11) Extracorporeal diagnostic agents The amount of production of extracorporeal diagnostic agents stood at billion yen, which made up 3.2% of the amount of gross drug production, up 10.2 billion yen (4.9%) from the previous year. Breakdown is indicated in Table 14. The amount of production was the largest with biochemical testing reagents, which made up 49.7% of total, followed by serum-immunological testing reagents (38.1%), blood testing reagents (6.5%), and general testing reagents (3.9%). Table 14. production of extracorporeal diagnostic agents Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 220, ,348 10, General testing reagents 8,685 8, Blood testing reagents 14,286 12,016 2, Biochemical testing reagents 109, , Serum-immunological testing reagents 83,959 76,738 7, Bacteriological testing reagents 3,406 2,264 1, Patho-tissue testing reagents (12) Vitamins The amount of production of Vitamins stood at billion yen, which made up 2.6% of the amount of gross drug production, down 6.3 billion yen (3.5%) from the previous year. Breakdown is indicated in Table 15. The amount of production was the largest with Vitamins A and D preparations, which made up 30.6% of total, followed by multivitamin preparations (excluding Vitamins A and D mixtures) (29.6%), Vitamin B preparations (excluding Vitamin B1 preparations) (26.7%), and Vitamin B1 preparations (4.0%). Table 15. production of vitamins Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 178, ,128-6, Vitamins A and D preparations 54,778 50,924 3, Vitamin B1 preparations 7,078 8,419-1, Vitamin B preparations (excluding Vitamin B1 preparations) 47,646 53,548-5, Vitamin C preparations 4,517 5,540-1, Vitamin E preparations 2,253 3, Vitamin K preparations 3,469 3, Multivitamin preparations (excluding Vitamins A and D mixtures) 52,846 53, Miscellaneous vitamins 6,148 6,

18 (13) Urogenital and anal organ agents The amount of production of urogenital and anal organ agents stood at billion yen, which made up 2.4% of the amount of gross drug production, down 8.7 billion yen (5.0%) from the previous year. Breakdown is indicated in Table 16. The amount of production was the largest with other urogenital and anal organ agents, which made up 90.9% of total, followed by hemorrhoidal preparations (7.9%), genital organ agents (including preventive agents against venereal diseases) (0.6%), and contraceptives (0.5%). Table 16. production of urogenital and anal organ agents Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 168, ,807-8, Urinary organ agents Genital organ agents (including preventive agents against venereal diseases) 1, Oxytocics Contraceptives Hemorrhoidal preparations 13,320 13, Other urogenital and anal organ agents 152, ,218-9, (14) Hormones The amount of production of hormones stood at billion yen, which made up 2.4% of the amount of gross drug production, up 13.9 billion yen (9.2%) from the previous year. Breakdown is indicated in Table 17. The amount of production was the largest with other hormones (including antihormones), which made up 48.9% of total, followed by thyroid and para-thyroid hormone preparations (23.4%), adrenal hormone preparations (13.1%), and pituitary hormone preparations (8.2%). Table 17. production of antineoplastics Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 166, ,914 13, Pituitary hormone preparations 13,680 17,543-3, Salivary gland hormone preparations Thyroid and para-thyroid hormone preparations 39,133 23,933 15, Anabolic steroids and preparations Adrenal hormone preparations 21,811 19,421 2, Androgen preparations Estrogen and gestagen preparations 9,264 8, Mixed hormone preparations Other hormones (including antihormones) 81,652 82,

19 (15) Antineoplastics The amount of production of antineoplastics stood at billion yen, which made up 2.2% of the amount of gross drug production, down 10.2 billion yen (6.2%) from the previous year. Breakdown is indicated in Table 18. The amount of production was the largest with other antineoplastics, which made up 46.9% of total, followed by antimetabolites (32.3%), antitumor plant extract preparations (13.4%), antitumor antibiotics (6.6%). Table 18. production of hormones Sub therapeutic category of drugs production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 153, ,720-10, Alkylating agents 1,135 1, Antimetabolites 49,638 52,866-3, Antitumor antibiotics 10,161 9, Antitumor plant extract preparations 20,592 16,827 3, Other antineoplastics 71,966 83,566-11,

20 3. Status of production by drug form category, by classification according to use and by therapeutic category of drugs (1) Drug form category Breakdown of the amount of production of drugs by drug form category is indicated in Table 19. The amount of production was the largest with tablets, which made up 50.7%, followed by capsules (6.2%), powders and granules, etc. (5.6%), and injectable solutions (5.1%). These four categories made up 67.6% of total. With regards to changes from the previous year, increase was indicated in capsules (21.1 billion yen, 5.2%), external solutions (7.2 billion yen, 2.2%), and powders and granules, etc. (3.6 billion yen, 0.9%) etc. On the other hand, decrease was shown in tablets (102.1 billion yen, 2.8%), ointments and creams(17.7 billion yen, 9.9%), and injectable solutions (17.5 billion yen, 4.8%) etc. Table 19. production by drug form category of drugs Drug form classification production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 6,894,014 6,976,712-82, Powders and granules, etc. 389, ,762 3, Tablets 3,497,293 3,599, , Pills 14,248 13,126 1, Capsules 426, ,009 21, Oral liquid preparations 165, ,184-8, Injectable solutions 351, ,988-17, Injectable powders 253, ,308-1, External solutions 331, ,820 7, Aerosols 12,775 13, Ointments and creams 160, ,555-17, Suppositories 18,793 21,455-2, Plasters, cataplasms and dermatologic pastes 214, , Others 1,059,124 1,025,471 33,

21 (2) Classification according to use Breakdown of the amount of production by classification according to use of drugs is indicated in Table 20. The amount of production of prescription drugs stood at 6,194.0 billion yen, which made up 89.8% of total, down 69.0 billion yen (1.1%) from the previous year. On the other hand, the amount of production of other drugs was billion yen, which made up 10.2% of total, up 13.7 billion yen (10.2%) from the previous year. Table 20. production by classification according to use Classification according to use production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % Total 6,894,014 6,976,712-82, Prescription drugs 6,193,983 6,263,010-69, Domestic drugs 4,632,291 4,590,426 41, Import drugs * 1,561,692 1,672, , Other medicines 700, ,702-13, OTC drugs 677, ,018-11, Drugs for household delivery 22,624 24,684-2, (3) Therapeutic category Breakdown of the amount of production by main therapeutic category of drugs is indicated in Table 21. Except public health agents, the proportion of prescription drugs is larger than that of other drugs. The proportion of other drugs is also relatively high in dermatologic preparations (37.6%), vitamins (37.1%), nutrients, tonics (33.6%), and sensory organ agents (32.1%) etc. 18

22 Table 21. production by main therapeutic category Ranking of amount of productions Main therapeutic category of drugs production Total Proportion production Sub-total Prescription drugs Proportion production Domestic Proportion Mil. yen % Mil. yen % Mil. yen % Total 6,894, ,193, ,632, Cardiovascular agents 1,255, ,247, , Central nervous system agents 796, , , Other agents affecting metabolism 666, , , Digestive organ agents 532, , , Blood and body fluid agents 497, , , Dermatologic preparations 380, , , Biological preparations 327, , , Allergic agents 258, , , Sensory organ agents 242, , , Antibiotics 234, , , Extracorporeal diagnostic agents 220, , , Vitamins 178, , , Urogenital and anal organ agents 168, , , Hormones (including antihormones) 166, , , Antineoplastics 153, , , Nutrients, tonics 152, , , Traditional Chinese medicines 149, , , Respiratory organ agents 118, , , Chemotherapeutics 110, , , Intracorporeal diagnostic agents (excluding extracorporeal diagnostic agents) 64, , , Dialysis agents 50, , , Peripheral nervous system agents 33, , , Radioactive drugs 33, , , Other agents not mainly for therapeutic purpose 17, , , Public health agents 17, , , Others 67, , , (Note) The ranking in the main therapeutic category of drugs is based on the order of amount of production in

23 and by classification according to use of drugs production Other drugs Import * Sub-total OTC drugs Drugs for household delivery Proportion production Proportion production Proportion production Proportion Mil. yen % Mil. yen % Mil. yen % Mil. yen % 1,561, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

24 4. The amount of production by region of drugs The amount of production by prefecture of drugs is indicated in Table 22. Production increased in 22 of 47 prefectures. Increase was the largest in Kanagawa at 58.7 billion yen (21.8%), while decrease was the largest in Saitama at 71.7 billion yen (9.3%). Table 22. production by prefecture Ranking Prefecture production Year-on-year change Percent distribution Change Proportion Mil. yen Mil. yen Mil. yen % % % All Japan 6,894,014 6,976,712-82, Saitama 696, ,948-71, Sizuoka 620, ,211-25, Toyama 608, , Osaka 531, ,117 22, Tokyo 331, ,792-13, Kanagawa 328, ,373 58, Tochigi 322, ,556-20, Hyogo 276, ,755-18, Aichi 268, , Tokushima 235, ,056 4, Shiga 210, ,860-36, Yamaguchi 206, ,465-7, Gifu 190, ,119-11, Yamagata 184, ,376 7, Ibaraki 181, ,947 2, Fukuoka 123, ,005-4, Iwate 119, ,031-10, Chiba 118, ,491 3, Mie 118, ,289-7, Saga 108, ,127 7, Fukushima 107, ,707 1, Nagano 91,262 89,206 2, Ishikawa 87,334 65,120 22, Gunma 81,902 75,959 5, Fukui 81,301 77,251 4, Kyoto 78,350 71,096 7, Akita 75,251 69,975 5, Kagawa 70,473 73,063-2, Yamanashi 69,866 73,099-3, Okayama 57,856 60,655-2, Hokkaido 54,453 52,321 2, Kumamoto 52,605 49,416 3, Nara 48,506 52,023-3, Niigata 34,339 36,834-2, Miyagi 27,009 26, Ehime 25,640 29,341-3, Oita 23,202 24,856-1, Hiroshima 20,002 17,077 2, Miyazaki 10,581 11, Shimane 7,404 6, Wakayama 3,518 3, Okinawa 2,388 2, Kagoshima 1,209 1, Nagasaki Kochi Aomori Tottori (Note) The ranking of prefectures is based on the order of amounts of production in

25 5. Composition of drugs by employee size and by production size (1) Composition by employee size 1) The number of manufacturing plants by employee scale (monthly average) is indicated in Table 23, which shows that 1,240 (72.5%) of 1,711 manufacturing plants had fewer than 50 employees. The number of manufacturing plants with 50 or more and below 300 employees stood at 399 (23.3%), and 73 (4.2%) of all manufacturing plants had 300 or more employees. Table 23. The number of manufacturing plants by employee size (monthly average) Employee size The number of manufacturing plants Percent distribution % % Total 1,711 1, or below ,000 and over ) The amount of production by employee size (monthly average) is indicated in Table 24, which shows that the amount of production at manufacturing plants with employees fewer than 50, which make up 72.5% of all, only stood at billion yen (6.8%). In contrast, manufacturing plants with 50 or more and below 300 employees produce 2,692.4 billion yen (55.9%), and those with 300 or more employees produce 1,797.0 billion yen (37.3%). Table 24. production by employee size (monthly average) Employee size production Percent distribution Mil. yen Mil. yen % % Total 4,813,139 4,856, or below 27,198 24, , , , , ,215,320 2,206, ,078,917 1,176, , , and over 39,922 34,

26 (2) Composition by production size Table 25 indicates the number of manufacturing plants and the amount of production by production size of drugs. While the number of manufacturing plants whose internal production and/or contract the amount of production in a month stood below 100 million yen stood at 1,390 (81.2%), their amount of production was billion yen, which made up only 2.9% of total internal production and/or contract production. In contrast, the number of manufacturing plants whose amount of production reached or exceeded 100 million yen was only 321 (18.8%), but their amount of production reached 4,673.5 billion yen, which made up 97.1%. Table 25. The number of manufacturing plants and amount of production by production scale Monthly amount of production The number of manufacturing plants with production etc. production Monthly average Percent distribution Amount Percent distribution % % Mil. yen Mil. yen % % Total 1,711 1, ,813,139 4,856, Less than 1 million yen million - less than 5 million yen ,107 7, million - less than 10 million yen ,224 7, million - less than 50 million yen ,170 59, million - less than 100 million yen ,259 68, million - less than 500 million yen , , million - below 1 billion yen , , billion yen and over ,678,520 3,733, Status of import and export of drugs Statistics of import of drugs have been clarified based on reports from marketing authorization holder offices of drugs, and from manufacturing plants of drugs, with regards to import of final products and to domestic packing production from imported preparations. Statistics of export are also based on reports from marketing authorization holder offices of drugs, and from manufacturing plants of drugs, which signifies that trades by way of trading companies etc. are not identified. Research does not cover import and export of drugs other than final products (e.g. bulk, raw powder). Therefore, use of the following figures requires relevant precautions. 23

27 (1) Export As indicated in Table 26, export amount of drugs in 2013 stood at billion yen, down 79.0 billion yen (5.8%) from the previous year. Trends in export amount by geographic region are indicated in Table 27. The amount was the largest with Asia at 59.3 billion yen (45.7%), followed by North America (47.3 billion yen, 36.5%), and Europe (14.5 billion yen, 11.2%). Export amount by major country, and by major country and by sub therapeutic category of prescription drugs, is respectively indicated in Table 28 and Table 29. Total 26. Trends in the amount of exported drugs (Index 2009 = 100) Year export Change Year-on-year change Proportion Index Mil. yen Mil. yen % % , ,463-18, ,402-6, , ,686-7, Table 27. Trends in the amount of exported drugs by geographic region (Index 2009 = 100) Geographic region export Index export Index export Index export Index export Index Mil. yen % Mil. yen % Mil. yen % Mil. yen % Mil. yen % Total 162, , , , , Asia 50, , , , , Europe 14, , , , , North America 92, , , , , South America , , , , Africa Oceania Others 4, , , , , (EU Regrouped) 11, , , , ,