AT A GLANCE
Rank: #20 (Last year: #21)
$5.41 Billion
Prior Fiscal: $5.53 Billion
Percentage Change: -2.2%
No. of Employees: 23,319
Global Headquarters: Shibuya-ku, Tokyo, Japan

KEY EXECUTIVES
Shinjiro Saito, President and CEO
Naoki Muto, Chief Accounting and Financial Officer
Shoji Hatano, President, General Hospital Company
Hikaru Samejina, President, Cardiac and Vascular Company
Antoinette Gawin, President, Blood Management Company; President and CEO, Terumo BCT Holding Corp.
Richard Cappetta, President and CEO, MicroVention Inc.
James Rushworth, President and CEO, Terumo Medical Corp.
Paul Holbrook, President and CEO, Vascutek Ltd.

Masayuki Okano, the 85-year old president of “painless” hypodermic needle maker Okano Kogyo, built his business over decades, honing his skills and forming countless relationships. And in about a year, it seems it will be over.

Okano had contemplated handing his Tokyo-based company to a younger member of his family, but reconsidered. He had always said he wanted to retire at 55 but carried on as new opportunities emerged. Okano Kogyo has its roots in 1924, traced back to a company his father had founded. The company got its start in the metal press business, forging parts like battery cases for cell phones out of sheet metal.

The company received its big break in 2000. An engineer from medical equipment manufacturer Terumo stopped by a pediatric clinic one day, the waiting room full of children with diabetes awaiting one of four painful daily insulin injections. The engineer felt for the children, who winced at each injection.

The question of how to painlessly administer insulin swam in his mind. The clear solution was to make the needle thinner. Easier said than done—the thinner the needle, the more difficult it is to inject the insulin. Terumo devised a method to make one side of the needle wider than the other to allow insulin flow, but the company wasn’t equipped to mass produce the needles. They needed a partner.

After being denied by about a hundred small factories, Terumo encountered Okano Kogyo and its six-man team. The company’s skill with mold and presses to make hypodermic needles with high precision caught Terumo’s eye, and today the companies churn out millions of painless needles. A patent co-owned with Terumo protects the product, but no competitor could copy its technology regardless, Okano Kogyo told Nikkei Asian Review last year.

The technology will endure—Okano intends to transfer his company’s secret recipe to Terumo. Several years ago, he recruited some Terumo employees and spent three to four years, bringing them up to speed. Though Okano will let his company die a natural death, Terumo will continue his legacy, easing the lives of those requiring multiple daily insulin injections.

Of course, needles are a small—albeit, important—part of Terumo’s portfolio. The Japanese medical device maker offers products spanning cardiac and vascular devices and equipment, general hospital products, and blood management technology. Terumo’s revenue differential is somewhat deceptive at first glance. The firm reported an almost 12-billion-yen sales expansion from the previous fiscal year, but once converted, foreign currency exchange fluctuation resulted in a 2.2 percent slip to reach the most recent fiscal year total of $5.41 billion.

The firm’s Cardiac and Vascular Company, which consists of interventional systems, neurovascular products, CV systems, and vascular graft offerings, made up the bulk of the company’s sales with 328.5 billion yen. Though this was a 1.4 percent bump, a Q&A session at the FY18 financial results briefing concerning the most recent fiscal year revealed Cardiac and Vascular revenue fell 12.5 billion yen lower than the expected guidance.

Shipping delays during last summer for products from its Ashitaka Factory, which makes certain cardiovascular products, proved to be responsible for the shortcoming. Terumo discovered there were issues in the procedure that optimizes the sterilization process, causing shipments of some products from that factory to be placed on hold last May. The firm resumed shipping last August but took a sales blow of about 11 billion yen. Terumo also cites that drug-eluting stent (DES) sales failed to grow as expected.

However, Terumo expanded its DES business by purchasing Beijing, China-based Essen Technology for 879 million Chinese yuan (about $129 million) upfront last July. Essen, a DES maker, offered Terumo an introduction into the Chinese coronary stent market, in which the company had not yet established a presence. The buy expanded the company’s DES sales coverage to over 40 countries and gave it an even stronger footprint in the rapidly growing Chinese market.

The Ultimaster Tansei DES obtained a CE mark last April and it launched in Europe in May. Ultimaster Tansei inherited the same stent, drug, polymer, and coating methods used for its predecessor Ultimaster DES, adding improvement to the tip and shaft to ease stent delivery in complex lesions with both radial and femoral access. The new stent touts a 54-size lineup ranging from 2.25 mm to 4 mm, and lengths from 9 mm to 38 mm. Terumo launched the Ultimaster Tansei DES in Japan last September.

The Kanshas drug-coated balloon catheter won a CE mark last June. Used to treat lower extremity peripheral arterial disease, Kanshas employs Terumo’s Unicoat uniform micro-crystal coating to ensure the coated drug is less likely to migrate before reaching the lesion. It then quickly transfers to vascular tissue when the balloon is expanded. Terumo introduced Kanshas in Europe last September, making it the first Japanese company to launch DCB sales there.

To streamline its Cardiac and Vascular business, Terumo merged its subsidiaries Vascutek and Bolton Medical into Terumo Aortic last April. Terumo Aortic is expected to accrue sales of almost $200 million and host over 1,100 employees worldwide. Its primary R&D and manufacturing facilities will remain in Glasgow, Scotland, (Vascutek) and Sunrise, Fla. (Bolton Medical). The combined business includes surgical grafts for abdominal, cardiothoracic, and peripheral applications as well as hybrid and catheter-based stent graft systems for abdominal and thoracic aortic aneurysms.

Last March, Terumo forked over $20 million for the XPro System, Taiwanese Medeon Biodesign’s large bore vascular closure system. The automated suture-mediated closure device simultaneously delivers two pairs of sutures during percutaneous large bore procedures. This includes TAVR, endovascular and thoracic endovascular aneurysm repair, and percutaneous balloon aortic valvuloplasty procedures. At the time of the acquisition, the XPro System was undergoing evaluation for CE mark certification in Europe.

The CDI Blood Parameter Monitoring System 550 was granted FDA clearance last November. During cardiopulmonary bypass surgery, continuous in-line monitoring is integral to perfusion safety. It quickly informs clinicians of changes in patient status and provides information on key parameters to help manage perfusion cases. The CDI System 550 measures or calculates the 12 critical blood parameters: pH, pCO2, pO2, K+, temperature, SO2, hematocrit, hemoglobin, base excess, bicarbonate, oxygen consumption, and oxygen delivery.

MicroVention, a U.S.-based Terumo subsidiary that specializes in catheter-based, minimally invasive neuroendovascular technologies, gained FDA approval for LVIS and LVIS Jr. last May. At the time, these were the first and only stents approved for stent-assisted intracranial aneurysm coil embolization. The conformable, resheathable, and retrievable stents provide high metal coverage and end-to-end visualization to ensure supports for the tiniest neurovascular embolization coils to treat wide-necked saccular intracranial aneurysms.

MicroVention’s SOFIA Catheter (Soft TOrqueable catheter For Intracranial Access) acquired an expanded indication last June. The new clinical indication included the contact aspiration technique to revascularize patients with acute ischemic stroke, secondary to intracranial large vessel occlusive disease.

The Terumo BCT (Blood Management) business, which manufactures blood component, therapeutic apheresis, and cellular technologies, accrued 105 billion yen last fiscal year, remaining mostly flat—with a very slight increase—from the year prior.

Terumo BCT president and CEO David Perez announced his retirement last August. He began his tenure with the company—then called COBE BCT—in 1999, guiding it through multiple ownership transitions. “Under his leadership, the company grew revenue almost sixfold, nearing $1 billion, and introduced multiple innovative products that have fundamentally changed and improved blood transfusion and cellular therapies,” Terumo Corp.  executives said in a statement at the time of Perez’s retirement announcement.

Former executive VP of global commercial Antoinette Gawin assumed Terumo BCT’s presidency last October and took the reins as CEO this past April. Gawin joined Terumo BCT in 2016, having migrated from global medical device manufacturer Baxter; she worked for 22 years at GE before that. “I am honored to be selected as David’s successor,” she said to the press at the time of Perez’s announcement. “I’m looking forward to working with David and other leaders over the coming months to ensure a smooth handover and continue to develop plans for 2019 and beyond.”

Terumo BCT’s Sodium Citrate 4% w/v Anticoagulant Solution USP obtained FDA approval last July. The solution anticoagulates whole blood during automated apheresis procedures. Sodium citrate, which blood centers and plasma collection organizations use during apheresis to gather plasma, had been on the official FDA shortage list for more than a year at the approval date. “We heard from numerous customers that the shortage of sodium citrate was starting to have an impact on patients,” Tim Costello, a VP at Terumo BCT, told the press. “This FDA approval will help alleviate the U.S. shortage and improve patient lives.”

The General Hospital division posted a 4.3 percent revenue gain, rising to 165.7 billion yen. This segment produces infusion pumps, syringe pumps, solution sets, syringes, IV solutions, pain management products, nutritious food, adhesion barriers, blood glucose monitoring systems, digital thermometers, and blood pressure monitors. It also houses a business responsible for contract manufacturing of prefilled syringes and devices to pharmaceutical companies for use in drug kits (prefillable syringes, needles for pharmaceutical packaging business).

Last December, a biosimilar that uses Terumo’s PLAJEX prefillable syringe launched in Europe. This was the first overseas commercial launch involving PLAJEX. Terumo makes Hulio (a biosimilar to Humira) on contract to Mylan N.V. It will be available as both a prefilled autoinjector suited for self-injection and a prefilled syringe focused on medical safety. Going forward, Terumo intends to use its material manufacturing technologies and prefillable syringe filling capabilities to augment its alliance businesses with pharmaceutical companies.