Japan ADHD (Attention Deficit Hyperactivity Disorder) Therapeutic Market Analysis

Japan Attention Deficit Hyperactivity Disorder (ADHD) Therapeutics Market Executive Analysis

The Japan Attention Deficit Hyperactivity Disorder (ADHD) therapeutics market size is at around $1.8 Bn in 2022 and is projected to reach $3.4 Bn in 2030, exhibiting a CAGR of 8% during the forecast period. For the fiscal year beginning in April of next year, budgetary requests from Japanese government agencies totaled $784 Bn, which is the second-highest amount ever. The initial general-account budget for fiscal 2023, which will be developed in accordance with the requests, is expected to be higher than the $790 Bn for the current fiscal year. The health ministry made the biggest budgetary request, asking for $240 Bn, as a result of skyrocketing medical costs and pension payments in a rapidly aging society.

Attention-deficit/hyperactivity disorder (ADHD) is a prevalent neuropsychiatric disorder characterized by inattention and/or excess. Symptoms of impulsivity and excessive behavior. The majority of ADHD symptoms are first noticed in childhood, but some, particularly inattention as opposed to hyperactivity and impulsivity, may persist into adulthood. According to a meta-analysis, the prevalence of ADHD in Japanese adults was found to be 1.65%, which is lower than the estimated 2.5% prevalence of ADHD in adults. This might suggest that a significant number of ADHD patients in Japan go undiagnosed and subsequently untreated. Adult ADHD had been less recognized in the field of psychiatry in Japan, but this has lately begun to change with the approval of medication used to treat this disorder.

By 2018, three medications—methylphenidate-osmotic-controlled release oral delivery system (OROS), atomoxetine, and guanfacine—had been authorized for use in Japan to treat adolescents with ADHD. According to previously published patterns in drug use for children with ADHD in Japan, since 2009, prescriptions for methylphenidate-OROS have accounted for about 30% of all prescriptions, while those for atomoxetine have been rising. The 2016 ADHD recommendations for Japan suggest methylphenidate-OROS or atomoxetine as the first-line treatments. Guanfacine is approved for use in 36 nations, including Japan, as of 2020. Since guanfacine was released on the market in 2017, after the guidelines were issued, it is uncertain how ADHD medications were prescribed to Japanese children after 2016. Because Methylphenidate (MPH) is a CNS stimulant with the potential for abuse, it is especially essential to understand the extent of its misuse, abuse, or off-label prescription. There are concerns regarding the safety and appropriate use of ADHD medications.

Market Dynamics

Market Growth Drivers

According to some figures, ADHD is becoming increasingly prevalent in Japan, especially among adults. The market for Japan ADHD therapeutics is anticipated to increase as a result of this trend.  The market is expected to expand as a result of technological developments, such as the advancement of telemedicine and digital therapeutics, which will likely make ADHD treatment more convenient and available to patients. The Japan ADHD therapeutics market is expanding as a result of the leading players' increased R&D efforts, as well as new product launches and drug approvals.

Market Restraints

Despite the rising prevalence of ADHD in Japan, the majority of cases go undiagnosed and, as a result, are neglected because a majority of individuals are still unaware of this neurological condition. In Japan, the cost of ADHD treatments and medications can be expensive, especially for those without health insurance. This might make treatment more expensive for some people, which would slow the expansion of the Japan ADHD therapeutics market.

Competitive Landscape

Key Players

• Nippon Shinyaku (JPN)
• Ohkura Pharmaceutical (JPN)
• Sasaki Chemical (JPN)
• Kogaku Laboratory (JPN)
• Kouken (JPN)
• Lupin
• Takeda Pharmaceutical
• Mallinckrodt
• Pfizer
• Purdue Pharma
• NEOS Therapeutics

Healthcare Policies and Regulatory Landscape

Applications for drugs and medical devices in Japan are examined by the Pharmaceutical and Medical Device Agency (PMDA), an independent agency. In order to evaluate the safety of new products, establish thorough rules, and keep track of post-market safety, the PMDA collaborates with Japan’s Ministry of Health, Labor, and Welfare (MHLW). The Pharmaceuticals and Medical Devices Act (PMD Act), also referred to as the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics, outlines the current PMDA rules in Japan. All facets of the Japanese medical product registration process, such as in-country representation, certification procedures, licensure, and quality assurance systems, are impacted by the PMD Act.  The Pharmaceutical Affairs Law (PAL) was superseded by the PMD Act on November 25, 2014. The PMDA performs re-evaluations of previously approved drugs and reviews new drugs, generic drugs, over-the-counter (OTC) drugs, "behind-the-counter" (BTC) drugs, and quasi-drugs. Based on their clinical importance, orphan drugs, and other priority medications receive priority reviews. The PMD Act greatly reduces the length of the phased clinical trial process for regenerative medical products, allowing for much quicker conditional authorization of their use.